Immunosuppressive Drugs

Revision Effective Date: 10/01/2026
HCPCS CODES:
Added: J7524, J7529, J7530, and J7531 to Group 1 Codes
Removed: J7514, J7517, and J7528 from Group 1 Codes


10/01/2026: 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: 01/01/2026
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: HCPCS codes J7505 and J7513 from section
HCPCS CODES:
Added: HCPCS code J7528 to
Group 1 Codes
Removed: HCPCS codes J7505 and J7513 from
Group 1 Codes


01/08/2026: 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: 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.

Revision Effective Date: 04/01/2025
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised: Quantity of immunosuppressive drugs dispensed from a 30-day supply to a 90-day supply effective for dates of service on or after 01/01/2025
CODING INFORMATION:
Added: JW and JZ modifiers effective for dates of service on or after 01/01/2025


05/22/2025: 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.

Revision Effective Date: 04/01/2025
HCPCS CODES:
Added: HCPCS code J7521


04/17/2025: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 01/01/2025
HCPCS CODES:
Added: HCPCS code J7514


01/16/2025: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 04/01/2024
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: J2919 as methylprednisolone HCPCS code
Removed: J2920 and J2930 as methylprednisolone HCPCS codes
HCPCS CODES:
Added: HCPCS code J2919
Removed: HCPCS codes J2920 and J2930
Revised: HCPCS J7516 narrative from "CYCLOSPORIN, PARENTERAL, 250 MG” to “INJECTION, CYCLOSPORINE, 250 MG”


05/02/2024: 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: 01/01/2024
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: 01/01/2020
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”
As required by CR 10901, the ICD-10 information has been moved to all Policy Articles. There is no change in coverage.

Revision Effective Date: 01/01/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: “physician” to “treating practitioner”
GENERAL:
Revised: Order information as a result of Final Rule 1713
REFILL REQUIREMENTS:
Revised: “ordering physician” to “treating practitioner”
DOCUMENTATION REQUIREMENTS:
Revised: “physician's” to “treating practitioner's”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: Prescriptions (orders) to SWO


02/06/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713.

Revision Effective Date: 01/01/2017
 GENERAL DOCUMENTATION REQUIREMENTS:
 Revised: Bullet spacing

No changes have been made to this LCD


 04/05/2018: 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
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and directions to Standard Documentation Requirements
Added: General Requirements
Revised: Refill Requirements
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: Direction to Standard Documentation Requirements
Removed: Information under Miscellaneous and Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article

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
HCPCS CODES:
Added: J7503 and J7512
Updated: J7508 narrative
Deleted: J7506
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to remove start date verbiage from Prescription Requirements (Effective 11/5/2015)

Revision Effective Date: 10/01/2015
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
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: ICD-9 CM reference

Revision Effective Date: 10/01/2014
DOCUMENTATION REQUIREMENTS:
Revised: Continued Need and Use Sections