Optimizing Telehealth Access to Addiction Care

Background

The American Society of Addiction Medicine (ASAM) is deeply committed to ensuring every person with substance use disorder (SUD) has access to high-quality, full-spectrum addiction care and to closing the addiction treatment gap.¹ This commitment includes advocating for optimizing telehealth access and utilizing it to advance health equity in addiction medicine. With the illicit drug supply becoming increasingly lethal,² and the COVID-19 pandemic’s exacerbation of challenges faced by people with SUD,³ racial and ethnic health disparities have widened with record numbers of drug overdose deaths.⁴ Although telehealth for addiction care grew more slowly than it did for other types of medical care before the onset of COVID-19,⁵ the pandemic catalyzed sweeping changes that brought telehealth beyond where it was previously underutilized or prohibited.

Prior to the COVID-19 pandemic, telehealth for addiction care had been limited by longstanding obstacles including lack of clinician comfort with telehealth,^6–8 laws and regulations,^9,10 reimbursement restrictions,¹¹ and licensing requirements. During the COVID-19 pandemic, telehealth became a valuable tool for more addiction clinicians,¹² providing greater access¹³ and convenience for patients,⁶ and was associated with improved addiction treatment retention^7,14 and lower odds of medically treated overdose.¹⁴ ASAM strongly supports policies that increase telehealth access to evidence-based addiction care, including the use of addiction medications. If policymakers and the medical community are not careful, however, telehealth policy related to addiction care may exacerbate existing health disparities, if complex or relatively expensive technologies are required to meet the standard of care.¹⁵ Efforts to measure and compare the quality of telehealth-delivered addiction care against care delivered in other settings⁷ should consider that without a telehealth option, many individuals would otherwise not receive any addiction care at all.

Federal agencies and states often use the terms “telehealth” and “telemedicine” interchangeably, and have various definitions^16,17 pertinent to permissible telehealth modalities, reimbursement, and the prescription of controlled medications.^18–20 The term “telehealth” will be used exclusively for the purposes of this statement. Synchronous telehealth is live, real-time interaction between patient and clinician; asynchronous telehealth is often called “store and forward,” and allows patient and clinicians to share information before or after appointments. Telehealth modalities include audio-visual and audio-only, which are both synchronous communications. Ancillary services, such as drug testing (toxicology), are often provided asynchronously with telehealth-delivered addiction care. Some ancillary services are more easily provided with remote technology, such as oral fluid-based or monitored breathalyzer tests.

Laws and regulations place limits on the use of telehealth to prescribe controlled medications. The Ryan Haight Online Pharmacy Consumer Protection Act (the Ryan Haight Act) of 2008 was intended to curb internet pharmacies and, with limited exceptions, requires an in-person medical evaluation prior to a clinician’s prescription of a controlled medication. There are seven “practice of telemedicine” exceptions²¹ to the Ryan Haight Act’s in-person evaluation requirement; one relates to a declared public health emergency (PHE). Legal and regulatory limits on the use of telehealth for controlled medications, such as the Ryan Haight Act, are among numerous factors that contribute to significant geographic variability in people with opioid use disorder’s (OUD) access to addiction medications.^22–24 Less than 14 percent of people with OUD receive addiction medications nationally.²⁵ People who are racially or ethnically minoritized with OUD are less likely to be offered the standard of care, especially buprenorphine,²⁶ and are more likely to live in communities with a higher prevalence of methadone-based care.²⁷ While it is a highly-effective opioid agonist treatment for OUD, methadone’s availability is largely limited to highly-regulated opioid treatment programs (OTPs) with strict requirements.²⁸ Improved telehealth access to addiction medication, including buprenorphine, has the potential to reduce disparities and increase access to care overall.

To overcome social distancing requirements during the COVID-19 PHE, federal agencies took emergency steps to increase telehealth access to addiction medications. The Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) allowed temporary regulatory flexibility for the initiation of buprenorphine for OUD by audio-only telephone, including at OTPs.²⁹ In March 2022, the DEA announced it “was working to make temporary regulations allowing medication-assisted treatment to be prescribed by telemedicine permanent.”³⁰ SAMHSA announced a one-year, post-PHE extension of its OTP exemption for an in-person physical evaluation for buprenorphine treatment for OUD, which has provided more time for SAMHSA to promulgate regulations to make this OTP flexibility permanent.³¹ SAMHSA still requires an in-person evaluation of a person with OUD to initiate methadone at OTPs.

