QUIC Form Resolutions
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Alphabetical order: |
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960001 - Billing Unit Discrepancies 960002 - FDA and HCFA Package Sizes 960003 - Nicorette (OTC Version) 2/4 mg 960004 - Aldara 5% Imiquimod 960005 - Avonex Administration Pack 970001 - Metaproterenol Sulfate (Example) 970002 - Fragmin (Dalteparin Sodium Injection) 970003 - FRAGMIN (dalteparin sodium injection) 970004 - Intron A 970005 - Copaxone 970006 - Lovenox 30mg prefilled syringe 970007 - Lovenox 40mg prefilled syringe 970008 - Desquam-X Bar 10% 3.75 oz. 970009 - Monurol 3gm sachet 980001 - HELIDAC 980002 - Handling Multi-dose Iyophilized vial billing within the standard 980003 - Infergen (Interferon alfacon-1) 980004 - STIMATE 980005 - Handling Multidose Iyophilized vial billing within the standard 980006 - Lovenox 40 980008 - Pedia-Pop Palsicles 990001 - Prevpac Patient Pac 990002 - Nicotrol Cartridge Inhaler 990003 - Relenza 990004 - Vanceril DS Convenience 990005 - Lovenox 200001 - Videx Pediatric Solution 200002 - Lovenox 200003 - Pulmozyme 200004 - Neupogen 200101 - Derma-Smoothe FS Atopic Pak 200202 - Infuvite 200203 - M.V.I. 12 200204 - Copaxone 200205 - Bacitracin 5MMU Powder 200206 - Colistin Sulfate Powder 200301 - Ultra TLC 200302 - Amevive 7.5mg 4 dose 200303 - Biafine RE 46 ml 200304 - Biafine RE 93 ml 200305 - First-Hydrocortisone gel 200306 - First-Testosterone cream 200307 - First-Testosterone ointment 200308 - Prestige Smart System 200309 - Synalgos-DC 200310 - Amevive 15 mg 4 dose 200401 - Many Bulk Chemicals 200402 - Duet DHA 200403 - Follistim AQ - 437.5 units/05.25 ml 200404 - Follistim AQ 737.5 units/0.885 ml 200405 - Icar Prenatal 200406 - Vfend 200407 - Albuterol Sulfate Inhalation Solution 200408 - Hytone 2.5% 200409 - S2 Inhalant 200410 - Androgel 1% Pump 200411 - Diastat Rectal Gel 200412 - Duet DHA Combo PK 200413 - Pretty Feet and Hands 200414 - Various Glucose Meter Control Solutions 200415 - Octagam 5% Vial 200416 - Pedialyte Freezer Pops 200417 - Xolair 200501 - FIRST Progesterone VGS 100 200503 - Rebif Titration Pack 200504 - Asmanex 200505 - Ultiguard 200506 - Twinject auto-injector 200507 - ZMAX 200508 - Sidekick 200509 - Keralac Nailstik 200510 - Diastat AcuDial Twin Pack 200511 - Keralac Nailstik 200601 - Efudex Occlusion 200602 - Tretin X 200603 - ZMAX 200604 - Pulmicort Inhalers 200605 - Exubera (Insulin for inhalation) 200606 - Intron A injection 200607 - Vaprisol 200608 - Cleeravue-M 200609 - Centary Kit 200610 - INTRON A Solution for Injection in Multidose Pens 200611 - MoviPrep 200612 - Nystatin Powder 200613 - AnaMantle HC Cream & AnaMantle HC Cream Kit 200614 - Atridox 200701 - ClindaReach 200702 - Lucentis 200703 - Pulmicort Flexhaler 200704 - Euflexxa 200705 - Torisel 200706 - Duplex Delivery Systems 200707 - Rinnovi Nail System 200708 - Somatuline 200709 - Coraz Lotion 200710 and 200711 - SymlinPen 200801 - Ceprotin 200802 - RhoGAM 200803 - SALICEPT SUS 200804 - Salex Cream and Lotion 200805 - Rowasa 200806 - BREVOXYL 200807 - NUTRIDOX CONVENIENCE KIT |
200407 - Albuterol Sulfate Inhalation Solution 960004 - Aldara 5% Imiquimod 200310 - Amevive 15 mg 4 dose 200302 - Amevive 7.5mg 4 dose 200613 - AnaMantle HC Cream & AnaMantle HC Cream Kit 200410 - Androgel 1% Pump 200504 - Asmanex 200614 - Atridox 960005 - Avonex Administration Pack 200205 - Bacitracin 5MMU Powder 200303 - Biafine RE 46 ml 200304 - Biafine RE 93 ml 960001 - Billing Unit Discrepancies 200806 - BREVOXYL 200609 - Centary Kit 200801 - Ceprotin 200608 - Cleeravue-M 200701 - ClindaReach 200206 - Colistin Sulfate Powder 200204 - Copaxone 970005 - Copaxone 200709 - Coraz Lotion 200101 - Derma-Smoothe FS Atopic Pak 970008 - Desquam-X Bar 10% 3.75 oz. 200510 - Diastat AcuDial Twin Pack 200411 - Diastat Rectal Gel 200402 - Duet DHA 200412 - Duet DHA Combo PK 200706 - Duplex Delivery Systems 200601 - Efudex Occlusion 200704 - Euflexxa 200605 - Exubera (Insulin for inhalation) 960002 - FDA and HCFA Package Sizes 200501 - FIRST Progesterone VGS 100 200305 - First-Hydrocortisone gel 200306 - First-Testosterone cream 200307 - First-Testosterone ointment 200403 - Follistim AQ - 437.5 units/05.25 ml 200404 - Follistim AQ 737.5 units/0.885 ml 970003 - FRAGMIN (dalteparin sodium injection) 970002 - Fragmin (Dalteparin Sodium Injection) 980005 - Handling Multidose Iyophilized vial billing within the standard 980002 - Handling Multi-dose Iyophilized vial billing within the standard 980001 - HELIDAC 200408 - Hytone 2.5% 200405 - Icar Prenatal 980003 - Infergen (Interferon alfacon-1) 200202 - Infuvite 970004 - Intron A 200606 - Intron A injection 200610 - INTRON A Solution for Injection in Multidose Pens 200511 - Keralac Nailstik 200509 - Keralac Nailstik 990005 - Lovenox 200002 - Lovenox 970006 - Lovenox 30mg prefilled syringe 980006 - Lovenox 40 970007 - Lovenox 40mg prefilled syringe 200702 - Lucentis 200203 - M.V.I. 12 200401 - Many Bulk Chemicals 970001 - Metaproterenol Sulfate (Example) 970009 - Monurol 3gm sachet 200611 - MoviPrep 200004 - Neupogen 960003 - Nicorette (OTC Version) 2/4 mg 990002 - Nicotrol Cartridge Inhaler 200807 - NUTRIDOX CONVENIENCE KIT 200612 - Nystatin Powder 200415 - Octagam 5% Vial 200416 - Pedialyte Freezer Pops 980008 - Pedia-Pop Palsicles 200308 - Prestige Smart System 200413 - Pretty Feet and Hands 990001 - Prevpac Patient Pac 200703 - Pulmicort Flexhaler 200604 - Pulmicort Inhalers 200003 - Pulmozyme 200503 - Rebif Titration Pack 990003 - Relenza 200802 - RhoGAM 200707 - Rinnovi Nail System 200805 - Rowasa 200409 - S2 Inhalant 200804 - Salex Cream and Lotion 200803 - SALICEPT SUS 200508 - Sidekick 200708 - Somatuline 980004 - STIMATE 200710 and 200711 - SymlinPen 200309 - Synalgos-DC 200705 - Torisel 200602 - Tretin X 200506 - Twinject auto-injector 200505 - Ultiguard 200301 - Ultra TLC 990004 - Vanceril DS Convenience 200607 - Vaprisol 200414 - Various Glucose Meter Control Solutions 200406 - Vfend 200001 - Videx Pediatric Solution 200417 - Xolair 200507 - ZMAX 200603 - ZMAX |
QUIC FORM 200407 - Albuterol Sulfate Inhalation Solution Resolution
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.QUIC FORM 960004 - Aldara 5% Imiquimod Resolution
