Respiratory care (respiratory therapy) is defined as those services prescribed
by a physician or a non-physician practitioner for the assessment and
diagnostic evaluation, treatment, management, and monitoring of patients with
deficiencies and abnormalities of cardiopulmonary function.  
  
Monitoring is defined as the periodic checking of the equipment in actual use
to ascertain proper functioning; real time tracking the individual's condition
to assure that he/she is receiving effective respiratory therapy services; and
periodic evaluation of the patient's progress in improvement of respiratory
function.  
  
Respiratory care (respiratory therapy) services may include but are not
limited to the following:

  * application techniques to support oxygenation and ventilation in an acute illness (e.g., establish/maintain artificial airway, ventilatory therapy, precise delivery of oxygen concentrations, aid in removal of secretions from pulmonary tree)
  * therapeutic use/monitoring of medicinal gases, pharmacologically active mists and aerosols, and equipment (e.g., resuscitators, ventilators)
  * bronchial hygiene therapy (e.g., deep breathing, coughing exercises, IPPB, postural drainage, chest percussion/vibration, and nasotracheal/endotracheal suctioning)
  * diagnostic tests ordered by and for the evaluation by a physician or NPP (e.g., pulmonary function test, spirometry, and blood gas analyses etc.)
  * pulmonary rehabilitation techniques (e.g., exercise conditioning, breathing retraining, and patient education regarding management of patient's respiratory problems) and
  * periodic assessment of the patient for the effectiveness of respiratory therapy services.

For Pulmonary Rehabilitation services, please refer to Noridian's Billing and
Coding: Pulmonary Rehabilitation Services Local Coverage Article under Related
Documents at the end of this policy.

The above services may be performed by respiratory therapists, physical
therapists, nurses, and other qualified personnel as described by relevant
state practice acts. Documentation in the medical record must clearly support
the need for respiratory therapy services to be separately reimbursed.  
  
Respiratory care (respiratory therapy) services can be considered reasonable
and necessary for the diagnosis and treatment of a specific illness or injury.
The service provided must be consistent with the severity of the patient's
documented illness and must be reasonable in terms of modality, amount,
frequency, and duration of treatment. The treatment must be generally accepted
by the professional community as safe and effective for the purpose used, and
recognized standards of care should not be violated.  
  
Medicare coverage of respiratory care (respiratory therapy) provided as
outpatient hospital or extended care services depends on the determination by
the attending physician (as part of his/her plan of treatment) that for the
safe and effective administration of such services the procedures or exercises
in question need to be performed by a respiratory therapist, physical
therapists, nurses, and other qualified personnel as described by relevant
state practice acts as listed above. In addition, Medicare may cover postural
drainage and pulmonary exercises furnished by a respiratory therapist as
incident to a physician's professional service.

Instructing a patient in the use of equipment, breathing exercises, etc. may
be considered reasonable and necessary for the treatment of the patient's
condition and can usually be given to a patient during the course of treatment
by any of the health personnel involved, (e.g., physician, nurse, respiratory
care practitioner or other qualified personnel). _These educational
instructions are bundled into the covered service and separate payment is not
made._ Separate billing for one-on-one education is rarely necessary and is
usually only reasonable at the start of the treatment plan. Initially, for
outpatient care where a series of visits provides "... an individualized
physical conditioning and exercise program using proper breathing techniques..."
separate billing for one-on-one intervention is both reasonable and necessary.
Provision of more information than is ordinarily provided during the course of
a treatment (e.g., extensive theoretical background in the pathology,
etiology, and physiological effects of the disease) is not considered
reasonable and necessary. Group sessions that only offer generalized (i.e.,
non-individualized) education and training are not covered.  
  
Therapeutic procedures with an individualized physical conditioning and
exercise program using proper breathing techniques can be considered for a
patient with activity limitations. Breathing retraining, energy conservation,
and relaxation techniques are often used. Ventilatory muscle training (VMT)
may be considered reasonable and necessary in a very select population of
pulmonary patients who demonstrate significantly decreased respiratory muscle
strength and who remain symptomatic despite optimal therapy. Routine exercise,
or any exercise, without a documented need for skilled care, is not covered.

**Pulmonary Function Tests**

Pulmonary Function Tests (PFTs) are a broad range of diagnostic procedures
that measure two components of the respiratory system's functional status: 1)
the mechanical ability to move air in and out of the lungs, and 2) the
effectiveness of providing oxygen to the body and removing carbon dioxide.

Pulmonary function tests are divided into five general areas:

  * Spirometry,
  * Lung Volume,
  * Diffusion Capacity,
  * Lung compliance, and
  * Pulmonary Studies during Exercise Testing. 

