Standards QUIC Form Resolutions

Requested clarification for the billing unit quantity for VARIOUS GLUCOSE METER CONTROL SOLUTIONS   NDC: various. Differences in the way the compendia determine the billing unit. In some cases a package containing the high and low solutions are identified as "each", for others it identified as "ml". Difference in the AWP/U between the drug files may cause reimbursement issues based on which drug file is used. Discussion at the November 2004 Meeting: This issue has been brought up several times to the compendia. It could be one or the other depending on what is in the package. Some have high and low solutions, while other have just high and others just low. Those with mix solutions are probably shown as a one in a sealed kit while the others are ml, except for those that don't show the ml but rather state that it is enough for XX tests. These cannot be looked at as a class but rather by individual package. Karen noted that the standard indicates that these should be ml. There are about 7 manufacturers and it was stated that there are 117 NDCs. Anne Johnston of Medco volunteered to compare the NDCs across compendia as long as there is exact instructions as to what she is to report on. A motion was moved and seconded to interpret these products as ml unless it is not clearly listed on the label, in which case it would be an each. The use of ml should be followed even if there are low and high solutions within the package. The motion carried. Each compendium will supply a list of their active NDCs for these drugs; these lists will be compared against each other to obtain a master list. The master list will be divided among the compendia in an effort to obtain labels from the manufacturers. Anne will then provide a status report at the March 2005 JTWG meeting. It was also a suggested that a FAQ be developed for these drugs.

REVISION
Background: A list of all active NDCs for these drugs across the compendia was compliled and the final list was reviewed at the August 2006 WG2 Product Identification meeting. The following discussion was held: Kathy Vieson of Gold Standard provided an update. She reviewed the final spreadsheet. The compendia group that reviewed this list recommends that we consider all Glucose Control Solutions as a one each since there is not consistency as to the packaging of these products--what is on the outside of the box and what is in the inside of the box. Additional rationale for making these a one each are:
-these are, as a standard, dispensed as a adjunct to a glucometer
-it is an easy change by the compendia
-easier to maintain going forward since it is difficult to get this information from the manufacturer
The packaging reviewed showed that what was on the outside of the package did not match what was inside the package in mls, there were two different control solutions within some packages, some packages didn't list the mls but noted that it was good for so many tests (having no idea how many mls were in the total package), and some have a high and a low solution. The recommendation is that each 11-digit NDC would be a one each regardless of what is in the package.

A motion was moved and seconded to show as an each as a supply. However, QUIC #2004014 was adjudicated as ml in November 2004. This product is not a drug but rather a supply. We are defining Control Solutions because of Section 5.1.6 of the BUS? It was felt that an FAQ would take care of this because of the labeling of the package says the quantity, actual number and the container and these products are not consistent. An FAQ will address this issue specifically for Glucose Control Solutions and no changes to the Standard will be required. Need a time for the conversion if passed. The motion carried with 2 in opposition. The change will be effective by the compendia at the end of the year (2006). Will this be just an FAQ, or an FAQ and a new line to 5.1.14, or an FAQ and changes made to 5.1.6? It would be best to specifically address this item as a new line under 5.1.14.

Requested clarification for the billing unit quantity for PRETTY FEET & HANDS NDC: 00225-0520-53. What should the billing unit be according to the NCPDP Billing Unit Standard? There is a difference in the billing unit standard between FDB and MediSpan. One compendium uses the billing unit of "ML" and the other "GM". One of the compendia list the package size as "90" the other list the package size as "88.7". Difference in the AWP/U between the drug files may cause reimbursement issues based on which drug file is used. Discussed at the November 2004 Meeting: The standard says to convert ounces to ml by multiplying by 30 unless specifically stated on the label. A motion was moved and seconded to adjudicate as 88.7 ml as is shown on the package. The motion carried.