The QUIC form was reviewed during two quarterly work group meetings, May 10, 1996 and November 7, 1996. The final resolution of QUIC #960004 was during the November 7, 1996 work group meeting.Coreen Pickett stated that Aldara is a new topical ointment product, with a one (1) to two (2) year release date. The issue is what NCPDP feels would be a unit of measure for the product. The standard states that topical ointments should be in "grams". However, it comes in a packet of .25 gm. The issue is to eliminate rounding to one (1) for each unit. It would then be considered, in a box, to be 3 gm's total and would then be 12, because each packet would be rounded to one (1). There will be 12 single use packets in a box. The question Coreen Pickett asked, would "eaches" be a solution? The work group stated that "eaches" would require a new release of the standard. Ed Edelstein stated that during the Telecommunication meeting, held on May 9th, it was proposed in the new version that everything would be in metric decimal quantity. Therefore, it is possible that by the time this product is on the market, everything will be measured in metric decimal. There is another issue with HCFA, if something is less than one (1), they want it reported as one (1).
Barbara Reed recommended that before a final decision can be made, the pricing compendia should be contacted to see how many other products fall into this category, if this information is available prior to the August meeting, it should be distributed to the attendees for their review.
The members of the work group collected information from the pricing compendia (First Data Bank, Medi-Span and Medical Economics) and voted that a change be made to product identification standard. The change would be "Unit of use packages with a quantity less than one becomes a quantity of ONE EACH." The update of this addition to the product identification standard will become effective February 1, 1997. The unit of measurement for the product Aldara - One Each Packet.
QUIC FORM 200310 - Amevive 15 mg 4 dose Resolution
QUIC Form 200310 requested clarification on the billing unit standard. The product has 4 dose packs per package. There was a motion that it should be listed as "4". The motion was seconded and the motion carried for both QUIC forms.QUIC FORM 200302 - Amevive 7.5mg 4 dose Resolution
QUIC Form 200302 requested clarification on the billing unit standard. The product has 4 dose packs per package. There was a motion that it should be listed as "4". The motion was seconded and the motion carried for both QUIC forms.QUIC FORM 200613 - AnaMantle HC Cream & AnaMantle HC Cream Kit NDCs: 00482480014 and 00482480020 Resolution
Requested clarification for the billing unit quantity. At the November 2006 WG2 meeting Scott Breakstone of Bradley Pharmaceuticals, Inc. presented the form. Scott presented the history of the packing of this product. Pictures of the products were viewed. Products were not introduced at the same time - the gram product came out first. The AnaMantel kit was adjudicated by this group about a year ago and there has been no change in the product. Would like to take the one reported as gram and make it a kit. But would not be averse to taking the kit and making it a gram. Either way is an exception to the standard. Utilization of the products---individual has a better market share than the kit. It was suggested that a new NDC be assigned---this would take awhile. The wipe is the only difference in the two products. A motion was moved and seconded to leave the products as is and to assist with the notification to the states that this is compliant. The motion carried with no opposition.QUIC FORM 200410 - Androgel 1% Pump NDC: 00051848888 Resolution
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.QUIC FORM 200504 - Asmanex Resolution
Requested clarification for the billing unit quantity for Asmanex. At the August 2005 WG2 meeting representatives from Schering-Plough were present.. It is a 30-day treatment regiment and the numbers of puffs are based on the severity level - mild, moderate, and severe. Packages of the products were distributed to the attendees - each package has one inhaler. Each package contains the same amount of the drug with a 30, 60, or 120 inhaler. There is also 45-day out-of-foil pouch stability. The 220 micrograms that is listed on the container is the amount that is delivered per spray. The 0.240 grams is the total formulation in each inhaler regardless of the inhalation size. There is an identical overfill for each inhaler. The overfill supports the stability and is not accessible to the patient. There is confusion arising from the 0.240-gram designation for Asmanex. How do you identify the product seems to be the problem. Making a change in the name does not work because - how is it being marketed to the physician. Some databases used at the pharmacy level are also being used for e-Prescribing and so they must be identifiable at that level. Additionally, in the RxNorm environment, these will all look the same. Schering does not support the concept of dose billing. It was noted that 0.24 grams as the total quantity is on the face of the package. A motion was moved and seconded to abide by the NCPDP standard and make these 0.24 grams. Does the proposal to make this an exception to the standard make the problem go away? We don't know but don't think so. While the compendia can add descriptors that would help clarify, there is no control on how the end user formats the data that they get from the compendia. The motion carried with no opposition. One attendee felt that this issue will go away with education but the e-Prescribing issue will not. Schering will work with the WG2 Co-Chairs as to the notification and the proper billing of this item will be sent out in the NCPDP Now.QUIC FORM 200614 - Atridox NDC: 63646-0191-00 Resolution
Requested clarification for the billing unit quantity. At the November 2006 WG2 meeting it was asked if this is a one each or ml? A motion was moved and seconded to consider this a non-injectable and list as a one each. The motion carried.QUIC FORM 960005 - Avonex Administration Pack Resolution
The issue is that they are asking for clarification on the billing for a new product, Avonex Administration Pack. Should the product be billed as four (4) which is the dispensed quantity, or should it be billed as one (1)?It was stated that in order to be compliant with NCPDP standards this should be a package of four (4), because pharmacists could split-up the package. Everybody was in agreement on this item.
