Category: Government Pricing

HRSA Stands By Its Interpretation of 340B Drug Discount Program Orphan Drug Availability, Despite Court Decision Vacating Regulation

The U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published today a statement responding to the recent court decision vacating the 340B Drug Discount Program Orphan Drug Rule.  As we previously reported, the D.C. District Court permanently enjoined HRSA from implementing its July 23, 2013 […]

340B Drug Discount Program Orphan Drug Rule Vacated:  ACA “New” Covered Entity Types No Longer Authorized to Purchase Orphan Drugs Under the 340B Program, Regardless of Indications

[UPDATE 6/18/2014: HRSA has issued a statement that it continues to stand by its interpretation of ACA permitting new covered entities to purchase orphan drugs under the 340B program for non-orphan use. See our more recent post for updated information.] The D.C. District Court permanently enjoined the U.S. Department of Health & Human […]

Important Dates for Coding and Reimbursement Announced: CMS Schedules Public HCPCS Meetings for Drugs, Biologics, DME and Various Other Products

In today’s Federal Register, the Centers for Medicare & Medicaid Services (“CMS”) announced the dates, time and location of the Healthcare Common Procedure Coding System (“HCPCS”) public meetings for calendar year 2014.  CMS hosts these meetings to discuss the preliminary coding and payment determinations for all new public requests for […]

CMS Posts Final National Average Drug Acquisition Cost Files – Possible Pharmacy Reimbursement Adjustments to Follow

As you head out for the holiday, you may want to stop by the Centers for Medicare & Medicaid Services (“CMS”) website to check out CMS’s latest gift – the posting of the final National Average Drug Acquisition Cost (“NADAC”) Files.  Along with the final NADAC files posted today (November […]

PhRMA Sues to Enjoin HRSA Implementation of Controversial 340B Program Orphan Drug Rule

On September 27, 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA), a major drug industry trade organization filed suit in the U.S. District Court for the District of Columbia to enjoin the Health Resources and Services Administration (HRSA) from implementing its July 23, 2013 final rule on “exclusion of Orphan […]

HRSA Finalizes 340B Drug Discount Program Orphan Drug Rule – 340B Discounts Available to New Covered Entities for Non-Orphan Indications

On June 22, 2013, the Health Resources and Services Administration (“HRSA”) released its final rule on the exclusion of orphan drugs for certain covered entities under the 340B Drug Discount Program.  The advance copy is currently available for viewing at the Office of the Federal Register Public Inspection Desk, and […]