BlueCross and BlueShield of Montana Medical Policy/Codes
Home Spirometry
Chapter: Durable Medical Equipment
Current Effective Date: November 26, 2013
Original Effective Date: November 26, 2013
Publish Date: August 26, 2013
Description

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.

Regulatory Status

In 2002, the IQTeQ Spirometer 2001 (IQTeQ Development) was cleared for marketing by the 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 FDA through the 510(k) process. The indications for use include use in the home.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Home monitoring of pulmonary function utilizing a spirometer is considered experimental, investigational and 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.

Rationale

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.

Otulana and colleagues 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 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 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 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.

In summary, the small number of published clinical data does not permit scientific conclusions regarding the clinical use of home monitoring of FEV-1 and FVC. Specifically, the data is inadequate to determine how reductions in FEV-1 and FVC relate to clinical symptoms, and how this information can be used to determine the necessity of transbronchial biopsies.

2013 Update

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 developed in 72 out of 226 (31.9%) patients. According to Kaplan-Meier event-free analysis, there was a significantly lower freedom from bronchiolitis obliterans syndrome 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.

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. (5) 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. (6) 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.

Summary

There are no new clinical trial publications or any additional information that would change the coverage position of this medical policy, which considers home spirometry to be experimental, investigational, and unproven.

Coding

Disclaimer for coding information on Medical Policies        

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

Experimental, investigational and unproven for all diagnoses.

ICD-10 Codes

Experimental, investigational and unproven for all diagnoses.

Procedural Codes: 94014, 94015, 94016, E0487
References
  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.
  2. Fracchia C, Callegari G, Volpato G et al. Monitoring of lung rejection with home spirometry. Transplant Proc 1995; 27(3):2000-1.
  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.
  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.
  5. 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.
  6. 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.
  7. Home Spirometry. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (March 2010) Medicine 2.01.33.
History
August 2013  New 2013 BCBSMT medical policy.  Home monitoring of pulmonary function utilizing a spirometer is considered experimental, investigational and unproven. 
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Home Spirometry