A9291, Prescription digital cognitive and/or behavioral therapy, fda cleared, per
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Documentation Required
- Prescription or order from a licensed healthcare provider specifying the digital therapeutic product.
- Documentation verifying FDA marketing clearance or approval for the specific software (de novo, 510(k), or PMA).
- Documentation that the software meets the Software as a Medical Device definition and is intended for therapeutic use (standalone software, not merely storage/transmission).
- Clinical documentation supporting the diagnosis of ADHD and the rationale for use of the digital therapeutic to improve attention.
- Copy of U.S. FDA marketing clearance/approval (de novo, 510(k), or PMA) for the specific device.
- Prescribing order or documentation from the licensed healthcare provider authorizing use of the SaMD.
Key Coverage Criteria
- Mobile-based health management applications are consideredmedically necessarywhenallof the following criteria in I and II have been met:
- Criteria to evaluate the mobile software application (MSA):The MSA has been approved or cleared by the Food and Drug Administration (FDA);andThere is credible scientific evidence which permits reasonable conclusions regarding the impact of the MSA on health outcomes;andThe MSA has been proven materially to improve the net health outcome or be as beneficial as any established alternative;AND
- The MSA has been approved or cleared by the Food and Drug Administration (FDA);and
- There is credible scientific evidence which permits reasonable conclusions regarding the impact of the MSA on health outcomes;and
- The MSA has been proven materially to improve the net health outcome or be as beneficial as any established alternative;AND
- Criteria to evaluate the appropriateness of the MSA for the individual:The MSA has been prescribed by a healthcare practitioner;andThere is documentation supporting that the MSA was ordered for a covered purpose such as preventing, evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and in accordance with generally accepted standards of medical practice;*andThe requested MSA is not primarily for the convenience of the individual, prescribing clinician, caregiver, or o [...]
20 Active Policies
ANTHEM-CG-ANC-08, CG-ANC-08 Mobile Device-Based Health Management Applications
PSY301.022, Digital Health Technologies for Attention Deficit/Hyperactivity Disorder
PSY301.024, Digital Health Technologies: Diagnostic Applications
PSY301.025, Digital Health Technologies: Therapeutic Applications
BCBSIL-PSY301.024, Digital Health Technologies: Diagnostic Applications
BCBSIL-PSY301.025, Digital Health Technologies: Therapeutic Applications
BCBSMT-PSY301.024, Digital Health Technologies: Diagnostic Applications
BCBSMT-PSY301.025, Digital Health Technologies: Therapeutic Applications
BCBSNM-PSY301.024, Digital Health Technologies: Diagnostic Applications
BCBSNM-PSY301.025, Digital Health Technologies: Therapeutic Applications
BCBSOK-PSY301.022, Digital Health Technologies for Attention Deficit/Hyperactivity Disorder
BCBSOK-PSY301.024, Digital Health Technologies: Diagnostic Applications
BCBSOK-PSY301.025, Digital Health Technologies: Therapeutic Applications
REGENCE-MED175, Digital Therapeutic Products
REGENCE-MED175.01, Digital Therapeutic Products for Attention Deficit Hyperactivity Disorder
REGENCE-MED175.03, Digital Therapeutic Products for Chronic Low Back Pain
REGENCE-MED175.05, Digital Therapeutic Products for Post-traumatic Stress Disorder and Panic Disorder
REGENCE-MED175.02, Digital Therapeutic Products for Substance Use Disorders
BCBSIL-PSY301.022, Digital Health Technologies for Attention Deficit/Hyperactivity Disorder
BCBSMT-PSY301.022, Digital Health Technologies for Attention Deficit/Hyperactivity Disorder
Related Codes
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