Schedule II and narcotic drug prescriptions will be off the table for telemedicine visits without an in-person evaluation. A proposed rule addressing telemedicine prescribing of pain medications after the COVID-19 public health emergency ends is not what some hospice providers hoped for. The Drug Enforcement Administration published its “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation” proposed rule in the March 1 Federal Register. The DEA intends to fast-track the rule, setting a comment deadline of March 31 with implementation expected by the May 11 end of the PHE, note attorneys Christopher Eades and Todd Nova with law firm Hall Render. The rule, which will replace PHE-era flexibilities, “proposes to allow controlled substance prescribing for a narrow set of telemedicine consultations,” notes attorney Joelle Wilson with law firm Polsinelli. “If approved, the proposed rule will add flexibility to the Ryan Haight Online Consumer Protection Act of 2008, which restricts prescribing controlled substances via telemedicine to practitioners that conduct an in-person medical evaluation of the patient,” Wilson notes in online legal analysis.
The DEA developed the rule “with the U.S. Department of Health and Human Services and in close coordination with the U.S. Department of Veterans Affairs,” the DEA notes in a release about the regulation. It proposes “to extend many of the flexibilities adopted during the public health emergency with appropriate safeguards,” the agency maintains. (The DEA issued a companion rule regarding prescribing buprenorphine via telemedicine as well.) Background: Prior to the PHE, exceptions allowing prescribing of controlled substances via telemedicine didn’t “generally include the ability to prescribe to a patient who is at home when participating in a telemedicine encounter,” Eades and Nova note in online analysis. “This requirement was softened temporarily as a result of the COVID-19 pandemic PHE when the DEA invoked its emergency authority to permit telemedicine prescribing of controlled substances without an in-person physical examination,” they recount. The new rule proposes to allow “prescribing only for Schedule III, IV, or V non-narcotic controlled medications,” or non-controlled drugs, without the in-person medical evaluation by the prescriber. An exception: The provider can prescribe Schedule II and/or narcotic meds when there is a “referral under the proposed rules from medical practitioner who conducted [a] prior in-person medical evaluation,” the DEA notes. “Referrals … predicated on a telemedicine visit exclusively would not constitute a qualifying telemedicine referral,” according to the proposed rule. In other words, “the proposed rules … will not affect a patient’s ability to receive controlled medications as a result of telemedicine consultations by a medical practitioner to whom a patient has been referred by a medical practitioner that has previously conducted an in-person medical examination of the patient,” the DEA says in a rule fact sheet for medical professionals. Time-limited exception: If the prescriber has “form[ed] a telemedicine relationship during the COVID-19 public health emergency,” the proposed rule “maintain[s] current telehealth flexibilities in place during the COVID-19 public health emergency for an additional 180 days from the end of the emergency,” the fact sheet elaborates. But “prescriptions written by medical practitioners via telemedicine during this 180-day period will require additional recordkeeping obligations.” After the 180 days, they will be treated as all other patients, the DEA specifies. Drawbacks: “Prescribing of controlled substances as a result of a telemedicine encounter would be time-limited for each patient (unless conducted by VA practitioners) such that practitioners could prescribe a medication only for a period of 30 days before an in-person medical evaluation must be conducted,” the National Association for Home Care & Hospice explains in its member newsletter. And “prescriptions written in response to a telemedicine encounter will require additional practitioner recordkeeping, including an indication on the prescription document that the prescription was written as the result of a telehealth encounter,” NAHC adds. Those restrictions add up to a regulation that won’t serve hospice patients well, hospices worry. “The rules, if implemented, could … create barriers to timely access to drugs for pain and symptom management in hospice care, palliative care, and home health care,” NAHC warns. “With this exception having been in place for nearly three years, many health care entities and providers have operationalized an approach to telemedicine that effectively relies upon this exception,” Eades and Nova observe. “These providers have anxiously awaited clarification regarding these rules with the PHE set to expire,” the Hall Render attorneys say. Bottom line: “While the DEA’s proposed rules would permanently expand the ability to prescribe through telemedicine, these proposed rules are more restrictive than the current COVID-19 exception,” Eades and Nova pronounce. Stakeholders should “understand the impact of these changes and develop comments on DEA’s proposals,” Wilson recommends. “Health care entities … should address these rules as part of a comprehensive virtual care compliance plan or policy,” Eades and Nova advise. “A failure to adjust clinical pathways to comply with these new rules, if finalized, may result in significant compliance and professional liability risk for both prescribers and dispensers,” they warn. Note: The 16-page rule, which includes commenting instructions, is at www.govinfo.gov/content/pkg/FR-2023- 03-01/pdf/2023-04248.pdf. A four-page rule highlight sheet for practitioners is at www.dea.gov/sites/default/files/2023-03/ Telehealth_Practitioner_Narrative_312023.pdf.