On June 22, 2022, the White House Office of National Drug Control Policy (ONDCP) issued guidance advocating for Congress and federal agencies to make permanent certain telehealth access measures for people struggling with substance use disorders (SUD). The guidance, titled Telehealth and Substance Use Disorder Services in the Era of Covid-19: Review and Recommendations (Guidance), made four recommendations geared at increasing telehealth access, utilization, and equity among individuals who have experienced an SUD. The ONDCP notes that ensuring access to adequate healthcare is particularly important for individuals living with SUD because these individuals are less likely to receive treatment in traditional settings.
In the Guidance, the ONDCP specifically examines the impact of telehealth on individuals living with SUD and ultimately concludes that “individuals living with SUD are part of a particularly vulnerable group of people who would likely benefit from increased accessibility to health care providers through telehealth.” As part of this examination, the ONDCP evaluates data from various sources regarding the use of telehealth and accessibility issues that were highlighted during the COVID-19 pandemic.
The COVID-19 Public Health Emergency (PHE) was declared on January 31, 2020, and spurred numerous federal and state agencies to expand access to and insurance coverage for telehealth services. The Centers for Medicare and Medicaid Services (CMS), which reimburses for certain telehealth services delivered using an “interactive telecommunication system.” An interactive telecommunication system is defined under Medicare Part B coverage for telehealth services (42 C.F.R. § 410.78) as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. Notably, starting in March 2020 under the PHE, CMS temporarily broadened the types of telehealth services for which Medicare would pay. For the first time, CMS covered “audio-only telehealth services for diagnosis, evaluation, or treatment of mental-health disorders for established patients when the originating site was the patient’s home.” CMS also expanded the list of providers that could provide telehealth services to Medicare patients and bill for such services.
Shortly after the pandemic began, in order to broaden access to health care the United States Department of Health and Human Services (HHS) announced that during the PHE, it would allow licensure waivers for physicians participating in federal health care programs (e.g. Medicare) so they could receive payment for telemedicine services in states where they did not hold a license. State governments and state professional licensing boards quickly followed, with almost every state modifying licensure requirements and/or renewal policies for health care providers, including out-of-state requirements for telehealth.
CMS was not the only agency to waive requirements in order to improve access to health care services using telehealth during the PHE. The Drug Enforcement Agency (DEA) notably waived the requirement under the Ryan Haight Online Pharmacy Consumer Protection Act that any practitioner (with limited exceptions) who issued a prescription for controlled substances must first conduct an in-person evaluation. In addition, the DEA and Substance Abuse and Mental Health Services Administration (SAMHSA) also waived certain requirements related to the prescription of controlled substances for SUD treatment (collectively, SUD Waivers). The SUD Waivers authorize qualified practitioners to prescribe certain controlled substances, such as buprenorphine, to SUD patients via telehealth without first conducting the required in-person evaluations. These waivers significantly changed the way the federal government regulated medication for addiction treatment and removed many of the barriers faced by individuals with SUD who seek treatment. The SUD Waivers are currently slated to end at the termination of the PHE.
The Guidance supplies four recommendations for enabling the permanent expansion of telehealth services for individuals contending with SUD. These recommendations are geared at Congress, federal agencies, and medical providers alike:
(1) Federal Support of Mutual Recognition and Reciprocity of Licenses
The Guidance first discusses the complexities that will be presented for health care providers practicing across state lines after the PHE ends. Though an interstate compact can streamline the cumbersome licensing process for providers who wish to practice across multiple states, state-by-state enactment of the compacts is inefficient. Each state must not only separately enact the compact, but it must use the precise language of the compact. If the compact is amended, the state must repeal and re-enact the compact to maintain compliance. Rather than enacting medical compacts on the state level, the Guidance recommends that the federal government undertake legislative and administrative approaches to encourage licensure reciprocity. While some states have made permanent the licensure flexibilities put into place during the PHE, other states have already rescinded the expanded telehealth licensure permissions from their respective emergency orders, regulations, or statutes. In response, the federal government could encourage permanent license reciprocity across states, such as through mandating licensure reciprocity in the context of Medicare and other federal program beneficiaries, and increasing opportunities for license portability.
