Pulmonary Function Testing

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for pulmonary function testing. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for pulmonary function testing and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
  • Chapter 15, Section 60, Services and Supplies
• CMS IOM Publication 100-08, Medicare Program Integrity Manual,
  • Chapter 13, Section 13.5.4, Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Notice: Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

Covered Indications

Pulmonary function testing (PFT) includes various non-invasive tests that demonstrate how well the lungs are working. The tests measure the capacity of the lungs and the exchange of air.

The evaluation of lung function is indicated to determine:

• The presence of lung disease or abnormality of lung function
• The extent of abnormalities and the potential causative disease process
• The extent of pulmonary impairment due to abnormal lung function
• The progression or improvement of the disease
• The type of disease or pulmonary abnormality
• The response to a course of therapy in the treatment of the particular condition
• The presence of lung disease or abnormality of lung function secondary to toxicity of medication

The tests addressed in this LCD include Spirometry, Lung Volume, Diffusion Capacity (DLCO), Lung Compliance and Indirect Calorimetry Calculations.

Spirometry

Spirometry makes up the most commonly applied section of PFT and it measures how much and how quickly air can be moved out of the lungs.

The general indications for spirometry are:

Diagnostic

• To evaluate symptoms, signs of impaired lung function or abnormal laboratory tests:
  
  • Symptoms: unexplained dyspnea, wheezing, orthopnea, cough or phlegm production
  • Signs: unexplained decreased breath sounds, over inflation, cyanosis, chest deformity, wheezing or unexplained adventitious sounds
  • Abnormal laboratory tests: hypoxemia, hypercapnia, polycythemia or abnormal chest radiographs.
• To measure the effect of systemic disease on pulmonary function (e.g., neuromuscular disease and connective tissue disease)
• To assess preoperative risk in those with history of known or suspected pulmonary dysfunction
• To assess prognosis or lack thereof (lung transplant, etc.)

Monitoring

• To assess therapeutic interventions:
  
  • Bronchodilator therapy
  • Steroid treatment for asthma, interstitial lung disease, etc.
  • Other, such as antibiotics in cystic fibrosis
• To monitor for adverse reactions to drugs with known pulmonary toxicity

Post-bronchodilator spirometry is used to rule out a reversible component to a patient’s bronchospasm and determine if the patient is a candidate for bronchodilator therapy. Post-bronchodilator studies will be covered when at least one of the following conditions is present and documented in the medical record:

• There are signs or symptoms that may be explained on the basis of bronchospasm
• Spirometry without bronchodilator is abnormal
• Reversibility of bronchospasm in response to bronchodilator therapy, or lack thereof, has not yet been demonstrated

Lung Volumes

The absolute lung volumes or capacities cannot be measured by spirometry. They are Total Lung Capacity (TLC), Residual Volume (RV) and Functional Residual Capacity (FRC). Measurement of these volumes or capacities is indicated for the evaluation of the pulmonary patient especially during the initial evaluation of the patient.

Additionally, lung volumes may be indicated to:

• Distinguish restrictive disease from COPD
• Evaluate bullous diseases and elucidate the data from other lung functions
• Assess therapeutic interventions, such as lobectomy and chemotherapy

Diffusion Capacity (DLCO)

DLCO is used to help distinguish between an intrinsic pulmonary process, such as interstitial lung disease and emphysema, and an extrapulmonary process, such as chest wall and neuromuscular disorders. DLCO is also useful in quantifying the degree of parenchymal destruction in COPD, and assessing pulmonary vascular diseases and interstitial diseases, even if vital capacity is normal. 

DLCO measurement is often indicated when spirometry and lung volume studies reveal restrictive disease.

Lung Compliance

Lung compliance measures the elastic recoil or stiffness of the lungs. It is more invasive than other PFTs, because the patient is required to swallow an esophageal balloon. Due to the invasive nature of the tests, compliance studies are performed only when all other PFTs give equivocal results or the results require confirmation by additional data.

Lung compliance may be increased in emphysema and reduced in interstitial lung disease.

Limitations

If reversibility of bronchospasm (bronchodilator responsiveness) has been either ruled out or demonstrated, repeat pre- and post-bronchodilator studies will be covered only when there is a clinical change in the patient's functional respiratory status, change in patient history or physical examination necessitating an adjustment or augmentation of bronchoactive medications, and this is documented in the patient's medical record.

The Medicare program specifically excludes screening testing. Examples of screening include, but are not limited to:

• An asymptomatic patient, with or without high risk of lung disease and no findings on physical examination or other testing to suggest lung abnormalities
• Studies performed as part of a routine exam
• Studies performed as part of an epidemiological survey

Services for vital capacity testing are included services and are not separately reimbursable.

When services for evaluating oxygen uptake, expired gas are performed for calorimetry calculation it will be limited to once every two years. Documentation, even at this level of frequency, will need to clearly demonstrate the reason for the test if reviewed.

For frequency limitations, please refer to the Utilization Guidelines section below.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

N/A

N/A

Refer to the Local Coverage Article: Billing and Coding: Pulmonary Function Testing, A57320, for all coding information.

Documentation Requirements

1. All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The medical record documentation must support the medical necessity of the services as stated in this policy.
4. All providers of pulmonary function tests should have a referral (a prescription) with clinical diagnoses and requested tests on file. Indications for the studies should be clearly described in clinical records and available for review.
5. All equipment and studies should meet minimum standards outlined by the American Thoracic Society.
6. Spirometry studies, in particular, require a minimum of three attempts that must meet minimum acceptability criteria.
7. All studies require an interpretation with a written report. Computerized reports must have a physician’s signature attesting to their accuracy.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Medicare would not expect to see most of the services in this LCD billed more than once annually and would not expect to see many of the services billed more than once in total.

Some patients, such as those under treatment for pulmonary fibrosis, may require more than one episode of respiratory testing each year, perhaps up to four times per year. For Medicare to cover repeated testing, medical necessity must be justifiable upon consideration of both the clinical condition of the patient and the expected clinical utility of the information that will be obtained from the testing. The patient’s record must clearly document diagnoses and conditions that necessitate repeated testing and such documentation must be available to Medicare upon request.

When post-bronchodilator studies are used with a diagnosis of morbid obesity for calorimetry calculation, it will be limited to once every two years. Documentation, even at this level of frequency, will need to clearly demonstrate the reason for the test if reviewed.

Notice: This LCD imposes utilization guideline limitations. Despite Medicare's allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.

L32762, Pulmonary Function Testing, Novitas Solutions Jurisdiction H Local Coverage Determination

Original JH ICD-9 Source LCD L34751, Pulmonary Function Testing

Other Contractor Policies

Contractor Medical Directors

N/A