So many of the decisions healthcare leaders make come down to reimbursement. It’s not just, will this treatment approach help patients — it’s, what can I get insurance to pay for?
Insurers often require a greater burden of proof than the FDA to agree to cover new medical products and procedures, even once they’re FDA-approved. Their “reasonable and necessary” standard emphasizes real-world value and cost-effectiveness, which differs from the FDA’s “safe and effective” criteria. That means coverage can be limited or delayed until payers see compelling evidence that a device changes outcomes and total cost of care.
The good news: reimbursement strategies are evolving. As the Affordable Care Act (ACA) passes 15 years since it became law, several states and hospitals have embraced value-based care models that incentivize fewer avoidable hospitalizations, fewer repeat procedures, and better long-term outcomes. The growth of these models shows up in reimbursement as well: new codes, new benefit categories, and new payment approaches now exist for technologies that reduce costly events, and medical device makers can leverage these to win reimbursement.
For device makers, especially those pursuing new or device-specific CPT/HCPCS codes, recent reimbursement “wins” point to repeatable strategies. Below, we’ll look at three examples — and what teams developing and commercializing new medical devices can learn from them.
1. CardioMEMS HF System (Abbott) – implantable PA pressure sensor for HF (heart failure)
CardioMEMS is an implantable pulmonary artery (PA) pressure sensor that lets clinicians remotely monitor heart failure patients and adjust therapy before they decompensate, or experience a sudden worsening of symptoms that requires immediate medical attention
The CHAMPION trial showed that PA pressure-guided management reduced heart failure hospitalization rates versus standard care. Follow-up analyses and post-approval studies similarly reported lower heart failure hospitalizations when clinicians used CardioMEMS data to guide HF therapy.
How CardioMEMS Won Reimbursement
CardioMEMS didn’t win reimbursement simply because it was novel — it won because Abbott and its investigators built a multi-layered value story around reduced hospitalizations and lower Medicare spending. Their value story consisted of:
1. A pivotal trial design focused on hospitalizations, not just physiology.
The CHAMPION trial was designed specifically to detect differences in heart failure hospitalizations. It showed significant reductions in heart failure admissions when therapy was guided by PA pressures from the device. Abbott then used that data and comprehensive cost modeling to show cost savings from fewer hospitalizations, physician visits, prescription drugs, long-term care, and outpatient hospital visits over 5 years. This positioned CardioMEMS squarely in the value-based care narrative as it is associated with fewer admissions and readmissions, and led to significant cost savings for a very expensive chronic condition.
2. Post-market Medicare claims data linked to real-world savings.
Abbott then supported a large post-approval study using U.S. Medicare claims, comparing patients who received CardioMEMS with matched controls. The analysis showed reduced heart failure hospitalizations and lower heart failure-related costs for Medicare beneficiaries, reinforcing that CHAMPION’s hospitalization benefits translated into routine clinical practice and real savings for the Medicare program.
3. Formal cost-effectiveness modeling framed in payer language.
Independent economic analyses found CardioMEMS to be cost-effective in the CHAMPION-like population, with an incremental cost-effectiveness ratio around $70,000 per QALY gained — within commonly accepted thresholds for HF interventions. This kind of modeling speaks directly to how payers evaluate “value versus cost.”
4. A deliberately data-driven care model and system design.
The CardioMEMS platform is built around daily, actionable PA pressure data and integrated heart failure management workflows. Abbott’s clinical evidence and marketing both emphasize that clinicians can systematically titrate heart failure therapy using objective sensor data to keep patients stable and out of the hospital. This “data-driven, protocolized” care model is attractive to payers because it is both scalable and measurable.
5. A comprehensive coverage submission that bundled evidence across trials and real-world studies.
In coverage deliberations, CMS reviewed the totality of evidence — CHAMPION data, follow-on trials (e.g., GUIDE-HF), the post-approval study, and European “real-world” studies — which consistently showed lower heart failure hospitalizations when care was guided by CardioMEMS data. That body of evidence supported national coverage and the establishment of dedicated device and procedure reimbursement.
