In the wake of the COVID-19 pandemic, the healthcare care industry went through dramatic transformations that impacted it forever, with telehealth becoming a vital connection between practitioners and their patients. The pandemic prompted the Drug Enforcement Administration (DEA) to implement emergency measures modifying the strict requirements of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. This Act required prescribing practitioners to conduct an in-person evaluation (with certain exceptions) before prescribing any controlled substances (Federal Register, 2023). As the world navigates the post-pandemic era, the DEA and the Department of Health and Human Services (HHS) have taken unprecedented steps to ensure healthcare remains accessible for those who need it the most, especially through the flexibility of telemedicine.

The DEA's implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was a crucial step in ensuring that online prescriptions were grounded in legitimate medical evaluations, but the COVID-19 pandemic necessitated temporary exceptions to maintain essential patient care.

If deemed safe and compliant with the law, the Attorney General and the Secretary of Health and Human Services are authorized by the Haight Act to create rules that permit telemedicine prescriptions without an in-person medical evaluation. Due to this Act, the Second Temporary Rule was issued, which extended exceptions determined by the DEA and the HHS is consistent with maintaining effective controls against medication misuse by ensuring public health and safety. Therefore, the HHS stated that no further rulemaking is necessary, finalizing that this rule is approved to continue under the existing legal framework (Federal Register, 2023). The DEA and HHS aim to continue the care for patients and consider comprehensive input before finalizing any permanent regulations. 

Xavier Becerra, the HHS Secretary said, “Improved access to mental health and substance-use disorder services through expanded telemedicine flexibilities will save lives. We still have millions of Americans, particularly those living in rural communities, who face difficulties accessing a doctor or health care provider in person. At HHS, we are committed to working with our federal partners and stakeholders to advance proven technologies and lifesaving care for the benefit of all Americans,” (DEA, 2023).

The reasons listed below explain the purpose of the extension of telemedicine flexibilities (Federal Register, 2023):

1. Maintain Access to Care

                    a.    Prevent disruptions in patient care for those who are not in a telemedicine practitioner-patient relationship yet until a final rule(s) is established.

       2.   Prevent Backlogs and Ensure Continuity

                    a.    Avoid healthcare providers from getting overwhelmed with in-person visits soon before and after the telemedicine exceptions expire.

                    b.    Assure patients and healthcare providers who rely on telemedicine can continue using it. 

       3.    Address Public Health needs

                    a.    Continue the initiation of buprenorphine treatment for opioid use disorder for the ongoing opioid crisis. 

       4.     Prepare Stakeholders for Future Regulations

                   a.     Allow patients, pharmacists, healthcare providers, and other stakeholders enough time to implement any new rules about prescribing controlled substances through telemedicine.

       5.      Consider feedback and Evaluate Alternatives

                   a.      Provide time to DEA and HHS to thoroughly review input from Telemedicine Listening Sessions.

                   b.      Let the DEA with HHS conduct a detailed evaluation of several regulatory options to create rules that expand telemedicine access safely and effectively. 

        6.      Avoid Problematic Practices

                  a.     Limit the second extension of flexibilities to a brief period so new telemedicine companies cannot promote inappropriate prescribing practices. 

The Second Temporary Rule was developed to satisfy the principles outlined in three Executive Orders (Federal Register, 2023):

-          E.O. 12866 (Regulatory Planning and Review): Agencies are directed to evaluate all costs and benefits of regulatory alternatives and select the ones that maximize net benefits, including economic, environmental, public health, safety effects, distributive impacts, and equity.

-          E.O. 13563 (Improving Regulation and Regulatory Review): Building on E.O. 12866, this order promotes a regulatory system that protects public health, welfare, safety, and the environment while encouraging economic growth, innovation, competitiveness, and job creation. 

-          E.O. 14094 (Modernizing Regulatory Review): Modifies specific rules of E.O. 12866 and E.O. 13563 to modernize regulatory review processes while implementing modernization goals outlined in the Presidential Memorandum of January 20, 2021. 

Miriam E. Delphin-Rittmon, the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA said, “Access to evidence-based treatment is a pillar of the HHS Overdose Prevention Strategy. We strongly support policies that promote access to effective and safe treatment for opioid use disorder, including through telemedicine platforms, and ensuring continued access to necessary controlled medications past the COVID-PHE,” (DEA, 2023).

There are no additional costs associated with the Second Temporary and it produces benefits like those described in the General Telemedicine Rule, through the reduction of expenses for prescribers and patients and transfer payments for the federal government. The exact cost savings and reduction in transfer payments are not specified due to several policies and rules needing to be finalized (Federal Register, 2023).

