September 11, 2023
Via www.regulations.gov
The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare and Medicaid
Department of Health and Human Services
Attention: CMS-1784-P
P.O. Box 8016
Baltimore, MD 21244-8016
RE: Medicare and Medicaid Programs; CY 2024 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies (CMS-1784-P)
Dear Administrator Brooks-LaSure:
The Digital Therapeutics Alliance (“DTA”) thanks the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) for the opportunity to provide comments on the Calendar Year (“CY”) 2024 Physician Fee Schedule Proposed Rule (“Proposed Rule”). Our comments focus on CMS’ request for information (“RFI”) to improve the Agency’s understanding of the opportunities and challenges related to the coverage, payment policies, and claims processing of digital therapeutics.
DTA is a 501(c)(6) non-profit trade association of industry leaders and stakeholders dedicated to broadening the understanding and adoption of digital therapeutics into healthcare. DTA is the leading international organization on digital therapeutics thought leadership and education with the mission of enabling expanded access to high-quality, evidence-based digital therapeutics for patients, qualified health care professionals (QHPs), and payors in order to improve clinical and health economic outcomes. With our 100 member companies across 17 countries, DTA champions the advancement of high-quality, evidence-based digital therapeutics. We submit the comments below in support of our members and in furtherance of our mission.
Digital therapeutics, or software-based interventions, have emerged as promising tools in managing various medical conditions, including mental health disorders, substance use disorders, and chronic diseases. The U.S. Food and Drug Administration (“FDA”) regulates digital therapeutics as “Medical Devices”, “Software as a Medical Device” (“SaMD”) or “Software in a Medical Device” (“SiMD”).
Digital therapeutics vary in both their delivery method to patients and distribution channels. Some FDA-approved/cleared digital therapeutics products may be standalone SaMD available through a patient’s existing hardware, such as tablets, watches, and virtual reality goggles, while other digital therapeutics products pair software with dedicated hardware. Distribution channels for digital therapeutics products include directly by QHPs, and by specialty pharmacies and DME suppliers upon prescription. Digital therapeutics utilization resolves many of the access to care barriers for Medicare beneficiaries, including increasing access to care for patient populations where QHPs and specialists are limited, such as rural communities. As CMS acknowledged in the RFI, there is a gap in coverage and reimbursement for digital therapeutics, which has limited beneficiary access to these innovative and convenient treatments. CMS already has authority to cover and reimburse digital therapeutics products under the durable medical equipment (“DME”) and incident-to physician service benefit categories. DTA and its members urge CMS to provide coverage of digital therapeutics products under existing benefit categories immediately and to clarify coverage routes for digital therapeutics products in the CY 2024 Physician Fee Schedule Final Rule.
DTA and its members strongly encourage CMS to take the following steps:
1. Clarify coverage pathways for digital therapeutics products under existing benefit categories. DTA strongly encourages CMS to clarify in the final rule that digital therapeutics products can be reimbursable under the (1) DME and (2) incident-to physician services benefit categories when certain coverage criteria are met.
2. Make technical modifications to the DME and incident-to reimbursement frameworks. DTA strongly encourages CMS to modify the coverage criteria and current reimbursement framework for DME and incident-to benefit categories to accommodate the innovative and diverse characteristics of digital therapeutics products. The revised frameworks for these benefit categories must include the reimbursement structure for administering digital therapeutics products and for the furnishing of digital therapeutics by QHPs in patients’ treatment plans. This will involve setting reimbursement rates based on the type of therapy, its effectiveness, and its impact on patient outcomes.
Reimbursement for Digital Therapeutics within the Durable Medical Equipment (DME) Benefit Category
DTA applauds CMS’ recent groundbreaking decision in April 2023 related to coding and benefit classification, where CMS assigned a distinctive Healthcare Common Procedure Coding System (HCPCS) Level II code under the DME benefit category for AppliedVR’s RelieVRx, a virtual reality apparatus and its linked software. This decision demonstrates CMS’ authority to cover digital therapeutics products under the existing DME benefit category. Nevertheless, the pathway to digital therapeutics coverage under the DME benefit category requires further clarification from CMS. DTA strongly encourages CMS to revise its DME regulations to clarify how Digital therapeutics products can be covered under the DME benefit category. In particular, CMS should:
1. Revise the accreditation standards to account for the unique qualities of digital therapeutics products;
2. Address how digital therapeutics products can be covered under DME coverage policies;
3. Align the DME payment policy to account for the duration of Digital therapeutics products in treatment plans with the understanding that transfer of title is not always warranted for Digital therapeutics products; and
4. Establish criteria within the statutory requirements for DME that would enable appropriate digital therapeutic products to qualify (e.g., eliminating non-statutory limitations such as the ability to be rented or used by multiple patients).
