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The 340B Program Omnibus Guidance: Not Ready for Prime Time

On January 30, 2017, the proposed 340B Drug Pricing Program (the “340B Program”) Omnibus Guidance (the “Guidance”) first issued by the Health Resources and Services Administration (HRSA) in August of 2015 was withdrawn from the Office of Management and Budget (OMB) review process.  It is widely believed that the “cause of death” for the Guidance … Continue Reading

RECAP: Highlights from the Sixty-Ninth World Health Assembly in Geneva, May 23rd to 28th

Every year in May, the health ministers from all 194 World Health Organization (WHO) Member States meet at the WHO headquarters in Geneva to attend the World Health Assembly (WHA). As the decision-making body of WHO, the WHA is responsible for reviewing and adopting global health strategies, determining the policies of the organization, and reviewing … Continue Reading

What Physicians Need to Know About the New California End of Life Option Act

On October 5, 2015, the California legislature passed the “End of Life Option Act” (the “Act”), which permits physicians to prescribe an aid-in-dying medication to terminally-ill patients.  The Act is set to take effect on June 9, 2016.  While health care providers will be obliged to give terminally-ill patients information about their end of life … Continue Reading

Top 5 Actions to Consider for the New York Not-for-Profit Law Overhaul Effective on July 1

On July 1, 2014, the New York Nonprofit Revitalization Act (the “Act”) took effect.  The Act is the most significant modification of New York’s Not-for-Profit Corporation Law (the “NPCL”) in approximately 40 years. New York not-for-profit corporations that have not already fully considered actions that are necessary to comply with or to take advantage of … Continue Reading

Lessons From A Cautionary Tale of Electronic Discovery Pitfalls in Health Care Litigation

E-discovery is especially challenging in healthcare related litigation due to the healthcare industry’s reliance on electronically stored information (ESI), the volume of medical records often at issue in health care litigation, especially, qui tam litigation, the time periods often at issue given the lengthy statutes of limitations and the relevance of the information that the records … Continue Reading

Proposed health IT strategy aims to promote innovation

On April 7, 2014, the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) released a draft report addressing a proposed strategy and recommendations on an “appropriate, risk-based regulatory framework pertaining to health information technology.”… Continue Reading

Provider Sponsored Health Plans

We are pleased to share an article written by Dennis Eder and Hank Osowski, titled “Provider Sponsored Health Plans,” available here.  It has been our privilege to work closely with Mr. Eder and Mr. Osowski, co-founders and managing directors of Strategic Health Group, to advise our shared provider-clients regarding the challenges and rewards of becoming … Continue Reading

Mobile Medical App Regulations on the Move – Proposed Bills To Further Alter the Regulatory Landscape of Mobile Medical Applications

Apple’s apps store lists close to a 100,000 health apps.  Together with wearable technology, direct-to-consumer testing services, and greater consumer participation in the decision to purchase health insurance, the healthcare market in the United States is undergoing a significant transformation.  Whether and how to regulate this evolving market is subject to substantial discussion and debate.… Continue Reading

Interstate Medical Licensing Compact Could Pave a Smoother Path for Telemedicine Providers

One of the largest hurdles to the growth of telemedicine – streamlined physician licensure in multiple states – soon may be addressed.  The Federation of State Medical Boards (FSMB) will vote on adopting the federation’s Interstate Medical Licensure Compact at its annual meeting in April.  The FSMB is a national non-profit organization representing all medical … Continue Reading

California Court of Appeal Makes It Easier to Add Business Owners to a Judgment

Individuals form limited partnerships, limited liability companies and corporations to limit their personal liability.  These legal structures encourage entrepreneurs to take risks.  The California Court of Appeal, Second Appellate District, however, has made it easier to add a business owner to a judgment that initially was entered only against the corporate or limited partnership entity … Continue Reading

The FDA Releases Long-Awaited Final Guidance on Mobile Medical Applications

On September 23, 2013, the U.S. Food and Drug Administration (the “FDA” or the “Agency”) issued long-awaited final guidance for developers of mobile medical or health applications (or “mobile medical apps”) used on smartphones and other mobile devices. The final guidance reflects a tailored approach by the Agency to analyzing mobile medical apps, and represents … Continue Reading

Thinking Ahead – Opinions About Trends and Challenges in Today’s Healthcare Industry: What Next for WellPoint After the CEO Selection?

This week brought the announcement that WellPoint Inc. selected Joseph Swedish to become its next Chief Executive Officer. Swedish will leave his position as CEO of nonprofit Catholic health system Trinity Health, which has grown to almost $12 billion in assets under Swedish’s leadership and is moving through a merger to become the fifth largest … Continue Reading
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