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Clinical Policy Title: Pulmonary functions tests

Clinical Policy Number: 07.01.07

Effective Date: July 1, 2017

Initial Review Date: June 22, 2017

Most Recent Review Date: June 5, 2018

Next Review Date: June 2019

Related policies:

CP# 07.01.04 Exhaled nitric oxide for diagnosis of lung disease

CP# 07.02.07 Lung transplants

ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.

For this policy, pulmonary function tests are defined as the noninvasive measurement of inhaled and

exhaled lung volume, total lung capacity, rates of air flow, and gas exchange.

Coverage policy

AmeriHealth Caritas considers the use of pulmonary function tests to be clinically proven and, therefore,

medically necessary when all of the following criteria are met (Csikesz, 2014; Global Initiative for Chronic

Obstructive Lung Disease, 2017; Miller, 2005):

A pulmonary diagnosis or evaluation cannot be made clinically, or test results are necessary

to manage the member’s clinical course.

The test information is needed to determine any of the following:

- The presence of lung disease or abnormal lung function.

- The type of abnormality.

- The extent of abnormality.

- The extent of disability due to abnormal lung function.

Policy contains:

Spirometry.

Pulmonary function tests.

Asthma.

Chronic obstructive pulmonary

disease.

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- One or more courses of therapy in the treatment of the particular condition.

The test is ordered by a treating physician and used in the member’s care.

The member is able to perform acceptable and reproducible maneuvers.

AmeriHealth Caritas considers the use of spirometry that measures volume and air flow on inhalation

and exhalation to be clinically proven and, therefore, medically necessary for the following indications

(National Institute for Health and Care Excellence, 2016; Meyer, 2016; Global Initiative for Chronic

Obstructive Lung Disease, 2010):

To evaluate abnormal symptoms or signs suggestive of pulmonary disease.

To measure the effect of systemic disease on pulmonary function (e.g., neuromuscular

disease and connective tissue disease).

To assess preoperative risk in members undergoing thoracic surgery, or members

undergoing major or complex surgery with known or suspected pulmonary disease.

To assess prognosis in lung transplant recipients.

To assess therapeutic effectiveness of bronchodilator therapy.

To monitor for adverse reactions to drugs with known pulmonary toxicity.

To assess reversibility of bronchospasm when signs or symptoms are consistent with

bronchospasm or pre-bronchodilator spirometry is abnormal.

- If reversibility of bronchospasm has been ruled out or demonstrated, repeat pre-

and post-bronchodilator study is medically necessary only when there is a significant

clinical change in the patient’s functional respiratory status requiring a change in

bronchoactive medications, and this is documented in the patient’s medical record.

AmeriHealth Caritas considers the use of spirometry for screening for asymptomatic patients with or

without a high risk of lung disease (e.g., prolonged smoking history) to be investigational and, therefore,

not medically necessary.

Limitations:

All other uses of pulmonary function tests are not medically necessary including, but not limited to:

When a diagnosis or evaluation can be made clinically or when test results are not necessary

to manage the patient’s disease.

Routine use at each office visit when physical exam and medical interview confirm either

the member’s claim of being stable or no clinically meaningful changes in pulmonary status.

As part of an epidemiological survey.

Peak flow meters (handheld spirometry) when used for diagnosing pulmonary disease.

Complete (or full) pulmonary function tests that incorporate body plethysmography, diffusion capacity,

bronchoprovocation, and other age-appropriate maneuvers should be reserved for more complex cases

to further quantify impairment and inform care management, particularly when there are

inconsistencies between history, physical features, and spirometry.

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For the purpose of medical review, the provider must use the various PFT modalities in a

purposeful and logical sequence in test selection.

Contraindications:

Pulmonary function tests can be physically demanding maneuvers and should be used

cautiously in patients with medical conditions that could be adversely affected by an

increase in: intrathoracic, intra-abdominal, and intracranial pressures; myocardial demand;

venous return; systemic blood pressure; chest wall and lung expansion; and risk for active

communicable diseases.

Patients should not be tested within one month of a myocardial infarction.

Quality assurance considerations:

Pulmonary function tests are medically necessary for members who are able to perform

acceptable and reproducible maneuvers. For young children with chronic lung disease or

recurrent wheeze, pulmonary function tests tailored to the specific disease can be

considered on a case-by-case basis.

Spirometry studies, in particular, require a minimum of three attempts that must meet

minimum acceptability criteria (Miller, 2005).

Personnel who perform all pulmonary function tests should have verifiable training in all

aspects of spirometry, lung volume, diffusion capacity, gas exchange, and pulmonary

exercise testing, including equipment operation, quality control, and test outcomes relative

to diagnosis and medical history.

