All posts by Sarah K. diFrancesca

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 […]

Comments to Draft Chicago Pharmaceutical Sales Representative License Rules Due April 2, 2017

As previously discussed, pharmaceutical sales representatives that conduct business in the City of Chicago will need to be licensed as of July 1, 2017. The Commissioner of the Chicago Department of Public Health (CDPH) and the Commissioner of the Chicago Department of Business Affairs and Consumer Protection (BACP) recently released […]

FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, […]

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 […]

OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), was released last week. The Proposed […]

FDA Issues Discussion Paper on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop held in 2015 regarding the oversight of LDTs. The Discussion Paper does not represent final […]

Pharmaceutical Reps Now Required to be Licensed in the City of Chicago; Includes Code of Ethics & Potential Transparency Reporting

Earlier this week, the Chicago City Council joined other government agencies in imposing licensure and marketing requirements on pharmaceutical representatives when it unanimously approved licensing requirements for pharmaceutical representatives in the City of Chicago. Individuals who conduct business in the City of Chicago as a pharmaceutical representative for 15 or more days […]