As you know the dosage descriptors for BCG vaccine HCPCS and CPT codes were set at the vial level, even though it may be possible to use less than the full vial to treat a particular patient. CMS has recently changed the billing units associated with the J-code for BCG vaccine to 1 mg. The change will become effective on July 1, 2019. The updated code could be used to facilitate more accurate payment of BCG doses that are less than a full vial (50mg).

CMS Part B drug payment policy does not provide guidance about whether a single use vial can or should be used for more than one dose of a drug. Regarding the use of a single dose vial on more than one patient, CMS has stated that

“The appropriate clinical use of drug products, including sterile products, depends on numerous factors, including, but not limited to: approved labeling, State law, the setting in which the product is prepared and used (including interpretive guidelines used during survey and certification), how the product is stored, sterility, and chemical stability. These factors are outside CMS's purview, and instead depend on laws and regulations that are in the jurisdiction of states or other federal agencies. In contrast, our Medicare payment policies neither encourage nor prohibit the use or administration of more than one dose from a single-use vial to one or more beneficiaries.”

That stated, we recognize that there are certain clinical situations where providers may decide that it is appropriate to use a single dose vial for more than one patient, including times when drugs are in short supply, the risks or delaying or foregoing therapy outweigh the benefits, and steps to mitigate risk are available.

In the case of BCG bladder instillations, we believe that a provider who buys a vial of the drug, uses it for more than one patient, and splits the vial into smaller doses in the office could bill for the drug using the new HCPCS code, J9030 (BCG live intravesical instillation, 1 mg). In such a situation, the provider would be expected to submit a charge that corresponds to the smaller amount of drug that is used (rather than charging for the full vial). Unused portions of the single use vial would be subject to the Discarded Drug Policy (Regulations and Guidance Manuals, section 40)

If the provider purchased a dose of a drug that was prepared by a compounding pharmacy or an outsourcing entity, then we believe it would be necessary to bill using the compounded drug code.

Juan L. Schaening-Perez, MD
Executive Contractor Medical Director
First Coast Service Options