Alternative covered services:

Physical examination and medical history.

Background

Pulmonary disease can affect the airways (large and small), lung parenchyma, pulmonary vasculature,

and the respiratory muscles. In 2014, the third-leading cause of death in the United States was chronic

lower respiratory disease comprising asthma and chronic obstructive pulmonary disease (chronic

obstructive pulmonary disease; emphysema and bronchitis; death rates from chronic lower respiratory

diseases were highest among older persons, white males and females, and blacks/African Americans

(Kochanek, 2016).

Accurate diagnosis of acute and chronic lung diseases can be challenging to achieve, particularly in

primary care, because medical history and physical examination are not reliable for the differential

diagnoses or estimating disease severity (José, 2014; Donner, 2011). Misdiagnosis of asthma may be as

high as 30 percent, and early diagnosis of chronic obstructive pulmonary disease is inadequately

addressed in many settings (Chung, 2014; Donner, 2011). Inappropriate interpretation of symptoms,

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unawareness of symptoms, underreporting of symptoms, and inadequate standards of care have been

implicated (Csikesz, 2014). Objective testing has become essential to appropriately characterize and

manage acute and chronic lung disease.

Assessment of pulmonary physiology involves measurement of pulmonary mechanics (airflows and lung

volumes), the ventilation-perfusion interrelationship, diffusion and gas exchange, and respiratory

muscle strength using maneuvers to measure and record the properties of these lung components.

Pulmonary function tests represent a battery of tests used to diagnose, stage, and monitor various

pulmonary diseases (National Heart, Lung, and Blood Institute [NHLBI], 2015). They include spirometry,

lung volume measurement, diffusing capacity for carbon monoxide, arterial blood gases, and exercise

testing. Radiography, skin testing, and certain biomarkers such as the fraction of exhaled nitric oxide

may be used in diagnosing lung disease (Csikesz, 2014).

Spirometry:

Spirometry is the most reproducible and readily available lung function test and is the primary focus of

this policy. It is an effort-dependent maneuver in which a seated (or sometimes standing) patient inhales

maximally into a mouthpiece from tidal breathing to total lung capacity and then rapidly exhales to the

fullest extent until no further volume is exhaled. A spirometer measures either displaced volume or

airflow by a flow-sensing device, such as a pneumotachometer, that mathematically derives volume. It is

simple and easy to perform, unlike other pulmonary function tests that are more time-consuming and

require specialized equipment and training. Instrumentation for spirometry can be portable, hand-held,

or stationary.

The three most commonly used spirometric values are forced vital capacity (FVC), forced expired volume

in one second (FEV1), and the FEV1/FVC ratio, but spirometry can provide other important measures of

pulmonary mechanics (Miller, 2005):

FEV1 — the maximal volume of air exhaled in the first second of a forced expiration from a

position of full inspiration; a sensitive indicator of larger airway disease.

FVC — the maximal volume of air exhaled with maximally forced effort from a maximal

inspiration. FEV at two seconds (FEV2) and FEV at three seconds (FEV3) may approximate

FVC in young children, and FEV at six seconds (FEV6) may approximate FVC.

Expiratory vital capacity (EVC) — the maximal volume of air exhaled from the point of

maximal inhalation.

FEF25–75 — the mean forced expiratory flow between 25 percent and 75 percent of the FVC;

an indicator of small airway disease.

FEV1/FVC — an indicator of airway obstruction if the value is less than 70 percent (Global

Initiative for Chronic Obstructive Lung Disease, 2010). An alternative measure, the

FEV1/FEV6, has been proposed.

Inspiratory capacity (IC) — the volume change recorded when taking a slow full inspiration

with no hesitation from a position of passive end-tidal expiration. IC is an indirect estimate

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of the degree of lung hyperinflation at rest, and is useful to assess changes in FRC with

pharmacological treatment.

Inspiratory VC — the maximal volume of air inhaled from the point of maximal exhalation,

achieved by a slow expiration from end-tidal inspiration.

Maximum voluntary ventilation (MVV) — the maximum volume of air a subject can breathe

over a specified period of time (12 seconds for normal subjects); largely superseded by FEV1.

Peak flow — the maximum expiratory flow achieved from a maximum forced expiration,

starting without hesitation from the point of maximal lung inflation; useful for assessing

flow rate patterns, hence airway integrity, over time.

Vital capacity (VC) — the volume represented from the position of full inspiration to

complete expiration (unforced).

