The Food and Drug Administration (FDA) released a new Draft Guidance June 20, 2014, that would make significant changes to the way mobile medical devices are regulated, despite only being claimed by the FDA in September 2013.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

Effective June 30, 2014, six attorneys and several staff members from Miles & Peters, P.C. will join Husch Blackwell LLP. Founded in 1980, Denver-based Miles & Peters focuses on health law matters and is especially well known for its work with post-acute providers, hospitals, ambulatory surgery centers and physician groups.

With the addition of these six attorneys, Husch Blackwell has welcomed 26 new attorneys across eight office locations since January 1, 2014.

The Federation of State Medical Boards recently endorsed a model policy that addresses the proper use of telemedicine services.  Only a few weeks later, a not-for-profit foundation released  a report highlighting the benefits of telemedicine and making recommendations for telehealth services.  It’s no surprise that telehealth and telemedicine have been in the news with increasing frequency given that the demand for telemedicine services are rising sharply.  According to a Law360 article, Deloitte Touche Tohmatsu Ltd. estimates that 75 million digital doctor visits will occur this year in North America.

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.