News & Analysis as of

Medicare Section 340B Comment Period

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

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The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...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

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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

McDermott Will & Emery

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

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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

Goodwin

CMS Issues Proposed Guidance on Inflation Rebates Under Medicare Part B

Goodwin on

On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance addressing the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how...more

Holland & Knight LLP

CMS Releases CY 2023 Outpatient and ASC Payment System Proposed Rule

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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

Polsinelli

SCOTUS 340B Decision Drives CMS to Restore Part B 340B Payments and Seek Comments on Remedies in the CY 2023 OPPS Proposed Rule

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On Friday, July 15th, CMS published its CY 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule) and gave 340B covered entities a glimpse into how the agency intends to react to...more

Baker Donelson

Medicare Proposes Deeper Drug Payment Cuts to 340B Hospitals

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On August 4, 2020, CMS issued a proposed rule to further reduce outpatient drug payment rates under Medicare to certain hospitals participating in the 340B drug pricing program. As part of the 2021 OPPS Proposed Rule, CMS...more

McDermott Will & Emery

CMS Advances 340B Drug Acquisition Cost Survey to OMB and Solicits Final Comments Directly to OMB

McDermott Will & Emery on

On February 7, 2020, the Centers for Medicare and Medicaid Service (CMS) published a notice signaling that it has submitted its previously published September 2019 proposed survey of hospital 340B drug costs for Office of...more

King & Spalding

CMS Publishes Proposed Rule for CY 2020 Hospital Outpatient Prospective Payment System, Includes Major Proposals on Price...

King & Spalding on

On July 29, 2019, CMS published a proposed rule revising the factors for determining Medicare payment rates under the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgery Center (ASC) Payment...more

K&L Gates LLP

340B Update: CMS Addresses Ongoing Litigation and Reimbursement Changes for 340B Drugs in CY 2020 OPPS Proposed Rule

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On July 29, 2019, the Centers for Medicare & Medicaid Services (“CMS”) released its annual proposed rule announcing potential changes to the Medicare Outpatient Prospective Payment System (“OPPS”) for upcoming Calendar Year...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

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• 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

K&L Gates LLP

CMS Solicits Comments On Part B Drug Reimbursement Changes Following On President’s Drug Pricing Blueprint

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On July 31, 2018, the Centers for Medicare & Medicaid Services (“CMS”) took a significant step forward in advancing the administration’s “American Patients First” Drug Pricing Blueprint (“Blueprint”), introducing new policy...more

Baker Donelson

Administration Drug Pricing Proposals Could Reduce Provider Payments

Baker Donelson on

As the Trump Administration moves forward with proposed policy changes to address high drug prices, a common theme is emerging: a number of the proposals have the potential to reduce Medicare reimbursement to hospitals and...more

K&L Gates LLP

CMS Issues Proposed Medicare PFS Rule for CY 2019

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On July 27, 2018, the Medicare Physician Fee Schedule (PFS) Proposed Rule for Calendar Year (CY) 2019 (PFS Proposed Rule) was published in the Federal Register....more

Polsinelli

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

Polsinelli on

In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

Foley & Lardner LLP

“Site Neutrality” for Off-Campus Outpatient Departments: Proposed Rule is Worse than You Expected!

Foley & Lardner LLP on

CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will be published in the Federal Register on July 14, 2016. One highly-anticipated...more

McDermott Will & Emery

CMS Proposed Rule Implements Limitations on Medicare Payments for Off-Campus Outpatient Hospital Departments

McDermott Will & Emery on

In Depth - Background - On July 6, 2016, the Centers for Medicare & Medicaid Services (CMS) released the CY 2017 Outpatient Prospective Payment System (OPPS) Proposed Rule, which includes proposed regulations to...more

Mintz - Health Care Viewpoints

The Proposed 340B Guidance:  Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

King & Spalding

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

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On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

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Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

McDermott Will & Emery

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

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The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

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