Children's Hospitals and Pediatric Providers

The U.S. Court of Appeals for the District of Columbia Circuit issued an opinion June 12, 2015, lambasting the Centers for Medicare & Medicaid Services’ (“CMS”) rationale in implementing the ban on “per-click” space and equipment leases under the Stark Law. This ban, which went into effect Oct. 1, 2009, was effectively challenged by the Council for Urological Interests (“Council”), which was also behind the successful challenge against the application of the Stark Law to hospital lithotripsy services in 2002.

Among the more colorful descriptions used by the Court in describing CMS’s position were that it was “incomprehensible,” “tortured”, and “the stuff of caprice.” And on an even more scathing note, the Court described CMS’s reading of the legislative history of the Stark Law as belonging to the “cross-your-fingers-and-hope-it-goes-away school of statutory interpretation.”

The Orphan Drug Act aims to incentivize treatment of rare disorders or conditions affecting fewer than 200,000 persons in the United States through: (1) federal funding of grants and contracts to perform clinical trials of orphan products; (2) a tax credit of 50 percent of clinical testing costs; and (3) an exclusive right to market the orphan drug for approved orphan indications for 7 years from the date of marketing approval. While these financial incentives certainly make the business decision to engage in orphan drug development more palatable, the FDA does not approve orphan drugs on a separate pathway, despite the limited understanding of the diseases in question that presents developers of these drugs with problems stemming from small sample size and lack of well-defined efficacy endpoints.

The District of Columbia reached a settlement agreement with Children’s Hospital, Children’s National Medical Center Inc. and its affiliates (collectively, “CNMC”) on June 15, 2015, to resolve allegations that CNMC violated the False Claims Act by submitting false cost reports and other applications to the U.S. Department of Health & Human Services (“HHS”) as well as to the Virginia and District of Columbia Medicaid programs. Further details can be found in the Department of Justice’s press release announcing the settlement.

The state of Georgia reached a civil settlement agreement on April 23, 2015, with Grady Health System based on allegations that Grady incorrectly coded claims for neonatal intensive care unit (NICU) patients, resulting in overpayments by Georgia Medicaid. For more details, read the Georgia Attorney General’s press release announcing the settlement.

Husch Blackwell Partner Winn Halverhout authored a briefing on the emerging use of medical marijuana in pediatric healthcare for the American Health Lawyers Association. The briefing, titled “Legal Aspects of Marijuana Applications in Pediatric Health Care,” addresses the development of state laws and cultural acceptance of marijuana.

The DOL’s self-imposed February deadline for announcing new FLSA regulations redefining “white collar” exemptions has come and gone with without any action from the DOL. No new deadline has been announced; however, the DOL’s website suggests that it still hopes to release the new regulations soon. Stayed tuned, and we will report back when the…

Over the last few decades, the healthcare industry has come to recognize that research on children is necessary to determine the safest and most effective treatments for pediatric patients. Whether your institution is part of a nationally renowned research program or participates in a few pharmaceutical research studies a year, the following two issues are critical when structuring research studies that involve pediatric patients.

The U.S. Court of Appeals for the 9th Circuit affirmed a lower court’s findings Feb. 10, 2015, that the acquisition by St. Luke’s Health System (“St. Luke’s”) of Saltzer Medical Group (“Saltzer”), a physician group consisting mostly of primary care physicians, violated Section 7 of the Clayton Act. This is the first case in which the Federal Trade Commission (“FTC”) litigated through trial a challenge to a physician acquisition.

In March 2014, President Obama directed the Secretary of Labor to prepare and propose new FLSA regulations. These new rules were to be announced late last year, but have been repeatedly delayed. Now it appears the new rules will be announced later this month. While the scope of the changes is unknown, it is anticipated the changes will reduce the number of employees who qualify for exempt status.

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…