Spirometry can be administered in the ambulatory, office, emergency room, and inpatient settings. It

can be performed without a bronchodilator for screening purposes or before-and-after a bronchodilator

for diagnostic purposes. Practitioners and patients may use hand-held peak expiratory flow (PEF or peak

flow) meters to monitor trends in air flow. Accurate interpretation of results requires maximal patient

effort and well-defined acceptability and reproducibility standards (Miller, 2005). Normative values are

derived from population studies of healthy subjects with similar age, race, weight, and height to which

measured values are compared to approximate disease severity.

Searches

AmeriHealth Caritas searched PubMed and the databases of:

UK National Health Services Centre for Reviews and Dissemination.

Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other

evidence-based practice centers.

The Centers for Medicare & Medicaid Services (CMS).

We conducted searches on April 25, 2018. Search terms were: “Pulmonary Disease, Chronic

Obstructive” (MeSH), “Mass Screening” (MeSH), “Respiratory Function Tests” (MeSH), “Spirometry”

(MeSH), “Forced Expiratory Volume” (MeSH), “Forced Expiratory Flow Rates” (MeSH), “Vital Capacity”

(MeSH), “Ambulatory Care” (MeSH), “Outpatient Clinics, Hospital” (MeSH), and “Outpatients” (MeSH).

We included:

Systematic reviews, which pool results from multiple studies to achieve larger sample sizes

and greater precision of effect estimation than in smaller primary studies. Systematic

reviews use predetermined transparent methods to minimize bias, effectively treating the

review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies.

Guidelines based on systematic reviews.

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Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple

cost studies), reporting both costs and outcomes — sometimes referred to as efficiency

studies — which also rank near the top of evidence hierarchies.

Findings

We identified two systematic reviews and 11 evidence-based practice guidelines for this policy. Medical

history and physical examination are essential but often inadequate means of excluding diagnoses or

characterizing the status of lung impairment, and symptoms often do not correlate with objective

assessment. Quantitative measures of lung function are standard of care for persons with acute or

chronic lung disease. Spirometry is the most frequently used PFT. It is an accurate, available,

noninvasive, safe, and relatively inexpensive first-line test for evaluating lung function.

As a diagnostic test, the evidence supports spirometry when medical history and physical examination

are inadequate to inform care, and quantitative information is necessary to (National Institute for

Health and Care Excellence, 2016; Meyer, 2016; Global Initiative for Chronic Obstructive Lung Disease,

2010):

Determine the presence, type, and severity of obstructive, restrictive, and combined

obstructive/restrictive lung defects.

Confirm a diagnosis.

Measure therapeutic response.

Assess preoperative risk in persons undergoing thoracic surgery or undergoing major or

complex surgery with known or suspected pulmonary disease.

Monitor allograft status before and after lung transplantation.

Other findings include:

Peak flow meters should be used to monitor changes in flow rates, but not to diagnose

pulmonary disease (Chung, 2014).

The value of spirometry in children younger than 6 years of age is less clear (Kang, 2016;

Lahiri, 2016; Rosenfeld, 2013). Spirometry can identify pulmonary exacerbations and

monitor treatment response in those children able to perform acceptable and reproducible

maneuvers. The evidence argues against routine use in diagnostic evaluation and clinical

monitoring of infants and very young children with cystic fibrosis, bronchopulmonary

dysplasia, or recurrent wheeze, but pulmonary function tests tailored to the specific disease

in this population can be considered on a case-by-case basis.

Complete or full pulmonary function tests that incorporate body plethysmography, diffusion

capacity, arterial blood gases, and other age-appropriate pulmonary function tests should

be reserved for more complex cases to further quantify impairment and inform care

management, particularly when there are inconsistencies between history, physical

features, and spirometry (Chung, 2014).

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Potential risks associated with pulmonary function tests relate to the physiologic effects and anatomical

demand that forced maneuvers can inflict on intrathoracic, intra-abdominal, and intracranial pressures;

myocardial demand; venous return; systemic blood pressure; and chest wall and lung expansion. There

is also an increased risk in acquiring active communicable diseases. Most contraindications to pulmonary

function tests are relative and require a delay in performing them until the issues resolve, as opposed to

outright avoidance.

Despite reports of underdiagnosis of chronic obstructive pulmonary disease and misdiagnosis of asthma,

spirometry as a screening test (often referred to as pre-bronchodilator spirometry) in asymptomatic

populations remains controversial. Screening comprises validated questionnaires, spirometry, or both.

The rationale for more intensive case-finding in asymptomatic populations using spirometry is to

identify lung disease at an earlier stage when treatment and prevention strategies can affect health

outcomes. While there is a need to improve early and accurate diagnosis of various lung conditions,

current evidence does not support a health, treatment, or smoking cessation benefit in screen-detected

populations (Guirguis-Blake, 2016). Multiple evidence-based guidelines do not support screening

spirometry in the absence of symptoms (Coates, 2013; Global Initiative for Chronic Obstructive Lung

Disease, 2010; Qaseem, 2011; U.S. Preventive Services Task Force, 2016).

