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Editorial |

Fractional Exhaled Nitric Oxide: Inflamed Coverage Achieves Remission FREE TO VIEW

Scott Manaker, MD, PhD, FCCP
Author and Funding Information

FINANCIAL/NONFINANCIAL DISCLOSURES: Dr Manaker received fees as a grand rounds speaker, lecturer, consultant, and expert witness on documentation, coding, billing, and reimbursement from hospitals, physicians, departments, practice groups, professional societies, insurers, and various attorneys. He received royalties as a Section Editor for UpToDate. Dr Manaker received travel and meal expenses for service on various professional society committees, including the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC); as a Director of CHEST Enterprises, a wholly owned for-profit subsidiary of the American College of Chest Physicians; as an Associate Editor for the journal CHEST; and as a member of the Hospital Outpatient Panel, a federal advisory commission to the Centers for Medicare & Medicaid Services (from 2010 to 2014).

CORRESPONDENCE TO: Scott Manaker, MD, PhD, FCCP, Hospital of the University of Pennsylvania, 100 Centrex, 3400 Spruce St, Philadelphia, PA 19104


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;149(5):1123-1125. doi:10.1016/j.chest.2015.12.007
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In 2007, the Current Procedural Terminology (CPT) Editorial Panel and Medicare established CPT code 94012 to report fractional exhaled nitric oxide (Feno) measurements. Feno reflects airway inflammation in asthma, as summarized in CHEST shortly thereafter. Both the CPT code approval and subsequent Medicare coverage were predicated on a reasonable evidence base at the time, demonstrating that for people with asthma, Feno test results could alter medical treatment and improve clinically meaningful outcomes. Major professional societies had already established technical standards for the reliable measurement of Feno; so why did it take almost a decade to reach reasonable numbers of annual claims reported to Medicare (Fig 1) and for many other payers to cover this diagnostic test?

FOR RELATED ARTICLE SEE PAGE 1340

Figure Jump LinkFigure 1 Paid Medicare claims, 2007-2014, for Current Procedural Terminology code 95012, measurement of fractional exhaled nitric oxide.Grahic Jump Location

Because of the initial capital equipment cost, and the cost of necessary supplies for each measurement in an individual patient, Feno measurement represents an expensive test. The potential for widespread use and especially overuse in the large population of people with asthma warranted a critical look at the supporting literature. In 2008, the available literature failed to persuade payers to cover Feno testing, and consequently Feno reimbursement ailed.

Even subsequent studies purporting to demonstrate a clear benefit for incorporation of Feno into clinical management had methodological design problems, and several meta-analyses failed to demonstrate a cumulative benefit. Such trial design problems confounded the interpretation of whether Feno yielded an incremental, beneficial role in various subpopulations of people with asthma beyond that offered from a routine history, physical examination, and peak flow monitoring. For example, Powell et al identified an important, hard-to-study clinical problem: poorly controlled, undertreated asthma during pregnancy. Unfortunately, in their trial, most patients were not receiving inhaled corticosteroids (ICSs) at study entry, and with only a single clinic visit 2 weeks after study entry, little time existed to optimize asthma care by standard therapy. The clinical care algorithm relied on the Asthma Control Questionnaire (ACQ) as the major determinant of whether to increase or decrease ICS dosages; and for patients in the ACQ category of “partial loss of control,” the trial algorithm did not call for a change in ICS or other therapy, potentially leaving asthma undertreated. Unsurprisingly, at the end of the study, patients monitored by Feno measurement used more ICSs and experienced fewer exacerbations than patients in the clinical algorithm arm. Feno advocates cite the study as evidence that Feno testing beneficially guides effective asthma therapy. In contrast, Feno critics cite the study as uninterpretable, essentially comparing an inadequate treatment regimen in the clinical algorithm group with an unproven Feno intervention, since ideally patients in both arms should have been receiving higher doses of ICS at both study entry and study end. These differences in perspective highlight the continuing uncertainty over whether the cost and benefit (eg, value) warrants widespread or frequent use of Feno testing in clinical practice.

