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Proposed Rules Centers for Medicare & Medicaid Services (CMS) Covered Entities

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

BakerHostetler

HHS Proposes Rule Strengthening Section 1557 Protections Against Nondiscrimination in Health Activities

BakerHostetler on

​​​​​​​On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the...more

K&L Gates LLP

340B Update: Appellate Court Upholds 340B Payment Reduction as CMS Proposes Further Reductions for 2021

K&L Gates LLP on

In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B...more

Mintz - Health Care Viewpoints

CMS Takes Another Swing at 340B Reimbursement Cuts. Will It Be Strike Three?

The proposed 2020 Outpatient Prospective Payment (OPPS) rule was published on August 9, 2019. Buried in the 819 pages of proposed changes and justifications, CMS took another swing at cutting Medicare Part B reimbursement...more

Polsinelli

CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

Polsinelli on

This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more

Foley & Lardner LLP

Proposed Rule Would Slash Medicare Payment for 340B Drugs

Foley & Lardner LLP on

The Centers for Medicare and Medicaid Services (CMS) has proposed reducing the Medicare payment rate to hospitals for most separately payable drugs purchased under the 340B program from average sales price (ASP) plus six...more

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