Health Law Advisor

On February 2, 2012, the U.S. Department of Labor (“DOL”) issued final regulations under Section 408(b)(2) of ERISA (the “Final 408(b)(2) Regulations”), which requires “covered service providers” to disclose to “responsible plan fiduciaries” (including employer plan sponsors and plan administrators) certain direct and indirect compensation they receive in connection with the services that they provide to a plan.  These regulations are part of the DOL’s initiative to increase transparency for plan fiduciaries and participants of fees and costs ...

by Jason B. Caron, O. Benton Curtis III, Anjali N.C. Downs, and Jennifer K. Goodwin

Almost two years after the passage of the Patient Protection and Affordable Care Act (“ACA”), the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule regarding overpayments to providers and suppliers, as provided for under Section 6402(a) of the ACA. To date, regulators, courts, clients, and members of the bar have interpreted the requirements of Section 6402(a) in various ways. The proposed rule provides CMS's view on this matter, and, given that CMS is proposing a ...

By Casey M. Cosentino and Eric J. Conn

“Texting while driving” is an epidemic in America, which has prompted forty-two states and the District of Columbia to ban (completely or partially) this conduct for drivers.  Here's a map of the U.S. states that have enacted some ban on texting while driving.  Studies suggest that texting while driving distracts drivers’ cognitive focus and removes their eyes from the road and hands from the wheel.  It is not surprising, therefore, that distracted driving is attributed with sixteen percent (16%) of all traffic fatalities in 2009.

The ...

by Kathleen A. Peterson, Benjamin S. Martin, Wendy C. Goldstein, and Constance A. Wilkinson

This issue of Implementing Health & Insurance Reform summarizes and discusses some issues raised by the proposed rule ("Proposed Rule") that the Centers for Medicare & Medicaid Services ("CMS") published on February 2, 2012, to implement changes to the Medicaid Drug Rebate Program ("MDRP") and to reimbursement limits for outpatient drugs covered by Medicaid.

In Part 1, we discuss proposals relating to the MDRP that would change the manner in which pharmaceutical manufacturers calculate ...

 by Jeffrey M. Landes, Susan Gross Sholinsky, Steven M. Swirsky, and Jennifer A. Goldman

On January 25, 2012, the Federal Trade Commission ("FTC") sent warning letters to three companies that market, in total, six mobile phone applications ("Apps") that provide users with background check reports. In the warning letters, the FTC states that the Apps may violate the Fair Credit Reporting Act ("FCRA"). According to a press release issued by the FTC on February 7, 2012, the FTC cautioned the Apps' marketers that, if they have reason to believe that the background reports provided will be ...

On February 1, 2012, a former intern of Hearst Corp.’s Harper’s Bazaar filed a purported class action alleging that the company violated the Fair Labor Standards Act (“FLSA”) and applicable state law by failing to pay minimum wage and overtime pay to her and the other interns. 

Although the lawsuit is against a publishing company, it nonetheless highlights a growing trend in health care.  The economic downturn has led many job seekers to get their foot in the door anyway they can, even if it means interning without pay.  Indeed, as the complaint against Hearst Corp. asserts ...

Please join us on Wednesday, February 22, 2012 at 9:00 am EST for a complimentary seminar/webinar  presented by Epstein Becker Green attorneys Kara M. Maciel and Jordan Schwartz.  They will address how the new ADA standards affect the health care industry and describe specific actions that employers should take to comply with these updated legal requirements and avoid significant financial penalties.

Registration is free and you can register by clicking here.

We are pleased to announce that Epstein Becker Green’s first app - Wage & Hour Guide for Employers - is now available for download in the App Store on iTunes, for both iPhones and iPads.  You can find the app by searching for “Wage Hour” or clicking here. 

The Wage & Hour Guide app enables employers to access up-to-date federal wage and hour guidelines as well as various state guidelines, which can differ by jurisdiction.  In addition, users can obtain insights and commentary about the latest wage and hour developments and issues by accessing Epstein Becker Green’s Wage and Hour ...

 Medicaid home care aide services providers need to act quickly to avoid the risk of non-payment for services.  The New York State Home Care Worker Parity Act, Public Health Law § 3614-c, establishes minimum “total compensation” requirements for “home care aides” who perform Medicaid-reimbursed work for certified home health agencies (“CHHAs”), long term home health care programs (“LTHHCPs”) and managed care plans (“MCPs”).  The Act applies to both mainstream managed care plans and all forms of managed long term care plans, and also affects licensed and ...

by Wendy C. Goldstein and Kathleen A. Peterson

On December 27, 2011, the U.S. Food & Drug Administration ("FDA"), Office of Prescription Drug Promotion ("OPDP") (formerly the Division of Drug Marketing, Advertising, and Communications) released a new draft guidance document titled "Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" (the "Draft Guidance"). The OPDP will accept comments on the Draft Guidance through March 29, 2011.

The FDA has a longstanding policy of permitting ...