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. For example, you may hire an app developer. Or perhaps you will take advantage of a cloud-based hosting platform that enables you to build a secure health app leveraging a third party’s infrastructure, such as Amazon or Google. Perhaps your app will integrate patient education content from a medical publisher or rely on analytics from an industry data aggregator. Careful contracting with third parties who provide these services and components will be critical to your health app’s success.  This fifth installment of our series will outline contracting principles for the construction of a health app. Continue Reading Building a Health App? Part 5: Contracting for Health App Construction

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. It also discusses the suit that California and 18 other states and the District of Columbia have filed in response to the Administration’s decision on CSR payments.

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). Health care extenders refer to a number of temporary policies that need reauthorization or annual appropriations, including but not limited to, the Children’s Health Insurance Program (CHIP), the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program, community health center funding, therapy caps, special needs plans (SNPs), and Medicaid disproportionate share hospital (DSH) payment reductions.

In this post we will discuss Medicaid DSH funding cuts and recent activity to address such cuts. Continue Reading Disproportionate Share Hospital Payments: A Minibus Rider

 

The Massachusetts Department of Public Health (DPH) has provided a much anticipated pathway to enable for-profit entities to operate Registered Marijuana Dispensaries (RMDs).  DPH’s Medical Use of Marijuana Program (the “RMD Program”) has released Guidance for Registered Marijuana Dispensaries Regarding Corporate Conversion, pursuant to Section 72 of An Act to Ensure Safe Access to Marijuana (Chapter 55 of the Acts of 2017, or the “2017 Act”), 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.  Continue Reading Massachusetts DPH Clears the Air for For-Profit Conversion of Medical Marijuana Dispensaries

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.

By way of background, the Medicare Part D reconciliation process is intended to ensure that the federal government pays each Part D plan sponsor appropriately. To arrive at the reconciliation report, CMS : (1) reviews data provided by the plan sponsor and other sources throughout the year, (2) considers what a plan sponsor paid for drugs during the plan year, what direct and indirect remuneration (DIR) a plan sponsor paid to or received from outside parties, and the total value of prospective payments made by CMS to the plan sponsor for the plan year, and (3) determines whether additional money is owed to or from the plan sponsor. Continue Reading CMS Completes Final Medicare Part D Reconciliation for 2016

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. The sensor, which is intended to help users quit smoking, tracks the real time effects of a user’s smoking behavior.  And just a few weeks ago, the FDA gave its approval to a cognitive behavioral therapy app to be used in outpatient therapy for substance use disorders related to alcohol, cocaine, marijuana and stimulants.  Continue Reading Building a Health App? Part 4: Avoiding an FTC Enforcement Action

Correction: An earlier version of this post incorrectly noted that the American Medical Association opposed the rule. The post has been updated to include the AMA’s full statement expressing support for proposed rule. [October 10, 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.

Most states currently restrict providers (including VA employees) from treating patients that are located in that state if the provider is not licensed there. As a result, the VA has had difficulty getting a sufficient number of providers to furnish services via telemedicine for fear that they will face discipline from those states for the unlicensed practice of medicine. Continue Reading Department of Veterans Affairs Aims to Trump State Telemedicine Rules

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. It also discusses Congess’ work on health extenders, CHIP, and the community health centers program, among other things. The preview also touches on MedPAC’s recommendation that CMS replace the Merit-based Incentive Payment System (MIPS) which the group believes is too much of a burden on physicians.

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. Part of the goal of the workshop is to identify obstacles to competition and discuss policy steps that can increase the availability of generic drugs to consumers.

The Hatch-Waxman Act (the Act), which Congress passed over 30 years ago, provides a regulatory and judicial framework to expedite generic entry into U.S. prescription drug markets. For many drugs, the Act has helped reduce patent-related barriers to generic drug entry, which, in turn, has increased competition that has led to lower drug prices. In 2010, Congress created a similar framework for biosimilar drug development under the Biologics Price Competition and Innovation Act. Continue Reading Federal Trade Commission Announces Workshop on Competition in the Prescription Drug Market

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. Continue Reading Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps