Government Issues

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The Food and Drug Administration (FDA) released a new Draft Guidance June 20, 2014, that would make significant changes to the way mobile medical devices are regulated, despite only being claimed by the FDA in September 2013.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.

Based on OIG enforcement action excerpts for the past week, tips for staying ahead in healthcare regulatory compliance efforts include:

For many years, healthcare providers – particularly children’s hospitals – took comfort in a belief held widely throughout the healthcare industry that the Stark Law did not apply to Medicaid. That belief has now been challenged by several district court cases involving alleged False Claims Act violations, most recently in U.S. v. All Children’s Health System.

Several parts of the America Invents Act (the “AIA”) became law on Sept. 16, 2012, sparking some of the most meaningful changes to patent law seen in decades. One hot provision in the new law is the ability for one to challenge a patent’s validity in a new inter partes review (“IPR”) process. This legal tool could prove to be very valuable in solving some of the biggest business challenges facing generic pharma. This post addresses the business case for generic pharma using the IPR process.

Smartphones and tablets are quickly becoming the ubiquitous tool for both personal and business activities. The convenience of the platforms, their mobility, and their ability to tie into the Internet means not only is the adoption rate of these devices outpacing the adoption of standard PCs worldwide, but they present a growing opportunity for mobile application developers.

The U.S. Department of Justice issued a press release (the “press release”) covering today’s announcement by Attorney General Eric Holder and Department of Health & Human Services (HHS) Secretary Kathleen Sebelius that Medicare Fraud Strike Force operations in six cities resulted in charges against 90 individuals, including 27 doctors, nurses and other medical professionals, for their alleged participation in fraud schemes involving approximately $260 million in Medicare false claims.

On April 1, 2014, the Department of Labor’s Office of Federal Contract Compliance Programs agreed to the dismissal of its December 2008 complaint against Florida Hospital of Orlando. This action follows DOL’s March 11, 2014 agreement to a five-year moratorium on compliance and enforcement actions against Tricare service providers. These developments reflect a significant rollback of OFCCP’s prior position as to the scope of its jurisdiction. In his March 11, 2014 letter to Congress, Secretary of Labor Thomas Perez recognizes that Congress had intended to limit OFCCP’s jurisdictional authority over Tricare healthcare providers.