In August 2020, the Centers for Medicare and Medicaid Services (CMS), the largest health insurer in the United States, suggested Its Innovative Technology Medicare Coverage (MCIT) is designed to provide nationwide Medicare coverage on the same day as the U.S. Food and Drug Administration (FDA) market authorization for a breakthrough device.this Breakthrough Device Program The FDA has accelerated the approval or approval process for certain medical devices that are more effective in treating or diagnosing life-threatening or irreversibly debilitating diseases or conditions. Building on the Breakthrough Device Program, MCIT can reduce time-to-market for breakthrough Designated Devices (BDDs) that can significantly improve patients’ lives.
After the November 2021 transition to a Biden administration, CMS abolition MCIT, one of the few useful rules in the Trump era.But after fierce industry and vendor criticism, CMS announced attend class Get feedback on an alternative to MCIT called Emerging Technology Transition Coverage (TCET).
In a STAT article I (Andrei Ostrovsky) wrote last year, I argued that MCIT could meaningfully help close treatment disparities for Medicare beneficiaries and balance responsible chronic disease management with Covid- The need for social distancing in the ’19 and beyond.Whether it’s MCIT or TCET, CMS must create an expedited process to cover innovative devices that benefit Medicare patients and close health equity disparities, which is key priorities CMS Administrator Chiquita Brooks-LaSure.
We conducted an analysis to help CMS design TCET so that it can reduce inequities in BDD reimbursement, particularly those focused on brain health, one of President Biden’s key priorities. State of the Union (SOTU) address.
To describe and quantify differences in BDD approval and coverage on brain health, we searched Google for Accelerated Access Pathway (EAP) and BDD from 2015 to March 2022. We aggregated the findings into a spreadsheet and categorized eligible BDDs. FDA-approved or approved, reimbursed by CMS, whether it’s digital therapy or diagnostics, whether they’re focused on behavioral health, and as a comparator, whether they’re focused on heart health. As an external source of verification, we compared this list to that of the Medical Device Manufacturers Association, and the results are comparable.
Source: Author Analysis
To date, 325 devices have received Breakthrough Designation. The analysis highlights that one of the challenges that MCIT aims to overcome—the bottleneck in determining whether Medicare should cover FDA-approved or approved BDDs—will not hinder innovation from reaching the market. Of the 325 BDDs, only 34 (roughly one in 10) received FDA marketing authorization. Of the 34 BDDs that received FDA marketing authorization, the majority, 23 (67.6%), were reimbursed by Medicare. There does not appear to be much of a backlog of BDDs that have received FDA marketing authorization but failed to achieve coverage.
However, a key issue that TCET could address remains: the growing disparity between reimbursement for one class of products versus another, and reimbursement for treatment and diagnosis in one disease state versus another. Of the 34 BDDs with FDA marketing authorization, only 7 (20.6%) were digital therapeutics or diagnostics. The single (2.9%) digital diagnoses reimbursed were for a somatic or physical condition, while the remaining digital treatments and diagnoses were not reimbursed and focused on behavioral health or neurology specialties.
Source: Author Analysis
Digging deeper into the data, we uncovered deeper product category and disease state differences. The vast majority (19 of 20, 95%) FDA-approved or approved BDDs in adult somatic or physical health professions were reimbursed by Medicare. Only 20 (5%) of these devices were digital therapeutic or diagnostic devices and were reimbursed.
In contrast, only a small fraction (4 of 13, 30.7%) FDA-approved or approved BDDs in behavioral health or neurology specialties were reimbursed by Medicare. Five of 13 of these devices (38.5%) were digital therapy or diagnostic devices, and none were reimbursed.
Five out of five (100%) FDA-approved or approved cardiology-focused BDDs are reimbursed by Medicare. Zero out of five (0%) FDA-approved or cleared BDDs focused on behavioral health or neurology are reimbursed by Medicare. In other words, CMS prioritizes healing heart valves over enhancing brain health.
Digital therapy and diagnostics may enable patients and families overcome obstacles Problems inherent in brick-and-mortar care, such as transportation issues, long waiting lists, and systemic racism among providers. CMS should ensure that breakthrough-designated digital treatments and diagnostics have an expedited pathway to reimbursement through TCET so that this rule does not conflict with Mental Health Equity and Addiction Equity ActCMS administrator Brooks-LaSure focused on closing health equity gaps, and President Biden’s SOTU charged with improving brain health.
In order for CMS to avoid violating mental health equity laws and running counter to its own priorities, it needs to reconcile its historical criticism of MCIT.Most notably, CMS leaders are worried Under MCIT, CMS can cover devices that do not have sufficient evidence to treat people with Medicare.
One way to address Medicare-specific evidence needs is to grant FDA market-authorized BDD temporary coverage and reimbursement during transition coverage while manufacturers develop additional evidence for the Medicare population. This approach can help balance equity in access to care with the need for evidence-based support.
CMS leaders’ concerns about the evidence limitations of MCIT in the Medicare population have created another obstacle for this administration to achieve its equity goals. Commercial, Medicaid, and exchange insurers rely on Medicare coverage determinations to make many of their own health policy decisions. Devices that are not covered by Medicare will lack the HCPCS code required to be covered by other payers. This means that BDDs with FDA marketing authorization to serve children and adults under the age of 65, especially the poor, are systematically underserved.
To address barriers to Medicare coverage for commercial, Medicaid, and exchange insurers, CMS can create modifiers to HCPCS codes that specify to which groups certain codes can be applied, such as the pediatric population and adults under the age of 65.
TCET’s inclusion of HCPCS code modifiers may not be sufficient to address current coverage differences for CMS. TCET should call on Medicare Centers to improve internal processes to have more expertise and priorities in brain health and non-Medicare populations. With subject matter experts from the Centers for Medicaid and CHIP Services (CMCS) and the Center for Medicare and Medicaid Innovations (CMMI), TCET should ask Center for Medicare leaders to collaborate more regularly with CMCS and CMMI leaders on coverage determination.
Despite all this criticism, we have to give Medicare Center credit for finally passing the approval HCPCS Level 2 Code A9291 stands for “Prescribing Digital Behavioral Therapy, FDA Approved, Per Course”. However, Medicare still does not reimburse this code, and this code lacks the specificity that most commercial insurers need to systematically reimburse all brain health-focused digital therapeutics.
Medicare is providing to reimburse New CPT code 989X5 for “remote therapy monitoring,” which can be used for reimbursement of certain digital therapies. However, reimbursement amounts are limited and primarily limited to musculoskeletal and respiratory indications.
This analysis showed that the CMS coverage process revealed differences by product category and disease state. The differences contradict the mental health equity statute, CMS administrator Brooks-LaSure’s focus on equity, and President Biden’s mandate to improve brain health. TCET can help close these gaps by providing interim coverage for BDDs with FDA marketing authorization through evidence development, creating HCPCS code modifiers for non-Medicare populations, and requiring Centers for Medicare to include experts in CMCS and CMMI in coverage determinations.
