Government Issues

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.

Recent trends in the U.S. Food and Drug Administration’s (“FDA’s”) utilization of Complete Response Letters (“CRLs”) would indicate there may be a disconnect between the intended use of CRLs and the reality of how they are actually being used by the FDA. Pharmaceutical companies seeking to acquire FDA regulatory approval for their New Drug Applications (“NDAs”) or Abbreviated New Drug Applications (“ANDAs”) will often receive a CRL from the FDA instead of an approval.

The U.S. Food and Drug Administration (“FDA”) panel’s unanimous recommendation to approve Sandoz’ application for a filgrastim biosimilar of Amgen’s Neupogen® on Jan. 7, 2015, brings into sharp focus the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) for resolving patent issues. The imminent approval by the FDA of Sandoz’ application now leaves resolution of patent issues for Sandoz to contend with as it prepares to launch its biosimilar filgrastim product. The lawsuit to resolve these issues, however, has just begun.

Despite getting a rare Writ of Mandamus from the D.C. Circuit Court of Appeals establishing that its internal investigations were covered by the attorney-client privilege, Kellogg Brown & Root must still turn them over. As predicted in our earlier posts on Barko v. Halliburton, Judge James Gwin has ruled that KBR waived the attorney-client privilege that would otherwise have shielded KBR’s internal investigation documents from discovery. His rationale is reflected in three opinions published in November and December 2014.

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.

The U.S. District Court for the Eastern District of Tennessee answered what it acknowledged was a novel question: whether statistical sampling and extrapolation are appropriate to establish liability under the False Claims Act (FCA). The court found the government could extrapolate from a sample of patient records to prove FCA liability. While the court’s decision approved the use of sampling, it emphasized the defendant could challenge the government’s methodology and that the government was not using sampling to prove all of the elements of the alleged FCA violations.