Nebulizers - Policy Article

Revision Effective Date: 02/01/2026
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: ICD-10-CM codes Z90.02 and Z96.3 to Group 5 Codes


06/18/2026: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 02/01/2026
MODIFIERS:
Added: “dispensing fees” to KX modifier information, as clarification


03/05/2026: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 02/01/2026
CODING GUIDELINES:
Added: Long description for J7699
Removed: Billing information for claims with dates of service from January 1, 2008 through March 31, 2008 pertaining to J7602 and J7603, due to timely filing limit
Revised: “Suppliers must be sure that they use the correct billing unit or the code when calculating the number of units of service to enter on the claim.” to “Suppliers must be sure that they use the correct billing unit of the code when calculating the number of units of service to enter on the claim.”
Revised: Billing unit of service language regarding J7626 for a 0.25 mg vial and a 0.5 mg vial, as clarification
Added: Billing unit of service information regarding J7626 for a 1 mg vial, as clarification
Removed: J7627 from the billing unit of service information (budesonide, unit dose), due to non-coverage of compounded solutions
Removed: Billing information for claims with dates of service on or after November 9, 2018, through June 30, 2019 pertaining to revefenacin, due to timely filing limit


02/19/2026: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 02/01/2026
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: “This does not apply to hypertonic saline J7131, which is administered as an inhalation drug and not a diluent.” to dispensing fee information
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Documentation requirements for ensifentrine
MODIFIERS:
Revised: GA, GZ, and KX modifier instructions to include nebulizers, drugs, and supplies
CODING GUIDELINES:
Added: HCPCS code J7601 to the FDA-approved unit dose codes when billed with a KP or KQ modifier information
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: ICD-10-CM code Q34.8 to Group 3 Codes
Added: Group 15 Paragraph, which is “For HCPCS code J7131:”
Added: Group 15 Codes, which are ICD-10-CM Codes E84.0, J47.0, J47.1, J47.9, Q33.4, Q34.8
Added: Group 16 Paragraph, which is “For HCPCS code J7601:”
Added: Group 16 Codes, which are ICD-10-CM Codes J41.0, J41.1, J41.8, J42, J43.0, J43.1, J43.2, J43.8, J43.9, J44.0, J44.1, J44.89, J44.9


12/18/2025: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2025
MODIFIERS:
Revised: “Effective January 1, 2024, the JZ modifier is also required when billing for drugs and biologicals from single-dose containers that are dispensed by the supplier but self-administered by the beneficiary or the beneficiary’s caregiver.” to “Effective for claims with dates of service on or after January 1, 2024, the JZ modifier is also required when billing for drugs and biologicals from single-dose containers dispensed by the supplier but have no unused and discarded amounts that are self-administered by the beneficiary or the beneficiary’s caregiver.”
Added: “Effective for claims with dates of service on or after January 1, 2025, the JW modifier is also required if a billing supplier is not administering a drug or biological, but there are unused and discarded amounts during the preparation process before supplying the drug or biological to the patient as described in scenario 3 below.”
Revised: “The JW modifier is not required for drugs dispensed by the supplier and self-administered by the beneficiary or the beneficiary’s caregiver in the beneficiary’s home, as it is not expected that the beneficiary or their caregiver provide discarded drug information to the supplier. The JZ modifier is required in this scenario (effective for claims with dates of service on or after January 1, 2024).” to “The JZ modifier is required for drugs and biologicals that are dispensed by the supplier but have no unused and discarded amounts during the preparation process and are self-administered by the beneficiary or the beneficiary’s caregiver in the beneficiary’s home.”
Revised: “Below are two scenarios in regard to the JW modifier.” to “Below are three (3) scenarios in regard to the JW and JZ modifiers.”
Added: “claim” to “In this scenario, the JW modifier must be billed on a separate claim line to provide payment for the amount of discarded drug or biological.,” as clarification
Added: “claim” to “The 70 mg dose is billed correctly by rounding up to 1 UOS (representing the entire 100 mg vial) on a single claim line item with the JZ modifier.,” as clarification
Added: “claim” to “The single claim line item of 1 UOS would be processed for payment of the combined total of 100 mg of the administered and discarded amounts.,” as clarification
Added: “claim” to “The discarded 30 mg must not be billed as another 1 UOS on a separate claim line item with the JW modifier.,” as clarification
Added: Scenario 3 billing information and example