These modifications and clarifications to the DME regulations would encourage the development and facilitation of beneficiary access to many innovative digital therapeutics products like AppliedVR. We strongly encourage CMS to collaborate directly with DTA in amending the DME regulations to provide coverage of digital therapeutics products under existing benefit categories immediately and to clarify coverage routes for digital therapeutics products in the CY 2024 Physician Fee Schedule Final Rule.
Reimbursement for Digital Therapeutics within the Physician Services Benefit Category
For several years, CMS has covered FDA regulated medical devices (e.g., SaMD) that are used as part of diagnostic (e.g. IDXDR) and monitoring (e.g., remote therapeutic monitoring) services under the incident-to physician services benefit category. DTA strongly encourages CMS to use its existing authority to rapidly cover and pay for digital therapeutics, which are SaMD that are used for therapeutic purposes, under the incident-to physician services benefit category, starting with the CY 2024 Physician Fee Schedule Final Rule.
DTA understands that there have been and continue to be coding proposals (e.g., shown in the Public Agenda for past and upcoming CPT Editorial Panel meetings) to consider digital cognitive behavioral therapy and remote therapeutic treatment and other digital therapeutics as incident-to services.6 Assuming these code proposals are adopted, this would provide an appropriate mechanism to facilitate coverage for these devices when furnished incident-to a healthcare practitioner’s service. Likewise, CMS may also use its authority to adopt such coding under the HCPCS system where CMS would establish a separate set of dedicated G-codes to account for when digital therapeutic devices are acquired by a Medicare-enrolled practitioner, and that practitioner then furnishes that device to a patient and manages their treatment.
With any of the coding proposals that CMS implements, DTA strongly recommends a coding solution under the incident-to service benefit category that accounts for:
In many aspects, QHPs utilize digital therapeutics furnished incident-to in a manner consistent with CMS’ treatment of supplies under the direct practice expense methodology. For example, QHPs acquire a digital therapeutics license, which amounts to a practice expense of the QHP in furnishing the digital therapeutics to the patient. Furthermore, these expenses are incurred uniquely for a specific patient’s treatment (rather than as an underlying expense for running the practice), and the license to the digital therapeutics is exclusive to that particular patient and as such, cannot be used by another patient.
CMS may need to adapt the practice expense methodology to account for the various financial structures of digital therapeutics furnished incident-to, such as digital therapeutics that are based on a subscription model. DTA encourages CMS to be flexible in determining the practice expense methodology for the various financial models of digital therapeutics furnished incident-to as the Agency has demonstrated its flexibility with its approach to software-based services in both the office setting and hospital outpatient setting.
Alternatively, if CMS determines that digital therapeutics furnished incident-to should be considered as items of equipment, DTA emphasizes the importance of recognizing that the purchase price represents the cost to the practice for the duration of the digital therapeutics treatment for a particular patient. The treatment duration could span over weeks or months, and as such, the costs should be amortized or apportioned over that time period (as opposed to years which is common for other equipment frequently priced by CMS).
Regardless of whether the digital therapeutics product is used as part of or independently of a clinic visit, it is always furnished by the treating QHP or obtained upon order from the treating QHP. Therefore, DTA urges CMS to cover digital therapeutics under the incident-to physician services benefit category and to adjust the practice expense methodology to account for the financial models of digital therapeutics.
By taking these steps, CMS can establish a clear and comprehensive coverage framework for digital therapeutics, ensuring that Medicare beneficiaries have access to these innovative treatments while maintaining appropriate quality and cost standards.
DTA responses to CMS RFI questions
The rest of our letter contains answers to the inquiries stated in CMS’s request for information. We have organized our responses in a way that ensures coherent and distinct answers to similar queries.
Questions:
The function of clinical practice and the process of making decisions in a clinical context
1. How do QHPs determine which patients might be best served by digital therapeutics? How do QHPs monitor the effectiveness of prescribed interventions, such as, but not limited to, for their patients on an ongoing basis once the intervention has begun?
