During the COVID-19 pandemic, the government extended much-needed flexibilities surrounding telehealth to facilitate access to care. Many of these flexibilities were lifesaving. This included allowing the prescription of controlled substances via telehealth to treat substance use disorders and psychiatric conditions.
Background
Prior to the pandemic, in most instances, a patient required at least one in-person medical evaluation before a provider could prescribe a controlled substance via telehealth. That requirement comes from the Ryan Haight Act of 2008. In 2001, eighteen-year-old Ryan Haight died from a prescription painkiller overdose. He used the internet to obtain a prescription and purchased the drugs from an on-line pharmacy.
Ten years after enacting the Ryan Haight Act, Congress recognized that the in-person visit requirement may be too stringent when there are safeguards in place and sound medical reasons for prescribing medications via telehealth. This was especially true as the country struggled (and continues to struggle) through the opioid epidemic. Congress responded with the SUPPORT Act of 2018, which, among other things, directed the US Drug Enforcement Agency (DEA) to create regulations establishing a special telehealth registration, which would eliminate the in-person visit requirement for registered providers.
The DEA had 12 months from the SUPPORT Act’s effective date, October 24, 2018, to create such regulations. The 12-month deadline came and went. Then the pandemic arrived, which ushered in flexibilities that rendered the special telehealth registration moot during the public health emergency (PHE). Now the PHE is about to end and so are the flexibilities under the Ryan Haight Act.
After the End of the PHE
After reflecting on the success of telehealth during the pandemic, federal and state governments codified many of the PHE-era telehealth flexibilities. Therefore, the end of the PHE on May 11, 2023 will have limited impact on telehealth service delivery in many areas. The flexibilities extended under the Ryan Haight Act, however, have not been extended or codified.
Many expected that the DEA would fill this gap by issuing the long overdue special telehealth regulations. After all, the agency had nearly five years to iron out the details and three years of experience with successful telehealth prescribing of controlled substances without in-person visits. Unfortunately, the DEA took a different approach.
The Proposed Rules from the DEA
On February 24, 2023, instead of proposed or interim final regulations on the much-anticipated special telehealth registration, the DEA issued two proposed rules purporting to adopt flexibilities. One proposed rule applies to the prescribing of non-narcotic Schedule III-V controlled substances via telehealth and the other addresses the induction visit for buprenorphine via telehealth. Neither follows Congress’ directive that the DEA create a special telehealth registration.
In short, the proposed rules provide only a 30-day flexibility for telehealth prescribing before an in-person visit is required and both would impose significant administrative burdens. Neither provides any meaningful flexibility and both create barriers to care.
Notably, in a footnote, the DEA brushes off Congress’ directive to create a special telehealth registration by saying:
In the SUPPORT [Act] . . ., Congress required DEA to promulgate regulations concerning such special registrations. [] This instance of rulemaking, which sets forth circumstances under which telehealth encounters may result in the prescription of controlled substances without an in-person evaluation and also provides safeguards for such prescriptions, is consistent with, and fulfills, DEA’s obligations under both the Ryan Haight Act and the SUPPORT Act.
I suspect that the DEA will hear more about its blatant disregard of Congress’ directive during the comment period and it may also get an earful from Congress.
Brief Overview of the Proposed Rules
The proposed rules seek to amend the same federal regulations, but one applies only to Schedule III-V non-narcotic drugs and the other to buprenorphine induction. The DEA offers a 1-page summary of the proposed rules. While the summary is helpful at a very high level, it does not include important details including those on the substantial administrative burdens the rules would create. Below is a brief overview of both proposed rules that provides additional detail.
Telehealth Prescribing of Controlled Substances When the Practitioner and Patient Have Not Had a Prior In-Person Visit (the Telehealth Prescribing Proposed Rule)
The Telehealth Prescribing Proposed Rule has three key components: (1) conditions applicable to prescribing controlled substances via telehealth, (2) the 30-day exception to prescribing without an in-person evaluation, and (3) the details on how a referring provider’s in-person evaluation can satisfy the Ryan Haight Act requirement. Below are the highlights.
Conditions Applicable to Prescribing Controlled Substances via Telehealth
- Issued pursuant to a telehealth encounter and for a legitimate medical purpose;
- Prescribing practitioner is located in the United States at the time of the telehealth encounter;
- Prescribing practitioner is DEA-registered and authorized to prescribe the controlled substance (or is exempted from those rules);
- The prescription must note that it has been issued based on a telehealth encounter; and
- Audio-only encounters permitted on the narrow basis set forth in a recent CMS rule (must be related to treatment of a “mental health disorder”; must be provided in the patient’s home (flexible definition); and the provider must be capable of offering a video visit but the patient either refuses or does not have the capability to engage in a video visit (reason must be documented)).
Prescription without an in-person evaluation
- Limited to Schedule III-V, non-narcotic medications;
- Limited to a 30-day supply, which may result from multiple prescriptions so long as the total supply does not exceed 30 days; and
- Prescribing provider must check the Prescription Drug Monitoring Program (PDMP) for history over the past year or the available period if less than a year is available.
- After 30 days, prescribing provider cannot issue additional telehealth prescriptions unless a qualifying medical evaluation occurs. The following will qualify:
- in-person evaluation with the prescriber;
- Three-way communication where the patient is physically present with a DEA-registered practitioner and the prescribing provider is remote by video conference (audio-only not allowed) to observe the evaluation (substantial documentation requirements); or
- a DEA-registered or exempt practitioner who treats the patient performs an in-person evaluation of the patient and issues a written referral (substantial documentation requirements).
Referring provider performs in-person evaluation
- Any controlled substance the prescribing practitioner is authorized to prescribe can be prescribed after such referral;
- Documentation requirements must be met;
- Prescribing provider must check the PDMP for history over the past year or the available period if less than a year is available.
Expansion of Induction of Buprenorphine via Telehealth Encounter (Buprenorphine Telehealth Induction Proposed Rule)
The Buprenorphine Telehealth Induction Proposed Rule applies only to Schedule III-V narcotic drugs specifically used for maintenance or detoxification treatment of an opioid use disorder (OUD). Buprenorphine is currently the only FDA-approved drug that fits this description (it includes Suboxone, which contains buprenorphine).
In summary, the Buprenorphine Telehealth Induction Proposed Rule would allow the induction of buprenorphine treatment and provision of a 30-day supply of buprenorphine via telehealth so long as permitted by state law and an in-person evaluation was conducted within 30 days of providing the prescription. Many of the proposed rules outlined above also apply here including those related to documentation and audio-only visits. In fact, the DEA asked for comment on whether the two proposed rules should be combined.
Comment Period
Both proposed rules are subject to a 30-day comment period. The DEA officially published the rules on March 1, 2023. Comments must be received by March 31, 2023. Electronic comments can be filed here.
Conclusion
What does all of this mean for providers trying to determine what to do come the end of the PHE? Since it is unlikely that the DEA will issue a final rule before May 11, 2023, it is best for providers to revert back to the Ryan Haight Act requirements as of May 12, 2023 (i.e. perform in-person evaluations prior to prescribing) unless the DEA issues other guidance or direction before then.