QUIC FORM 200205 - Bacitracin 5MMU Powder Resolution
This QUIC Form requested clarification on how to determine the estimated gram weight for the product. There was a motion that it should be defined as "One Each", effective as of 2nd Quarter of 2003 (April 1, 2003). The motion passed. This cannot be changed in the current standard but could be reflected in the next version.QUIC FORM 200303 - Biafine RE 46 ml Resolution
QUIC Form 200303 requested clarification on the billing unit standard. Attendees believed that the product had recently been changed from ml to gram but did not have a copy of the box present to confirm the change. There was a motion that both products should be listed in ml's or grams (which ever is most current) and not "One Each". The motion was seconded and approved.QUIC FORM 200304 - Biafine RE 93 ml Resolution
QUIC Form 200304 requested clarification on the billing unit standard. Attendees believed that the product had recently been changed from ml to gram but did not have a copy of the box present to confirm the change. There was a motion that both products should be listed in ml's or grams (which ever is most current) and not "One Each". The motion was seconded and approved.QUIC FORM 960001 - Billing Unit Discrepancies Resolution
Ed Edelstein reported that Lisa Norton submitted a report with 193 NDC's with unit of measurement discrepancies between the HCFA file and her product/pricing database. Ed Edelstein contacted several manufacturers to discuss several discrepancies specific to their products. The manufacturers then contacted HCFA, which in turn stated that they would change to the appropriate unit of measure. Intron from Schering, is a powdered filled vial and should be "each." However, Schering contacted HCFA and after discussion, the decision was to leave it as is. Ed Edelstein stated that Goldline was willing to change amoxicillin and penicillins to "ml's" from "eaches". Rugby's discrepancies have been addressed and corrected. Ed Edelstein stated that those products that can be corrected by the manufacturer will be, however, there will be a period of adjustment. Both Ed Edelstein and Linda Schock agreed to continue working on this effort.QUIC FORM 200806 BREVOXYL Resolution
Requested clarification for the billing unit quantity. At the November 2008 WG2 meeting the form was discussed. Issue: To confirm the billing unit for a new product - BREVOXYL® Creamy Wash (benzoyl peroxide 4% or 8%) Complete Pack. The Pack contains a 170.1-g tube of BREVOXYL® Creamy Wash (of either strength); and two 21-g PANOXYL® bars (benzoyl peroxide 5%). Our belief is that this product, since all components are measured in grams, should NOT be a kit. Therefore, we believe the correct billing unit is 212.1 grams. Mike DiFiore of Stiefel Laboratories, Inc. discussed this product. Based on discussions by the Product Review and Billing Unit Exception Task Group the determination was made that BREVOXYL® Creamy Wash (benzoyl peroxide 4% or 8%) Complete Pack does NOT have the billing unit of a "kit"” The package says it is a kit but according to the BUS standard, if everything contained within the product is the same billing unit then the billing unit is the total number of those grams. So the appropriate billing unit is the total grams within the pack or 212.1. The gram amounts are shown on the side panel. Stiefel’s regulatory would not allow the indication of 212.1 grams on the box but would allow that information to go in the communication to the pharmacist. There is nothing in the standard that tells how to bill bars. The biggest concern is if the billing unit amount will be easily recognizable by the person entering the amount. If the total gram amount is not added to the package, it will end up hurting the product in the long run. The company is doing everything to be proactive. A motion was moved and seconded to adjudicate as 212.1 grams. The motion carried without opposition.QUIC FORM 200609 - Centary Kit Resolution
Requested clarification for the billing unit quantity. At the May 2006 WG2 meeting David Hegarty of Ortho Neutrogena presented the form. The new Centany Kit will contain a 15gm or 30gm tube of Centany and Johnson and Johnson First Aid gauze pads in a package of 10 for occlusion. These two individual products will be housed inside an outer box that will have an NDC#. The outer box will have clear communication of the products included. A motion was moved and seconded to approve as a kit. The motion carried without opposition. It shows on the package, "Dispense as a complete unit."QUIC FORM 200801 CEPROTIN That is available in single-dose vials that contain the following nominal product strengths: BLUE BAR: 500 IU per vial: (NDC: 0944-4175-05) GREEN BAR: 1000 IU per vial: (NDC: 0944-4175-10) Resolution
Requested clarification for the billing unit quantity. At the February 2008 WG2 meeting the form was discussed. The exception to these has been removed in the BUS Implementation Guide and these products are now designated as an each. Terri Meredith suggested that we add Protein C to the list given in Section 5.1.7 of the BUS Implementation Guide. It was countered that items listed in 5.1.7 and 5.1.8 should be combined into a more generic category. A motion was moved and seconded to adjudicate this QUIC form to an each per unit according to the standard. The motion carried with no opposition. A motion was moved and seconded to combine items 5.1.7 and 5.1.8 in the BUS Implementation Guide to one item and a more general description for these products given. The motion carried without opposition. This item will be assigned to the BUS Exception Review TG to come up with the verbiage.QUIC FORM 200608 - Cleeravue-M NDC: 14168-2610-02 Resolution
Requested clarification for the billing unit quantity. At the May 2006 WG2 meeting Rick Coulon of StoneBridge Pharma gave a presentation. He provided a product overview which gave the purpose of the drug and the promotion plan. Cleeravue-M is a kit combining 50mg minocycline tablets (60 ct) with a unique, patented eyelid cleanser. The kit combines two essential elements for treating moderate to severe eyelid infection/inflammation (Blepharitis). First, minocycline is prescribed to control the eyelid margin infection and agents that modify secretions of the Meibomian glands often associated with eyelid infection/inflammation (Blepharitis). Secondly, the eyelid cleanser combines an antiseptic with hypoallergenic surfactant to remove debris and oils that build-up and often clogs the Meibomian glands causing inflammation and poor tear quality resulting in dry eye symptoms in patients with this condition. The product will be launched in July 2006. A motion was moved and seconded to approve as a kit. The motion carried without oppositionQUIC FORM 200701 - ClindaReach Resolution
