A: CMS has initiated the same type of payment that we are familiar with under the OPPS. For those who receive payment under the Medicare Physician Fee Schedule (MPFS) for drugs, it is a bit of a new concept. CMS will assign a single HCPCS code for the biosimilar, and all biosimilars for the same biological will be reported with the same HCPCS code. For example, cyclophosphamide is manufactured by more than 20 different companies. Regardless of the manufacturer, the drug is reported with HCPCS code J9070 (cyclophosphamide, 100 mg) and reimbursed under APC 1408 based on the average sales price information. This same concept will apply for biosimilars, which are eligible for pass-through payment, as well as subject to the same packaging and separately payable considerations as other drugs/biologicals.

 

As additional manufacturers begin providing filgrastim biosimilar, HCPCS code Q5101 (injection, filgrastim [G-CSF], biosimilar, 1 microgram) will be reported with the appropriate number of units for the dose ordered and administered, and will be reimbursed at the same rate under APC 1822 for 2016.

 

There is another reporting requirement for biosimilars. Based on discussion in the MPFS final rule, beginning January 1, 2016, CMS is going to issue manufacturer-specific modifiers that must be appended to the HCPCS code for the biosimilar based on which manufacturer supplied the product administered to the patient. Transmittal 1542 describes the process and notes that once the modifiers are communicated, it is a mandatory that the modifiers be reported on the claim. The first modifier is -ZA for Sandoz, which is the current manufacturer for filgrastim biosimilar.

 

As the number of biosimilars grows, and the number of manufacturers providing the biosimilars increases, this will be a huge operational consideration as the modifier will be specific to the product provided to an individual patient. It is a great idea to be proactive and begin working on how to operationalize this requirement.