Since 2007, the Medicare program has covered a modest, but increasing number of Feno measurement claims among beneficiaries (Fig 1). Should an excessive or seemingly abusive number of claims be received, Medicare has a well-established program of coverage policies that can limit payments on the basis of clinical diagnoses, the frequency of testing, or both. This process of initial coverage, and subsequent coverage limits only with demonstrated or inferred abuse, allows for rapid access to clinically important innovations.

Now an increasing number of other payers likewise cover Feno measurement. But in this issue of CHEST, Mummadi and Hahn also highlight that it has taken a decade to achieve reimbursement coverage for a seemingly proven diagnostic test. Matching payment policy to emerging technology is a common problem. Other examples in the field of chest medicine where technological advancements, assignment of a CPT code, and Medicare coverage preceded widespread coverage among other payers include navigational bronchoscopy and bronchial thermoplasty., Such payment barriers stifle innovation and slow commercialization of novel, truly beneficial therapies.

Payment barriers also create a barrier for patients to access novel, truly beneficial therapies. Postapproval trials, with many cited by Mummadi and Hahn for Feno testing, can powerfully and informatively persuade Medicare and other payers to cover new innovations. Increasingly, Medicare is approving coverage for expensive, high-risk devices and therapies (such as transcatheter replacement of cardiac valves and implantable pulmonary artery pressure remote monitoring devices) combined with requests for postapproval studies. Yet, many phase IV or postapproval studies specifically requested by the US Food and Drug Administration or Medicare are often not completed or published in a timely manner., Postmarketing studies can be critically important, and lead to product recall [eg, drotrecogin alfa (Xigris)] or recognition that seemingly therapeutic innovations are truly beneficial only for highly selected subpopulations (eg, lung volume reduction surgery).

Global payment for management of a single disease, covering a specific duration of time, is a proposed solution to this vexing problem of coverage barriers. The idea that appropriate costs from expensive but cost-effective diagnostics and therapeutics will be more than offset by total health-care system savings over time is prevalent in this era of advanced payment models and health-care system reform. However, individual physicians order diagnostics and prescribe therapies, not accountable care organizations or other administrative entities. If expensive, low-value services still provide professional fees to physicians, and total system savings are shared with those physicians, based mostly on the volumes of services, such shared reductions in total savings are unlikely to change the behavior of physicians ordering such low-value services; and appropriate physician incentives for high-value services remain to be clearly defined.

Mummadi and Hahn now highlight that Feno testing have achieved widespread coverage in the United States, although the coverage remains patchy by individual payers compared with other countries, where the value of Feno measurement is accepted and covered at the national level. The decade-long journey of Feno to achieving coverage highlights the need to improve the available evidence base at the time of approval of a drug, device, or test; and then the subsequent delivery, dissemination, and reimbursement coverage of these clinically meaningful innovations at the point of care. Previously ailing, Feno reimbursement seems in remission; but we need a cure for accelerating the coverage process from product conception through delivery of innovations to the patient populations that will derive cost-effective benefit.

References

American Medical Association.RBRVS DataManager Online[computer program]. Chicago, IL: American Medical Association; 1995-2016.
 
Lim K.G. .Mottram C. . The use of fraction of exhaled nitric oxide in pulmonary practice. Chest. 2008;133:1232-1242 [PubMed]journal. [CrossRef] [PubMed]
 
American Thoracic SocietyEuropean Respiratory Society 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;171:912-930 [PubMed]journal. [CrossRef] [PubMed]
 
Mummadi S.R. .Hahn P.Y. . Update on exhaled nitric oxide in clinical practice. Chest. 2016;149:1340-1344 [PubMed]journal
 
Powell H. .Murphy V.E. .Taylor D.R. .et al Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial. Lancet. 2011;378:983-990 [PubMed]journal. [CrossRef] [PubMed]
 
National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program.Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD: National Heart, Lung, and Blood Institute; revised August 2007. NIH publication 07-4051. National Heart, Lung, and Blood Institute website.www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Accessed November 30, 2015.
 