As the use of spirometry increases, principally in office-based settings, access to quality spirometry is a

major concern. The results must be interpreted carefully as all lung function tests are effort dependent.

The American Thoracic Society, the European Respiratory Society, and Global Initiative for Chronic

Obstructive Lung Disease have developed clinical practice and quality assurance guidelines for

pulmonary function tests to improve testing quality and interpretation (Miller, 2005; Global Initiative for

Chronic Obstructive Lung Disease, 2017). Pulmonary function tests should be performed and interpreted

by providers with demonstrated proficiency in test performance and interpretation.

Policy updates:

We did not identify any recently published guidelines/other or peer-reviewed publications in 2018.

Summary of clinical evidence:

Citation Content, Methods, Recommendations

Global Initiative for Chronic

Obstructive Lung Disease

(2017)

Guideline: From the Global

Strategy for the Diagnosis,

Management and

Prevention of chronic

obstructive pulmonary

disease

Key points:

The role of screening at-risk populations in primary care is more controversial.

Whether early detection in relatively asymptomatic smokers significantly increases

tobacco cessation rates is unclear.

The most cost-effective method would appear to be a case-finding technique and

performing spirometry in those at risk of chronic obstructive pulmonary disease.

Clinicians should suspect chronic obstructive pulmonary disease and perform

spirometry when indicators are present in an individual aged over 40 years: chronic

cough or sputum production, dyspnea, and/or history of exposure to risk factors (e.g.,

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Citation Content, Methods, Recommendations

tobacco smoke, occupational dusts, home cooking, and biomass fuels).

Guirguis-Blake (2016) for

AHRQ

Screening for chronic

obstructive pulmonary

disease

Key points:

Systematic review of diagnostic accuracy: five studies (n=3,048) of three externally

validated chronic obstructive pulmonary disease questionnaires; two studies of pre-

bronchodilator PF; two studies of pre-bronchodilator microspirometry FEV1/FEV6; one

study of post-bronchodilator microspirometry FEV1/FEV6; one study of a staged

approach incorporating both the chronic obstructive pulmonary disease Diagnostic

Questionnaire and FEV1/FEV6 tests; five randomized controlled trials (RCTs) (n=1,620)

of the effectiveness of chronic obstructive pulmonary disease screening in influencing

smoking cessation rates; and 14 treatment RCTs in screen-detected patients.

Overall quality: low to moderate. High risk of bias, incomplete reporting of study design

elements and harms.

Insufficient evidence to support that systematic screening for chronic obstructive

pulmonary disease in primary care improves health outcomes, or offers a treatment or

smoking cessation benefit in screen-detected populations.

Kang (2016) for the

American Academy of

Neurology and the American

Association of

Neuromuscular &

Electrodiagnostic Medicine

Guideline: Evaluation,

diagnosis, and management

of congenital muscular

dystrophy (CMD)

Key points:

Physicians should monitor pulmonary function tests such as spirometry and oxygen

saturation in the awake and sleep states of patients with CMD, with monitoring levels

individualized on the basis of the child’s clinical status (Level B).

Lahiri (2016)

Guideline: From the CF

Foundation for Preschoolers

With CF

Key points:

For children with CF, ages 2 to 5 years, spirometry should be attempted as early as age

3 years, depending on the developmental stage of the individual child (Consensus

recommendation).

For children with CF, ages 3 years and older, use spirometry to identify pulmonary

exacerbations and monitor treatment response in those children able to perform

acceptable and reproducible maneuvers (Consensus recommendation).

National Institute for Health

and Care Excellence (2016)

Guideline: Routine preoperative tests for elective surgery

Key points:

Routine pulmonary function tests and arterial blood gas analysis before surgery are not

recommended, based on low or very-low-quality evidence suggesting that test may

provide reassurance both to the patients and clinician before surgery, but had no real

impact on perioperative or general clinical management.

- Exception: Thoracic surgery or those with respiratory problems undergoing

major or complex surgery.

Spirometry alone is sufficient for guiding perioperative management in most patients.

Pulmonary function tests may have a role in optimizing the patient before surgery under

the advice of an anesthetist, leading to better postoperative management.

There is uncertainty about which patients with known or suspected respiratory disease

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Citation Content, Methods, Recommendations

require preoperative lung function tests, what time period prior to surgery these are

required, and whether spirometry or more sophisticated tests are indicated.

