Category: Regulatory

HHS Touts 340B Rebate Pilot Proposal to Appeals Court, Hospitals File Amicus Brief Urging Court to Reject Rebates

August 7, 2025 Shannon Young, Associate Editor/Senior Writer Views

HHS highlighted its proposed 340B rebate pilot in an Aug. 1 brief filed with the U.S. Court of Appeals for the District of Columbia Circuit.

The U.S. Department of Health and Human Services (HHS) touted the agency’s recently announced plan to pilot a 340B rebate [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Trump Calls on Drugmakers to Implement ‘Most Favored Nation’ Pricing, Resurrects Idea to Extend MFN to all Medicaid Patients

August 7, 2025 Shannon Young, Associate Editor/Senior Writer Views

President Donald Trump sent a July 31 letter to 17 major drugmakers to begin implementing his proposed “most-favored nation” model for prescription drugs.

President Donald Trump is urging more than a dozen leading pharmaceutical manufacturers to begin implementing his proposed “most-favored nation” (MFN) [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

340B Providers, Drug Industry Raise Concerns Over HRSA’s 340B Rebate Model Pilot Proposal

July 31, 2025 Shannon Young, Associate Editor/Senior Writer Views

340B provider groups and drugmakers raised concerns Thursday over HRSA's proposed 340B rebate guidance.

340B covered entities and drugmakers offered competing criticisms Thursday of the Health Resources and Services Administration’s (HRSA) newly released 340B [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

HRSA Proposes 340B Rebate Model Pilot for Narrow Set of Drugs Under Strict Conditions

July 31, 2025 William Newton, Associate Editor/Senior Writer Views

The Health Resources and Services Administration published its highly-anticipated proposed 340B rebate guidance this morning, proposing a narrowly-scoped pilot program.

The Health Resources and Services Administration unveiled its highly anticipated proposed 340B rebate guidance on the morning of July 31.

The Health Resources and Services Administration (HRSA) today unveiled its highly anticipated 340B rebate guidance, proposing a pilot program that [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Who Are the Federal Judges Deciding the High-Stakes Drugmaker 340B Rebate Appeals?

July 31, 2025 William Newton, Associate Editor/Senior Writer Views

Circuit Judges Neomi Rao, Patricia Millett and Cornelia Pillard are scheduled to hear oral arguments in Washington, D.C. this September on a five drug companies' 340B rebate appeal.

Three federal appeals judges—who have all ruled on 340B matters in the past—will hear oral arguments in September in a [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

340B Health Survey: Most Hospitals Would Struggle to Stay Open, Maintain Care Levels Under 340B Rebate Model

July 31, 2025 Shannon Young, Associate Editor/Senior Writer Views

340B Health surveyed hundreds of its member hospitals on the likely effects of drugmakers' proposed 340B rebate models.

A majority of 340B hospitals surveyed said the costs associated with implementing drugmakers’ proposed rebate models would hinder their ability [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

OPA Director Touches on 340B Rebate Litigation and Other Key Matters at 340B Coalition Conference

July 22, 2025 Shannon Young, Associate Editor/Senior Writer Views

Office of Pharmacy Affairs (OPA) Director Chantelle Britton addresses 340B stakeholders during remarks to open the 340B Coalition’s annual summer conference in National Harbor, Md. on Monday.

A key federal regulator highlighted the Health Resources and Services Administration’s (HRSA) legal fight against proposed drugmaker 340B rebate models [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Lilly, Indivior, Kedrion to Refund 340B Covered Entities for Overcharges, Others Announce NDC Changes

July 22, 2025 Shannon Young, Associate Editor/Senior Writer Views

Three drugmakers recently announced refunds to 340B covered entities, while two others announced NDC changes.

Three drugmakers are offering refunds to 340B covered entities that purchased certain drugs between 2022 and 2025 following recalculations of [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

For the First Time, CMS Proposes Claims-Based Methods to Identify 340B Drugs Billed to Medicare Part D

July 17, 2025 William Newton, Associate Editor/Senior Writer Views

CMS recently proposed two policies for identifying 340B claims billed to Medicare Part D.

In a first for the agency, the Centers for Medicare and Medicaid Services (CMS) is proposing to track 340B drugs [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

CMS Proposes Accelerated OPPS Cuts to Offset 340B Remedy Payments and Medicare Drug Survey That Could Lead to Significant Part B Cuts

July 16, 2025 Shannon Young, Associate Editor/Senior Writer Views

CMS has issued a draft 2026 Hospital Outpatient Prospective Payment System (OPPS) rule, which proposes accelerated cuts to offset 340B remedy payments. The agency also proposed a controversial Medicare drug survey.

The Trump administration this week proposed accelerating hospital outpatient payment cuts to offset previous 340B hospital lump sum repayments and [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Category: Regulatory

HHS Touts 340B Rebate Pilot Proposal to Appeals Court, Hospitals File Amicus Brief Urging Court to Reject Rebates

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Trump Calls on Drugmakers to Implement ‘Most Favored Nation’ Pricing, Resurrects Idea to Extend MFN to all Medicaid Patients

Please Login or Become a Paid Subscriber to View this Content

If you are already a

News Alert

340B Providers, Drug Industry Raise Concerns Over HRSA’s 340B Rebate Model Pilot Proposal

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Breaking News

HRSA Proposes 340B Rebate Model Pilot for Narrow Set of Drugs Under Strict Conditions

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Who Are the Federal Judges Deciding the High-Stakes Drugmaker 340B Rebate Appeals?

Please Login or Become a Paid Subscriber to View this Content

If you are already a

340B Health Survey: Most Hospitals Would Struggle to Stay Open, Maintain Care Levels Under 340B Rebate Model

Please Login or Become a Paid Subscriber to View this Content

If you are already a

OPA Director Touches on 340B Rebate Litigation and Other Key Matters at 340B Coalition Conference

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Lilly, Indivior, Kedrion to Refund 340B Covered Entities for Overcharges, Others Announce NDC Changes

Please Login or Become a Paid Subscriber to View this Content

If you are already a

For the First Time, CMS Proposes Claims-Based Methods to Identify 340B Drugs Billed to Medicare Part D

Please Login or Become a Paid Subscriber to View this Content

If you are already a

News Alert

CMS Proposes Accelerated OPPS Cuts to Offset 340B Remedy Payments and Medicare Drug Survey That Could Lead to Significant Part B Cuts

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

News Alert

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Breaking News

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

News Alert

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Staff Email

Site Footer Live