Daniel Tashnek, JD

Within the nearly 1,750 pages of the 2022 Medicare Physician Fee Schedule proposed rule were many significant policies that, if approved, could greatly affect practices. One particular subject that has largely flown under the radar concerns remote therapeutic monitoring (RTM). This emerging concept should be of interest to organizations with current or future plans to implement telehealth and/or remote patient monitoring (RPM) programs.

, issued July 13, greatly expanded what was known and understood about RTM but still left many questions unanswered. We hope and expect these questions will be answered in the coming months as RTM transitions from an undefined service to one that practices may want to offer patients.

To help you get up to speed on RTM, here are eight things to know.

Remote Therapeutic Monitoring’s Debut: What you should know (for now)

Feedback on the 2022 Medicare Physician Fee Schedule proposed rule must be submitted by 5:00 p.m. ET on Sept. 13, 2021.

, a healthcare software company that simplifies the provision of preventive medical services, chronic care management and remote patient management. Daniel is also a practicing healthcare attorney specializing in regulatory compliance, reimbursement, scope of practice, and patient care issues.

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The proposed rule, issued July 13, greatly expanded what was known and understood about RTM but still left many questions unanswered.

In news that has largely flown under the radar, the Office of Inspector General 

 that the Centers Medicare & Medicaid Services (CMS) will be conducting a series of audits of Medicare Part B telehealth services over two phases. Among the services named in these audits is remote patient monitoring (RPM).

For practices that have already established RPM programs or those that are thinking about launching a program, this news is significant. It will be some time before we find out what auditors are focusing on and discovering during these audits. However, there are a few areas where practices are more likely to get tripped up concerning compliance, particularly given the general confusion on the requirements in the industry. In addition, there are actions practices can take now to more clearly follow the spirit and letter of the regulations to increase their program compliance and avoid auditor scrutiny.

Before we get into those areas and actions, understand that while the announcement concerning RPM audits may have come as a surprise, it's not unexpected. RPM, like other telehealth services, has witnessed rapid and significant growth due to the COVID-19 pandemic, and Medicare reaffirmed its long-term commitment in providing coverage for RPM in the 2021 

. The push for normalization of RPM enforcement is an indicator that RPM is now firmly established as a viable and important care management service.

Practices with RPM programs that find themselves in hot water following an audit are likely to do so because of two reasons:

They are violating rules by choice to try to make more money. Hopefully, these will be outliers.

They misunderstand rules and requirements and/or partner with a vendor that cuts corners, either unintentionally or intentionally. While this is more likely to be the case, the billing provider is responsible for each RPM claim they file, and auditors are not known for accepting ignorance as an excuse and reason to not levy a penalty.

What are auditors likely to focus on during their audits? We expect at least these areas to receive close scrutiny:

The rules concerning the number of days in which RPM services are rendered is an area causing billing confusion and errors for many practices. The confusion generally stems from a 

 issued early in the pandemic that permitted providers to deliver and bill for RPM services to patients with suspected or confirmed cases of COVID-19.

The waiver stated that CMS would allow RPM services to be reported to Medicare for periods of time of fewer than 16 days, but no less than two days, during the pandemic. This has been referred to as the "2-day requirement." Where this requirement gets confusing is that CPT 99453 and 99454 require the use of a medical device that digitally collects and transmits 16 or more days of data every 30 days for the billing of these codes. This has been referred to as the "16-day requirement."

To make a long story short, Medicare publications after the first announcement of the 2-day waiver did not clearly associate the 2-day requirement with patients having suspected or confirmed cases of COVID-19. This led some RPM providers to interpret that the waiver requirement could apply to 

 patients during the public health emergency.

Such an interpretation is incorrect. Last month, CMS took the unusual step to publish a 

 that seems to put the question about the 2-day requirement to bed. If a practice with an RPM program is found by auditors to be applying the 2-day requirement to patients who do not have suspected or confirmed diagnosis of the coronavirus, this is likely to be problematic.