General indications for any of the pulmonary function tests include:

  * To determine the presence of lung disease or abnormality of lung function; 
  * To determine the type of abnormality; 
  * To determine the extent of abnormality; 
  * To determine the extent of disability due to abnormal lung function, and
  * To determine and evaluate one or more courses of therapy in the treatment of the particular condition. 

General limitations for any of the pulmonary function tests include:

  * All diagnostic tests payable by Medicare must be ordered by a treating physician and used in patient care. Community standards always apply. 
  * The various modalities to assess pulmonary function must be used in a purposeful and logical sequence.
  * Tests performed as components rather than a single test will be denied.
  * **Medicare does not cover screening tests.** Medicare coverage excludes routine (screening) tests for asymptomatic patients with or without high risk of lung disease (e.g., prolonged smoking history). It also excludes studies as part of a routine exam, and studies as part of an epidemiological survey. 

**Medical necessity is an overriding requirement for Medicare coverage of
diagnostic testing.** When a diagnosis or evaluation can be made clinically or
when test results are not necessary to manage the patient's disease, then
Pulmonary Function Testing is not reasonable and necessary. In addition, on
routine visits for other medical conditions, when a patient claims to be
stable or does not report clinically meaningful changes in pulmonary status, a
physical exam and interview confirm this, repeat testing is unlikely to be
necessary. Noridian has found that in many patients routine use of PFTs at
each office visit is not a necessary and reasonable clinical practice and as
such, cannot be reimbursed.

Providers should pay particular attention to guidelines for the usage of the
CPT codes relative to Medicare's standards of reasonable and necessary care
found in the Billing and Coding article attached under Related Local Coverage
Documents below.

**1\. Spirometry:  **

Spirometry is performed by having the patient breathe into a mouthpiece that
is connected to an instrument called a spirometer. The spirometer records the
amount of air and the rate that it is breathed in and out over a specified
amount of time (approximately 10 seconds). Some of the test measurements are
obtained by normal breathing and other measurements require forced inhalation
and exhalation.

Spirometry is most useful for assessing obstructive lung diseases such as
asthma and chronic obstructive pulmonary disease (COPD).  
  
Refer to the Billing and Coding article attached under Related Local Coverage
Documents below for the CPT codes for Spirometry. Routine and/or repetitive
billing for unnecessary batteries of tests is not clinically reasonable.

**Specific indications for spirometry include:**  
Diagnostic indications:

  * Detect the presence or absence of lung dysfunction suggested by history or clinically significant physical signs and symptoms,
  * Detect the presence or absence of lung dysfunction suggested by other abnormal diagnostic tests (e.g., radiography, arterial blood gas analysis).

Monitoring indications:

  * Quantify the severity of known lung disease,
  * Assess the change in lung function over time,
  * Assess the change in lung function following administration of or a change in therapy,
  * Assess the risk for surgical procedures known to affect lung function.

**Limitations to performing spirometry are:**

  * Routine or repetitive batteries of tests are not clinically reasonable.
  * In many scenarios, simple spirometry is a mainstay of pulmonary function testing and is usually sufficient to differentiate between obstructive and restrictive disorders and evaluate their severity. Extensive testing may often not be necessary for adequate clinical assessment.
  * Post-bronchodilator spirometry is used to evaluate the reversible component of bronchospasm and to determine if the patient is a bronchodilator therapy candidate. Claims for spirometry will be subject to medical review as follows: there are clinical signs and symptoms consistent with bronchospasm; or spirometry without bronchodilator is abnormal; or reversibility or nonreversibility of bronchospasm has not been demonstrated. Repeat studies are covered only with clinically significant change, necessitating adjustment/augmentation of therapy, appropriately documented.
  * General clinical contraindications to spirometry include: hemoptysis of unknown origin, pneumothorax, unstable cardiovascular status, thoracic/abdominal or cerebral aneurysms, recent eye surgery, recent thoracic or abdominal surgery, and presence of acute disease processes that interfere with test performance.

**2\. Lung volume**  
  
The entire lung volume is not measured by simple spirometry because it is
larger than the air quantity exhaled/inhaled. Lung volume is measured when a
person breathes nitrogen or helium gas through a tube for a specified period
of time. The change in concentration of the gas in a chamber attached to the
tube is measured before and after test breathing, allowing estimation of the
lung volume. Measures include total lung capacity, residual volume, and
functional residual capacity.  
  
Lung volume tests are most useful for assessing restrictive lung diseases such
as those caused by scarring inside the lungs or by abnormalities in the
ribcage or muscles of the chest wall.  
  
CPT codes for lung volume determination may be added when clinically relevant
(see Section 4).

