Legislative activity related to telehealth and AI picked up during the fourth quarter of 2023. Several new developments could have far-reaching implications for healthcare stakeholders. Here is a recap on some of the policy updates impacting virtual care.
White House Executive Order on AI
On October 30, 2023, the White House released an Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. The EO seeks to make sure AI systems are safe, secure, and trustworthy as users flock to the technology, presenting guidelines on:
- Sharing safety test results
- Preventing bias in algorithms
- Using AI in smart drug development
- Establishing penalties for harm from AI
- Expanding grants for AI research in vital areas like healthcare
In the EO, the Administration addresses both the transformative potential and risks of AI, outlining broad actions to govern the development and use of the technology. Legal consultants with McDermott Will & Emery (MWE) offered a great deep-dive into the healthcare-specific points in the EO, including these important milestones:
Protecting Consumers, Patients, Passengers and Students
- Within 90 days of the EO’s publication, the HHS Secretary is required to establish an HHS AI Task Force.
- Within one year of establishment, the Task Force is required to develop a strategic plan on policies and frameworks for the responsible deployment of AI in healthcare.
- Within 180 days of the EO’s publication, the HHS Secretary is required todevelop a strategy to determine whether health AI technologies maintain appropriate levels of quality.
- Within 365 days of the date of this order, the HHS Secretary is required to establish anAI safety programthat establishes acommon framework for approaches to identify and capture clinical errors resulting from AIdeployed in healthcare settings.
Promoting Innovation
- Within 90 days of the EO’s publication, in coordination with the heads of agencies that the director of the US National Science Foundation (NSF) deems appropriate,launch a pilot program implementing the National AI Research Resource (NAIRR).
- Within 540 days of the EO’s publication, the director of NSF should establish at leastfour new national AI research institutes and identify grantmaking opportunities to support responsible AI development and use.
As MWE put it, “This is a pivotal moment for AI governance. Many of the key, material details and AI governance standards will be developed during the next six months to one year. For organizations interested in developing or using AI or machine learning tools in healthcare, there will be far-reaching implications as new standards, compliance expectations, and other guidelines emerge.”
Controlled Substance Flexibilities
Also of note in October 2023, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) once again extended flexibilities related to the prescription of controlled substances via telehealth through the end of 2024.
- A practitioner can prescribe a controlled substance to a patient using telemedicine, even if the patient isn’t at a hospital or clinic registered with the DEA.
- Qualifying practitioners can prescribe buprenorphine to new and existing patients with opioid use disorder based on a telephone evaluation.
As reported by Healthcare Dive, this marks the second extension of relaxed prescribing rules, making it possible for clinicians to prescribe drugs like opioid use disorder and ADHD medications without first conducting an in-person evaluation.
With many of the telehealth flexibilities enacted during the pandemic set to expire at the end of next year, 2024 is “shaping up to be the Super Bowl for telehealth,” as Kyle Zebley, the American Telemedicine Association (ATA) senior vice president for public policy and executive director of ATA Action, put it.
Telehealth Permanency Hearing
On November 14, 2023, the Senate Finance Committee’s Subcommittee on Health Care held the “Ensuring Medicare Beneficiary Access: A Path to Telehealth Permanency” hearing to discuss the fate of Medicare telehealth flexibilities slated to expire on December 31, 2024.
During the hearing, four healthcare providers working in telehealth offered expert witness testimonies outlining essential flexibilities to make permanent:
- Allowing video visits for all conditions for all Medicare beneficiaries.
- Allowing physicians to provide care and services to patients via audio-only modalities.
- Expanding beyond qualified healthcare centers to allow licensed physical therapy, occupational therapy, and speech-language pathology practitioners to utilize telehealth services.
Opinions still differ on the future of telehealth payment parity. Some recommend reimbursing telehealth services at a lower rate to avoid market distortions while others argue that providers will cease offering these services without parity. As the Center for Telehealth and e-Health Law (CTeL) put it in a recent summary of the hearing, “Oftentimes, without the option of services provided via telehealth, patients are left with the “choice” of no care at all. Which isn’t really a choice at all.”
The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act bill was re-introduced in June 2023 in a renewed attempt to make COVID-19 telehealth flexibilities permanent. Meanwhile, the clock is ticking as we inch closer to the 2024 expiration date.