News & Analysis as of

Reimbursements Medicare Drug Pricing

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

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

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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

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

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

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

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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

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

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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

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

King & Spalding

Supreme Court Overturns Medicare Outpatient Drug Rate Cut for 340B Hospitals

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On June 15, 2022, the Supreme Court issued a unanimous ruling in American Hospital Assn. v. Becerra declaring that CMS’s 2018 and 2019 reimbursement outpatient drug rate cut to 340B hospitals was “contrary to the statute and...more

Quarles & Brady LLP

Supreme Court Decision Maintains Status Quo for Disproportionate Share Percentage Calculation: What Does It Mean for the 340B...

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Last week, the Supreme Court released a decision relating to how the Department of Health and Human Services (HHS) requires hospitals to calculate its disproportionate share percentage. While this percentage is primarily used...more

Foley & Lardner LLP

340B Hospitals Win in Medicare OPPS Supreme Court Decision

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The Supreme Court issued a long-awaited victory to 340B hospitals this week, when it held in American Hospital Association et al. v. Becerra et al. that the Department of Health and Human Services (HHS) had set unlawful...more

Bricker Graydon LLP

Supreme Court unanimously sides with American Hospital Association, 340B hospitals over outpatient drug reimbursement rates; 340B...

Bricker Graydon LLP on

On Friday, June 24th, the Supreme Court unanimously agreed with the American Hospital Association (AHA) and 340B hospitals regarding their challenge to outpatient prescription drug reimbursement methodologies issued by the...more

McDermott Will & Emery

Recent Litigation Shines Spotlight on Hospital and Physician Group Transactions

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The US Department of Justice recently intervened in an qui tam alleging false and fraudulent claims involving the acquisition of physician practice locations by a health system and subsequent management of the health system’s...more

K&L Gates LLP

CMS Proposes to Rescind Most Favored Nation Drug Pricing Rule

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The Centers for Medicare & Medicaid Services (CMS) published a proposed rule (Proposed Rule) on 10 August 2021 that rescinds the Most Favored Nation (MFN) Model interim final rule, which was issued on 27 November 2020 (the...more

Polsinelli

Medicare 340B Payment Cut Déjà vu – Biden Administration Continues Trump Administration Part B Payment Reductions

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On Monday, July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule). While the Proposed Rule...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - July 2021

Latham & Watkins LLP on

Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more

K&L Gates LLP

Hospitals Ask Supreme Court to Reverse Site-Neutral, 340B Payment Rulings

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How far can an agency go to allow agency-developed policy objectives to supersede concerns about faithful adherence to the law? Similarly, how much should health systems and others regulated by Medicare be concerned about...more

Sheppard Mullin Richter & Hampton LLP

Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more

Baker Donelson

Medicare Issues Interim Final Rule to Lower Payments to Hospitals and Physicians for Certain Drugs Starting January 1, 2021

Baker Donelson on

On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period (IFC) to implement a payment model that will significantly reduce Medicare reimbursement rates for...more

McDermott Will & Emery

CMS Proposes Further OPPS Reductions to 340B Drug Reimbursement Rates

McDermott Will & Emery on

On August 4, 2020, the Centers for Medicare & Medicaid Services (CMS) released its CY 2021 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule. CMS proposes to reduce OPPS payments for 340B drugs from...more

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