Medical Policies - DME
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Home monitoring of pulmonary function utilizing a spirometer is considered experimental, investigational and/or unproven.
NOTE: Home spirometry for monitoring pulmonary function should not be confused with incentive spirometry. Incentive spirometry is commonly utilized to mobilize secretions and increase lung volumes following thoracic surgery.
Home spirometry devices allow for the monitoring of pulmonary function in the home. Their primary proposed use is by lung transplant recipients to aid in the early diagnosis of infection and rejection. They can potentially also be used in other situations that require pulmonary function monitoring.
In the immediate post-operative period, lung transplant recipients must be carefully monitored for the development of either rejection episodes or infectious complications. Monitoring techniques include complete pulmonary function testing, serial chest x-rays, bronchioalveolar lavage, and transbronchial biopsy. Transbronchial biopsy is thought to be the only objective method of distinguishing between these 2 common complications. Transbronchial biopsy is typically performed on a routine schedule, with additional biopsies performed if the patient becomes symptomatic. Home spirometry is proposed as a technique to provide daily monitoring to promptly identify presymptomatic patients who may benefit from a diagnostic transbronchial biopsy.
Home spirometry uses battery-operated spirometers that permit regular daily measurement of pulmonary function in the home, typically forced expiratory volume in 1 second (FEV-1) and forced vital capacity (FVC). The device has been primarily investigated among lung transplant recipients as a technique to provide early diagnosis of infection and rejection. Home spirometry may also be referred to as ambulatory spirometry.
In 2002, the IQTeQ Spirometer 2001 (IQTeQ Development) was cleared for marketing by the United States Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use in pulmonary function evaluation in various settings including homes with a physician’s prescription.
In 2003 the SpiroPro SpO2 (VIASYS Healthcare) was cleared for marketing by the U.S. FDA through the 510(k) process. The indications for use include use in the home.
Immediately postoperatively, lung transplant recipients must be carefully monitored for the development of either rejection episodes or infectious complications. Techniques include complete pulmonary function testing, serial chest x-rays, bronchioalveolar lavage, and transbronchial biopsy. Transbronchial biopsy is thought to be the only objective method of distinguishing between these two common complications. Transbronchial biopsy is typically performed on a routine schedule, with additional biopsies performed if the patient becomes symptomatic. Home spirometry has been investigated as a technique to provide daily monitoring to promptly identify presymptomatic patients who may benefit from a diagnostic transbronchial biopsy. However, published data are minimal.
Use of Home Spirometry in Lung Transplant Recipients
Otulana and colleagues (1) reported on the use of home spirometry in an initial case series of 15 heart-lung transplant recipients. The authors hypothesized that the results of routine spirometry might better guide the use of transbronchial biopsy. The authors reported that episodes of rejection or infection were associated with a 10% decrease in forced expiratory volume in 1 second (FEV-1) and recommended that this decrease should prompt a transbronchial biopsy. However, all patients also had symptoms at the same time, so it is unclear how the spirometry contributed to the decision to perform a transbronchial biopsy. On nine occasions, the FEV-1 was unchanged at the time of a routine scheduled transbronchial biopsy. Histologic results were normal in these patients.
Fracchia and colleagues (2) reported on a case series of nine heart-lung transplant recipients who underwent monitoring of lung rejection with home spirometry. Similar to the study of Otulana, patients underwent a “symptom” transbronchial biopsy if their FEV-1 or forced vital capacity (FVC) showed a decrease of 10%. Only three patients underwent a symptom biopsy, which revealed moderate rejection. It was not reported whether the patient was clinically symptomatic at that time. In addition, during routinely scheduled transbronchial biopsies, acute rejections were observed even in the face of normal FEV-1 values.
A retrospective cost analysis published in 2007 evaluated home monitoring in 138 lung transplant recipients who were monitored for at least 1 year. (3) The analysis found that adherence to a program of home monitoring that included home spirometry was associated with lower overall costs (higher outpatient, lower inpatient). However, there was no comparison group of patients with lung transplant who did not have home monitoring and there are likely patient factors that impact adherence and preclude attributing the cost savings to the program.
