Intravenous Immune Globulin

Affected Providers

Practitioners and suppliers who write prescriptions for or dispense intravenous immune globulin (IVIG).

HCPCS & CPT Codes

Local Coverage Determination (LCD): Intravenous Immune Globulin (L33610) has the current HCPCS and CPT codes.

Background

According to the 2024 Medicare Fee-for-Service Supplemental Improper Payment Data, the improper payment rate for IVIG is 4.6%, with a projected improper payment amount of $7.6 million.

We outline other policy requirements in:

• Article: Billing and Coding: Intravenous Immune Globulin (A56779)
• Article: Intravenous Immune Globulin (A52509)
• LCD L33610
• Medicare Benefit Policy Manual, Chapter 15, section 50.6

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provides coverage of IVIG for treating primary immune deficiency diseases in the home.

Section 1861(zz) of the Social Security Act defines “intravenous immune globulin” as an approved pooled plasma derivative for treating primary immune deficiency disease. We cover this benefit when both apply:

• The patient has a diagnosed primary immune deficiency disease
• The IVIG is administered in the patient’s home and the physician determines that it’s medically appropriate to do so

For coverage of IVIG under this benefit, it’s not necessary to administer the derivative through a piece of DME.

Preventing Denials

We cover IVIG use in treating primary immunodeficiency under the IVIG benefit. A patient’s therapy is eligible for reimbursement if it meets the reasonable and necessary requirements set out in the related LCD L33610. Also, the therapy must meet statutory payment policy requirements.

We cover IVIG if it meets all these criteria:

1. It’s an approved pooled plasma derivative for treating primary immune deficiency disease
2. The patient has a diagnosis of primary immune deficiency disease (see ICD-10-CM Codes that Support Medical Necessity in Article A52509)
3. The IVIG is administered in the home
4. The treating practitioner has determined administering IVIG in the patient’s home is medically appropriate

If all the criteria aren’t met, we deny the IVIG and related services, supplies, and accessories as noncovered.

Use HCPCS code Q2052 to bill the DME Medicare Administrative Contractor (MAC) for services, supplies, and accessories used in the home for administering IVIG. We pay only 1 unit of service of Q2052 per infusion date of service.

We don’t cover HCPCS codes J1573 and J2791. They aren’t indicated for the treatment of primary immune deficiency disease (see criterion 2).

Bundled Payments

Division FF, section 4134, of the Consolidated Appropriations Act of 2023, mandated that we establish a permanent, bundled payment for items and services related to administering IVIG in a patient’s home.

The permanent, bundled home IVIG items and services payment is effective for home IVIG infusions provided on or after January 1, 2024.

Payment for these items and services must be a separate bundled payment made to a DME supplier for all items and services provided in the home during a calendar day.

It’s up to the provider to determine the services and supplies that are appropriate and necessary for administering the IVIG to each patient. This may or may not include the use of a pump; however, we don’t cover a pump under the home IVIG items and services payment.

Documentation Requirements

To justify payment, you must meet specific requirements when ordering DMEPOS.

Required documentation of medical necessity for IVIG includes but isn’t limited to:

• History and physical; supporting physician rationale (current within the last 12 months)
• Physician orders not more than 30 days old to date of service specifying dose, frequency, administration route, and office or progress notes that clearly document the necessity for both initiating and continuing IVIG
• ICD-10-CM diagnosis codes supporting medical necessity with each claim; we deny claims you submit without this evidence as not medically necessary
• Documentation supporting the diagnosis
• A copy of applicable lab and procedure test results
• Document of an accurate weight in kilograms before each infusion since the dosage is based mg/kg/dosage
• Prior failed conventional therapies or documentation that conventional therapy is contraindicated
• Medication administration records
• After the first infusion order, orders (which must not be more than 30 days old) should be accompanied by documentation in the record with the response to prior infusions

Example of Improper Payments Due to Insufficient Documentation for IVIG

A supplier bills the claim for HCPCS code J1554 (Injection, immune globulin (Asceniv), 500 mg) and submits the following documentation at the review contractor’s request:

• Standard written order (SWO) with no HCPCS code
• Medical record
• Document saying the patient meets the medical necessity criteria
• Proof of delivery

What Documentation Was Missing?

According to the documentation submitted, the supplier billed for the item without getting a completed SWO first.

What Happens Next?

The review contractor completes the claim as an insufficient documentation error, and the MAC recoups payment.

Recommendation

To avoid billing errors and improper payments, providers must include all medical necessity documentation in the patient’s medical record for DMEPOS.