CMS Establishes New Code for Digital Behavioral Therapies

The Centers for Medicare & Medicaid Services (CMS) has established a new medical code for digital behavioral therapies. The new Healthcare Common Procedure Coding System (HCPCS) Level II code, A9291, is effective April 1, 2022. Level II codes are used for services outside a health care provider’s office.

The new code was created after Pear Therapeutics applied create a code its digital therapeutics, including reSET (for substance abuse disorder), reSET-O (for opioid use disorder) and Somryst (for insomnia). All have been authorized by the FDA.

“CMS believes that establishing a code at this time may facilitate options for non-Medicare payers to provide access to this therapy in the home setting. CMS continues to be open to hearing from manufacturers and payers about their experience in implementing this code relative to the three products from Pear Therapeutics and other manufacturers,” CMS officials said.

“This is an important reimbursement milestone for healthcare providers, payers and patients, and marks another step towards standard of care for coverage and payment for the PDT category,” Corey McCann, M.D., Ph.D., president and chief executive officer of Pear Therapeutics, said in a press release.

Like traditional medicines, PDTs are developed in a GMP-compliant environment, tested in randomized controlled trials demonstrating safety and effectiveness, evaluated and authorized by regulators like FDA, and used under the supervision of a prescribing clinician.

Each therapy lesson is comprised of a cognitive behavioral therapy component and skill building exercises. Therapy lesson content is delivered primarily via text or audio, and may include videos, animations and graphic.

Analysis of real-world data of patients with opioid use disorder who used an 84-day prescription of reSET-O compared with patients who did not use the digital therapeutic resulted in net cost savings over the 9-month period of $2,708 and a 46% lower incidence of hospital-related stays, according to a published study.

More than 30 organizations now provide access to Pear’s digital therapeutics by either listing on a formulary as a covered benefit or purchasing products in bulk, according to the company. Pear’s products have also been made available on major national product formularies, including two of the top five pharmacy benefit managers. Massachusetts became the first state to cover PDTs for all Medicaid patients, effective November 1, 2021.

Pear Therapeutics is one leading company in the digital therapeutics space, which also includes Akili Interactive Labs, Happify, Proteus Digital Health, WellDoc, among others. The COVID-19 pandemic increased the use of such digital products, and the market is expected to grow 20% from 2021 to 2028, according to one report.