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Guidance (the “Guidance”) first issued by the Health Resources and Services Administration (HRSA) in August of 2015 was withdrawn from the Office of Management and Budget (OMB) review process.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 was the Trump Administration’s January 20, 2017 Memorandum (the “Memorandum”) directing agencies to immediately withdraw all unpublished regulations pending before OMB.[1]
Continue Reading The 340B Program Omnibus Guidance: Not Ready for Prime Time

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 and approving the program budget. At the 69th WHA — which took place from May 23rd to 28th — Member States approved several highly anticipated and historic resolutions concerning WHO governance reform, emergency response capacity, and priority setting for the 2030 Sustainable Development Agenda.
Continue Reading RECAP: Highlights from the Sixty-Ninth World Health Assembly in Geneva, May 23rd to 28th

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 options, including their right to request aid-in-dying medication, provider participation in the Act is completely voluntary.  Furthermore, healthcare organizations have a limited ability to actively prohibit their employees and independent contractors from participating in certain end of life activities authorized by the Act.

This blog post will provide physicians with a brief overview of their rights and obligations under the Act. The information herein will be of particular import to medical groups as they navigate service agreements with healthcare partners that wish to opt-out of the Act.


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

As reported in the New York Times, Walmart has taken the plunge into the retail primary care healthcare delivery market.  Walmart has opened six primary care locations in South Carolina and Texas and plans to open another six by year end.  These primary care clinics are intended to offer a broader range of services than the approximately one hundred acute care clinics leased by hospital operators at Walmart locations across the country.  Walmart’s strategy is to include and focus on chronic disease management, especially in areas where doctors are scarce such as rural areas.
Continue Reading The True Meaning of “Save Money. Live Better” – Walmart Enters the Primary Care Market

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 the Act should do so now. 


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

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 contain.  A May 8, 2014, Report and Recommendation (Report) on a motion for sanctions alleging spoliation of medical records, in U.S. ex. rel. Elin Baklid-Kunz v. Halifax Hospital Medical Center et. al., offers a cautionary tale for both in-house and retained counsel about the importance of a coordinated and meticulously executed plan for producing electronically stored information (ESI).  After summarizing the underlying claims and discovery issues, this article offers guidance for laying the foundation of a sound, manageable ESI production plan.
Continue Reading Lessons From A Cautionary Tale of Electronic Discovery Pitfalls in Health Care Litigation

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 Proposed health IT strategy aims to promote innovation

Is the Office of the National Coordinator for Health Information Technology (ONC) overstepping its statutory authority in pursuing enhanced regulatory activity? A June 3, 2014 letter from the House Committee on Energy and Commerce to ONC explores this very question.[1]
Continue Reading House committee questions authority of a DHHS staff division to regulate health IT

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

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 boards within the United States.  The telemedicine policy is a newly proposed licensing option under which qualified physicians seeking to practice in multiple states would be eligible for expedited licensure in all states participating in the Compact.
Continue Reading Interstate Medical Licensing Compact Could Pave a Smoother Path for Telemedicine Providers