Please support Telehealth.org’s ability to deliver helpful news, opinions, and analyses by turning off your ad blocker. 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.
Resources
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.
Patient Resources
- Is My Prescription a Controlled Medication? Controlled-Non Controlled List
- Can My Medication be Prescribed through Telemedicine? Controlled Substance Guidance
Practitioners Resources
- 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.”
I would be very concerned of practitioners prescribing stimulants such as adder all and/or benzodiazepines such as xanax,ativan,klonipen,valium for ” mental health issues.Detox/meical withdrawal is 1 thing for 5 days but 30 days? we already have a lot of bad actors
Michael, Caution is definitely in order. I don’t know the inner working of companies that take cash payments, but proper screening to prevent doctor shopping would be essential for some of the meds you mentioned. It would be optimal for the pharmacies to be wired in so any prescriber would be able to see the patient’s history of medication purchases. That type of integration has been discussed at conferences for decades, but I don’t know how widely it is being used.
A skeptic might say that spending the needed funds to pull in pharmacy data for each potential patient before prescribing would be a low priority for some companies. The process would most likely be expensive and reduce sales.
Another often ignored issue that skeptics might mention is that Internet companies should use an evidence-based model as required by the Federal Trade Commission, but they often don’t. They just get started with a good sales pitch and try to fly under the radar until they make enough money to conduct research behind the scenes. The gamble is that no one will die or complain until they work out their models. When dangerous medications are in the mix, innocent people have to file legal complaints or die before the public learns what’s actually happening behind the scenes.
Another concern I’ve heard voiced is that the most vulnerable people in many startups are the licensed practitioners – the unwitting clinicians who think they are being avant-guard when in reality, they are being set up to be the scapegoats when people get harmed. After all, they are licensed and should know better. And their contracts have covertly-worded clauses that put the responsibility squarely on their necks alone.
I would be very concerned of practitioners prescribing stimulants such as adder all and/or benzodiazepines such as xanax,ativan,klonipen,valium for ” mental health issues.Detox/meical withdrawal is 1 thing for 5 days but 30 days? we already have a lot of bad actors
Michael, Caution is definitely in order. I don’t know the inner working of companies that take cash payments, but proper screening to prevent doctor shopping would be essential for some of the meds you mentioned. It would be optimal for the pharmacies to be wired in so any prescriber would be able to see the patient’s history of medication purchases. That type of integration has been discussed at conferences for decades, but I don’t know how widely it is being used.
A skeptic might say that spending the needed funds to pull in pharmacy data for each potential patient before prescribing would be a low priority for some companies. The process would most likely be expensive and reduce sales.
Another often ignored issue that skeptics might mention is that Internet companies should use an evidence-based model as required by the Federal Trade Commission, but they often don’t. They just get started with a good sales pitch and try to fly under the radar until they make enough money to conduct research behind the scenes. The gamble is that no one will die or complain until they work out their models. When dangerous medications are in the mix, innocent people have to file legal complaints or die before the public learns what’s actually happening behind the scenes.
Another concern I’ve heard voiced is that the most vulnerable people in many startups are the licensed practitioners – the unwitting clinicians who think they are being avant-guard when in reality, they are being set up to be the scapegoats when people get harmed. After all, they are licensed and should know better. And their contracts have covertly-worded clauses that put the responsibility squarely on their necks alone.