Category: 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 […]

Off-Label Use Gets Congressional Hearing

Tomorrow, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug Administration (FDA) can provide clarity for drug and device companies regarding dissemination of truthful and non-misleading data […]

OIG and HCCA Release Compliance Program Effectiveness Resource Guide

On March 27, 2017, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Health Care Compliance Association (HCCA) released Measuring Compliance Program Effectiveness: A Resource Guide (Guide). The Guide is the joint work product of a group of 40 compliance professionals and OIG staff […]

Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures […]