At the EDGE2022 Policy Conference sponsored by the American Telemedicine Association in Washington, D.C. in December 2022, the topic of protecting access to telehealth services in a post-COVID-19 era was front and center in multiple presentations and panel discussions. Many presenters, myself included, focused on the image of potentially millions of patients “falling off a telehealth cliff” if and when access to virtual care services reverted back to pre-COVID-19 restrictions. Stakeholders including advocacy groups, healthcare providers, telehealth companies, and leaders in government proposed a range of strategies and options to help make sure that patients can continue to access the telehealth services they need while providers can continue to be reimbursed appropriately for those services.
During the pandemic, leaders in government worked to modify the regulations related to telehealth services under a public health emergency (PHE) authorization. Among the changes in the use of telehealth services introduced by the PHE, one of the most impactful was the temporary waiver of restrictions mandated by the Ryan Haight Act. Introduced by Congress in 2008, the Ryan Haight Act includes a requirement that drugs classified by the DEA as “controlled substances” can only be prescribed to patients by qualified medical providers following a required in-person examination. It also included plans for the DEA to establish a special registration process to confirm doctors who are qualified to prescribe controlled substances without the need for patients to have an in-person visit.
It’s been 14 years since the Ryan Haight Act was introduced and the DEA has yet to establish this special registration process, despite the fact that many telehealth service providers have outlined appropriate protocols and procedures designed to support the highest achievable levels of security and safety for patients while significantly reducing the risk of abuse.
While there have been many studies demonstrating the positive benefits of telehealth in terms of access to high-quality care, reduced costs, and improved convenience, the fact that the PHE guidelines are not permanent means that many patients and providers must continually plan for a day when access to these services could become severely limited. To head off this potential crisis, in November 2022 a consortium of leaders, stakeholders, and medical practices in strong support of telehealth addressed a letter to the U.S. Attorney General and the U.S. Drug Enforcement Agency urging for the waivers under the PHE to be extended while the DEA finalizes and announces the special registration process. You can read the letter here.
In December 2022, the Omnibus Appropriations Bill passed by Congress included several critical two-year extensions for telehealth provisions included in the PHE, such as:
- waiving geographic restrictions and originating site requirements;
- expanding the list of practitioners eligible to provide telehealth services;
- allowing telehealth services at rural health clinics and federally qualified health centers; and,
- delaying the in-person visit requirement before a patient receives mental health services.
The End of the PHE and Some Provisions That Have Not Been Extended
While the guidelines under the PHE represent an important advantage for millions of patients and providers, the Omnibus Bill, unfortunately, does not call for extensions in these policies in several key areas.
Now that President Biden has formally announced the end date of the PHE, May 11, 2023, there is widespread concern about the potential for disruption of care for the thousands of patients who have established a valid provider-patient relationship via telemedicine during the COVID-19 PHE. This concern is especially focused on patients who have been receiving safe and clinically appropriate treatment with a controlled substance. This uncertainty could also affect clinical and administrative operations at many medical practices as well as the future of reimbursement for many telehealth services:
- According to the Centers for Medicare & Medicaid Services (CMS), many services are reimbursable under Medicare Part B only when administered under the direct supervision of a physician. In these cases, a supervising physician must be physically present when the services are delivered to the patient. In cases where supervising clinicians are needed, they are expected to be available immediately to provide assistance or guidance during the service or procedure. Through the PHE, this requirement was temporarily waived, allowing for remote supervision through the use of two-way communications. CMS refused to extend this waiver according to the 2023 Physician Fee Schedule. Unless CMS reconsiders, this waiver is scheduled to end at the end of this calendar year.
- As a result of the pandemic, CMS agreed to temporarily reimburse telehealth visits at the same rate as in-person visits. Without lawmaker intervention, these equitable rates are scheduled to continue only through the end of 2023.
- In response to the PHE, in March 2020 the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that medical providers would be allowed to deliver care via telehealth based on their clinical judgment even if access to HIPAA-compliant software and tools was not available. In effect, OCR enacted “enforcement discretion” only through the last day of the PHE. This means providers will need to radically change their operations if they have not already adopted and implemented HIPAA-compliant systems and processes when delivering care virtually.
Potential Modifications for Telehealth
To support the highest possible levels of access to care and reimbursement for patients, the virtual care industry is also planning for some important modifications in business standards and protocols in the years ahead. During the EDGE2022 Conference, I joined with many industry leaders in outlining some essential steps that will support a path forward that can help us achieve and maintain target levels of quality, safety, and convenience in the delivery of virtual care services.
The plan calls for telehealth service providers who intend to continue to practice and deliver clinically appropriate treatment through a controlled substance to be open to adopting a hybrid delivery-of-care system that includes telehealth services combined with the need to maintain a physical location for service delivery. It also calls for continuous engagement in patient advocacy efforts designed to support access to care in the years ahead.
While the benefits of virtual care were evident before the COVID-19 pandemic, the industry response has provided many new insights about the positive impact that telehealth services can have in terms of patient safety, convenience, and reduced costs. The best approaches will work to align the goals and needs of all stakeholders, including patients, medical practices, service providers, payers, and leaders in government. As a first step, we need to remove all scenarios where significant changes in access and reimbursement can occur overnight so that we can develop long-term plans that will maximize the benefits of virtual care in the years ahead.