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:
- It is an approved pooled plasma derivative for the treatment of primary immune deficiency disease; and
- The patient has a diagnosis of primary immune deficiency disease (See Diagnosis Codes that Support Medical Necessity section below); and
- The IVIG is administered in the home; and
- 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.
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. 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.
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).
Multi-use vials are not subject to payment for discarded amounts of drug or biologicals.
The DME MACs expect rare use of the JW modifier on claims due to HCPCS code descriptors and their associated Units of Service (UOS) for DMEPOS in addition to the limited instructions for use.
Below are two scenarios in regard to 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. As of July 1, 2023, the JZ modifier is required in this situation. 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 with the JZ modifier.
- 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 ALYGLO (immune globulin intravenous, human-stwk) for dates of service from December 15, 2023 to December 31, 2024 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 ALYGLO for dates of service on or after January 1, 2025 must be submitted using HCPCS code J1552 (INJECTION, IMMUNE GLOBULIN (ALYGLO), 500 MG). One UOS equals five hundred (500) mg.
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.