Actions by federal agencies to implement regulations that would increase telehealth access to addiction medications have been long awaited by stakeholders. In 2018, the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment Act (the SUPPORT Act) directed the U.S. Attorney General, in consultation with the Secretary of Health and Human Services (HHS), to issue final regulations to implement the “special registration” “practice of telemedicine” exception under the Ryan Haight Act. While no such regulations have been promulgated to date, in March 2022, the DEA submitted a proposed rule to the Office of Information and Regulatory Affairs (OIRA), indicating those proposed regulations were under review at the Office of Management and Budget (OMB), and the Unified Agenda[*] has noted an expected notice of proposed rulemaking (NPRM) for August 2022.³² Federal agencies’ delay in the Ryan Haight Act-related rulemaking may be associated with an environment that is increasingly impeding clinicians’ medical discretion to treat patients with OUD with addiction medication.

The DEA’s temporary, emergency actions during the COVID-19 PHE have allowed telehealth-initiated prescribing of controlled medications beyond buprenorphine for OUD. During this time, the U.S. Justice Department and the Federal Trade Commission (FTC) have initiated investigations of at least one telehealth provider with clinicians prescribing controlled medications for mental health conditions.^33,34 Payers and pharmacies have ceased relations with certain telehealth companies with clinicians prescribing controlled medications.^35–38 In addition, the HHS Office of the Inspector General (OIG) has advised clinicians of potentially fraudulent telehealth arrangements, such as those that paid clinicians “a fee that correlated with the volume of federally reimbursable items or services ordered or prescribed.”³⁹ Some national pharmacy chains may be becoming increasingly cautious about dispensing any controlled medication prescribed through telehealth for patients who have not had an in-person visit.⁴⁰ Thus, telehealth-based prescriptions for controlled medications may now be subject to increased scrutiny by pharmacists, including buprenorphine for OUD. In some cases, pharmacists may be refusing to dispense buprenorphine prescribed through telehealth or requiring verbal confirmation from the prescriber.^41,42[†]  

At least 21 million people in the U.S. do not have broadband access, constraining their use of audio-visual telehealth.⁴³ Infrastructure barriers often limit the digital inclusion of individuals who are marginalized and minoritized,²⁶ including barriers to technology, device ownership, and digital literacy.^43,44 Socioeconomic factors, including age, limited English proficiency, and social isolation have an disparate impact across communities and affect people’s ability to engage with addiction medicine by telehealth.⁴⁵ Black and lower-income people are more likely to engage in audio-only, rather than audio-visual visits, compared to White and higher-income people.^43,46,47 Investments in infrastructure, individual technological capacity, and telehealth readiness are a public health policy problem.^48,49 The U.S. Congress has promoted digital inclusion through broadband infrastructure investment and initiatives to increase digital access and expand digital literacy.⁵⁰ Federal agencies are also acting reduce barriers to digital inclusion, for example, by promoting practices at the state and local levels to combat digital discrimination like ‘red-lining.’^50,51

Prior to the COVID-19 pandemic, poor payment parity and questions regarding interstate licensing limited telehealth for addiction care.⁵² During the COVID-19 pandemic, payers’ temporary establishment of payment parity between telehealth and in-person care removed an extensive disincentive to the provision of telehealth-delivered addiction care.⁵³ The Centers for Medicare and Medicaid Services (CMS) has now permanently expanded the definition of telehealth services under Medicare that are eligible for reimbursement to include audio-only services for the diagnosis, evaluation, or treatment of mental health disorders (including SUD) in established patients, which includes certain services offered at OTPs.⁵⁴ CMS and SAMHSA have encouraged state Medicaid programs to expand telehealth for addiction care,⁵⁵ although state Medicaid telehealth coverage is variable, particularly related to audio-visual and audio-only modalities.^56,57 During the COVID pandemic, nearly every state temporarily modified medical clinician licensure requirements or renewal policies, including requirements for the delivery of out-of-state (OOS) telehealth services, to enable licensure portability.^58–60 Licensure wait times can exacerbate workforce shortages,⁶¹ which are acute for addiction specialists.⁶² The Interstate Medical Licensure Compact (IMLC) creates a pathway to expedite already licensed physicians that seek to practice medicine in multiple states and strengthens public protection by facilitating state medical board sharing of investigative and disciplinary information.⁶³