Skloot (2016) for the ATS

Guideline: Asthma in the

elderly

Key points:

Spirometry and airway reactivity measurements are first-line methods for diagnosing

and monitoring asthma in the elderly.

Age-adjusted values are essential for interpretation to avoid overdiagnosing respiratory

impairment.

Normative data for nonwhite individuals and for those older than 75 years are sparse.

USPSTF (2016)

Guideline: Screening for

chronic obstructive

pulmonary disease

Key points:

“D” recommendation against screening for chronic obstructive pulmonary disease in

asymptomatic adults based on the conclusion that screening for chronic obstructive

pulmonary disease had no net benefit and large associated opportunity costs.

Inadequate evidence to conclude on the harms of screening, improvement in health

outcomes, improvement in smoking cessation, or alterations in disease course;

opportunity costs may be large, and resources needed to screen using spirometry with

or without questionnaires can be substantial (Guirguis-Blake, 2016).

Haroon (2015)

Effectiveness of case-finding

strategies for chronic

obstructive pulmonary

disease in primary care

Key points:

Systematic review and meta-analysis of three RCTs, one controlled trial, and 35

uncontrolled studies that included pre-screening with questionnaires (n=13), handheld

flow meters (n=5), or direct invitation to diagnostic spirometry (n=30).

Overall quality: low. Heterogeneous studies, lack of comparison groups, inadequate

reporting, and diversity in the definition of chronic obstructive pulmonary disease.

Any approach identified more undiagnosed chronic obstructive pulmonary disease

versus usual care; targeting those at higher risk (e.g., smokers) and pre-screening (e.g.,

using questionnaires) is likely to increase the yield, but impact on clinical care and

patient outcomes is unknown.

Well-conducted RCTs are needed.

Chung (2014) for the

ERS/ATS

Guideline: Definition,

evaluation and treatment of

severe asthma

Key points:

Spirometry with both inspiratory and expiratory loops, following pre- and post-

bronchodilator administration, should be obtained to confirm reversible airflow limitation.

Further testing with complete pulmonary function tests, including diffusing capacity and

bronchoprovocation testing, in the case of relatively preserved lung function can be

considered on a case-by-case basis, particularly when there are inconsistencies

between history, physical features, and spirometry.

Meyer (2014) for the

International Society for

Heart and Lung

Transplantation, ATS, and

ERS

Guideline: Diagnosis and

management of bronchiolitis

obliterans syndrome (BOS)

Key points:

In most transplant centers, lung transplant recipients (including asymptomatic patients)

receive sustained follow-up including routine clinical evaluation, spirometry (both in the

clinic and in remote in-home settings), and other methods for monitoring allograft status

(such as fiber-optic bronchoscopy, as appropriate).

Such monitoring is generally sustained beyond the first 6–12 months following

transplantation.

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Citation Content, Methods, Recommendations

in lung transplantation

recipients

Coates (2013) for the

Canadian Thoracic Society

Guideline: Spirometry in

primary care

Key points:

Based on the joint ATS/ERS standards for pulmonary function tests (Miller, 2005).

Potential risks associated with spirometry and other forced expiratory maneuvers relate

to increased intrathoracic, intra-abdominal, and intracranial pressures; myocardial

demand; venous return; systemic blood pressure; chest wall and lung expansion; and

active communicable diseases. This calls for prudence in patients with medical

conditions that could be adversely affected by these physiological consequences.

Rosenfeld (2013) for the

ATS

Guideline: Optimal lung

function tests for monitoring

CF, BPD, and recurrent

wheezing in children less

than 6 years of age

Key points:

Recommendations covered infant pulmonary function testing (raised-volume rapid

thoracic compression and plethysmography); preschool spirometry; specific airway

resistance; the interrupter technique; the forced oscillation technique; and multiple-

breath washout.

All tests are safe and feasible; sedated infant lung function testing requires extensive

training; unclear impact of testing on patient outcomes.

Reference data are predominantly from non-Hispanic white children, device- and

technique-dependent, and derived from low-quality data.

Insufficient evidence to support routine use in diagnostic evaluation and clinical

monitoring of infants and young children with CF, BPD, or recurrent wheeze; may be

valuable for specific concerns (e.g., ongoing symptoms or treatment monitoring), and as

outcome measures in clinical research studies.

Qaseem (2011) for the ACP,

ACCP, ATS, and ERS

Guideline: Diagnosis and

Management of Stable

chronic obstructive

pulmonary disease

Key points:

Spirometry should be obtained to diagnose airflow obstruction in patients with

respiratory symptoms (grade: strong recommendation, moderate-quality evidence).

Spirometry should not be used to screen for airflow obstruction in individuals without

respiratory symptoms (grade: strong recommendation, moderate-quality evidence).