Requested clarification for the billing unit quantity for Duet DHA Combo Pk, NDC: 64731-0840-30. The work group should review how this drug should be billed to Third Parties. Is it possible to get a standard package size that is billed to all Third Parties? This product is packaged in 30 blister packs of 2 tabs each for a total of 60 tabs, one dose equaling two tablets. Some Third Parties want to see 30 and others want to see 60. The Duet is creating numerous billing issues for Target Pharmacies. The pack size inconsistencies create billing mistakes; numerous invalid quantity/pack size rejects and negative gross margins. Discussed at the November 2004 Meeting: This request was previously received on QUIC form #20040002. This form was reviewed and its outcome was that an extension of the current 1.4 situation for "each" should be made and to make the billing unit be "60 each". A motion was moved and seconded to keep as was previously adjudicated. The CC will get back with the company to see why there is still an issue.

Requested clarification for the billing unit quantity for Diastat Rectal Gel NDC: Several. I would like to have a clearer understanding as to why Diastat should be billed as a 1 each. What makes this product different than Avonex, which is reported as 4 each? Should Diastat be billed as 2 each because each of the pre-filled gel syringes and packets of lubricant make up 1 kit? Pharmacies that are billing Missouri Medicaid are being asked to submit claims for this product in a manner that is not consistent with the NCPDP standard. It is making the billing process difficult, cumbersome and costly. This form was pended at the August 2004 meeting for further discussion at the November 2004 Meeting: The manufacturer, Xcel Pharmaceutical's Inc., was invited to attend this meeting but could not. Discussion via a conference call was held with Anne Lones of Xcel last Friday. There were 3 employees of Xcel on the call and even they had different views of dispensing units. They were to get back to us before this meeting but we have not heard from them. The package does not show any instructions as to breaking of the package. The compendia all have this listed as one and have for several years. The issue arose when the company reported this to CMS as a quantity of 2. State issue brought this forward as they were asking for a quantity of 2. Does each syringe have an NDC noted? We do not know that. One attendee stated that if each syringe has an NDC, they would want to list it as one each in their pharmacy. There is established industry acceptance today for this as a quantity of one - it should be listed, according to the industry, as one kit. There are two vials, two packs of petroleum jelly, and one patient package insert. A motion was moved and seconded to pend the form and recommend to the manufacturer that it should be a one. Motion was withdrawn. If no additional information is expected from the manufacturer, a motion was moved and seconded to adjudicate the form as a one. A letter will be sent to the state that is asking for a quantity of 1. The motion carried with one in opposition. There was recommendation to develop a FAQ for the dispensing of this drug based on the WG's decision.

Requested clarification for the billing unit quantity for Androgel 1% Pump, NDC 00051848888. The package insert indicates that product contains 2 X 88 grams capable of dispensing 75 grams from each pump. Per historic decisions, products have been listed with a package size based on what the product contains. Should this product be listed as 150 (75 times 2) grams or 176 (88 times 2) grams? Discussed at the August 2004 JTWG meeting. The WG agreed that what is on the outside package (what is readily available to the pharmacist) should be used. Motion moved and seconded that this product be defined as 150 grams. The motion carried with no opposition.

Requested clarification for the billing unit quantity and unit quantity and unit for 0.5 ml unit of use packets of S2 (racemic epinephrine), in a foil pouch. After much discussion, it was decided this is an extension of the current 1.9 situation for "each". A motion was made to make the billing quantity and unit be "30 each". A motion was made and to accept as presented. The vote was 1 opposed and the remainder approved. The motion carried. Compendia will make the necessary change to the databases for Q3/first release in July product.

Requested clarification for the billing unit quantity and unit for Hytone 2.5% oz tube. The label on the product and box list the package size as 1 oz. The package insert states that the package size is 1 oz (28.35 gm). Per the BUS, if the package size is noted in ounces for a cream or ointment and no metric size is noted, the billing quantity and unit will be 30 grams. A motion was made to make the package size for Hytone 2-1/2% ointment be 30 grams. The motion was seconded. Motion was approved unanimously. Compendia will make the necessary change to the databases immediately.

Requested clarification for the billing unit quantity and unit for 0.5 ml unit of use inhalation solution container of Albuterol Sulfate in a foil pouch. After much discussion, it was decided this is an extension of the current 1.9 situation for "each". A motion was made to make the billing quantity and unit be "30 each". A motion was made and to accept as presented. The vote was 2 opposed and the reminder approved. The motion carried. Compendia will make the necessary change to the databases for Q3/first release in July product.