Nebulizers

Revision Effective Date: 02/01/2026
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised: “The following table represents the maximum milligrams/per month of inhalation drugs that are reasonable and necessary for each nebulizer drug.” to “The following table represents the maximum per month of inhalation drugs that are reasonable and necessary for each nebulizer drug.,” as clarification
Revised: “Maximum Milligrams/Month” to “Maximum Per Month” in the header of the second column within the tables that pertain to the maximums per month of inhalation drugs and solutions, as clarification
Revised: “When albuterol, levalbuterol, or metaproterenol are prescribed as rescue/supplemental medication for beneficiaries who are taking formoterol or arformoterol, the maximum milligrams/per month that are reasonably billed are:” to “When albuterol, levalbuterol, or metaproterenol are prescribed as rescue/supplemental medication for beneficiaries who are taking formoterol or arformoterol, the maximum per month that are reasonably billed are:,” as clarification
Revised: “Albuterol/Ipratroprium combination” to “Albuterol/Ipratropium combination” in the first column of the second table pertaining to inhalation drugs and solutions


02/19/2026: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary.

Revision Effective Date: 02/01/2026
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised: Small volume nebulizer and related compressor coverage information to include coverage when it is reasonable and necessary to administer the FDA-approved inhalation solution of hypertonic saline (J7131) for specified diagnoses (with reference to Group 15 ICD-10-CM Codes in the LCD-related Policy Article)
Revised: Small volume nebulizer and related compressor coverage information to include coverage when it is reasonable and necessary to administer the FDA-approved inhalation solution of ensifentrine (J7601) as an add-on therapy for specified diagnoses (with reference to Group 16 ICD-10-CM Codes in the LCD-related Policy Article and reference to the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS in the LCD-related Policy Article)
Added: “Use of ensifentrine (J7601) without either dual LABA/LAMA maintenance therapy or triple LABA/LAMA/ICS maintenance therapy will be considered not reasonable and necessary.”
Revised: The table that represents the maximum milligrams/month of inhalation drugs that are reasonable and necessary for each nebulizer drug, by adding one row that includes “Ensifentrine” in the Inhalation Drugs and Solutions column and that includes “180 mg/month – 60 units/month” in the Maximum Milligrams/Month column
Revised: The table that represents the maximum milligrams/month of inhalation drugs that are reasonable and necessary for each nebulizer drug, by adding one row that includes “Hypertonic Saline” in the Inhalation Drugs and Solutions column and that includes “240 ml/month” in the Maximum Milligrams/Month column
SUMMARY OF EVIIDENCE:
Added: Information related to ensifentrine
Added: Information related to hypertonic saline
ANALYSIS OF EVIDENCE (RATIONALE FOR DETERMINATION):
Added: Information related to ensifentrine
Added: Information related to hypertonic saline
HCPCS CODES:
Added: HCPCS J7131 and J7601 to Group 3 Codes
BIBLIOGRAPHY:
Added: Information related to ensifentrine
Added: Information related to hypertonic saline
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A60378)

Revision Effective Date: 01/01/2024
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”


12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

Revision Effective Date: 01/01/2023
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: Instructions to DRUG WASTAGE section to see MODIFIERS section of the LCD-related Policy Article
Removed: JW and JZ modifier instructions from DRUG WASTAGE section


06/15/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 01/01/2023
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: JZ modifier to the DRUG WASTAGE section
SUMMARY OF EVIDENCE:
Removed: Summary of evidence information, due to not being applicable to the non-discretionary changes
ANALYSIS OF EVIDENCE (RATIONALE FOR DETERMINATION):
Removed: Analysis of evidence information, due to not being applicable to the non-discretionary changes
CODING INFORMATION:
Added: JZ modifier
BIBLIOGRAPHY:
Removed: Bibliography information, due to not being applicable to the non-discretionary changes


01/12/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 06/05/2022
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Group 3 Codes reference for small volume nebulizer (A7003, A7004, A7005) and related compressor (E0570)
Revised: Language regarding coverage of E0574, to include administration of Treprostinil inhalation solution to beneficiaries with pulmonary hypertension only and reference to Group 11 Codes in the LCD-related PA
Revised: Coverage criteria for treprostinil and iloprost
Added: Separate criteria language for iloprost
Removed: Thromboembolic disease of the pulmonary arteries from criteria for treprostinil and iloprost
Added: Criterion 4 to treprostinil coverage criteria and reference to Group 11 Codes in the LCD-related PA
Added: Reference to Group 14 Codes in the LCD-related PA for iloprost
SUMMARY OF EVIDENCE:
Added: Information related to treprostinil inhalation solution for PH-ILD and related to iloprost and treprostinil inhalation solution for CTEPH
ANALYSIS OF EVIDENCE:
Added: Information related to treprostinil inhalation solution for PH-ILD and related to iloprost and treprostinil inhalation solution for CTEPH
BIBLIOGRAPHY:
Added: Section related to treprostinil inhalation solution for PH-ILD and related to iloprost and treprostinil inhalation solution for CTEPH
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A59085)