Requested clarification for the billing unit quantity. At the May 2007 meeting Scott Lundahl, Vice President of Regulatory Affairs for DUSA, was present to conduct the discussion. Scott brought an example of the applicator and demonstrated how it was used. There is no cleanser included that is used on the cleansing pads (64 - pads). The Billing Unit Standard was reviewed. It is labeled as a system and the FDA requested that they list the primary NDC as a kit. There is no refill kit and a complete kit is sold every time. The NCPDP QUIC form review group determined in their preview that this was a kit. A motion was moved and seconded to adjudicate this form as a kit. The motion carried.QUIC FORM 200206 - Colistin Sulfate Powder Resolution
This QUIC Form requested clarification on how to determine the estimated gram weight for the products. There was a motion that each would be defined as "One Each", effective as of 2nd Quarter of 2003 (April 1, 2003). The motion passed. This cannot be changed in the current standard but could be reflected in the next version.QUIC FORM 200204 - Copaxone Resolution
Product contains 32 vials of Copaxone and a self-administration package, which includes 32 vials of sterile water, 32, 3 cc syringes, 32 Mixject Vial Adapters, 32 injection needles and 100 alcohol preps. Based on the NCPDP standard, these items are 1 kit. The question was raised as to whether standard of practice should influence the assignment of units of measure; i.e. how it is being dispensed. Clarification is needed on how the standard applies to a kit.Motion was made to strictly apply the standard to the product and define Copaxone as a one EA kit. The standard will need to be amended in the future to better address the current business needs for defining unit of measure for this type of product. After additional discussion, the motion carried. A breakdown of the color-categorization of votes was taken.
QUIC FORM 970005 - Copaxone Resolution
The unit for Copaxone will remain as 32 each. However, Dave Frobel of Caremark wanted the group to address his companies billing concerns as some payers will not pay for the days supply of 32 if that exceeds the maximum on their plan. Caremark feels that because the product is a kit, they cannot break it up to dispense it because of the three different components in it. Dave Frobel asked the group to give suggestions on how to deal with this issue.Linda Schock stated that HMR was considering changing the quantity due to this problem. However, the issue remains until such time as HMR changes the quantity. The group suggested that Caremark go back to the payers who are rejecting the claims and work with them on an individual basis to see if the pharmacist can receive prior authorization. It was suggested that Caremark ask the manufacturer, HMR, to tell the payers that the product needs to be dispensed as a kit, due in part to the fact that it is frozen. The group also felt that Caremark could use the fact that they had come to NCPDP's Work Group 2 to demonstrate that they are making good faith efforts to resolve the issue.
QUIC FORM 200709 Coraz Lotion (NDC#: 14629-0516-01 for combination and 14629-0515-01 for Coraz and 14629-0903-06 for Pulere) Resolution
Requested clarification for the billing unit quantity. At the November 2007 WG2 meeting the form was discussed. The form was adjudicated with Form 200707 - please see 200707 Rinnovi Nail System above.QUIC FORM 200101 - Derma-Smoothe FS Atopic Pak Resolution
The QUIC form stated that FirstData Bank shows this product as a "kit" and therefore with a package size of 1 ea., but RedBook lists this product with a package size of 360ml. The question was raised as to how the pricing compendias notify pharmacies and their customers of changes. It was reported that they communicate with their customers. The suggestion was made to also communicate with the pharmacies. A motion was made to list the Derma-Smoothe FS Atopic Pak as a "1 ea". The motion was moved and seconded. The motion carried.QUIC FORM 970008 - Desquam-X Bar 10% 3.75 oz. Resolution
The work group decided that "A BAR OF SOAP" should be considered as ONE EACH in the standard. Since a bar of soap is only sold in this form and is not dispensed (or cut-up) as a gram in the pharmacies. Medi-Span has agreed with this determination and will change their database to reflect ONE EACH, as First Data Bank & Red Book has it listed. The standard will further define a bar of soap as an example under the definition of EACH.QUIC FORM 200510 - Diastat AcuDial Twin Pack (10mg & 20mg) Resolution
Requested clarification for the billing unit quantity for Diastat AcuDial Twin Pack. The product comes packaged the same way. The difference between this produce and the previous Diastat reviewed is that you can dial and get the dose that you want to give for this product. For all the reasons that we made it a kit before, the reasons are still there. A motion was moved and seconded to make this a kit. The motion carried with no opposition.QUIC FORM 200411 - DIASTAT RECTAL GEL Resolution
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.QUIC FORM 200402 - Duet DHA Resolution
Requested clarification for the application of the Billing Unit Standard for Duet DHA. Duet DHA is a convenience pack of prenatal vitamins and 30 tablets and 30 capsules on a blister card with 30 cavities. After much discussion, it was decided that is an extension of the current 1.4 situation for "each". A motion was made to make the billing unit be "60 each". The motion was seconded and voted on. The vote was 5 opposed and the remainder approved. The motion carried. Compendia will make the necessary change to the databases immediately since the product has not yet been made available.QUIC FORM 200412 - DUET DHA COMBO PK Resolution
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.QUIC FORM 200706 Duplex Delivery Systems NDC: Multiple Products Resolution
Requested clarification for the billing unit quantity. At the November 2007 WG2 meeting the form was discussed. Anne read above and the decision tree was used---which showed "each" as the billing unit. The BUS Implementation Guide was reviewed. A motion was moved and seconded to approve all the B.Braun Duplex products be classified as a one each ---all on the form and others that are in this package medium---with the conversion by the compendia to be made on January 1, 2008. Some concern was expressed regarding changing this and the impact to rebates. It was noted that the manufacturer is notified of the WG's decision. The motion carried without opposition.QUIC FORM 200601 - Efudex Occlusion Pack NDC: 00187-3600-60 Resolution
