Government Issues

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.

A New York district court issued the first judicial opinion Monday, Aug. 3 on the Affordable Care Act’s “60-day rule,” which requires that a Medicare or Medicaid overpayment be reported and returned within 60 days of the date on which the overpayment was “identified.” The decision by Judge Edgardo Ramos provided a definition of what it means to “identify” an overpayment and thus begin the 60-day time period in which overpayments must be reported and returned. Given that the 60-day rule maintains that any person who knowingly fails to comply with this obligation within the 60-day timeframe has violated the False Claims Act (“FCA”), the potential implications of Judge Ramos’s decision are significant.

On Thursday, July 16, 2015, the Texas Health and Human Services Commission (HHSC) held a public meeting regarding its request to seek an extension of its Section 1115 Medicaid Transformation Waiver. The current waiver covered a five year period ending September 30, 2016. Under the waiver Texas has expanded Medicaid managed care, created a funding pool to offset uncompensated care and provided incentives for hospitals and other providers to develop delivery system infrastructure in Texas. Over the waiver period, Texas will commit $29 Billion to the uncompensated care and delivery system payment pools (approximately 58% or $16.82 Billion represent federal funds).

The U.S. Department of Health & Human Services Office of Inspector General (OIG) issued a special fraud alert on June 9, 2015, stating that physician compensation arrangements may result in significant liability. Hopefully this is not a surprise to any physician or entity that treats federal health plan beneficiaries. However, given that, historically, OIG regulatory actions largely (although not exclusively) focused on the entity from which a physician received compensation, such as hospitals, laboratories, durable medical equipment suppliers, pharmacies, etc., the June 9, 2015, fraud alert highlights the potential for physician liability in these arrangements.

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 LA Times reported on March 18, 2015, that one of California’s biggest health insurers, Blue Shield of California, had lost its tax-exempt status. The report came after California’s Franchise Tax Board quietly revoked Blue Shield’s state tax-exempt status back in August 2014. One of the biggest reasons for doing so was because of Blue Shield’s huge financial reserves.

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…