New Consensus Statement on the Management of Remote Device Clinics: Review of New Responsibilities, Third-Party Considerations, and Billing and Reimbursement

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EP LAB DIGEST. 2023;23(10):18-19.

A revised consensus statement specific to remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) was recently released by the Heart Rhythm Society (HRS).¹ This 2023 consensus statement establishes a new standard of care that should be offered to everyone.²

This standard of care places new and significant responsibilities on essentially everyone involved with CIED management and monitoring. In a confluence of challenges, this expansion of responsibilities is happening just as the industry faces impending payment cuts, coding changes, a shortage of qualified device technicians, and already high service demands on device company representatives.

Importance of Remote Monitoring

RM received a Class 1A recommendation as the standard of care in the 2015 consensus statement on remote monitoring.³ The 2023 consensus statement notes that since 2015, studies “have continued to show the value of RM and its potential positive effects on morbidity and mortality, cementing RM as an essential part of CIED patient care.”³ Specifically, studies have shown that RM reduces hospitalizations, length of stay, and the time to detect device malfunctions and arrhythmias.

Although RM has been the standard of care since 2015, the 2023 consensus statement reveals that up to 50% of all patients fail to activate their RM transmitter. Among the strategies to improve compliance are patient education about RM before implantation, initiation of RM before discharge, clear roles in team-based care, dedicating sufficient staff time, leveraging third-party resources to share the workload, and continuous patient engagement after RM begins.

The 2023 consensus also evaluated past efforts to educate this patient group. Medicare requires all primary prevention defibrillator candidates to participate in a shared decision-making process using an evidence-based tool; it is a “condition of coverage.” The consensus states, “In a study that assessed the readability of patient education materials on ICDs from various sources (including industry, hospital resources, and patient support organizations), it was determined that 95% of the materials exceeded the recommended 8th grade reading level.”¹

In addition to emphasizing the need to replace existing patient education material on primary prevention defibrillator implantation, the 2023 consensus declares that additional patient education about RM is now required. Guided by a publication on readability of patient education materials available at the point of care,⁴ specific patient education material related to RM and an evidence-based tool for primary prevention defibrillator candidates have been crafted. These resources are available for free.⁵

New Responsibilities

The 2023 consensus statement outlines a new standard of care for both RM and in-person device management. It reshapes the roles of implanting physicians, RM clinics, in-person device clinics, and device company representatives. Although there are subtle differences in recommendations for various devices, the central ideas can be grouped by the responsible entity.

Implanting Physician Responsibilities

Before implantation, physicians should ensure patients, their families, and caregivers receive thorough education about RM to inform decisions about device selection.

Post implantation, it is imperative to begin RM before discharging patients with subcutaneous cardiac rhythm monitors. For those with pacemakers and defibrillators, remote monitoring should start either before discharge or within 2 weeks.

Necessary resources must be allocated to uphold the standard of care. Considering the technological capabilities and the mix of devices, an estimated 3 full-time employees are required for every 1000 patients managed both in-clinic and remotely.

The statement also underlines the significance of updating manufacturer websites when devices are replaced, when patients move to different clinics, or when patients pass away.

In-Person Device Clinic Responsibilities

Though the consensus statement’s title implies a focus on RM, it introduces many responsibilities for technicians managing devices in person. These added duties will intensify in-person device clinic visits since most devices will require reprogramming tailored to the patient, indication, device model, and RM setup that accounts for extraneous variables.

Subcutaneous cardiac rhythm monitors are prominently featured in the consensus statement. While most of these devices currently use default settings, custom programming and frequent reprogramming of each device is now recommended. Sensitivity settings should be fine-tuned to enhance arrhythmia detection and adjusted when frequent undersensing or oversensing occurs.

Most device clinics will need to adapt their workflow to the new standard. The statement indicates that it is vital to establish policies, procedures, and defined team roles. Regular quality improvement reviews should be conducted, patients should receive hands-on education, and high-priority alerts must be addressed within a business day.

Remote Monitoring Clinic Responsibilities:

The consensus stresses the value of “continuous connectivity” whenever feasible and offers a definition. It states that continuous connectivity entails “continuous data collection within the device with automatic transmission using manufacturer-specific transmission frequency, which often occurs once daily. While the data collection is continuous, the transmissions and monitoring are not continuous.”¹ This focus will influence device selection, as some device models cannot support continuous connectivity and others will have significantly reduced battery longevity if such connectivity is activated.

Alongside reinforcing that RM is a class 1A recommendation, the consensus urges that “every reasonable effort” be made to reestablish connections when monitoring is interrupted. Efforts should encompass monitoring disconnections, urging patients to reconnect, and addressing financial concerns tied to the recurring out-of-pocket costs of RM.

The role of RM clinics has been expanded to include site-based transmissions for in-person clinics lacking device interrogation capabilities and in situations where such transmissions would expedite patient care.

Clinics should communicate the results of RM transmissions to patients. This will inevitably create a significant workload, as results will need to be processed in a comprehensible format for patients, and staff will need to handle the ensuing queries.

