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.
Committed to You: Healthcare, Life Sciences and Pharmaceuticals team mid-year update
With the mid-year mark upon us, we’ve taken a step back to assess activity in our group. We’re pleased to share several exciting developments in 2014 specifically related to our Healthcare, Life Sciences & Pharmaceuticals industry team.
Since Jan. 1, 2014, we have welcomed 11 new attorneys to our Healthcare, Life Sciences and Pharmaceuticals team.
Update: The changing landscape of mobile medical app regulation, less than one year later
The Food and Drug Administration (FDA) released a new Draft Guidance June 20, 2014, that would make significant changes to the way mobile medical devices are regulated, despite only being claimed by the FDA in September 2013.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.
Animal Health Licensing: Navigating the Regulatory Environment
The world of animal health is constantly changing, and animal health companies must stay on top of regulatory changes to have a successful license. Michael Annis and I recently presented on what an animal health company needs to manage when considering an in-license or an out-license and the regulatory impact on a licensing strategy. In…
Pediatric Hospitals and Medicaid Managed Care Networks
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.
OSHA issues brochure on safe patient handling in nursing homes
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.
Six Healthcare Attorneys Join Husch Blackwell and Add to Denver and Phoenix Presence
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.
Organizations Aim to Standardize Telehealth Practices
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.
Compliance tips this week: Lessons learned from recent OIG enforcement actions
Based on OIG enforcement action excerpts for the past week, tips for staying ahead in healthcare regulatory compliance efforts include:
- Carefully review arrangements involving the receipt of cash in paper bags from service providers to which Medicare referrals are made. Also assess space rental and other arrangements with referral sources or destinations. www.justice.gov/usao/nj/Press/files/Onyenso,%20Chikezie%20Sentencing%20PR.html
Recent Stark Law Developments: Is the Medicaid comfort zone coming to an end?
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.