Category: Corporate Compliance

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 […]

OIG Releases FY2016 Work Plan: Areas to be Reviewed Include SNFs, Drug Pricing, HIPAA

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released this week its FY2016 Work Plan (Work Plan). The OIG Work Plan summarizes new and ongoing OIG reviews of various HHS programs and activities, which are selected based on a number of factors such as mandatory OIG review […]

Court Holds Corporate Integrity Agreement May Be Basis for Reverse False Claim Liability

This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon, Inc. The motion to dismiss relates to claims made by the whistleblowers under 31 U.S.C.§ […]