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 disability due to abnormal lung function.
  • The progression of the disease.
  • The type of disease or lesion.
  • 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.
Limitations:
  • For the purposes of medical reviews, the carrier expects the provider to follow a thoughtful, purposeful sequence in his selection of tests.
  • Provision of services described by CPT codes 94011, 94012 and 94013 must be accomplished with a physician in attendance at the bedside. Medicare will not cover these services if provided by an IDTF.
  • The Medicare program specifically excludes screening testing. Examples of screening also include, but are not limited to:
    • An asymptomatic patient, with or without high risk of lung disease.
    • Studies as part of a routine exam.
    • Studies as part of an epidemiological survey:
      • Procedure code 94150 is a “bundled” service, which means there is no separate reimbursement for this code.
      • CPT codes 94014, 94015 and 94016 are not covered since their clinical efficacy has not been established.
  • The following summary algorithm is a useful guide that may be considered in medical necessity reviews.
Spirometry
Indications

Spirometry makes up the most commonly applied section of Pulmonary Function Testing (PFT). General indications are:
Diagnostic
  • To evaluate symptoms, signs or abnormal laboratory tests:
    • Symptoms: unexplained dyspnea, wheezing, orthopnea, cough or phlegm production.
    • Signs: unexplained decreased breath sounds, overinflation, 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.
  • To assess prognosis (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.
Limitations:

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. Claims for code 94060 will be covered when at least one of the following conditions is present and documented in the medical record:
  • There are signs or symptoms consistent with bronchospasm.
  • Spirometry without bronchodilator is abnormal.
  • Reversibility of bronchospasm in response to bronchodilator therapy, or lack thereof, has not yet been demonstrated.
If reversibility of bronchospasm (bronchodilator responsiveness) has already been either ruled out or demonstrated, repeat pre- and post-bronchodilator study (94060) will be covered only when there is a significant clinical change in the patient’s functional respiratory status necessitating an adjustment or augmentation of bronchoactive medications, and this is documented in the patient’s medical record.

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 when the vital capacity is reduced. Lung volumes may also be indicated to:
  • Distinguish restrictive disease from COPD.
  • Evaluate bullous diseases and elucidate the date from other lung functions.
  • Assess therapeutic interventions, such as lobectomy and chemotherapy.
Diffusion Capacity (DLCO)

Diffusion capacity (DLCO) measurement is often indicated when spirometry and lung volume studies reveal restrictive disease. 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. Diffusion capacity 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.
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. 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.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, 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.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient’s medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient’s medical need.
    • At least as beneficial as an existing and available medically appropriate alternative.
Bill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12X, 13X, 21X, 22X, 23X, 71X, 73X, 75X, 77X, 83X, 85X
Bill Type Note: Code 73X end-dated for Medicare use March 31, 2010; code 77X effective for dates of service on or after April 1, 2010.
Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/orRevenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual Publication 100-04, Claims Processing Manual, for further guidance.
046X, 0410, 0412 and 0419
CPT/HCPCS Codes
Note:
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
94010©
Breathing capacity test
94011©
Up to 2 yrs old, spirometry
Note: Use code 94011 for infant and child.
94012©
= 2 yrs, spiromtry w/dilator
Note: Use code 94012 for infant and child.
94013©
= 2 yrs, lung volumes
Note: Use code 94013 for infant and child.