**Indications for a lung volume test are as follows, when consistent with
community standards of reasonable clinical practice:**

  * Evaluation of the type and degree of pulmonary dysfunction,
  * Evaluation of dyspnea, cough, and other symptoms,
  * Early detection of lung dysfunction,
  * Follow-up and response to therapy,
  * Preoperative evaluation,
  * Track pulmonary disease progression,
  * Assess the effectiveness of therapy for pulmonary conditions,
  * Pre and post-op evaluations for Lung Volume Reduction Surgery (LVRS).

**Limitations to performing a lung volume test are:**

  * Functional Residual Capacity (FRC) may be artificially high if the measurement is taken at a higher lung volume secondary to pain or anxiety,
  * Subject cooperation is necessary,
  * A complete evaluation may require the use of inhaled gases,
  * Repetitive testing of total lung volume is not usually clinically necessary.

**3\. Diffusion Capacity**  
  
Diffusion capacity is measured when a person breathes in a measured amount of
carbon monoxide for a very short time (often just one breath). While breathing
out, the concentration of carbon monoxide is measured. The difference in the
amount of carbon monoxide inhaled and the amount exhaled allows estimation of
how rapidly gases can travel from the lungs into the blood.  
  
Diffusion capacity tests are most useful for the assessment of how well the
lung tissues transfer oxygen from the air inside the lungs, across thin
membranes, into the blood.

**Indications for diffusion capacity (DLCO) are as follows, when consistent
with community standards of reasonable clinical practice:**

  * Evaluate and follow up parenchymal lung diseases associated with dusts or drug reactions or Sarcoidosis,
  * Evaluate and follow up emphysema and cystic fibrosis,
  * Differentiate between chronic bronchitis, emphysema, and asthma in patient with obstructive patterns,
  * Evaluate the pulmonary involvement in systemic diseases (e.g., rheumatoid arthritis, systemic lupus),
  * Help in the evaluation of some types of cardiovascular disease (e.g., primary pulmonary hypertension, pulmonary edema, acute or recurrent thromboembolism),
  * Predict arterial desaturation during exercise in chronic obstructive pulmonary disease,
  * Evaluate and quantify the disability associated with interstitial lung disease,
  * Evaluate the effects of chemotherapy agents or other drugs known to induce pulmonary dysfunction,
  * Evaluate hemorrhagic disorders.

**Limitations to performing a diffusion capacity test are:**

  * Mental confusion or muscular incoordination preventing the subject from adequately performing the maneuver,
  * Single breath DLCO requires breath holding at maximal inhalation. Some patients may be limited by syncopal symptoms triggered by an associated Valsalva or Muller maneuver which may slow the heart rate.

**4\. Lung Compliance**

Lung compliance studies are performed only when all other PFTs give equivocal
results or results which must be confirmed by additional lung compliance
testing. Lung compliance measures the elastic recoil/stiffness of the lungs.
It is more invasive than other PFTs, because the patient is required to
swallow an esophageal balloon.

**5\. Pulmonary Studies during Exercise Testing:  **

Pulmonary stress testing is done in two (2) forms.

  * The simple pulmonary stress testing is a test that allows quantification of workload and heart rate activity, while measuring the degree of oxygen desaturation. This test is undertaken to measure the degree of hypoxemia or desaturation that occurs with exertion. It is also used to optimize titration of supplemental oxygen for the correction of hypoxemia.
  * A more complex protocol involves the measurements of oxygen uptake, CO2 production, and O2. Indications for this protocol include the following:
    * To distinguish between cardiac and pulmonary causes for dyspnea;
    * To determine the need for and dose of ambulatory oxygen;
    * To assist in developing a safe exercise prescription for patients with cardiovascular or pulmonary disease;
    * To predict the morbidity of lung resection; or
    * To titrate optimal settings in selected patients who have physiologic pacemakers. ****

**Qualifications of personnel**  
Personnel who perform all pulmonary function tests should have verifiable
training in all aspects of spirometry, lung volume, diffusion capacity, lung
compliance, and pulmonary exercise testing, including equipment operation,
quality control, and test outcomes relative to diagnosis and medical history.  
  
This A/B MAC would anticipate that clinical practices with heavy emphasis on
extensive batteries of complex pulmonary function tests and primary focus on
treating severe pulmonary disease would often be managed by pulmonologists or
by other physicians with specialized experience in respiratory disorders, and
that such pulmonary testing centers would often have staff with specific
training in respiratory therapy (for example, associate degree in respiratory
therapy, licensure as a Respiratory Care Practitioner, or National Board of
Respiratory Care (NBRC) certification).  
  
According to National Regulations, clinics which are (a) not physician owned
and which are (b) billing Medicare primarily for diagnostic tests may be
required to enroll as IDTFs. For example, a nonphysician owner who establishes
a diagnostic PFT clinic by leasing office space, equipment, and hiring
technicians, and hires a retired ophthalmologist to provide off-site (general)
supervision of diagnostic testing without treatment would be more
appropriately enrolled as an IDTF.

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