QHPs employ a systematic and patient-centric approach to identify suitable candidates for digital therapeutics and oversee the effectiveness of the treatment. This approach encompasses several key stages:
It’s important to recognize that the specific approach may vary depending on factors such as the healthcare setting, the type of digital therapeutic, and individual patient needs. However, across all situations, patient involvement, education, and sustained communication are fundamental elements in the successful implementation and monitoring of digital therapeutics.
2. What QHPs and auxiliary staff are involved in furnishing RPM and RTM services, including training patients on its use, and to what extent is additional training or
supervision of auxiliary staff necessary to provide an appropriate for and/or recommended standard of care in the delivery of these services?
We would like to express our gratitude for the opportunity to provide input on the technical aspects concerning RTM and RPM. This includes a critical consideration for the future when there may be HCPCS or CPT codes to encompass monitoring and therapeutic devices, such as digital therapeutic devices. In this future scenario, these devices could be concurrently used by QHPs for services that are deemed reasonable and necessary.
Nevertheless, it’s important to note that the current RTM codes do not encompass the therapeutic aspect or the therapeutic devices described in this communication. This limitation means that the existing codes, as they are currently structured, cannot be applied to digital therapeutics. While we do address some of the technical questions regarding RTM and RPM, we firmly believe that it is of utmost importance for CMS to rectify this coding gap for digital therapeutics devices, especially those that provide therapy alongside monitoring, rather than just focusing on monitoring alone.
RPM and RTM services involve a diverse group of healthcare QHPs and auxiliary staff to ensure their effective deployment and patient training. The extent of additional training or supervision required for auxiliary staff varies based on their roles, patient population needs, and the product itself. Key QHPs include physicians or nurse QHPs responsible for diagnosis and care planning, specialist physicians for condition-specific oversight, and registered nurses involved in patient education and monitoring. Auxiliary staff such as Certified Medical Assistants, healthcare technicians, and medical administrative assistants may assist with device setup, data collection, and administrative tasks.
The training requirements for these roles encompass device familiarity, patient education, and adherence to healthcare regulations. Supervision, periodic retraining, and ongoing education are often essential to maintain a high standard of care. The extent of additional training or supervision needed depends on factors like device complexity and organizational policies. Ensuring clear protocols and adequate training is vital for healthcare facilities to effectively deliver RPM and RTM services, and keeping staff up-to-date with evolving technology and best practices in remote monitoring.
3. How are data that are collected by the technology maintained for recordkeeping and care coordination?
Data collected by digital therapeutics are crucial for recordkeeping and care coordination. Proper management and storage of this data are essential to ensure patient care quality, regulatory compliance, and effective communication among QHPs.
Data that is collected by the digital therapeutics technology is shared with the referring HCP and can be stored in the HCP’s Electronic Health Records (“EHRs”) and made available to the patient.
Here is how these data are typically maintained for recordkeeping and care coordination:
In summary, digital therapeutics data is stored in electronic health records, secure cloud-based platforms, and interoperable systems. QHPs, patients and digital therapeutics manufacturers play essential roles in ensuring data accuracy, privacy, and timely sharing to support effective care coordination and recordkeeping. Compliance with data security regulations and best practices is paramount in maintaining the integrity and confidentiality of patient data.
RPM & RTM Codes
4. What information exists about how an episode of care should be defined, particularly in circumstances when a patient may receive concurrent RTM or digital CBT services from two different clinicians engaged in separate episodes of care?
Defining an episode of care, especially when a patient concurrently receives RTM or Digital Cognitive Behavioral Therapy (CBT) services from separate clinicians, involves several important considerations. It is crucial to prioritize clear care coordination and effective communication among clinicians to ensure a comprehensive approach to the patient’s well-being. Each episode of care should have well-defined goals, objectives, and care plans, especially when clinicians are providing distinct services or managing various aspects of the patient’s health. A patient-centered approach is essential, emphasizing the importance of considering the patient’s preferences and input when crafting care plans and determining how concurrent services are delivered. For instance, in the case of a patient with PTSD, who may be
receiving multiple treatments including a digital therapeutics product as part of the plan, it is vital to adhere to defined treatment durations, often specified by clinical trials and regulatory clearance, such as the FDA’s 510k clearance, which may, in this case, be a duration of 4 weeks.
