DEA

The Big Picture - On February 24, the Drug Enforcement Administration (DEA), in consultation with the Department of Health and Human Services (HHS), ...

On the other hand, after the PHE ends, an in-person visit will be required for a patient to sustain treatment long-term and even the flexibility to initiate treatment without an in-person visit applies only to select controlled substances; individuals who need methadone or Adderall will be required to have an in-person visit even to initiate medication. If the prescribing practitioner cannot gain access to the system or database, the practitioner may only prescribe a seven-day supply of the medication and must document the dates and times that it attempted to gain access. Given the impending end of the PHE, DEA was challenged to balance the policy goal of maintaining access to care given the ongoing opioid crisis and persistent health care access challenges with a desire to protect the public from overprescribing of controlled substances via telemedicine. The proposed rules do not include any grandfathering provisions, meaning that all patients who have never had an in-person encounter with their prescribing practitioner must have an in-person exam in order to continue being prescribed medication. Authorized practitioners have been able to prescribe buprenorphine and other controlled substances without an in-person visit as a result of DEA flexibilities combined with the Substance Abuse and Mental Health Services Administration’s (SAMHSA) pandemic flexibilities. Both the referring practitioner and the prescribing practitioner must document the referral, among other things (see recordkeeping requirements below), in their medical records. [here](https://www.federalregister.gov/public-inspection/2023-04248/telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had) and [here](https://www.federalregister.gov/public-inspection/2023-04217/expansion-of-induction-of-buprenorphine-via-telemedicine-encounter)) that address the prescribing of controlled substances based solely on a telemedicine encounter. Failure to conduct this in-person medical evaluation can constitute a per se violation of the Controlled Substances Act and result in civil and criminal penalties. Prescriptions meeting this criterion are called a “telemedicine prescription.” Prescriptions for Schedule II and narcotic Schedule III, IV, and V medications may not be prescribed via a telemedicine-only encounter. Comments on the proposed rules are due by March 31, and the agency is likely to face significant pressure to go further in offering more flexibility to use telehealth for the prescribing and management of controlled substances. The proposed rules offer greater flexibility to start a 30-day prescription for non-narcotic Schedule III-V medications, as well as for buprenorphine (which is classified as a Schedule III narcotic medication). States also play a role in overseeing controlled substance prescribing and dispensing and often have their own regulatory scheme governing telemedicine prescribing, which can be more restrictive than federal requirements.

DEA proposed rules to make permanent telemedicine flexibilities used during COVID 19. Specifically, telemedicine prescribing of certain controlled ...

DEA proposes to allow controlled substance prescribing to continue under such relationships for up to 180 days following the end of the federal COVID-19 public health emergency. Alternatively, the practitioner may prescribe controlled substances via telemedicine after receiving a qualifying written telemedicine referral from another DEA-registered practitioner (following an in-person encounter between the patient and the referring practitioner). In the Tele-Prescribing Rule, DEA explained its proposal to exclude Schedule II controlled substances and all narcotics from the scope of the rule. The proposed rules respectively address (1) telemedicine prescribing of certain controlled substances without an in-person medical examination ( [Tele-Prescribing Rule](https://www.dea.gov/sites/default/files/2023-02/Telemedicine%20%28DEA407%29.pdf)), and (2) expansion of buprenorphine prescribing via telemedicine encounters ( [Buprenorphine Rule](https://admin.dea.gov/sites/default/files/2023-02/Expansion%20of%20Bup%20%28DEA948%29.pdf)). The Tele-Prescribing Rule would allow for the prescription of a non-narcotic schedule III-V controlled medication in certain circumstances following a telemedicine encounter not preceded by an in-person medical evaluation. [issued](https://www.dea.gov/press-releases/2023/02/24/dea-announces-proposed-rules-permanent-telemedicine-flexibilities) a pair of proposed rules to make permanent certain “telemedicine flexibilities” related to the prescribing of controlled substances via telehealth that have been relied upon by prescribers and patients during the COVID-19 pandemic.

A DEA proposal would require an in-person examination for telehealth patients in order for them to stay on buprenorphine for longer than 30 days.

New studies show that the share of opioid overdoses caused by buprenorphine did not rise even in the wake of increased telehealth access. Correction: A previous version of this article misstated who is affected by the new regulation. If the rule is finalized, previously initiated telehealth patients would have a 180-day grace period, but would then need to see a prescriber in person before continuing treatment. Moreover, nearly all overdoses that did involve buprenorphine involved other drugs as well, like other opioids, alcohol, or benzodiazepines, a class of anxiety medication. “This draft regulation seems to fly in the face of that, and will make it harder for people with a really serious health issue to get the help they need.” Even if the current draft is finalized, however, buprenorphine will remain dramatically more accessible than it was before the onset of the Covid-19 pandemic. Physicians have been allowed to issue first-time buprenorphine prescriptions via telemedicine for nearly three years, thanks to emergency rules first enacted by the Trump administration during the onset of the Covid-19 pandemic in 2020. Rahul Gupta, the director of the Office of National Drug Control Policy, has urged doctors to prescribe buprenorphine more. It comes as part of a broader crackdown on doctors who prescribe controlled substances via telehealth — in particular, opioids used to treat pain and stimulants used to treat ADHD, like Adderall and Ritalin. “It’s less about what’s ideal in every case, because there are patients where there are all sorts of impracticalities” preventing an in-person visit, he said. While doctors can currently give out both new buprenorphine prescriptions and refills after telemedicine visits, the new rule would require an in-person examination for telehealth patients who want to stay on the medication for longer than 30 days. Opponents, however, say that any reduction in buprenorphine access will have the opposite impact.

The federal effort to limit the overprescription of controlled substances via telehealth is causing "confusion and consternation" in the behavioral health ...

Then, Carlson drove them to a third store, acutely aware, the whole time, that this mundane afternoon would have been nearly impossible for her to experience less than a year earlier. Next week, hundreds of scientists from around the world will convene in London for an international summit on genome editing. Researcher Michael Agadjanyan at the Institute for Molecular Medicine in Huntington Beach, along with David Sultzer from UCI MIND and Lon Schneider from USC, received a $12 million grant from the National Institute on Aging to support clinical trials aiming to keep “the long goodbye” at bay. Civica, a nonprofit drugmaker based in Utah, for example, has said it plans to begin selling biosimilar insulin for roughly $30 per vial by 2024 — $5 more than the new price of Eli Lilly’s generic insulin. Drugmakers could get fast approval for certain drugs — with preliminary data — on the promise that they would do more research after the fact to make sure the drugs worked. Insulin, an Alzheimer's vaccine, and more are also in the news.

On February 24, 2023, the U.S. DEA announced proposed rules for prescribing controlled substances via telemedicine after the COVID-19 PHE expires.

Lacktman predicts that “special labeling will lead to widespread industry confusion and will act as a ‘dog whistle’ that will lead providers to pull back on telehealth use” and “many pharmacies will start denying all orders from telemedicine prescribers to avoid the problem.” Foley & Lardner LLP Partner Nathaniel Lacktman discussed these rules and with multiple media outlets, saying that they are both “complex and more restrictive” than regulations for remote prescribing over the last three years. Drug Enforcement Agency (DEA) announced proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency (PHE) expires.