Home spirometry devices allow for the monitoring of pulmonary function in the home. Battery-operated spirometers permit regular daily measurement of pulmonary function, typically forced expiratory volume in 1 second (FEV-1) and forced vital capacity (FVC). Home spirometry may also be referred to as ambulatory spirometry.
The primary proposed use is to aid in the early diagnosis of infection and rejection in lung transplant recipients. These devices have also been suggested for use in monitoring pulmonary function in chronic obstructive pulmonary disease (COPD), Cystic Fibrosis and asthma.
Home monitoring of pulmonary function is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
There remains a lack of high-quality evidence to determine if home monitoring of pulmonary function results in improved health outcomes.
American College of Physicians. (2011). Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Retrieved June 2, 2016 from http://annals.org.
De Wall, C., Sabine, D., Gregor, W., Mark, G., Axel, H., Thomas, F., et al. (2014). Home spirometry as early detector of azithromycin refractory bronchiolitis obliterans syndrome in lung transplant recipients. Respiratory Medicine, 108, 405-412. (Level 4 evidence)
Fadaizadeh, L., Najafizadeh, K., Shajareh, E., Shafaghi, S., Hosseini, M., & Heydari, G. (2016). Home spirometry: assessment of patient compliance and satisfaction and its impact on early diagnosis of pulmonary symptoms in post-lung transplantation patients. Journal of Telemedicine and Telecare, 22 (2) 127-131. Abstract retrieved June 2, 2016 from PubMed database.
Finkelstein, S., Lindgren, B., Robiner, W., Lindquist, R., Hertz, M., Carlin, B., et al. (2013). A randomized controlled trial comparing health and quality of life of lung transplant recipients following nurse and computer-based triage utilizing home spirometry monitoring. Telemedicine and e-Health, 19 (12), 897-903. (Level 2 evidence)
International Society for Heart & Lung Transplantation, American Thoracic Society, European Respiratory Society. (2014). Clinical practice guideline: diagnosis and management of bronchiolitis obliterans syndrome. Retrieved June 2, 2016 from http://erj.ersjournals.com.
Lechtzin, N., West, N., Allgood, S., Wilhelm, E., Khan, U., Mayer-Hamblett, N., et al. (2013). Rationale and design of a randomized trial of home electronic symptom and lung function monitoring to detect cystic fibrosis pulmonary exacerbations: the early intervention in cystic fibrosis exacerbation (eICE) trial. Contemporary Clinical Trials, 36 (2), 460-469. Abstract retrieved June 2, 2016 from PubMed database.
Murgia, F., Bianciardi, F., Solvoll, T., Tagliente, I., Bella, F., Carestia, A., & Bella, S., (2015). Telemedicine home program in patients with cystic fibrosis: results after 10 years. La Clinica Terapeutica, 166 (69), e384-e388. Abstract retrieved June 2, 2016 from PubMed database.
Palmetto Government Benefits Administrators. (2018, February). (LCD) for non-covered services other than CPT category III noncovered services (L36954). Retrieved March 1, 2018 from https://www.cms.gov.
Robson, K. & West, A. (2014). Improving survival outcomes in lung transplant recipients through early detection of bronchiolitis obliterans: daily home spirometry versus standard pulmonary function testing. Canadian Journal of Respiratory Therapy, 50 (1), 17-22. (Level 1 evidence)
Russell, A., Adamali, H., Molyneaux, P., Lukey, P., Marshall, R., Renzoni, E., et al. (2016). Daily home spirometry: an effective tool for detecting progression in idiopathic pulmonary fibrosis. American Journal of Respiratory Critical Care Medicine, 2016 Apr 18 [Epub ahead of print]. Abstract retrieved June 2, 2016 from PubMed database.
Shakkottai, A., Kaciroti, N., Kasmikha, L., & Nasr, S.Z. (2018). Impact of home spirometry on medication adherence among adolescents with cystic fibrosis. Pediatric Pulmonology, doi:10.1002/ppul.23950. [Epub ahead of print] Abstract retrieved March 2, 2018 from PubMed database.
U. S. Food and Drug Administration. (2011, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K031643.(SpiroPD®) Retrieved June 2, 2016 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2012, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K120635 (EasyOne®). Retrieved November 4, 2013 from http://www.accessdata.fda.gov.
Wang, W., Finkelstein, S., Hertz, M. (2013). Automatic event detection in lung transplant recipients based on home monitoring of spirometry and symptoms. Telemedicine and e-Health, 9 (9), 658-663. (Level 3 evidence)
ORIGINAL EFFECTIVE DATE: 12/13/2008
MOST RECENT REVIEW DATE: 2/14/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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