94014©
Patient recoded spirometry
94015©
Patient recorded spirometry
94016©
Review patient spirometry
94060©
Evaluation of wheezing
94070©
Evaluation of wheezing
94200©
Lung function test (mbc/mvv)
94240©
Residual lung capacity
94250©
Expired gas collection
94260©
Thoracic gas volume
94350©
Lung nitrogen washout curve
94360©
Measure airflow resistance
94370©
Breath airway closing volume
94375©
Respiratory flow volume loop
94400©
Co2 breathing response curve
94450©
Hypoxia response curve
94680©
Exhaled air analysis, o2
94681©
Exhaled air analysis, o2/co2
94690©
Exhaled air analysis
94720©
Monoxide diffusing capacity
94750©
Pulmonary compliance study
94770©
Exhaled carbon dioxide test
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS codes 94010, 94060, 94200, 94240, 94250, 94260, 94350, 94360, 94370, 94375, 94400, 94450, 94680, 94681, 94690, 94720, 94750 and 94770:
Covered for:
011.00–011.06
Pulmonary tuberculosis
011.10–011.16
Pulmonary tuberculosis
011.20–011.26
Pulmonary tuberculosis
011.30–011.36
Pulmonary tuberculosis
011.40–011.46
Pulmonary tuberculosis
011.50–011.56
Pulmonary tuberculosis
011.60–011.66
Pulmonary tuberculosis
011.70–011.76
Pulmonary tuberculosis
011.80–011.86
Pulmonary tuberculosis
011.90–011.96
Pulmonary tuberculosis
012.00–012.06
Other respiratory tuberculosis
012.10–012.16
Other respiratory tuberculosis
012.20–012.26
Other respiratory tuberculosis
012.30–012.36
Other respiratory tuberculosis
012.80–012.86
Other respiratory tuberculosis
031.0
Pulmonary diseases, due to other mycobacteria
039.1
Actinomycotic infections, pulmonary
045.00–045.03
Acute poliomyelitis
114.0
Primary coccidioidomycosis (pulmonary)
116.0
Blastomycosis
117.1
Sporotrichosis
117.5
Cryptococcosis
135
Sarcoidosis
138
Late effects of acute poliomyelitis
162.0
Malignant neoplasm of trachea
162.2–162.5
Malignant neoplasm of trachea, bronchus and lung
162.8–162.9
Malignant neoplasm of trachea, bronchus and lung
163.0–163.1
Malignant neoplasm of parietal pleura
163.8–163.9
Malignant neoplasm of parietal pleura
164.0–164.3
Malignant neoplasm of thymus, heart, and mediastinum
164.8–164.9
Malignant neoplasm of thymus, heart, and mediastinum
165.0
Malignant neoplasm of upper respiratory tract, part unspecified
165.8–165.9
Malignant neoplasm of other and ill-defined sites within the respiratory system and intrathoracic organs
197.0
Secondary malignant neoplasm of lung
212.3–212.5
Benign neoplasm of respiratory and intrathoracic organs
228.1
Lymphangioma, any site
231.2
Carcinoma in situ of bronchus and lung
235.7
Neoplasm of uncertain behavior of trachea, bronchus and lung
239.1
Neoplasms of unspecified nature of the respiratory system
277.00–277.01
Other and unspecified disorders of metabolism
277.81–277.84
Other specified disorders of metabolism
277.89
Other specified disorders of metabolism
289.0
Polycythemia, secondary
335.20
Amyotrophic lateral sclerosis
344.89
Other specified paralytic syndrome
357.0
Acute infective polyneuritis (Guillain-Barré syndrome)
358.00–358.01
Myasthenia gravis
359.1
Hereditary progressive muscular dystrophy
415.11- 415.12
Pulmonary embolism and infarction
415.19
Other pulmonary embolism and infarction
416.0–416.2
Chronic pulmonary heart disease
416.8–416.9
Chronic pulmonary heart disease
428.0–428.1
Heart failure
428.20–428.23
Systolic heart failure
428.30–428.33
Diastolic heart failure
428.40–428.43
Combined systolic and diastolic heart failure
428.9
Heart failure, unspecified
446.20–446.21
Hypersensitivity angiitis
446.29
Other unspecified hypersensitivity angiitis
466.0
Acute bronchitis
466.11
Acute bronchiolitis due to respiratory syncytial virus (RSV)
466.19
Acute bronchiolitis due to other infectious organisms
480.3
Pneumonia due to SARS-associated coronavirus
490
Bronchitis, not specified as acute or chronic
491.0–491.1
Chronic bronchitis
491.20–491.21
Obstructive chronic bronchitis
491.22
Obstructive chronic bronchitis with acute bronchitis
492.0
Emphysematous bleb
492.8
Other emphysema
493.00–493.02
Asthma
493.10–493.12
Asthma
493.20–493.22
Asthma
493.81–493.82
Other forms of asthma
493.90–493.92
Asthma, unspecified
494.0–494.1
Bronchiectasis
495.0–495.9
Extrinsic allergic alveolitis
496
Chronic airway obstruction, not elsewhere classified
