At the May 2015 WG2 meeting the form was discussed.
Requested: Clarification of the BUS:
Nascobal
® (Cyanocobalamin, USP) Nasal Spray 500 mcg
Request: The Pricing compendiums have listed the above NDC with a UOM of EACH and a Package Size of 4. We are requesting that the UOM be updated to mLs and the Package Size corrected to 0
.5mLs. Package consists of 4 bottles of 0
.125mL which equals 0
.5mLs. This is not a single use package.
Why Needed: This NDC is a new package size for additional NDCs which have package sizes in mLs. The Pricing compendiums have listed this new NDC with a UOM of EACH and a Package Size of 4. This presents an issue as we cannot calculate a weighted average AMP for a product that has different units of measure for different package configurations. This NDC package consists of 4 bottles of 0.125mL which is equal to 0.5 mLs, therefore it is not one unit or an Each. This is not a single use product and is not intended to be broken into the individual inner packs. A 30 day script is for 4 uses, not one use. In order to be in compliance with CMS guidelines on the calculation of Average Manufacturer Price (“AMP”), this NDC also needs be in mLs in order to calculate the correct weighted average. We reviewed the ‘Billing Unit Decision Tree’ and ‘Billing Unit Standard’ documentation on the NCPDP website which states that when a product is packaged in less than a 1 mL quantity it is ‘Likely billed per Each’, not that it is ‘required’ to be billed per Each. It is our understanding per the disclosure on the NCPDP website that the decision tree tool is not intended to be used as the final verification when choosing billing units.In addition to not receiving claims in mls, our concern is that with an inner NDC and a package size of 4 and a UOM of Each we may receive Managed Care and Medicaid claims with a unit of 4 instead of 1. This would make it very difficult to determine what units were actually dispensed since Eaches are usually package sizes of 1. We are requesting this change in order to ensure the claims come in correctly so that we can accurately calculate a weighted average AMP.
Manufacturer Release 73 (
http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Downloads/Rx-Releases/MFR-Releases/mfr-rel-073.pdf) states that a unit of measure of EACH should NOT be used for a liquid like Nascobal without CMS permission precisely because of the problem with calculating a weighted AMP when a manufacturer sells multiple package sizes of a given product. Manufacturer Release 73 also states that product with a unit of measure of EACH cannot have any UPPS other than “1” and this is why products available in different package sizes cannot use EACH as a unit of measure. The States that rely on compendium information cannot generate rebate invoices that are correct when the compendium assigns a UOM of Each.
In addition, CMS has provided advice on setting the UPPS for products with both an inner and an outer package in Manufacturer Release 71 (
http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Downloads/Rx-Releases/MFR-Releases/mfr-rel-071.pdf). In this case, the UPPS would be 0.125 mL for the 49884-270-52 inner package product since that is the amount in one individual spray device and the UPPS for the NDC 49884-270-82 would be 0.5 mLs.
Outcome Anticipated: We are requesting that the UOM be updated to mLs and the Package Size to .5mLs.
Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of March 10th
: (Michele Capela, Jen Draught and Kim Bridgewater of Par Pharmaceutical were on the call to assist with questions.)
Prior to the TG call, the compendia discussed this product via email and determined the Billing Unit = “Each” with a package quantity of 4 for the NDC 49884-0270-82 and a package quantity of 1 for the NDC 49884-0270-52 (inner pack) based on the following sections of the Billing Unit Standard:
4.2.1 BILLING UNIT OF “EACH” (EA)
Unit-of-use packages or self-contained single dose packages with a quantity less than one milliliter or gram should be billed as “one each”. For example, ointment in packets of less than 1 gram or eye drops in dropperettes that are less than 1 ml. This rule does not apply to injectable products.
5.1 DOSAGE FORMS BILLED AS “EACH” (EA)
5.1.12 Unit-of-use packages or self-contained single dose packages with a quantity less than one milliliter or gram should be billed as “one each”. For example, ointment in packets of less than 1 gram, eye drops in dropperettes that are less than 1 ml, or nebulizer solution in package of less than 1 ml.
The product contains less than 1 mL.
On the TG call Par provided background and explained the packaging of this product. They have two other products with the same core 9 NDC that are reported in mLs. Because there are different billing units for the same product (same core 9), Medicaids would have to convert for rebate purposes. It was noted that the 0.125 is not printed on the outer carton but 0.5 is printed on the outer carton. The inner pack may be dispensed although it is not intended to be dispensed. The product is priced per package size. It was explained that the billing unit is determined by dispensable unit and not by salable unit. What the pharmacist gives to the patient. In this case, although not intended, one inner pack could be dispensed. It was also explained the standard deals with the delivery volume and not the contained volume. The delivery volume of 0.1 mL is not shown on the label but does appear on the description section of the Package Insert. All on the call agreed this is an overfill situation. The request to change the billing unit from each to ml could only be made by an exception to the BUS and if made, the total dispensed would be 0.4 mL because of the overfill and not 0.5. It was also noted the manufacturer had no option to change the core 9 for this product because the FDA requires this line extension. It was asked why it is easier to be an each than an ml. It was explained that the BU standard has nothing to do with dosing and it is what we can count. Non-injectable products that are less than one are billed as eaches. All on the call agreed the BU should be each with a total quantity of 4 per sections noted above. This is the recommendation that will be taken to WG2 where a final determination will be made at the May WG meeting. Jen, Kim and Michele were invited to attend that meeting and were thanked for bringing this product to us for discussion and consideration.
At this meeting, a motion was made and seconded to classify the BU=“Each” with a package quantity of 4 for the NDC 49884-0270-82 and a package quantity of 1 for the NDC 49884-0270-52 (inner pack) per sections 4.2.1 and 5.1.12 of the Billing Unit Standard of the BUS. It was asked to clarify why the BUS requires non-injectable products of less than one to be billed as eaches. Kay noted this is a legacy practice going back to the original publication of the BUS in the 1980s where due to the inability to report a metric decimal, less than one was rounded up to the next whole number. The motion carried with 7 opposed and 22 in favor. The Product Review and BU Exceptions TG will review less-than-one items (non-injectable) and report back to the work group. Injectable products are by the mL.