Government Issues

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.

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”).

The U.S. Department of Justice (DOJ) and the New York State Attorney General intervened in a federal False Claims Act (FCA) case on June 27, 2014, accusing Mount Sinai Health System of failing to report and return Medicaid overpayments within 60 days of identifying them. See U.S. ex rel Kane v. Healthfirst, Inc., et al., No. 11-2325 (S.D.N.Y). This case is one of the first examples of litigation involving “the 60-day repayment provision” under the Affordable Care Act (ACA).

The Federal Trade Commission (FTC) recently issued a policy paper urging state legislators to carefully evaluate proposals that limit nurse practitioners’ scope of practice. Nurse practitioners (also known as Advanced Practice Registered Nurses, or APRNs) are registered nurses who have been both educated and received specialized training beyond the requirements for a registered nurse. Notably, the FTC paper concluded that expanding the scope of APRN practice would create more competition in the health care sector – helping to control costs, improve quality, promote innovation, and expand access to care.

The Patent Trial and Appeal Board (PTAB) issued its first final written decisions June 20, 2014, in four inter partes reviews (IPR) of pharmaceutical-related patents. The four decisions effectively invalidated all 58 of the challenged patent claims spread across four patents owned by Merck & Cie and South Alabama Medical Science Foundation (SAMSF) who previously accused Husch Blackwell client Gnosis SpA of infringement.

The Centers for Medicare & Medicaid Services (CMS) published its final revisions (“Final Rule”) to the Medicare Conditions of Participation (CoPs) on May 12, 2014. Among other things, CMS proposed to revise its current interpretation of the hospital medical staff composition at 42 C.F.R. § 482.22 and modified the prohibition on the use of a unified and integrated medical staff for a multi-hospital health system.

The Food and Drug Administration (FDA) released a new Draft Guidance June 20, 2014, that would make significant changes to the way mobile medical devices are regulated, despite only being claimed by the FDA in September 2013. In that original Guidance, the FDA defined a new industry that it intended to regulate: the creators and providers of mobile medical apps. Such apps originally included many different kinds of apps, from blood glucose monitors to apps that displayed MRI or ECG visual data.

Many pediatric hospitals have an opportunity to be a lead provider of patient care and administrative services to patients in states that are outsourcing Medicaid program administration to managed care companies.  Winn Halverhout presented on this topic for an AHLA webinar titled “Innovative Pediatric Hospital/Provider Partnerships.”

Thirty-seven states currently outsource all or part of their Medicaid administration to managed care companies.  Many states are dividing into regions and awarding Medicaid contracts in each region to only one or a handful of managed care companies, which creates opportunities for pediatric providers that MCCs regard as critical providers within a service region.  Pediatric hospitals are well-positioned to be the lead provider if they can build a critical mass of physicians and other pediatric care providers in the contract region.

The U.S. Occupational Safety and Health Administration (OSHA) recently published a new brochure titled “Safe Patient Handling: Preventing Musculoskeletal Disorders in Nursing Homes.” In the brochure, OSHA recommends strategies to reduce musculoskeletal disorders (MSDs) in nursing homes. OSHA recognizes that nurses and other healthcare workers experience some of the highest rates of non-fatal occupational injuries and illnesses of any industry sector.