Rapid adoption of telehealth during the COVID-19 pandemic resulted in clinicians balancing the use of telehealth with an emerging and evolving standard of care.⁶⁴ Telehealth can be safe and effective for many mental health conditions,^5,65,66 but research on telehealth-delivered addiction care is quite limited. Prior reviews have documented few, small, retrospective, telehealth-related studies on SUD care.^67,68 No randomized controlled trial has been published on telehealth-delivered addiction medications for SUD. Although there are limitations in the methods of the prior studies, there are some indications that telehealth use for SUD care can be associated with comparable outcomes, treatment retention, and patient satisfaction.^69–72

During the COVID-19 pandemic, HHS’ temporary pause of enforcement of privacy/Health Insurance Portability and Accountability Act (HIPAA) regulations enabled the use of additional internet platforms.¹¹ SAMHSA issued 42 CFR Part 2 regulations guidance to clinicians.⁷³ Federal agencies are currently working to harmonize HIPAA and 42 CFR Part 2 regulations, as required by the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) of 2020.⁷⁴ As a result, clinicians have significant uncertainty regarding their compliance with privacy/HIPAA regulations in this environment, particularly around storage of video and other electronic communication records.

A person’s access to telehealth-delivered addiction care depends on whether their clinician offers those services, and whether they’re covered by the person’s health plan.⁷⁵ While telehealth can improve access to clinicians by eliminating geographic barriers to care, it does not solve insurance network adequacy problems.^76,77 For example, if health plans limit their SUD care network to specific telehealth providers and unduly steer people only to those services (and away from their regular or other clinician), or exclusively limit patients to telehealth-based care, this action would inappropriately limit patient autonomy to choose the modality best suited to their needs.^78,79

Telehealth accelerated innovations in care models that lowered thresholds to accessing addiction care.⁸⁰ For people with SUD, especially those with unstable housing, HIV or Hepatitis C infection, and/or criminal legal involvement, experiencing stigma⁸¹ within traditional healthcare systems can be a barrier to accessing care. Increased use of telehealth can aid delivery of addiction care by increasing access to addiction specialists in unconventional settings and community-based care.⁸² Integrating telehealth into less stigmatizing settings where persons who use drugs receive services, such as syringe services programs, has significant promise.⁸³ Establishing effective strategies to take full advantage of the opportunities provided by telehealth services can create opportunities to close the gaps in care for marginalized patient populations and help them achieve sustainable recovery.  

