Pear Therapeutics Announces Milestone Decision by the American Medical Association CPT® Editorial Panel to Clarify the Coding of Remote Therapeutic Monitoring of Cognitive Behavioral Therapy

(CPT® is a registered trademark of the American Medical Association (AMA))

• The AMA has announced revisions to its new family of Category I CPT codes for Remote Therapeutic Monitoring (RTM) Services and the Remote Therapeutic Monitoring Treatment Management Services (RTM-TMS) guidelines to clarify coding of Cognitive Behavioral Therapy (CBT) monitoring services.

• Changes include: 1) the addition of a Category I CPT code 989X6 to report Remote Therapeutic Monitoring device supply to monitor CBT; 2) revisions to the RTM-TMS guidelines to clarify reporting of CBT; and 3) the deletion of Category III CPT codes 0X47T (permanent code 0702T to report therapeutic monitoring of a standardized online digital CBT program) and 0X81T (permanent code 0703T to report the associated management services).

• These revisions, which will go into effect as of January 1, 2023, will allow for the reporting of CBT monitoring services as part of RTM/RTM-TMS on a monthly basis. Meanwhile, Category I RTM/RTM-TMS CPT codes that describe services related to remote monitoring of therapy adherence and therapy response, will be available starting on January 1, 2022.

• In some instances, providers may elect to use remote monitoring to help manage patients receiving remote therapy through digital medical tools like Pear’s FDA-authorized PDTs including reSET®, reSET-O®, and Somryst® that deliver treatment of substance use disorder, opioid use disorder, and chronic insomnia, respectively, including the healthcare provider’s ability to remotely monitor therapeutic progress.

BOSTON–(BUSINESS WIRE)–Pear Therapeutics, Inc. is pleased to share that the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel has announced revisions to existing CPT codes clarifying the coding of remote therapeutic monitoring for cognitive behavioral therapy (CBT) services. These changes include: 1) the addition of CPT code 989X6 to report Remote Therapeutic Monitoring device supply to monitor CBT; 2) revisions to the Remote Therapeutic Monitoring (RTM) and Remote Therapeutic Monitoring Treatment Management Services (RTM-TMS) guidelines to clarify reporting of CBT; and 3) the deletion of Category III CPT codes 0X47T (permanent code 0702T to report therapeutic monitoring of a standardized online digital cognitive behavioral therapy program) and 0X81T (permanent code 0703T to report the associated management services).

These changes have an effective date of January 2023 – CPT’s Summary of Panel Actions for September-October 2021 may be found here: https://www.ama-assn.org/system/files/september-october-2021-summary-of-panel-actions.pdf.

Meanwhile, Category 1 RTM and RTM-TMS CPT codes, which were first announced in 2020, will be available starting on January 1, 2022, to describe physician and other qualified healthcare professional work including monitoring therapy adherence and response. These codes may be applicable to the work of HCPs monitoring therapy adherence and therapy response with respect to Pear’s commercially available PDTs, reSET®, reSET-O® and Somryst® for the treatment of substance use disorder, opioid use disorder, and chronic insomnia, respectively, including the healthcare provider’s ability to remotely monitor progress.

Appropriate billing and coding for healthcare services are the provider’s responsibility and should always be based on the patient’s clinical condition, services provided, and payer guidelines. A comprehensive review of all recent changes related to remote therapeutic monitoring is recommended.

“AMA’s clarifications and addition to codes describing services related to clinician monitoring of FDA-authorized medical devices delivering Cognitive Behavioral Therapy (CBT) are another significant milestone in providing coding for healthcare providers across the United States,” said Corey McCann, M.D., Ph.D., President and Chief Executive Officer of Pear Therapeutics. “Ultimately, RTM Category 1 codes will provide additional CPT coding options for healthcare providers when using digital health technologies.”

On October 29, 2021, AMA released the CPT® Editorial Summary of Panel Actions (https://www.ama-assn.org/system/files/september-october-2021-summary-of-panel-actions.pdf), which reflects the discussion at the most recent CPT® Editorial Panel meeting in September 2021. CPT® coding serves as a uniform nomenclature used for medical services to improve harmonization of reporting, increase the accuracy of medical services and procedures, and to improve efficiency across healthcare. CPT® terminology is the most widely accepted medical language for public and private health insurance programs. The CPT® Editorial Panel is tasked with maintaining an open process that convenes meetings to solicit input from stakeholders across healthcare.

