Immunosuppressive Drugs - Policy Article

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.

Revision Effective Date: 01/01/2025
MODIFIERS:
Added: JW and JZ modifier guidelines


05/22/2025: 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.

Revision Effective Date: 01/01/2023
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: “PA” to “pancreas transplant alone”


05/04/2023: 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: 01/01/2023
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: Medicare entitlement statement to include coverage beyond 36 months for beneficiaries eligible and enrolled in the Part B immunosuppressive drug benefit (PBID)


11/17/2022: 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: 01/01/2020:
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 FED. REG VOL 217):
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: 01/01/2020:
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
MODIFIERS:
Revised: “ordering physician” to “treating practitioner”
 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”
 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”


02/06/2020: 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
 NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
 Revised: Criterion V to allow drugs to be dispensed two days prior to discharge to the home
 Removed: Statement regarding KX modifier
CODING INFORMATION:
Removed: Bill type code inadvertently added


02/28/2019: 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: Corrected typo inbeneficiary and outbeneficiary to inpatient and outpatient


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
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Continued Medical Need and Continued Use sections (clerical error)

Revision Effective Date: 01/01/2017
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Modifiers requirements
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements Language Article

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 Dates: 01/01/2016
CODING GUIDELINES:
Removed: J7506 from billing example, replaced with J7510

Revision Effective Date: 10/01/2015
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: ICD-9 diagnosis references
CODING GUIDELINES:
Added: J7599 billing guidelines