National Asthma Education

and Prevention Program -

Expert Panel Report 3

(2007)

Guideline: Diagnosis and

management of asthma

Key points:

Recommends spirometry to demonstrate obstruction and assess reversibility, including

in children ≥5 years of age using a short-acting bronchodilator.

Recommends considering spirometry to establish a diagnosis of asthma if any of these

indicators is present:

- Wheezing, history of cough (particularly at night), recurrent wheezing,

dyspnea, or chest tightness.

- Symptoms occur or worsen in the presence of exogenous factors (infection,

exposure to allergens, airborne particles, changes in weather), strong

emotional expression, and menstrual cycles.

- Symptoms occur or worsen at night, awakening the patient.

Office-based physicians who care for asthma patients should have access to spirometry

for diagnosis and periodic monitoring using equipment and techniques that meet ATS

standards.

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References

Professional society guidelines/other:

Chronic Obstructive Pulmonary Disease: Screening. Release date: April 2016. U.S. Preventive Services

Task Force (USPSTF) website.

https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/chronic-

obstructive-pulmonary-disease-screening. Accessed April 25, 2018.

Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and

treatment of severe asthma. Eur Respir J. 2014; 43(2): 343 – 373.

Coates AL, Graham BL, McFadden RG, et al. Spirometry in primary care. Can Respir J. 2013; 20(1): 13 –

21.

From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for

Chronic Obstructive Lung Disease (GOLD) 2017. GOLD website. http://goldcopd.org. Accessed April 25,

2018.

Kang PB, Morrison L, Iannaccone ST, et al. Evidence-based guideline summary: evaluation, diagnosis, and

management of congenital muscular dystrophy: Report of the Guideline Development Subcommittee of

the American Academy of Neurology and the Practice Issues Review Panel of the American Association

of Neuromuscular & Electrodiagnostic Medicine. Neurology. 2015; 84(13): 1369 – 1378.

Lahiri T, Hempstead SE, Brady C, et al. Clinical Practice Guidelines from the Cystic Fibrosis Foundation for

Preschoolers with Cystic Fibrosis. Pediatrics. 2016; 137(4).

Meyer KC, Raghu G, Verleden GM, et al. An international ISHLT/ATS/ERS clinical practice guideline:

diagnosis and management of bronchiolitis obliterans syndrome. Eur Respir J. 2014; 44(6): 1479 – 1503.

Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. Eur Respir J. 2005; 26(2): 319 –

338.

National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis

and Management of Asthma. Full Report 2007. National Heart, Lung, and Blood Institute website.

https://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf. Accessed April 25, 2018.

Preoperative tests (update). Routine preoperative tests for elective surgery. National Institute for Health

and Care Excellence (NICE) website. https://www.nice.org.uk/guidance/ng45/evidence/full-guideline-

87258149468. Accessed April 25, 2018.

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Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive

pulmonary disease: a clinical practice guideline update from the American College of Physicians,

American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann

Intern Med. 2011; 155(3): 179 – 191.

Rosenfeld M, Allen J, Arets BH, et al. An official American Thoracic Society workshop report: optimal

lung function tests for monitoring cystic fibrosis, bronchopulmonary dysplasia, and recurrent wheezing

in children less than 6 years of age. Ann Am Thorac Soc. 2013; 10(2): S1 – s11.

Peer-reviewed references:

Csikesz NG, Gartman EJ. New developments in the assessment of COPD: early diagnosis is key. Int J

Chron Obstruct Pulmon Dis. 2014; 9: 277 – 286.

Donner CF, Virchow JC, Lusuardi M. Pharmacoeconomics in COPD and inappropriateness of diagnostics,

management and treatment. Respir Med. 2011; 105(6): 828 – 837.

Haroon SM, Jordan RE, O'Beirne-Elliman J, Adab P. Effectiveness of case finding strategies for COPD in

primary care: a systematic review and meta-analysis. NPJ Prim Care Respir Med. 2015; 25: 15056.

José BP, Camargos PA, Cruz Filho AA, Correa Rde A. Diagnostic accuracy of respiratory diseases in

primary health units. Rev Assoc Med Bras (1992). 2014; 60(6): 599 – 612.

Kochanek KD, Murphy SL, Xu JQ, Tejada-Vera B. Deaths: Final data for 2014. National vital statistics

reports; vol 65 no 4. 2016. National Center for Health Statistics website.

https://www.cdc.gov/nchs/data/nvsr/nvsr65/nvsr65_04.pdf. Accessed April 25, 2018.

Pulmonary Function Tests. National Heart, Lung, and Blood Institute (NHLBI) website.

https://www.nhlbi.nih.gov/health/health-topics/topics/lft. Accessed April 25, 2018.

