Digital Therapeutics Alliance Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule
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On behalf of the
To best support the Administration's goal of ensuring that Medicare beneficiaries have access to new cures and technologies that improve health outcomes, we support CMS' effort to streamline the approval, coverage, and coding processes associated with novel therapies. The MCIT proposed rule takes a meaningful step in this direction.
Foundation Setting
As the leading international organization on digital therapeutic (DTx) thought leadership and education, the
Each of DTA's initiatives are focused on enabling expanded access to high-quality, evidence-based digital therapeutics for patients, healthcare providers, and payors in order to improve clinical and health economic outcomes.
Background on Digital Therapeutics (DTx)
Digital therapeutics, a new category of medicine, deliver therapeutic interventions directly to patients using scientifically developed, evidence-based, and clinically evaluated software to treat, manage, and prevent diseases and disorders. DTx products are subject to rigorous patient-centered core principles (below),/1 an industry code of ethics,/2 and product development best practices./3
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DTx products are used independently, alongside medications, or in tandem with clinician-delivered therapy. They differ from pure lifestyle, wellness, adherence, diagnostic, and telehealth products, and are distinct from the over 350,000 digital health apps available online.
The term "digital therapeutic" only applies to products that deliver therapeutic interventions to prevent, manage, or treat a medical disorder or disease; incorporate best practices relating to product design, clinical evaluation, usability, and data security; and are reviewed by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.
Digital therapeutics address a wide array of health conditions./4
DTx products are currently available for a broad array of chronic diseases and mental health conditions, with products being developed for ADHD, anxiety, asthma, cancer side effect management, diabetes, depression, insomnia, migraine, movement disorders, and opioid and substance use disorders -- to name a few.
Patient access to DTx products is generally granted through a prescription, referral from a clinician, or delivery of an activation code via an electronic health record, employer, or third-party payor.
While exceptions may exist within this overview, digital therapeutics typically align with one of these three categories based on the product's primary purpose:/5
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As clinicians, healthcare systems, employers, and payors continue integrating these products into patient care, digital therapeutics will increasingly influence the delivery and consumption of healthcare around the nation and world.
Products across the digital health ecosystem serve different, but complementary purposes. Depending on each product's intended use and risk, it is subject to increasing degrees of clinical evaluation, regulatory oversight, and real-world data requirements./6
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It is important for CMS to consider which products from this ecosystem are necessary to meet the intent of the Administration's goal to ensure that Medicare beneficiaries have access to new cures and technologies that improve health outcomes.
Unique Benefits DTx Products Provide
Therapy Accessibility and Scalability
Compared to traditional medications which rely on physical distribution and dispensing processes, DTx products are software-based and are able to be hosted on multi-purpose platforms (e.g., patient-owned smartphone, tablet). This introduces an entirely new degree of product scalability and patient access opportunities. Therefore, instead of having a geographic-dependent delivery model, it is possible to deploy a needs-based delivery model.
As a result of increased product access and scalability, payors and policymakers are now able to ensure that care is delivered to entire populations that have otherwise been unable to secure care - either due to geographic limitations, cultural and language boundaries, well-documented disparities, or health condition severity. Patients who have previously not received care now have the opportunity to receive personalized therapeutic interventions based on their specific needs and abilities, in an engaging way, independent of their work or education schedule, with familiar languages and cultural references, in the privacy and safety of their own environment, and with access to actionable insights that convey their movement toward clinical improvement.
Real World Outcomes
In another departure from traditional medications, digital therapeutics generate a wide variety of real-world data (RWD) outcomes related to patient use and clinical impact. This includes patient-specific measures (e.g., actionable clinical outcomes, standardized patient assessments, physiologic data via associated sensors), patient and clinician utilization (e.g., patient utilization and engagement, product onboarding metrics, clinician prescribing parameters), and product functionality (e.g., product performance, analytics, quality measures).
