Overcoming Challenges in RTM Device Reimbursement with IoT

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By Carsten Brockmann

November 19, 2024

Estimated reading time: 11 minutes

One of the fastest-growing medical technology (medtech) segments is remote therapeutic monitoring (RTM). RTM includes Internet of Things (IoT) devices, such as wearables, implants and mobile apps.

These devices capture real-time data and monitor a patient’s health condition and progress. This enables health care providers to adjust treatment as needed. RTM IoT devices are revolutionizing health care and improving patient outcomes cost-effectively.

Change Lives with Real-Time Health Data

Before, patients had difficulty sharing this data, and health professionals faced obstacles in obtaining and billing for it. RTM with reimbursement codes makes all this possible and easier to track and manage.

As telehealth and the demand for medtech devices grow, reimbursement policies are being updated and expanding. RTM reimbursement must be optimized and approved for new devices as they come to market to manage health issues like chronic disease better. Otherwise, delays could stunt progress in patient care and the device market.

The right IoT connectivity technology must be reliable and secure. It must also be easy to manage regardless of where the patient is. Patients and health care professionals rely on always-on connectivity. It’s vital to maintain the requirements for reimbursement.

Growing Medtech Reimbursement Market

The adoption of new and more affordable medtech devices is driving the medical device reimbursement market. By 2027, it’s predicted that the global medical device reimbursement market will increase at a compound annual growth rate (CAGR) of 8.4%. It will reach a market value of $602.9 billion.

Three key trends are fueling the adoption of innovative medtech devices.

They include:

  • A rise in the number of Americans with chronic disease: Roughly 60% of Americans suffer from one chronic condition, and 40% have two or more.
  • An increase in the number of Americans reporting chronic pain: Over 51.6 million Americans are living with chronic pain. A survey by the U.S. Pain Foundation discovered that chronic pain restricted 99% of respondents from daily routine activities.
  • Americans are living longer, resulting in an aging population: Americans 65 and older are projected to reach 82 million by 2050, a 47% increase.

The government is heavily advocating for digital health care and RTM. Remote health care has proven to manage chronic diseases better, reduce costs and make health care more accessible.

Any massive growth comes with challenges. This includes approvals for reimbursement for medtech devices like RTM.

What Companies Need to Know about Reimbursement and Changes in RTM

Medical device reimbursement is a complex process in which insurance companies pay health care providers for prescribed devices and services.

There are many rules and restrictions on services and billing. Innovators must stay informed about expanding coverage and code changes to maximize potential reimbursement opportunities. Without proper reimbursement, a medical device would become too costly for providers.

CMS RTM Reimbursement Policies

Centers for Medicare & Medicaid Services (CMS) finalized telehealth service policies, including RTM for 2024. Here are a few key areas to note:

The biggest win for digital health companies, providers and patients is stand-alone reimbursement for RTM services. These are provided by federally qualified health centers (FQHCs) and rural health clinics (RHCs). The proposed rule is also open to feedback from stakeholders on these policies.

On the other hand, some things must be resolved. A generic RTM device billing code was not approved. CMS still had concerns about assigning a reimbursement value for devices with a wide range of costs and benefits.

The 2024 final rule is a start in making progress. Unfortunately, there are several areas of uncertainty in the codes, such as:

  • Support for the growing RTM device list and services for patients
  • Who on the clinical staff qualifies for reimbursement to avoid billing errors
  • What defines a medical device that RTM can fit into

In addition, there are different codes for services and products that make things even more complex.

Current Procedural Terminology (CPT®) service codes identify initial setup and patient education on the devices. There are codes for medication adherence and therapy response. Interactive communications and activity over a certain period are also tracked to ensure patients stick to their therapy plan.

If the initial therapy study is positive, the Healthcare Common Procedure Coding System (HCPCS) reimburses for devices, supplies and services not covered by CPT codes. CMS is covering RTM costs for chronic conditions from sleep apnea to diabetes. The next section explains some of these use cases.

RTM in Managing Chronic Diseases

RTM is a proactive approach to health care services and chronic disease management that improves a patient’s quality of life. Patients can self-report the data to their providers or automatically generate it by connected medical devices.

Practitioners can track patients’ use and response to as-needed medications like insulin. This RTM data allows them to determine the correct therapy regimen.

Several use cases for connected health care leverage RTM. The following three use cases range from legacy to cutting-edge.

1. Sleep Apnea

Doctors have used continuous positive airway pressure (CPAP) devices to treat sleep apnea for decades. RTM takes this a step further by measuring therapy adherence and treatment response.

In 2024, health care reimbursement in the U.S. has evolved to embrace the proven benefits of digital RTM, particularly for conditions like sleep apnea. Specific CPT and HCPCS codes streamline reimbursement for RTM, enabling financial coverage for patients and providers. Continuous monitoring and timely emergency intervention improve patient care and outcomes.

2. Diabetes

Medicare and Medicaid have expanded coverage for continuous glucose monitoring (CGM) sensors and insulin pumps, vital for diabetes management. Patients with diabetes treated with insulin or who have a history of hypoglycemia may be eligible for CGM devices.

Qualified practitioners and physicians must conduct six-month evaluations of diabetes control before prescribing CGM. Evaluations can be done through telehealth visits. RTM is a key component for reimbursement. It ensures patients receive the necessary care and support for their diabetes treatment plan.

3. Chronic Pain Management

Chronic pain costs the United States $635 billion per year while leaving patients disabled. For decades, virtual reality (VR) therapy has been studied and used to treat various acute and chronic pain conditions. Only recently did immersive VR headset technology finally become accessible and easy to use. Combined with cognitive behavioral therapy (CBT) techniques, immersive VR therapy is even more effective.

HCPCS reimbursement codes recognize VR therapies when monitored remotely. Immersive home-based VR therapies offer pharmacological options for pain management. These could transform chronic pain management.

There is unlimited potential for medtech devices to improve patient outcomes while reducing medical costs.

Unlock New Revenue Streams for Device Makers

The 2024 HCPS coding for RTM creates new opportunities for patients and health care professionals. It also unlocks new revenue streams for medical device manufacturers.

Increase Sales Potential

RTM devices eligible for reimbursement are financially viable for providers and patients. This opens the doors to more device sales potential for manufacturers.

Boost Market Adoption

Reimbursement incentivizes health care providers to integrate RTM devices into their practices. More providers lead to wider market adoption and more demand for these devices.

Strengthen Collaborations and Partnerships

Greater adoption can drive partnerships between health care providers and device manufacturers to improve reimbursement outcomes. Collaboration on new and improved devices can build relationships for other sales opportunities.

Despite the demand for RTM and new opportunities, there are challenges.

RTM Device Reimbursement Challenges

Approval of medtech devices goes through stringent regulatory requirements. Devices must be approved by the FDA and used as intended. Unfortunately, there is a lack of standards for policies across different regions.

A University of Chicago study examined the implications of Medicare’s outdated reimbursement policies for new medical devices. They found that delaying Medicare coverage for new medical devices between 2010 and 2022 saved a little money upfront. Nevertheless, the negative effects on patients were 11 times more significant in delaying health improvements.

In addition to affecting patient health, outdated policies increase health care costs. Coverage delays for new FDA-approved medical devices cost between $1.90 million and $2.80 million per year.

Outdated reimbursement policies and coverage delays are all missed opportunities to improve patient health and decrease costs to the U.S. Cuts in reimbursements affect the profitability of medical d

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Carsten Brockmann