AMARILLO, TX – On September 19, 2024, the United States Office of the Inspector General (OIG) issued a report regarding its recommended changes to remote patient monitoring of health data of Medicare beneficiaries (the “Report”). In summary, the report recommends enhanced and additional oversight of RPM claims submitted to Medicare for reimbursement.

Background
Since 2018, when Medicare first began covering remote patient monitoring (“RPM”), also referred to as remote physiologic monitoring, RPM claim submissions to Traditional Medicare and Medicare Advantage plans continue to grow in popularity as technology improves the ability for patients to independently collect their own health data and transmit it to their provider to allow the provider to better treat and manage the patient’s condition.

As OIG states in the Report, “there are three main components [of RPM] education and set up, device supply, and treatment management… Medicare pays for each of these components separately and pays the same rate regardless of the type of device used or health data collected.” Because Medicare coverage for RPM covers a wide range of types of psychologic data, medical devices, and chronic and acute conditions (including hypertension, which affects more than 60 percent of Medicare enrollees), OIG predicts that use of RPM, and therefore the number of RPM claims submitted to Traditional Medicare and Medicare Advantage plans, for reimbursement will continue to grow exponentially in the coming years.

To that end, OIG issued the Report, at least in part, to recommend that CMS implement certain safeguards, requirements, and detection/monitoring activities to best reduce or mitigate the risk of fraud, waste, and abuse in the RPM space.

Overview of Select OIG Concerns and Recommendations
As stated above, RPM has three main components that are essential to adequate monitoring and a provider’s remote management of a patient’s condition. However, the OIG found that “43 percent of enrollees who received [RPM] did not receive at least one of the [three] components.” Though Medicare pays for each component separately, and “although CMS does not require that providers bill for all three components, the high percentage of enrollees who did not receive all components raises questions about whether these services are being used as intended.” This suspicion is further compounded by CMS reports that companies “cold call” Medicare beneficiaries and make other unsolicited contact with Medicare beneficiaries to sign them up for RPM.

In addition to the concerns that companies are abusing RPM and submitting claims even in situations where remote monitoring is unnecessary for the patients’ conditions, or is not actually occurring, OIG is concerned that the billing guidelines for each component of RPM lack the specificity that would enable CMS to effectively detect instances of fraud, waste, or abuse. An example that OIG notes in its Report is that “Medicare requires that [RPM] be used to treat an acute or chronic condition. Yet, Medicare does not always have information about what condition is being monitored,” and that the “diagnosis” entry for thousands of RPM claims read “other specified counseling”, “other specified health status”, and “encounter for examination and observation for other specified reasons.” Due to these ambiguous diagnoses, OIG reports that “CMS does not have enough information to analyze whether the services were used appropriately and aligned with enrollees’ medical needs.”

Pursuant to these concerns, and others as described in the Report, OIG has provided five recommendations to CMS that OIG believes may reduce or mitigate the risk of fraud, waste, and abuse in the RPM space. CMS’s response to the Report (included as Appendix D to the Report) demonstrates that CMS concurs with, or will take into consideration, each OIG recommendation provided in the Report. Therefore, providers should be aware that changes to the Medicare billing requirements and regulations pertaining to RPM may be in the not-so-distant horizon.

Industry Backlash
Noting OIG’s recommended changes to the Medicare billing requirements and regulations, and CMS oversight over RPM, RPM providers and advocacy groups have already started pushing back on both the factual assertions and conclusions/recommendations provided by the Report. For example, on September 24, 2024, an advocacy group, Alliance for Connected Care (“ACC”), formally requested that OIG retract the Report, based on ACC’s assertion that several facts within the report were inaccurate, over generalized, out of RPM providers’ control, or biased. To date, OIG has not issued a response to this request, but a representative of the OIG has stated they are reviewing ACC’s request to determine if the Report should stand, be amended, or be retracted.

Conclusion
The healthcare regulatory landscape is ever changing; nonetheless, DME suppliers should remain up to date with OIG’s recommended changes to Medicare’s oversight of RPM reimbursement and have a plan in place to adjust their business activities and compliance programs according to these changes if, or when, such changes are enacted.

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or [email protected].

Kianna L. Sitarski, JD, is an attorney with the Health Care Group at Brown & Fortunato, PC, a law firm based in Texas with a national health care practice. She represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Sitarski can be reached at (972) 684-5788 or [email protected].

AAHOMECARE’S EDUCATIONAL WEBINAR

Billing Nonassigned:  Steps to Replace Lost Income

Presented by: Jeffrey S. Baird, Esq., Brown & Fortunato & Noel Neil, ACU-Serve

Tuesday, October 15, 2024

1:30-2:30 p.m. CENTRAL TIME

DME suppliers, like other health care providers, are being squeezed by traditional Medicare and Medicare Advantage (“MA”). In the traditional Medicare space, an example of this is the loss by DME suppliers of the 75/25 blended rates. To offset, at least in part, the decrease in reimbursement from traditional Medicare, DME suppliers should look seriously at billing traditional Medicare beneficiaries on a nonassigned basis. The movement to billing nonassigned is aided by the willingness of aging Baby Boomers to pay cash for “Cadillac” products, as opposed to being relegated to accepting “Cavalier” products when the DME supplier takes Medicare assignment. Billing nonassigned means that the Medicare beneficiary pays cash up front to the DME supplier and is directly reimbursed by Medicare. This program will discuss the multiple issues arising out of billing on a nonassigned basis, including the following: (i) What does it mean to bill non-assigned? (ii) If the supplier bills an item nonassigned, can the supplier set the price without limitation? (iii) Must the supplier submit a claim to Medicare so that the beneficiary can be reimbursed? (iv) Can the supplier sell a capped rental item for cash? (v) Does the supplier need to obtain documentation supporting medical necessity? (vi) Is the supplier at risk of having to repay Medicare and/or the beneficiary in the event of a subsequent audit?

Register for Billing Nonassigned:  Steps to Replace Lost Income on Tuesday, October 15, 2024, 1:30-2:30 p.m. CT, with Jeffrey S. Baird, Esq. and Noel Neil.

Members:  $99
Non-Members:  $129