ACTION for PDTs: Mental Health and Substance Use Disorder

ACTION for PDTs: MH/SUD is an alliance of stakeholder organizations working collectively to raise awareness of and expand access to PDTs used in  patients with mental health conditions and substance use disorders (MH/SUD).  

We seek to expand the adoption and coverage of, and access to PDTs, so individuals living with MH/SUD can lead healthier lives. With that in mind, ACTION for PDTs: MH/SUD seeks to achieve the following goals: 

• Encourage the adoption of evidence-based, U.S. Food and Drug Administration (FDA)-regulated PDTs for MH/SUD
• Advocate for comprehensive coverage of and access to PDTs 
• Improve therapeutic outcomes
• Drive inclusion to reduce inequities, disparities, and social determinants of health
• Optimize options for patients and providers 
• Ensure that novel technologies that deliver medical care are adequately regulated to ensure safety and efficacy 

Our members include:

• Patient and caregiver advocacy groups
• Health policy organizations
• Professional associations
• Research, innovation, and technology organizations
• Individual patients, caregivers, and loved ones
• Individual health care providers and academics
• Commercial supporters

For more information about ACTION for PDTs: MH/SUD, review our prospectus here. 

Individuals with mental health and substance abuse disorders (MH/SUD) have often faced significant barriers to access effective treatment for their conditions when they need it. PDTs are a new category of FDA-regulated medicine that uses technology to provide around-the-clock treatment to patients, leading to increased adherence and improved outcomes. Using prescription software applications to deliver evidence-based cognitive behavioral therapy (CBT), PDTs allow patients access to treatment for their MH/SUD, at their convenience, on their smartphone or tablet.

The prevalence of MH/SUD continue to increase in the United States. Individuals with these disorders face stigma, discrimination, and significant barriers to diagnosis and treatment.  

According to recent statistics: 

• One in five Americans ages 18 and above – or about 20.6 percent of adults – experience a mental health (MH) disorder in any given year. This includes schizophrenia, depressive disorder, attention-deficit/hyperactivity disorder (ADHD), anxiety, bipolar disorder, and eating disorders. An estimated 31.7 million women and 20 percent of people ages 55 or older had a mental illness, with one study finding that 13 percent of Medicare beneficiaries ages 65 and older,  reported symptoms of depression.
  
  
• As reported by the National Center for Drug Abuse Statistics, 29.2 million Americans aged 18 years and over have a substance use disorder (SUD), and approximately 2 million had an opioid use disorder (OUD), including misuse of prescription pain medications, heroin, or fentanyl. This includes nearly one million adults aged 65 and older who live with an SUD and approximately 300,000 Medicare beneficiaries who are diagnosed  annually with an OUD.
  
  
• According to data from the National Institute of Mental Health, among the 51.5 million adults diagnosed with a MH  disorder in 2019, only 23 million (44.8 percent) received any form of treatment. Similarly, the Substance Abuse and Mental Health Services Administration (SAMSHA) reports that less than 20 percent of individuals with an SUD receive treatment.
  
  
• Contributing to the treatment gap is a growing shortage of MH/SUD treatment providers and facilities, especially in states with large rural populations and in urban health care deserts. An analysis by the Kaiser Family Foundation found that 119 million Americans live in an area with a MH provider shortage leading to only 26.9 percent of treatment needs being met nationwide. According to the American Society of Addiction Medicine, in 2019, only roughly 4,400 certified addiction specialist physicians were actively practicing in the U.S. – far below the 6,000 that were needed based on an estimate in 2009, long before the peak of the opioid crisis. Less than 20 percent of individuals with an SUD receive treatment.
  
  
• The cost of untreated or ineffective treatment of MH/SUD is high. The National Alliance on Mental Illness estimates that untreated mental illness costs up to $300 billion annually due to lost productivity and associated costs due to absenteeism, employee turnover and increases in medical and disability expenses. The National Institute on Drug Abuse notes that substance use costs the U.S. over $600 billion annually; however, several conservative estimates show that every dollar invested into SUD treatment yields a return of between $4 and $7 in reduced drug-related crime, criminal justice costs, and theft. When savings related to health care are included, total savings exceed costs by a ratio of 12 to 1.

These statistics make it clear that there is a need for new options that remove the obstacles to effective MH/SUD treatment.  

What Are PDTs? 
PDTs are evidence-based medical interventions that use technology available on a tablet or smartphone to provide 24/7 treatment and keep patients and health care providers connected.  Used independently, alongside medications, or in coordination with clinician-delivered care, PDTs provide patients with therapy or support when and where they need it, thereby ensuring individuals stay on their treatment plans. 

As with traditional medicines, PDTs are prescribed by health care practitioners, backed by safety and efficacy data from clinical trials, and cleared and/or approved  by the FDA for specific conditions.  

Use of PDTs in Treating MH/SUDs
PDTs aim to prevent, manage, or treat a wide range of diseases and conditions. With regards to MH/SUD, PDTs are currently available or in development for the following conditions: 

Below represents the MH/SUD conditions where PDTs are FDA-cleared:

• Attention-deficit hyperactivity disorder (ADHD) 
• Chronic Insomnia
• Opioid Use Disorder
• Substance Use Disorder  

Additionally, there are therapeutics in development for the following MH/SUD conditions:

• Alcohol use disorder 
• Anxiety disorders 
• Depression 
• Post-traumatic stress disorder (PTSD) 
• Schizophrenia 

The most common application for PDTs is to deliver CBT, a form of psychological treatment that involves efforts to change thinking and behavioral patterns. Research indicates that the skills individuals learn through CBT remain long after the completion of treatment.  

