All posts by Jennifer K. Shanley

PhRMA Releases Updated Code on Interactions with Health Care Professionals

The Pharmaceutical Research and Manufacturers of America (“PhRMA”) recently issued an updated Code on Interactions with Health Care Professionals (the “Updated Code”). The Updated Code’s preamble states that it reinforces PhRMA’s intentions that interactions with health care professionals are professional exchanges designed to benefit patients and to enhance the practice of medicine. […]

OIG Releases Advisory Opinion Regarding Laboratory and Physician Practice Agreement

On March 25, 2015, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion No. 15-04. In the opinion, the OIG addresses a laboratory’s proposal to enter into agreements with physician practices to provide all laboratory services for the practices’ patients. Under the proposed […]

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 […]

FDA Submits Notice for Collection of Information Regarding Direct-to-Consumer Advertisements

The Food and Drug Administration (FDA) recently submitted a proposed collection of information on disclosing risks in direct-to-consumer (DTC) prescription drug television (TV) advertisements to the Office of Management and Budget (OMB) for review and clearance. According to the notice published in the Federal Register on January 13, 2015, prescription […]

Business Forward Hosts HHS’s Director of Private Sector Engagement for a Discussion on Health Care for Small Businesses

On Wednesday, October 15, 2014, Business Forward hosted a discussion with Rhett Buttle, the Director of Private Sector Engagement at the U.S. Department of Health and Human Services (HHS). Mr. Buttle began by providing background on the Affordable Care Act and then opened the line for questions. During Mr. Buttle’s discussion of […]

CMS Issues Final Rule on Marketplace Auto-Enrollment

On September 5, 2014, the Centers for Medicare and Medicaid Services (CMS) published a final rule, effective October 6, 2014, that, among other things, specifies the auto-enrollment process for consumers who receive health insurance coverage through a qualified health plan offered under a federally-facilitated marketplace (Marketplace). According to a fact sheet released by CMS, “[a]s […]

Federal Health Insurance Marketplace Sends Notices Regarding Citizenship and Immigration Data Inconsistencies

The Centers for Medicare & Medicaid Services (“CMS”) announced that the Federal Health Insurance Marketplace (“Marketplace”) began sending follow-up notices to consumers with citizenship or immigration data inconsistencies who have not responded to previous notices via mail, email, and phone. CMS cautions that consumers who have not yet responded must act […]