Brian G. Flood of Husch Blackwell LLP‘s Austin office participated in a recent forum on “Managing Fraud and Bribery Risks in the Healthcare Sector.”
The Q&A Forum forms part of a Special Report on Corporate Fraud & Corruption, which appears in the February 2015 issue of Financier Worldwide magazine.
For the Q&A Forum, Financier…
Due diligence is often perceived as a mundane part of the mergers & acquisitions (M&A) process, but its importance in healthcare transactions is critical. Due diligence is one of the first steps of any transaction and involves a buyer undertaking an in-depth examination of the target to evaluate the business and uncover potential issues or liabilities. In the healthcare industry, diligence is especially important considering the heavy regulation of the industry, the unique areas of risk, and the significant liabilities that could be imposed upon a buyer if issues and liabilities are not identified before the transaction closes.
The new Rules (for Vending Machines and Menus) are based on changes made as the result of the Affordable Care Act. These changes were made by adding two new sections to Section 403 of the Food, Drug and Cosmetics Act, which describes Mislabeled Foods. The new sections, found under FDCA §403(q)(5)(H), enables the FDA to regulate the labeling requirements for Restaurants, Retail Food Establishments and Vending Machines.
Late last year, the U.S. Food and Drug Administration finalized a new set of Rules pursuant to the new §403 governing how and where caloric content must be displayed. As a result, beginning on Dec. 1, 2015, and Dec. 1, 2016, certain restaurants and vending machine operators, respectively, will be forced to disclose the calorie content of their products to consumers.
Under HIPAA rules, covered entities are required to report breaches of unsecured protected health information (PHI) to the Secretary of the Office of Civil Rights (OCR). The deadline for reporting breaches of PHI discovered during 2014 that affected fewer than 500 individuals is March 1, 2015.
Last week, Judge Richard J. Leon of the Federal District Court for the District of Columbia vacated the “third-party” regulation on the federal companionship exemption, which would have prevented third-party employers from utilizing the companionship exemption from minimum wage and overtime, as well as the “live-in” exemption from overtime.
On Dec. 31, 2014, the judge temporarily stayed the regulations that would have significantly altered the duties an exempt companion could provide. The regulations, which were set to go into effect at midnight on Dec. 31, would have prevented exempt companions from providing any “general household work” at all, and would have prevented them from engaging in any “care” of the client for more than 20 percent of their working time.
The Internal Revenue Services (IRS) issued Notice 2014-67 on Oct. 24, 2014, to “amplify” Revenue Procedure 97-13 by (i) creating a new five-year safe harbor for management contracts, and (ii) expanding the permitted types of productivity awards allowed.
Rev. Proc. 97-13 describes certain “safe harbor” arrangements that tax-exempt healthcare facilities financed with tax-free bonds can rely on to ensure any “management, service or incentive payment contract” between the facility and a service provider does not result in private business use. Many physician service agreements fall within this category.
A Dec. 1 Strafford webinar on the legal and regulatory challenges of Ebola will feature five Husch Blackwell attorneys. The 90-minute CLE webinar with interactive Q&A will provide guidance to healthcare counsel and their clients in addressing HIPAA and EMTALA concerns when treating Ebola patients.
The panel will discuss state and federal mandatory reporting requirements, employment issues and lessons learned from the first U.S. Ebola cases.
The U.S. Department of Health & Human Services (HHS) Office for Civil Rights (OCR) released a bulletin on Nov. 10 reminding entities covered under the Health Insurance Portability and Accountability Act (HIPAA) that the protections continue to be in effect during emergencies, including Ebola and other outbreaks. HHS wants to make sure healthcare providers are aware of the ways in which patient information may be shared under the HIPAA Privacy Rule in emergency situations.
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.
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