Accurate documentation within EHRs or similar systems is of utmost importance. These systems should be designed to support data separation and provide accessibility for the clinicians involved. Establishing mechanisms for data sharing and integration, while respecting patient privacy and obtaining consent, is essential to facilitate informed decision-making and prevent duplication of efforts. Adherence to regional or healthcare system-specific regulatory and legal requirements regarding episode definition and patient data sharing, particularly concerning privacy and data security, is crucial. Billing and reimbursement practices should align with the defined episodes and the services provided, while periodic reviews should assess progress and allow for necessary adjustments. Patient education on the different episodes of care, clinician roles, and care coordination is essential to promote understanding and encourage active patient engagement. Guided by ethical principles such as patient autonomy and beneficence, episode definition should prioritize the patient’s best interests in all decisions. Flexibility and adaptability are key when defining episodes of care, tailoring them to meet each patient’s unique needs while ensuring effective communication, clinician collaboration, and regulatory compliance.
5. What are the advantages and disadvantages of a generic RTM device code, versus specific RTM codes?
6. Would generic device codes undermine or stall progress toward a wider set of specific codes that would provide less ambiguity on reimbursement?
The utilization of generic RTM device codes and specific RTM codes in healthcare billing and coding comes with its own set of advantages and disadvantages. Generic codes offer simplicity, flexibility, and cost-effectiveness by streamlining administrative tasks and adapting to various RTM devices. However, determining reimbursement for generic RTM codes presents challenges when payers are tasked with assessing the intricacy and clinical necessity of particular RTM services. This challenge may lead to claim rejections and appeals and/or reduced and disparate reimbursement rates among payers and QHPs. Moreover, the utilization of generic codes may restrict the availability of detailed data required for healthcare decision-making, resource allocation, and research and may further discourage digital
therapeutics innovation due to their ambiguous reimbursement.
Conversely, specific RTM codes provide comprehensive billing information, improved reimbursement rates, and enhanced capabilities for data analysis. These codes enable more accurate tracking of the utilization and effectiveness of different RTM services. Nonetheless, managing a multitude of specific codes can be administratively intricate and may lead to inefficiencies in the coding and documentation processes.
Whether to employ generic or specific RTM codes largely depends on the unique needs of healthcare organizations, the complexity of their RTM services, and the requirements of payers. The presence of generic codes might discourage the creation of specific codes because of their initial administrative ease. Nevertheless, such administrative ease is likely temporary due to the difficulties of determining reimbursement rates for various digital therapeutics products under the generic codes.
To address these complexities, healthcare organizations, payers, and stakeholders should thoroughly evaluate the ramifications of employing generic codes and strive for a balanced approach that fosters the development of specific codes when deemed necessary. This approach can ensure precise billing and facilitate comprehensive data collection to support well-informed healthcare decision-making.
7. We noted in previous rulemaking that even when multiple medical devices are provided to a patient, the services associated with all the medical devices can be billed by only one practitioner, only once per patient, per 30-day period, and only when at least 16 days of data have been collected. We seek information on the type and frequency of circumstances that involve multiple medical devices and multiple clinicians. How might allowing multiple, concurrent RTM services for an individual beneficiary affect access to health care, patient out-of-pocket costs, the quality of care, health equity, and program integrity?
The RPM and RTM professional work codes (99457, 99458, 98980, and 98981) are not – and should not – be subject to any single provider limitations. To do so, would be akin to limiting Medicare beneficiaries to a single physician for all medical necessities. RPM and RTM professional work via treatment management services should be allowed to be performed and billed/reported by any practitioner or specialist who is working with a single patient, per 30-day period, and not contingent by the 16 days of data collection requirement since that policy was not defined by CMS on codes 99457, 99458, 98980, and 98981 (as described in the
preceding section supra).
It should also be noted that CPT has not set stipulations on the number of physician QHPs and nonphysician QHPs that may concurrently bill 99453 and 99454. It is very possible that more than one provider may be involved in RPM of the same patient, under separate treatment plans, for separate conditions (consider the following):
– Comorbid patient is under the simultaneous care and supervision of the following:
CMS should not suggest that only one provider may bill remote monitoring codes, per patient, per 30-day period. Additionally, there should be no implicit priority between medical specialties. Doing so creates provider confusion, and additional burdens to QHPs who may become reluctant to conduct remote monitoring services.
Data Privacy and Patient Safety
In response to:
8. What standards have interested parties developed or consulted to ensure the physical safety and privacy of beneficiaries utilizing digital cognitive behavioral therapy (CBT) and/or other digital therapeutics for behavioral health?
