The FDA recently issued a draft Guidance on how manufacturers
can respond to unsolicited requests for information on off-label
(unapproved or non-cleared) uses of their prescription drugs or
medical devices. Although the draft Guidance may add some clarity
and updates of past pronouncements on the subject to address
current forms of communication, anyone hoping for a relaxation of
the rules should not get too excited.
By way of background, new drugs and some medical devices must be
approved, and most medical devices must be cleared, by the FDA
before they can be lawfully marketed. The FDA's approval of the
drug or device is limited to particular indications or uses that
are stated on the label....
Specific Questions relating to this article should be addressed directly to the author.
This third, and final, installment in the "Year in Review" series examines how criminal health care fraud enforcement has changed in the past year, including the use of non-health-care-related statutes, the focus on specific industries, and the increased number of alleged violators targeted in takedowns.
On May 4, 2012, the Centers for Medicare and Medicaid Services ("CMS") announced that it will not require applicable manufacturers and group purchasing organizations ("GPOs") to begin collecting data on relevant payments under the Physician Payment Sunshine Act until January 1, 2013.
An investigation by the HHS Office for Civil Rights was triggered by a report that the PC was posting clinical and surgical appointments for its patients on an internet-based calendar that was publicly accessible.
The Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) has just sent another strong signal to healthcare providers and plans that it intends to enforce the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules aggressively, and that it does not intend to give a pass to small healthcare providers or practices.
Last month the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion No. 12-02, which favorably analyzed an arrangement whereby healthcare providers offer discount coupons for their medical services and products to patients by posting them on a website.
On December 19, 2011, the U.S. Centers for Medicare & Medicaid Services (CMS) published a proposed rule to implement the Physician Payments Sunshine Act, which was included as part of the Patient Protection and Affordable Care Act of 2010.
In this first installment of Mintz Levin’s Health Care Fraud Enforcement Defense Group’s periodic updates on health care enforcement activities in 2012, Brian Dunphy, Hope Foster, Samantha Kingsbury, Tracy Miner, and Stephanie Willis focus on significant civil settlements, criminal prosecutions, and regulatory developments that occurred in the first quarter of 2012.
This week, the Seventh Circuit issued a decision in Schaffer-Larose v. Eli Lily & Company, in which it held that pharmaceutical reps are exempt under the FLSA's administrative exemption.
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