Subject:
Home Spirometry
Description:
_______________________________________________________________________________________
IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
__________________________________________________________________________________________________________________________
Battery operated spirometers 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.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Home monitoring of pulmonary function is considered investigational.
Medicare Coverage:
There is no National Coverage Determination (NCD) for Home Spirometry. In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has determined that patient-initiated spirometric recording services (CPT codes 94014, 94015 and 94016) are covered when LCD L35360 criteria and Article A57320 criteria is met. For additional information, please refer to Local Coverage Determination (LCD): Pulmonary Function Testing (L35360) and Local Coverage Article: Billing and Coding: Pulmonary Function Testing (A57320). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE-SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[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. (Otulana et al, 1990) 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 9 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 9 heart-lung transplant recipients who underwent monitoring of lung rejection with home spirometry. (Fracchia et, 1995) Similar to the study of Otulana, patients underwent a "symptom" transbronchial biopsy if their FEV-1 or FVC showed a decrease of 10%. Only 3 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 paucity of published clinical data does not permit scientific conclusions regarding the clinical use of home monitoring of FEV-1 and FVC. Specifically, there are inadequate data 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.
A review of the peer-reviewed literature (2003-2005) focused on studies demonstrating a relationship, if any, of earlier detection of infection or lung transplant rejection with home spirometry. No such articles were found. Home spirometry use is also being explored for use by children with asthma or cystic fibrosis to measure changes in lung function longitudinally. However, there were no publications on clinical trials for home spirometry use in children nor evidence that home spirometry provides any greater health advantage over peak flow meters.]
The literature published from 2006 through February 2007 was reviewed. The articles identified did not lead to any changes in the policy statement. A publication reported results on using this approach to detect pulmonary complications in recipients of allogeneic stem cell transplants. (Guihot et al, 2007) While the authors concluded it was a useful procedure, further investigation is needed to determine potential impact on outcomes.
A literature search using PubMed was conducted through May 2020. None of the articles identified led to a change in the current policy statement.
________________________________________________________________________________________
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
___________________________________________________________________________________________________________________________
Index:
Home Spirometry
Ambulatory Spirometry
Spirometry, Home or Ambulatory
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. Finkerstein SM, Scudiero A et al. Decision support for triage of lung transplant recipients on the basis of home-monitoring spirometry and symptom reporting. Heart Lung. 2005 May-Jun;34(3):201-8.
4. Thompson R, Delfino RJ, Tjoa T, et al. Evaluation of daily home spirometry for school children with asthma: new insights. Pediatr Pulmonol 2006 Sep;41(9):819-28.
5. Brouwer AF, Roorda RJ, Brand PL. Home spirometry and asthma severity in children. Eur Respir J 2006 Dec;28(6):1131-7.
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 Sep;42(9):813-8.
7. 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.
8. Adam TJ, Finkelstein SM, Parente ST et al. Cost analysis of home monitoring in lung transplant rejection. Int J Technol Assess Health Care.2007;23(2):216-22.
9. 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.
10. Sengpiel J, Fuehner T, Kugler C, et al. Use of telehealth technology for home spirometry after lung transplantation: a randomized controlled trial. Prog Transplant. 2010 Dec;20(4):310-7.
11. Puri V, Zoole JB, Musick J, et al. Handheld office-based spirometry versus laboratory spirometry in low-risk patients undergoing lung resection. Innovations (Phila). 2011 Jul;6(4):257-61.
12. Timmins SC, Diba C, Thamrin C, et al. The feasibility of home monitoring of impedance with the forced oscillation technique in chronic obstructive pulmonary disease subjects. Physiol Meas. 2013 Jan;34(1):67-81.
13. Finkelstein SM, Lindgren BR, Robiner W, 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(2):897-903.
14. Robson KS, West AJ. Improving survival outcomes in lung transplant recipients through early detection of bronchiolitis obliterans: Daily home spirometry versus standard pulmonary function testing. Can J Respir Ther 2014 Spring;50(1):17-22.
15. UpToDate. Evaluation and treatment of acute lung transplant rejection. Literature review current through May 2016. Topic last updated June 8, 2016.
16. Pilewski J. Evaluation and treatment of acute lung transplant rejection. In: UpToDate, Trulock EP, Hollingsworth H (Eds), UpToDate, Waltham, MA. (Accessed on June 12, 2017.)
17. Pilewski J. Evaluation and treatment of acute lung transplant rejection. In: UpToDate, Hollingsworth H (Eds), UpToDate, Waltham, MA. (Accessed on April 30, 2018.)
18. Pilewski J. Evaluation and treatment of acute lung transplant rejection. In: UpToDate, Trulock EP, Hollingsworth H (Eds), UpToDate, Waltham, MA. (Accessed on May 3, 2019.)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
_________________________________________________________________________________________
Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
____________________________________________________________________________________________________________________________ |