While RWD is used by patients and clinicians to adjust and optimize critical aspects of therapy, this data may also be translated into fit-for-use, formal real-world evidence (RWE) for healthcare payor and policymaker product evaluation processes. Importantly, it is now possible for decision makers to analyze outcomes related to specific patient cohorts and derive detailed real-world insights on clinical and health economic endpoints. It is possible that certain evaluations based on real-world output will eventually replace aspects of evaluations based purely on information derived through secondary sources (e.g., patient registries, EHR systems, claims databases).
Therapies That Improve Over Time
Additionally, compared to traditional medications that are not modified once FDA approval is granted, DTx products are iterative in nature and continue to evolve throughout their lifecycle.
While some of these iterations may require regulatory review if the core algorithm is changed, the majority of iterations by product manufacturers (e.g., product functionality changes, patient engagement optimizations) are delivered to users in real time to ensure immediate benefits.
Value of DTx Products for Medicare and Medicaid Beneficiaries
Digital therapeutics exist at the unique intersection of being classified as a medical device from a regulatory standpoint, while delivering to patients in clinical practice interventions alongside - or even in place - of medication-based and in-person therapies. Given the new opportunities and benefits that are presented by this category of medicine, it is important for CMS to consider how DTx products may improve patient access to clinically validated therapies.
For instance, individuals living in rural and underserved settings encounter challenges that others may not regularly experience. Barriers to healthcare include factors such as mismatched clinician supply and demand, long distances between patient homes and sites of care, and isolation measures during Covid-19 that prevent ongoing in-person visits.
Traditional therapies in
Value of DTx Products in Providing Care to Underserved Populations
Building on the ease of DTx product scalability and access through patient-owned devices, digital therapeutics create new treatment and self-management options for a broad range of chronic and mental health conditions. DTx products can easily reach high-risk, rural, and underserved populations who often lack access to healthcare services even during the best of times. This include digital therapeutics' ability to:
* Easily scale and be accessible via a smartphone or tablet;
* Discretely deliver therapy to patients in their home environments;
* Offer therapy independent of a patient's work or education schedule;
* Provide some therapies in languages such as Spanish, Arabic, German, and French;
* Lower stigma that may be associated with the delivery of certain traditional therapies;
* Directly impact life and disease state outcomes; and
* Provide meaningful results and insights on personalized goals and outcomes.
Unbalanced DTx Access Across Underserved Populations
While numerous patients who receive their insurance coverage through private payors and employers in the
FDA Leadership
"In the context of the COVID-19 public health emergency, the use of digital health technologies, including software as a medical device or other digital therapeutics solutions, may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine. In addition, the use of such technologies has the potential to facilitate "social distancing" by reducing patient contact with, and proximity to, health care providers, and can ease the burden on hospitals, other health care facilities, and health care professionals that are experiencing increased demand due to the COVID-19 public health emergency."
The importance of the FDA conducting fit-for-purpose product reviews, granting breakthrough status for qualifying DTx products, granting product clearances through the 510(k) and De Novo pathways, and engineering the pre-certification pilot program for digital therapeutics and other software as a medical device (SaMD) products has been elevated even further by the recent establishment of
In building on
MCIT Recommendations
While the MCIT proposed rule is a much-needed pathway to reimburse for innovative devices, further clarity is required related to what forms of products qualify under this rule. Because no benefit category exists under the Medicare framework for DTx products, it is imperative to:
1.) Create a DTx benefit category;
2.) Determine which DTx products fit under currently available benefit categories, such as Durable Medical Equipment (DME); and,
3.) Ensure that the DME category enables for appropriate recognition of qualifying digital therapeutics.
Establish a New DTx Product Benefit Category
Multiple types of digital therapeutics may not fall within a currently existing benefit category under Medicare. This in turn represents a large barrier to the uptake of such products by Medicare clinicians, precluding countless Medicare beneficiaries from realizing the improved outcomes and reduced costs these products offer.
DTA is supporting legislation that would cover technologies that do not fall within an existing benefit category. We urge CMS to also support this legislation. But recognizing that CMS does not on its own have authority to include technologies that do not fit within a benefit category, we urge CMS to work with industry and other stakeholders to review and consider changes to existing regulatory policies that lack clarity or specification and actually create unnecessary barriers to coverage of some breakthrough technologies.
