Largest Minnesota health system urging others to cover the FDA-authorized treatments
PreferredOne, Fairview’s health benefits management company, is the first health insurance provider in Minnesota to cover two innovative prescription digital therapeutics (PDTs) to treat addiction: reSET® and reSET-O®, which are manufactured by Pear Therapeutics, Inc. The software-based treatments are authorized by the U.S. Food and Drug Administration (FDA) and are indicated to treat substance use disorder and opioid use disorder, respectively.
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PreferredOne, Fairview’s health benefits management company, is the first health insurance provider in Minnesota to cover two FDA-approved prescription digital therapeutics to treat addiction. (Provided by Pear Therapeutics)
reSET and reSET-O are the first two PDTs to receive market authorization to treat disease from FDA. PDTs are apps that are downloaded to a patient’s mobile device after being prescribed. Both products, which are adjunctive to outpatient counselling, provide patients with algorithm-driven cognitive behavioral therapy, fluency training, and contingency management, while clinicians receive access to clinical dashboards to inform in-office and tele visits. reSET is used as a monotherapy and reSET-O is used in combination with transmucosal buprenorphine.
"M Health Fairview is committed to ensuring our patients have coverage for these innovative mental health resources, and we’re excited that PreferredOne is leading the way in Minnesota by offering these products," said Beth Heinz, executive of mental health and addiction services for M Health Fairview. "The only way to ensure broad access is for other payors to join us in reimbursing these products. Patients in all systems will benefit when more providers join this effort and enable physicians to prescribe these solutions."
The COVID-19 pandemic arrived amid an ongoing addiction crisis, and it exacerbated health issues for many Minnesotans. Only 1 in 10 people with a substance use disorder receive treatment in the U.S., according to the Minnesota Department of Health.
"We applaud PreferredOne and M Health Fairview’s commitment to addiction and mental health coverage," said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. "Now, more than ever, people struggling with substance use disorders need access to recovery support and treatment due to the impact of the pandemic. Together we can address this unmet need, and we hope that other health plans in Minnesota will join in taking this step to ensure access to innovative evidence-based therapeutics for all Minnesotans."
About M Health Fairview
M Health Fairview is the newly expanded collaboration between the University of Minnesota, University of Minnesota Physicians, and Fairview Health Services. The healthcare system combines the best of academic and community medicine – expanding access to world-class, breakthrough care through our 10 hospitals and 60 clinics.
PreferredOne, a wholly-owned subsidiary of Fairview Health Services, leads the market with products and services that conserve employer health plan dollars while helping more than 364,000 members achieve their best health. Comprehensive local and national provider networks together with an emphasis on health care cost and quality maximize the value of employee health benefits.
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:
Warnings: reSET is intended for patients whose primary language is English and whose reading level is at the 7th grade level 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 represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.
reSET should not be used by individuals outside active enrollment in a SUD treatment program. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET is not intended to reduce the amount of face-to-face clinician time.
The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12-weeks 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 full Clinician Brief Summary for reSET for more information.
reSET-O Important Safety Information
Indications for Use
reSET-O is 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 prescription digital therapeutic.
Important Safety Information:
Warnings: reSET-O is intended for patients whose primary language is English 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).
reSET-O should not be used by individuals outside active OUD treatment. It is not intended to replace treatment by you, the patient’s medical provider. It should be used as an adjunct to clinician treatment, buprenorphine treatment and contingency management.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). 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. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
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.
This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the full Clinician Brief Summary Instructions for reSET-O for more information.
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Aimee Jordan | Media Relations Manager, M Health Fairview
email@example.com | 612-672-4165
Sara Holje | Director of Marketing, PreferredOne