REMOTE MONITORING SERVICES UNDER REVIEW: MEDICARE COVERAGE POLICIES MAY BE COMING
Six of the seven Medicare Administrative Contractors (MACs) are scheduled to jointly host a multijurisdictional contractor advisory committee (CAC) meeting on February 28, 2023. This CAC panel meeting will allow the MACs to obtain feedback from a panel of experts on the strength of currently published evidence on remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) for non-implantable medical devices.
CAC meetings often, but not always, are held in advance of the publication of a draft local coverage determination (LCD), specifying the circumstances or criteria under which items and services may be covered by Medicare in a particular geographic region. Given the increasing utilization of remote monitoring services, interested stakeholders should consider attending the upcoming CAC meeting and begin gathering data to support the clinical efficacy of non-implantable medical devices for RPM and RTM services.
REMOTE MONITORING BACKGROUND
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded its payment for remote monitoring services, which generally use digital technologies (medical devices, together with software) to collect medical and other forms of health data from patients in one location and electronically transmit the information to the patient’s healthcare provider in a different location for assessment and care management. Monitoring devices and software can collect a wide range of health data from the point of care, including both self-reported and device-measured health information. This data is electronically transmitted to health professionals who review the data, engage in interactive communications with the patients (in some cases), and may make treatment management decisions in part based on this information.
RPM services involve monitoring physiological conditions (e.g., weight, blood pressure, blood sugar) through medical devices, which transmit data obtained from patients automatically to healthcare providers for assessment and recommendations. In 2017, the American Medical Association modified an existing code for RPM services and created additional RPM codes as the initial primary category of remote patient monitoring services. The RPM codes became effective in 2019, and CMS clarified several issues in fall 2020 as part of the annual Medicare Physician Fee Schedule rulemaking cycle. The five codes for RPM services are CPT® codes 99091, 99453, 99454, 99457 and 99458. These include two practice-expense-only codes (99453 and 99454) and three codes for treatment management and ongoing monitoring services (99091, 99457 and 99458).
In contrast to RPM services, RTM services involve the use of medical devices to monitor a patient’s health or response to treatment using nonphysiological data. RTM can be used to monitor medication adherence, response to therapy, musculoskeletal activity and respiratory activity. This means that RTM can be used, for example, to monitor treatment specific to pain, functional status, and adherence and response to therapy. Effective January 1, 2022, the American Medical Association created five new codes for RTM services (98975, 98976, 98977, 98980 and 98981) as a separate category of remote patient monitoring services. Similar to RPM, these include three practice-expense-only codes (98975, 98976 and 98977) and two codes for treatment management (98980 and 98981).
Beginning in 2019, CMS established payment rates and provided guidance on certain requirements and appropriate utilization for remote monitoring services, specifically for RPM services. In response to the COVID-19 public health emergency, CMS also issued several waivers and flexibilities that expanded providers’ ability to furnish remote monitoring services to patients, including flexibilities regarding who can furnish the services, the types of technology that can be used and how many days of monitoring must be obtained in order to bill.
Not surprisingly, the availability of Medicare reimbursement for remote monitoring services has led to an explosion of interest in furnishing remote monitoring services, since Medicare is a major payor for healthcare items and services in the United States. Between 2019 and 2021, the utilization of the RPM codes reimbursed by Medicare for services furnished in a physician office setting grew by more than 1,500% for CPT codes 99454 and 99457. The remaining RPM codes similarly had a significant increase in utilization. Due to the exponential growth of these services, it is perhaps unsurprising that the MACs would, at a minimum, consider implementing policies that, if finalized, could restrict utilization of remote monitoring services to conditions and devices supported by clinical evidence.
MEDICARE COVERAGE POLICIES
In general, Medicare covers and provides payment only for healthcare items and services that are “reasonable and necessary” for the diagnosis or treatment of an illness or injury and within the scope of a Medicare benefit category. CMS makes national coverage determinations (NCDs) through an evidence-based process with opportunities for public participation. NCDs are coverage policies that apply nationwide to all Medicare beneficiaries and can grant, limit or exclude Medicare coverage for specific medical items or services. In the absence of a national coverage policy, MACs are permitted to publish LCDs. LCDs provide guidance to the public within a specified geographic area regarding whether a particular item or service is covered by Medicare for that geography or region and, if so, under what circumstances. LCDs may not conflict with NCDs, but an LCD may supplement an established NCD.
