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, physicians work to find optimal ways to provide care to patients with opioid use disorder (OUD) or other substance use disorders (collectively with OUD, “SUD”) during the COVID-19 pandemic. It is estimated that 40–60 percent of individuals with SUD relapse.1 The fear is that those in recovery could relapse due to isolation and lack of support groups and in-person treatment. The Substance Abuse and Mental Health Services Administration (SAMHSA) and state agencies have issued guidance to physicians and others on how to provide care to this vulnerable patient population during this time.
Treatment by Telehealth and Telephone Visits
Due to the pandemic, SAMHSA has strongly encouraged the expanded use of telehealth services for the evaluation and treatment of patients. This guidance was issued to attempt to reduce the spread of COVID-19 in healthcare facilities and physician offices. In addition, SAMHSA issued guidance regarding treating patients who are in quarantine due to COVID-19, who require telehealth visits to reduce exposure to other patients and healthcare providers.2 Not only does SAMHSA recommend it for individual treatment but also for group cognitive behavioral therapy for SUD.3 With this promotion of telehealth services, SAMHSA and other agencies have issued guidance on how to provide optimal telehealth care while complying with federal and state law.
Online Prescribing of Controlled Substances
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act), a federal law, has governed the prescription of controlled substances via telehealth since April 13, 2009. The Ryan Haight Act prohibits patients being prescribed controlled substances via telehealth in their home unless a narrow exception is met. On March 16, 2020, the Drug Enforcement Administration (DEA) provided that because of the COVID-19 public emergency, DEA registered physicians and other practitioners in the United States could prescribe Schedule II-V controlled substances to patients that the practitioner has not seen in-person so long as all of the following conditions are met:
- The prescription is for a legitimate medical purpose;
- Telehealth communication is with an audio-visual, real-time, two-way interactive communication system; and
- The practitioner is complying with federal and state laws.4
On March 19, 2020, SAMHSA also issued guidance regarding online prescribing of buprenorphine for patients.5 Practitioners with DATA 2000 waivers (practitioners who have met SAMHSA qualifications to prescribe buprenorphine for maintenance or detoxification treatment in settings other than an opioid treatment program) may now treat new patients and prescribe buprenorphine via telehealth. SAMHSA determined that such telehealth communication may include prescribing buprenorphine via telephone. In response, the DEA provided that usually the DEA would not find it permissible that the initiation of treatment with a controlled substance be “based on a mere phone call.”6 However, the DEA determined that the COVID-19 public health emergency, along with the SAMHSA exception, has led to practitioners with DATA 2000 waivers being able to “prescribe buprenorphine to new patients with OUD for maintenance treatment or detoxification following an evaluation via telephone voice calls, without first performing an in-person or telemedicine evaluation” so long as the prescription is still for a legitimate medical purpose.
Practitioners should note, though, that state law still applies and not all states have taken a more flexible approach to the in-person medical evaluation prior to initially prescribing controlled substances. For example, New York still requires an in-person evaluation prior to prescribing controlled substances for new patients.7
Licensure Flexibility for Telehealth
Before the COVID-19 pandemic, most states required practitioners to be licensed in their state to treat patients within that state. During the COVID-19 pandemic, some states have provided flexibility in their state licensure requirements by allowing out of state medical practitioners, such as physicians, to practice within the state or to provide telehealth services to patients within the state.8 In certain states, this flexibility has extended beyond physicians to behavioral health providers, such as psychologists and social workers, to address behavioral health needs through telehealth during the COVID-19 pandemic.9
Behavioral health professionals should consult state laws and current state executive orders in each state they see patients regarding licensure requirements and the ability to practice across state lines. In addition, as states open up in a phased approach, additional requirements regarding infection control and processes may be required to balance in-person care that is needed with the risk of exposure.
Virtual Recovery Resources
SAMHSA has issued a list of multiple “virtual recovery programs,” which, as part of SAMHSA’s COVID-19 resources, SAMHSA advises should be used during an infectious disease outbreak when social distancing and self-quarantine are needed to limit and control the spread of disease.10 Such programs include, but are not limited to, Alcoholics Anonymous, Cocaine Anonymous, and Marijuana Anonymous.