05/22/2025: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
CODING GUIDELINES:
Revised: “0.83%” to “0.083%” in the example regarding the provision of albuterol solution and billed units of service for HCPCS code J7613


12/05/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: Information pertaining to aztreonam lysine and amikacin liposome, to clarify that the inhalation solutions, nebulizer, and related accessories are noncovered under the Medicare Part B DME benefit
Added: "(The aztreonam lysine inhalation solution and related accessories may be eligible for coverage under a different Medicare benefit (e.g., Medicare Part D))."
Added: "(The amikacin liposome inhalation solution and related accessories may be eligible for coverage under a different Medicare benefit (e.g., Medicare Part D))."


06/20/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
CODING GUIDELINES:
Removed: Coding and billing information pertaining to multifunction ventilators coded E0467
CODING VERIFICATION REVIEW:
Removed: Section header and PDAC coding verification review (CVR) information, including CVR information pertaining to products coded E0467


05/16/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: Amikacin liposome noncoverage information
CODING GUIDELINES:
Added: “The nebulizer used to administer amikacin liposome must be coded and billed using HCPCS code A9270, noncovered item or service.”


05/09/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
MODIFIERS:
Added: "Effective January 1, 2024, the JZ modifier is also required when billing for drugs and biologicals from single-dose containers that are dispensed by the supplier but self-administered by the beneficiary or the beneficiary’s caregiver."
Revised: "The JW and JZ modifiers are not required for drugs dispensed by the supplier and self-administered by the patient or caregiver in the patient’s home." to "The JW modifier is not required for drugs dispensed by the supplier and self-administered by the beneficiary or caregiver in the beneficiary’s home, as it is not expected that the beneficiary or their caregiver provide discarded drug information to the supplier. The JZ modifier is required in this scenario (effective for claims with dates of service on or after January 1, 2024).”
Removed: The JZ modifier from the statement regarding expected rare use.
Added: "As of July 1, 2023, the JZ modifier is required in this situation." to Scenario 2
Added: Information to include the JZ modifier in the billing instructions for the 70 mg dose in Scenario 2


03/14/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 10/01/2023
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: ICD-10-CM Codes J12.82, U07.1 and U09.9 to Groups 3, 8 and 12 Codes due to ICD-10-CM Code updates
Removed: ICD-10-CM Code J15.6 from Groups 2, 3, 7, 12 and 13 Codes due to ICD-10-CM Code updates
Added: ICD-10-CM Codes J15.61 and J15.69 to Groups 2, 3, 7, 12 and 13 Codes due to ICD-10-CM Code updates
Added: ICD-10-CM Codes J44.81 and J44.89 to Groups 2, 3, 6, 7, 8, 12 and 13 Codes due to ICD-10-CM Code updates


10/05/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2023
MODIFIERS:
Revised: JW and JZ modifier instructions to align with the CMS 2023 Physician Fee Schedule final rule


06/15/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2023
MODIFIERS:
Added: JZ modifier instructions


01/12/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 06/05/2022
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Removed: HCPCS codes K0730 and Q4074 from Group 11 Paragraph
Added: ICD-10-CM code I27.23 to Group 11 Codes
Removed: ICD-10-CM code I27.24 from Group 11 Codes
Added: Group 14 Paragraph for HCPCS codes K0730 and Q4074
Added: Group 14 Codes section for ICD-10-CM codes


04/21/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 05/17/2020
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 FED. REG VOL 217):
Revised: “provides” to “provide”
Removed: “The link will be located here once it is available.”
Added: “The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.” with a hyperlink to the list


