Value-Based Change – Proposed Modifications to Stark Law and AKS May Impact Patient Engagement

If you are having trouble finding good reading material for the holidays, let me recommend to you the recent proposed changes to the Stark Law and Anti-Kickback Statute (AKS) recorded in the Federal Register by the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS).  At 154 pages, single-spaced, in three columns, there is something here for everyone who wants help falling asleep at night.  For the rest of us, there are some important nuggets to be mined from such dense proposals to change the way physicians provide care to patients in the form of value-based care arrangements. 

I will leave most of the details of what constitutes value-based care (VBC) and how the volume of CMS’s proposed amendments relating to these VBC arrangements should improve access to quality and coordinated care by patients to our friends over at Hymen, Phelps & McNamara. Their FDA Law Blog is an invaluable resource for understanding the legal implications of all the proposed changes.  Rather, I want to look specifically at how patient engagement showed up in the proposed rules and what that might mean for patients and industry.

The first thing to note is that the pharmaceutical and medical device industries are specifically excluded from OIG’s proposed changes to the AKS.  Why does this matter to those of us concerned with patient-focused policy?  Because industry has treated engagement with patients with the same consideration as they do engagement with healthcare practitioners.  In order to not run afoul of the AKS, industry must carefully document and evaluate their financial relationships with HCPs.  When it comes to engaging patients, industry conservatively tends to apply the same rules to engaging patients as they do to HCPs.  Thus, industry’s engagement with patients is limited by laws intended to prevent financial abuses that could occur between industry and HCPs.  This doesn’t make much sense. So, the hope would be that the rules could change in such a way that industry-patient interactions could flow more freely, with patients receiving suitable remuneration for their efforts (e.g. providing input during research and development or sitting on a clinical trial team) and sponsors not running into a trouble with the law.  Unfortunately, the changes being proposed by OIG currently will have no effect on industry-patient interactions.

What is included in the proposed changes is a new rule that would provide a safe harbor for certain tools and supports provided to patients to improve quality, health outcomes, and efficiency (§ 1001.952(hh)).  It’s not quite what we are looking for, but I find this an exciting development as it is evidence that OIG is contemplating the need to engage patients throughout their care pathways to improve quality of care and health outcomes. One could imagine many types of tools, particularly software as a medical device (SaMD), that could fall under this safe harbor.  The proposed language has some kinks to be worked out to ensure all the tools that could be used in these circumstances are included in the statutory safe harbors.  But, I know that several patient and industry organizations are working diligently to provide CMS and OIG with comments and suggestions that will hopefully accomplish this goal.

While much more needs to be done to carve out safe harbors for industry to engage with patients throughout the total product lifecycle and the total patient care lifecycle, I am encouraged to see movement in the right direction.  I have heard through the proverbial grapevine that changing Stark and AKS within the context of the physician-patient relationship was a politically easier path to take given the current policy-making climate.  The idea is to implement the propose changes within this limited VBC context before trying to include industry-patient provisions that may be more politically difficult to navigate.  I can respect the step-wise perspective and I am realistic that big policy changes take time.  But, it is frustrating when patients are the ones losing out as a result of political maneuvering.  We all benefit when patients have a voice in the medical product lifecycle.  Let’s use this opportunity to provide comments on the current proposed rules to remind OIG and CMS that we expect them to take up the issue of industry-patient interactions in the next round of policy change, whether it’s a political hot-potato or not.