LCD and Policy Article Revisions Summary for December 18, 2025 - JA DME

Joint DME MAC Publication
Posted December 18, 2025

Outlined below are the principal changes to the DME MAC Local Coverage Determination (LCD) and Policy Article (PA) that have been revised and posted. The policy included is Nebulizers. Please review the entire LCD and PA for complete information.

Nebulizers

LCD

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)

PA

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.

Note: The information contained in this article is only a summary of revisions to the LCDs and/or PAs. For complete information on any topic, you must review the LCDs and/or PAs.
 

With the update(s) listed above, Noridian would like to remind users how to find the policy that was previously effective. When billing, the supplier should follow guidance that was effective on the date of service. The below steps can be followed to find all previous policies:

1. Open the currently effective policy on the Medical Coverage Database (MCD)
   1. Links to the MCD can be found on the Active LCDs page on the Noridian website
      1. There is a link at the top of the Active LCD page that goes to a full list of the LCDs or PAs, depending on which link is selected OR
      2. There are direct links to all LCDs under the 'LCD ID number and Effective Date' column
2. Scroll down to the bottom of the policy
3. Find the section labeled Public Version(s)
4. Look for the link to the policy that was effective on the dates of service in question.
5. Click on hyperlink to go to the policy.