Category: Compliance

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 […]

HHS Attorney Advises to Expect More Aggressive HIPAA Enforcement

Jerome Meites, a chief regional civil rights counsel for the U.S. Department of Health and Human Services (“HHS”), provided important insight into upcoming HIPAA enforcement at the recent American Bar Association conference in Chicago .  Since June 2013, over $10 million has been paid by entities to settle alleged HIPAA violations.  Mr. Meites predicted that, […]

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 […]