500–505
Pneumoconioses and other lung diseases due to external agents
508.1
Chronic and other pulmonary manifestations due to radiation
508.8–508.9
Respiratory conditions due to other and unspecified external agents
511.0
Pleurisy without mention of effusion or current tuberculosis
511.81
Malignant pleural effusion
511.89
Other specified forms of effusion, except tuberculous
515
Postinflammatory pulmonary fibrosis
516.3
Idiopathic fibrosing alveolitis
516.8
Other specified alveolar and parietoalveolar pneumonopathies
517.2
Lung involvement in systemic sclerosis
517.8
Lung involvement in other diseases classified elsewhere
518.0
Pulmonary collapse
518.7
Transfusion related acute lung injury (TRALI)
518.81
Acute respiratory failure
518.89
Other diseases of lung, not elsewhere classified (chronic pulmonary vascular occlusive disease)
519.11
Acute bronchospasm
519.19
Other diseases of trachea and bronchus
519.4
Disorders of diaphragm
519.8
Other diseases of respiratory system, not elsewhere classified
710.0
Systemic lupus erythematosus
714.81
Rheumatoid lung
737.10
Kyphosis (acquired) (postural)
737.30
Scoliosis [and kyphoscoliosis], idiopathic
754.2
Congenital musculoskeletal deformities of spine
754.81
Pectus excavatum
780.50–780.59
Sleep disturbances
782.5
Cyanosis
786.00–786.07
Dyspnea and respiratory abnormalities
786.09
Other dyspnea and respiratory abnormality
786.1–786.2
Symptoms involving respiratory system and other chest symptoms
790.91
Abnormal arterial blood gases
793.1
Nonspecific (abnormal) findings on radiological and other examination of lung field
799.01-799.02
Other ill-defined and unknown causes of morbidity and mortality, asphyxia (hypoxemia)
909.5
Late effect of adverse effect of drug, medicinal or biological substance
987.0–987.9
Toxic effect of other gases, fumes, or vapors
998.81
Emphysema (subcutaneous) (surgical) resulting from a procedure
V12.60–V12.61
Diseases of respiratory system
V12.69
Other diseases of respiratory system
V42.1
Heart replaced by transplant
V42.6
Lung replaced by transplant
V58.63
Long-term (current) use of antiplatelet/antithrombotic
V58.69
Long-term (current) use of other medications
Medicare is establishing the following limited coverage for CPT/HCPCS code 94070:
Covered for:
493.01
Extrinsic asthma with status asthmaticus
493.10
Intrinsic asthma, unspecified
493.11
Intrinsic asthma with status asthmaticus
493.20
Chronic obstructive asthma, unspecified
493.81
Exercise induced bronchospasm
493.82
Cough variant asthma
493.90
Asthma, unspecified, unspecified
493.91
Asthma, unspecified type, with status asthmaticus
493.92
Asthma, unspecified, with (acute) exacerbation
518.7
Transfusion related acute lung injury (TRALI)
518.89
Other disease of lung, not elsewhere classified (bronchial allergy/hypersensitivity)
786.05
Shortness of breath
786.2
Cough (unexplained)
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Note: Limited coverage is not being established at this time for CPT codes 94011, 94012 or 94013.
Diagnoses That Support Medical Necessity
N/A
ICD-9-CM Codes That DO NOT Support Medical Necessity
V70.0
Routine general medical examination at a health care facility
V70.6
Health examination in population surveys
V70.7
Examination of participant in clinical trial
V72.82
Preoperative respiratory examination
V76.0
Special screening for malignant neoplasms of the respiratory organs
V81.3
Screening for chronic bronchitis and emphysema
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation Requirements
  • Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
  • 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.
  • All equipment and studies should meet minimum standards outlined by the American Thoracic Society.
  • Spirometry studies, in particular, require a minimum of three attempts that must meet minimum acceptability criteria.
  • All studies require an interpretation with a written report. Computerized reports must have a physician’s signature attesting to their accuracy.
Appendices
N/A
Utilization Guidelines
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 (ICD-9-CM diagnosis codes 515 or 516.3) 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.
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.