Download Exhaled Nitric Oxide Measurement

JOHNS HOPKINS HEALTHCARE
Medical Policy: Exhaled Nitric Oxide
Measurement for Respiratory Disorders
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number: CMS05.05
Effective Date: 03/03/2008
Review Date: 09/05/2014
Page 1 of 5
ACTION:
New Policy
Revising Policy Number: CMS05.05
Superseding Policy Number
Archiving Policy Number
Retiring Policy Number
Johns Hopkins HealthCare provides a full spectrum of health care products and services for
Employer Health Programs, Priority Partners, and US Family Health Plan. Each line of business
possesses its own unique contract and guidelines which, for benefit and payment purposes,
should be consulted to know what benefits are available for reimbursement. Specific contract
benefits, guidelines or policies supersede the information outlined in this policy.
POLICY:
For US Family Health Plan see TRICARE Policy Manual 6010.57-M, February 1, 2008,
Respiratory System: Chapter 4, Section 8.1.
I.
II.
Johns Hopkins HealthCare (JHHC) considers the measurement of exhaled nitric oxide
medically necessary for the management of asthma patients.
Johns Hopkins HealthCare (JHHC) considers the measurement of exhaled nitric oxide not
medically necessary for all other disorders because it is considered experimental,
investigational, or unproven.
BACKGROUND:
Measurement of fractional nitric oxide (NO) concentration in exhaled breath (FENO) is a
quantitative, noninvasive, simple, and safe method of measuring airway inflammation that
provides a complementary tool to other ways of assessing airway disease, including asthma.
While FENO measurement has been standardized, there is currently no reference guideline for
practicing health care providers to guide them in the appropriate use and interpretation of
FENO in clinical practice.
Review Dates: 03/02/09, 6/4/2010, 8/1/11, 5/29/12, 9/5/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Exhaled Nitric Oxide
Measurement for Respiratory Disorders
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number: CMS05.05
Effective Date: 03/03/2008
Review Date: 09/05/2014
Page 2 of 5
In the setting of chronic inflammatory airway disease, including asthma, conventional tests such
as FEV1 reversibility or provocation tests are only indirectly associated with airway
inflammation. FENO offers added advantages for patient care including, but not limited to (1)
detecting eosinophilic airway inflammation, (2) determining the likelihood of corticosteroid
responsiveness, (3) monitoring airway inflammation to determine the potential need for
corticosteroid, and (4) unmasking otherwise unsuspected nonadherence to corticosteroid therapy.
FENO values can be affected by several factors, including measurement technique, exhalation
flow rate, nasal NO contamination, the NO analyzer used, age, height, smoking status, and antiinflammatory medications.
In a symptomatic adult patient with a FENO of less than 25 ppb; 20 ppb in children (low FENO
cut-point is 25 ppb in adults; 20 ppb in children), eosinophilic airway inflammation is unlikely. High FENO (high FENO cut-point is 50 ppb in adults; 35 ppb in children) is likely to indicate
significant airway eosinophilia. It is also likely to indicate that a symptomatic patient has steroidresponsive airway inflammation. For FENO values between 25 and 50 ppb (intermediate FENO
cut-points are between 25 ppb and 50 ppb in adults; 20–35 ppb in children), cautious
interpretation is required.
In a patient with ongoing asthma, symptoms may occur despite apparently adequate antiinflammatory treatment. A common cause of persistently high FENO is poor adherence to
inhaled corticosteroids (ICS) therapy. Other explanations could be poor inhaled drug delivery or
continued exposure to allergens.
CODING INFORMATION:
CPT Copyright 2014 American Medical Association. All rights reserved. CPT is a registered
trademark of the American Medical Association.
Note: The following CPT/HCPCS codes are included below for informational
purposes. Inclusion or exclusion of a CPT/HCPCS code(s) below does not signify or imply
member coverage or provider reimbursement. The member's specific benefit plan
determines coverage and referral requirements. All inpatient admissions require preauthorization.
PRE-AUTHORIZATION REQUIRED
Compliance with the provision in this policy may be monitored and addressed through
post-payment data analysis and/or medical review audits
Review Dates: 03/02/09, 6/4/2010, 8/1/11, 5/29/12, 9/5/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Exhaled Nitric Oxide
Measurement for Respiratory Disorders
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Employer Health
Programs (EHP) **See
Specific Summary Plan
Description (SPD)
CPT ®
CODES
95012
Priority Partners (PPMCO)
refer to COMAR guidelines
and PPMCO SPD then
apply policy criteria
Policy Number: CMS05.05
Effective Date: 03/03/2008
Review Date: 09/05/2014
Page 3 of 5
US Family Health Plan (USFHP),
TRICARE Medical Policy
supersedes JHHC Medical Policy.
If there is no Policy in TRICARE,
apply the Medical Policy Criteria
DESCRIPTION
Nitric oxide expired gas determination
REFERENCES:
PRIMARY SCIENTIFIC CLINICAL RESEARCH REFERENCE ARTICLES
1.
2.
3.
4.
5.
Dweik R A, Boggs PB, Erzurum SC, Irvin CG, Leigh M, Lundberg JO, Olin A-C,
Plummer AL, Taylor DR. An Official ATS Clinical Practice Guideline: Interpretation
of Exhaled Nitric Oxide Levels (FENO) for Clinical Applications. American Journal of
Respiratory and Critical Care Medicine, VOL 184, No 5 (2011). [Abstract]. Retrieved
from: http://www.atsjournals.org/doi/abs/10.1164/rccm.9120-11ST.
Chowdhury BA, (2008, July 23). Exhaled Nitric Model for Inhaled Corticosteroid
Dose-response. Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology. Retrieved from:
www.fda.gov/ohrms/dockets/ac/08/slides/2008-4370s2-11-FDA-Chowdhury.ppt .
