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Remote Monitoring

Asthma affects >20 million adults in the United States as of 2021. Yearly it costs more than $50 billion. In 2021, asthma was the cause of about 1 million emergency room visits and 94,000 hospitalizations1. Asthma was the primary cause of death in >3500 children and adults in 20211. With the need to care for patients remotely, the COVID-19 epidemic lead to advances in virtual care, including remote monitoring The World Health Organization has defined the use of remote technology to provide health care and information mobile health (mHealth)2.

Asthma care lends itself to various novel remote technologies. They can be differentiated into 5 different categories including 1) Smart digital inhalers, 2) mobile spirometers, 3) digital peak expiratory flow and FEV1 monitors, 4) various Apps, 5) other mHealth devices.

Smart Digital Inhalers
Smart digital inhalers have the potential to improve both adherence and technique. They can either be attached to MDIs (metered dose inhalers) and/or DPIs (dry powder inhalers) or they are embedded in the actual inhaler system. All the current inhalers utilize Bluetooth technology to transmit information to a patient APP or to secure provider portals.  The attached digital inhalers have a battery life of approximately 1 year3.
1.    BreatheSuite System (BreathSuite)- Attachment with MDIs
2.    Capmedic (Cognita) - Attachment with MDIs
3.    Digihaler (Teva)- Embedded in Teva DPI devices
4.    Haile (Adherium)- Attachment with MDIs, DPIs (Diskus), Turbuhaler, Handihaler
5.    Propeller (Propeller Health)- Attachment with MDIs, DPIs (Diskus), Turbuhaler, Handihaler, Ellipta, and SMIs (Respimat)
6.    Respiro (Amiko)- Attachment with MDIs and DPIs (Diskus), Turbuhaler, Handihaler

Mobile Spirometry
Mobile spirometers need to be a medical device as defined by the FDA to be able to be billed. These also pair wirelessly utilizing Bluetooth technology and all current FDA approved devices have provider portals available. They all meet American Thoracic Society (ATS) and European Respiratory Society (ERS) standards. Notably not all portable spirometers meet low-flow measurements. For severe asthmatics, consider a product like GoSpiro4. Below are the commercially available FDA- approved mobile spirometers.
1.    AioCare (Vyaire Medical)
2.    GoSpiro (Monitored Therapeutics, Inc.)
3.    In2itive e-Diary (Vitalograph)
4.    NuvoAir (NuvoAir, Inc.)
5.    Safey Pocket Spirometer (Safey Medical Devices_
6.    Spirobank Smart (MIR)

Digital Peak Expiratory Flow and FEV1
Apps
There are> 500 asthma related apps available. Additionally, there are multiple apps for allergic rhinitis with various pollen forecast and air quality trackers.

Other mHealth devices
Digital oximeters and activity trackers would be included in this grouping.

Potential Benefits to mHealth
There needs to be ongoing studies to determine benefits. Potential benefits of any mHealth are reduced hospitalizations and/or length of stay if able to be remotely monitored, better outcomes in patients living in remote locations, better preventative care or better preemptive care based in increasing symptoms.

Potential limitations or Concerns to Consider
1.    Costly – requires access to high-speed internet, may not be covered with traditional insurance
2.    Technological proficiency- need to be relatively proficient to learn to use and upload data
3.    Increased liability- risk of data breaches with EHP system, increased data being uploaded regularly which need to be reviewed and potentially treated

Billing and Payment for mHealth
Remote physiological monitoring (RPM) and Remote therapeutic monitoring (RTM) codes require that the devices meet the FDA definition of a medical device. RPM is a set of codes for non-face-to-face monitoring and analysis of physiological factors.  RPM codes require the device to digitally record and upload physiological data.  RTM can be used to monitor adherence. RTM codes can be self- reported by patient.

Medicare requirements:
•    Must be an established patient with the provider
•    Consent to receive RPM at time of services

Guidelines for RMP services billed for CPT codes 99453 and 99454
•    Physiological data must be electronically and automatically uploaded to a secure portal for analysis and interpretation
•    Device must be FDA approved and meet the definition of a medical device
•    RPM data must be collected for minimum 16 out of 30 days (there were waivers during the Public Health Emergency)
•    RMP may be used to monitor an acute care or chronic disease condition
•    Services that are provided by auxiliary personnel under supervision of a practitioner (eligible to bill Medicare for E/M services)
                                                                                                                                                           
References
1.    Most recent National Asthma Data | CDC. (n.d.). Retrieved September 24, 2023, from https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm
2.    Tuberculosis: global task force on digital health. 2015. World Health Organization. Retrieved September 24, 2023. http://www.who.int/newsroom/q-a-detail/tuberculosis-global-task-force-on-digital-health
3.    Kouri, A., & Gupta, S. (2023). Mobile Health for Asthma. Chest Pulmonary, 1(1), 100002. https://doi.org/10.1016/j.chpulm.2023.100002
4.    Stenzler, Alex, and Martin Stegenga. "Understanding Why Not All FDA-Cleared Spirometers Should Be Used for COPD Patients." Respiratory Therapy 15.1 (2019): 2020.
5.    Mosnaim, G., Greiwe, J., Jariwala, S., Pleasants, R. A., & Merchant, R. (2022). Digital inhalers and remote patient monitoring for asthma. The Journal of Allergy and Clinical Immunology: In Practice, 10(10), 2525–2533. https://doi.org/10.1016/j.jaip.2022.06.026
6.    Maurer, L., Bansal, C., & Bansal, P. (2022). Methods to engage patients in the modern clinic. Annals of Allergy Asthma & Immunology, 128(2), 132–138. https://doi.org/10.1016/j.anai.2021.11.013
7.    Telehealth and remote patient monitoring. (2023, May 11). telehealth.hhs.gov. https://telehealth.hhs.gov/providers/preparing-patients-for-telehealth/telehealth-and-remote-patient-monitoring
8.    Himes, B. E., Leszinsky, L., Walsh, R. N., Hepner, H., & Wu, A. C. (2019). Mobile Health and Inhaler-Based monitoring devices for asthma management. The Journal of Allergy and Clinical Immunology: In Practice, 7(8), 2535–2543.
9.    Remote Patient Monitoring | ACP. (n.d.). https://www.acponline.org/practice-resources/business-resources/telehealth-guidance-and-resources/remote-patient-monitoring-billing-coding-and-regulations-information

These links are for research only. They are not endorsed by the American Academy of Allergy, Asthma & Immunology (AAAAI).

12/7/2023