Access and reimbursement for digital therapeutics has never been more critical for individuals and families, particularly during the COVID-19 crisis where these remotely accessible treatments can make a tremendous difference in the lives of those who live with chronic, behavioral, and mental health conditions.
Recognize Qualifying DTx Products Through Current CMS Frameworks
CMS must exercise its leadership and current regulatory authority to determine which currently existing benefit categories could be used to cover and pay for digital therapeutic products.
The only promising route to market for breakthrough devices that have achieved market authorization will be the proposed MCIT pathway, which requires the device to have an existing benefit category such as DME. There is no reason that certain digital therapeutic products should not qualify for DME.
Ensure DME Category Appropriately Recognizes Qualifying Digital Therapeutics
We urge CMS to work with industry stakeholders to consider any necessary changes to the existing DME framework in order to properly recognize digital therapeutics and enable critical patient access pathways.
Some considerations for review include:
* The types of products represented within the DTx industry that do or do not qualify for DME inclusion based on the modality used to deliver therapy, the product's medical purpose, and location of use.
* Potential necessity of and associated requirements for manufacturers with qualifying DME products to enroll as a qualified DME supplier.
* Whether current DME categories sufficiently address the clinical and health economic value that DTx products provide to patients, caregivers, and clinicians.
Ideally, any modifications necessary to appropriately recognize qualifying DTx products under the DME category would be made through a rulemaking process, as opposed to another legislative effort.
Additional Considerations
As CMS further pursues the elements presented in the MCIT proposed rule, we encourage the following questions to be taken into consideration:
* Would Medicare consider expanding this pathway to additional categories of products that meet CMS' goal of providing Medicare beneficiaries with access to new cures and technologies that improve health outcomes - especially if they offer significant advantages over existing approved or cleared alternatives - but have not received breakthrough status?
* Given the number of DTx products that may be 510(k) exempt (and align with industry core principles), would CMS consider including 510(k) exempt devices in the proposed rule, in addition to those devices that receive Premarket Approval (PMA); 510(k) clearance; or the granting of a De Novo classification request?
* Assuming that the demand for the Breakthrough Device Program through the FDA will increase, how will this decision impact
* How will CMS address subsequent non-breakthrough products that may deliver new efficiencies or improved outcomes compared to a product that has received breakthrough status?
* With the potential introduction of this new rule, how does CMS intend to identify which products it will conduct parallel reviews for?
* Is CMS considering whether it might revise existing CPT codes or reimbursement processes to ensure that the total work and expenses for clinicians related to these new services provided through Medicare are accurately captured and reflected in the reimbursement?
Thank you for the opportunity to provide commentary on this guidance document. We look forward to ongoing conversations regarding this and other related processes.
View charts at: https://downloads.regulations.gov/CMS-2020-0098-0271/attachment_1.pdf
Sincerely,
Executive Director
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Footnotes:
1/ https://dtxalliance.org/wp-content/uploads/2019/11/DTA_DTx-Definition-and-Core-Principles.pdf
2/ https://dtxalliance.org/wp-content/uploads/2019/11/DTA_DTx-Industry-Code-of-Ethics_11.11.19.pdf
3/ https://dtxalliance.org/wp-content/uploads/2019/11/DTA_DTx-Product-Best-Practices_11.11.19.pdf
4/ https://dtxalliance.org/wp-content/uploads/2020/03/DTx-Disease-State-Targets_03.20.pdf
5/ https://dtxalliance.org/wp-content/uploads/2019/11/DTA_DTx-Product-Claim-Categories_11.11.19.pdf
6/ https://dtxalliance.org/wp-content/uploads/2020/10/DTx-Paper_Rural-Health_10.20.pdf
7/ https://dtxalliance.org/wp-content/uploads/2020/10/DTx-Paper_Rural-Health_10.20.pdf
8/ https://www.fda.gov/media/87363/download
9/ https://www.fda.gov/medical-devices/digital-health-center-excellence
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The proposed rule can be viewed at: https://beta.regulations.gov/document/CMS-2020-0098-0002
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