| November 6, 2015
On October 30, 2015, the Senate passed and the President signed H.R. 1314, the Bipartisan Budget Act of 2015. Section 602 of the bill amends the Medicaid Drug Rebate Program (MDRP) to impose a price increase penalty on generic drugs. Until now, the price increase penalty only applied to...
| November 9, 2015
The objective of the International Committee for Harmonization (ICH)’s Guideline for Good Clinical Practice (GCP) “is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions should be...
| November 5, 2015
Keeping up with the alerts supplied through the Centers for Medicare & Medicaid Services (CMS) for Open Payments transparency reporting has been a complicated business over the past two years. For some manufacturers, settling into a routine of data capture and cleansing, as well as formatting and reporting, has...
| November 4, 2015
This post belongs to a series of blog articles on OIG’s Seven Elements of an Effective Compliance Program. Click here for more information on this series. Responding to a compliance concern After a concern is reported, how a company handles that report will define its perception as either a company...
and Mel Noel
| November 3, 2015
The VHA Pharmacy Benefits Management Services’ (PBM) annual Public Law 102-585 reporting guidance letter, emailed to manufacturers on October 15, 2015, contains no significant changes from last year in its substantive guidance for meeting reporting obligations imposed by VA’s Master Agreement. However, the letter does include one fact that...
| November 2, 2015
On October 14, 2015, a statement indicating summary judgement was issued by the United States District Court for the District of Columbia related to Pharmaceutical Research and Manufacturers of America’s (PhRMA) challenge to the Health Resources and Services Administration’s (HRSA) interpretive guidance, Interpretative Rule: Implementation of the Exclusion of...
| October 28, 2015
This post belongs to a series of blog articles on OIG’s Seven Elements of an Effective Compliance Program. Click here for more information on this series. Element 6 combines two activities: Communicating the disciplinary guidelines Enforcing the guidelines Element 6 is dependent on the performance of training activities (Element 3),...
| October 21, 2015
This post belongs to a series of blog articles on OIG’s Seven Elements of an Effective Compliance Program. Click here for more information on this series. Evaluate compliance program effectiveness One factor for compliance program success is a company’s ability to effectively audit and monitor business activities in comparison to...
| October 14, 2015
Effective communication between the compliance officer and employees is an important part of compliance program design and maintenance. Employees should have a variety of mechanisms through which they can report, anonymously if they wish, suspected or actual misconduct.
| October 7, 2015
The OIG states in their Compliance Program Guidance: “The proper education and training of officers, directors, employees, contractors, and agents, and periodic retraining of personnel at all levels, are critical elements of an effective compliance program.”