By Alison Knopf
In 2017, Gail Groves Scott, MPH, manager of the Substance Use Disorders Institute at the University of the Sciences in Philadelphia, wrote a passionate piece in the Philadelphia Inquirer about the importance of expanding existing Drug Enforcement Administration (DEA) rules to expand and relax hospital regulations. Ms. Scott sought to remove the “three-day rule,” which limits treatment with methadone or buprenorphine for an opioid use disorder (OUD) to three days. A related rule requires hospitals to say whether the opioid addiction diagnosis is primary or secondary to other diseases for which the patient is being treated at the hospital, Ms. Scott wrote.
Under existing DEA regulations, hospitals are allowed to dispense methadone and buprenorphine for OUDs without an opioid treatment program (OTP) license, for three days. Ms. Scott wants to greatly extend that, because three days is not long enough to stabilize someone who has an OUD. Experts want hospitals to refer patients to OTPs— which would be better suited to stabilize them. But if a patient must be hospitalized, there should be provisions for that patient to receive agonist medication, notes Ms. Scott.
And that’s not all. The DEA should extend this waiver to nonhospital residential programs and correctional facilities, says Ms. Scott.
In a policy brief written by Ms. Scott, a copy of which was obtained by AT Forum, Ms. Scott explains that:
- Hospital clinicians must have a regulatory “waiver” if they dispense buprenorphine to treat acute withdrawal (beyond 3 days) or write a discharge prescription. These rules impede efforts to streamline care continuums and access to the most effective “medications for addiction treatment” (ie, MAT, with buprenorphine and methadone).
- Hospitals, jails, nursing homes, and non-hospital residential facilities providing inpatient treatment, or “rehab,” must have a “waivered” physician, nurse practitioner, or physician assistant order buprenorphine pharmacotherapy; yet less than 5% have this credential. Plus, the facility must register as a licensed OTP to initiate or maintain OUD patients on methadone (outside of a confusing loophole for hospitals about “secondary” treatment). Or, they must contract with an OTP to deliver “take-home” methadone doses, although they don’t have an OTP nearby. Yet if the diagnosis is pain, not OUD, there are none of these costly barriers. OTP regulations were based on the outdated model separating behavioral health care from mainstream health care (rooted in stigma), yet integration of care is our goal today.
Specifically, Ms. Scott recommends that the “three-day rule” for dispensing buprenorphine in hospitals treating acute withdrawal—waiver or not—should be expanded to 7 to 14 days. This would allow acute provision of medication to bridge patients to outpatient appointments or inpatient admission, she said.
Primary and Secondary Diagnosis
In addition, Ms. Scott recommends removal of the requirement that the hospital waiver applies only to an OUD diagnosis, secondary to another treatment condition for unlimited dispensing, within a hospital or long-term treatment facility. “This confusing rule becomes a compliance liability that deters innovation in drug overdose prevention and OUD treatment in hospitals,” said Ms. Scott. “Enforcement has never been practical, in any case. (Should the DEA be auditing individual patient charts and assessing which diagnosis was ‘primary’?)”
Finally, the waiver for the hospital—as revised—should be extended to corrections facilities and licensed residential treatment programs, she said.
Ms. Scott has clear recommendations for changing regulations, including language, and she has widespread support in the field.
“Just to be clear, the three-day rules were obviously created by someone other than an addiction medicine physician,” said Jane Liebschutz, MD, MPH, visiting professor of medicine at the University of Pittsburgh. “I assume that whoever made those rules did not actually care for patients, because the rules don’t address the actual experience of patient care.”
Indeed, the DEA made the rule. According to the DEA, the “three day rule” allows a practitioner who is not separately registered as a narcotic treatment program to administer (but not prescribe) narcotic drugs to a patient, under certain conditions. Administration must be for the purpose of relieving acute withdrawal symptoms, while arranging for the patient’s referral for treatment, as follows:
- Not more than one day’s medication may be administered or given to a patient at one time
- This treatment may not be carried out for more than 72 hours
- This 72-hour period cannot be renewed or extended
The DEA was not available for an interview on this topic, due to the government shutdown.
Ms. Scott continues to be involved in efforts to change regulations regarding methadone and buprenorphine. As she explains in her Philadelphia Inquirer story, she has held the hand of a loved one recovering from an overdose.
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