The U.S. Department of Health & Human Services Office of Inspector General (“OIG”) issued a proposed rule Oct. 2 that would add new safe harbors to the Anti-Kickback Statute (“AKS”) regulations and interpret existing, statutory safe harbors. The rule would also amend the Civil Monetary Penalties (“CMP”) regulations by adding statutory exceptions to the regulatory definition of “remuneration” and codifying the so-called “gainsharing CMP” found in the Social Security Act.

Now that patients with Ebola have landed on U.S. soil, hospitals and other healthcare providers must prepare for the possibility that a patient with Ebola will walk through the doors. In this Oct. 30 webinar, Husch Blackwell presenters will look at some of the pressing legal issues related to treating patients with communicable diseases such as Ebola, and what providers can do now to prepare their clinical, compliance and legal teams.

In the Electronic Health Records (EHR) space, unconnected and competing systems carry the potential for organizational train wrecks.

Until robust, efficient, and mandatory interoperability standards emerge, providers should consider linking systems through other means, as failure to do so may lead to malpractice and regulatory compliance issues.

A new White Paper, Driving the Golden Spike:…

Husch Blackwell attorneys Ed Barker and Joe Geraci discussed hospital legal issues related to a recent Ebola patient with the Texas Lawyer publication. The two-day period between the recent Dallas, Texas, Ebola patient’s first visit and isolation is the key to potential legal issues for the hospital, according to Barker and Geraci.

The Ebola patient…

Join our attorneys for an in-depth look at healthcare compliance and gain practical information about effectively navigating an audit or investigation. The Oct. 1 webinar “Getting Real: Real-Life Compliance issues” is part of the Husch Blackwell Healthcare Horizons webinar series.

What You Will Learn

  • How to work with auditors to obtain a fair conclusion
  • How to respond to investigations and control risk as an investigation progresses
  • How to develop effective communication plans

Dietary supplements represent a huge sector of the consumer market and changes in both intellectual property law and the regulations governing the market entry and advertising of these products is changing.

The new America Invents Act allows anyone to challenge the validity of patents under the inter partes review (IPR) process. In a Sept. 9 webinar, Husch Blackwell Partner Joseph Cwik, who recently won the first pharmaceutical IPR case, will provide an overview of this new process and explain how it is more cost-effective, efficient and successful than the traditional litigation.

The Kentucky Supreme Court issued an opinion Aug. 21, 2014, (Tibbs v. Bunnell, Ky., No. 2012-SC-000603-MR)  in which it held that the incident report developed by the University of Kentucky Hospital (“hospital”), through the hospital’s Patient Safety Evaluation System (“PSES”), following the death of a patient, was not protected as patient safety work product (“PSWP”) under the Patient Safety and Quality Improvement Act of 2005 (the “Act”).

Husch Blackwell was highly recognized as Best Lawyers, a well-respected peer review publication, released its new rankings for 2015. This year, 19 of our Healthcare, Life Sciences & Pharmaceuticals industry group attorneys were selected as leaders in their respective fields.

First published in 1983, Best Lawyers is based on a national survey involving more than 5.5 million detailed evaluations of lawyers by other lawyers.

The U.S. Department of Health & Human Services (“HHS”) issued final regulations in January 2013 modifying the privacy, security and enforcement provisions under the Health Information Portability and Accountability Act of 1996 (“HIPAA”). Covered entities and business associates were generally required to comply with the final regulations by Sept. 23, 2013. To reduce administrative burden and costs of renegotiating existing business associate agreements, HHS provided a transition period. Business associate agreements in place as of Jan. 25, 2013, and not modified or renewed between March 26, 2013, and Sept. 23, 2013, were deemed to comply with the new regulations for up to 12 months. All relevant entities should note that the deemed compliance period ends Sept. 22, 2014.

On July 11, 2014, the Internal Revenue Service (“IRS”) released a Technical Advice Memorandum (“TAM”) dated March 7, 2008, which concluded that, contrary to the general rule set forth in Revenue Ruling 85-110 (“Rev. Ruling 85-110”), a tax-exempt hospital’s income from laboratory testing services to patients of private physicians is not subject to the unrelated business income tax.