Category: Compliance
Resource Launch: 20 Key Considerations for Implementing an Effective Corporate Compliance Program
Cooley is excited to release a new resource for health care and life sciences companies: 20 Key Considerations for Implementing an Effective Corporate Compliance Program. This quick reference document provides an overview of key areas that a company should consider as it seeks to implement and improve its corporate compliance programs. […]
OIG Releases Advisory Opinion Regarding the Effect of Exclusion
On February 13, 2015, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) posted an advisory opinion regarding the effect of exclusion from Medicare, Medicaid and other federal health care programs. Pursuant to a criminal plea and a civil False Claims Act settlement to resolve allegations of health […]
HHS OIG Releases Annual Solicitation for New and Modified Anti-Kickback Safe Harbors and for New Special Fraud Alerts
On December 29, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released its annual solicitation (the “Solicitation”) for proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal Health Care Program Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) (the “AKS”), as well […]
No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information
Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human prescription drugs, including biological products (the “Proposed Rule”). Currently, although manufacturers often voluntarily make their product PIs available electronically, they are […]
HHS Issues Reports on HIPAA Breaches and HIPAA Compliance
Last week, the U.S. Department of Health and Human Services (“HHS”) released two reports to Congress, pursuant to its obligations under the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”): a report on Breaches of Unsecured Protected Health Information for 2011 – 2012 (the “Breach Report”) and a […]
Explosion of Big Data: What the Release of CMS Medicare and Sunshine Payment Data Means for Industry
The Centers for Medicare & Medicaid Services (CMS) released this month the 2012 Medicare payment data for individual physicians. CMS also recently wrapped up its Phase I collection of data related to payments and transfers of value from pharmaceutical, medical device and biotechnology manufacturers and group purchasing organizations to physicians […]
FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines
In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”). This revises the FDA’s 2009 draft guidance document on the subject, which was […]
