We are in unprecedented times facing a public health crisis with increasing death tolls, limited healthcare supplies, and strained healthcare systems. Clinicians are maintaining care during a state of emergency while simultaneously minimizing unnecessary exposure. This scenario has added complexity for those who treat patients with Substance Use Disorders (SUD), specifically Opioid Use Disorders (OUD), where treatment options are significantly impacted by government regulations and commonly require frequent provider-to-patient contact. The field of addiction treatment is rapidly evolving during this crisis, and it is, therefore, our objective to inform and articulate pertinent regulatory and clinical service delivery changes based on our experience as an early epicenter impacted by COVID-19 within the United States.
The US Department of Health and Human Services (HHS) declared a public health state of emergency on January 31, 2020, thus setting forth a series of temporary regulatory changes effective during this declaration to the prescribing of controlled substances impacting the use of buprenorphine and methadone for the treatment of OUD.1-5 The Drug Enforcement Agency (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA), effective since March 31, 2020, have provided added flexibility to DATA waived clinicians treating OUD by authorizing the initial use of buprenorphine for new patients using telemedicine without first conducting an in-person evaluation; and later authorizing the use of a telephone assessment without requiring an initial examination in-person or via telemedicine.6 DATA 2000 waivered providers have also been authorized by the DEA to prescribe outside of the state in which they hold DEA registrations.7 Opioid Treatment Programs (OTP) which offer methadone in addition to other medication-assisted treatment options for OUD have also obtained federal regulatory flexibility authorizing telemedicine (virtual or by telephone) for the continuation of treatment; blanket exceptions to enable existing patients to be dispensed take home doses—14 days of methadone for less clinically stable patients and up to 28 days for those deemed stable; exemption of a physical examination for new buprenorphine patients only—methadone patients are still required a complete in-person physical evaluation prior to initiation of medication.1-5 In addition, HIPAA and 42 CFR part 2, which specifically protects information related to substance use disorder treatment, have been temporarily modified during this crisis.8-9 From our experience, partnership among both federal and regional agencies, such as the New York State Office of Addiction Services and Supports (OASAS) and New York City Department of Health, was another critical component which promptly supported and facilitated rapid implementation by clinical service providers.
These regulatory changes are prompted by inundated health systems, and the hope that SUD treatment can be obtained and maintained safely outside normative contexts. Inpatient addiction focused admissions have become disrupted as limited resources and space are needed to provide acute care for COVID-19 patients. Ambulatory addiction specialty services within our health system have expeditiously transitioned to providing comprehensive treatment including prescriber visits, individual counseling, and group therapy utilizing a telehealth platform. Telehealth offers an avenue to continue to provide clinical services to those already in care as well as engage those new to treatment as the most viable option to ameliorate part of the problem. However, its deployment has its own considerations, especially among marginalized and underserved populations.4 And lastly, the limited use of toxicology testing as well as ongoing potential for reductions to in-person visits, in particular OTP attendance, remain areas of clinical focus which could benefit from further enhancements to telehealth systems.
The implementation of these clinical modifications, in combination with coordinated regulatory flexibility, provides a path forward to ongoing comprehensive SUD treatment services during the current COVID-19 public health emergency as well as future crises. The coordination and continuing care for our patients is paramount, and it is essential that as we move forward, we continue to identify and inform on how best to navigate the current crisis to ensure proper treatment for SUDs.
Acknowledgements: With much appreciation to Dr. Joseph Conigliaro, Dr. Blaine S. Greenwald, Bruce Goldman, and the dedicated, innovative, and adaptable multi-facility addiction services teams at Northwell Health, as well as OASAS and COMPA.