At a press conference in 1986, President Ronald Reagan said he felt the nine most terrifying words in the English language were “I’m from the government and I’m here to help.”
Many health care innovators know the chill, wondering whether some well-intentioned arrangement might techno-legally run afoul of some chapter or verse of an anti-kickback or coding or other law. Most of these laws come from a good place: a bad thing happened in the world and enough people believed it might not fix itself that they brought the problem to Uncle Sam. But because health care plays such an important safety net function, and also because the government is the biggest player in it — think Medicare and Medicaid and CHIP and the VA — the uncle has gone a little nuts.
One area where health care innovation may be bumping against unintended consequences of a well-meaning law is the Ryan Haight Online Pharmacy Consumer Protection Act. It was enacted in 2008 to regulate internet prescriptions after Ryan Haight, an active 18-year-old, overdosed and died after taking Vicodin he obtained a prescription for from a physician online that was then dispensed from an online pharmacy.
The act added much-needed restrictions on obtaining controlled substances like Vicodin and Klonopin online. It also included the requirement that a prescriber must initially evaluate a patient in person in order to prescribe a controlled substance, regardless of why it was being prescribed. According to the law, that means a medical evaluation “conducted with the patient in the physical presence of the practitioner.”
As an initial reaction to the heartbreaking story of Haight, this seems like a no-brainer preventive step by well-meaning lawmakers to stop the tragic overdoses that have become all too familiar. However, the act that bears Haight’s name is now inadvertently putting the brakes on a huge innovation in health care accessibility: digital health.
The enemy the act seeks to fight is online pill mills, the thoughtless dispensers of prescriptions in exchange for light work (or no work) that can lead to illicit distribution, substance use disorder, overdoses, and deaths. The assumption here is that virtual providers are more likely to be fooled — or to be phony — than in-person ones. Interestingly, many of the pill mills in Florida that poured gas on the fire of that state’s opioid epidemic were largely in-person clinics, not telemedicine providers.
Juxtaposed against this polemical narrative against telemedicine is the simple fact that digital health, by eliminating the massive barriers to access bound up in medical office buildings, expensive equipment, and extensive staffing, is yielding a better understanding of patients, the determinants of their health, and the opportunities for cure than in-person providers have ever been able to do.
The advent of digital health represents an unprecedented shift in how people access health care and achieve overall health equity. Untethered from geography, health care organizations now have the ability to match the right provider with the right patient at the right time, no matter where the patient or provider may live and work.
Take substance use disorders as an example. Americans in all parts of the country grapple with addictions, but the availability and quality of treatment they can access varies highly. Virtual-first providers like Workit and Bicycle Health are working to invert this paradigm by bringing equitable, personal addiction treatment to areas currently underserved by providers. They’re actively contributing to some of the most cutting-edge research in the substance use disorder space. Yet their missions are drastically curtailed by the simplistic ordinances built with a pre-digital mindset that the Ryan Haight Act and some state-specific regulations impose.
In finding solutions, it’s useful to ponder this basic question: Do all patients benefit from in-person exams? The answer, in short, is no.
An exam is an adjunct to clinical decision-making, not a substitute for it. There is no evidence that in-person exams reduce unnecessary or harmful controlled substance prescribing (and recall that many of the pill mills in Florida and elsewhere were in-person clinics). And though overprescribing opioids has been deadly and heinous, there are many medications considered to be controlled substances that are prescribed in a wide range of everyday common scenarios in which a physical exam adds nothing to the clinician’s medical decision-making.
To offer a few common examples, a primary care clinician may need to prescribe: two lorazepam tablets to a man with flight anxiety; one week of guaifenesin with codeine for a woman recovering from mild bronchitis to quell her cough at night; or a stimulant to help a patient with ADHD function at work.
