Talk to your doctor about your LEP… and their LAP

It sounds like a pharmaceutical advertisement, doesn’t it? You can imagine some animated body part tugging a person towards a restroom, a fuzzy rendition of a cat coaxing us to sleep or, my favorite, a couple reclining in a pair of bathtubs, all working to convince us to counter our LEP.  But to paraphrase the immortal Inigo Montoya, “I do not think that word means what you think it means.”

While we could talk for hours regarding the wisdom of direct-to-consumer advertising in the pharmaceutical industry, that is not what we are talking about here.  LEP is not a medical condition, but it is so serious it can derail a medical practice. 

The Affordable Care Act (ACA) includes many provisions regulating the way physicians practice, and section 1557 prohibits discrimination. Discrimination is central to concerns over LEP.  Many may be surprised to learn that failure to take reasonable steps to provide meaningful access to patients with LEP – Limited English Proficiency – can result in suspension from Federal Healthcare programs, the DOJ may bring suit for a civil rights violation against the provider, and more. 

The Department of Health and Human Services has drafted a list of the fifteen languages most commonly encountered by US providers (see Top 15 Languages by State). Providers are obligated to take reasonable steps to ensure meaningful access to these groups. Do these regulations mean Texas physicians need to hire a Gujarati interpreter? An Alaskan clinic an Ilocano translator? A Maine hospital a team of Nilotic speakers?  A practice may not need to add a staff of translators, but there are some specific requirements that must be addressed. And yes, expect the market for health translators to boom after this final rule for implementation of ACA Section 1557.  

Practices must post notices regarding accessibility requirements in the common languages for that locale. These can be downloaded for your locale at this HHS webpage. In addition to posting notices, a practice must have in place a mechanism for providing translator services when necessary to provide meaningful access to individuals with limited English proficiency.  These services must include translation of documents and oral interpretation. The services must be provided free of charge and in a timely manner. Lawyers will ultimately spend hours arguing over the appropriate definition of terms “timely” and “meaningful.” (Practices should be aware that in the legal world, lawyers’ hours typically equate to doctors’ dollars.)

One special caution for practices accustomed to having a staff member serve as an impromptu translator; translation services must be a part of the employee’s written job description. Practices may also want to develop a LAP – a Language Access Plan. It is not required, but as is often the case with federal regulation, having a written plan is used to determine an entity’s compliance with the regulation.

The regulation and proper implementation is Section 1557 will impact medical practices significantly, complicating the delivery of quality care even more. Practices should be proactive and address these issues now.

If you want to know more about this or other legal issues relevant to the delivery of health care, contact the Spiers Group today.

HHS, ONC, OCR, FDA, and Your Smart Devices

Smart phones are, well, smart. They are little hand held supercomputers. They have more computing power than my first home built computer; I think they can do more than my first two or three “store bought” computers as well. Indeed, NASA engineers would have loved to have something so powerful back when they used pencil, paper, and the slide rule to put a man on the moon.  (If you are like my kids, scratching your head and muttering “Slide rule? What is a slide rule?” click here for a well done piece by Elissa Nadworny at NPR.)

Phones are not the only thing getting smarter. Today we are confronted with a variety of smart devices. We can wear watches that communicate with our phones (after all, they are smart!) to track our heart rate, blood oxygen saturation, activity level, blood glucose, and sleep patterns, to name but a very few of the possibilities.  We can wear other monitors that communicate with our phones, sending even more information to the cloud – and from there we can share information with fitness rivals, friends, neighbors, and, yes, even providers. These devices can serve as motivators, trainers, record keepers, and more – all in a small package that is convenient and simple to use.

It seems only logical that we try to develop these devices to their fullest. Imagine having a device that will allow you to assess your health and well-being in your jacket pocket? That would be the epitome of personalized medicine, right? What risks are there? Aren’t we talking about something that will make medical care cheaper, faster, and more convenient? We have so many choices, surely it is a simple matter for each of us to pick the right one for our needs.

The solution is not quite as complex as the inner workings of my phone, but it is not as simple as we might think.  We have a myriad choices of apps that do a variety of incredible things. But there lies the issue; it is not the quantity of offerings, it is the quality of the offerings that is concerning.

Just as, shocking to some, everything found on the internet is not true, not every app delivers the same quality. And some have crossed a threshold that will have implications for the entire industry. Anytime we discuss quality, the conversation will invariably segue to regulation, and the opportunity for regulation gets regulators all excited. This is where we find ourselves these days; regulators ready to reach into your pocket to decide what apps you can use on your phone.

What does this mean? It could be trouble for medical app developers who have grown accustomed to little or no regulation. The industry has known this day would come. FDA, for example, has spent the better part of five years contemplating what to do in this sector.  Part of the challenge is that mobile health apps are subject to various existing laws written back in the day of the slide rule. Federal agencies have been wrestling with how to apply these laws to current technology. The US Department of Health and Human Services (HHS), the Office of the National Coordinator for Health Information Technology (ONC), the Office for Civil Rights (OCR), and the Food and Drug Administration (FDA) have produced an interactive tool that aims to allow app developers to determine what laws might apply to mobile health apps.  The tool is not perfect, but it does give some general guidance. It is a good place to start before you wade through this FDA guidance regarding mobile medical applications, this FDA portal regarding medical apps, and the OCR’s web portal addressing questions relevant to HIPAA – and the list goes on.