AMA announced their CPT Editorial Panel accepted the addition of code 989X6 to report remote therapeutic monitoring device supply to monitor cognitive behavioral therapy; the revision of the Remote Therapeutic Monitoring Services guidelines and the Remote Therapeutic Monitoring Treatment Management Services guidelines (CPT code family 98975, 98976, 98977, 98980, and 98981) to clarify reporting of cognitive behavioral therapy; and the deletion of codes 0X47T, 0X81T (now permanent codes 0702T and 0703T).

PDTs are a new therapeutic class that use software to treat serious disease. Like traditional medicines, PDTs are developed in a Good Manufacturing Practices (GMP) compliant environment, tested in randomized controlled trials to demonstrate safety and effectiveness, evaluated for authorization by regulators like FDA, and used under the supervision of a prescribing clinician. Pear’s PDTs are designed to collect real world data for use by prescribing clinicians and for population health management by payers and health systems.

About Pear Therapeutics

Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a portfolio of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst®, for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.

reSET Important Safety Information

Indications for Use:

reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older, who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 day) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse.

It is intended to:

• increase abstinence from a patient’s substances of abuse during treatment, and
• increase retention in the outpatient treatment program.

Important Safety Information for Clinicians:

Warnings: reSET is intended for patients whose primary language is English with a reading level of 7^th grade or above, and who have access to an Android/iOS tablet or smartphone. reSET is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).

Clinicians should not use reSET to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.

reSET is not intended to be used as a stand-alone therapy for substance use disorder (SUD). reSET does not replace care by a licensed medical practitioner and is not intended to reduce the amount of face-to-face clinician time. reSET does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.

Patients with substance use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with substance use disorder also have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should engage in their normal care practices to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves.

The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12 weeks (90 days) in the SUD population. The ability of reSET to prevent potential relapse after treatment discontinuation has not been studied.

The effectiveness of reSET has not been demonstrated in patients currently reporting opioids as their primary substance of abuse.

This Press Release does not include all the information needed to use reSET safely and effectively. Please see the Clinician Brief Summary for reSET for more information.

reSET-O Important Safety Information

Indications for Use:

reSET-O prescription digital therapeutic is a 12-week (84 day) software application intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.

Important Safety Information for Clinicians:

Warnings: reSET-O is intended for patients whose primary language is English with a reading level of 7^th grade or above, and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).

Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.

reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not replace care by a licensed medical practitioner and is not intended to reduce the frequency or duration of in-person therapy. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.

Patients with opioid use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with opioid use disorder have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should undertake standard of care to monitor patients for medical problems and mental health disease, including risk for harming others and/or themselves.

The long-term benefit of reSET-O has not been evaluated in studies lasting beyond 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.

This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the Clinician Brief Summary Instructions for reSET-O for more information.

Somryst Important Safety Information

Indications for Use

Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia – CBT-I) to patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms.

Important Safety Information:

Warnings: Somryst is not for everyone. Please use your clinical judgement to determine whether Somryst is right for your patient.

• Somryst is not for emergency use. Please instruct patients to dial 911 or to go to the nearest emergency room in the event of a medical emergency,
• Patients should be clearly instructed not to use Somryst to communicate severe, critical, or urgent information to their Health Care Provider.
• Somryst is not meant to be used as treatment without supervision of a Health Care Provider.
• Somryst is not meant to be a substitution for any treatment medication.
• Somryst contains sensitive medical information. Please instruct patients to protect their information by password-protecting their smartphone and tablet, ensuring no one else may access their device.
• Sleep Restriction (and Consolidation) within Somryst can cause sleepiness, especially in the early stages of using the PDT. Somryst should not be used if the patient needs to be alert or cautious to avoid serious accidents in their job or daily life. Examples include:
  • Long-haul truck drivers
  • Long-distance bus drivers
  • Air traffic controllers
  • Operators of heavy machinery
  • Some assembly line jobs
• The usage data collected in therapy lessons by Somryst are not intended to be used as a standalone assessment of treatment progress.

This press release does not include all the information needed to use Somryst safely and effectively. Please see the full Clinician Brief Summary Instructions for Somryst for more information.

Contacts

Media and Investors:
Meara Murphy

Senior Director, Corporate Communications

meara.murphy@peartherapeutics.com