To avoid impacting the balance of power between federal and state governments or between the federal government and Indian Tribes, the Second Temporary Rule has also been created according to these three executive orders to be clear and legal without causing disputes or regulatory burdens (Federal Register, 2023):

-          E.O. 12988, Civil Justice Reform

• Purpose: Improve the legal process by reducing uncertainty, minimizing litigation, and establishing clear legal standards.
• The Second Temporary Rule meets the standards outlined in sections 3(a) and 3(b)(2) of E.O. 12988.

-          E.O. 13132, Federalism

• Purpose: Address the balance of power between the federal government and states.
• The Second Temporary Rule does not bring up any federalism concerns by not significantly impacting the state governments, the interactions or responsibilities between the federal and state governments, and does not shift power or responsibilities among different levels of the state.

-          E.O. 13175, Consultation and Coordination with Indian Tribal Governments 

• Purpose: Ensures that federal policies respect the rights of Indian Tribes and promote government-to-government consultations.
• The Second Temporary Rule does not significantly impact Indian Tribes by not having any substantial direct effects on the tribes, the federal-tribal relationships, and the power distribution between the federal government and Indian Tribes.

The Administrator, known as the DEA, also reviewed the Second Temporary Rule under the Regulatory Flexibility Act (RFA) and approved the rule by stating that it would not have a significant economic impact on many small entities or businesses. The DEA will continue to assess the impact of the rule on small entities when final rules are issued (Federal Register, 2023). 

Per the Paperwork Reduction Act of 1995, this temporary rule does not introduce new requirements for collecting information or modify any existing requirements. This Act governs the ways the federal agencies collect information from the public and ensures that such collections are necessary and not burdensome. Additionally, the temporary rule does not require state or local governments, individuals, businesses, or other organizations to keep records or report information on telemedicine practices, the prescription of controlled substances, or any related activities affected by this rule (Federal Register, 2023). 

The COVID-19 public health emergency has had a profound impact on healthcare, with telemedicine emerging as a crucial lifeline for both patients and practitioners. To alleviate the burden on patients who need ongoing care and those with established patient-practitioner relationships, the DEA and the HHS implemented the Second Temporary Rule. This rule aims to sustain the benefits of telemedicine, ensuring patient access to medications needed while preparing for a smooth transition to new regulatory standards by the end of 2024. This proactive approach highlights public health and safety and adapts regulations to changing healthcare needs (Federal Register, 2023).

References:

• Drug Enforcement Agency (DEA). (2023). DEA Announces Proposed Rules for Permanent Telemedicine Flexibilities. Retrieved from https://www.dea.gov/press-releases/2023/02/24/dea-announces-proposed-rules-permanent-telemedicine-flexibilities

• Drug Enforcement Agency (DEA). (2023). DEA, SAMHSA Extend COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications for Six Months While Considering Comments from the Public. Retrieved from https://www.dea.gov/press-releases/2023/05/09/dea-samhsa-extend-covid-19-telemedicine-flexibilities-prescribing

• Federal Register. (2023). Modernizing Regulatory Review. Retrieved from https://www.federalregister.gov/documents/2023/04/11/2023-07760/modernizing-regulatory-review

• Federal Register. (2023). Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. Retrieved from https://www.federalregister.gov/documents/2023/10/10/2023-22406/second-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled

Pete Nielsen LAADC, CADC II, CAI, SAP

President & CEO at CCAPP | 800-564-5927

Pete Nielsen is the President and Chief Executive Officer for the California Consortium of Addiction Programs and Professionals (CCAPP), CCAPP Credentialing, CCAPP Education Institute and the Behavioral Health Association of Providers (BHAP), and Publisher of Counselor Magazine

CCAPP is the largest statewide consortium of addiction programs and professionals, and the only one representing all modalities of substance use disorder treatment programs. BHAP is the leading and unifying voice of addiction-focused treatment programs nationally.

Mr. Nielsen has worked in the substance-use disorders field for 20 years. In addition to association management, he brings to the table experience as an interventionist, family recovery specialist, counselor, administrator, and educator, with positions including campus director, academic dean, and instructor.

Mr. Nielsen is the secretary of the International Certification and Reciprocity Consortium, and the publisher for Counselor magazine. He is a nationally known speaker and writer published in numerous industry-specific magazines. Mr. Nielsen holds a Master of Arts in counseling psychology and a Bachelor of Science in business management.