Health Care

The Massachusetts Department of Public Health (DPH) has provided a much anticipated pathway to enable for-profit entities to operate Registered Marijuana Dispensaries (RMDs). Which enables non-profit entities with a Provisional or Final Certificate of Registration to operate a RMD, or current applicants, to convert to a for-profit Massachusetts domestic corporate entity. 

CMS has completed the 2016 Final Part D Payment Reconciliation. Each Medicare Part D plan sponsor’s reconciliation reports will be available on October 12, 2017.

The U.S. Department of Veterans Affairs (“VA”) is taking a significant step towards expanding needed services to Veterans by proposing a rule to preempt state restrictions on telehealth.

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 9, 2017. This week's preview discusses many topics, including the Trump administration's roll back of the ACA's mandate that employers cover birth control coverage.

The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow.  Last week, the U.S. Food and Drug Administration (“FDA”)  approved a new smartphone-based "carbon monoxide breath sensor system" that measures carbon monoxide levels on a user's breath.

On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and U.S. Food and Drug Commissioner Dr. Scott Gottlieb will give the keynote addresses.

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration ("FDA") refers to as "mobile apps." The goal of this post is to provide you with a basic understanding of FDA's evolving approach to mobile apps so that you can make informed decisions about the legal consequences of your app's functionality.

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 2, 2017. This week’s preview focuses on the wake left by Secretary Price's exit, including its impact on the administration's deregulatory agenda.

Last week, ML Strategies released an Advisory providing a comprehensive review of the Republican’s efforts this past year to repeal and replace the Affordable Care Act.  

Earlier this month, Mintz’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update that looks at 23 health care-related qui tam cases unsealed in June 2017. The Update provides an in-depth analysis of six cases in which the government intervened, and discusses why these cases are notable in the health care industry.  

The second in a series of weekly blog posts covering legal issues for consideration during the early stages of development of a health app and providing best practices to help guide you through a successful launch.

A New Jersey Supreme Court case earlier this summer has New Jersey lawyers re-examining their clients’ business structures under the State's corporate practice of medicine doctrine.

On September 19, 2017, the Tennessee Department of Health ("TDOH") granted the request for a Certificate of Public Advantage (“COPA”) from Wellmont Health System and Mountain States Health Alliance. This approval paves the way for the two entities to form a single corporate entity called Ballad Health.

As Texas, Florida, and the Caribbean rebuild after the latest string of deadly hurricanes and prepare for the possibility of future storms, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) reminded health care providers of the importance of ensuring the availability and security of health information during and after natural disasters.

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of September 18, 2017. This week’s preview focuses on the prognosis for the Graham-Cassidy bill to block grant ACA funding to states, including potential roadblocks imposed by Senators John McCain (AZ), Susan Collins (ME) and Lisa Murkowski (AK).

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. 

On Monday, September 11, our colleagues in the Antitrust Section published an alert describing a developing antitrust lawsuit against Franciscan Health System (“CHI Fanciscan”): State of Washington v. Franciscan Health System, et al. No. 3:17-cv-05690 (W.D. Wash. Aug. 31, 2017).

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of September 11, 2017. This week’s preview focuses on Congress' efforts to stabilize the ACA marketplaces, as well as the proposal from Senators Lindsey Graham (SC) and Bill Cassidy (LA) to use block grants to fund Medicaid expansion and private insurance subsidies.

Since our  March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred at the Executive Branch management level.

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.”