News & Analysis as of

Comment Period Rebates

Sheppard Mullin Richter & Hampton LLP

HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more

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

Holland & Knight LLP

CMS Releases CY 2025 Medicare Physician Fee Schedule Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Revisions to Payment Policies Under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B (CMS-1807-P) Proposed...more

Epstein Becker & Green

Comments to CMS Guidance on the Medicare Prescription Drug Inflation Rebate Program Due March 11, 2023

On February 9, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued a fact sheet and its initial guidance documents addressing the Medicare Prescription Drug Inflation Rebate Program for Medicare Parts B and D...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

Carlton Fields

Is It Time to Come Out and Play? New Rules Proposed on What Constitutes Rebating

Carlton Fields on

While everyone was working from home, the NAIC's Innovation and Technology (EX) Task Force (Innovation TF) was busy creating proposed new game rules on rebating. ...more

Steptoe & Johnson PLLC

West Virginia Coal Severance Tax Legislation

On March 27, 2019, Governor Justice signed two bills that impact the coal severance tax in West Virginia: 1) HB 3142, which reduces the rate of severance tax imposed on steam or thermal coal and 2) HB 3144, which creates a...more

Verrill

OIG Proposes Revisions to Anti-Kickback Safe Harbor Regulations Affecting Prescription Drug Rebates

Verrill on

Recently, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) in the Federal Register to amend the federal anti-kickback statute safe harbor...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

Hogan Lovells

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

Hogan Lovells on

In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more

Robinson+Cole Health Law Diagnosis

HHS Proposes to Amend AKS Safe Harbors to Exclude PBM Rebates and Incentivize Consumer Drug Discounts

On February 6, 2019, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a proposed rule (Proposed Rule) that would amend the safe harbor regulations under the Federal Anti-Kickback...more

Epstein Becker & Green

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

Dorsey & Whitney LLP

Drug Rebates Threatened Under Proposed Anti-kickback Rule

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The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical...more

Bass, Berry & Sims PLC

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

Holland & Knight LLP

Administration Proposes Changes to the Drug Rebate Program

Holland & Knight LLP on

On Jan. 31, 2019, the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) issued a long-awaited proposed rule that would, if finalized, remove the existing legal "safe harbor" that protects...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

Foley Hoag LLP

Medicaid Program: Covered Outpatient Drugs, Final Rule with Comment Period Summary

Foley Hoag LLP on

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing the prescription drug rebate provisions enacted as part of the health care reform law, the Affordable Care Act...more

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