The United States Department of Health and Human Services (“HHS”) declared a public health emergency to address the national opioid crisis on October 26, 2017. Over two years later, while the country is still addressing the national opioid crisis, federal and state agencies, opioid treatment programs (“OTPs”), and practitioners seek to provide care to patients with opioid use disorder (“OUD”) during the COVID-19 pandemic. Last week, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) issued initial guidance to OTPs and practitioners on how to provide care to this vulnerable patient population.
All stable patients should stay home
One of the essential elements of OTPs for a significant amount of patients, especially at the beginning of recovery, is being physically present at a clinic/facility and receiving daily or almost daily doses of prescribed medication for OUD. While this requirement provides some therapeutic benefit and decreases the likelihood of diversion for certain patients, such requirement increases the possibility of exposure to or transmission of COVID-19 among program staff, patients, and others. SAMHSA provided that all states can request blanket exceptions for all stable patients in an OTP to receive 28 days of take-home doses for OUD. SAMHSA notes that states can also request up to 14 days of take-home doses for OUD for patients who are less stable but an OTP determines could safely handle.
In response, states such as Pennsylvania have implemented the SAMHSA exceptions and are waiving their own state regulations regarding standard limitations of take-home doses. Pennsylvania allows county authorities to use grant funding from the Pennsylvania Department of Drug and Alcohol Programs to assist OTPs to provide clinical services using telehealth technology.
Exemption for treatment by telehealth and telephone visits
While SAMHSA states that federal law requires a complete in-person medical evaluation before a patient admission to an OTP, SAMHSA has the authority to grant exemptions to OTPs from certain federal requirements. SAMHSA determined to exempt OTPs from the in-person medical examination requirement so long as there can be an adequate examination of the patient via telehealth (including if needed the use of telephone).
- The exemption only applies to new OTP patients that will be prescribed buprenorphine not methadone. SAMHSA also notes that practitioners with a DATA 2000 waiver (which allows clinicians to dispense or prescribe buprenorphine in settings other than OTPs) may treat new patients and prescribe buprenorphine via telehealth (including if needed the use of telephone).
- SAMHSA continues to require an in-person medical examination for new OTP patients that will be prescribed methadone due to risks new OUD patients may have when initiating low methadone doses at the beginning of OUD treatment.
- A practitioner working in an OTP may continue treating an existing OTP patient with methadone or buprenorphine so long as take-home doses comply with federal and state law (including the blanket exceptions for stable and less stable patients noted above).
- A practitioner with a DATA 2000 waiver and working outside the context of an OTP may continue treating existing patients with buprenorphine.
Medication delivery for patients in quarantine
SAMHSA issued guidance to OTPs on how to provide medication to patients quarantined at home.
- OTPs should document that a patient is required to be under isolation or quarantine based on a confirmed source (e.g., a physician order) and ensure such documentation is in the patient’s record.
- OTPs subsequently should locate a third party, such as a family member or neighbor, that may pick up the medication from the OTP and deliver medication to the patient using the OTP’s chain of protocol that should already be in place based on federal and state standards.
- If a patient cannot identify a third party to deliver medication, then SAMHSA recommends that a OTP prepare a “doorstep” delivery of such medication.
- Such delivery must be in a lock box and SAMHSA provides examples of ways to communicate with patients prior to delivery to reduce the possibility of diversion (e.g., having a staff member from at least six feet away observe that the medication is picked up by an appropriate person).
Conclusion
SAMHSA hopes the guidance as discussed above will assist OTPs and practitioners that treat patients with OUD ensure that their patients receive their necessary medication while mitigating the spread of COVID-19. It is expected that SAMHSA will continue to review and revise its guidance as well as implement new guidance, perhaps regarding prescribing of methadone, moving forward.
SAMHSA’s site for all guidance regarding COVID-19, including but not limited to what is referenced above, can be found here.
For more information and thought leadership regarding COVID-19, visit our Coronavirus Response Team page. Additionally, we are hosting a webinar titled COVID-19: The latest updates and guidance for hospitals and health care entities, on Wednesday, March 25th, at 1:30 p.m. Eastern. If you are interested in participating, please click here.