Requested clarification for the billing unit quantity. At the March 2006 WG2 meeting Alisha Nelson with Valeant led the discussion. This product came out about 2 months ago. This product contains 80 occlusions in addition to a 40 gm tube. The condition (sores/lesions) appears to worsen for those patients that use the medication and so it was recommended by doctors that the bandages be added. Request is to make this product a kit. Is the core 9 different---yes, it is. How is it listed by compendia now? One each. Why? The cotton balls and bandaids cover thisalso there are two different billing units. The outside label says kit and maps out the contents. The NDC is on the outside of the package. The unit of measurement to CMS is a kit and Medicaids are aware of this. A motion was moved and seconded to approve as a kit. The motion carried with no opposition.QUIC FORM 200704 Euflexxa (NDC#: 55566-4100-01) Resolution
Requested clarification for the billing unit quantity. At the August 2007 WG2 meeting it was asked if we include the overfill as 2.25? Is the 2.25 the volume of the syringe and not what is in the syringe? Yes. A motion was moved and seconded to approve as 2 ml. The compendia list it as 2ml. Can we make a suggestion that the manufacturer should remove the overfill information? Yes. Karen noted that part of the task group to look at exceptions to the BUS, will be to ask the FDA to provide the delivered amount rather than the overfill amount on the package labeling. There is no FDA requirement to provide the overfill. Randy Levine of the FDA will be at the NCPDP WG11 meeting tomorrow and Karen will be talking to him about this. The motion carried without opposition.QUIC FORM 200605 - Exubera (Insulin for inhalation) Resolution
Requested clarification for the billing unit quantity. At the March 2006 WG2 meeting David Searle of Pfizer's Trade Group was present to discussion this request. This is the first in a new class of inhaled insulins. It is device based and must be replaced every 12 months. The Chamber must be replaced every 12 months and the Insulin Release Unit must be replaced every 2 weeks. There are 3 combinations to be stocked by the pharmacy - 1mg and 3mg combo; 1 mg Patient Pack; and 3 mg Patient Pack. Each package will contain 2 release units. Combination package will allow for a single copay for Patients needing both 1 mg and 3 mg. Most patients will start with a combination pack. Packaging was not available as this has not even gone through regulatory yet. It is important that the labeling reflects one kit containing the amounts, it will be much clearer to the pharmacy. What they are asking for is that the billing unit be 90 for the 1mg box, 90 for the 3 mg box and 180 for the combo. This really fits into the kit category. From the Standard---the following units include when a drug should be ignored for purposes of billing. The billing unit of the drug item determines the billing unit of this package. The six bullet is Actuation devices (i.e. lancets, lancet devices) and the seven bullet is Inhalation. Ross reinforced the need for a short name using this drug as an example. There is no other way to do this but with the 180 for the combo. But there are two strengths within the same pack and we already have a precedence on this. The release unit is a prescription product and will be boxed and offered at a nominal charge. Will probably have a UBC and not an NDC for these units. Distribution will be to all pharmacies. Release date is hoped to be the end of June 2006 but that date is very fluid. A motion was moved and seconded to keep the billing unit as 90/90/180 each. The motion carried with no opposition.QUIC FORM 960002 - FDA and HCFA Package Sizes Resolution
Ed Edelstein stated that the drug compendia's do not match the package quantity sizes on the HCFA database, which occurs when you have metric decimal. Ed Edelstein gave several examples of the discrepancies. Ed Edelstein volunteered to match all of the metric decimal quantities on First Data Bank's database against the HCFA reported quantities and to contact the manufacturers to see what they have on their label.QUIC FORM 200501 - FIRST Progesterone VGS 100 Resolution
Requested clarification for the billing unit quantity for FIRST Progesterone VGS 100, NDC: 65628-0062-01. Requesting validation from Workgroup 2 that a package size of 30 is the proper metric decimal quantity for the product, since it is a compounded product. At the March 2005 meeting a motion was moved and seconded to make the billing unit be 30 suppositories. The motion carried.QUIC FORM 200305 - First-Hydrocortisone gel Resolution
QUIC 200305 requested clarification of billing unit standard. Both products are supplied in a 60 gm container. There was a motion to list both products as "60 gm". The motion was seconded and approved.QUIC FORM 200306 - First-Testosterone cream Resolution
QUIC 200306 requested clarification of billing unit standard. Both products are supplied in a 60 gm container. There was a motion to list both products as "60 gm". The motion was seconded and approved.QUIC FORM 200307 - First-Testosterone ointment Resolution
QUIC 200307 requested clarification of billing unit standard. Both products are supplied in a 60 gm container. There was a motion to list both products as "60 gm". The motion was seconded and approved.QUIC FORM 200403 - Follistim AQ - 437.5 units/05.25 ml Resolution
Requested clarification for the billing unit quantity and unit for Follistim AQ 437.5 units. The product contains "one syringe filled with 0.525 ml of follitropin beta". The total volume of the drug is 0.525 ml, but the usable amount is 0.36 ml and the remainder is overfill. A motion was made to make the billing quantity and units to be 0.525 ml. Motion was seconded and discussed. Motion was approved unanimously.QUIC FORM 200404 - Follistim AQ 737.5 units/0.885 ml Resolution
Requested clarification for the billing unit for Follistim AQ 737.5 units. The product contains "one syringe filled with 0.885 ml, but the usable amount is 0.72 ml and the remainder is overfill. A motion was made to be consistent with Follistim AQ 437.5 units/0.525 ml and make the billing quantity and units to be 0.885 ml. Motion was seconded and discussed. Motion was approved unanimously.QUIC FORM 970003 - FRAGMIN (dalteparin sodium injection) Resolution
The work group members agreed that we couldn't make exceptions to the basic requirement of the Standard document. Injectables in liquid form whether in a vial, ampule, or syringe are always considered to be "milliliters". Changing a product to an "each" because it has a metric decimal quantity is not going to solve the problem. This will only compound the problem, because in fixing one situation, we create chaos by violating the Standard. When there is no consistency, there is no Standard.In addition, this is not really a billing unit issue; it is a metric decimal quantity issue. The work group is trying very hard to resolve the metric decimal problem.
