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Comment Letter

Comments to CMS on Payment for Physician-Patient Clinical Trial Discussions

Press Contact: Jason Millman (213)-821-0099

A physician shows information on a tablet to an older woman during a medical consultation.

Image / Shutterstock

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Schaeffer experts submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the agency’s proposal to create a billing code to reimburse providers for discussing clinical trials with patients.

The experts study barriers to trial enrollment through the USC Clinical Trial Recruitment Lab, with a particular focus on Alzheimer’s disease and related dementias (ADRD). Their comments expressed support for creating a dedicated HCPCS G-code for clinical trial counseling and encouraged CMS to ensure it reflects the complexity of conducting trials for cognitive-impairment treatments.

Their key recommendations:

  • Documentation requirements should be kept minimal, consistent with the lean approach CMS has proposed.
  • The code should reflect the added time needed to address caregivers and study partners, which are often required by ADRD trials.
  • Medicare should make the service available via telehealth to protect access for rural and underserved patients.

The full comment letter is available here.