News & Analysis as of

Department of Health and Human Services (HHS) Outpatient Prospective Payment System (OPPS) Prescription Drugs

Holland & Knight LLP

Holland & Knight Health Dose: July 22, 2025

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With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more

Holland & Knight LLP

CMS Releases CY 2025 OPPS and ASC Final Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule with comment...more

McDermott+

Breaking Down Federal Policies to Address Drug Shortages

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In the wake of persistent drug shortages that compromise patient care and safety, the Biden administration and Congress have proposed policies to strengthen the pharmaceutical supply chain. Using authorities under both...more

McDermott Will & Schulte

This Week in 340B: February 14 – 20, 2024

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

Dinsmore & Shohl LLP

$9 Billion+ to be Repaid to 340B Hospitals- Is your Hospital Eligible?

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In June of 2022, the Supreme Court of the United States unanimously held in American Hospital Association v. Becerra that the United States Department of Health and Human Services (“HHS”) and the Centers for Medicare and...more

Holland & Knight LLP

CMS Issues Final Rule Remedying Underpayments to 340B Covered Entities

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The Centers for Medicare & Medicaid Services (CMS) released a final rule on Nov. 2, 2023, detailing how the agency will remedy underpayments from 2018 to 2022 for drugs acquired via the 340B Drug Pricing Program. The final...more

McDermott+

McDermottPlus Check-Up: November 10, 2023

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CONGRESS - Senate Finance Committee Holds Markup on Better Mental Health Care, Lower-Cost Drugs, and Extenders Act. The bipartisan package includes Medicare and Medicaid extenders, provisions to expand the mental health...more

Foley & Lardner LLP

CMS Proposes Remedy for 340B-Acquired Drug Payment Policy for CY 2018-2022

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Along with its calendar year (CY) 2024 Medicare Outpatient Prospective Payment System (OPPS) proposed rule, the Centers for Medicare & Medicaid Services (CMS) have also published the long-awaited proposal to remediate the...more

Bricker Graydon LLP

340B Update: Proposed Rule on Drug Acquisition Cost Cuts Suggests Lump Sum Repayment

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The Department of Health and Human Services has published a proposed rule to address short payments on drug acquisition costs for 340B hospitals from 2018 to September 2022. On June 15, 2022, the Supreme Court unanimously...more

Holland & Knight LLP

CMS Proposes Returning $9 Billion to More Than 1,600 Hospitals

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The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - November 2022

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Inflation Reduction Act and Health Reform: The Centers for Medicare & Medicaid Services (CMS) is continuing its efforts to staff the new Medicare Drug Rebate and Negotiations group and has posted various related job openings....more

Foley Hoag LLP - Medicaid and the Law

HHS Ordered to Correct Medicare Payments to 340B Hospitals for Remainder of 2022

We have noted before the link between the Medicaid prescription drug rebate program and the 340B program. As we wrote in an earlier Client Alert, in June 2022, the U.S. Supreme Court struck down HHS’s Medicare payment cuts to...more

Robinson+Cole Health Law Diagnosis

340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court Win

We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary...more

Quarles & Brady LLP

UPDATE: U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling

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On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more

Verrill

Hospitals Win 340B Medicare Rate Cut Suit, But When, How, and How Much They Will Recoup Remains Unclear

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In a recent unanimous decision, the Supreme Court found that the Centers for Medicare and Medicaid Services (“CMS”), part of the federal Department of Health and Human Services (“HHS”), erred when it significantly reduced...more

Bricker Graydon LLP

2022 Medicare OPPS/ASC Proposed Rule includes updated reimbursement rates, new policies, and reversals of recent policy changes

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On July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2022 Hospital Outpatient Prospective System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (Proposed Rule). In...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

Bricker Graydon LLP

Supreme Court makes certiorari determinations on two Medicare-related cases

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A number of health care related cases have come before the United States Supreme Court this session, including two cases on topics we have previously reported on: Medicare’s site-neutral payment policy for off-campus...more

ArentFox Schiff

Supreme Court To Hear Case Impacting Medicare Reimbursement for 340B Drugs

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The United States Supreme Court has agreed to hear a case that has a direct impact on the 340B Drug Discount Program (the 340B Program) and how Medicare will reimburse hospitals for dispensing of 340B covered drugs, as well...more

McDermott Will & Schulte

July Surprise - Supreme Court Agrees to Review Medicare Payment Cuts to 340B Drugs

The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...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

Verrill

340B Providers Get Partial Relief from New Dispute Resolution Regulation

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1. 340B ADR Process Established - At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical...more

Bricker Graydon LLP

Court of appeals rules that HHS has the authority to cut 340B hospitals’ Medicare payments for outpatient drugs by 28.5 percent

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On July 31, 2020, the Court of Appeals for the District of Columbia Circuit dealt another loss to hospitals with its decision reversing the District of Columbia District Court’s prior decision and reinstating the Department...more

McGuireWoods Consulting

Washington Healthcare Update - January 2020 #1

Wednesday, Jan. 8, 2020 - House Committee on Energy and Commerce: “Legislation to Improve Americans’ Health Care Coverage and Outcomes” - The Subcommittee on Health of the Committee on Energy and Commerce will hold a...more

McGuireWoods Consulting

Washington Healthcare Update - December 2019 #2

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This Week in Washington: The House and Senate will leave for the holidays by Dec. 20....more

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