For any item to be covered, it must

1. be eligible for a defined benefit category;
2. be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; and
3. meet all other applicable statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered, a written signed and dated order must be received by the supplier. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

Intravenous immune globulin (IVIG) is covered if all of the following criteria are met:

1. It is an approved pooled plasma derivative for the treatment of primary immune deficiency disease; and
2. The patient has a diagnosis of primary immune deficiency disease; and
3. The IVIG is administered in the home; and
4. The treating physician has determined that administration of the IVIG in the patient’s home is medically appropriate.

If all of the criteria are not met and the IVIG is not administered with an infusion pump, the IVIG will be denied as non-covered - no benefit category. A provider can bill the member for the non-covered service.

Coverage under the IVIG benefit is limited to the IVIG itself, not to related supplies and services. If the IVIG is not administered with an infusion pump, related supplies will be denied as non-covered – no benefit category. A provider can bill the member for the non-covered service.

Codes J1573 and J2791 are non-covered. They are not indicated for the treatment of primary immune deficiency disease (# 2 above).

If the IVIG is administered using an infusion pump, the infusion pump and related administration supplies are denied as not medically necessary because they do not meet the coverage criteria specified in the Medicare Advantage Medical Policy Bulletin E-17, External Infusion Pumps.

If the coverage criteria for IVIG specified are not met and the IVIG is administered with an infusion pump, the IVIG will be denied as not medically necessary (because the pump is denied as not medically necessary).

Drugs may be covered only if dispensed and billed by the entity that actually dispenses the drug to  member, and that entity must be permitted under all applicable federal, state, and local laws and regulations to dispense drugs. Only entities licensed in the state where they are physically located may bill for IVIG. Claims submitted by entities not licensed to dispense drugs will be denied for as not medical necessity.

Refer to Medicare Advantage Medical Policy Bulletin E-17, External Infusion Pumps for information concerning coverage of subcutaneous immune globulin.

The MMA created a benefit for the provision of intravenous immune globulin (IVIG) for members with a diagnosis of primary immune deficiency disease (PID). If a physician determines that the administration of IVIG in the patient's home is medically appropriate for a patient with a diagnosis of PID, coverage for IVIG is provided in the home setting. IVIG provided in the home for a diagnosis other than PID may be covered under the Part D benefit. Payment is limited to that for the IVIG itself and does not cover items and services related to administration of the product. Administration and related Home Infusion Therapy services are reimbursed as a health service benefit. A hospital or SNF cannot be considered the member's "home" for this purpose.

Claims for IVIG in the home are only to be paid for the diagnosis of PID.  IVIG is not paid under Part B when given in the home setting for any diagnosis other than PID. When IVIG is provided in the home for any indication other than PID and when the member does not have the Medicare Part B benefit, the provider can bill the member for the denied service.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

The supplier must enter an ICD-9 diagnosis code corresponding to the patient's diagnosis on each claim.

When Not Otherwise Classified (NOC) drug code J1566 or J1599 are billed for miscellaneous immunoglobulin drugs, the claim must be accompanied by a clear statement identifying the drug provided (brand or generic name, dosage strength) and the amount dispensed.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

If the IVIG is not administered through an infusion pump and if supplies are billed, code A4223 (infusion supplies not used with external infusion pump, per cassette or bag (list drugs separately) must be used for the supplies.

If the IVIG is administered through an infusion pump refer to Medicare Advantage Medical Policy Bulletin E-17, External Infusion Pumps for additional information.

EY – No physician or other licensed health care provider order for this item or service.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Medicare IOM 100-02, Benefit Policy Manual, Chapter 15, Section 50.6

Covered Diagnosis Codes