Recommendations

1. Federal agencies, states, and payers should standardize telehealth definitions and terminology.
2. Addiction medicine professionals should offer telehealth options to optimize access to addiction care.
3. Requirements for ancillary services, such as toxicology testing, should not be barriers to accessing addiction care via telehealth and may be delivered via telehealth in some circumstances.
4. Federal law should be amended to create a new telehealth evaluation alternative to the Ryan Haight Act’s in-person medical evaluation requirement, which would permit the initial issuance of a prescription for a controlled medication approved by the Food and Drug Administration to treat SUD, using an audio-visual, real-time, and two-way interactive communication system and without any requirement for special registration. If and when the DEA issues final regulations to implement the “special registration” “practice of telemedicine” exception under the Ryan Haight Act, those regulations should be consistent with principles of broad access and low barriers to addiction care.
5. Regulatory flexibilities tied to the COVID-19 PHE are relevant to the opioid overdose crisis and should be extended under that PHE or other available authority. Federal agencies should continue to study the impact of the use of audio-only technology for buprenorphine treatment for OUD, including the impact on health inequities and outcomes.
   1. DEA regulations should continue to allow for the initiation and maintenance of buprenorphine with audio-only technology during the opioid overdose crisis PHE, and SAMHSA regulations should continue to allow for same at OTPs. DEA and SAMHSA should work to make these flexibilities permanent, as appropriate, based on findings of further studies.
   2. SAMHSA regulations should make permanent other OTP-related telehealth flexibilities implemented during the COVID-19 PHE.
   3. SAMHSA and DEA regulations should allow for the initial medical evaluation for treatment of OUD with methadone by audio-visual telehealth technology.
   4. Federal and state laws, regulations, and guidance related to telehealth-delivered addiction care should not add restrictions or barriers that could increase risk of abrupt discontinuation of addiction care.
6. States should align their telehealth policies with federal telehealth policies to the extent the latter allow for increased access to, and retention in, evidence-based addiction care.
7. States should adopt legislation to prohibit pharmacies, pharmacy benefit managers, and health insurers from interfering with a state-licensed pharmacist’s corresponding responsibility under the federal Controlled Substances Act; such legislation should appropriately empower state medical or pharmacy boards to review and potentially veto corporate policies that limit or restrict controlled addiction medication prescriptions or their dispensing⁸⁴ on basis of relation to telehealth, prior to the policies’ implementation. Any such existing corporate policy should be suspended.
8. The use of audio-only and audio-visual telehealth modalities for addiction care should be studied to inform best practices, ensure better health outcomes, and advance health equity.
9. Federal and state governments should expand programs that reduce inequities in digital access for people with SUD, promote digital literacy, and make strategic investments in telehealth infrastructure, while acting decisively to prevent and eliminate digital discrimination.
10. Jurisdictions and institutions should ensure virtual interpretation services are provided to patients with non-English language preference to increase access to care.
11. Payers should cover telehealth-delivered addiction care on the same basis and to the same extent they cover the provision of the same service through in-person care,⁸⁵ including prescribing through telehealth if such prescribing is permissible under applicable federal and state law.
    1. Reimbursement rates for telehealth-delivered addiction care should be fair and equitable⁸⁵ and account for facility fees to support telehealth services for beneficiaries who are unhoused or otherwise difficult-to-reach and treat populations and in need of telehealth services at a safe, confidential location. 
    2. Utilization management techniques⁸⁶ on benefits provided through telehealth for addiction care should be fully consistent with standards of care and clinical practice that are generally recognized by federal agencies or medical societies with expertise in addiction treatment.
12. States should join the Interstate Medical Licensure Compact to increase access to addiction care, especially given the more widespread adoption of telehealth.
13. Further studies, including prospective clinical trials, are needed to measure and compare the effectiveness of different telehealth modalities (audio-visual and audio-only) for addiction care, focusing on utilization, quality of care, and impacts in real world healthcare systems. Studies should attempt to account for the fact that the alternative to telehealth-delivered addiction care is often no care.
14. Federal agencies should study the impact of pausing HIPAA enforcement against healthcare providers in connection with the good faith provision of telehealth during the COVID-19 PHE to inform long-term policy approaches that will protect patient privacy and confidentiality in telehealth care, without creating barriers to accessing care. Federal agencies should provide clear, user-friendly HIPAA telehealth guidance for the period following the COVID-19 PHE.
15. Telehealth should not supplant adequate in-person addiction care. Health plans should have adequate SUD provider networks that allow beneficiaries the option to access telehealth and in-person addiction care.
16. Tele-harm reduction services, including syringe services, should be studied, and expanded to the extent they improve health outcomes.
17. Policymakers, and to the extent applicable, payers, should support telehealth service expansion in jails and prisons to increase access to addiction treatment, including addiction medications.
    

     

     

    Adopted by the ASAM Board of Directors October 2, 2022.

    This policy statement is endorsed by the American College of Academic Addiction Medicine, the American College of Medical Toxicology, and the American Osteopathic Academy of Addiction Medicine.

     

     

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        [*] The Unified Agenda is a semiannual compilation of information about regulations under development by federal agencies, published in the spring and fall.

        [†] Some pharmacists' discomfort dispensing buprenorphine may be due to concerns about potential diversion (and may be partially alleviated with increased communication with prescribers).