While the post-Affordable Care Act regulatory environment may be too constraining for some private equity funds to invest in physician-owned hospitals, many funds — especially those already investing in a health care platform such as United Surgical Partners International — still view the industry very optimistically, say attorneys with McGuireWoods LLP.
In addition to providing clear guidance for designing nondiscriminatory wellness programs, recent insight from the U.S. Departments of Treasury, Labor and Health and Human Services may also bring more outcome-based programs and new plan designs that shift costs to employees who do not participate, says Priscilla Ryan of Sidley Austin LLP.
The recent $500 million settlement of Ranbaxy USA Inc., the largest drug safety-related settlement with a generic manufacturer to date, has broad implications for U.S. Department of Justice and Food and Drug Administration enforcement trends. However, significant questions exist regarding the basis for False Claims Act liability, say attorneys with Skadden Arps Slate Meagher & Flom LLP.
Under cases involving health care organizations and their Stark Law violations, the government has enforced actions and settlements ranging from $10 million to nearly $40 million in the first half of 2013. These cases highlight a new effort toward Stark Law violations and ultimately, a change in the way organizations should approach fair market value issues, say attorneys with Krieg DeVault LLP.
There are several critical decision factors to weigh to assess whether Technology Assisted Review is right for a discovery project — for example, the nature of the case, internal capabilities, production considerations and overall comfort with this technology, say Michele Lange and Joseph White of Kroll Ontrack Inc.
New and increased taxes that went into effect Jan. 1, 2013, are hitting employers and employees in several areas. Now is the time for employers to consider their options for qualified retirement plans, such as the individual account plan and cash balance plan, says Lee Polk of Epstein Becker & Green PC.
Arbitrators can still interpret contracts pretty much any way they want, according to the U.S. Supreme Court’s unanimous ruling in Oxford Health Plans LLC v. Sutter. The holding should come as no great surprise as it reflects decades of federal arbitration law, yet the unanimous ruling is a surprise, given what preceded it, says Christopher King of Homer Bonner Jacobs.
The message from Idaho State University's recent $400,000 Health Insurance Portability and Accountability Act settlement is clear — the Office of Civil Rights is serious about Security Rule compliance. Yet many, if not most, providers have ignored or do not understand the specific, technical requirements of the rule, says Kim Stanger of Holland & Hart LLP.
Recently, the U.S. Food and Drug Administration issued an "It Has Come to Our Attention Letter" to Biosense Technologies, the developer of a urine analyzer mobile app. Although the FDA does not indicate why it opted to publicly disclose this letter, one can assume that it did so due to the regulatory uncertainty in this area and the desire to put other app developers on notice of the issue, says Paul Rubin of Ropes & Gray LLP.
Tietz v. Abbott Laboratories Inc. has significant implications for the future of failure-to-warn litigation involving prescription drugs as it has opened the door to the argument that a drug manufacturer has a duty to send a "Dear Doctor" letter before the letter is approved by the U.S. Food and Drug Administration, say attorneys with Morrison & Foerster LLP.