Representatives of all MACs except for National Government Services, Inc., (NGS) will host the CAC meeting on February 28, 2023. Collectively, the MACs participating in the CAC meeting represent the majority of the United States, with the exception of Illinois, Minnesota, Wisconsin, Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island and Vermont.
The purpose of the CAC meeting is to obtain advice from a select panel regarding the strength of published evidence on RPM and RTM for non-implantable devices and any compelling clinical data to assist in defining meaningful and measurable patient outcomes (e.g., decreases in emergency room visits and hospitalizations) for Medicare beneficiaries. Specific questions will be published approximately two weeks prior to this meeting. The public does not have an opportunity to participate in this meeting but will be able to register for the meeting and observe the discussion.
MACs are required to establish CACs to provide an opportunity for healthcare providers to be informed of evidence that will be used in developing an LCD and are intended to improve communications between MACs and the healthcare industry more broadly. CACs are advisory only, however, and the final decision on whether to publish a draft LCD remains with each MAC.
The forthcoming CAC meeting is just one step in a process that could lead to the development of an LCD. Should a MAC decide to develop an LCD following the CAC meeting, the proposed LCD will be published on the Medicare Coverage Database and on the MAC’s website. After the proposed LCD is made public, there will be open meetings concerning the proposed policy and an opportunity for the public to comment in writing before the LCD is finalized. The public must have at least 45 days to comment on the draft LCD. After a proposed LCD is published, final action must be taken on the LCD within 365 days of when the draft LCD is published. Proposed LCDs may be finalized as proposed, finalized with revisions or withdrawn. A final LCD must be published at least 45 days before the policy becomes effective.
In line with CMS’s gradual expansion of payment for remote monitoring services, CMS has established limited payment policies for RPM and RTM services, enabling providers to furnish and bill for remote monitoring services. To date, however, there have been no established coverage policies for remote monitoring services. At this point, CMS has not given any indication that an NCD for remote monitoring services is likely to be implemented.
Often, but not always, CAC meetings precede the issuance of a proposed coverage policy. Given the explosion of interest in remote monitoring services, it is very likely that the forthcoming CAC meeting presages the publication of a proposed LCD. The CAC meeting will also provide insight into how the MACs view the clinical evidence and utility of remote monitoring services.
Collectively, the MACs hosting the CAC meeting represent every Medicare contractor jurisdiction in the United States, with the exception of NGS. A restrictive coverage policy implemented by these MACs could impact a substantial majority of Medicare beneficiaries. However, the individual MACs participating in the CAC meeting remain free to implement separate LCDs, and it is not outside the realm of possibility that each of the MACs may approach coverage for RPM and RTM services differently.
Interest in remote monitoring services (both RTM and RPM) services has burgeoned over the past several years. Medicare has seen a significant increase in the utilization of remote monitoring services, and it is unsurprising that the MACs have initiated a process that may lead to an implementation of an LCD that might place controls on the utilization of these services. A multijurisdictional CAC meeting strongly suggests that the MACs have seen the astronomical growth in utilization for RPM and RTM services and are seriously considering implementing at least one LCD to control and manage such utilization.
As noted above, CAC meetings merely represent the beginning of the LCD development process. If MACs publish a draft LCD, stakeholders with an interest in Medicare coverage for remote monitoring services will have the opportunity to participate in open meetings and submit written comments summarizing clinical evidence supporting the utility and effectiveness of remote monitoring technologies in advance of any restrictive policy becoming effective. The CAC meeting is a valuable opportunity, however, to understand what evidence the MACs are currently considering and understand what input the invited healthcare professionals provide to the MACs in advance of the LCD development.
A proposed LCD could implement Medicare coverage limits on, for example, the types of devices and patient conditions for which remote monitoring services are considered reasonable and necessary. Similarly, an LCD could implement limits on the duration of monitoring that will be covered.
Any digital health company that is involved in furnishing devices, software or clinical support services that rely on the RPM or RTM codes should consider registering for the CAC meeting to gain insight into the feedback the MACs receive. Digital health companies also should begin gathering and compiling an evidentiary base on how the use of their technology impacts the patient and measurably improves patient care. This effort should include evidence on what specific medical devices and patients are supported by clinical data, and how the use of RPM or RTM services impacts patient management and improves patient outcomes (for example, lowers the likelihood of side effects post-surgery, reduces the incidence of chronic condition exacerbation, or reduces recurrent hospitalizations or office visits). Healthcare providers with evidence to support the clinical utility of RPM and RTM services should similarly focus on compiling such evidence. This evidence will be crucial for establishing that the use of particular devices for certain diagnoses provides clinical benefit to the patient.