Exhaled Nitric Oxide Encounter Profile

Hospital/Clinic Name Date

Physician Name

Address

Date

RE: Patient Name:

Subscriber Name:

Claim Number:

Date of Service:

Medical Necessity of Exhaled Nitric Oxide per CPT ? 95012 and Payment Services

This letter serves as an appeal to your board certified allergist/pulmonologist for a denied claim for services provided to your member, _____________, on ______________.

Diagnosis:

Indications for Exhaled Nitric Oxide:

Assessment/Plan:

Asthma is defined as a chronic inflammatory process which leads to airflow limitation and increased responsiveness to asthma triggers. Standard methods for diagnosing and monitoring asthma traditionally focus on symptoms and airway constriction. Until now, routine assessment of the underlying level of inflammation has not been possible. Today a substantial amount of data exists to confirm the clinical value of exhaled nitric oxide. The American Thoracic Society (ATS) has published guidelines for the standardization of exhaled nitric oxide measurement1. In addition, the NHLBI Asthma G uidelines state that there is a positive role for exhaled nitric oxide measurement as an inflammatory marker2. More than 1500 publications in peer reviewed journals establish NO as the most effective marker of airway inflammation.

· Exhaled NO improves diagnostic accuracy 3-6 : The levels in asthmatics are 2-6 times higher, thereby identifying eosinophilic asthma in symptomatic patients which minimizes inappropriate or ineffective therapy.

· Exhal ed NO predicts anti-inflammatory response 7,8 , 9 : Steroid response can be expected in patients with an ongoing eosinophilic inflammation. Exhaled NO can be used for immediate and non-invasive identification of steroid responsiveness. Patient with normal Exhaled NO values and no symptomatic response to anti-inflammatory treatment may not have an underlying inflammation.

· Exhaled NO determines the best treatment for chronic cough 10 : Patients with an elevated exhaled NO value and chronic cough are likely to respond positively to inhaled corticosteroids, while those with normal values are unlikely to respond.

· Exhaled NO values, low and high , are of clinical significance 11 : There is improved management and general practitioner diagnostic confidence when treating patients presenting with non-specific respiratory symptoms.

· Exhaled NO improves the patient’s understanding of their airway disease, and improves compliance 12-17 : Exhaled NO values change rapidly depending upon anti-inflammatory treatment intake or allergen exposure, therefore elevated NO values in patients taking maintenance doses of inhaled corticosteroids determines whether or not the patient is adhering to the therapy prescribed, has a poor inhalation technique, is still exposed to allergens, or has been prescribed enough anti-inflammatory therapy.

· Exhaled NO is cost effective 18 : Both healthcare costs for unscheduled patient visits due to loss of asthma control and the cost of inhaled corticosteroids are reduced.

· Exhaled NO optimizes dose adjustments 1 9: Steroid dose titration according to the patient’s needs is possible with the routine monitoring of exhaled nitric oxide.

· Exhaled NO predicts asthma relapse 20 : When asymptomatic children in clinical remission stopped taking steroids, an exhaled NO value ≥49 ppb, 2-4 weeks later is an effective predictor of asthma relapse.

Please feel free to contact me (Tel nr, email) for further discussion or with any questions.

Best Regards,

, MD

Department of

Hospital/Clinical Name

References:

1. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30.

2. NHLBI National Heart, Lung and Blood Institute. Expert Panel Report 3: Guidelines for the diagnosis and management of asthma—full report 2007. August 28, 2007. Available at: www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf.

3. Dressel H, de la Motte D, Reichert J, Ochmann U, Petru R, Angerer P, Holz O, Nowak D, J?rres RA, Exhaled nitric oxide: Independent effects of atopy, smoking, respiratory tract infection, gender and height. Resp. Med. 2008 Jul;102(7):962-9.

4. Malmberg LP, Petays T, Haahtela T, et al. Exhaled nitric oxide in healthy nonatopic school-age children: determinants and height-adjusted reference values. Pediatr Pulmonol 2006; 41: 635-42.

