News & Analysis as of

Drug Pricing HRSA Public Health Service Act

Manatt, Phelps & Phillips, LLP

HRSA Threatens to Sanction J&J Absent Withdrawal of 340B Rebate Plan

On September 17, the Health Resources and Services Administration (HRSA), which administers the prescription drug discount program established under Section 340B of the federal Public Health Service Act, sent a letter to...more

Manatt, Phelps & Phillips, LLP

Johnson & Johnson Announces Rebate Model for Certain 340B Drugs; HRSA Pushes Back

On August 23, Johnson & Johnson (J&J) issued a written notice to disproportionate share hospitals that participate in the prescription drug discount program established under section 340B of the federal Public Health Service...more

King & Spalding

HHS Advisory Opinion Rejects Drug Manufacturers’ Attempts to Limit Contract Pharmacy Use by 340B Covered Entities

King & Spalding on

On December 30, 2020, the HHS Office of General Counsel (OGC) issued Advisory Opinion No. 20-06 finding the 340B Federal Drug Pricing Program requires drug manufacturers to extend 340B pricing to covered outpatient drugs...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

Manatt, Phelps & Phillips, LLP

President Trump Signs Drug Pricing Executive Orders: How Will They Impact Pharma and Providers?

Prescription drug pricing is emerging as one of several healthcare issues that may become a focus of the presidential race as well as contested congressional races this fall. With pending legislative attempts to control drug...more

Sheppard Mullin Richter & Hampton LLP

The 340B Drug Pricing Program: New CMS Final Rule Draws a Motion for Preliminary Injunction from Hospital Groups

On November 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the final rule, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting...more

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