Revision Effective Date: 05/17/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Statement regarding base and related accessories and supplies (BPM Ch. 15, Section 110.3)
Clarified: “considered for coverage” to drug and equipment criteria
Added: Revefenacin to inhalation solutions for the management of obstructive pulmonary disease - For Dates of Service on or after 11/9/2018 (FDA Approval Date)
Revised: “alpha” to “alfa” in relation to HCPCS code J7639
Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA
Added: Statement to refer to ICD-10 codes in the LCD-related Policy Article
Revised: “alpha” to “alfa” in table with maximum milligrams/month
Added: Revefenacin to table with maximum milligrams/month
Added: Information regarding concurrent use of long-acting and short-acting muscarinic antagonists
Revised: Format of HCPCS code references, from code ‘spans’ to individually-listed HCPCS codes
Revised: "physician" to "practitioner"
Revised: Order information as a result of Final Rule 1713
REFILL REQUIREMENTS:
Revised: "ordering physicians" to "treating practitioners"
SUMMARY OF EVIDENCE:
Added: Information related to revefenacin
ANALYSIS OF EVIDENCE:
Added: Information related to revefenacin
HCPCS CODES:
Added: J7677 to Group 3 Codes in the HCPCS code table
CODING INFORMATION:
Removed: Field titled “Bill Type”
Removed: Field titled “Revenue Codes”
Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: Prescriptions (orders) to SWO
BIBLIOGRAPHY:
Added: Section related to revefenacin
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A58035)

Revision Effective Date: 01/01/2019
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Statements to refer to diagnosis code section below
Added: Refer to Covered ICD-10 Codes in the LCD-related Policy Article
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Moved: All diagnosis codes to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Moved: Statements about noncovered diagnosis codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction

Revision Effective Date: 10/01/2017


Coverage Indications, Limitations and/or Medical Necessity:
Update: References to ICD-10 Codes that Support Medical Necessity
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Added: New ICD-10 codes to Groups 11, 12, 13
Deleted: Non-valid ICD-10 codes from Group 11, 12, 13
Revised: ICD-10 code descriptions in Groups 2, 3, 7, 12, 13
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Update: Language to add “justify”, for Medicare reimbursement


10/26/2017: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

Revision Effective Date: 01/01/2017
Removed: Standard Documentation Language
Added: New reference language and Directions to Standard Documentation Requirements
Added: General Requirements
Revised: Refill Requirements
Revised: Drug Wastage verbiage
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and Directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Directions to Standard Documentation Requirements
Removed: Information from Miscellaneous
Removed: PIM reference from Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article

Revision Effective Date: 07/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard documentation language - ACA requirements – Effective 04/28/16
Added: A7007 and A7017 related accessories table for E0572
Added: Denial verbiage for JW Modifier when coverage criteria not met - Effective 01/01/17
HCPCS MODIFIERS:
Added: JW Modifier – Effective January 1, 2017
DOCUMENTATION REQUIREMENTS:
Revised: Standard documentation language for orders and ACA requirements, added New order requirements, and Correct coding instructions; revised Refill requirements to change "should" to "must",  revised Proof of delivery instructions – Effective 04/28/16
Added: JW Modifier instructions – Effective January 1, 2017

Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.

Revision Effective Date: 01/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Deleted: HCPCS Code A7011 from Accessories tables
HCPCS CODES:
Deleted: HCPCS Code A7011
Added: HCPCS Code J7999
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Group 5 Codes:
Deleted: Code A7011 from the List of HCPCS codes
Group 7 Codes:
Added: ICD-10 Code E84.0 to Group 7 for J7608
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation language to remove start date verbiage from Prescription Requirements (Effective 11/05/2015)
MISCELLANEOUS:
Deleted: Duplicative information about what is required on orders
Updated: HCPCS Code Q9977 cross-walked to J7999
Added: Standard product identification requirements for NOC codes

Revision Effective Date: 10/31/2014
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
Added: Instructions for Equipment Retained from a Prior Payer
Revised: Repair to beneficiary-owned DMEPOS
MISCELLANEOUS:
Added: Instructions for HCPCS code Q9977 - Effective 07/01/2015