How RPM Companies Can Leverage the New Remote Therapeutic Monitoring CPT Codes Expected in 2022
If you are in the digital health industry, particularly the remote patient monitoring (“RPM”) space, you have likely heard of the remote therapeutic monitoring (“RTM”) codes finalized in the 2022 Medicare Physician Fee Schedule Final Rule (the “Final Rule”). With these new codes set to go into effect January 1, 2022, RPM vendors already in the remote monitoring arena should start preparing now for how they can take advantage of this new reimbursement opportunity.
Strategies for expanding market share with Remote Therapeutic Monitoring codes
Below are just a few ways RPM companies might consider expanding into RTM.
Source new products and incorporate them into your existing model
If you already have relationships with trusted manufacturers of physiologic monitoring devices, consider that those manufacturers may be well positioned to help you source or manufacture new therapeutic monitoring devices as well to add as a new service line.
Partner with an existing vendor in the therapeutic space
There are vendors in the market already operating in the therapeutic monitoring space with medical devices that capture medication adherence (think pill dispensers), pain (think Software as a Medical Device or “SaMD” solutions), musculoskeletal conditions (think devices that measure range of motion), and respiratory conditions (think connected inhalers). RPM vendors might partner with one or more of these companies to expand their offering via joint marketing efforts or a reseller relationship for a faster go-to-market strategy.
Add a SaMD component that collects therapeutic measurements
If you intend to serve a unique patient base, perhaps it makes sense to develop your own software to measure the most valuable data and analyze it accordingly to generate pertinent output for providers. Although this may be an expensive and time-consuming endeavor, it likely also carries a great deal of differentiation to protect against competition.
If you are already in the therapeutic space and wondering how to maximize your business’s potential in light of the new codes, think about these options from your perspective – should you look to partner with an existing RPM vendor or add new physiologic devices (e.g. blood pressure monitors and pulse oximeters) as a new service line?
What to watch out for in the final 2022 Medicare Physician Fee Schedule
It’s no secret that the RTM codes open immense opportunities for patients, providers, and digital health companies alike. However, there are unique challenges that may arise if you want to successfully leverage the codes. Here’s what to pay attention to:
Billing Requirements
We know from the Final Rule that there is nuance with respect to how the new RTM codes function versus how the existing RPM codes are implemented. For example, the American Medical Association CPT Codebook (the “Codebook”) states that providers cannot bill both RPM and RTM codes for the same patient(s) within the same month. This is likely disappointing for providers and vendors who service patients with multiple or complex conditions that could benefit from both physiologic and therapeutic monitoring. Additionally, while the RPM codes allow for clinical staff to provide services under general supervision of the billing practitioner, the RTM codes require direct supervision, meaning the supervising practitioner and clinical staff providing services must be co-located in the same office suite while rendering services. Seemingly small details can have a big impact on your business model.
Medical Device Requirements
Like RPM, RTM will require a medical device to collect the data being monitored for the service to be billable. This means that the data collected from patients must be collected through a “medical device” as defined by the FDA. This does not necessarily mean the device has to go through the FDA “clearance” or “approval” pathway, but it will be subject to FDA regulations which may require registration or clearance. If you plan to outsource devices or partner with a third-party, be sure to ask them about this and make sure they are compliant to avoid liability later.
Fraud and Abuse Implications for Business Models
This is one of the biggest areas of risk and uncertainty that we deal with in the digital health space. As with most areas of the healthcare industry, understanding the regulatory framework is crucial to ensuring a compliant business model that does not create federal or state legal risks for you or your customer. While other industries might allow for commission payments to contracted salespeople, rewarding referrals and customers, or charging a percentage of your customer’s revenue in exchange for your services, these are all arrangements that may carry high levels of risk in the healthcare industry and can result in heavy fines and criminal penalties if not structured appropriately. This is particularly true in innovative spaces like RPM and RTM where there is less precedent and less clarity from a legal perspective. You’ll need to make sure your legal team has a good handle on both the legal and strategic implications of your intended business model to sufficiently mitigate risk.
Where to go from here
Now that you understand the differences between RPM and RTM and have thought about some strategies for expanding your market share, you may want to talk it through with a digital health attorney. Nixon Gwilt Law works with innovators like you every day, and our close monitoring of regulatory matters, industry trends, and reimbursement pathways means we can also add valuable nuance and insight to your decision-making process.
Are you ready to explore how these reimbursement changes can expand your market share? If so, click the blue button below to start the conversation with our digital health team.