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|Wellness Programs Alive and Well?|
Brenna M. Clark, Adam B. Cohen, Andrea M. Gehman, Paul R. Lang, Carol A. Weiser; Sutherland Asbill & Brennan LLP;
April 24, 2015, previously published on April 23, 2015The Equal Employment Opportunity Commission (EEOC) has issued proposed regulations under the Americans with Disabilities Act (ADA) regarding employer-provided wellness programs that were published in the Federal Register on April 20, 2015. The proposed regulations are intended to reconcile rules...
|HHS Announces Next Generation ACO Model of Payment and Care Delivery|
Thomas E. Dutton, Scott A. Edelstein, David W. Grauer, Calvin P. Griffith, Todd P. Kelly; Jones Day;
April 24, 2015, previously published on April 1, 2015On March 10, 2015, the U.S. Department of Health and Human Services (“HHS”) announced the Next Generation Accountable Care Organization Model (“Next Gen ACO Model”), a new initiative sponsored by the Centers for Medicare & Medicaid Services’ (“CMS”)...
|China Publishes Draft Amendment to the GB 9685 Hygienic Standard on the Uses of Additives in Food Containers and Packaging Materials|
David J. Ettinger, Mark Thompson; Keller and Heckman LLP;
April 24, 2015, previously published on April 03, 2015On January 20, 2015, China’s National Health and Family Planning Commission (NHFPC) published an amendment to the current Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials (GB 9685-2008) for comments from the general public. Comments on the amended...
|Indiana’s Right to Try Law: Catalyst for Expanded Access to Experimental Drugs for Terminally Ill Patients|
Dave C. Bromund; Taft Stettinius & Hollister LLP;
April 23, 2015, previously published on March 30, 2015Indiana Governor Mike Pence signed into law Indiana’s new Right to Try legislation on March 24, but this law (and similar legislation proposed and enacted in other states) may have already catalyzed expanded access for terminally ill patients to potentially life-saving experimental drugs....
|Choice of Entity Decisions in Light of Medicare and Other Tax Law Changes|
Sonya S. Jindal, Lourdes E. Perrino; Taft Stettinius & Hollister LLP;
April 23, 2015, previously published on April 16, 2015In light of the Patient Protection and Affordable Care Act1 and the Health Care and Education Reconciliation Act of 2010,2 small and family owned businesses have been reevaluating choice of entity considerations. This article summarizes the most common business entity forms and some of the major...
|Xarelto Lawsuit Filed in West Virginia Against Drug’s Makers|
Waters Kraus LLP;
April 22, 2015, previously published on April 10, 2015A West Virginia man is suing Janssen Research & Development and Bayer Corporation, along with several of their affiliates, for misrepresenting the risks associated with Xarelto. Jermaine Tavon McMillan’s lawsuit was filed in federal court in West Virginia in February.
|Removal of Transvaginal Mesh May Not Fix Problems|
Kyla Gail Cole; Waters & Kraus, LLP;
April 22, 2015, previously published on April 1, 2015The dangers of vaginal mesh were recently addressed by the American College of Obstetricians and Gynecologists in an article that reviews data made available in the last year. Authored by John R. Fischer, M.D. of the Department of Obstetrics and Gynecology at the Uniformed Services University of...
|Defining the Bounds of the Public Disclosure Bar and the Scope of "News Media"|
Eric P. Berlin, Heather M. O'Shea, Allyson C. Spacht; Jones Day;
April 22, 2015, previously published on April 2015On March 3, 2015, a court in the Southern District of Texas granted a defendant pharmaceutical company's motion for summary judgment on claims brought under the False Claims Act for alleged false claims made through various government programs, including Medicaid and Medicare, for reimbursement for...
|Power Morcellation May Spread Benign Disease as Well as Cancer|
Kyla Gail Cole; Waters & Kraus, LLP;
April 22, 2015, previously published on April 8, 2015Power morcellation, according to three Johns Hopkins physicians, can cause benign uterine disease to spread. Three case reports from the Baltimore Maryland hospital demonstrated that use of the morcellator medical device may require more extensive surgery later and increase a patient’s risk...
|Metal-on-Metal Hip Implants Pose Potential Risk for Patients|
Sara E. Coopwood; Waters & Kraus, LLP;
April 22, 2015, previously published on March 25, 2015Metal-on-metal hip implants can lead to metal debris migrating from the device into the blood and surrounding tissue, according to the European Commission’s (EC’s) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). The EC described the potential health risk in...