FDA Guidance on Digital Devices for Mental Health During COVID-19

To protect the public’s health during the COVID-19 pandemic, the Food & Drug Administration (FDA) released guidance expanding the availability of digital health therapeutic devices and applications for psychiatric disorders by clarifying which regulatory requirements it does not plan on enforcing as well as which products do not necessitate FDA oversight. This guidance intends to limit extraneous contact between patients (users) and providers by providing regulatory flexibility for low risk products. The policies will last until the national public health emergency ends.

  • Kelly L. George
  • Chloe Diamond
  • Dana Macher

Provider Impact of COVID-19 Telehealth Policies by Specialty

Approximately ⅓ of physician services payments are eligible for telehealth reimbursement under Medicare (fee-for-service) FFS through existing Center for Medicare and Medicaid Services (CMS) guidance as of January 2020, in addition to temporary coding guidance specific to COVID-19 effective as of March 1, 2020. Avalere’s analysis highlights the immediate potential for specific physician specialties to utilize telehealth based on temporary flexibilities regarding which procedures are eligible for telehealth reimbursement.

  • Jenna Ivan
  • Timothy Epple
  • Abby Moorman
  • Brian Failor
  • Chandler Burris-Jones

COVID-19 Complicates Access to Provider-Administered Autoimmune Treatments

The large-scale disruptions resulting from COVID-19 are significantly reshaping how patients receive care. In particular, patients taking infused and injectable drugs administered by a healthcare professional at a physician office, infusion center, or hospital outpatient department now face greater challenges receiving their medications.

  • Lance Grady
  • Elizabeth Carpenter
  • Biruk Bekele
  • Mitchell Cole
  • Kayla Amodeo
  • Michael Schneider

Where We Stand on COVID-19 Treatments

Globally, the need to flatten the epidemic curve of COVID-19 cases has become the top public health priority to save lives and minimize the burden on the health care system. In the absence of treatments and prophylactics for the novel coronavirus, social distancing and quarantine strategies continue to be implemented in the US.

  • Omar Hafez
  • Kelly L. George
  • Hillary Stires
  • Chloé Chepigin
  • Jack Fagan

New Federal Rule Could Affect Infusion Site of Care Amid COVID-19 Pandemic

The Centers for Medicare & Medicaid Services (CMS) issued a new Interim Final Rule (IFR) that is intended to allow additional beneficiaries, especially those who are at high-risk, to receive home infusions amid COVID-19 transmission concerns. Specifically, the CMS clarified the definition of “homebound” under the Medicare Home Health Benefit and temporarily suspended enforcement of the National and Local Coverage Determinations (NCD and LCD) related to home infusion services. Uncertainties remain as to how these new flexibilities will be utilized, as well as how these flexibilities could impact treatment outcomes.

  • Mark Gooding
  • Abby Moorman
  • Chad Brooker
  • Kayla Amodeo
  • Lance Grady

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