Centers for Medicare & Medicaid Services. Medicare Coverage Database. Baltimore, MD: Centers for Medicare & Medicaid Services; updated December 15, 2015.www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx. Accessed December 1, 2015.
 
Edell E. .Krier-Morrow D. . Navigational bronchoscopy: overview of technology and practical considerations—new Current Procedural Terminology codes effective 2010. Chest. 2010;137:450-454 [PubMed]journal. [CrossRef] [PubMed]
 
Maharajan A.K. .Hogarth D.K. . Payer coverage for bronchial thermoplasty: shifting the traditional paradigm for refractory asthma therapy. Chest. 2013;144:1051-1054 [PubMed]journal. [CrossRef] [PubMed]
 
Rathi V.K. .Krumholz H.M. .Masoudi F.A. .Ross J.S. . Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011. JAMA. 2015;314:604-612 [PubMed]journal. [CrossRef] [PubMed]
 
Ross J.S. .Mulvey G.K. .Hines E.M. .Nissen S.E. .Krumholz H.M. . Trial publication after registration in ClinicalTrials.gov: a cross-sectional analysis. PLoS Med. 2009;6:e1000144- [PubMed]journal. [CrossRef] [PubMed]
 
Emanuel E.J. .Ubel P.A. .Kessler J.B. .et al Using behavioral economics to design physician incentives that deliver high-value care. Ann Intern Med. 2016;162:114-119 [PubMed]journal
 

Figures

Figure Jump LinkFigure 1 Paid Medicare claims, 2007-2014, for Current Procedural Terminology code 95012, measurement of fractional exhaled nitric oxide.Grahic Jump Location

Tables

References

American Medical Association.RBRVS DataManager Online[computer program]. Chicago, IL: American Medical Association; 1995-2016.
 
Lim K.G. .Mottram C. . The use of fraction of exhaled nitric oxide in pulmonary practice. Chest. 2008;133:1232-1242 [PubMed]journal. [CrossRef] [PubMed]
 
American Thoracic SocietyEuropean Respiratory Society 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;171:912-930 [PubMed]journal. [CrossRef] [PubMed]
 
Mummadi S.R. .Hahn P.Y. . Update on exhaled nitric oxide in clinical practice. Chest. 2016;149:1340-1344 [PubMed]journal
 
Powell H. .Murphy V.E. .Taylor D.R. .et al Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial. Lancet. 2011;378:983-990 [PubMed]journal. [CrossRef] [PubMed]
 
National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program.Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD: National Heart, Lung, and Blood Institute; revised August 2007. NIH publication 07-4051. National Heart, Lung, and Blood Institute website.www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Accessed November 30, 2015.
 
Centers for Medicare & Medicaid Services. Medicare Coverage Database. Baltimore, MD: Centers for Medicare & Medicaid Services; updated December 15, 2015.www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx. Accessed December 1, 2015.
 
Edell E. .Krier-Morrow D. . Navigational bronchoscopy: overview of technology and practical considerations—new Current Procedural Terminology codes effective 2010. Chest. 2010;137:450-454 [PubMed]journal. [CrossRef] [PubMed]
 
Maharajan A.K. .Hogarth D.K. . Payer coverage for bronchial thermoplasty: shifting the traditional paradigm for refractory asthma therapy. Chest. 2013;144:1051-1054 [PubMed]journal. [CrossRef] [PubMed]
 
Rathi V.K. .Krumholz H.M. .Masoudi F.A. .Ross J.S. . Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011. JAMA. 2015;314:604-612 [PubMed]journal. [CrossRef] [PubMed]
 
Ross J.S. .Mulvey G.K. .Hines E.M. .Nissen S.E. .Krumholz H.M. . Trial publication after registration in ClinicalTrials.gov: a cross-sectional analysis. PLoS Med. 2009;6:e1000144- [PubMed]journal. [CrossRef] [PubMed]
 
Emanuel E.J. .Ubel P.A. .Kessler J.B. .et al Using behavioral economics to design physician incentives that deliver high-value care. Ann Intern Med. 2016;162:114-119 [PubMed]journal
 
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