A 2009 study conducted in Germany reported on results of a prospective study comparing outcomes 7 years post-transplant in lung transplant recipients who did and did not adhere to a 2-year program of home spirometry, beginning 6 months after the transplant. (4) A total of 271 patients met eligibility criteria and were invited to participate; of these, complete home spirometry data over 2 years was available for 226 (83%) participants. Follow-up data at 7 years was available for 183 of the 226 patients (81%) who completed home spirometry measurements; excluded were 36 patients who died and 7 who were lost to follow-up. Patients were placed in the following 3 categories according to their use of home spirometry: good adherers (performed at least 80% of expected home spirometry), moderate adherers (performed between 50% and 79% of expected home spirometry) or non-adherers (performed less than 50% of expected home spirometry). Adherence was rated separately for each of four 6-month periods (months 6-12, months 13-18, months 19-24 and months 25-30). Adherence was highest during the first 6-month period; over 80% of participants were considered good adherers. The proportion of good adherers decreased to about 70% in the second period, and then to about 55% during both the third and fourth periods. Over the 7 years of follow-up, bronchiolitis obliterans syndrome (BOS) developed in 72 out of 226 (31.9%) patients. According to Kaplan-Meier event-free analysis, there was a significantly lower freedom from time in non-adherers compared with good or moderate adherers (p<0.014). However, the re-transplantation rate and mortality rate were not significantly associated with home spirometry adherence; 5% of patients received a second transplant and the mortality rate was 20%. While this study reported the association between spirometry and health outcomes, it was not randomized, and although the authors attempted to control for risk factors, there may be differences between groups that affected adherence and impacted disease status.
In 2013, Finkelstein et al. (5) studied the relative performance of a computer-based Bayesian algorithm compared with a manual nurse decision process for triaging clinical intervention in lung transplant recipients participating in a home monitoring program. The randomized controlled study had 65 lung transplant recipients assigned to either the Bayesian probability or nurse triage study arm. Subjects monitored and transmitted spirometry and respiratory symptoms daily to the data center using an electronic spirometer/diary device. Subjects completed the Short Form-36 survey at baseline and after 1 year. End points were change from baseline after 1 year in FEV-1 and QOL (SF-36 scales) within and between each study arm. There were no statistically significant differences between groups in FEV-1 or SF-36 scales at baseline or after 1 year. Results were comparable between nurse and Bayesian system for detecting changes in spirometry and symptoms, providing support for using computer-based triage support systems as remote monitoring triage programs become more widely available. The study concluded that the feasibility of monitoring critical patient data with a computer-based decision system is especially important given the likely economic constraints on the growth in the nurse workforce capable of providing these early detection triage services.
In 2014, Fadaizadeh et al. (6) conducted a pilot study to evaluate the role of home spirometry in the follow-up of lung transplant recipients and early detection of complications in these patients. PC-based portable spirometry set was used to evaluate the well-being of two lung transplant recipients on a regular daily basis for a 6-month period. Patient satisfaction and compliance, and device sensitivity in detecting complications were evaluated. Results of follow-up were compared with 2 matched control patients. Patient adherence to home spirometry was 80% in one and 61% in the other patient and both patients were satisfied with the method, although this satisfaction declined towards the end of the study period. The main reason for low adherence was insufficient internet access. This method succeeded in early detection of infectious complications. The study concluded that home spirometry seems to be a reliable method for follow-up of lung transplant recipients, but further studies in a larger group of patients is recommended.
In 2013, Wang et al. (7) studied the use of automatic event detection in lung transplant recipients based on home monitoring of spirometry and symptoms. The goal of this study was to develop, implement, and test an automated decision system to provide early detection of clinically important bronchopulmonary events in a population of lung transplant recipients following a home monitoring protocol. Spirometry and other clinical data were collected daily at home by lung transplant recipients and transmitted weekly to the study data center. Decision rules were developed using wavelet analysis of declines in spirometry and increases in respiratory symptoms from a learning set of patient home data and validated with an independent patient set. Results: Using FEV-1 or symptoms, the detection captured the majority of events (sensitivity, 80–90%) at an acceptable level of false alarms. On average, detections occurred 6.6–10.8 days earlier than the known event records. The authors determined that spirometry is useful for early discovery of pulmonary events and has the potential to decrease the time required for humans to review large amount of home monitoring data to discover relatively infrequent but clinically important events.