5. Smith AD, Cowan JO, Filsell S, McLachlan C, Monti-Sheehan G, Jackson P, Taylor DR. Diagnosing asthma – Comparisons between exhaled nitric oxide measurements and conventional tests. Am J Respir Crit Care Med 2004;169:473-8.

6. Malmberg LP, Pelkonen AS, Haahtela T, Turpeinen M. Exhaled nitric-oxide rather than lung function distinguishes preschool children with probable asthma. Thorax 2003;58:494-9.

7. Smith AD, Cowan JO, Brassett KP, Filsell S, McLachlan C, Monti- Sheehan G, Herbison GP, Taylor DR. Exhaled nitric oxide: a predictor of steroid response. Am J Respir Crit Care Med 2005;172:453-9.

8. Zeiger RS, Szefler SJ, Phillips BR, Schatz M, Martinez FD, Chinchilli VM, Lemanske RF Jr, Strunk RC, Larsen G, Spahn JD, Bacharier LB, Bloomberg GR, Guilbert TW, Heldt G, Morgan WJ, Moss MH, Sorkness CA, Taussig LM; CARE Network of the NHLBI. Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma. J Allergy Clin Immunol. 2006 Jan;117(1):45-52.

9. Bratton DL, Lanz MJ, Miyazawa N, White CW, Silkoff PE. Exhaled nitric oxide before and after montelukast sodium therapy in school-age children with chronic asthma: A preliminary study. Pediatr Pulmonol 1999;28:402-407.

10. Hahn PY, Morgenthaler TI, Lim KG. Use of exhaled nitric oxide in predicting response to inhaled corticosteroids for chronic cough. Mayo Clin Proc 2007; 82: 1350–5.

11. Hewitt RS, Modrich CM, Medlicott T, Cowan JO, Taylor DR. Supporting the diagnosis of non-specific respiratory symptoms in primary care: the role of exhaled Nitric Oxide measurement and spirometry. Prim Care Respir J; 2008 Apr; 17(2):97-103.

12. Silkoff PE, et al. The Aerocrine exhaled nitric oxide monitoring system NIOX is cleared by the US Food and Drug Administration for monitoring therapy in asthma. J Allergy Clin Immunol 2004;114:1241-56.

13. Sorkness CA, Lemanske RF, Jr., Mauger DT, et al. Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: The Pediatric Asthma Controller Trial. J Allergy Clin Immunol 2007; 119: 64-72.

14. Piacentini GL, Bodini A, Costella S, et al. Allergen avoidance is as sociated with a fall in exhaled nitric oxide in asthmatic children. J Allergy Clin Immunol 1999;104:1323-4.

15. Delgado-Corcoran C, Kissoon N, Murphy SP, Duckworth LJ. Exhaled nitric oxide reflects asthma severity and asthma control. Pediatr Crit Care Med 2004 Vol.5, No.1.

16. Stirling RG, Kharitonov SA, Campbell D, et al. Increase in exhaled nitric oxide levels in patients with difficult asthma and correlation with symptoms and disease severity despite treatment with oral and inhaled corticosteroids. Asthma and Allergy Group. Thorax 1998;53:1030-4.

17. Payne DN, Wilson NM, James A, Hablas H, Agrafioti C, Bush A. Evidence for different subgroups of difficult asthma in children. Thorax 2001;56:345-50.

18. Berg J, Lindgren P. Economic evaluation of FENO measurement in diagnosis and 1-year management of asthma in Germany. Respir Med 2008; 102: 219–31.

19. Smith AD, Cowan JO, Brassett KP, Herbison GP, Taylor DR. Use of Exhaled Nitric Oxide Measurements to Guide Treatment in Chronic Asthma. N Engl J Med 2005;352:2163-73.

20. Pijnenburg MW, Hofhuis W, Hop WC, De Jongste JC. Exhaled nitric oxide predicts asthma relapse in children with clinical asthma remision. Thorax 2005;60:215-8.