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
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.
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.
Pulmonary function tests.
Chronic obstructive pulmonary
- 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.
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.
For the purpose of medical review, the provider must use the various PFT modalities in a
purposeful and logical sequence in test selection.
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
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.
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
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,
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 ga