Health Law Advisor

By Arthur J. Fried.

In what is being called an historic announcement, Department of Health and Human Services Secretary Sylvia Mathews Burwell announced on Monday the setting of clear goals and timeframes for moving Medicare from volume to value payments.  The stated goals are to tie 30% of all Medicare provider payments to quality and cost of care by 2016, moving to 50% by 2018.   Nearly all fee-for-service payments will be aligned with quality and value – 85% by 2016 and 90% in 2018.  This transformation will be achieved by the expansion of mechanisms already in use – Accountable Care ...

On January 9, 2015, New Jersey Governor Chris Christie signed new legislation that will require health insurance carriers authorized to issue health benefits plans in the state—including insurance companies, health service corporations, hospital service corporations, medical service corporations, and health maintenance organizations—to encrypt personal information. Triggered by a series of data breaches involving the health information of almost a million residents, Senate Bill No. 562 (“SB 562”) was passed unanimously by both houses of the state legislature ...

As a lawyer practicing in the telemedicine space, I am rarely surprised these days.  But every once in a while I will read or hear something that stops me in my tracks. That is exactly what happened when I read a blog post by an FTC Commissioner which, among other things, calls for government policies that help facilitate greater adoption of telemedicine.  The post was part of a broader piece about the FTC's role in promoting competition and innovation in health care.

By way of quick background, the Federal Trade Commission is the federal agency charged with protecting ...

When FDA published its draft guidance Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices in June 2014, I, like many others with an interest in pharmaceutical and medical device promotion, believed that the issue of social media promotion of drugs and medical devices was largely settled. Even with the limited concessions offered by FDA to reduce the traditional risk disclosure requirements, absent a substantial shift in FDA's position, Twitter was not going to be a medium that ...

FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.

The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are "low risk" and are intended to:

1. Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
2. Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy ...

Our colleague Joshua A. Stein authored Epstein Becker Green’s recent issue of its Take 5 newsletter.   In this special edition, Josh focuses on the 25^th Anniversary of the ADA and recent developments and future trends under Title III of the ADA. 

1. Website Accessibility
2. Accessible Point-of-Sale Devices and Other Touchscreen Technology
3. Movie Theater Captioning & Audio (Narrative) Description
4. The Availability of Sign Language Interpreters at Health Care Facilities
5. “Drive By” Design/Construction Lawsuits

• H-1B Nonimmigrant Season Opens on April 1, 2015, for Fiscal Year 2016
• President Obama Issues Executive Order on Immigration
• States Sue to Enjoin the Executive Order
• Federal Court in the District of Columbia Allows Worker Challenge to OPT Program
• DOS Issues New J-1 Rules for 2015
• DOS Issues January 2015 Visa Bulletin 

At the January 8-9, 2015 FDA public meeting on the agency's proposal to regulate a portion of lab developed tests (LDTs), there was much debate regarding whether FDA has jurisdiction over IVDs made at clinical laboratories. Not coincidentally, on January 7, the day before the meeting, the American Clinical Laboratory Association released a white paper developed for the Association by a couple of prominent constitutional law scholars.  The paper outlined the arguments at a high level against FDA jurisdiction over lab developed tests generally. But with all due respect to the authors as well as the speakers at the FDA public meeting, the discussion to date is taking place at such a high level that I do not find it particularly helpful. Mostly the discussions merely stake out the positions held by interested parties. They don't advance the collective understanding of the issues.

In connection with the public meeting, I developed five questions which help me think through the legal issues. I'd like to share those questions, in an effort to drive the discussion to a more granular level where differences can be more effectively debated and resolved. In addition, as with any lawyer, I'm drawn to precedent, so I'd like to share how FDA has tackled similar issues before. At the end of this post, based on precedent but also my conclusion that both sides are overstating their legal positions, I offer a path forward down the middle-of-the-road.

5 Questions That Frame FDA Authority Over IVDs Made at Labs

In posing these questions, I start with the most basic and simple and then move closer and closer to the current facts. In each case, I'll also give you what I think the answer is.

Last week both CDER and CDRH released a list of guidance documents they intend to develop or finalize over the next year.  However, it is interesting to note that the approach and information provided by each FDA center diverged significantly.  CDRH provided details as to the priority of guidances they plan on developing, offered specific metrics they will use to measure success, and opened up a docket to receive stakeholder comments.  CDER also provided a list of guidances; however the process to administer comments and specificity on what guidance documents would be prioritized was ...