Prescriptions Pick Up
One of the essential elements of recovery for SUD is receiving periodic doses of prescribed medication for SUD. While this requirement provides some therapeutic benefit and decreases the likelihood of diversion for certain patients, it increases the possibility of exposure to or transmission of COVID-19 when patients have to go pick up prescriptions on a regular basis. During the COVID-19 pandemic, the DEA noted that Schedule III through V controlled substances can have early refills of prescriptions so long as the early refills are allowed by state law and regulation.11
Some states have implemented the ability for early refills or emergency refills by pharmacies and have also required insurance companies to cover such prescriptions. For example, Virginia allows pharmacists to dispense a one-time early refill of Schedule III through V controlled substances so long as there is a reason for the early refill.
As the COVID-19 pandemic continues, it remains to be seen whether certain states will further relax their dispensing of controlled substances rules. Some states may determine that in order to promote social distancing there should be more discretion by pharmacists and prescribers on when early refills should be permitted for certain patients.
Practitioners that work with patients with SUD may be subject to 42 CFR Part 2 (Part 2), which protects certain SUD information.12 While the disclosure of Part 2 records normally requires patient consent, SAMHSA provided guidance on how SUD information from a “[P]art 2 program” may be disclosed during the COVID-19 pandemic.13 Specifically, SAMHSA emphasizes that Part 2 currently allows the sharing of SUD information without patient’s consent “to the extent necessary to meet a bona fide medical emergency.” Such information can subsequently be re-disclosed as well for treatment purposes.
While the above exception is narrow for only a “bona fide medical emergency,” practitioners that treat patients with SUD will eventually see less burden with sharing SUD information due to the significant changes to Part 2 under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).14 The CARES Act, enacted March 27,2020, seeks to bring Part 2 more in alignment with the Health Insurance Portability and Accountability Act (HIPAA)15 by, in part, allowing a Part 2 program to use or disclose Part 2 information once a patient provides written consent for treatment, payment, and healthcare operations as permitted by HIPAA. Subsequently, any disclosure for such purposes may then be redisclosed as permitted by HIPAA. As the CARES Act's main purpose was to address the COVID-19 pandemic, significant changes to Part 2 will only be operationalized once SAMHSA promulgates regulations to implement the new Part 2 rule, which may be after the COVID-19 pandemic. Once such regulations are finalized, however, practitioners will see significantly less burden in sharing SUD information.
The COVID-19 pandemic has changed how physicians and other behavioral health providers care for those patients who are being treated with SUD. Some states are now considering lifting stay-in-place orders and reopening certain healthcare services. Screening, telehealth, and infectious disease controls guidance will remain important as healthcare facilities begin to open for non-emergent care. During this pandemic, physicians and other behavioral health providers will still need to care for those who may be positive for the coronavirus at the same time they care for those who have not had the virus. Even in the aftermath, healthcare providers can learn from the data collected during this pandemic to determine the best ways to ensure access to treatment and modification of care plans in the future. For now, physicians and other behavioral health providers must consider the risks of exposure to COVID-19, along with the risks of not seeking care in person. It is important in these times to check state executive orders, along with SAMHSA, Centers for Disease Control and Prevention and Centers for Medicare & Medicaid Services guidance to stay informed and compliant with the rapid changes during this pandemic.
- Nat’l Inst. on Drug Abuse, Drugs, Brains, and Behavior: The Science of Addiction, https://www.drugabuse.gov/publications/drugs-brains-behavior-science-addiction/treatment-recovery.
- The Substance Abuse and Mental Health Services Administration, OTP Guidance for Patients Quarantined at Home with Coronavirus, available at https://www.samhsa.gov/sites/default/files/otp-covid-implementation-guidance.pdf
- The Substance Abuse and Mental Health Services Administration, Considerations for the Care and Treatment of Mental and Substance Use Disorders in the COVID-19 Epidemic, available at https://www.samhsa.gov/sites/default/files/considerations-care-treatment-mental-substance-use-disorders-covid19.pdf.
- U.S. Department of Justice, Drug Enforcement Administration, COVID-19 Information Page, available at https://www.deadiversion.usdoj.gov/coronavirus.html.
- The Substance Abuse and Mental Health Services Administration, FAQs: Provision of methadone and buprenorphine for the treatment of Opioid Use Disorder in the COVID-19 emergency, available at https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
- U.S. Department of Justice, Drug Enforcement Administration, DEA Policy Use of Telephone Evaluations to Initiate Buprenorphine Prescribing, available at https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Final)%20+Esign.pdf.
