Featured Morrison & Foerster Partners Speak At FDLI's Digital Health Technology And Regulation Conference - Food, Drugs, Healthcare, Life Sciences

Published on November 19th, 2021 📆 | 3440 Views ⚑


Morrison & Foerster Partners Speak At FDLI’s Digital Health Technology And Regulation Conference – Food, Drugs, Healthcare, Life Sciences

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Morrison & Foerster Partners Speak At FDLI’s Digital Health Technology And Regulation Conference

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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

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.

  1. 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?   
  2. 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.
  3. 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

Telehealth 2021:  Regulatory and Reimbursement

  1. 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. 
  2. 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
  3. 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.

Because of the generality of this update, the information
provided herein may not be applicable in all situations and should
not be acted upon without specific legal advice based on particular

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