Definition of "interactive communication"

Another area of confusion with RPM concerns the technology that CMS would permit providers to use to perform "interactive communication" with patients, as referred to in CPT 99457 and 99458. CMS has defined interactive communication as a conversation occurring in real time that includes synchronous, two-way interactions that can be enhanced with video or other kinds of data. Some RPM providers and software vendors have interpreted that this definition meant text messaging could be used as an acceptable method for delivering billable interactive communication time.

As of the final 2021 rule, this is no longer the case. Time spent texting with patients can be counted towards RPM management time but does not satisfy the requirement for interactive communication. As such, at least some of the billable time for each RPM code must be audio communication with the patient or caregiver. The clarification presents a potential problem for some practices as text messaging is a communication option found in many RPM software platforms. If practices continue to use texting for RPM, they need to ensure that at least some of the service time is spent on a phone or video call for each billed RPM care management code (99457/99458) or the program will be found to be out of compliance with CMS rules.

A common misconception is that practices can permit their patients to self-report measurements into an app or patient portal or otherwise manually convey measurements to their physician. Although this may qualify for other services, data captured this way cannot be counted towards Medicare RPM. While practices should encourage their patients to be active participants in their care and cognizant of their RPM readings, RPM device measurements must automatically sync—usually via Bluetooth, Wi-Fi, or cellular data—with the RPM platform without any transcription by the patient.

We're not going to spend too long on this topic, but the key takeaway here: understand and properly follow RPM coding and billing rules. If you're outsourcing RPM coding and billing, make sure the vendor you partner with follows the rules. Violations of coding rules—especially those associated with generating higher payments than a practice deserves (e.g., upcoding)—can lead to significant problems.

Staying on the right side of the Medicare

While the Medicare RPM rules can be tricky, and are undergoing regular changes, the keys to maintaining compliance and avoiding an audit are fairly straightforward: ensure you understand and follow the most current rules and partner with vendors that do the same.

Compliance must be an integral component of a practice's RPM program. Although this is true for any service, it is particularly important with services such as RPM where multiple clinical staff may be furnishing different parts of the service throughout the month. If compliance is not built into the program workflow, a practice can easily find itself in legal jeopardy.

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Compliance must be an integral component of a practice's RPM program.

CMS to audit remote patient monitoring: What practices need to know

In December, the Centers for Medicare & Medicaid Services (CMS) released its 2021 Medicare physician fee schedule 

. Within the final rule were some significant changes concerning remote patient/physiological monitoring (RPM) and the provision of other remote services. Practices with existing RPM programs or those thinking about launching programs in 2021 should take the time to understand these changes and ensure that their programs comply with the new rules.

Here are 10 of the most significant takeaways from the final rule.

1. Revised definition of interactive communication

In the final rule, CMS declared that for CPT codes 99457 and 99458, an "interactive communication" is defined as a conversation occurring in real time that includes synchronous, two-way interactions that can be enhanced with video or other kinds of data.

In addition to the new definition, CMS originally stated that it expected all time spent towards 99457 and 99458 to be "interactive communication." This caused quite a commotion as it meant that activities such as text messaging, care planning and general care management would no longer be countable towards RPM billing codes.

 on January 19 where the agency clarified that the 20 minutes of time associated with 99457 and 99458 “should include care management services and synchronous, real-time interactions.” This clarified that interactive communication contributes to the total time, but is not the only activity that should be included in the total time. The document reaffirms that at least 

 of the time for each code needs to be "interactive communication," but it leaves the required proportions still up in the air for future rulings.

2. Clarification concerning device requirements

The final rule clarified uncertainties surrounding the types of devices supplied to patients as part of CPT 99454. Of note, CMS stated that such devices must meet the definition of a medical device per the 

 and electronically (i.e., automatically) collect and transmit a patient's physiologic data rather than permit patients to self-report or self-collect data.

The latter is important because it clarifies the separation between self-reported and automated RPM patient data. There have been a few new platforms in the RPM market that would have patients take pictures of their device readings or manually enter them into an app each day. This ruling makes clear that these and other mechanisms of self-recording data are no longer acceptable.

Despite significant industry pushback, CMS finalized that it will reimplement the requirement that an established patient-physician relationship exist for the furnishing of RPM following the end of the COVID-19 public health emergency.

