Category: Government Pricing

OIG Report on Reasonable Assumptions in Manufacturer Reporting

Last week the Department of Health and Human Services Office of Inspector General (OIG) published a report titled “Reasonable Assumptions in Manufacturer Reporting of AMP and Best Prices” (Report) that reviewed the use of assumptions made by a sample of drug manufacturers participating in the Medicaid Drug Rebate Program (MDRP) […]

White House Withdraws Rebate Rule

Earlier this morning, the White House announced that they were scrapping a proposed rule (the rebate rule) that, among other items, would have [would eliminate the current safe harbor protection under the Anti-Kickback Statute for pharmaceutical manufacturer rebates to Medicare Part D plans, Medicaid MCOs and the PBMs with which […]

HHS Proposed Rule Would Remove Safe Harbor Protection for Certain Discounts

On January 31, 2019, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule designed to combat rising drug costs (“Proposed Rule”). The Proposed Rule seeks to eliminate rebates paid by pharmaceutical manufacturers to plan sponsors or their pharmacy benefit managers (“PBMs”) […]

Drug Price Transparency Bill Enacted in Oregon

The Governor of Oregon signed into law this week House Bill 4005, the Prescription Drug Price Transparency Act (Act). The Act requires manufacturers to report by March 31st each year information regarding each prescription drug for which: (i) the price was $100 or more for a one-month supply or for a course of treatment […]

California Governor Signs Drug Price Reporting Bill

California Governor Jerry Brown signed S.B. 17 into law on Monday. As we reported when S.B. 17 was sent for Governor Brown’s signature, the law requires manufacturers of prescription drugs with a wholesale acquisition cost (WAC) of more than $40 to give 60 days’ notice of any increase in WAC […]

Medicare Part B Demo Declared Dead

On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model  (Part B Demo).  The Part B Demo had come under heavy fire from industry groups, some patient organizations, providers and a bipartisan collection of policymakers in […]

Final Medicaid Drug Rebate Program AMP Rule: Some Technical Highlights

We reported yesterday that the Centers for Medicare & Medicaid Services (CMS) Final Average Manufacturer Price (AMP) Rule (the “Final Rule”) was released and will be published in the Federal Register on February 1.  If you are still reading, despite the fact that we included “Technical Highlights” in today’s title, we […]