Reimbursement Strategy Recap
Abbott gained reimbursement for CardioMEMS by making it obvious to payers that the device helped avoid expensive heart failure admissions, justifying
- A dedicated implant procedure code and device payment under OPPS;
- A code for the implantable device itself, and;
- A code for remote monitoring for longitudinal management.
Abbott’s approach combined data from RCTs, Medicare claims, and economic models with a data-driven device design to demonstrate how CardioMEMS reduces a specific high-cost event (HF hospitalization) and lowers costs for Medicare. Then Abbott translated that into a clear coding and payment structure, connecting the dots for payers so they didn’t have to.
Relevant Codes
- CPT 33289 - “Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring” (covers implant, right heart catheter, etc.).
- Remote monitoring is generally billed with CPT 93264 (remote monitoring of pulmonary artery pressure sensor, once per 30 days), per Abbott’s coding guide.
- HCPCS C2624 - “CardioMEMS™ Sensor and Guidewire… implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components,” established as an OPPS device category code.
- CMS OPPS rules explicitly discuss device category C2624 and pass-through payment offsets for this code, showing that it had distinct, additional payment above the base procedure.
2. RelieVRx® (AppliedVR) – VR digital therapeutic for chronic low back pain
RelieVRx is an at-home, skills-based virtual reality therapy for chronic low back pain (cLBP). It delivers Cognitive Behavioral Therapy and behavioral pain management training via an immersive VR headset for adults with moderate to severe cLBP lasting more than three months, as an adjunctive non-opioid therapy. The prevalence and impact of chronic pain and the need for non-opioid therapies are key factors underscoring the clinical need and reasons it’s received FDA De-Novo authorization. VR is seen as a scalable, low-risk alternative to high-cost, high-risk treatments like opioids and interventional procedures.
How RelieVRx Won Reimbursement
RelieVRx’s reimbursement win (HCPCS E1905) came from a thoughtful, phased strategy that combined robust clinical evidence, clever benefit-category positioning, and a clear system-value story. Their approach consisted of:
1. Building rigorous, sham-controlled evidence base around patient-important outcomes.
- A pivotal double-blind, randomized, sham-controlled trial of an 8-week home-based behavioral VR program for cLBP showed clinically meaningful improvements in pain intensity and pain interference versus a strong active control condition.
- Follow-up studies demonstrated durability of pain reduction and functional improvements out to 6 and 24 months in many participants, suggesting the therapy could have sustained impact beyond the initial 8-week course.
This evidence package was central to FDA’s De Novo authorization of RelieVRx for reducing pain and pain interference in chronic low back pain.
2. Framing the product as a real medical device that fits into an existing benefit category: Durable Medical Equipment (DME).
AppliedVR didn’t ask CMS to invent a brand-new reimbursement construct for a VR app. Instead, they:
- Emphasized that RelieVRx is a prescription-only, locked VR medical device system consisting of a dedicated headset, proprietary software, and a defined therapeutic program that can only be used for the prescribed indication and treatment course.
- Argued that this meets the criteria for durable medical equipment (DME) — hardware used repeatedly at home, serving a medical purpose, and appropriate for use in the home environment.
CMS accepted this framing and classified RelieVRx as DME, establishing HCPCS Level II code E1905: “Virtual reality cognitive behavioral therapy device (CBT), including pre-programmed therapy software.” It was set up as a time-limited rental with a defined payment schedule, mapping neatly onto the 8-week treatment course.
According to a MDIC case study, this was the first immersive VR therapeutic to receive both a unique HCPCS code and a DME benefit category determination, with CMS publishing a purchase price for the device — paving the way for coverage and adoption.
3. Connecting the clinical evidence to a system-level value story: the need for non-opioid, home-based, scalable care.
In public and payer-facing materials, AppliedVR consistently positioned RelieVRx as:
- A non-pharmacologic, home-based therapy for chronic back pain, addressing payer concerns about opioid-related risk and cost.
- A way to potentially reduce reliance on higher-cost interventions such as long-term opioid therapy, interventional procedures, and some pain-related emergency visits, by improving pain self-management and function.
- A scalable behavioral therapy that can be deployed across health systems, including large integrated systems and the Veterans Health Administration, using the same device and protocol.
