Accelerating Science-Driven Reimbursement For Digital Therapeutics In State Medicaid Programs

“For evidence-based, prescribed digital therapeutics to reach the most vulnerable populations, they need to be reimbursable by Medicaid.

[..] One example is WellDoc, an FDA-cleared digital therapeutic that has been shown to improve outcomes for patients with Type 2 Diabetes, leading to cost savings for employers and health plans. Another example is the FDA-cleared digital health platform Propeller Health, an evidence-based platform for asthma and chronic obstructive pulmonary disease (COPD).

There are also digital therapeutics earlier in the FDA-clearance pipeline with growing literature demonstrating reproducible clinical effect. One example is Cognoa, an evidence-based FDA breakthrough-designated company that focuses on diagnosis and treatment of pediatric developmental disorders like autism. Another FDA breakthrough-designated company with a substantial and growing literature base is AppliedVR, a virtual reality platform with five randomized controlled trials (RCTs) that show significant reductions in pain among diverse patients. Other companies, like Learn to Live, an online platform that delivers cognitive behavioral therapy (CBT) for stress, depression and social anxiety using mental health coaches and self-directed learning, have promising early research.

Characteristics of optimal technology benefit coverage determination processes

  • Engage a broad array of stakeholders early and often in the design of a new coverage determination process
  • Shift away from the state Medicaid agency solely bearing the burden of proof to sharing that responsibility with the benefit requester
  • Make coverage determinations transparent, systematic, and evidence-based
  • Ensure diverse makeup of committee making coverage determinations so that the evidence included in a proposal is reviewed with scrutiny from multiple perspectives, especially including consumers
  • Move away from analog, word-document based submissions toward digitized online submissions
  • Include a conflict of interest disclosure in the online submission
  • Standardize and make transparent whether evidence ratings refer to the amount of evidence, quality of evidence, or strength of effect and relevance/inclusion of the Medicaid population of interest
  • Ensure equity is a highly ranked variable in the coverage determination process
  • Make benefit coverage determination scores and thresholds for coverage transparent and provide clear justification to allow submitters to improve future submissions
  • Make easily available information on how state agency leaders implement decisions
  • Release clinical data on the impact of coverage decisions and encourage research for continued program improvement

[..] In 2016, Washington published its evidence-based method for screening and evaluating emerging medical technologies and making coverage decisions. This process is employed when technology advocates or manufacturers request that Washington State health care purchasers pay for new and emerging technologies. This has offered advocates an opportunity to submit scientific evidence and information classically associated with a more formal health technology assessment.

[..] One of WHTAP’s [Washington State Health Technology Assessment Program] biggest assets is the diverse makeup of the committees that compile the application materials, which has ensured that the evidence was reviewed with scrutiny from multiple perspectives such as providers, policy makers, and payers. It is the authors’ strong recommendation that these committees include consumer representation as well.

This process has allowed Washington State to make evidence-based coverage decisions at a fraction of the cost of classic technology assessment. To date, of twelve reviews over six years, one health technology was approved for coverage, ten were not covered, and one did not require a coverage decision.

The Washington State approach is particularly compelling because the WHTAP has direct decision‐making authority; its findings are binding on state agencies, and decision‐making processes take place in public; in contrast, the United States Preventive Services Task Force (USPSTF) deliberates behind closed doors.

[..] Improving on prior benefit coverage determination innovations, Louisiana Medicaid developed a templatized toolkit for their state Medicaid agency to use [click here for the initial online form], creating the Turbotax-equivalent for new technology benefit coverage determination. [..] Stakeholder input influenced tangible changes, such as the usability and easy-to-locate nature of the benefit coverage request website, as well as the overall flow of the process. The resultant toolkit has potential to set the stage to advance healthcare for vulnerable populations in the state through its six-step benefit coverage determination process: benefit nomination; selection and prioritization of proposed benefits for review; evidence review; policy development; communication with stakeholders; and, management of conflicts of interest.

[..] The Center for Medicaid and CHIP Services (CMCS) has not yet formally broached the subject of digital therapeutics. Given that federal authority is needed for states to get on average 60 percent federal financial participation (FFP) for major changes to state plans, benefit category selection justification needs to be sufficiently clear so that CMCS can approve FFP for digital therapeutics, if a state chooses to seek CMCS approval.

[..] Digital therapeutics can be viewed through the lens of multiple benefit categories including 1) pharmacy benefit, 2) pharmacy benefit as “other related item”, 3) device, DME, or testing, or 4) other mandatory or optional Medicaid benefit services.

[..] There is still much work needed to improve benefit category clarity for digital therapeutics at the federal level, including the establishment of an appropriate benefit category as well as performance of a gap analysis among Common Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes. The gap analysis should include a review of the existing CPT and HCPCS codes that could be used in alignment with digital therapeutics as well as identifying where there is a lack of codes for existing and emerging digital therapeutics. It is also critical to determine which billing codes and benefit categories are appropriate for each type of clinician and patient scenario to address evolving practice models and prevent potential fraud, waste, and abuse (FWA). Fortunately, as digitally native interventions, digital therapeutics have an unparalleled ability, unlike traditional services, drugs, or devices, to precisely track usage and apply artificial intelligence and machine learning (AI/ML) to detect and prevent FWA using their digital exhaust.

[..] while the Louisiana process advanced innovation in benefit coverage determinations, it did not take into account an important lesson from the Washington experience: it is important to establish processes to release clinical data on the impact of coverage decisions and encourage research for continued program improvement. Data showing how utilization has changed after committee actions would be particularly useful. Building on the Washington lesson, it is important that state Medicaid programs use impact data to review and revise coverage determinations accordingly.”

Full post, Ostrovsky A and Simko M. Health Affairs Blog 2020.10.30