Articles and Blogs

Summary On Wednesday, May 1, 2013, the U.S. Department of Justice (“DOJ”) announced that it had reached a settlement with a two-hospital, Montana-based health system (“System”) arising from financial relationships between the System and a combination of 139 employed and independent physicians and physician groups.  Under the terms of the Settlement Agreement, the System... READ MORE

The graduate medical education (“GME”) landscape continues to evolve, even as the basic structure of Medicare GME reimbursement remains in place. Recently, noteworthy proposals and changes include proposed legislation that would provide for 15,000 new residency positions over five years to increase the number of residents in training and a change to the regulations that... READ MORE

Executive Summary On April 17, 2013, the Office of Inspector General (“OIG”) issued an updated version of its Self-Disclosure Protocol (“Protocol”).  In 1998, the OIG published the original Protocol to establish a process for health care providers to voluntarily identify, disclose and resolve instances of potential fraud involving federal health care programs, particularly with... READ MORE

The U.S. Food and Drug Administration (“FDA”) wants to give manufacturers of medical devices in vitro diagnostics (“IVDs”) and biological products the authority to use certain symbols and images on their product labeling to convey safety information and instructions for use. A proposed rule published April 19 would revise the agency’s regulations at 21... READ MORE

The Internal Revenue Service (“IRS”) published proposed regulations (“Proposed Regulations”) on April 5, 2013 that expand upon and provide clarification for the community health needs assessment (“CHNA”) requirements of Section 501(r)(3) of the Internal Revenue Code (the “Code”). The Proposed Regulations also provide guidance on how and when penalties may be imposed for failing to... READ MORE

Executive Summary April 16, 2013 is National Healthcare Decisions Day. The goal of the day is to encourage Americans to think and talk about their health care goals and communicate their health care decisions by executing advance health care directives. READ MORE

When you purchase an item, you assume that it can be used in any reasonable manner and the warranties will apply.  The same is true of buyers of medical products.  Take the humble tongue depressor.  Regulated by the Food and Drug Administration (“FDA”) pursuant to 21 C.F.R. § 800.6230, the tongue depressor is “…a... READ MORE

Under the Americans with Disabilities Act (“ADA”)1,health care providers have an obligation to provide the deaf and hard of hearing with auxiliary aids needed to access and understand aural information and to engage in effective communication.2  Auxiliary aids include, among other things, qualified interpreters.  Under federal law, a “qualified interpreter” is defined as an... READ MORE

On February 7, 2013, the United States Health Resources and Services Administration (“HRSA”) released guidance entitled “Statutory Prohibition on Group Purchasing Organization Participation” (“GPO Exclusion Guidance”).  This guidance addresses requirements related to drugs purchased at a discount under the 340B Program by hospitals subject to the 340B Program GPO exclusion restriction.  These include disproportionate... READ MORE

Executive Summary In Masri v. LIRC, 2012AP1047 (April 2, 2013), the Wisconsin Court of Appeals affirmed a decision by the Labor and Industry Review Commission (“LIRC”) that Wisconsin’s Health Care Worker Protection Act (“HCWPA”) applies only to employees of health care facilities and that an unpaid intern is not an employee for purposes of... READ MORE