The combination of randomized trial data, durability evidence, and this system-level narrative made it credible that a finite VR therapy course could provide sustained benefit and, over time, help lower overall pain-care costs — which supported CMS’s decision to create E1905 and treat RelieVRx as DME.
Reimbursement Strategy Recap
RelieVRx won reimbursement by generating high-quality randomized evidence for meaningful outcomes (pain and function), aligning the product with an existing benefit category, Durable Medical Equipment, and telling a clear story about the need to shift care from high-cost, high-risk interventions to a home-based, scalable, non-opioid therapy.
Relevant Codes
- HCPCS E1905: Virtual reality CBT device, including pre-programmed therapy software (created specifically for RelieVRx with potential to apply to similar VR therapeutics).
- Classified as DME, with a defined rental/payment structure aligned to the therapy course.
Unlike CardioMEMS, the “reduced hospitalizations” piece here is more indirect (via reduced high-risk procedures and opioid use), but the reimbursement win (E1905) is unambiguously tied to a value-and-access story, with greater value and accessibility of care via the RelieVRx system.
3. Remote Patient Monitoring (RPM) codes as an enabler for new device reimbursement across device categories
Any connected implantable or wearable device whose value story is “fewer admissions and emergency visits” has a good chance at being able to leverage existing reimbursement, such as for remote patient monitoring. CMS and HHS define Remote Patient Monitoring (RPM) as using connected devices (BP cuffs, glucose meters, and more) to collect physiologic data at home and transmit it to providers to manage chronic conditions. This is a broad classification and currently includes codes like:
- 99453 - initial setup and patient education for remote physiologic monitoring.
- 99454 - device supply and data transmission, per 30 days.
- 99457 / 99458 - treatment management services (time-based professional/clinical staff management with interactive communication).
How RPM Reimbursement Emerged — and What That Means for New Device Reimbursement Pathways
RPM did not start with a single device; it started with an accumulating body of evidence and policy momentum, including:
- Evidence that remote monitoring reduces acute-care utilization: Systematic reviews and meta-analyses have shown that remote monitoring programs, particularly device-based monitoring for chronic conditions, can reduce hospitalizations, length of stay, and emergency department visits in a substantial share of trials.
- CMS formalizing RPM as a billable care management service: Beginning around 2018–2020, CMS explicitly created and clarified RPM codes (such as 99453, 99454, 99457, 99458) in the Medicare Physician Fee Schedule, recognizing remote physiologic monitoring as a distinct service with its own payments rather than “bundling it away” inside office visit codes.
- Recognizing RPM as part of value-based, longitudinal chronic care: CMS now treats RPM (and related remote therapeutic monitoring) as care management services that can be provided under general supervision, supporting scalable team-based models for chronic disease management and aligning with broader telehealth and value-based care efforts.
RPM codes are themselves a structural reimbursement win for digital and connected devices, showing that individual devices don’t have to prove “device X reduces readmissions” to get a brand-new code. Instead, they need to demonstrate that they fit within the clinically and operationally defined RPM framework and enable the kind of reductions in acute utilization that prior RPM programs have shown.
This means if your connected device helps clinicians manage chronic disease remotely, your reimbursement path may be less about inventing a new code and more about showing that your device and associated care model qualify under existing RPM/RTM infrastructures.
How Device Development Choices Can Support Reimbursement
Clinical and economic evidence is crucial — but the design of the device and system can make or break your ability to generate that evidence and tell a convincing reimbursement story. Three design themes stand out.
1. Make the device inherently data-driven
Devices that naturally generate high-quality, clinically interpretable data make it much easier to:
- Show reductions in high-cost events (e.g., hospitalizations, emergency visits, revisions).
- Demonstrate changes in guideline-relevant metrics (e.g., blood pressure, PA pressure, arrhythmia burden, pain interference scores).
- Support real-world evidence and post-market studies from claims and registries.
CardioMEMS is a clear example: the implant and cloud platform were designed from the start to deliver daily PA pressure trends, enabling protocolized therapy adjustments and strong post-market evidence that payers trust.
For your device, that might mean:
- Embedding sensors and connectivity (Bluetooth, cellular, or near-field communication).
- Designing clear, standardized metrics and dashboards for clinicians.