Screening for Chronic Obstructive Pulmonary Disease: A Systematic Evidence Review for the U.S.

Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality

(US); 2016 Apr. (Evidence Syntheses, No. 130). NCBI website.

https://www.ncbi.nlm.nih.gov/books/NBK361185/. Accessed April 25, 2018.

CMS National Coverage Determinations (NCDs):

No NCDs identified as of the writing of this policy.

Local Coverage Determinations (LCDs):

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L33707 Pulmonary Diagnostic Services. CMS website. http://www.cms.gov/medicare-coverage-

database/details/lcd-details.aspx?LCDId=33707&ver=12Accessed April 25, 2018.

L34247 Pulmonary Function Testing CMS website. http://www.cms.gov/medicare-coverage-

database/details/lcd-details.aspx?LCDId=34247&ver=22. Accessed April 25, 2018.

DL34247 Pulmonary Function Testing CMS website. http://www.cms.gov/medicare-coverage-

database/details/lcd-details.aspx?LCDId=37285&ver=5. Accessed April 25, 2018.

DL37289 Pulmonary Function Testing CMS website. http://www.cms.gov/medicare-coverage-

database/details/lcd-details.aspx?LCDId=37288&ver=4. Accessed April 25, 2018.

L35360 Pulmonary Function Testing CMS website. http://www.cms.gov/medicare-coverage-

database/details/lcd-details.aspx?LCDId=35360&ver=32. Accessed April 25, 2018.

InterQual

CP: Procedures. Electrophysiology (EP) testing +/- radiofrequency ablation (RFA), cardiac.

CP: Procedures Adult. Radiofrequency ablation (RFA), cardiac.

Commonly submitted codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is

not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and

bill accordingly.

CPT Code Description Comments

94010 Spirometry, including graphic record, total and timed vital capacity, expiratory flow rate measurement(s), with or without maximal voluntary ventilation

94011 Measurement of spirometric forced expiratory flows in an infant or child through 2 years of age

94012 Measurement of spirometric forced expiratory flows, before and after bronchodilator, in an infant or child through 2 years of age

94013 Measurement of lung volumes (ie, functional residual capacity [FRC], forced vital capacity [FVC], and expiratory reserve volume [ERV]) in an infant or child through 2 years of age

94060 Bronchodilation responsiveness, spirometry as in 94010, pre-and post-bronchodilator administration

94070 Bronchospasm provocation evaluation, multiple spirometric determinations as in 94010, with administered agents (eg, antigen[s], cold air, methacholine)

94150 Vital capacity, total (separate procedure)

94200 Maximum breathing capacity, maximal voluntary ventilation

94250 Expired gas collection, quantitative, single procedure (separate procedure)

94375 Respiratory flow volume loop

94400 Breathing response to CO2 (CO2 response curve)

14

CPT Code Description Comments

94450 Breathing response to hypoxia (hypoxia response curve)

94617 Exercise test for bronchospasm, including pre- and post-spirometry, electrocardiographic recording(s), and pulse oximetry

94618 Pulmonary stress testing (eg, 6-minute walk test), including measurement of heart rate, oximetry, and oxygen titration, when performed

94621 Pulmonary stress testing; complex (including measurements of CO2 production, O2 uptake, and electrocardiographic recordings)

94640

Pressurized or nonpressurized inhalation treatment for acute airway obstruction for therapeutic purposes and/or for diagnostic purposes such as sputum induction with an aerosol generator, nebulizer, metered dose inhaler or intermittent positive pressure breathing (IPPB) device

94664 Demonstration and/or evaluation of patient utilization of an aerosol generator, nebulizer, metered dose inhaler or IPPB device

94680 Oxygen uptake, expired gas analysis; rest and exercise, direct, simple

94681 Oxygen uptake, expired gas analysis; including CO2 output, percentage oxygen extracted

94690 Oxygen uptake, expired gas analysis; rest, indirect (separate procedure)

94726 Plethysmography for determination of lung volumes and, when performed, airway resistance

94727 Gas dilution or washout for determination of lung volumes and, when performed, distribution of ventilation and closing volumes

94728 Airway resistance by impulse oscillometry

94729 Diffusing capacity (eg, carbon monoxide, membrane) (List separately in addition to code for primary procedure)

94750 Pulmonary compliance study (eg, plethysmography, volume and pressure measurements)

ICD-10 Code Description Comments

B44.81 Allergic bronchopulmonary aspergillosis

C33-C34.92 Malignant Neoplasm of trachea, unspecified part of left bronchus or lung