In 2014, de Wall et al. (8) researched home spirometry as an early detector of azithromycin refractory BOS in lung transplant recipients which evaluated the utility of home spirometry (HS) versus office spirometry (OS) in assessing treatment response to azithromycin in BOS. Two hundred thirty-nine (n=239) lung transplant recipients were retrospectively studied. Change in TEV1 (ΔFEV-1 ± 10 %) from FEV-1 at azithromycin initiation for greater than or equal to 7 consecutive days in HS or greater than or equal to 2 measures in OS were taken as cut-off for response or progression. Based upon HS, 161/239 (67 %) patients were progressive despite macrolide, 19 of who exhibited transient improvement in FEV-1 (11 %). Time to progression was 29 (13 to 96) days earlier with HS than in OS. A total of 46 (19 %) recipients responded in HS after median 81 (22 to 343) days, while 22 % remained stable. Concordance in azithromycin treatment response between OS and HS was observed in 210 of 239 patients (88 %). Response or stabilization conferred significant improvement in survival (p = 0.005). Transient azithromycin responders demonstrated improved survival when compared to azithromycin refractory patients (p = 0.034). HS identified azithromycin refractory patients significantly earlier than OS, possibly facilitating aggressive treatment escalation that may improve long-term outcome. The investigators recommended that treatment response to azithromycin be assessed 4 weeks after initiation. Responders demonstrated best survival, with even transient response conferring benefit. Macrolide-refractory BOS carried the worst prognosis
In 2016, UpToDate (9) evaluated the treatment of acute lung transplant rejection. The summary included the following recommendations for the evaluation and diagnosis of acute cellular rejection:
• Spirometry has been reported to have a sensitivity of 60 percent in detecting rejection (grade ≥A2) or infection among bilateral lung transplant recipients. A decline of 10 percent in spirometric values that persists for more than two days has been reported to indicate either rejection or infection. In single lung transplant recipients, spirometry is less helpful as changes may reflect progression of the underlying disease in the native lung.
• Performance of patient-administered home spirometry several times a week may lead to earlier detection of BOS, but the effect on long-term outcomes is less clear. The potential benefit of frequent spirometry remains an area of active research.
Use of Home Spirometry Excluding Lung Transplant Recipients
Several studies have addressed home spirometry for patients other than lung transplant recipients. A 2007 publication reported results on using home spirometry to detect pulmonary complications in recipients of allogeneic stem cell transplants. (10) While the authors concluded it was a useful procedure, further investigation is needed to determine potential impact on outcomes.
Another study included 50 asthmatic children aged 6 to 17 years. (11) This was a sequence randomized study measuring peak expiratory flow and FEV-1 using both a hospital-based pneumotachograph and a home spirometer (Koko Peak Pro). The study found both clinically and statistically significant differences between measures obtained using the two techniques in a controlled (professionally supervised) clinical setting. The results from each meter were reproducible but not interchangeable. The mean values for both measures were significantly lower when using the home spirometer compared to the hospital spirometer. This study also had the limitation that it did not report on the impact of home spirometry on outcomes.
In 2012, Deschildre et al. (12) (focused a study on pediatric patients with severe asthma that develop frequent exacerbations despite intensive treatment. The study aimed to assess the outcome (severe exacerbations and healthcare use, lung function, quality of life and maintenance treatment) of a strategy based on daily home spirometry with teletransmission to an expert medical center and whether it differs from that of a conventional strategy. Fifty children with severe uncontrolled asthma were enrolled in a 12-month prospective study and were randomized into two groups: treatment managed with daily home spirometry and medical feedback (HM) and conventional treatment. The children's mean age was 10.9 years (95% confidence interval 10.2-11.6). Forty-four children completed the study (21 in the HM group and 23 in the conventional treatment group). The median number of severe exacerbations per patient was 2.0 (interquartile range 1.0-4.0) in the HM group and 3.0 (1.0-4.0) in the CT group (p=0.38 with adjustment for age). There were no significant differences between the two groups for unscheduled visits (HM 5.0 (3.0-7.0), Conventional treatment 3.0 (2.0-7.0); p=0.30), lung function (pre-β(2)-agonist FEV-1, p=0.13), Pediatric Asthma Quality of Life Questionnaire scores (p=0.61) and median daily dose of inhaled corticosteroids (p=0.86). A treatment strategy based on daily FEV-1 monitoring with medical feedback did not reduce severe asthma exacerbations.