In the case of FRAGMIN, if HCFA is rounding the .2ml to 1 (which is what we believe they do with quantities less than 1), they are using 1 as the quantity anyway. This makes your concern (with this particular product) disappear.
WG2 Product Identification considered your requests and voted to deny the exception to the Standard for the reasons stated above.
QUIC FORM 970002 - Fragmin (Dalteparin Sodium Injection) Resolution
The work group members agreed that we couldn't make exceptions to the basic requirement of the Standard document. Injectables in liquid form whether in a vial, ampule, or syringe are always considered to be "milliliters". Changing a product to an "each" because it has a metric decimal quantity is not going to solve the problem. This will only compound the problem, because in fixing one situation, we create chaos by violating the Standard. When there is no consistency, there is no Standard.In addition, this is not really a billing unit issue; it is a metric decimal quantity issue. The work group is trying very hard to resolve the metric decimal problem.
In the case of FRAGMIN, if HCFA is rounding the .2ml to 1 (which is what we believe they do with quantities less than 1), they are using 1 as the quantity anyway. This makes your concern (with this particular product) disappear.
WG2 Product Identification considered your requests and voted to deny the exception to the Standard for the reasons stated above.
QUIC FORM 980005 - Handling Multidose Iyophilized vial billing within the standard Resolution
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.
QUIC FORM 980002 - Handling Multi-dose Iyophilized vial billing within the standard Resolution
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.
QUIC FORM 980001 - HELIDAC Resolution
Andy Bowman of Micromedex, Inc. who is the product manager for Red Book database will research the issue and report back to the work group. The group was in agreement that the correct billing unit quantity for this product was 56.QUIC FORM 200408 - Hytone 2.5% Resolution
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.QUIC FORM 200405 - Icar Prenatal Resolution
Requested clarification for the application of the billing unit standard for Icar Prenatal. Icar Prenatal is comprised of 1 bottle of 30 prenatal multivitamins, 1 bottle of 60 calcium tablets and 1 bottle of 30 omega - 3 fatty acid tablets. After much discussion, it was decided this is an extension of the current 1.4 situation for "each". A motion was made to make the billing unit "120 each". The motion was seconded and voted on. The vote was 5 opposed and the reminder approved.QUIC FORM 980003 - Infergen (Interferon alfacon-1) Resolution
There was discussion on the importance of pharmacies and states using the metric decimal quantity in billing. It was noted that other products have the same problem and that this issue comes up repeatedly at the Work Group meetings. A motion was made to continue to promote the value of using metric decimal quantities throughout the industry. The motion was moved and seconded. The motion carried.QUIC FORM 200202 - Infuvite Resolution
The Infuvite Pediatric consists of two vials to be mixed before administration. The NCPDP Billing Unit Standard does not specifically address two items under one NDC that are liquids. QUIC #200202 asks for clarification of how these should be listed and billed. Rule 2.2 will be applied and additional definition will be required in the Implementation Guide. Motion was passed to approve with recommendation of the WG that the billing unit for each of the NDC's should be "ml" and the change should be made at the quarter (July).QUIC FORM 970004 - Intron A Resolution
Ed Edelstein, a representative of First Data Bank, agreed to change the unit of measurement of one kit to six each. According to the standard a kit is described as two different or discreet items in the same package, intended for dispensing as a unit. Ed Edelstein also mentioned a similar item, Copaxone, by the manufacturer, Hoescht Marion Rousell, which was also entered into the First Data Bank database as a one kit and will be changed to be consistent with Medi-Span and Medical Economics (Red Book) and to comply with the standard to 32 each.QUIC FORM 200606 - Intron A injection NDC: 00085-1133-01 and 00085-1168-01 Resolution
Requested clarification for the billing unit quantity. At the March 2006 WG2 meeting Kay led the discussion specifically to the product line. It is listed on all the compendia at one point as 2.5 ml. Recently, the labeling was changed to show a "to contain volume of 3.2 and 3.8". Other products will sometimes include what is left in the syringe and it did not have an affect on the NDC. What are the precedence for other situations where there is overfill? If a manufacturer has labeled a product for the quantity to dispense (i.e. includes the overfill), for example Intron A contains 1.5 ml to be dispensed as 6.2 ml doses, the reported dispensing quantity should be 1.5 mls. This has been on the database for ages. If someone looks at the package or insert today, they will probably put the number there rather than what is on the database. Kay noted the need to discuss the new agenda item on how to handle Billing Unit/Package Size changes for existing products in the marketplace. It causes huge problems and we need a way to manage this. Tom Bizzaro had thought to suggest to pend because it is a much larger issue but will not since the compendia are not in sync. Terri state that we need to get the manufacturer here to discuss before we make a change. Randy Levin noted that this appears to be a problem because of the inconsistency of the labeling. The FDA didn't understand until now that this inconsistency causes issues downstream and this fits perfectly with the SPL as we are now expressing this as a data element. SPL will make this consistent from label to another. FDA would insure the consistency. This is not just a rebate issue downstream but also on the billing side - rejections would occur. Even though we don't talk price here, the number of doses is what is being paid for and if one goes from 1.5 to 1.6 to accommodate overfill, there will be a perception that the payer is paying for something that is not being delivered. Also, the rebate issue and if you start reporting the volume as greater than what the patient is getting the clinical programs start to kick in and the DUR edits are skewed. Lastly, the reporting packages - where one used to report to the manufacturer that XX number of does have been dispensed, the number has now been inflated because of the overfill consideration. This is causing billing issues today because of the discrepancies between the compendia. Did Medispan change only one of the NDC? Not sure. If we make a change we need to address all the NDCs. For Vials there is no consideration of overfill but there is on syringes. We are inconsistent within the same product. First DataBank also made the change to match Medispan - 113301 is shown as 3.2 mls and 116801 is 3.8 mls. Even if the compendia were all in agreement changing of this causes rejections and once the product has been dispensed you do not want to go back and change the quantity to something that was not on your label. A motion was moved and seconded to comply with the billing unit standard for both NDCs (3.2 and 3.8) and notify Schering to attend the next meeting so that they are aware of the issue that this has caused. The motion carried with one in opposition.QUIC FORM 200610 - Intron A Solution for Injection in Multidose Pens NDC: 00085124201, 00085123501, 00085125401 Resolution