Requiring patients in similar circumstances to haul themselves into a medical office for an exam that has no clinical utility is a harm that should not be encouraged. Unnecessary testing, even unnecessary exams, often lead to incidental findings. The subsequent cascade of workups are always costly, and at times harmful to patients. A trusting physician-patient relationship, a thorough evaluation — with the physician or app determining the need for an exam — and close follow-up from a dedicated care team are what is actually critical in these situations, not a perfunctory exam.
Instead of an arbitrary requirement for a physical exam, safe, appropriate prescribing for both in-person and virtual care providers should include full knowledge of the patient’s health history and an accessible, trusted, longitudinal prescriber. In addition to knowledge of the patient and a longitudinal relationship, prescribers must follow evidence-based practices, a prerequisite for care in any setting, assisted by robust clinical decision support.
Obtaining a patient’s historical health history from other care institutions could be modeled after a standard designed to prevent money laundering, called Know Your Customer. Before a consumer can open an account and start a business relationship with a bank, that financial institution must make efforts to prove the identity, suitability, and inherent risks of that individual in order to reduce fraud and abuse. Tools and techniques vary and have changed over the years, from agents manually checking documents in person to knowledge-based questions and two-factor authentication. Today, we are beginning to see frictionless KYC in minutes with selfies and mobile pictures of key documents.
Such tools can be brought to bear on the problem of identity in health care and, with it, unlock safer online engagement between patients and providers for prescribing. With this kind of patient history, we imagine a wide range of checks and balances being baked into the software that gates prescriptions: Have you collected the patient’s past medical history from claims and charts across the rest of the health care system? Have you reviewed that history with the patient? Are there abnormal numbers of refill requests in a patient’s digital prescription history?
These are vastly more powerful mechanisms to stop misuse and abuse than the pure notion of being in the same room — once — without any historical knowledge or data.
Digital health innovations are already transforming accessibility and longitudinal relationships between patients and physicians. On average, in a bricks-and-mortar primary care practice, people between the ages of 18 and 65 interact with their primary care physician one to two times per year. Before the pandemic emerged in the U.S. in March 2020, these were almost exclusively in-person visits. In a virtual-first primary care practice such as ours, Firefly Health, hassle-easing technology and the lack of pricey overhead enables an unprecedented level of access between patients and their trusted care team. In a virtual-first primary care model, patients interact with their care teams on average 41 times per year. This near-continuous care helps develop deep, trusting relationships between patients and their care teams and increases the overall quality of care — exactly what the Ryan Haight Act was trying to achieve.
Our company and others, like Ria Health, which focuses on alcohol use disorder, Oshi Health, which focuses on gastrointestinal disorders, and many more are taking the cost of a physical plant and plowing it into high-tech access that provides quick response times and comprehensive care. These companies have in common a vastly more contextual, intimate understanding of their patients than in-person care generally allow.
And the class of outdated legislation and regulation that the Ryan Haight Act represents could end these budding revolutions before they’ve begun.
Americans now know, probably more than we ever wanted to, the degree to which we can function with virtual connections. And that can often be more efficient than connecting in person — if we can bring our laws along with us.
If the thousands of new venture-backed digital health companies that are making an early impact on the cost and accessibility of health care are prevented from writing essential prescriptions just because they are virtual, a vast unintended harm will be done. Digital health parity is not just about payment — it also needs to include parity in prescribing regulations. Without such parity, the provider monopolies that exist today in various regions will again be rid of their most important disrupters, along with some of the most important changes in health care seen in years.
We are sure there are other ways of accomplishing the goals of preventing patient harm that are better than the anachronistic Ryan Haight Act and are open to any of them. Mandating a superfluous in-person exam is an indiscriminate barrier to access and high-quality care. As an industry and a country, let’s focus the conversation on enabling digital health innovation to improve access to care for all.
Nisha Basu is a primary care physician and medical director at Firefly Health, a virtual-first primary care practice and health plan, and part-time lecturer at Harvard Medical School. Jonathan Bush is the co-founder and chief executive officer of Zus Health, a health care technology platform vendor, and executive chairman of Firefly Health.
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