Chronic Obstructive Pulmonary Disease(COPD)
In 2013, Jódar-Sánchez et al. (13) conducted a pilot study of the effectiveness of home telehealth for patients with advanced COPD treated with long-term oxygen therapy. Patients were randomized into a telehealth group (n = 24) and a control group (n = 21) who received usual care. Patients in the telehealth group measured their vital signs on weekdays and performed spirometry on two days per week. The data was transmitted automatically to a clinical call center. After 4 months of monitoring the mean number of accident and emergency department visits in the telehealth group was slightly lower than in the control group (0.29 versus 0.43, P = 0.25). The mean number of hospital admissions was 0.38 in the telehealth group and 0.14 in the control group (P = 0.47). During the study a total of 40 alerts were detected. The clinical triage process detected 8 clinical exacerbations which were escalated for a specialist consultation. There were clinically important differences in health-related quality of life in both groups. The mean score on the St. George's Respiratory Questionnaire (SGRQ) was 10.9 versus 4.5 in the control group (P = 0.53). The EuroQol-5D score improved by 0.036 in the telehealth group and by 0.003 in the control group (P = 0.68). The study found no statistically significant differences in the number of emergency room visits orhospital admissions in persons with COPD who weremanaged with home spirometry.
Idiopathic Pulmonary Fibrosis
In 2016, Russell et al. (14) stated that recent clinical trial successes have created an urgent need for earlier and more sensitive endpoints of disease progression in idiopathic pulmonary fibrosis (IPF). Domiciliary spirometry permits more frequent measurement of FVC than does hospital-based assessment and therefore affords the opportunity for a more granular insight into changes in IPF progression. These researchers determined the feasibility and reliability of measuring daily FVC in individuals with IPF. Subjects with IPF were given hand-held spirometers (Carefusion, UK) and provided with instruction on how to self-administer spirometry. Subjects recorded daily FEV-1 and FVC for up to 490 days. Clinical assessment and hospital based spirometry was undertaken at 6 and 12 months and outcome data was collected to 3 years. Daily spirometry was recorded by 50 subjects for a median period of 279 days (range of 13 to 490). There were 18 deaths during the active study period. Home spirometry showed excellent correlation with hospital obtained readings. The rate of decline in FVC was highly predictive of outcome and subsequent mortality when measured at 3-months (hazard ratio [HR] 1.040, CI: 1.021 to 1.062, p = <0.001), 6-months (HR 1.024, CI: 1.014 to 1.033, p < 0.001) and 12-months (HR 1.012, CI: 1.007 to 1.016, p = 0.001). The authors concluded that measurement of daily home spirometry in patients with IPF is highly clinically informative and, for the majority, is feasible to perform. The relationship between mortality and rate of change of FVC at 3 months suggested that daily FVC may be of value as a primary end-point in short, proof-of-concept IPF studies.
In 2016, UpToDate (15) published a review on “Clinical manifestations and diagnosis of idiopathic pulmonary fibrosis” which states that “Complete pulmonary function testing (PFT; spirometry, lung volumes, diffusing capacity for carbon monoxide and resting and ambulatory pulse oximetry are obtained in virtually all patients with suspected interstitial lung disease. These tests are helpful in establishing the pattern of lung involvement (e.g., restrictive, obstructive, or mixed) and assessing the severity of impairment. In patients with interstitial pulmonary fibrosis, PFTs typically demonstrate a restrictive pattern (e.g., reduced FVC, but normal ratio of FEV-1), a reduced diffusing capacity for carbon monoxide, and, as the disease progresses, a decrease in the six-minute walk distance”. The review does not mention ambulatory/home spirometry as a management tool.
Society Guidelines and Position Statements
The Guidelines for the Diagnosis and Management of Asthma (2007) and The International Society for Heart Lung Transplantation (2016) do not mention the use of home spirometry as a treatment modality. (16, 17)
There is inadequate evidence that home spirometry will improve the patient outcomes oflung transplant recipients, asthmatics, chronic obstructive pulmonary disease (COPD) patients and and those with other pulmonary disorders. The small number of published clinical data does not permit scientific conclusions regarding the clinical use of home monitoring of forced expiratory volume (FEV-1) and forced vital capacity (FVC). Specifically, the data is inadequate to determine how reductions in FEV-1 and FVC relate to clinical symptoms therefore, home spirometry is considered experimental, investigational, and/or unproven.
