At the November 2014 WG2 meeting the form was discussed. Alisha Nielsen was present to answer questions and give a short presentation on the product.
Requested: New Product/Package Information
Request: 1 dose 600 MG IV administration (Outer NDC): 3 X 20 mL vials (200 mg/20mL) to be admixed and administered to the patient in 1 IV Infusion. (Inner Vial) 1 X 200 mg/20mL. Contents include: 1 20 mL vials, package insert.
Why Needed: Ensure the databases are in alignment (ML). Package size for OUTER NDC: 60 ML 600 MG (3 x 20 ml vials) Package Size for INNER NDC: 20 ml (1 x 20 ml vial) – Vials are filled with 21.7 ml of Peramivir solution in order to deliver 20 ml.
Outcome Anticipated: Billing Unit = ML (Per section 5.2.2 of the BUS) OUTER NDC = Package Size 60 ML case size 1 (Considering all 3 vials are the course of therapy) INNER NDC = Package Size 20 ML (1 vial of a 3 vial IV Infusion course of therapy).
Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group via email and the recommendation made that the BU=mL based upon 5.2.2 of the BUS.
5.2.2 Injectables that are liquid-filled vials, including multi-chamber products, ampoules, and syringes must be billed as the total number of milliliters (ML) dispensed. If multi-chambered vials with both components are liquid, the billing unit is the sum of the milliliters of the product. If a manufacturer has labeled a product for the quantity to dispense (i.e. excluding the overfill), the reported quantity for dispensing should be total number of milliliters. See section "Frequently Asked Questions", question 7.28 and 7.34. NOTE: if the product is derived from a biologic source and has a variable volume, see section 5.1.7.
At this meeting, a motion was made and seconded to classify the BU=mL per Section 5.2.2 of the BUS.
The motion carried without opposition.
At the November 2014 WG2 meeting the form was discussed. Trevor Ware representing The Medicine Company was in attendance to present the form and answer questions.
Requested: Clarification of the BUS
Request: The Medicines Company would like to clarify that the Billing Unit Standard for Orbactiv™ is "GRAM" (GM). The product is supplied in single-use vials, each containing 400 mg of oritavancin diphosphate. In accordance with section 4.2.3 of the Billing Unit Standard Implementation Guide, Orbactiv™ is "measured by its weight."
Why this request is needed: The Medicines Company would like to clarify that the dosage form of Orbactiv™ is "powders," as described in section 5.3.3 of the Billing Unit Standard Implementation Guide, and as such has an appropriate billing unit of "GRAM."
Orbactiv™ is an antibiotic used to treat patients with Acute Bacterial Skin and Skin Structure Infection ("ABSSSI"). The product received FDA approval on August 6, 2014, and the product’s labeling describes dosage as "A 1200 mg single dose treatment administered by intravenous infusion over 3 hours." The product is supplied as a sterile lyophilized powder in single-use vials containing 400 mg of oritavancin diphosphate. Orbactiv is supplied as three 400 mg vials per carton that are given as a single intravenous injection. At the time of use, physicians reconstitute each 400 mg vial with 40 mL of Sterile Water for Injection. After reconstitution, the 1200 mg of Orbactiv™ are further diluted in approximately 1000 mL of 5% Dextrose Injection ("D5W"). The patient is then administered Orbactiv™ in a single 1200 mg IV dose of 1000 mL D5W over three hours.
Because Orbactiv™ is first being marketed and commercially sold as of the date of this QUIC form, there are no current or historical CMS billing practices to take into consideration. However, assigning a billing unit of “GRAM” would be consistent with CMS’ treatment of similar products. Vibativ (J3095, Injection, telavancin, 10 mg), which is in the same class of antibiotics as Orbactiv™—lipoglycopeptide—has a billing descriptor in grams. Similarly, other antibiotics sold in the form of lyophilized powder in single-use vials and then subsequently reconstituted are also billed by CMS in grams. Examples include Sterile Vancomycin Hydrochloride, USP (J3370 Injection, vancomycin hcl, 500 mg) and Cubicin (J0878 Injection, daptomycin, 1 mg).
Outcome anticipated: As explained above, as a "powder," Orbactiv™ should be assigned a billing unit of "GRAM." See Billing Unit Standard Implementation Guide section 5.3.3. Oritavancin is not yet on the market, and The Medicines Company would like to ensure consistency between compendia listings and payors upon launch of the product, as well as between oritavancin and other, currently marketed antibiotics sold as lyophilized powders. Because oritavancin is supplied and measured by weight, a billing unit of GRAM will not cause payors to overpay or underpay. The anticipated outcome is that a billing unit standard of "GRAM" will be assigned.
Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of October 21st:
There was consensus from all on the call that per section 5.1.2 of the Billing Unit Standard the billing unit = one each because it is a reconstitutable powder for injection. The group also noted there are other products listed similarly that are covered by CMS for which there are no problems.
At this meeting, a motion was made and seconded to classify the BU=EACH (with a quantity of 3 for the box) per Section 5.1.2 of the BUS. The motion carried without opposition.
At the November 2014 WG2 meeting the form was discussed.
Request: The Medi-RDT Kit (NDC 38779-7218-01) from Medisca contains the following items used to compound Rapid Dissolve Tablets. For billing purposes, is this product listed as a 1 EA Kit? Or, as 100 GM (amount of the base)?
Why Needed: Clarification of billing quantity and billing unit is requested to ensure consistency.
Outcome Anticipated: The Medi-RDT Kit (NDC 38779-7218-01) contains components with 2 different billing units (GM and EA), so it is anticipated that it would be billed as a 1 EA Kit based upon section 5.5.1 of the BUS. Since it doesn’t include an active ingredient to compound a finished dosage form, it is not a compounding kit so BUS 5.5.3 does not apply.
Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of September 9th:
The Medi-RDT Kit (NDC 38779-7218-01) contains components with 2 different billing units (GM and EA), so it is anticipated that it would be billed as a 1 EA Kit based upon section 5.5.1 of the BUS. Since it doesn’t include an active ingredient to compound a finished dosage form, it is not a compounding kit so BUS 5.5.3 does not apply. Consensus was BU= one each kit per BUS 5.5.1.
At this meeting, a motion was made and seconded to classify the BU=EACH (kit) per Section 5.5.1 of the BUS. The motion carried without opposition.