CurrentClover HealthPolicy 6533-A

Blairex, Hyper-Sal, NebuSal, Pulmosal and Saline/Sodium Chloride Products for Nebulizer Use

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This policy governs Medicare Part B coverage and prior authorization for saline/sodium chloride unit-dose and 500 mL or 1000 mL products used with nebulizers. Coverage is limited to dilution of covered concentrated nebulizer drugs or management of thick, tenacious pulmonary secretions associated with specified conditions when all approval criteria are met.

Policy Summary

PayerClover Health

PolicyBlairex, Hyper-Sal, NebuSal, Pulmosal and Saline/Sodium Chloride Products for Nebulizer Use

Policy CodePolicy 6533-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the covered indication, product quantity or unit-dose volume, intended nebulizer use, applicable product or nebulizer code, and relevant diagnosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsMaximum authorization period

3–15 mLCovered unit-dose volume

500 or 1000 mLCovered secretion quantities

2Clinical indication pathways

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CurrentClover HealthPolicy 6533-A

Blairex, Hyper-Sal, NebuSal, Pulmosal and Saline/Sodium Chloride Products for Nebulizer Use

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Sign up for clover_health Policy 6533-A alerts

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Policy Summary

PayerClover Health

PolicyBlairex, Hyper-Sal, NebuSal, Pulmosal and Saline/Sodium Chloride Products for Nebulizer Use

Policy CodePolicy 6533-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the covered indication, product quantity or unit-dose volume, intended nebulizer use, applicable product or nebulizer code, and relevant diagnosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsMaximum authorization period

3–15 mLCovered unit-dose volume

500 or 1000 mLCovered secretion quantities

2Clinical indication pathways

A4216, A4218Dilution product codes

Covered Indications and Medical-Necessity Criteria

Dilution of concentrated nebulizer drugs

Covered when ALL of the following are met:

Product and administration: The member is using unit-dose products measuring 3 mL to 15 mL with HCPCS code A4216 or A4218; the requested product is used with a nebulizer; and the requested product is used to dilute a concentrated form of a covered nebulizer drug.3 mL to 15 mL; A4216 or A4218
Diagnosis: The member has one of the diagnosis ICD-10 codes listed in the dilution pathway diagnosis group.
See the applicable dilution pathway diagnosis codes.

Bronchiectasis, cystic fibrosis, tracheostomy, or tracheobronchial stent

Covered when ALL of the following are met:

Product quantity and use: The member is using 500 mL or 1000 mL quantities; the requested product will not be used to dilute a concentrated form of a nebulizer drug; and the requested product will be used with a nebulizer having HCPCS code A7007, A7017, or E0585.500 mL or 1000 mL; A7007, A7017, or E0585
Clinical findings: The member has thick, tenacious pulmonary secretions associated with the diagnosis.
Diagnosis: The member has one of the diagnosis ICD-10 codes listed in the secretion-management diagnosis group.
See the applicable secretion-management diagnosis codes.

Covered Products, Quantities, and Diagnosis Codes

Dilution pathway product HCPCS codesHCPCSCovered

A4216	Unit-dose products (3 mL to 15 mL)
A4218	Unit-dose products (3 mL to 15 mL)

Secretion-management nebulizer HCPCS codesHCPCSCovered

A7007	Nebulizer
A7017	Nebulizer
E0585	Nebulizer

Dilution pathway diagnosis ICD-10 codesICD-10Covered

B20	Human immunodeficiency virus [HIV] disease
B59	Pneumocystosis
J41.0	Simple chronic bronchitis
J41.1	Mucopurulent chronic bronchitis
J41.8	Mixed simple and mucopurulent chronic bronchitis
J42	Unspecified chronic bronchitis
J43.0	Unilateral pulmonary emphysema [MacLeod's syndrome]
J43.1	Panlobular emphysema
J43.2	Centrilobular emphysema
J43.8	Other emphysema

1–10 of 134

1/14

Bronchiectasis, cystic fibrosis, tracheostomy, and tracheobronchial stent diagnosis ICD-10 codesICD-10Covered

A15.0	Tuberculosis of lung
E84.0	Cystic fibrosis with pulmonary manifestations
J39.8	Other specified diseases of upper respiratory tract
J47.0	Bronchiectasis with acute lower respiratory infection
J47.1	Bronchiectasis with (acute) exacerbation
J47.9	Bronchiectasis, uncomplicated
J98.09	Other diseases of bronchus, not elsewhere classified
Q33.4	Congenital bronchiectasis
Z43.0	Encounter for attention to tracheostomy
Z93.0	Tracheostomy status

Unit-dose volume

Covered unit-dose volume3 mL to 15 mL

Product typeUnit-dose saline/sodium chloride products

Applicable HCPCS codesA4216 and A4218

Secretion-management quantity

Covered quantities500 mL or 1000 mL

Use restrictionThe product will not be used to dilute a concentrated form of a nebulizer drug

Authorization, Documentation, and Approval Requirements

Prior Authorization

Dilution of Concentrated Nebulizer Drugs

Authorization for 12 months may be granted when the member uses unit-dose saline/sodium chloride products in quantities of 3 mL to 15 mL to dilute a concentrated form of a covered nebulizer drug, with a nebulizer, and all applicable criteria are met.

