Category: Government Pricing

Final MDRP AMP Rule is Out! Will be Effective on April Fools Day 2016. (No joke.)

If you were looking for something fun to read while snow shuts down our nation’s capital tomorrow, the Centers for Medicare & Medicaid Services (CMS) just released the long-awaited Final Medicaid Drug Rebate Program Rule on Average Manufacture Price (AMP) (et al.)!  The publication of this Final AMP Rule follows the 2012 publication of […]

Joining the Debate, Hillary Clinton Releases Plan to Curb Drug Prices

In the wake of the uproar about drug pricing, Hillary Clinton unveiled on Tuesday, a plan to address the rising cost of prescription drugs. The plan will focus on ending “excessive” profits, lowering out-of-pocket costs, encouraging greater competition from generics and biologics and leveraging Medicare to negotiate drug prices. To […]

HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 27, 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the Federal Register (the “Proposed Rule”).  The 340B Drug Discount Program is the program by which drug and biologic […]

OIG Report Encourages States to Explore Alternate Methods for Calculating Medicaid Supplemental Rebates

On December 12, 2014, the U.S. Department of Health & Human Services Office of Inspector General (OIG) published a report titled: “States’ Collection of Offset and Supplemental Medicaid Rebates”  (OEI-03-12-00520).  This report was based on the findings of a 2013 OIG survey of all fifty states and the District of […]

HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015.  The Work Plan is a compilation of the OIG’s plans for new and ongoing reviews and activities (including audits, evaluations, and certain […]

PhRMA Challenges HRSA Interpretative Rule on Orphan Drugs in the 340B Drug Discount Program

On October 9, 2014, the Pharmaceutical Research & Manufacturers of America (“PhRMA”) filed a lawsuit seeking to enjoin the Health Resources Services Administration (“HRSA”) from implementing its July 23, 2014 “Interpretive Rule” regarding orphan drugs in the 340B Drug Discount Program (the “2014 Interpretive Rule”).  PhRMA’s lawsuit alleges that the 2014 […]

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 […]