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the Access to Prescription Digital Therapeutics Act - The Sidebar - Sidekick health

Why Everyone’s Talking About the Access to Prescription Digital Therapeutics Act

by Dr. Nessie Riley, Healthcare Content Writer

This new legislation is an important step in expanding access to Prescription Digital Therapeutics, bringing transformative healthcare to millions of Americans.

The Access to Prescription Digital Therapeutics Act of 2022 aims to officially define prescription digital therapeutics (PDTx) at the federal level and establish new Medicare and Medicaid benefit categories for PDTx. The bill was introduced on March 10, 2022 by Senator Capito and co-sponsored by Senator Shaheen, and, if passed, could improve healthcare access for more than 148 million Americans.1-3

What are Digital Therapeutics and Why do Some Need a Prescription?

Digital Therapeutics (DTx) are software-based interventions intended to prevent, manage, or treat mental or physical conditions4  and while many DTx are available to consumers directly, PDTx differ in that they require a prescription for use, following a thorough consultation with a physician.

PDTx are subject to the same stringent requirements as pharmacotherapy or medical devices, and must demonstrate evidence of clinical effectiveness, safety, and quality through clinical trials in order to be approved by the FDA and be made available to patients.

Prescription Digital Therapeutics are an excellent example of how innovative technology can address some of the health challenges providers and patients continue to face. – Senator Shelley Moore Capito (co-sponsor of the Access to Prescription Digital Therapeutics Act of 2022)5 

What are the Benefits of PDTx?

With the same functional benefits as DTx, PDTx offer access to healthcare that may otherwise be hindered by accessibility barriers to traditional treatment such as stigma, lack of daily support, or logistics. This is particularly the case for those of racial or ethnic minorities or those on low income, who are disproportionately affected by the diseases that PDTx can help to manage, such as diabetes, depression, and substance abuse disorders.6 Through access to sustained clinical support and monitoring, these patients can be treated more effectively and experience better outcomes than with traditional therapy alone.

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According to a recent survey by Pear and Avalere, 80% of payers believe PDTx would be effective complementary therapy, but 67.5% felt that FDA authorization of the PDTx to be ‘very important’ when deciding to cover it in claims.7 The lack of clear regulation and slow approval of the FDA for DTx may explain why only 40% of payers are currently covering PDTx.7 

Making PDTx available through national health insurance provisions like Medicare and Medicaid would not only allow greater access to a wider range of supportive therapy for more than 44% of Americans receiving state healthcare support,1-3  it would also set a precedent for private insurance companies to increase their coverage of PDTx too, opening up digital therapeutic solutions as a mainstream tool in healthcare nationwide.

Our bill ensures these prescription digital therapeutics are covered by Medicare so more patients, including seniors, have access to the cutting-edge care they deserve. – Senator Jeanne Shaheen (sponsor of the Access to Prescription Digital Therapeutics Act of 2022)5 

 What Does the Access to Prescription Digital Therapeutics Act Aim to Achieve?

The bill is a bipartisan piece of legislation aimed at establishing PDTx as federally-recognized therapeutics, ensuring that reimbursement from payers can be achieved more easily so that patients can benefit from the unique support these digital healthcare solutions can provide.

Core Components of the Bill8:

  1. To establish an official definition for PDTx at the federal level.
  2. To establish a new Medicare and Medicaid benefit category for PDTx.

 Implications of the Bill for the Wider DTx Community

  • Advancement of PDTx Reimbursement

Once a framework has been established within legislation, PDTx could be standardized with reimbursement coding, paving the way for pain-free access. Some payers are reluctant to reimburse PDTx due to a lack of clinical evidence,9  but with a legal definition for these therapeutics, standardization of reliable research on their efficacy would soon follow.

  • Increased Access to PDTx

If physicians knew that PDTx could be reimbursed for state-funded care, prescribing habits would evolve to integrate PDTx more frequently into patient care plans. Patients who rely on substantial support from Medicare or Medicaid would be some of the first to feel this positive impact on accessibility to DTx.

Additionally, with such a large proportion of US healthcare costs attributed to chronic illnesses, DTx like Sidekick Health that are rooted in the formation of positive habits, can have a substantial impact on addressing the lifestyle factors that have been shown to influence the progression of these chronic diseases. Being able to have such solutions prescribed would enable patients to make lasting behavioral modifications, improving their health along the way.

