News & Analysis as of

Comment Period Centers for Medicare & Medicaid Services (CMS) Section 340B

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

Husch Blackwell LLP on

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

Goodwin

340B Rebate Pilot Program Proposed by HRSA

Goodwin on

On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more

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

McDermott Will & Schulte

CMS Sneaks 340B Billing Proposals into Medicare Physician Fee Schedule: What 340B Stakeholders Need to Know

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Medicare Physician Fee Schedule (MPFS) proposed rule, which includes proposals related to identification of Medicare Part B and Part D claims...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

McDermott Will & Schulte

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

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 & Schulte

Proposed Changes to DSH Payment Calculation Regulations Could Impact 340B Hospitals

On February 28, 2023, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would change how Medicare disproportionate share hospital (DSH) payments are calculated with respect to the counting of...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

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

Polsinelli

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

Polsinelli on

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

Baker Donelson on

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 & Schulte

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

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

Holland & Knight LLP

CMS Releases 2020 Hospital OPPS and ASC Payment System Proposed Rule

Holland & Knight LLP on

• The Centers for Medicare & Medicaid Services (CMS) has published the Calendar Year (CY) 2020 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule. •...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

K&L Gates LLP on

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

Polsinelli

CMS Takes Bold Action on Price Transparency & Physician Supervision in CY 2020 OPPS Proposed Rule

Polsinelli on

On July 29, 2019, the Centers for Medicare & Medicaid Services (“CMS”) released the CY 2020 Hospital Outpatient Prospective Payment Systems (“OPPS”) proposed rule [CMS-1717-P]. ...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

Polsinelli

340B In The Spotlight – Key Program Developments

Polsinelli on

In this issue, Polsinelli’s 340B and Reimbursement teams provide an update on the most recent developments in the ongoing 340B /Part B Payment litigation and also highlight recent Government Accountability Office (“GAO”)...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

K&L Gates LLP

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

K&L Gates LLP on

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

K&L Gates LLP on

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

Mintz - Health Care Viewpoints

July 2018: Where Are We Now With 340B?

It seems like every week, there are multiple new developments in the 340B program. While it has just been a few weeks since my last 340B blog post, since that time we have had another Senate hearing, a new GAO Report, a new...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

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