(2) Permanently Enact and Expand PHE Telehealth Prescribing Changes
Next, the Guidance recommends the permanent enactment and expansion of PHE telehealth regulations geared at increasing access to telehealth services, including the waiver of the originating site requirement. The waiver of the originating site requirement has been critical in expanding access to telehealth services. Prior to the PHE, the originating site requirement was a barrier to Medicare’s reimbursement of telehealth services because Medicare would only reimburse services if the patient received the service from a “qualified originating site,” such as a medical provider’s office. This precluded Medicare patients from receiving telehealth services in their homes or outside of a traditional health care setting. The Guidance notes that this waiver would need to be made permanent through an act of Congress. The Guidance also specifically recommends that the DEA expand and make permanent the SUD Waivers discussed above. Currently, the waivers apply with respect to prescribing buprenorphine for opioid use disorders, but the Guidance recommends making the waivers permanent and expanding them to cover all methadone prescriptions to increase access to opioid use disorder treatment.
(3) Increase Funding for Mobile App and Assistive Telehealth Services
The Guidance also advocates for an increase in funding for telehealth platforms. The Guidance highlights that telehealth “cannot be the future of medicine” if the services do not account for how persons in vulnerable populations, those with SUD, those with limited financial means, persons of color, and those with developmental and physical challenges utilize the technology. Thus, the Guidance articulates the importance of equipping platforms with adaptive technology, mobile applications, and public Wi-Fi access to ensure equitable access to telehealth. To ensure equitable access, the Guidance recommends that medical providers hire a telehealth coordinator that would work with these populations to foster digital literacy, training, and education. The Guidance also emphasizes the important of increasing high-speed Internet access in rural and remote areas and commends the American Rescue Plan Act’s multi-billion dollar appropriation dedicated to expand high-speed Internet access across the United States.
(4) Consider the Privacy and Ethical Implications of Telehealth Use
Finally, the Guidance urges the federal government to consider the expansion of platforms that can be used for telehealth services. During the PHE, HHS waived certain HIPAA requirements in order to encourage providers to treat patients via telehealth. HHS allowed providers to use certain non-public facing applications, such as FaceTime, Facebook Messenger, Google Hangouts, Zoom, and Skype for telehealth services, even if these programs were not fully compliant with HIPAA, so long as the provider did so in “good faith.” Those in the SUD field have advocated for this waiver to become permanent, arguing that if patients have more choices over the available platforms, it is more likely that patients will seek out health care. Though the Guidance warns that use of these applications can give rise to confidentiality concerns, a “cost-benefit analysis of providing more people with access to health care providers…weighs heavily in favor of working with tech companies to gain HIPAA compliance.” In addition to patient privacy, the Guidance also recommends that policy makers, legislators, and health care providers consider patient consent, accessibility, data use, and protection when providing telehealth access and services to patients.
While the White House’s acknowledgment of the benefits of telehealth and the support of making certain waivers permanent is encouraging news for telehealth providers, the fact that the Guidance is specific to SUD treatment suggests that broader changes relating to telehealth prescribing of controlled substances may not have the support of the White House and other policymakers. If the PHE waivers are not made permanent, many of the gains that have been made recently in increasing access to behavioral health and other services will be lost.
About this Author
Lara is a trusted advisor to clients ranging from traditional health care providers to disrupter digital health platforms as they navigate the practical and regulatory challenges of health care innovation. Her unique depth of knowledge across HIPAA privacy and other regulatory issues governing the use of data, state and federal fraud and abuse laws, business planning and operational issues has led colleagues to describe Lara as the “Swiss Army knife” of health care problem-solving.
Working at the intersection of health care and technology, Lara counsels telemedicine and other…
Cody focuses his practice on health care transactions and advises health care organizations on regulatory, compliance, and governance matters. He regularly negotiates and drafts documents for mergers, acquisitions, and reorganizations. Cody assists clients with formation and dissolution, governance disclosures to state regulatory bodies, employment agreements, and licensure and certification applications. His practice involves preparing a wide variety of corporate and commercial agreements, including license and service agreements. In addition, Cody represents clients in the technology and…
Jean focuses her practice on health care transactional, regulatory, and compliance matters. She represents a variety of clients across the health care industry, including hospitals, physician organizations, health care systems, and long-term and urgent care providers.
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DUBLIN, Sept 5 (Reuters) – Ireland's data privacy regulator has agreed to levy a record fine of 405 million euros ($402 million) against social network