U.S. Drug Enforcement Administration Proposes Permanent Tele-Prescribing Rules, Offering Registration Framework for Remote Prescription of Controlled Substances

On January 17, 2025, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (Notice) to allow for remote prescription of certain controlled substances within the telemedicine exception provided by the Ryan Haight Act (Act). The Act generally prohibits prescribing drugs without at least one “in-person medical evaluation” with a healthcare provider, but it excepts from this requirement providers “engaged in the practice of telemedicine.” During the COVID-19 public health emergency, DEA used this telemedicine exception to allow providers to tele-prescribe Schedule II-V controlled substances, implementing temporary flexibilities to that effect via a March 25, 2020, letter and a March 31, 2020, letter. DEA, the Department of Health and Human Services and the Substance Abuse and Mental Health Services Administration have extended those temporary measures three times since, with minor modifications, all while seeking industry comments on how to make the measures permanent. The regulations proposed in the Notice would create permanent tele-prescribing exceptions by constructing a framework for different providers to obtain special registration to tele-prescribe controlled substances. As these rules differ from the exceptions granted in the 2020 letters—exceptions that will expire December 31, 2025—affected providers should review the proposed regulations and prepare to register accordingly in the event the rules are finalized.

The March 25, 2020, letter permitted providers to tele-prescribe controlled substances to patients without an in-person encounter in states where they are not registered to dispense, and the March 31, 2020, letter permitted providers to tele-prescribe buprenorphine to opioid use disorder patients without an in-person encounter. The regulations proposed in the Notice offer a broader, more-segmented scheme for granting exceptions to the Act but also limit some of those permissions. The proposed regulations recognize two types of “Special Registrants”: clinician practitioners (physicians and mid-level practitioners) and platform practitioners (covered online telemedicine platforms). These Special Registrants could apply for three types of Special Registrations for Telemedicine:

  • a Telemedicine Prescribing Registration, authorizing qualified clinician practitioners to prescribe Schedule III-V controlled substances via telemedicine,
  • an Advanced Telemedicine Prescribing Registration, authorizing qualified, specialized clinician practitioners (e.g., psychiatrists, hospice care physicians) to prescribe Schedule II-V controlled substances via telemedicine, and
  • a Telemedicine Platform Registration, authorizing covered online telemedicine platforms, in their capacity as platform practitioners, to dispense Schedule II-V controlled substances.

Unlike the exceptions in the 2020 letters, however, these proposed regulations would require Special Registrants to obtain Special Registrations in each state where they prescribe. They would also require Special Registrants to conduct nationwide background checks of all patients prescribed controlled substances through this program.

Providers currently tele-prescribing under the exceptions granted by the 2020 letters have time to comply. Further, the change of administration on January 20, 2025, may result in further changes to these rules. Nonetheless, given the significant differences proposed by the Notice, and the fact that the existing exceptions will expire at the end of 2025, affected providers are encouraged to consider now what would be required for them to register under the proposed regulations.

OCR Loosens HIPAA Enforcement Amidst Coronavirus Pandemic

Let’s face it, there has not been much positive news lately surrounding the Coronavirus (“COVID-19”).  However, the Office For Civil Rights (“OCR”), the agency within the Department of Health and Human Services (“HHS”) that enforces the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy and Security Rules, announced several recent measures to allow health care providers avoid certain HIPAA penalties and sanctions amidst the COVID-19 pandemic.

There are several measures OCR/HHS has taken to lessen the regulatory burden of HIPAA for health care providers amidst COVID-19.  Here is the latest breakdown of important pronouncements and guidance set forth by OCR/HHS to help providers deal with COVID-19 and HIPAA compliance:

Continue reading “OCR Loosens HIPAA Enforcement Amidst Coronavirus Pandemic”

Telemedicine

I recently worked on a telepsych agreement for a hospital client.  Under the agreement, a distant site will provide mental status assessments of emergency department patients remotely.  Some of the issues flowing from the contract that we addressed were whether patient consent was required for the telepsych consult and how to credential the distant site providers.  Legal and regulatory requirements for patient consent vary state by state and there are credentialing options for distant site providers.  With or without a legal or regulatory requirement for patient consent, we recommended obtaining patient consent, when possible as best practice.  We addressed how our hospital client would pay the distant site providers, but one thing we didn’t address in the telepsych agreement was payer coverage for telepsych services.

We understand that 31 states and the District of Columbia require private insurers to cover telehealth, but that the laws differ state to state.  Medicaid and Medicare also cover telehealth in varying degrees.

In March, I attended a three day meeting of women business leaders in health care where telehealth was a topic in multiple formal and informal discussions.  My previous experience in telehealth had been limited to working with a few direct to consumer telemedicine platforms and intensive care monitoring.  I now know that I can get psychiatric, nutrition and a multitude of other services via telehealth.    Telehealth is expanding exponentially.  While it will never fully replace a face to face visit with a health care provider, it does offer a way to better address certain patient needs.

Stay tuned to this Blog for more thoughts on telehealth.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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