Standards QUIC Form Resolutions

Disposition: The final decision by NCPDP membership was to NOT grant an exception to Herceptin to be billed as mg. While Work Group 2 recommended the exception, the final determination is made by all members of NCPDP. The information below is for documentation of the Work Group action on QUIC Form 980005.

The discussion on proposed changes and updates to the Billing Unit Standard to incorporate a milligram was brought about by QUIC #980005 - concerning HERCEPTIN from Genentech. The QUIC form requested an exception to the NCPDP Billing Unit Standard to accommodate a reconstitutable, multidose vial configuration that has a four-week shelf life after reconstitution. The product must be administered in a physician's office over multiple office visits. The question concerned the NCPDP Standard Billing Unit's ability to accommodate a multidose vial configuration.

This is a unique product and billing unit. WG2 discussed two options at the November meeting: add milligram as a valid unit of measure, or allow HERCEPTIN to be an exception to the standard. HCFA granted Genentech the each milligram designation exception. Approximately 10 states were able to bill physician's services in the retail pharmacy benefits. This will limit the number of rebates for this product. HERCEPTIN is currently unique; however, there may be other products like it in the future.

After brief discussion, a motion was made to allow HERCEPTIN to be an each milligram designation exception. The motion was moved and seconded. The motion carried. It was noted that if similar products come onto the market in the future, the manufacturer would need to get approval from Work Group 2 to be an exception.

A motion was made that NCPDP should suggest a June 1, 1999 implementation date for this exception. A friendly amendment was made to change the date to July 1, 1999 because it is the beginning of a new quarter. The friendly amendment was accepted. The motion was moved and seconded. The motion carried.

See QUIC Form 980005 for updated information.
The group identified that the current billing unit standard defines any powder filled vial single and or multi-dose as a ONE EACH VIAL. The group could think of no other product that was multi-dose and was meant to be used in a vial within a limited time frame. The group came up with the following suggestions:

The standard could be modified to handle injectible powder filled products, similar to antibiotics that come in a powder form and are mixed as needed. The unit of measurement would be based on a per ML basis. A concern by several pharmacists within the work group was the measurement of a product on a per ML basis after reconstitution. The manufacturer may equate a mg to liquid to be 20 ML, when in actuality the mixing may produce, 18 ML or 23 ML. The modification request to the standard could only occur after FDA approval of the product.

Many group members felt that it would best if two sizes of single-dose product were placed on the market. A 250 MG and 100 MG. each would have it's own NDC # to bill and track. Multidose vials are problematic in pharmacy dispensing, especially since often times there is a wastage issue associated with this vial configuration.

There was no easy way of communicating this vial configuration to the industry. The pharmacists present indicated that they would use a vial, bill the vial and waste the remaining. Consensus was that is was easier to waste product than to bill per ML or MG and appear to be billing incorrectly and be subject to fraud, especially in the government programs. With Physician billing, the "J Code" would specify the unit of measurement for the product, however, the "J Code" would not be assigned for at least a year.

The group urged the requester, who represented the manufacturer, to NOT sell the product is the multidose configuration as it would be problematic in the drug delivery industry.