C78.00-C78.02 Secondary malignant neoplasm of unspecified lung - Secondary malignant

neoplasm of left lung

C78.30-C78.39 Secondary malignant neoplasm of unspecified respiratory organ - Secondary

malignant neoplasm of other respiratory organs

D14.12 Benign neoplasm of trachea

D14.30-D14.32 Benign neoplasm of unspecified bronchus and lung - Benign neoplasm of left

bronchus and lung

D57.01 Hb-SS disease with acute chest syndrome

D57.211 Sickle-cell/Hb-C disease with acute chest syndrome

D57.811 Sickle-cell thalassemia with acute chest syndrome

D86.0-D86.9 Sarcoidosis of lung

E84.0 Cystic fibrosis with pulmonary manifestations

E84.19 Cystic fibrosis with other intestinal manifestations

I26.01-I26.99 Septic pulmonary embolism with acute cor pulmonale

J17 Pneumonia in diseases classified elsewhere

J18.8-J18.9 Other pneumonia

J20.0-J21.9 Acute bronchitis

J22 Unspecified acute lower respiratory infection

J39.8 Other specified diseases of upper respiratory tract

15

ICD-10 Code Description Comments

J40 Bronchitis, not specified as acute or chronic

J41.0-J42 Simple chronic bronchitis

J43.0-J43.9 Emphysema

J44.0-J45.998 Chronic obstructive pulmonary disease with acute lower respiratory infection

J47.0-J47.9 Bronchiectasis with acute lower respiratory infection

J60 Coalworker's pneumoconiosis

J61 Pneumoconiosis due to asbestos and other mineral fibers

J62.0-J62.8 Pneumoconiosis due to talc dust - Pneumoconiosis due to other dust

containing silica

J63.0-J63.6 Aluminosis (of lung) - Pneumoconiosis due to other specified inorganic dusts

J64-J65 Unspecified pneumoconiosis

J66.0-J66.8 Airway disease due to other specific organic dusts

J67.0-J67.9 Farmer's lung - Hypersensitivity pneumonitis due to unspecified organic dust

J70.0-J70.9 Acute pulmonary manifestations due to radiation - Respiratory conditions due

to unspecified external agent

J80-J81.0 Acute respiratory distress syndrome, Pulmonary Edema

J82 Pulmonary eosinophilia, not elsewhere classified

J84.01 Alveolar proteinosis

J84.02 Pulmonary alveolar microlithiasis

J84.09 Other alveolar and parieto-alveolar conditions

J84.10 Pulmonary fibrosis, unspecified

J84.111-J84.117 Idiopathic interstitial pneumonia, not otherwise specified - Desquamative

interstitial pneumonia

J84.17 Other interstitial pulmonary diseases with fibrosis in diseases classified

elsewhere

J84.2 Lymphoid interstitial pneumonia

J84.81 Lymphangioleiomyomatosis

J84.82 Adult pulmonary Langerhans cell histiocytosis

J84.89 Other specified interstitial pulmonary diseases

J95.1-J95.3 Acute/Chronic pulmonary insufficiency following surgery

J95.821-J95.822 Acute/Acute and chronic postprocedural respiratory failure

J96.00-J96.92 Acute respiratory failure, unspecified

J98.01-J98.09 Acute bronchospasm, other diseases of bronchus, not specified

J98.11-J98.4 Atelectasis - Other disorders of lung

J98.6 Disorders of diaphragm

J98.8 Other specified respiratory disorders

J99 Respiratory disorders in diseases classified elsewhere

M31.0 Hypersensitivity angiitis

M32.13 Lung involvement in systemic lupus erythematosus

M33.01 Juvenile dermatomyositis with respiratory involvement

M33.11 Other dermatomyositis with respiratory involvement

M33.21 Polymyositis with respiratory involvement

M33.91 Dermatopolymyositis, unspecified with respiratory involvement

M34.81 Systemic sclerosis with lung involvement

M35.02 Sicca syndrome with lung involvement

R04.2 Hemoptysis

16

ICD-10 Code Description Comments

R04.89 Hemorrhage from other sites in respiratory passages

R04.9 Hemorrhage from respiratory passages, unspecified

R05 Cough

R06.00-R06.09 Dyspnea, unspecified

R06.2 Wheezing

R06.3 Periodic breathing

R06.81 Apnea, not elsewhere classified

R06.82 Tachypnea, not elsewhere classified

R06.83-R06.89 Snoring, Other abnormalities of breathing

R09.2 Respiratory arrest

R91.1-R91.8 pulmonary nodule - Other nonspecific abnormal finding of lung field

Z01.81 Encounter for preprocedural respiratory examination

HCPCS

Level II Code Description Comments

N/A Not Applicable