Articles and Blogs

PCORI Offers Funding to Develop Research Network On April 23, the Patient-Centered Outcomes Research Institute (“PCORI”) announced funding up to $68 million in efforts to build a research network to support comparative effectiveness studies.

We’re All Getting Old The U. S. Census Bureau predicts that by 2050 nearly 20 million workers or about 20% of the national workforce will be 65 or older.  That represents an increase of 75% while the number of workers ages 25 to 54 is predicted to grow by only 2%. The health care workforce…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 respect…Read More

HHS Inspector General Revises Self-Disclosure Protocol On April 17, the HHS Office of Inspector General (“OIG”) released a revised self-disclosure protocol (PDF) called the OIG Provider Self-Disclosure Protocol.  The protocol describes what a hospital must confide to the government in order to avoid prosecution or get a possible reduction in penalties.

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 CFR…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 comply…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.

Introduction Three cases are addressed in a review of the False Claims Act decisions of the past month. The first, US v. Anchor Mortage Corp., is a significant Seventh Circuit case addressing the proper treble damages calculation under the statute. The second, US ex rel. Carter v. Halliburton, considers the application of the Wartimes Suspension of…Read More

Obama Releases HHS Budget for FY 2014 On April 10, HHS posted a 126-page summary of President Obama’s fiscal year (“FY”) 2014 budget for the agency. The budget proposes $5.6 billion in Medicare payment cuts for FY 2014. Hospital-related cutbacks were proposed for graduate medical education, critical access hospitals and bad debt payments.

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 device…Read More