Billing and Coding: Immune Globulin

  
This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L35093 (Immune Globulin). Please refer to the LCD
for reasonable and necessary requirements.  
  
 **Coding Guidance  
  
Notice**: It is not appropriate to bill Medicare for services that are not
covered (as described by the entire LCD) as if they are covered. When billing
for non-covered services, use the appropriate modifier.  
  
The use of the JA and JB modifiers is required for drugs which have one HCPCS
Level II (J or Q) code but multiple routes of administration. Drugs that fall
under this category must be billed with the JA modifier for the intravenous
infusion of the drug or billed with the JB modifier for the subcutaneous
injection of the drug.  
  
HCPCS codes J1561 and J1569 must be billed with either modifier JA for the
intravenous formulation or modifier JB for the subcutaneous formulation.  
  
 **Not Otherwise Classified (NOC) Drug Billing  
  
** **Office/Clinic  
  
** Providers submit NOC codes (e.g., J1599) in the 2400/SV101-2 data element
in the 5010 professional claim transaction (837P). When billing an NOC code,
providers are required to provide a description in the 2400/SV101-7 data
element. The 5010 TR3 Implementation Guide instructs: "Use SV101-7 to describe
non-specific procedure codes." (Do not use the 2400 NTE segment to describe
non-specific procedure codes with 5010). The SV101-7 data element allows for
80 bytes (i.e., characters, including spaces) of information.  
  
In order for the A/B MAC to correctly reimburse NOC drugs and biologicals,
providers must indicate the following in the 2400/SV101-7 data element, or
Item 19 of the CMS 1500 form:

  * The name of the drug,
  * The total dosage (plus strength of dosage, if appropriate), and
  * The method of administration.

**Important:** List **one** unit of service in the 2400/SV1-04 data element or
in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and
biologicals even if multiple units are provided. Medicare determines the
proper payment of NOC drugs and biologicals by the narrative information, not
the number of units billed.  
  
Claims for NOC drugs and biologicals will reject as unprocessable if any of
the information listed above is missing, or if the NOC code is billed with
more than one unit of service. (Note: The remittance notice will include
remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the
drug furnished," even if the rejection is due to the number of units billed).

**Ambulatory Surgical Centers (ASCs) and Hospital Outpatient Departments  
  
** HCPCS code C9399, Unclassified drug or biological, should be used for new
drugs and biologicals that are approved by the United States (U.S.) Food and
Drug Administration (FDA) on or after January 1, 2004, for which a specific
HCPCS code has not been assigned.  
  
 **Drug Wastage  
  
** When billing for Part B drugs and biologicals (except those provided under
a competitive acquisition program [CAP]), the use of the JW modifier to
identify unused drugs or biologicals from single use vials or single use
packages that are appropriately discarded is required. The discarded amount
shall be billed on a separate claim line using the JW modifier. Providers are
required to document the discarded drug or biological in the patient's medical
record.  
  
Any amount wasted must be clearly documented in the medical record and should
include the date and time, amount of medication wasted, and the reason for the
wastage.  
  
The use of the JZ modifier (attesting that there were no discarded amounts) is
required on claims to report there are no discarded amounts of unused drugs or
biologicals from single use vials or single use packages.  
  
Claims for drugs separately payable under Medicare Part B from single-dose
containers are required to report either the JW or JZ modifier, to identify
any discarded amounts or to attest that there are no discarded amounts,
respectively.

  * The JW and JZ modifier policy does not apply for drugs that are not separately payable, such as packaged OPPS or ASC drugs, or drugs administered in the FQHC or RHC setting.
  * The JW and JZ modifiers do not apply to drugs assigned status indicator N (Items and Services Packaged into APC Rates) under the OPPS. Similarly, the JW and JZ modifiers do not apply to drugs assigned payment indicator "N1" (ASC).

  
**Documentation Requirements**

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    1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
    2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
    3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
    4. The medical record documentation must support the medical necessity of the services as stated in the LCD.
    5. The information contained in the medical record should include all relevant diagnostic laboratory studies, prior history of bleeding, infection, disease progression, prior medical/surgical therapies, vaccination response, and any other information essential in establishing that the patient meets the coverage indications as set forth in the NCD and LCD.
    6. An accurate weight in kilograms should be documented prior to the infusion since the dosage is based on mg/kg/dosage.