  • Acknowledgement of the Important Role of DTx in a Patient Treatment Journey

Demand for DTx will only rise with the embedding of PDTx in legislation, testament to the importance of DTx in a holistic treatment package. DTx go far beyond what a simple wellness app can offer, and are recognized as integral, clinical therapeutics in their own right. Such digital healthcare solutions have already been relied upon throughout the pandemic to provide remote healthcare but soon payers, pharma, providers, and patients will be able to benefit from the permanent shift towards value-based care that PDTx can provide.

 What are the Chances of the Bill Being Passed?

March 28, 2022 saw the release of the Biden administration’s fiscal year 2023 budget, which included vital language on improving access to mental health services for Americans. The budget strongly emphasises the need for comprehensive coverage of ‘behavioral health providers’ in private health insurance as well as Medicare and Medicaid.10  This is certainly a positive step towards the introduction of PDTx, which can play a crucial role in supporting mental health improvement through behavioral modifications.

Whilst the budget for 2023 looks promising, there is no doubt that support from additional members of Congress would be beneficial to see the bill signed into law. Establishing more detailed industry guidance would also assist payers in forming robust reimbursement protocols for PDTx, enabling physicians to prescribe these effective treatment options more easily. Demand from both physicians and patients for high-quality digital solutions to healthcare can only help drive the shift towards routine adoption of PDTx in treatment plans.

Living in the modern age requires medicine to adapt to address the needs and challenges of accessing quality care. Prescription digital therapeutics, software-based health care treatments, present significant benefits to patients and provide a new tool to help improve peoples’ lives. – Congressman Mike Thompson (co-sponsor of the Access to Prescription Digital Therapeutics Act of 2022)5 

For DTx companies like Sidekick, having a federal-level framework for PDTx means that already-established DTx can be developed with confidence to become prescription-ready. It is clear that DTx are here to stay and we are excited to see the progress made this week, but there may be a slightly longer road to PDTx becoming integrated methods of treatment unless further pressure is applied by both congress and industry to the passing of this pivotal bill.

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Resources

  1. S. Population Estimated at 332,403,650 on Jan. 1, 2022, U.S. Department of Commerce 2022. Accessed March 24, 2022. Available at: https://www.commerce.gov/news/blog/2022/01/us-population-estimated-332403650-jan-1-2022
  2. September 2021 Medicaid & CHIP Enrollment Data Highlights, Medicaid.gov. Accessed March 24, 2022. Available at: https://www.medicaid.gov/medicaid/program-information/medicaid-and-chip-enrollment-data/report-highlights/index.html
  3. CMS Fast Facts, Centers for Medicare and Medicaid. Accessed March 24, 2022. Available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Fast-Facts
  4. Digital Therapeutics Alliance, Digital Therapeutics Definition and Core Principles Fact Sheet (November 2019). Available at https://dtxalliance.org/wp-content/ uploads/2021/01/DTA_DTx-Definition-and-Core-Principles.pdf.
  5. https://www.shaheen.senate.gov/news/press/senators-shaheen-capito-reps-mckinley-thompson-introduce-bipartisan-access-to-prescription-digital-therapeutics-act
  6. McKnight-Eily, Lela R et al. “Racial and Ethnic Disparities in the Prevalence of Stress and Worry, Mental Health Conditions, and Increased Substance Use Among Adults During the COVID-19 Pandemic – United States, April and May 2020.” MMWR. Morbidity and mortality weekly report vol. 70,5 162-166. 5 Feb. 2021, doi:10.15585/mmwr.mm7005a3
  7. Pear Therapeutics & Avalere Survey, Pear Prescription Digital Therapeutics (PDT) Digest 2021
  8. 3791, Access to Prescription Digital Therapeutics Act of 2022, March 10, 2022
  9. Dang, Amit et al. “Role of digital therapeutics and the changing future of healthcare.” Journal of family medicine and primary care 9,5 2207-2213. May 31, 2020, doi:10.4103/jfmpc.jfmpc_105_20
  10. Budget of the U.S. Government Fiscal Year 2023, Biden Administration Released March 28, 2022.