Effros RM, Su J, Casburi R, Shaker R, Biller J, Dunning M, (2005, March). Utility of
Exhaled Breath Condensates in Chronic Obstructive Pulmonary Disease: A Critical
Review [Abstract]. Current Opinion in Pulmonary Medicine, 11(2), 135-139.
Retrieved from: http://journals.lww.com/co-pulmonarymedicine/Abstract/2005/03000/
Utility_of_exhaled_breath_condensates_in_chronic.6.aspx.
Rodway GW, Choi J, Hoffman LA, Sethi JM, (2009, February). Exhaled Nitric Oxide
in the Diagnosis and Management of Asthma: Clinical Implications [Abstract].
Chronic Respiratory Disease, Volume 6(1), 19-29. Retrieved from:
http://www.ncbi.nlm.nih.gov/pubmed/19176709.
Petsky HL, Cates CJ, Li AM, Kynaston JA, Turner C, Chang AB. Tailored
Interventions Based on Exhaled Nitric Oxide versus Clinical Symptoms for Asthma in
Children and Adults. Cochrane Database of Systematic Reviews, 2009, Issue 4, Art.
No.: CD006340. DOI: 10.1002/14651858.CD006340.pub3. Retrieved from:
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006340.pub3/abstract;jsessio
nid=742FF43FCF632661D0CF8C253972F052.f04t02.
Review Dates: 03/02/09, 6/4/2010, 8/1/11, 5/29/12, 9/5/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Exhaled Nitric Oxide
Measurement for Respiratory Disorders
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number: CMS05.05
Effective Date: 03/03/2008
Review Date: 09/05/2014
Page 4 of 5
CLINICAL TECHNOLOGY RESEARCH AND CONSULTING REFERENCES
6.
7.
8.
9.
Hayes, Inc., Medical Technology Directory, (last reviewed 2014, March 27; published
2013, April 23). Nitric Oxide Breath Analysis for the Diagnosis and Management of
Asthma. Retrieved from:
https://www.hayesinc.com/subscribers/articleList.do?query=nitric+oxide&keyword_ty
pe=all&status=all&tf_from_date=&tf_to_date=.
Deykin A, Massaro AF, (last updated 2013, December 17). Exhaled Nitric Oxide
Analysis and Applications. Retrieved from:
http://www.uptodate.com/contents/exhaled-nitric-oxide-analysis-andapplications?source=search_result&selectedTitle=1%7E25.
Fanta CH, Fletcher SW, (last updated 2014, May 7). Diagnosis of Asthma in
Adolescents and Adults. Retrieved from: http://www.uptodate.com/contents/diagnosisof-asthma-in-adolescents-and-adults?source=search_result&selectedTitle=2%7E25.
Rosen DM, Colin AA, (last updated 2013, October 23). Overview of Pulmonary
Function Testing in Children. Retrieved from:
http://www.uptodate.com/contents/overview-of-pulmonary-function-testing-inchildren?source=search_result&search=nitric+oxide&selectedTitle=9%7E150.
HEALTH PLAN REFERENCES
10. BlueCross BlueShield Regence, (2014, April 1). Medicine - Measurement of Exhaled
Nitric Oxide and Exhaled Breath Condensate in the Diagnosis and Management of
Asthma and Other Respiratory Disorders. Policy No: 108. Retrieved from:
http://blue.regence.com/trgmedpol/medicine/med108.pdf.
11. Aetna, Clinical Policy Bulletin, (last review 2013, November 15). Breath Tests of
Airway Inflammation: Exhaled Nitric Oxide and Exhaled Breath Condensate pH.
Policy No.0691. Retrieved from:
http://www.aetna.com/cpb/medical/data/600_699/0691.html.
12. CIGNA Medical Coverage Policy, (effective 2014, February 15). Exhaled Nitric Oxide
and Exhaled Breath Condensate in the Management of Respiratory Disorders. Policy
No.0439. Retrieved from:
https://cignaforhcp.cigna.com/public/content/pdf/coveragePolicies/medical/mm_0439_
coveragepositioncriteria_exhaled_nitric_oxide_monitoring.pdf.
13. CareFirst BlueCross BlueShield Medical Policy (2013, June). Exhaled Nitric Oxide
Measurement for Treatment of Asthma: Policy No: 2.01.057. Retrieved from:
http://notesnet.carefirst.com/Ecommerce/medicalpolicy.nsf/vwWebTableX/DD8C6F0
DE1F458DA85257BD30068531C?OpenDocument.
Review Dates: 03/02/09, 6/4/2010, 8/1/11, 5/29/12, 9/5/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Exhaled Nitric Oxide
Measurement for Respiratory Disorders
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number: CMS05.05
Effective Date: 03/03/2008
Review Date: 09/05/2014
Page 5 of 5
REGULATORY GOVERNMENT REFERENCES
14. Food Drug Administration (FDA), (2003, July 7). Class II Special Controls Guidance
Document: Breath Nitric Oxide Test System. Retrieved from:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guida
nceDocuments/ucm070892.pdf.
15. TRICARE Policy Manual 6010.57-M (2008, February 1), Respiratory System,
Chapter 4, Section 8.1. Retrieved from:
http://manuals.tricare.osd.mil/DisplayManualFile.aspx?Manual=TP08&Change=113&
Type=AsOf&Filename=C4S8_1.PDF&highlight=xml%3dhttp%3a%2f%2fmanuals.tric
are.osd.mil%2fPdfHighlighter.aspx%3fDocId%3d33043%26Index%3dD%253a%255c
Index%255cTP08%26HitCount%3d4%26hits%3d11%2b30%2b62%2b10f%2b
Review Dates: 03/02/09, 6/4/2010, 8/1/11, 5/29/12, 9/5/14