4. Permitted consent obtainable at time of service

CMS has finalized the rule permitting providers to obtain patient consent to receive RPM services when services are initially furnished rather than in advance.

5. Approved furnishing of services by auxiliary personnel

CMS established permanent policy that allows auxiliary personnel to furnish CPT 99453 and 99454 services under a physician's supervision. CMS has previously 

 auxiliary personnel to mean "… any individual who is acting under the supervision of a physician, regardless of whether the individual is an employee, leased employee, or independent contractor of the physician, or of the legal entity that employs or contracts with the physician."

CMS clarified that only physicians and non-physician practitioners who are eligible to furnish evaluation and management services are permitted to bill RPM services using CPT 99453, 99454, 99091, 99457, and 99458. This aspect of the requirements was already well understood.

In the correction document, the agency clarified its position that only a single practitioner can bill 99453 and 99454 during a 30-day period. This clarification runs counter to the enforcement and prior general understanding of the RPM codes and may warrant questioning the patient if they are already receiving RPM services from another practitioner during enrollment. 

7. Expanding coverage to acute conditions

CMS had initially described RPM as services rendered to patients with chronic conditions. With the final rule, it clarified that practitioners may furnish RPM services to patients with acute conditions as well.

8. Reestablishing 16 measurement-days to bill

CMS confirmed that it will maintain the existing requirement that 16 days of data for each 30- day period must be collected and transmitted to bill CPT 99453 and 99454. The 16-day requirement was confirmed despite an industry push to lower the figure, with some hoping it would drop to as few as six days.

9. Clarification on the two measurement-day waiver for suspected/diagnosed COVID patients.

One major point of confusion was the current waiver on the 16 measurement-day rule for CPT 99454 that allows billing with only two measurement-days when the patient is suspected to have or has been diagnosed with COVID-19.

 issued by CMS concerning the final rule reiterated the current existence of this waiver and confirmed that it will expire once the public health emergency ends. However, the fact sheet and the final rule fail to mention that this requirement was established during the public health emergency and applies solely to patients who have a suspected or confirmed case of COVID-19

 These omissions caused considerable confusion in the industry, going so far as to prompt several large RPM companies to inform their customers that they can bill under the two measurement-day waiver for any patient regardless of COVID-19 status.

The correction document appears to clear up the confusion. It states...

"The medically necessary services associated with all the medical devices for a single patient can be billed … only when at least 16 days of data have been collected."

While this does not specifically reference the public health emergency/COVID-19 waiver, the agency's repeated emphasis on "16 days" clearly shows that it is the current default requirement. As such, the two measurement-day waiver only applies—as the waiver itself states—to patients who have a suspected or confirmed cases of COVID-19. 

10. Approved billing CPT 99091 concurrently with newer RPM codes

Up until the 2021 final rule was released, it was widely believed that it was not permissible to bill the old (i.e., original) provider-specific CPT 99091 used for RPM at the same time as 99457, which went into effect in 2019. But the final rule seems to essentially reverse this interpretation, with CMS now permitting providers to bill for "complex" RPM management when the provider must spend significant time managing the patient and their RPM care plan.

Further, CMS noted that 99091 can be billed each 30 days whenever such complex provider management occurs without affecting the practice's ability to bill clinical staff time via CPT 99457 each calendar month.

Significant developments further defining RPM

With remote patient monitoring still somewhat in its infancy, it's not surprising to see a final rule that brings so many substantial changes to the service, including some that further enhance the value of RPM. For example, CMS's decision to expand the services covered under the 20 minutes of service delivery associated with CPT 99457 and 99458 to include "non-interactive" service time is a considerable victory for patients and providers. Particularly encouraging about the changes in the latest final rule is that CMS appears to be fully embracing RPM. Thus, we anticipate that the agency will be willing to consider and enact changes that support and encourage patient engagement and the growth of RPM programs.

Going forward, as RPM further solidifies its value and role in the delivery of care, we can expect new rules and revisions to existing rules on the federal and possibly state levels. Providers will benefit most from well-tailored RPM programs designed within the current requirements that also have the means to be flexible as requirements inevitably shift.