- Building analytics to summarize risk, trends, and adherence.
- Ensuring that the data can be mapped cleanly into EHRs and claims-based outcomes analysis.
The more your device outputs actionable metrics tied to expensive outcomes, the easier it is to build a payer-facing story.
2. Reduce device size and procedural invasiveness
There is a growing body of data showing that smaller, less invasive devices often support:
- Shorter procedures and hospital stays.
- Fewer surgical complications.
- Better cosmetic and patient-experience outcomes.
For example, the trend toward smaller and leadless cardiac devices has enabled more minimally invasive procedures and has been associated with shorter hospital stays and easier recovery in many patients. These are exactly the kinds of benefits that resonate in value-based care environments.
For an implantable or interventional device, design choices that may support reimbursement include:
- Miniaturizing the device to enable percutaneous or single-incision approaches instead of open surgeries.
- Eliminating leads, large pockets, or bulky components where possible.
- Using designs that are compatible with outpatient or same-day procedures.
A smaller, less invasive device is easier to position as enabling reduced length of stay, lower peri-procedural risk, and fewer device-related complications — all of which support a stronger cost-effectiveness argument.
3. Increase device lifespan to avoid costly replacement surgeries
For many implantable devices, replacement procedures drive significant cost and risk: each battery replacement or generator change is another procedure, hospitalization, and potential source of complications (e.g., pocket infections, lead damage, or re-interventions). Studies in implantable cardioverter-defibrillators (ICDs) have shown that extending device longevity can meaningfully reduce long-term therapy costs and the cumulative risk of replacement-related complications.
Design choices that extend device life — for example, improving energy efficiency, optimizing power architectures, or enabling safer “end-of-life” management — can:
- Reduce the number of replacement surgeries over a patient’s lifetime.
- Lower cumulative hospital and procedure costs.
- Strengthen your cost-effectiveness and budget-impact models.
For value-based purchasers and payers, “fewer replacement episodes over 10–15 years” is a highly compelling part of the economic story.
How to Use These Examples for Your Device
If you’re building a business case or reimbursement strategy around an implantable or wearable medical device, these cases suggest some patterns that do move payers to create new reimbursement categories and codes:
- Anchor the value story in a specific high-cost event: CardioMEMS and heart failure monitoring focused on reducing 30-day/90-day heart failure readmissions. VR for pain focused on reduced surgeries, opioid use, and emergency visits. For your device, the key value-based care and cost reduction benefit may be reducing unplanned surgical revisions, device-replacement procedures, and/or complications leading to readmissions.
- Generate evidence that your device and care model actually change those events: Trials that show a clear reduction in hospitalizations or procedures per patient-year have helped device makers successfully gain new reimbursement in recent years. They focus on more than just surrogate endpoints, providing clear data on the benefits of the new device and care model and, where possible, tying them to similar and already proven devices and models.
- Design your device so it naturally produces the data you need to prove value. Build in remote monitoring, actionable metrics, and clear workflows for clinicians. Make it easy to show usage, adherence, and outcome changes over time.
- Link your evidence to a clear coding and payment path: Reference similar codes and benefit categories, even if they don’t perfectly fit at first, such as:
- A device-specific implant and monitoring bundle (CardioMEMS-style).
- A digital therapeutic/DME (RelieVRx, E1905-style).
- RPM/RTM (99453, 99454, 99457, and 99458).
- When needed, pursue new codes — but do so with a strong, trial-and-real-world value story in hand.
- A device-specific implant and monitoring bundle (CardioMEMS-style).
- Tell the “system value” story explicitly in your coding and coverage submissions: The examples above all speak to system-level value — fewer admissions, fewer procedures, fewer opioid prescriptions, lower total cost of care — in addition to better patient-level outcomes. Device makers who clearly connect device features and clinical outcomes to reductions in or avoidance of high-cost events will have a much easier time earning coverage, winning new codes, and expanding adoption.
Developing a new device and considering ways to make your device reimbursement pathway smoother? Reach out to discuss what’s worked for others. Wireless power and data transfer are key components in enabling easier commercialization and reimbursement for new devices, as part of an overarching design approach that makes devices more effective and easy-to-use. If you’re not sure where to start, we can help.
