Prescription Digital Therapeutics describes technology-based healthcare therapeutic interventions for the treatment of medical and behavioral conditions. These devices are described as Software as a Medical Device (SaMD) by the United States Food and Drug Administration (U.S. FDA). Prescribed Digital Therapeutics are intended to be used as a part or whole of a treatment plan for appropriate health diagnoses, that fall within the scope of approved use of the digital health software.
U.S. FDA approved digital therapeutics prescribed by a licensed health care professional for therapeutic intervention may be considered medically necessary when ALL the following criteria are met:
Digital Therapeutics not meeting the criteria as indicated in this policy are considered not medically necessary.
A9291 |
A9292 |
98978 |
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FDA approved digital app for contraceptive use with prescription may be considered medically necessary when used as contraception only.
Currently Approved Digital Therapeutics: |
Approved for Intervention or Treatment: |
Natural Cycles |
Contraception |
Digital Therapeutics not meeting the criteria as indicated in this policy are considered not medically necessary.
A9291 |
A9293 |
98978 |
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Virtual reality cognitive behavioral therapy device (cbt), including pre-programmed therapy software is considered not medically necessary.
E1905 |
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Refer to Medical Policy M-86, Digital Diagnostics, for additional information.
American Psychological Association- 2021
Mental health digital therapeutics involve the use of software programs to deliver evidence-based and validated interventions to treat or manage mental and behavioral health disorders, such as chronic insomnia and substance use disorders. They can be used independently or as an adjunct to medications or other therapies to optimize patient care and health outcomes. Digital therapeutics are not typically direct-to-consumer mental health apps you can download on your own. By definition, digital therapeutics meet classification for Software as a Medical Device and, therefore, fall under FDA oversight. A digital therapeutic may require explicit FDA review and clearance which then requires a prescription in order to be offered to patients or be subject to ‘enforcement discretion’ depending on its claims and existing regulatory code (Carl et al., 2020). In April 2020, the FDA announced temporarily waiving certain requirements for digital health devices for treating psychiatric disorders. There are currently 7 FDA approved prescription only mental health digital therapeutics, with 4 of the 7 receiving approval after June 1, 2020.
Digital Therapeutics is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you need these services, contact the Civil Rights Coordinator.
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475
, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697
(TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association. Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania. Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York]. All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