Requested clarification for the billing unit quantity. At the August 2006 meeting Kay Morgan of Gold Standard lead the discussion These all have the alcolhol swabs - should this be a KIT or ml? A motion was moved and seconded to consider these as a KIT to follow the BUS. This was not sent on to the manufacturer. Any change is going to be major for the manufacturer but the manufacturer has this as one KIT. This was verifed on the CMS Drug Rebate site - www.cms.hhs.gov - and all were one each. The motion carried without opposition. The compendia will make the change at the end of fourth quarter 2006. Karen Eckert of Wolters Kluwer Health asked if the existing FAQ, 7.19, is sufficient to cover as an example for overfill. Another FAQ needs to be scripted and the 7.19 will be adjusted by Karen.QUIC FORM 200511 - Keralac Nailstik (50% Urea) NDC: 10337-648-10 Resolution
See QUIC Form 200509 Resolution.QUIC FORM 200509 - Keralac Nailstik (50% Urea) NDC: 10337-648-10 Resolution
Requested clarification for the billing unit quantity for Keralac Nailstik (50% Urea). Scott Breakstone of Bradley Pharmaceuticals, Inc. presented his request which was sent in as #2005011. Scott noted that they are concerned that this is billed correctly. The next round of packaging will change the package to show the total of 14.4 ml. There is nothing we can do to help make sure that this is dispensed as a full unit. If it is broken it should be billed as the ml. There is an NDC on the applicator that and a different NDC on the outer package. This is a problem---not sure if the pharmacist will bill inside or outside NDC and this lends itself to the breaking of the produce. The days supply could vary by the number and size of the nail(s). A motion was moved and seconded to consider this a 14.4 ml. The motion carried with no opposition. This product has been out for a month and not sure when the new packaging would come out.QUIC FORM 990005 - Lovenox Resolution
HCFA has submitted a program release (#91, 8/4/99) to all State Medicaid Directors to bill the Unit of Measurement (UOM) for the product Lovenox Prefilled Syringe by ONE EACH SYRINGE. This change is necessary due to RPR having experienced numerous disputes due to pharmacies being unable to accommodate the metric decimal quantity and bill correctly by the milliliter in the Medicaid Rebate Program. State Medicaid's must adhere to HCFA changes. However, the pricing compendia, First Data Bank (FDB) reports the product by a milliliter, which is the NCPDP standard.It was noted that before RPR requested this UOM change, they surveyed Medicaid pharmacists that preferred to have the product UOM by the syringe versus the milliliters. The work group discussed this QUIC request, which has come before the group several times. It was noted that the rebate program is unit of measure intense and especially problematic without pharmacies, payers and manufacturers using metric decimal quantities.
The work group voted to apply the standard as written and to send a letter to Martha McNeil, Texas Medicaid, to explain the decision. The work group stressed the need for marketing the NCPDP Billing Unit Standard to HCFA and manufacturers, which may help, prevent these issues in the future
QUIC FORM 200002 - Lovenox Resolution
Lovenox is sold as syringes and listed as mls. However, due to the fact that some pharmacies and state Medicaid programs are unable to process decimal quantities, HCFA has instructed state Medicaid's to bill Lovenox as a one each syringe to avoid costly Medicaid Rebate disputes. The goal of the QUIC form is to request that an exception be added to the standard to except either Lovenox as a one each syringe, or to change all pre-filled syringes to represent one each syringe.After much discussion, a motion was made to continue to apply the standard as it is. The motion was moved and seconded. The motion carried.
QUIC FORM 970006 - Lovenox 30mg prefilled syringe Resolution
A per syringe is non-standard. Changing this product to read one each syringe is inconsistent with the standard. The standard recognizes this product as a liquid, since this is the form in which the manufacturer packaged it. The work group determined that at this time no exception to the standard would be made and this product would continue to be viewed as a ML. The pricing compendia present at the work group, First Data Bank, Medi-Span & Red Book agreed that this product should be listed as .3 ML and .4 ML respectively. This is an issue regarding rounding procedures necessitated by the non-use of metric decimal quantities.QUIC FORM 980006 - Lovenox 40 Resolution
There was discussion on the importance of pharmacies and states using the metric decimal quantity in billing. It was noted that other products have the same problem and that this issue comes up repeatedly at the Work Group meetings. The resolution was to deny the request for an exception to the standard because metric decimal quantities will alleviate the problem. A motion was made to continue to promote the value of using metric decimal quantities throughout the industry. The motion was moved and seconded. The motion carried.QUIC FORM 970007 - Lovenox 40mg prefilled syringe Resolution
A per syringe is non-standard. Changing this product to read one each syringe is inconsistent with the standard. The standard recognizes this product as a liquid, since this is the form in which the manufacturer packaged it. The work group determined that at this time no exception to the standard would be made and this product would continue to be viewed as a ML. The pricing compendia present at the work group, First Data Bank, Medi-Span & Red Book agreed that this product should be listed as .3 ML and .4 ML respectively. This is an issue regarding rounding procedures necessitated by the non-use of metric decimal quantities.QUIC FORM 200702 Lucentis NDC: 50242-080-01 Resolution
Requested clarification for the billing unit quantity. At the May 2007 WG2 meeting the form was pended until further clarification could be made At the August 2007 meeting representatives Jennifer Moore and Chi-Ying Chang of Genentech were present to provide discussion of the QUIC form. There is no mention of .2 ml on the box. There is not more than 1 dose in the vial. The standard today says that we include the overfill (Intron A). The compendia have this listed as .05 ml. A motion was moved and seconded to list as .05 ml which is an exception to the BUS today but it might not be in the next update of the BUS. The motion carried without opposition.QUIC FORM 200203 - M.V.I. 12 Resolution
Product has 2, 5 ml. Vials and one vial with two chambers which are mixed before administration. NCPDP standard is not clear on listing of products. A standard definition for listing two vials that are mixed before administration is requested. Rule 2.2 will be applied and additional definition will be required in the Implementation Guide. Motion was passed to approve with recommendation of the WG that the billing unit for each of the NDC's should be "ml" and the change should be made at the quarter (July).QUIC FORM 200401 - Many Bulk Chemicals Resolution
Requested clarification for the billing unit of bulk chemicals, even when the chemical is a liquid but is labeled as the amount of "grams". There was a motion that the Billing Unit for bulk chemicals would be the number of grams (gm) or milliliters (ml) dispensed, as noted on the label, unless the gram weight amount is variable from lot to lot. Bulk chemicals with variable potencies are billed as one each. A motions was made to accept this solution as presented. The motion was moved and seconded The new version of the BUS will add clarification text and the FAQ to address this situation.QUIC FORM 970001 - Metaproterenol Sulfate (Example) Resolution
Ed Edelstein reviewed the QUIC #970001, which was reviewed at the task group level during the May 1997 meeting. Ed Edelstein presented the group with the actual language of the QUIC request and told the group that the task group voted to expand the definition in the standard.Ed Edelstein presented the expanded definitions and explained about the multiples of units in metric decimal that need to be rounded up. Example: 2 units with 3.5 grams = 4.0 grams X 2 = 8. Two examples of the necessary recalculation of the unit prices were also included. Ed Edelstein also explained that this expanded definition would now go to MC for approval, with final approval by the Board of Trustees.
