Intravenous Immune Globulin - Policy Article

**NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES**

For any item to be covered by Medicare, it must 1) be eligible for a defined
Medicare 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 Medicare statutory and
regulatory requirements. Information provided in this policy article relates
to determinations other than those based on Social Security Act 1862(a)(1)(A)
provisions (i.e. "reasonable and necessary").

Intravenous immune globulin used for the treatment of primary immunodeficiency
is covered under the Intravenous Immune Globulin benefit. (IOM 100-2, Ch. 15,
50.6) In order for a beneficiary's equipment to be eligible for reimbursement
the reasonable and necessary (R&N) requirements set out in the related Local
Coverage Determination must be met. In addition, there are specific statutory
payment policy requirements, discussed below, that also must be met.

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 (See Diagnosis Codes that Support Medical Necessity section below); and
  3. The IVIG is administered in the home; and
  4. The treating practitioner has determined that administration of the IVIG in the patient's home is medically appropriate.

If all of the criteria are not met the IVIG and the related services, supplies
and accessories will be denied as noncovered - no benefit category.

Services, supplies and accessories used in the home for the administration of
IVIG are billed to the DME MAC using HCPCS code Q2052. Only one unit of
service of Q2052 shall be paid per infusion date of service.

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

Refer to the External Infusion Pumps LCD for information concerning coverage
of subcutaneous immune globulin.

**REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed.
Reg Vol 217)**

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a
Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the
DME MACs provide a list of the specified codes, which is periodically updated.
The required Face-to-Face Encounter and Written Order Prior to Delivery List
is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol
217) that do not meet the face-to-face encounter and WOPD requirements
specified in the LCD-related Standard Documentation Requirements Article
(A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied
as not reasonable and necessary. If the WOPD is not obtained prior to
delivery, payment will not be made for that item even if a WOPD is
subsequently obtained by the supplier. If a similar item is subsequently
provided by an unrelated supplier who has obtained a WOPD, it will be eligible
for coverage.

**POLICY SPECIFIC DOCUMENTATION REQUIREMENTS**

In addition to policy specific documentation requirements, there are general
documentation requirements that are applicable to all DMEPOS policies. These
general requirements are located in the DOCUMENTATION REQUIREMENTS section of
the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located
at the bottom of this Policy Article under the Related Local Coverage
Documents section for additional information regarding GENERAL DOCUMENTATION
REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed
below.

The supplier must enter a diagnosis code corresponding to the patient's
diagnosis on each claim.  
  
 **MODIFIERS**

JW AND JZ MODIFIERS

Effective for claims with dates of service on or after January 1, 2017, the JW
modifier is required when billing for unused and discarded amounts of drugs
and biologicals from single-dose containers that are administered by the
supplier.

Effective for claims with dates of service on or after July 1, 2023, the JZ
modifier is required when billing for drugs and biologicals from single-dose
containers that are administered by the supplier but have no unused and
discarded amounts.

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.

Multi-use vials are not subject to payment for discarded amounts of drug or
biologicals.

The DME MACs expect rare use of the JW or JZ modifiers on claims due to HCPCS
code descriptors and their associated Units of Service (UOS) for DMEPOS in
addition to the limited instructions for use.

There are two scenarios that can occur when billing with the JW modifier:

Scenario 1  
When the HCPCS code UOS is less than the drug quantity contained in the single
use vial or single dose package, the following applies:

  * The quantity administered is billed on one claim line without the JW modifier; and,
  * The quantity discarded is billed on a separate claim line with the JW modifier.

In this scenario, the JW modifier must be billed on a separate line to provide
payment for the amount of discarded drug or biological. For example:

  * A single use vial is labeled to contain 100 mg of a drug.
  * The drug's HCPCS code UOS is 1 UOS = 1 mg.
  * 95 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.
  * 5 mg remaining in the vial are discarded.
  * The 95 mg dose is billed on one claim line as 95 UOS.
  * The discarded 5 mg is billed as 5 UOS on a separate claim line with the JW modifier.
  * Both claim line items would be processed for payment.

Scenario 2  
When the HCPCS code UOS is equal to or greater than the total of the actual
dose and the amount discarded, use of the JW modifier is not permitted. If the
quantity of drug administered is less than a full UOS, the billed UOS is
rounded to the appropriate UOS. For example:

  * A single use vial is labeled to contain 100 mg of a drug.
  * The drug's HCPCS code UOS is 1 UOS = 100 mg.
  * 70 mg of the 100 mg in the vial are administered to the beneficiary by the supplier.
  * 30 mg remaining in the vial are discarded.
  * The 70 mg dose is billed correctly by rounding up to one UOS (representing the entire 100 mg vial) on a single line item.
  * The single line item of 1 UOS would be processed for payment of the combined total 100 mg of administered and discarded drug.
  * The discarded 30 mg must not be billed as another 1 UOS on a separate line item with the JW modifier. Billing an additional 1 UOS for the discarded drug with the JW modifier is incorrect billing and will result in an overpayment.

**CODING GUIDELINES**

HCPCS code Q2052 is billed for services, supplies, and accessories used in the
home for the administration of IVIG. HCPCS code Q2052 may be billed separately
from, or on the same claim as, the IVIG. Q2052 should be billed as a separate
claim line on the same claim and for the same place of service as the related
IVIG HCPCS. In cases where the IVIG product is mailed or delivered to the
patient prior to administration, the date of service (DOS) for the
administration of the IVIG may be no more than 30 calendar days after the DOS
on the IVIG product claim line. Claims for Q2052 will cycle for a total of 15
business days to identify an eligible IVIG drug billed in the previous 30
days. After 15 business days, if no eligible IVIG HCPCS is found in history,
the claim line for the Q2052 will be denied.

Q2052 must be billed on a separate claim line for each date of service when
billed on a single claim. Claims that contain more than one claim line of
Q2052 on the same date of service will be returned as unprocessable.

Suppliers should report the infusion visit length in 15-minute increments (15
minutes=1 unit) when billing for Q2052 in accordance with rounding rules
below. The units are for informational purposes only and a maximum of one unit
of service of Q2052 per infusion date will be paid regardless of the units of
service billed.

Unit | Time  
---|---  
1 | <23 minutes  
2 | = 23 minutes to <38 minutes  
3 | = 38 minutes to <53 minutes  
4 | = 53 minutes to <68 minutes  
5 | = 68 minutes to <83 minutes  
6 | = 83 minutes to <98 minutes  
7 | = 98 minutes to <113 minutes  
8 | = 113 minutes to <128 minutes  
9 | = 128 minutes to <143 minutes  
10 | = 143 minutes to <158 minutes  
  
Claims for Panzyga for dates of service from August 2, 2018 to June 30, 2023
must be submitted using the HCPCS code J1599 (INJECTION, IMMUNE GLOBULIN,
INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), NOT OTHERWISE SPECIFIED, 500 MG).
One UOS equals five hundred (500) milligrams (mg).

Claims for Panzyga for dates of service on or after July 1, 2023 must be
submitted using HCPCS code J1576 (INJECTION, IMMUNE GLOBULIN (PANZYGA),
INTRAVENOUS, INTRAVENOUS, NON-LYOPHILIZED (E.G. LIQUID, 500 MG). One UOS
equals five hundred (500) mg.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC)
contractor for guidance on the correct coding of these items.