- The New York Department of Health Bureau of Narcotic Enforcement has taken the position that an in-person physical examination is still required prior to prescribing a controlled substance pursuant to 10 NYCRR § 80.63(d). While the Bureau recognizes that the DEA waived the in-person physical examination requirement during the COVID-19 pandemic so long as certain conditions are met (as discussed above), the Bureau will not change its position on the state requirement for in-person physical examination for controlled substance prescriptions until there is an Executive Order or other governmental ruling waiving this requirement.
- Under California Governor Gavin Newsom’s emergency proclamation order of March 4, 2020, out-of-state licensees may be recognized to practice in California through a request to the California EMS Authority to support California providers. The request can be submitted by a California provider/facility or a telehealth or staffing agency that is contracted with a California medical facility to serve California residents. See also Iowa Board of Medicine announcement regarding COVID-19 Emergency Proclamation from Governor Kim Reynolds on April 27, 2020, available at https://medicalboard.iowa.gov/, providing that a physician may practice telemedicine in Iowa without an Iowa medical license and all rules which rules that impose conditions on the provision of telehealth or telemedicine remain suspended.
- See e.g. New York Executive Order 202.18 and Executive Order 202.15 permitting social workers, mental health counselors, marriage and family therapists and psychologists currently licensed outside of New York and in good standing in the state they hold a license to practice their profession and treat patients in New York by using distance technology. See also Delaware Joint Order of the Department of Health and Social Services and the Delaware Emergency Management Agency on March 24, 2020 providing that out-of-state behavioral health providers licensed outside the state of Delaware may provide mental health services via telehealth in Delaware.
- The Substance Abuse and Mental Health Services Administration, Your Recovery is Important: Virtual Recovery Resources, available at https://www.samhsa.gov/sites/default/files/virtual-recovery-resources.pdf.
- U.S. Department of Justice, Drug Enforcement Administration, Registrant Guidance on Controlled Substance Prescription Refills, available at https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-017)(DEA065)%20Early%20RX%20Refill%20-%20OMB%203-20-20%202200%20DAA%20approved.pdf.
- Pursuant to 42 U.S.C. § 290dd-2, SAMHSA promulgated 42 CFR Part 2.
- The Substance Abuse and Mental Health Services Administration, COVID-19 Public Health Emergency Response and 42 CFR Part 2 Guidance, available at https://www.samhsa.gov/sites/default/files/covid-19-42-cfr-part-2-guidance-03192020.pdf.
- Coronavirus Aid, Relief, and Economic Security Act, Pub. L. No. 116-136, § 3221(b), 134 Stat. 281, 256-57 (2020).
- Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, H.R. 3103, 104th Cong. (1996).
About the Authors
Sarah Swank is a healthcare attorney in the Washington, DC office of Nixon Peabody with more than 20 years’ experience as senior in house counsel in two of the largest national healthcare systems and as outside counsel at two nationally recognized law firms. Ms. Swank’s practice focuses on providing strategic and practical advice and thought leadership to hospitals and health systems, academic medical centers and physician organizations that navigate a complex regulatory and compliance environment. She frequently speaks and writes on the transformation of the healthcare industry, ACOs, public health, telehealth, AI and now COVID-19 response and compliance. She is a member of the Nixon Peabody Coronavirus Response Team, a Vice Chair on the Publications Board of ABA Health Section and the Vice Chair of Education for the In-House Counsel Practice Group for the American Health Law Association (AHLA). She may be reached at [email protected].
Jena Grady is a healthcare attorney in the New York City office of Nixon Peabody. She uses her previous public behavioral health experience to assist providers to navigate complex regulatory and legal issues that arise while delivering behavioral health and integrated care including, but not limited to, substance use record disclosures, licensing requirements and reimbursement challenges. Additionally, Ms. Grady assists clients in healthcare transactions, including joint ventures and contractual arrangements, while also working with private equity firms seeking investments within the healthcare field including mental health. She may be reached at [email protected].
Joanna Cohen is a healthcare attorney in the New York City office of Nixon Peabody. She advises healthcare and behavioral health providers on transactions, including joint ventures, mergers, acquisitions and other contractual arrangements. She assists clients with navigating their operations and transactions to be compliant with federal and state fraud and abuse laws and regulations, including the federal Anti-Kickback Statute, the federal Stark Law and state law equivalents, and most recently, with federal and state laws and regulations relating to the COVID-19 pandemic. She may be reached at [email protected].