Articles and Blogs

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

On Wednesday, April 3, the Internal Revenue Service (“IRS”) released a new round of Proposed Regulations that expand upon, and address uncertainties regarding, the requirements of Code Section 501(r) applicable to tax-exempt hospital organizations. These new Proposed Regulations provide guidance on the community health needs assessment requirements and related excise tax and reporting obligations.... READ MORE

Following the recent CMS Administrator’s Ruling CMS-1455-R, CMS issued a Program Transmittal with claims processing instructions related to the rebilling of denied inpatient claims under the interim rebilling policy.  A corresponding article intended for hospitals was released on March 22, 2013 and can be found on the CMS website here. READ MORE

Executive Summary On March 26, 2013, the Office of Inspector General (“OIG”) released a special fraud alert (“Alert”) regarding physician-owned distributorships (“PODs”). PODs are entities that sell, or arrange for the sale of, implantable medical devices that may be used by the physician-owners or others for procedures on patients in hospitals and ambulatory surgery centers... READ MORE