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On February 24, the Drug Enforcement Administration (DEA) announced its long-awaited proposal for permanent rules regarding telehealth prescriptions for controlled medications. They explained their focus on expanding patient access to critical therapies beyond the May 11 end of the COVID-19 public health emergency. Developed with the US Department of Health and Human Services and the US Department of Veterans Affairs, the proposed rules propose to extend many of the flexibilities adopted during COVID.
The proposed rule would allow telehealth prescribing for the following:
- Consultations that do not involve the prescribing of controlled medications.
- Consultations by a medical practitioner that has previously conducted an in-person medical examination of a patient.
- Consultations and prescriptions by a medical practitioner to whom a patient has been referred, as long as the referring medical practitioner has previously conducted an in-person medical examination of the patient.
Proposed Telehealth Prescription Restrictions
The DEA has taken the stance that it must provide safeguards for practitioners who see new patients who are to be prescribed a controlled substance but have not yet received an in-person evaluation of a patient. For these patients, the DEA is proposing that patients be required to obtain an “in-person evaluation or referral from a medical practitioner that has conducted an in-person evaluation, as long as the prescription is otherwise consistent with any applicable Federal and State laws. Under such circumstances, practitioners would be allowed to prescribe:
- A 30-day supply of Schedule III-V non-narcotic controlled medications
- A 30-day supply of buprenorphine for the treatment of opioid use disorder.
The American Telemedicine Association (ATA) has been leading the voice of opposition to limitations imposed on telehealth prescribing since the enforcement of the Ryan Haight Act of 2008. Following the DEA announcement, the ATA issued an immediate response, which characterized the DEA proposal as too restrictive. Their press release included the following by Kyle Zebley, the ATA’s senior vice president, public policy, and executive director, ATA Action:
The proposed rules from the DEA are significantly more restrictive than is warranted. Our concern lies with the potential public health crisis this could cause for individuals needing access to clinically appropriate prescriptions of controlled substances for a wide variety of medical circumstances, including for mental health and substance use disorders. The continuity of care for countless Americans will be severed, potentially leaving these patients to fall through the cracks of our healthcare system without access to needed medications.
He continued with the following statement:
As the ATA, ATA Action, provider groups, and patient advocates have long stated, mandatory in-person visits are clinically unnecessary barriers to appropriate care.
As suggested in the last comment by the ATA is mounting evidence that restrictions are unnecessary. Although not visible in the press release issued by the DEA, the ATA press release offers additional information about when the DEA’s final decision will take effect. The ATA press release states the following:
We appreciate some of the positive provisions offered by the proposed rules, including allowing care to be delivered uninterrupted for 180 days after the end of the COVID-19 Public Health Emergency for those prescribing relationships that have been established during the last three years.
A statement was also made by HHS Secretary Xavier Becerra, who stated the following:
Improved access to mental health and substance use disorder services through expanded telemedicine flexibilities will save lives… We still have millions of Americans, particularly those living in rural communities, who face difficulties accessing a doctor or health care provider in-person. At HHS, we are committed to working with our federal partners and stakeholders to advance proven technologies and lifesaving care for the benefit of all Americans.
The full text of the proposals is here and here. The public has 30 days to review and comment on the proposals, which DEA will consider before drafting final regulations. DEA is appreciative of the public’s feedback.
- Is My Prescription a Controlled Medication? Controlled-Non Controlled List
- Can My Medication be Prescribed through Telemedicine? Controlled Substance Guidance
- Proposed Rules Summary Telemedicine Rules Summary.pdf
- Proposed Rules Highlights for Medical Practitioners Telehealth Highlights Medical Practitioners.pdf
Where to Comment
The public can comment on the DEA’s proposed rules for 30 days. Comments are to be submitted through the Federal eRulemaking Portal, available by following the instructions for submitting comments here. The stated mission of the DEA’s Diversion Control Division is to “prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.”