On Wednesday, the Centers for Medicare and Medicaid Services (“CMS”) issued a second round of long-awaited red tape reduction initiatives aimed at ameliorating overly burdensome provider regulations. The changes, memorialized within a Final Rule scheduled for publication on May 12, 2014 (available for review here: http://federalregister.gov/a/2014-10687) (“Unpublished Final Rule”) include significant easing of Conditions of … Continue Reading
On December 27, 2013, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General of the Department of Health and Human Services (“OIG”) published final rules (“Final Rules”) regarding the electronic health records (“EHR”) donations Stark Law Exception (42 C.F.R. 411.357(w)) and Anti-Kickback Statute Safe Harbor (“AKS Safe Harbor”) (42 C.F.R. … Continue Reading
Navigating the legal, regulatory and practical issues in implementing mobile telecommunications technology for healthcare applications can be treacherous. At the heart of this growing industry dynamic is the increasing scrutiny now coming from various federal agencies in this area, including the US Food and Drug Administration and Federal Communications Commission. The article noted below discusses … Continue Reading
Yesterday, the U.S. Dept. of Health and Human Services Office of Inspector General (“OIG”) clarified its stance on a growing practice – provider attempts to circumvent fraud and abuse laws by structuring financial arrangements to apply only to business concerning non-Federal program beneficiaries. The OIG reiterated its dim view of this practice, citing an underlying … Continue Reading
Shortly before Halloween of last year, a Squire Sanders healthcare client received an omen that all was not well – a Civil Investigative Demand (“CID”) served by the United States Department of Justice (DOJ). Broad, aggressive, and without identifying any pending legal complaint (CIDs usually don’t), the CID made a frighteningly lengthy list of demands … Continue Reading
