Intravenous Immune Globulin - Policy Article - Effective October 2015

Revision Effective Date: 07/01/2026
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: “IOM 100-2, Ch. 15, §50.6” to “CMS Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.6”
CODING GUIDELINES:
Revised:
Long description for J1569
Revised: “Claims for Qivigy (immune globulin intravenous, human-kthm 10% solution) for dates of service on or after September 26, 2025 must be submitted using the HCPCS code J1599” to “Claims for Qivigy (immune globulin intravenous, human-kthm 10% solution) for dates of service from September 26, 2025 to June 30, 2026 must be submitted using the HCPCS code J1599”
Added: Direction for billing Qivigy using J1577, effective for dates of service on or after July 1, 2026


06/25/2026: 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: 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: “drug” to “drugs” in “Multi-use vials are not subject to payment for discarded amounts of drugs or biologicals.”
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: 01/01/2025
CODING GUIDELINES:
Revised:

Direction for billing ALYGLO using HCPCS code J1599 for dates of service on or after December 15, 2023
Added: Direction for billing ALYGLO using HCPCS code J1552, effective for dates of service on or after January 01, 2025


12/19/2024: 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:
Added:
Direction for billing
ALYGLO
 (immune globulin intravenous, human-stwk)

effective for dates of service on or after December 15, 2023


07/18/2024: 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: 01/01/2024
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: Services, supplies and accessories to noncovered statement when statutory criteria not met
Removed: Statement to refer to the LCD when IVIG administered with an infusion pump and statutory criteria not met
Removed: Statement regarding IVIG benefit limited to IVIG itself
Added: Services, supplies and accessories are billed with HCPCS code Q2052 and only one unit of service shall be paid per infusion date of service
CODING GUIDELINES:
Removed: Use of HCPCS code A4223 instructions when IVIG not administered with an infusion pump
Removed: Reference to the External Infusion Pump LCD and Policy Article when IVIG is administered with an infusion pump
Added: Coding instructions for Q2052


11/30/2023: 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: 07/01/2023
CODING GUIDELINES:
Added: Direction for billing Panzyga


06/22/2023: 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: 10/01/2022
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: ICD-10-CM code D81.82 to Group 1 codes per update to Medicare Benefit Policy Manual, Chapter 15, section 50.6


11/24/2022: 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):
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

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: “physician” to “practitioner”
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

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: 08/13/2019
ICD-10 CODES THAT ARE COVERED:
Added: Codes D80.2, D80.3, D80.4, D80.6, D80.7, D81.5, D82.1, D82.4, D83.1 and G11.3 per update to Medicare Benefit Policy Manual, Chapter 15, section 50.6


07/25/2019: 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.

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

Revision History Effective Date: 01/01/2017
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Modifier 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 Date: 10/01/2015
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: Diagnosis codes from this section
Added: Reference to diagnosis codes section