The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond, November 9-10, 2021.
Morrison & Foerster’s Stacy Cline Amin and Bethany Hills led panel discussions during the two-day conference. Stacy Cline Amin, who served on the conference planning committee, moderated a panel discussion on congressional perspectives and considerations in the digital health space. Bethany Hills participated on a panel discussion on evolutions in telehealth regulation and reimbursement, with a focus on recent developments in 2021.
Below are key topics and takeaways discussed during the panels.
Congressional Perspectives in Digital Health
This panel featured senior staff from both of the FDA’s committees of jurisdiction, the Senate Health Committee and the Senate Finance Committee, the House Energy & Commerce Committee, as well as senior staff who led the negotiations for the 21st Century Cures Act.
- At the time the 21st Century Cures Act was drafted and negotiated, Congress had in mind smart watches and similar digital health technology that is far less complicated than the realities of the technology today. The advancements and increased technological complexity have brought a slew of intricate questions about when and how FDA regulation should come into play and whether Congress should provide more clarity for the industry. For example, how should clinical decision support be defined, and at what point should it be subjected to FDA regulatory review or approval?
- In the artificial intelligence and machine learning (AI/ML) space, panelists discussed the challenges of regulating technology that is continuously changing and the potential incompatibility of AI/ML technologies with existing regulatory frameworks, such as change protocols. Panelists emphasized the importance of having patients and providers at the table in these ongoing discussions and ensuring that Congressional stakeholders and constituents can understand the technology and mechanics in order to make meaningful decisions.
- Congress is considering these issues as part of the Medical Device User Fee Amendments. Panelists encouraged industry stakeholders and constituents to provide comments and insights to Congressional representatives and staff as these discussion continue.
Telehealth 2021: Regulatory and Reimbursement Developments
- As we begin to approach the end of the pandemic, the waivers and exemptions extended during the public health emergency have begun to be withdrawn. Without action from Congress, most Medicare beneficiaries of telehealth will lose access to the majority of telehealth services available during the pandemic. While many stakeholders are advocating for permanent changes to law regarding telehealth access, a simple extension of the current wavier period is more likely as a near-term action. Of note, the Centers for Medicare and Medicaid Services (CMS) has already expanded its definition of telehealth services to include audio-only services for mental health services.
- CMS has created carve-outs for services that may not be defined exactly as telehealth services, but that are supportive of and integrated with telehealth, such as remote physiologic and therapeutic monitoring. Changes to the RPM and RTM codes and guidelines indicate a certain degree of desired flexibility, but also come with additional questions and areas of ambiguity.
- Digital health companies are taking advantage of the health insurance adoption of telehealth, maximizing the benefit of telehealth and its potential to lower costs while enhancing patient care. However, there are a number of challenging issues going forward, particularly with digital-first health insurance offerings and direct-to-consumer (DTC) telehealth products that incorporate insurance‑like features. In addition, many states issued waivers permitting clinicians to practice across state borders without licensure during the pandemic. As state-level licensure waivers are winding down, this poses challenges for digital health providers in constructing and maintaining viable provider networks for insurance and DTC markets.
For questions on any of the topics discussed at this meeting, please contact the authors or a member of MoFo’s FDA Regulatory + Compliance practice.