Providers will benefit most from well-tailored RPM programs designed within the current requirements that also have the means to be flexible as requirements inevitably shift.

2021 Remote Patient Monitoring Changes: 10 key takeaways for practices

As the COVID-19 outbreak continues to spread, physicians are under immense pressure to maintain continuity in caring for their patients while promoting social distancing. In response to this, Medicare has urged providers to use telehealth for the provision of services to all beneficiaries. 

The main narrative from Medicare has been focused on providing telehealth E/M visits. Although there is a need for such visits, there are other non-face-to-face Medicare services that can protect patient health, provide an opportunity to educate patients on the current crisis, and increase practice revenue to help balance out the drastic shortfall in outpatient visits.

To help keep your practice (and patients) healthy during the crisis, consider providing the following five Medicare services.

, is relatively easy to provide via telehealth, and has been overlooked by many practices. Providers are allowed to reach out to patients to schedule and perform AWVs, making it a great opportunity to contact some of your most vulnerable patients to check up on their health and educate them on COVID-19 prevention and response. 

Since the AWV can be performed under Medicare's "direct supervision" standard, it can be 

 primarily by clinical staff, giving practices a solution for using staff who might otherwise be idle due to the reduced in-person patient volume. Further, many practices have been reporting difficulties collecting the copayments required for telehealth E/M visits, which are completely waived for the AWV. This can be a great incentive for patients not sold on the idea of telehealth to try the program.

During such a tumultuous time, patients may also want to discuss advance care planning (ACP) which can be billed as a separate service. ACP has its copay waived when provided with an AWV.

The current telehealth waiver also covers many 

. These services can largely be billed together during the same televisit and in conjunction with an AWV. When grouped together, they can make a single telehealth call go further for patients and practices. Many of the preventive services, particularly those involving behavioral and mental health, are critical as patients are needing to manage more of their health concerns at home.

Medicare has bolstered its reimbursement for "care management" services, such as RPM, over the past few years. These services are performed outside of an office visit, but are not considered telehealth services by Medicare and thus avoid telehealth restrictions.

RPM was expanded by Medicare in 2020 and is particularly well suited for the current crisis. Even the FDA has acknowledged the importance of RPM, having recently announced a 

 to allow device manufacturers expanded leeway to produce RPM devices to help meet demand.

Many practices have patients with chronic conditions who come into the office periodically for what amount to vital checkups. With the crisis, these patients have largely been told they must remain at home. RPM allows providers to electronically collect and monitor health data, such as blood pressure, glucose, or weight, from their patients. As of 2020, RPM can be furnished under Medicare's "general supervision" standard, meaning it can be conducted by auxiliary staff. The devices themselves can be mailed to a patient for use in the program once the patient has provided verbal consent to participate in the program.

CCM is Medicare's original care management service. Medicare has expanded CCM steadily for years, including major improvements in 2020. 

CCM reimburses practices for spending 20 or more minutes communicating with and managing patients with two or more chronic conditions. CCM is another general supervision service, so patient communication can be conducted by clinical staff.

Although enrolling a patient into CCM requires a 

 than the other services on this list, ongoing support for patients with chronic conditions is critical during this pandemic. Risk for major complications from COVID-19 are much more likely in older patients with chronic conditions. Two-thirds of Medicare patients have 

Finally, let's discuss a relatively new Medicare service that covers brief telephone or messaging communication with patients. The vast majority of Medicare telehealth services, even under the current waiver, require real-time video communication. Although the virtual check-in does not pay much, it has extremely low time requirements and can be furnished over the phone. This is especially helpful for less technologically adept patients.

The virtual check-in has a sister service called remote evaluation or "store and forward." This pays a provider to briefly evaluate an image or video sent by the patient.

Daniel Tashnek is the co-founder and vice president of Prevounce Health, a healthcare software company that simplifies the provision of preventive medical services, chronic care management, remote patient management, and diagnostic laboratory services. Daniel is also a practicing healthcare attorney specializing in regulatory compliance, reimbursement, scope of practice, and patient care issues.

Medicare has urged providers to use telehealth for the provision of services to all beneficiaries.