With PHE Over, Teleprescribing Regulatory Landscape Shifts

With the COVID-19 public health emergency (PHE) now expired as of May 11, 2023, the Drug Enforcement Agency (DEA) has proposed new permanent rules meant to balance the need to curb prescription abuse with the reality that more healthcare services are being provided virtually.

Unlike the swift-moving COVID-19 pandemic, the opioid crisis started long before public health officials declared it an emergency. In fact, in 2008 Congress passed a law aimed squarely at the problem. With narrow exceptions, the Ryan Haight Act made it illegal for physicians to write prescriptions for controlled substances unless they had seen the patient in person. The law was named after an 18-year-old who died from an overdose of Vicodin (acetaminophen and hydrocodone) after obtaining a prescription from a doctor he had never seen in person and filling the prescription at an online pharmacy.

In early 2020, when many people switched to telemedicine for routine medical care amid COVID-19 lockdowns, the government temporarily relaxed those rules in order to make it easier for patients to access prescription medications without leaving home.

With the COVID-19 public health emergency (PHE) now expired as of May 11, 2023, the Drug Enforcement Agency (DEA) has proposed new permanent rules meant to balance the need to curb prescription abuse with the reality that more healthcare services are being provided virtually.

Jared Kaltwasser, a regular contributor to Managed Healthcare Executive; Nioura F. Ghazni, J.D., MBA; and Sara H. Shanti, J.D., discussed the proposed changes and their potential impacts on healthcare providers. Ghazni and Shanti are partners with Sheppard Mullin, a law firm headquartered in Los Angeles.

Can you discuss the Ryan Haight Act? Why was a law such as this necessary?

Shanti: With the rapid growth and use of the internet for access to goods and services, including pharmaceuticals, the Ryan Haight Act (RHA) amended the Controlled Substances Act to prevent the dispensing of controlled substances through the internet without appropriate professional medical interaction. In short, RHA was enacted to combat the misuse of online pharmacies and websites and, ultimately, to combat the internet’s contribution to the dangerous distribution and overuse of controlled substances. To achieve this objective, RHA generally mandated that before a controlled substance could be prescribed through the internet, an in-person medical evaluation had to be conducted or an exception had to be met.

Sara H. Shanti, J.D.

How did the pandemic affect the rules for prescriptions based on virtual visits? What have been the results of the emergency rule changes?

Shanti: The PHE allowed the DEA to waive RHA’s in-person medical evaluation requirement. Balancing the need to limit the strain on healthcare and the spread of COVID-19 with the need to ensure that patients had access to medical care, the DEA allowed practitioners to more freely prescribe Schedule II-V controlled substances through telemedicine.

Ghazni: The waiver of the in-person requirement brought an immediate and significant increase of telemedicine appointments and telemedicine prescribing. While many of the original concerns contemplated by the enactment of RHA continued to be prevented, new abuses came from the heavy reliance on the waiver’s wide reach to protect remote prescribing.

Shanti: For example, after years of RHA enforcement being quiet, the DEA has recently launched a number of actions against providers for overprescribing or incentivized prescribing through telemedicine. With the increased ease of prescribing, certain controlled substances, such as Adderall (amphetamine and dextroamphetamine) have experienced shortages. As a result, some patients have struggled to get access to prescriptions that are susceptible to overprescribing.

What are the most important changes in the new proposed rules as they currently stand?

Nioura Ghazni, J.D., MBA

Ghazni: With the PHE coming to an end, the DEA announced new proposed rules to ensure telemedicine remains available and flexible. Specifically, the proposed rules extend the current PHE waiver of the in-person evaluation requirement until Nov. 8, 2023, for those patients who were first seen via telemedicine during the PHE, without an in-person medical evaluation, and were prescribed a controlled substance.

The proposed rule sets a new “qualifying telemedicine referral” exception so that a practitioner may issue a prescription for Schedule II-V controlled substances through telemedicine with a qualifying referral from a practitioner who has conducted an in-person medical evaluation of the patient.

The rule also creates a new “initial prescription” exception, allowing a practitioner to prescribe up to a 30-day initial prescription for a Schedule III-V controlled substance via telemedicine without a prior in-person medical evaluation or other qualifying referral (excluding Schedule II and narcotic substances).

Shanti: Separate from RHA, during the PHE, the Centers for Medicare & Medicaid Services (CMS) promulgated a similar waiver to ensure Medicare beneficiaries received continued access to care through reimbursable telemedicine services. The broadening of telemedicine by CMS during the PHE directly impacted the 2023 Consolidated Appropriations Act to allow Medicare beneficiaries the ability to continue to receive telemedicine at any location instead of pre-PHE limited sites, such as clinics, through Dec. 31, 2024.

Do you have recommendations or advice for healthcare organizations as they consider when and whether to allow providers to write prescriptions based on telemedicine visits?

Shanti: Documentation is key, including documenting at the onset of any telemedicine visit the RHA and state exceptions that may apply to allow for any telemedicine prescribing. Additionally, practitioners must ensure that they meet all of their professional and care standards, whether the patient is in person or virtual. Providers should also continue to be aware that billing and prescribing practices are available and tracked by regulators and, in some cases, public websites. These activities can be audited and compared against other practices to determine potential fraud or overprescribing.

Are there gaps in the regulations that you see or perhaps areas where the new rules are too strict?

Shanti: Providers are identifying extraordinary opportunities for hybrid health, which include both in-person and virtual visits and which RHA’s proposed rules appear to support. However, the industry would welcome guidance on RHA’s existing “physical presence” exception that allows for telemedicine prescribing when a patient is being treated in the physical presence of an individual DEA registered practitioner.

Ghazni: Because of personnel shortages and healthcare strains, defining key terms used under this physical presence exception would be helpful to allow providers to maximize limited resources. Finally, we note that RHA is just the floor of regulatory considerations in this space. State telemedicine laws are active in the face of the PHE’s termination and professional licensing standards must be met in order for telemedicine services to be fully compliant. Fraud, waste and abuse laws, such as Stark and the Anti-Kickback Statute, must also be carefully considered, especially related to the proposed “qualifying telemedicine referral” exception.