With respect to SUDs, PDTs can be used in combination with other types of treatment provided by a health care professional, such as face-to-face counseling, and prescription medicines. PDTs give providers access to secure, asynchronous, or real-time data from patients, so clinicians can monitor progress and manage the personalized treatment plans.  

Addressing the Barriers to Use of PDTs in Treating MH and SUDs
Currently, Medicare does not provide coverage for PDTs. Medicaid and private payers generally follow Medicare’s coverage determination. Thus, there is an urgent need to create a new Medicare benefit category specifically for PDTs that could also pave the way for Medicaid and private payers to offer similar coverage. Additionally, given that emerging nature of the technology, there is a need for patients and providers to be educated on the benefits and availability of PDTs for individuals with MH/SUD. 

ACTION for PDTs: MH/SUD conducts education and advocacy around six areas of purpose: 

1. Adoption
   The “A” in ACTION stands for “Adoption.” With the goal of encouraging adoption of PDTs as evidence-based, FDA-regulated medical interventions, the working group serves as an information resource for patients, health care providers, payers, lawmakers, and policy makers on the latest capabilities of PDTs in preventing, managing, and treating MH/SUD.
   
   
2. Coverage and Access 
   The “C” in ACTION stands for “Coverage and Access.” To allow for adequate adoption of PDTs in treating MH/SUD, health plans must provide comprehensive coverage of and access to PDTs. Despite the medical benefits of PDTs, currently, there is not a statutory benefit category that allows for Medicare coverage. The impact extends far beyond seniors because Medicare policy usually serves as a model for state Medicaid programs and commercial insurance plans. Therefore, the working group will educate Congress on the need for a pathway that provides comprehensive coverage for PDTs to qualifying patients. The working group will also advocate for the development new laws, regulations, and policies that ensure both public and private payers cover and provide meaningful access to PDTs for MH/SUD.
   
   
3. Therapeutic Outcomes  
   The “T” in ACTION stands for “therapeutic outcomes.” PDTs are used independently or in concert with medications, devices, or other therapies to optimize patient care and improve patient outcomes. Accordingly, the coalition will raise awareness of the evidence showing that PDTs can improve patient outcomes in a wide range of mental health conditions and substance use disorders.
   
   
4. Inclusion 
   The “I” in ACTION stands for “Inclusion.” PDTs can play a vital role in reducing the health inequities, disparities, and social determinants of health that keep underserved communities from accessing quality care for MH/SUD. Therefore, the working group will encourage greater use of PDTs to overcome the treatment barriers resulting from the shortage of providers and treatment facilities, especially in areas with large rural populations and in urban health care deserts.
   
   
5. Options
   The “O” in ACTION stands for “Options.” Recognizing that patients with MH/SUD require individualized treatment, the working group will advocate for policies that ensure patients, in consultation with their providers, have access to all FDA-regulated PDTs indicated for their condition so they can choose the one best suited for them without unnecessary interference or barriers from policymakers and third-party payers.
   
   
6. Novel Technology
   The “N” in ACTION stands for “Novel Technology.” Novel Technology is critical to the evolution of medicine. In encouraging the adoption of PDTs, it is important to understand that these therapeutics are regulated by the FDA, similar to traditional medicine. They must go through rigorous clinical trials establishing positive patient outcomes to receive FDA approval or clearance. For this reason, the working group will educate stakeholders, so they fully comprehend the significance of clinical rigor and testing to ensure safety and efficacy of PDTs. 

The following are materials, scientific journal articles, and reports that provide the latest facts on PDTs in treating and managing MH/SUD, the clinical studies associated with PDTs, and the financial impact of PDTs on the health system. 

• Digital Therapeutics: Reducing Rural Health Inequalities, Digital Therapeutic Alliance -- This report addressed health inequalities in rural parts of the United States and found that PDTs for diabetes, COPD, stroke, coronary artery disease, cancer, and suicide could help mitigate many substantial gaps in care.
  
  
• Cost-Effectiveness Analysis of a Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder, J. Mark Access Health Policy -- This twelve-week  found that the inclusion of PDTs was less costly and more effective than treatment as usual without PDTs.
  
  
• Real-world changes in US health system hospital-based services following treatment with a prescription digital therapeutic for opioid use disorder, National Library of Medicine -- This one-year study found that engagement and continued treatment with a PDT and buprenorphine was associated with substantial real-world reductions in medical costs over a six month period following initiation with the PDT.
  
  
• Evaluation of the cost-utility of a prescription digital therapeutic for the treatment of opioid use disorder, National Library of Medicine -- This study found that a PDT for OUD was associated with an overall reduction in total incremental costs in comparison to treatment as usual without the PDT.
  
  
• Prescription Digital Therapeutics Emerge as Healthcare's Newest Frontier, Alliance for Patient Access -- This blog post discuss how PDTs work, benefits for patients, and the current challenges for PDT coverage. 

Fact Sheets & Backgrounders

Aimed Alliance -- HCPCS Fact Sheet 

Aimed Alliance California working group backgrounder-- Prescription Digital Therapeutics: Introducing Software as Medicine

Aimed Alliance California working group fact sheet -- Prescription Digital Therapeutics: Fact Sheet

Comments

Aimed Alliance -- Comment to the Centers for Medicare and Medicaid Services on the Need for a HCPCS code for PDTs. 

Center for U.S. Policy -- Comment to the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC).

Events

ACTION for PDT Webinar: Addressing Chronic Diseases, Mental Health, and Substance Use In America: Optimizing Care with Prescription Digital Therapeutics -- Executive Summary

ACTION for PDTs: MH/SUD members include a diverse group of like-minded organizations and individuals working toward the common goal of improving adoption, coverage, and access to PDTs to treat MH/SUD.  

If you are interested in joining ACTION for PDTs, please click here.  

Contact Us

If you have questions, please contact us at ACTIONforPDTs@gmail.com.