HCPCS: A4216 or A4218
The requested product must be used with a nebulizer.
The product must be used to dilute a concentrated form of a covered nebulizer drug.

Prior Authorization

Thick, Tenacious Pulmonary Secretions

Authorization for 12 months may be granted for treatment of bronchiectasis, cystic fibrosis, tracheostomy, or tracheobronchial stent when the member has thick, tenacious pulmonary secretions associated with the diagnosis and all applicable criteria are met.

Use 500 mL or 1000 mL quantities.
The product must not be used to dilute a concentrated form of a nebulizer drug.

Policy Overview

This policy addresses saline/sodium chloride products used with nebulizers under Medicare Part B. Coverage is limited to two clinical pathways: dilution of a concentrated, covered nebulizer drug using 3 mL to 15 mL unit-dose products, or management of thick, tenacious pulmonary secretions associated with bronchiectasis, cystic fibrosis, tracheostomy, or tracheobronchial stent. Authorization is available for up to 12 months when all applicable approval criteria are met and the member has no exclusions to the prescribed therapy.

Key Clinical Terms

Thick, tenacious pulmonary secretions

Defined termThick, tenacious pulmonary secretions

Associated conditionsBronchiectasis, cystic fibrosis, tracheostomy, or tracheobronchial stent

Coverage contextSecretions must be associated with the member’s diagnosis for treatment under the secretion-management pathway

Dilution of concentrated nebulizer drugs

Defined termDilution of concentrated nebulizer drugs

Dilution methodUse of saline or sodium chloride to reduce the concentration of a concentrated nebulizer drug

Administration

Policy Summary

PayerClover Health

PolicyBlairex, Hyper-Sal, NebuSal, Pulmosal and Saline/Sodium Chloride Products for Nebulizer Use

Policy CodePolicy 6533-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the covered indication, product quantity or unit-dose volume, intended nebulizer use, applicable product or nebulizer code, and relevant diagnosis.

SourceLink

On This Page

Applicable nebulizer HCPCS codes

A7007, A7017, or E0585

Authorization duration

Authorization periodUp to 12 months

Dilution pathwayUnit-dose products measuring 3 mL to 15 mL used to dilute a concentrated covered nebulizer drug

Secretion-management pathway500 mL or 1000 mL quantities used for thick, tenacious pulmonary secretions associated with specified conditions

The product must be used with a nebulizer billed with HCPCS A7007, A7017, or E0585.

The diagnosis must be supported by an applicable ICD-10 code: A15.0, E84.0, J39.8, J47.0, J47.1, J47.9, J98.09, Q33.4, Z43.0, or Z93.0.

Documentation Required

Required Clinical and Product Documentation

Submit clinical and product documentation showing the covered indication, requested quantity or volume, nebulizer use, and applicable billing codes. Documentation must establish that all approval criteria are met and that no exclusion to the prescribed therapy applies.

For dilution: document unit-dose product use in the 3 mL to 15 mL range, nebulizer use, dilution of a covered concentrated nebulizer drug, and HCPCS A4216 or A4218.
For thick pulmonary secretions: document use of a 500 mL or 1000 mL product, nebulizer use, thick and tenacious secretions associated with the diagnosis, and applicable nebulizer HCPCS A7007, A7017, or E0585.
Support the diagnosis with an applicable ICD-10 code when required: A15.0, E84.0, J39.8, J47.0, J47.1, J47.9, J98.09, Q33.4, Z43.0, or Z93.0.

Documentation Required

Supporting Evidence for Other Indications

For indications other than those specifically enumerated in this policy, submit supporting evidence from Medicare-approved compendia with the authorization request.

Applicable to non-enumerated indications assessed on an individual basis.

Note

Non-Enumerated Indications

Indications outside the specifically covered pathways are not automatically covered and will be assessed on an individual basis. The submission must include supporting evidence from Medicare-approved compendia.

Covered pathways are dilution of concentrated nebulizer drugs and thick, tenacious pulmonary secretions associated with bronchiectasis, cystic fibrosis, tracheostomy, or tracheobronchial stent.
Individual assessment does not waive applicable documentation requirements or exclusions.

Denial Risk

Failure to Meet Approval Criteria

Authorization or payment may be denied when the applicable approval criteria are not satisfied or an exclusion to the prescribed therapy applies.

For dilution requests, criteria include use of a 3 mL to 15 mL unit-dose product, HCPCS A4216 or A4218, nebulizer use, and dilution of a covered concentrated nebulizer drug.
For thick pulmonary secretion requests, criteria include a 500 mL or 1000 mL quantity, no use for dilution of a concentrated nebulizer drug, qualifying nebulizer HCPCS, thick and tenacious secretions, and an applicable diagnosis code.

The diluted product is administered through a nebulizer