News & Analysis as of

Proposed Rules Section 340B Prescription Drugs

McGuireWoods Consulting

Washington Healthcare Update - February 2024 #2

This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....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

Holland & Knight LLP

CMS Releases CY 2024 OPPS and ASC Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2024 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1786-P),...more

Bricker Graydon LLP

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

Bricker Graydon LLP on

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

Polsinelli

CMS Proposes $9B in Relief for 340B Hospitals

Polsinelli on

340B Covered Entities (CEs) are getting a glimpse into what they can expect to be repaid due the fallout from CMS’ unlawful 340B payment reduction that was struck down by the U.S. Supreme Court in June 2022.  CMS discussed a...more

McDermott Will & Emery

CMS Releases Proposed Remedy for 340B-Acquired Drugs Purchased in CYs 2018–2022

McDermott Will & Emery on

On July 7, 2023, the Centers for Medicare and Medicaid Services (CMS) released the proposed rule, Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased for Calendar Years 2018–2022, to...more

McDermott Will & Emery

Court Rules in Favor of Manufacturers in 340B Contract Pharmacy Case

Earlier today, the US Court of Appeals for the Third Circuit issued a much-anticipated decision in one of the 340B contract pharmacy cases. The decision is a win for drug manufacturers who have sought to restrict access to...more

Foley Hoag LLP

HRSA Proposes to Overhaul 340B Dispute Process

Foley Hoag LLP on

On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more

Holland & Knight LLP

CMS Releases CY 2023 Outpatient and ASC Payment System Proposed Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1772-P),...more

Bricker Graydon LLP

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

Bricker Graydon LLP on

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

McDermott Will & Emery

HRSA Issues Proposed Rule Requiring Community Health Center Grant Recipients to Provide Certain Drugs to Low-Income Patients at...

McDermott Will & Emery on

On September 24, 2020, the Health Resources and Services Administration (HRSA) released a proposed rule that, if finalized, would require 340B-participating recipients of federal grants under Section 330(e) of the Public...more

K&L Gates LLP

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

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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 Proposes Additional Cuts to Part B Reimbursement of 340B Drugs

On August 4th, the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) published the 2021 Hospital Outpatient Prospective Payment System (OPPS) proposed rule. The rule proposes to...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 2

K&L Gates LLP on

In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...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

ArentFox Schiff

2020 Proposal for Medicare Part B Drug Reimbursement: Business as Usual

ArentFox Schiff on

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed update to the hospital outpatient prospective payment system (Proposed Rule)....more

McGuireWoods Consulting

Washington Healthcare Update

This Week: Happy New Year! The 116th Congress begins and healthcare issues are part of the "buzz" of day one. Part of the government is still closed. ...more

Holland & Knight LLP

New Proposed Medicare Part B Drug Reimbursement Model Raises Questions

Holland & Knight LLP on

• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals. • The proposed structure, called the International Pricing Index (IPI)...more

Hogan Lovells

340B program: Proposed rule would accelerate the effective date of the CMP Final Rule from July 1, 2019, to January 1, 2019

Hogan Lovells on

This week, the Health Resources and Services Administration (HRSA) issued a Proposed Rule (Proposed Rule) to cease any further delay of the 340B Ceiling Price and Civil Monetary Penalties regulation (CMP Final Rule) and...more

McDermott Will & Emery

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

McDermott Will & Emery on

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

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