February 25, 2022— Arlington, VA — As the leading international organization on digital therapeutic thought leadership and education, the Digital Therapeutics Alliance (DTA) welcomes the Centers for Medicare & Medicaid Services’ (CMS) recent decision to establish a new Level II Healthcare Common Procedure Coding System (HCPCS) code to describe ‘Prescription Digital Behavioral Therapy, FDA Cleared, per Course of Treatment,’ which includes digital therapeutics (DTx). The coding decision reflects the growing recognition that DTx products are an important element of care for patients with mental and behavioral health conditions and facilitates options for payors to provide access to these innovative treatments.
The CMS coding decision was published on February 16, 2022 and the code for prescription digital behavioral therapy is scheduled to become effective on April 1, 2022:
| HCPCS Code | Description |
| A9291 | Prescription digital behavioral therapy, FDA cleared, per course of treatment |
Given the growing need for effective mental and behavioral healthcare, access and affordability remain obstacles for too many of those seeking treatment, particularly for the most vulnerable populations. DTA members are addressing these challenges by making evidence-based treatments more accessible and improving patient outcomes with innovative DTx products for conditions like depression, anxiety disorders, opioid and substance use disorders, and insomnia.
CMS’ decision recognizes digital therapeutics as an important element of patient care and that a standardized coding mechanism is necessary to ensure payors can cover these interventions under existing reimbursement pathways. This change provides an important step toward establishing a standard for the coverage and payment of DTx products.
With the option to reimburse prescription digital behavioral therapies through either pharmacy or medical benefits, this code facilitates options for payors to cover, clinicians to deliver, and patients to access these treatments.
“As a significant milestone for the DTx industry, this is a turning point in how DTx products are integrated into healthcare workflows,” shares Andy Molnar, DTA Chief Executive Officer. “Establishing a HCPCS code for prescription digital behavioral therapies is an important first step to ensure patient access to DTx products. We thank DTA member Pear Therapeutics for their leadership in initiating this process, and CMS for their decision to establish a new HCPCS code that enables a pathway to provide coverage for these treatments.”
This important milestone is one of many necessary steps to establish broad scalability of DTx products across all patient care settings. DTA and our members are therefore leading efforts to further enable clear and scalable pathways for reimbursement that support wider integration of DTx products into the larger healthcare ecosystem, such as working with CMS to further clarify the future of this coding mechanism, and advocating for legislative changes that establish DTx coverage for patients under Medicare and Medicaid programs.
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About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn and Twitter.
Media Contact:
Hannah Fairman, hfairman@dtxalliance.org