Respiratory Devices

POLICY NUMBER

L.1.01.406

DESCRIPTION

1. Pulse oximetry technology is used routinely in clinical care settings to measure arterial oxygen saturation in real time. A pulse oximeter is a machine that attaches to a fingertip, toe, ear, or other site to estimate oxygen levels in the body. The machine uses light energy to “look” at the hemoglobin protein in red blood cells, and find out how much of the hemoglobin proteins have oxygen in them. It is frequently used in emergency rooms, urgent care centers, intensive care units, oxygen clinics, hospitals, and other clinical settings. Health care professionals interpret the data obtained from the device and determine the appropriate treatment for the patient. Like most medical measurement devices, this machine require special evaluation to make sure it is working properly, and not giving false information.

2. A spacer (also known as a chamber, reservoir, Aerochamber®, InspirEase®) is a tube device which attaches to a metered dose inhaler (MDI) for asthma treatment. Some spacers have small masks attached. The asthma medicine is first sprayed into the spacer; then the patient inhales it into the lungs. This drug delivery device helps send more medicine into the lungs in some patients.

3. A peak flow meter is a device that measures breathing capacity and is used by asthmatics or other patients with breathing difficulties:

• Some peak flow meters have special attachments to record measurements, which can be displayed on a computer. The AirWatch® system is considered by the U.S. Food and Drug Administration (FDA) to be a peak flow meter. Compared to regular plastic tube peak flow meters, the AirWatch® meter has electronic parts, and the information from readings can be downloaded into a computer. The AirWatch® meter can also check another reading, FEV1, which is a different measurement of breathing.

Indications for  Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Conditions are discussed in a separate policy.

Indications for  Oxygen Therapy  are discussed in a separate policy.

Indications for  Inhaled Nitric Oxide  are discussed in a separate policy.

Indications for the  Measurement of Exhaled Nitric Oxide and Exhaled Breath Condensate in the Diagnosis and Management of Respiratory Disorders  are discussed in a separate policy.

Indications for  Home Cardiorespiratory Monitoring  are discussed in a separate policy.

Indications for the treatment of  Sleep Disorders  are discussed in a separate policy.

Pulse Oximetry for Home Use  is discussed in a separate policy.

POLICY

The following respiratory devices are considered medically necessary:

• Spacers for use with metered dose inhalers (MDIs)

• Peak flow meters for patients with respiratory disorders

For coverage criteria of pulse oximetry in the home setting, refer to the Pulse Oximetry for Home Use medical policy.

When noninvasive ear or pulse oximetry testing is performed in a professional's office, it is considered integral to the professional's medical or surgical care. Therefore, the device is not a distinct or separate service, and separate payment will not be made for the pulse oximeter in these instances.

Computerized peak flow meters (including AirWatch®). Special features such as computerized recording devices are considered convenience enhancements and are not eligible for additional coverage.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

2/1988: DME Manual specifies pulse oximeter coverage.

8/1997: Approved by Medical Policy Advisory Committee (MPAC) as Vest Percussor.

8/1998: MPAC approved limitation to ThAIRapy® Bronchial Vest/System; policy renamed Oscillatory Devices for Treatment of Cystic Fibrosis.

11/1999: Additional respiratory devices approved by MPAC; policy renamed.

5/9/2001: Device name change added; ABI VEST® Airway Clearance System (formerly know as ThAIRapy® Vest).

2/7/2002: "The following respiratory devices are not covered" changed to "not medically necessary."

5/2/2002: Type of Service and Place of Service deleted.

3/7/2003: Code Reference section updated.

7/18/2003: Device name change added: Vest™ Airway Clearance System (formerly known as ABI Vest® Airway Clearance System and ThAIRapy® Vest).

7/2/2004: Oscillary devices added to Policy Guidelines.

10/18/2005: Code Reference section updated; HCPCS: E0481 added.

9/22/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy.

10/02/2006: Policy updated, all devices not medically necessary.

10/5/2006: Coding updated. HCPC codes A7025, A7026, E0481, E0483, E1399 moved to non-covered table. S8185 added to policy.

9/24/2009: Description Section revised to include links to Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders Medical Policy, Oxygen Medical Policy, Inhaled Nitric Oxide as a Treatment of Hypoxic Respiratory Failure Medical Policy, Measurement of Exhaled Nitric Oxide in the Diagnosis and Management of Asthma and Other Respiratory Disorders Medical Policy, Home Apnea Monitors Medical Policy, Sleep Disorders Medical Policy, and Aerosolized Antibiotics as a Treatment of Chronic Sinusitis Medical Policy. Information on Cystic fibrosis and oscillatory devices removed. Policy Statement Section revised to remove oscillatory devices information. Coding Section revised to remove ICD9 Diagnosis code 277.0 from Covered Codes Table, and revised to remove HCPCS codes A7025, A7026, E0481, E0483, E0484, S8185 from Non-Covered Codes Table. Verbiage added to Covered Codes Table, "* Some covered procedure codes may have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section." Verbiage added to Non-Covered Codes Table, "*This is not an all inclusive list of non-covered procedure codes."

10/19/2009: Coding Section updated to add HCPCS codes S8096, S8097, S8100, and S8101 to the Covered Codes Table, CPT codes 94760, 94761, and 94762 added to the Non-Covered Codes Table, Added verbiage to HCPCS code E1399 (may use for coding the AirWatch® system) under the Non-Covered Codes Table.

06/21/2011: Added link to the Pulse Oximetry for Home Use medical policy and deleted the following policy statement: "In a home setting, a health care professional is not available to evaluate and respond to the data obtained from a pulse oximeter. Therefore, the device is considered inappropriate for home use and is not a covered service."

08/31/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 procedure code 93.18 from the Covered Codes table in the Code Reference section.

05/31/2016: Policy number L.1.01.406 added. Policy Guidelines updated to add medically necessary definition.

05/16/2018: Medical policy links updated in policy description.

01/24/2023: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

02/15/2024: Policy reviewed; no changes.

03/26/2025: Policy reviewed; no changes.

SOURCE(S)

1. Blue Cross & Blue Shield Association policy #1.01.15

2. Hayes Medical Technology Directory

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Investigational Codes 

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