Visante 
White cell colony stimulating factors like pegfilgrastim and its biosimilars may have specific coverage and documentation requirements for Medicare coverage. Each Medicare Administrative Contractor may have a Local Coverage Determination (LCD) that details these requirements. One example is from Palmetto GBA (LCD #L37176) which is summarized below.
It is important that the patient meet coverage criteria as outlined in the LCD such as meeting risk factors. The Palmetto LCD provides a list of fourteen risk factors that determine eligibility for coverage as well as outlining when secondary prophylaxis would be considered as reasonable and necessary.
Timing may be an important factor in coverage. For pegfilgrastim and biosimilars, the LCD also is explicit that the drug must be given more than14 days before, or more than 24 hours after the completion of myelosuppressive chemotherapy as reflected in FDA-approved labeling. The only exception is for patients receiving dose dense 14-day chemotherapy cycles when coverage is provided outside of the 14 day/24 hour window.
The LCD also provides detailed documentation requirements such as:
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Risk factors when patients receive agents/doses uncommonly associated with myelosuppression
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For chronic neutropenia: appropriate evaluation of cause of neutropenia and when appropriate a history of recurrent fevers and/or infections with documentation of absolute neutrophil count
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Time the last dose of cytotoxic chemotherapy ended
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Time the G-CSF drug was administered
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Documentation of dose dense 14-day chemotherapy if G-CSF administered outside of the 14 day/24 hour window
A unique delivery device (on-body injector) is available for pegfilgrastim which can be placed on the patient’s arm while in the clinic/physician office and then the drug is administered 27 hours after application. The pegfilgrastim is billed with the new HCPCS code, J2506-injection, pegfilgrastim, excludes biosimilar, 0.5 mg, but there is a unique CPT code for the administration: 96377- application of on-body injector (includes cannula insertion) for timed subcutaneous injection. It is recommended that this code be used rather than a therapeutic injection code to communicate to the payer that the on-body injector was applied, and the dose administered 27 hours post-application (i.e. on a different date of service).
If charges are generated when drugs are administered, it is important to work with Nursing to ensure that the application of the on-body injector is documented so that a charge is transmitted. This may mean that nursing must document that the dose was “given” even though the injector was only applied with the dose actually administered the next day. Nursing should be made aware of the documentation requirements in the IT system so that a charge is generated automatically, or a manual charge for the drug and administration are added to the account.
SHOUT-OUTS
1. Clinical Pharmacists should be aware of coverage requirements for Medicare patients and ensure that any LCD criteria be met and documented in the medical record.
2. When coverage criteria are not clearly met for a patient, the appropriate team should issue an Advance Beneficiary Notice of Noncoverage notifying the patient that they may be financially responsible for the charges.
3. G-CSF products should be administered according to the timing (more than 14 days before or more than 24 hours after myelosuppressive therapy) in the FDA labeling for routine administration or any exceptions should be supported by medical record documentation.
4. Pharmacy and Nursing should work together if an on-body injector is utilized to ensure that the documentation status of the placement of the injector is sufficient to generate a charge, or that manual charges are added to the account for the product and unique administration code.
5. Billers should be aware of the unique administration code for on-body injectors so that the product formulation is communicated to the payer to avoid claim rejections.
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