Device Company Responsibilities

As outlined in the consensus, device companies bear the responsibility of training and educating clinic staff. This includes training to enhance individual patient connectivity and programming indication-specific alerts. Representatives should also promptly inform clinics and patients when RM disconnects to reestablish connectivity, assist practices in identifying patients affected by recalls, recommend optimal alert settings, and provide the necessary resources for early RM.

The 2023 consensus emphasizes that device company representatives should not gather, process, or prioritize data on behalf of the clinic staff, nor should they replace local qualified personnel. This reinforces guidance previously presented by HRS which established that the industry-employed allied professional (IEAP) is not an unpaid employee of the health care system or health care provider, and that the IEAP should not have direct access to the electronic medical record.⁷

Third-Party Considerations

Several facets of the new standard will cause the workload of in-clinic staff to surge significantly. Clinic staff is now expected to program devices with greater precision and frequency. While personalized sensitivity and alert settings should minimize false alerts, they will likely boost the number of actionable alerts that need to be addressed promptly. The consensus sets a guideline of 3 full-time staff for every 1000 device patients managed both in-person and remotely. Attracting and retaining the required number of qualified device technicians will pose challenges for many clinics.

The 2023 consensus also endorses the involvement of third parties to assist with RM workload. It acknowledges the reasonableness of using third-party resources and stresses informing patients of their involvement. It also permits clinic staff to send data to RM clinics when in-house equipment or personnel are insufficient and in situations where such transmissions would expedite care.

Billing and Reimbursement

The new standard of care will potentially make optimization of subcutaneous cardiac rhythm monitor programming the most frequently reported in-person device clinic service. This will be a new service for many clinics, so it represents a new revenue stream.

At the current national Medicare rate, each of these services will generate about $62. They should be reported with code 93285, “Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; subcutaneous cardiac rhythm monitor system.”

Since the advent of RM, the technical components of monitoring cardiovascular physiologic and subcutaneous cardiac rhythm monitor data have been reported with a stand-alone code. In 2023, the technical component of these services is reported with code G2066, while the professional components are reported with code 93297 (cardiovascular physiologic data) and 93298 (subcutaneous cardiac rhythm monitors). Starting at the beginning of 2024, code G2066 will be deleted, and codes 93297 and 93298 will become global services.

If the practice provides the technical and professional components of RM, they will report codes 93297 or 93298 without any modifiers. However, if the practice does not provide the technical component of RM, they will need to report 93297-26 or 93298-26 (the 26 modifier indicates that only the professional component of RM is being reported). A third party would report 93297-TC or 93298-TC when submitting claims for the technical components of RM. Additional rules and payment limitations apply when the technical component of these diagnostic tests is purchased from an outside provider. These rules are commonly referred to as “anti-markup” and “purchased diagnostic test” rules in Medicare publications.

G2066 is a contractor priced code; in 2023, providers in some areas receive less than $30 every month for monitoring these devices, while others receive around $300 every month for the same service. Deletion of code G2066 and conversion of codes 93297 and 93298 will usher in national pricing for these services.

In the proposed 2024 Physician Fee Schedule,⁶ Medicare has presented a payment rate of $31.11 for the technical component of remotely monitoring cardiovascular physiologic data and $71.72 for the technical component of monitoring subcutaneous cardiac rhythm monitors. These proposed rates would create windfalls for some, hardships for others.

Summary

The 2023 consensus statement on RM introduces a comprehensive new standard of care that places additional demands on everyone involved with CIED management and monitoring. The challenges posed by the expanded responsibilities, in conjunction with potential payment cuts, code changes, and a shortage of skilled technicians, will be significant. The path ahead demands a coordinated effort, adaptability, and collaboration to truly elevate patient care. Taking advantage of staff education opportunities from device companies and leveraging third-party RM companies to share the workload will be two of the most effective strategies going forward. 

Disclosure: Jim Collins, CPC, CCC, discloses that he is the Chief Compliance Officer at IronRod.Health.

References

1. Ferrick AM, Raj SR, Deneke T, et al. 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Heart Rhythm. 2023;S1547-5271(23)02011-8. doi:10.1016/j.hrthm.2023.03.1525

2. The 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic: an international collaboration on standards of care and best practices for the remote clinic. EP Lab Digest. Published June 9, 2023. Accessed August 29, 2023. https://tinyurl.com/2x7g39ym

3. Slotwiner D, Varma N, Akar JG, et al. 2015 HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular electronic implantable devices. Heart Rhythm. 2015;12(7):e69-100. doi:10.1016/j.hrthm.2015.05.008

4. Stossel LM, Segar N, Gliatto P, Fallar R, Karani R. Readability of patient education materials available at the point of care. J Gen Intern Med. 2012;27(9):1165-1170. doi:10.1007/s11606-012-2046-0

5. IronRod Health. Accessed August 29, 2023. https://l.ead.me/beFokV

6. CMS-1784-P. CMS.gov. Accessed August 29, 2023. https://www.cms.gov/medicare/medicare-fee-service-payment/physicianfeesched/pfs-federal-regulation-notices/cms-1784-p

7. Haines DE, Austin C, Kusumoto FM, et al. Heart Rhythm Society policy statement update: recommendations on the role of industry-employed allied professionals. Heart Rhythm. 2023;20(1):157-162. doi:10.1016/j.hrthm.2022.08.029