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94014, 94015, 94016
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1. Otulana BA, Higenbottam T, Ferrari L et al. The use of home spirometry in detecting acute lung rejection and infection following heart-lung transplantation. Chest 1990; 97(2):353-7. PMID 2298060
2. Fracchia C, Callegari G, Volpato G et al. Monitoring of lung rejection with home spirometry. Transplant Proc 1995; 27(3):2000-1. PMID 7792865
3. Adam TJ, Finkelstein SM, Parente ST et al. Cost analysis of home monitoring in lung transplant recipients. Int J Technol Assess Health Care 2007; 23(2):216-22. PMID 17493307
4. Kugler C, Fuehner T, Dierich M et al. Effect of adherence to home spirometry on bronchiolitis obliterans and graft survival after lung transplantation. Transplantation 2009; 88(1):129-34. PMID 19584692
5. Finkelstein SM et al. A randomized controlled trial comparing health and quality of life of lung transplant recipients following nurse and computer-based triage utilizing home spirometry monitoring. Telemed J E Health. 2013 Dec; 19(12):897-903. PMID: 24083367
6. Fadaizadeh L et al. Using Home Spirometry for Follow up of Lung Transplant Recipients: "A Pilot Study". Tanaffos 2013; 12(1):64-69.
7. Wang W et al. Automatic event detection in lung transplant recipients based on home monitoring of spirometry and symptoms. Telemed J E Health. 2013; 19(9):658-663.
8. de Wall C et al. Home spirometry as early detector of azithromycin refractory bronchiolitis obliterans syndrome in lung transplant recipients. Respir Med. 2014; 108(2):405-412.
9. Pilewski J. Evaluation and treatment of acute lung transplant rejection. In: UpToDate Post TW (Ed), UpToDate, Waltham, MA. Topic last updated: 2016. Available at <http://www.uptodate.com> (accessed September 28, 2016).
10. Guihot A, Becquemin MH, Couderc LJ et al. Telemetric monitoring of pulmonary function after allogeneic hematopoietic stem cell transplantation. Transplantation 2007; 83(5):554-60.
11. Brouwer AF, Roorda RJ, Brand PL. Comparison between peak expiratory flow and FEV(1) measurements on a home spirometer and on a pneumotachograph in children with asthma. Pediatr Pulmonol 2007; 42(9):813-8. PMID 17639585
12. Deschildre et al. Home telemonitoring (forced expiratory volume in 1s) in children with severe asthma does not reduce exacerbations. Eur Respir J. 2012 Feb; 39(2):290-6. PMID 21852334.
13. Jodar-Sanchez F et al. Implementation of a telehealth programme for patients with severe chronic obstructive pulmonary disease treated with long-term oxygen therapy. J Telemed Telecare 2013; 19(1):11-17. PMID 23393057
14. Russell AM et al. Daily home spirometry: An effective tool for detecting progression in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2016 Apr 18. [Epub ahead of print]. PMID: 27089018.
15. King TE, Jr. Clinical manifestations and diagnosis of idiopathic pulmonary fibrosis. In: UpToDate Post TW (Ed), UpToDate, Waltham, MA. Topic last updated August 22, 2016. Available at <http://www.uptodate.com> (accessed September 30, 2016).
16. National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma 2007; Available at <www.ncbi.nlm.nih.gov> (accessed September 30, 2016).
17. International Society for Heart Lung Transplantation. The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: A 10-year update. J Heart Lung Transplant 2016; Available at < http://www.jhltonline.org> (accessed September 27, 2016).
18. Home Spirometry (Archived). Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (March 2010) Medicine 2.01.33.
|10/15/2017||Reviewed. No changes.|
|11/15/2016||Document updated with literature review. Coverage unchanged.|
|11/15/2015||Document updated with literature review. Coverage unchanged.|
|10/15/2014||Reviewed. No changes.|
|10/1/2013||Document updated with literature review. The following change was made to coverage: Addition of note on incentive spirometry. CPT/HCPCS code(s) updated.|
|4/15/2008||Policy reviewed .|
|11/15/2006||Revised/updated entire document|
|2/1/2002||Revised/updated entire document|
|11/1/2000||Revised/updated entire document|
|1/1/2000||New medical document|
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