Health Care

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice ("DOJ") has been particularly aggressive in using the False Claims Act to pursue recoveries from individuals, health care providers, and drug manufacturers that participate in federal health benefit programs.

Consumers are increasingly turning to health apps for a variety of medical and wellness-related purposes. This has in turn caused greater amounts of data—including highly sensitive information—to flow through these apps. These data troves can trigger significant compliance responsibilities for the app developer, along with significant legal and contractual risk.

As Part of an ongoing series, we have previously provided details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program, Medicare therapy caps, and community health center funding. This post marks the first in an exploratory series illuminating the structure, funding, and outlook of the Special Needs Plans (SNPs).

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 23, 2017. The preview discusses the Alexander-Murray stabilization package introduced by Senators Lamar Alexander (R-TN) and Patty Murray (D-WA).

Last week, ML Strategies released an Advisory providing a comprehensive review of the sweeping health care legislation recently released by the Massachusetts Senate.

As you take your health app from innovative idea to reality, you will be engaging in a development project that will likely entail the procurement of technology, services and perhaps even content from third parties.

As a part of our ongoing blog series we have provided details on the structure, funding, and outlook of several expiring health care provisions, that we’ve referred to as the health care minibus. The minibus includes all of the health care extenders left behind from the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 16, 2017. The preview discusses the Administration's decision to stop paying the cost-sharing reductions (CSRs) that plans have been receiving to cover lower-income individuals under the Affordable Care Act.

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.