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Many times, larger scale concerns and emergencies can be directly tied to ill-suited regulations that have deep and consequential effects on the population. President Trump’s announcement on October 26 that the Department of Health and Human Services would declare a 90-day public health emergency in response to the opioid addiction crisis shines the light on the severe lack of health services available to rural, middle America, and specifically around the dated regulations that govern Telehealth services. We need updated regulations that do not disenfranchise the lesser populated demographic, and we want to work with you together to do so.

Working with thousands of clients across the nation, we see the challenges and opportunities that you face with this. We want to partner together and help providers expand their delivery methods and expand their capabilities in who they can reach and serve. Know that this is top of mind for us, and that our legal team is working on this. Please read on for our Microsoft Health Legal team’s views regarding this announcement and the call for updating the regulations around Telehealth.

Steve Mutkoski, Government Affairs Director, Microsoft Worldwide Health and Nathan Leong, Lead Counsel, Microsoft U.S. Health & Life Sciences

The Department of Health and Human Services declaration of a 90-day public health emergency in response to the deadly opioid addiction crisis plaguing the country is a welcome initial step for citizens and their communities who are bearing the burden of this serious public health crisis.  One element of declaration opens up the option for telehealth services to be more widely used to aid patients struggling with addiction by allowing use of those services to prescribe medications related to drug addiction and mental health issues.  This modest policy change is welcomed, but it also highlights a need for a deeper conversation about a more comprehensive update to the federal and state regulatory frameworks that have resulted in our healthcare system missing out on the tremendous potential of telehealth, including remote diagnosis, care and monitoring.

When we talk to customers about Digital Transformation in healthcare, we inevitably wind up talking about telehealth and the potential that technology has to offer increased access to care for patients, as well as reducing costs of treatment through use of new communications and monitoring technologies.  Despite wide availability of technologies that allow reliable, safe and secure video and data connections between patients and physicians, the U.S. healthcare sector as a whole has been slow to utilize such technologies.

The complex regulatory framework governing telemedicine is a major cause of this failure to better leverage telemedicine.  The specific mention of telemedicine in the President’s announcement is a reference to regulatory restrictions imposed by the Ryan Haight Online Pharmacy Protection Act of 2008, which effectively prohibits physicians from prescribing controlled substances electronically until the physician has met the patient in person (we oversimplify here slightly, but that is how many practitioners have come to interpret the Act).  Of course that restriction was put in place to prevent electronic prescribing of the very medications that have caused this crisis, but ironically the restriction prevents prescribing of anti-addiction medications such as methadone and suboxone via telehealth consultations.

Although removing this barrier is a positive initial step, there is so much more we must do to foster an environment of telehealth innovation and reach even more of our citizens in need. The Centers for Medicare & Medicaid Services (CMS) regulations governing the reimbursement of telemedicine are certainly one place to start rethinking the current regulatory complexity and inhibition.  Issued in 1997, they set the tone early on by allowing only very narrow opportunities for reimbursement of telemedicine services.  The original regulations permitted reimbursement only for a very limited set of engagements which are, effectively, referrals to a remotely located specialist from the primary provider’s location (an “eligible originating site”).  This inauspicious beginning for the regulation of telehealth in the U.S. is something we have not yet overcome, even with subsequent amendments that have sought to slightly broaden the reimbursement of telehealth by CMS.  The current iteration of the regulations permit reimbursement only for telemedicine in “non-metropolitan statistical areas” (aka, rural areas), still require the require the patient to be at an “eligible originating site,” and require the use of a “interactive telecommunications system” (which to be clear, would rule out many of the modern tools that we use in everyday life to communicate with family, friends and co-workers).  The flaws in the regulations are clear:  We know that telemedicine would bring benefits to non-rural areas as well and the restrictions on the “originating site” and allowable means of communication are at odds with the way people use technology to communicate and conduct their affairs today.  While the CMS regulations obviously don’t apply to all payors and providers, they have heavily influenced state regulations and they have created an environment in the U.S. healthcare system that is not receptive to the uptake of telehealth more broadly. 

While outdated regulations have impeded the utilization of telehealth services in the U.S., they have not deterred work all work, including work to confirm the clinical science of telehealth.  A number of studies have demonstrated that telehealth services work as well as in person visits to physicians, and the results are incredibly positive as studies look into specific treatments, including for diagnosis and care related to diabetic retinopathy, heart failure and mental health and drug addiction.  In addition to these formal studies showing the efficacy of telehealth services, we know from powerful stories our customers share with us, from both here in the U.S. and around the rest of the world, of the amazing potential of telehealth and telemedicine services.  We are seeing success with telemedicine whether its enabling access to services where physicians with appropriate specialization and patients are geographically separated, making it more convenient for patients to get a critical annual eye exam without a visit to another provider or making it easier for patients to seek help for ailments such as mental health issues that have social stigma attached to them.  And we are seeing our customers and partners push well beyond the dated confines of what would be reimbursed under the CMS regulations, for example by creating modern systems of engagement that utilize the full range of communications technologies to stay connected with recovering addicts 24/7, leading to significant gains for the percentage of their patients that abstain from drugs for 12 months after treatment.

We welcome the pending rule change to broaden slightly the use of telehealth services in treating opioid addiction, but as we highlight above, it is time for a more comprehensive overhaul of telehealth regulations that brings us into the 21st Century and allows us to better meet healthcare needs with the modern technologies that we have all integrated into our daily lives.  We close by asking our customers and partners to share with us their challenges with and questions about the telehealth regulatory landscape and we urge them to consider reaching out to regulators and policymakers to call for the updating of these regulations.