Archaic in-person exam law is holding back digital prescribing

AAt a press conference in 1986, President Ronald Reagan said he felt the nine most terrible words in the English language were, "I am from the government and I am here to help."

Many healthcare innovators know the cold and wonder if a well-intentioned agreement could technically-legally conflict with a chapter or verse of anti-kickback or coding or other law. Most of these laws come from a good place: something bad has happened in the world and enough people believed it wouldn't go away on its own that they brought the problem to Uncle Sam. But because healthcare is such an important safety net role and the government is the biggest player in it - think Medicare and Medicaid and CHIP and the VA - the uncle went a little crazy.

One area where healthcare innovations may encounter the unintended consequences of a well-intentioned 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.

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The law added much-needed restrictions on obtaining controlled substances such as Vicodin and Klonopin online. It also included a requirement that a prescribing physician must first personally examine a patient in order to prescribe a controlled substance, regardless of why it was prescribed. According to the law, this means a medical examination that “is carried out with the patient in the presence of the practitioner”.

As a first reaction to Haight's heartbreaking story, this seems like a simple preventative step by well-meaning lawmakers to stop the tragic overdoses that have become all too well known. However, the act that bears Haight's name is now inadvertently holding back a huge innovation in healthcare accessibility: digital health.

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The enemy the law seeks to fight is online pill factories, the mindless dispensing of prescriptions in exchange for light work (or no work) that can lead to illicit distribution, substance use disorders, overdoses, and death. The assumption here is that virtual providers are more likely to be deceived - or faked - than personal ones. Interestingly, many of the Florida pill factories that fueled the fire of that state's opioid epidemic were mostly personal clinics rather than telemedicine providers.

This polemical narrative against telemedicine is contrasted by the simple fact that digital health, by removing the massive barriers to access in doctor's offices, expensive equipment and extensive staffing, leads to a better understanding of patients, the determinants of their health, and the healing options, as personal providers are ever in were able to.

The advent of digital health represents an unprecedented shift in the way people can access health care and achieve overall health equity. Regardless of geographic location, healthcare organizations now have the ability to match the right provider with the right patient at the right time, regardless of where the patient or provider lives and works.

Take substance use disorders as an example. Americans in all parts of the country struggle with addictions, but the availability and quality of treatment to which they can access varies widely. Virtual-first providers like Workit and Bicycle Health are working to reverse this paradigm by bringing equitable, personal addiction treatment to areas currently underserved by providers. You actively contribute to some of the most cutting-edge research in the field of substance use disorders. However, your missions are drastically constrained by the simplistic ordinances created with a pre-digital mindset dictated by the Ryan Haight Act and some country-specific regulations.

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In finding a solution, it is helpful to ask yourself this basic question: Do all patients benefit from a personal examination? In short, the answer 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 prescriptions (and remember, many of the tablet factories in Florida and elsewhere were personal clinics). And while the over-prescribing of opioids has been deadly and obnoxious, there are many drugs that are considered controlled substances and are prescribed in a variety of everyday scenarios where a physical exam does nothing in the clinician's medical decision-making.

To give some general examples, a GP may need to prescribe: a man who is afraid of flying, two lorazepam tablets; a week of guaifenesin with codeine for a woman recovering from mild bronchitis to help suppress her night-time cough; or a stimulant to help a patient with ADHD function at work.

Forcing patients in similar circumstances to come to a doctor's office for an examination that has no clinical benefit is harm that should not be encouraged. Unnecessary tests, including unnecessary examinations, often lead to incidental findings. The subsequent cascade of work-ups is always expensive and sometimes harmful for the patient. A trusting doctor-patient relationship, a thorough examination - in which the doctor or the app determines the need for an examination - and close follow-up care by a dedicated nursing team are decisive in these situations, not a superficial examination.

Rather than an arbitrary physical exam requirement, a safe, adequate prescribing for both personal and virtual health care providers should include a thorough understanding of the patient's medical history and an accessible, trusted longitudinal prescriber. In addition to patient knowledge and a longitudinal relationship, prescribers must follow evidence-based practices, a prerequisite for care in any setting, supported by solid clinical decision support.

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The collection of a patient's medical history from other care facilities could be modeled on a money laundering prevention standard called Know Your Customer. Before a consumer can open an account and do business with a bank, that financial institution must make efforts to demonstrate the identity, suitability and inherent risks of that person in order to reduce fraud and abuse. Tools and techniques vary and have changed over the years, from agents manually reviewing documents to knowledge-based questions and two-factor authentication. Today we're starting to see smooth KYC in minutes with selfies and mobile pictures of important documents.

Such tools can solve the problem of identity in healthcare, enabling safer online interaction between patients and prescription providers. With this type of patient history, we envision a wide range of checks and balances built into the prescription control software: Did you collect the patient's medical history from applications and charts in the rest of the healthcare system? Did you discuss this medical history with the patient? Are there an unusually high number of refill requests in a patient's digital prescribing history?

These are far more effective mechanisms for stopping abuse and abuse than the mere idea of ​​being in the same room without any historical knowledge or data.

Digital health innovations are already changing the accessibility and longitudinal relationships between patients and doctors. On average, people between the ages of 18 and 65 in an inpatient family doctor's practice have contact with their family doctor once or twice a year. Before the pandemic broke out in the US in March 2020, these were almost entirely personal visits. In a virtual primary care practice like ours, Firefly Health, hassle-free technology and the absence of costly overheads enable unprecedented access between patients and their trusted care team. In a virtual first primary care model, patients interact with their care teams an average of 41 times per year. This near-continuous care helps build deep, trusting relationships between patients and their care teams and increases the overall quality of care - exactly what the Ryan Haight Act wanted to achieve.

Our company and others like Ria Health, which focuses on alcohol abuse, Oshi Health, which focuses on gastrointestinal disorders, and many more are taking the cost of a physical facility and investing in high-tech access that is fast Provides response times and comprehensive support. These companies have a far more contextual and intimate understanding of their patients than personal care in general would allow.

And the class of outdated laws and regulations that the Ryan Haight Act represents could end these burgeoning revolutions before they even begin.

Americans now probably know more than we ever wanted to about the extent to which we can function with virtual connections. And that can often be more efficient than connecting personally - if we can bring our laws with us.

When thousands of new venture-funded digital health companies, which have an early impact on the cost and accessibility of health care, are prevented from writing basic prescriptions just because they are virtual, great unintended damage will be done. Digital health parity isn't just about pay - it needs to incorporate parity into prescribing rules as well. Without such parity, the vendor monopolies that exist in different regions today will get rid of their main disruptors and some of the most important changes in healthcare in years.

We are sure that there are other ways of achieving patient harm prevention goals that are better than the anachronistic Ryan Haight Act and open to all. The requirement for a redundant personal examination is an indiscriminate barrier to access and quality care. As an industry and country, let's focus the conversation on enabling digital innovation in healthcare to improve access to healthcare for all.

Nisha Basu is the GP and Medical Director at Firefly Health, a virtual primary care practice and health plan, and a part-time lecturer at Harvard Medical School. Jonathan Bush is the co-founder and chief executive officer of Zus Health, a provider of technology platforms for the healthcare industry, and executive chairman of Firefly Health.

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