LCD and Policy Article Revisions Summary for September 18, 2025 - JD DME
LCD and Policy Article Revisions Summary for September 18, 2025
Joint DME MAC Publication
Posted September 18, 2025
Outlined below are the principal changes to the DME MAC Local Coverage Determination (LCD) and Policy Articles (PAs) that have been revised and posted. The policies included are Eye Prostheses, Facial Prostheses, High Frequency Chest Wall Oscillation Devices, Immunosuppressive Drugs, Knee Orthoses, Lower Limb Prostheses, Mechanical In-exsufflation Devices, and Oral Anticancer Drugs. Please review the entire LCDs and PAs for complete information.
Eye Prostheses
PA
Revision Effective Date: 01/01/2020
CODING GUIDELINES:
Added: "Prosthetic devices that are custom fabricated for the individual beneficiary are not solely restricted to standard methods of fabrication and can include alternative fabrication methods (e.g., additive manufacturing). Correct coding of custom fabricated items includes compliance with the HCPCS long description of the individual HCPCS code, along with any other published coding guidelines." as clarification
09/18/2025: 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.
Facial Prostheses
PA
Revision Effective Date: 01/01/2020
CODING GUIDELINES:
Added: "Prosthetic devices that are custom fabricated for the individual beneficiary are not solely restricted to standard methods of fabrication and can include alternative fabrication methods (e.g., additive manufacturing). Correct coding of custom fabricated items includes compliance with the HCPCS long description of the individual HCPCS code, along with any other published coding guidelines." as clarification
09/18/2025: 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.
High Frequency Chest Wall Oscillation Devices
PA
Revision Effective Date: 10/01/2025
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Removed: ICD-10-CM code G35 from Group 1 Codes, due to ICD-10-CM code updates
Added: ICD-10-CM codes G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, G35.D, and G71.036 to Group 1 Codes, due to ICD-10-CM code updates
09/18/2025: 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.
Immunosuppressive Drugs
LCD
Revision Effective Date: 04/01/2025
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: "Immunosuppressive drugs are covered only for the specific labeled indications and approval for marketing by the FDA (bp 102c15, §50.5.1)."
Added: Three conditions when covered drugs are included in benefit based on CMS Benefit Policy Manual updates effective 01/01/2025
09/18/2025: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS direction.
PA
Revision Effective Date: 01/01/2025
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: "Antibiotics, hypertensives, and other drugs that are not directly related to rejection are not covered."
Added: "or a 90-day" to the sentence "One unit of service of supply fee code Q0511 is covered for the first covered immunosuppressive drug that is dispensed in a 30-day or 90-day period."
Added: "or a 90-day" to the sentence "If covered drugs are dispensed by more than one pharmacy during a 30-day or 90-day period, one unit of Q0511 is covered for each pharmacy."
Added: "or 90-day" to the sentence "One unit of service of supply fee code Q0512 is covered for each subsequent covered immunosuppressive drug that is dispensed in that 30-day or 90-day period (See exception below when Q0510 is covered in place of Q0511 or Q0512.)"
Added: "or 90" to the sentence "If more than one unit of service of code Q0511 is billed per 30 or 90 days by a single pharmacy, the excess units of service will be denied as incorrect coding."
09/18/2025: 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.
Knee Orthoses
PA
Revision Effective Date: 10/01/2025
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Removed: ICD-10-CM code G35 from Group 4 Codes, due to ICD-10-CM code updates
Added: ICD-10-CM codes G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, G35.D to Group 4 Codes, due to ICD-10-CM code updates
09/18/2025: 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.
Lower Limb Prostheses
PA
Revision Effective Date: 04/01/2025
CODING GUIDELINES:
Added: "Prosthetic devices (such as sockets, inserts, and applicable additions [e.g., light weight material]) that are custom fabricated for the individual beneficiary are not solely restricted to standard methods of fabrication (e.g., wet lamination and prepreg composite) and can include alternative fabrication methods (e.g., additive manufacturing). Correct coding of custom fabricated items includes compliance with the HCPCS long description of the individual HCPCS code, along with any other published coding guidelines." as clarification
09/18/2025: 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.
Mechanical In-exsufflation Devices
PA
Revision Effective Date: 10/01/2025
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Removed: ICD-10-CM code G35 from Group 1 Codes, due to ICD-10-CM code updates
Added: ICD-10-CM codes G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, G35.D, G71.036 to Group 1 Codes, due to ICD-10-CM code updates
09/18/2025: 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.
Oral Anticancer Drugs
PA
Revision Effective Date: 10/01/2025
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: ICD-10-CM code Z85.4A to Group 1 Codes, Group 2 Codes, Group 3 Codes, Group 4 Codes, Group 6 Codes, Group 7 Codes, and Group 9 Codes, due to ICD-10-CM code updates
Added: ICD-10-CM code Z80.44 to Group 8 Codes and Group 9 Codes, due to ICD-10-CM code updates
09/18/2025: 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.