9. What are some potential considerations for protecting the privacy and confidentiality of the patient population in digital therapeutics, including compliance with State behavioral health privacy requirements?
FDA regulates medical devices using a risk-based framework involving a classification of each device into one of three classes: Class I, II, or III. Regulatory control and requirements increase from Class I (lowest risk) to Class III (highest risk). FDA generally must review marketing applications describing the safety and performance (including relevant testing) for each Class II or III device and provide specific authorization before such devices may be commercialized; however, Class I (and some Class II) devices are exempt from this pre-market review and authorization process. Such pre-market review and authorization process allows FDA to
confirm that the risks associated with each Class II or III device are acceptable in light of the potential medical benefits provided by the device. FDA has classified CBT devices currently on the market at 21 CFR 882.5801 (including CBT for gastrointestinal conditions, substance use disorders, sleep disorders and pain relief) into Class II, and therefore, the agency must review the safety and performance of such devices and ensure that each has an acceptable risk profile and that each manufacturer has implemented appropriate controls to mitigate such risks. Other CBT devices intended to treat or mitigate the symptoms or effects of other specific
diseases or conditions are regulated by FDA as Class II or III medical devices (depending on the associated risks to patients) and require pre-market review and authorization to ensure that any potential risk to a patient’s physical safety is appropriately minimized or mitigated.
QHPs assess patients prior to prescribing a digital therapeutic and are required to treat patients within the standard of care. As with all medical devices and therapeutic interventions, the level of involvement by QHPs to meet the standard of care would depend on the patient and the risks of the specific therapeutic. Notably, digital therapeutics increase a QHP’s capability to monitor, manage and treat patients by:
There are multiple factors that drive information privacy and security considerations, ranging from ethical concerns and consumer/customer expectations to regulatory compliance and breach costs. Due to increasing cybersecurity risks and the complexity of the regulatory regime, manufacturers, organizations and other stakeholders often consult with experts in healthcare cybersecurity, data privacy, and ethics to develop and implement effective safety and privacy measures for digital therapeutics. Individually identifiable health information (IHI) is subject to a complex regulatory regime in the United States. At a minimum, consumer IHI is
generally subject to compliance with the privacy and security expectations of the Federal Trade Commission in connection with Section 5 of the Federal Trade Commission Act in some cases multiple state laws that apply to the privacy and security of consumer information (including a breach of security). HIPAA requirements also apply, as well as state laws specifically protecting IHI. For CBT, state laws protecting mental health information can also apply, in addition 42 C.F.R. Part 2 and similar state laws if substance use disorder treatment records are involved (either directly or by contract).
Manufacturers of digital therapeutics publish privacy policies and operate in strict compliance with pertinent privacy laws. This commitment ensures the preservation of beneficiaries’ privacy and the safeguarding of personal data through the implementation of robust cybersecurity safeguards and protocols. Digital therapeutics manufacturers often are under contractual terms with QHPs and healthcare organizations relating to privacy and security of information that are more stringent than legal requirements, in addition to undergoing information security due diligence and audits. As further discussed below, there are multiple standards and frameworks available to address these considerations.
Digital therapeutics meet the definition of a medical device and thus are subject to applicable FDA cybersecurity requirements. HIPAA privacy and security requirements also apply. In addition to FDA and HIPAA regulatory frameworks and guidance, numerous other privacy and security frameworks, standards, and certifications exist, for example:
Organizations and stakeholders also frequently consult guidelines relevant to privacy and security considerations, for example various healthcare organizations, such as the American Psychological Association and the World Health Organization have developed guidelines specifically for telemedicine and digital health.
Conclusion
In conclusion, we reiterate our request, stated at the beginning of our RFI responses, that CMS move forward in the CY 2024 PFS Final Rule with defining digital therapeutics coverage and payment pathways within Medicare’s existing DME and incident-to benefit categories.
The Digital Therapeutics Alliance thanks CMS again for the opportunity to comment on the RFI regarding the benefits of digital therapeutics and the current challenges to beneficiary access to digital therapeutics. If you have any questions about these comments, please do not hesitate to contact DTA Director of US Government Affairs Sara Elalamy at sara@dtxalliance.org.
Sincerely,
Andy Molnar
Chief Executive Officer
Digital Therapeutics Alliance
CC: Meena Datta, Partner, Sidley Austin
Elizabeth Hardcastle, Partner, Sidley Austin
Sama Kahook, Associate, Sidley Austin