04/14/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 05/17/2020
CODING GUIDELINES:
Revised: Coding instructions for multifunction ventilators (E0467) (Effective 01/01/2019)
CODING VERIFICATION REVIEW:
Added: Section header and PDAC coding verification review (CVR) information
Added: CVR requirement for products coded E0467


11/11/2021: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 05/17/2020
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: Trademark symbol from
Foradil Aerolize, per AMA guidelines
Revised: Day references to include hyphen
CODING GUIDELINES:
Added: “(CVR)” after reference to coding verification review
Added: “(PCL)” after reference to “Product Classification List”
Revised: Coding verification review information, to include incorrect coding denial language for products billed using HCPCS that require written coding verification review
Added: HCPCS codes J7605, J7606, and J7686 to statement regarding KP KQ modifiers


03/25/2021: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 05/17/2020
CODING GUIDELINES:
Revised: Guidance for billing HCPCS code E0467 based on DOS (Effective April 3, 2020)


07/16/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 05/17/2020
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: STATUTORY PRESCRIPTION (ORDER) REQUIRMENTS section
Removed: REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO 42 CFR 410.38(g) section
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217):
Added: Section and related information based on Final Rule 1713
CODING GUIDELINES:
Revised: “alpha” to “alfa” in relation to HCPCS code J7639
Added: Coding guidelines for J7677
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Covered” updated to “ICD-10 Codes that Support Medical Necessity”
Added: HCPCS code J7677 to Group 8 Paragraph
Revised: ICD-10 code descriptor for J44.0, per ICD-10 code update
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Not Covered” updated to “ICD-10 Codes that DO NOT Support Medical Necessity”


04/02/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2019
CODING GUIDELINES:
 Revised: E0467 Coding Guidelines to include custom fabricated oral appliances


04/04/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2019
CODING GUIDELINES:
Removed: E0571 Coding Guidelines
Added: E0467 Coding Guidelines
ICD-10 CODES THAT ARE COVERED:
Added: Diagnosis codes formerly listed in the LCD
Removed: I27.23 and I27.29 from Group 11 Codes due to conflict with coverage criteria
ICD-10 CODES THAT ARE NOT COVERED:
Added: Notation excluding unlisted diagnosis codes from coverage for specific HCPCS. Notation that all diagnosis codes are excluded from coverage for a specified list of HCPCS. Notation that for all other HCPCS codes, diagnosis codes are not specified.

02/21/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2017
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: Dispensing Fee billing timeline for refill prescriptions
CODING GUIDELINES:
Added: Billing instructions for accessories used in conjunction with E0574


04/05/2018: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2017
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:


Added: REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PERSUANT TO 42 CFR 410.38(g), previously in the Policy Specific Documentation Requirements section

Revision Effective Date: 01/01/2017
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: ACA Standard Documentation Language
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: 42 CFR 410.38(g), diagnosis on claim instructions, and Modifier requirements
RELATED LOCAL COVERAGE DOCUMENTS:
Added:LCD-related Standard Documentation Requirements Language Article

Revision Effective Date: 07/01/2016
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: Standard documentation language-adding Statutory Prescription (Order) Requirements, revising ACA requirements – Effective 04/28/16
Revised: Dispensing fee date example from 04/20 to 04/10

Effective July 1, 2016 oversight for DME MAC Articles 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 Articles.

Revision Effective Date: 01/01/2016
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: Start date verbiage from Prescription Requirements (Effective 11/05/2015)
CODING GUIDELINES:
Updated: HCPCS Code Q9977 cross-walked to J7999

Revision Effective Date: 10/31/2014
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: Language for billing metered-dose inhalers not administered through DME
Removed: “When required by state law” from ACA new prescription requirements
Revised: Face-to-Face Requirements for treating practitioner
CODING GUIDELINES:
Added: Instructions for code Q9977 – Effective 07/01/2015