Category: Corporate Compliance
California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products
The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B. 17 would impose new reporting requirements on pharmaceutical manufacturers related to certain price increases of some already marketed drugs and the introduction of new drugs onto the […]
OIG Releases September Work Plan Items; Includes Part D Sponsor Reporting of Rebates and Price Concessions to Medicare
As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The September updates include 9 new Work Plan items: Federal Marketplace Enrollment Systems. OIG will assess operational readiness, internal controls, and IT security in preparation for the fifth open enrollment period. […]
OIG Releases August Work Plan Items
As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The August updates released this week include 4 new Work Plan items: Review of Patient Safety Organization Program, including implementation of the program among hospitals and oversight by Agency for Healthcare Research […]
OIG Work Plan Will Now Be Updated Monthly; 14 New Items Added for July
The Office of Inspector General (OIG) for Health and Human Services (HHS) recently announced that it will begin updating its Work Plan initiatives monthly rather than its previous twice-yearly publications, which was most recently released in November 2016. The OIG Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken […]
Enforcement Trend: Patient Assistance Programs
Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance programs. Patient assistance programs also have been the subject of recent Congressional inquiries related generally to the increasing price of certain […]
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 […]
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 […]