QUIC FORM 970009 - Monurol 3gm sachet Resolution
The manufacturer supplies Monurol package in a powder packet. The standard for a powder packet is NOT grams but ONE EACH. All pricing compendia, First Data Bank, Medi-Span & Red Book have powder packets in their systems described as a ONE EACH not gram. In the standard, a powder pack must be billed as an each. The work group decided that changing this product to reflect a gram would result in inconsistency to the standard.QUIC FORM 200611 - MoviPrep NDC: 6564920175 Resolution
Requested clarification for the billing unit quantity. At the November 2006 WG2 meeting it was noted that the review group felt that this would be listed as 2000 mls. A motion was moved and seconded to classify as one each. For consistency keep as 2000 mls. We ignore the mixing container in kits and there are not 2 separate billing units. There are not 2 unique NDCs on the packets inside. The motion carried with some opposition. WG2 might need to look at section 5.1.9 of the Implementation Guide since it could require a change based on how this product was just classified.QUIC FORM 200004 - Neupogen Resolution
QUIC 200004 deals with the same issue as the previous QUIC form. NCPDP's standard is to round before calculating the quantity and First Health states that the quantity should be calculated first and then rounded, again they are abiding by the guidelines that HCFA gives with respect to billing most closely to what was actually dispensed. A motion was made to handle this the same as the previous QUIC form. (Apply the current standard). The motion was moved and seconded. The motion carried.QUIC FORM 960003 - Nicorette (OTC Version) 2/4 mg Resolution
Ed Edelstein stated that this is the new over-the-counter version of Nicorette. The product that contains 108 pieces also contains an audiotape. The Nicorette 48 does not contain an audiotape. The question is, is the one with the audiotape a "kit" and the one without the tape an "each." Ed Edelstein stated that the core 9 - NDC number is the same for both items. The work group recommended that the unit of measurement for these items stay as 48 each and 108 each, and to call the audiotape a package insert.QUIC FORM 990002 - Nicotrol Cartridge Inhaler Resolution
The QUIC Form states that First Data Bank, San Bruno and First DataBank, Indianapolis identify this product with a package size of 42, indicating the number of doses available. The manufacturer does not list a metric decimal quantity for the product. RedBook lists the package size as one (1) for one unit. It requests that all editorial agencies recognize the package size of Nicotrol Cartridge Inhaler utilizing the same number.The Work Group discussed what is the smallest indivisible unit that can be dispensed. The Work Group also discussed whether or not this product was eligible for rebates. A motion was made to recommend a billing unit quantity of "42" for the Nicotrol Cartridge Inhaler. It was moved and seconded. The motion carried.
QUIC FORM 200807 NUTRIDOX CONVENIENCE KIT (NDC: 58790-216-87) Resolution
Requested clarification for the billing unit quantity. At the November 2008 WG2 meeting the form was discussed. Issue: A review is needed to determine the appropriate billing unit for this product under the Billing Implementation Guide. This product contains: Doxycycline Monohydrate Capsules 75mg - bottle of 30 TheraTears Nutrition (Omega-3 supplement with Vitamin E) - bottle of 90 iHeat Portable Warm Compress System (10 Warming units plus 1 iHeat Mask) Mike DiFiore led discussion on this form. From the review that Mike performed, he determined that the gel and capsules are eaches, leaving the nondrug entities that are, according to the BUS, defined as eaches. Each what? The BUS states that it is not a kit unless there are different billing units within or contains one of the suggested items listed in the standard that are not considered drugs (cotton balls for example). But is this eaches of what-tablets, pills? The nondrug products have nothing to do with the administration of the drug. A list of the nondrug items excluded from a kit was reviewed by the attendees. Concerns from the rebate and AMP perspective were addressed. But from the billing unit standard perspective, this is 131 eaches. All the compendia have agreed to list as 131. One of the things that we were considering to modify within the BUS was clarification of complimentary items as not considered in the calculation of the billing unit. For this item, would the mask and heating item be considered a complimentary item? Or do we make this an exception? But one would still be entering a unit for a nonrebatable product. We do not want to get to the point where we say we are only counting the billing units of the real drug within the product. We should take and apply the BUS as we would for any product regardless of what it is to be used for or how it is rebated. But because we know that this will be an issue in the market, would we consider making this an exception by making it a kit? The comment was made that to make an exception would only weaken the rules of the standard. The rules should apply to all and an exception should not be made just because the manufacturer puts it on the package. A straw poll of what the attendees felt the billing unit should be was conducted:- Kit - Billing Unit of One and an exception to the standard = 5
- 120 –None
- 131—The rest of the room (about 30)
QUIC FORM 200612 - Nystatin Powder (NDCs: 50383058905; 50383058915; 50383058950) Resolution
There was a motion moved and seconded to have the compendia list these products as 26mg, 10mg, and 90mg respectively for each NDC. The motion carried. No date for a change by the compendia was given. A motion was moved and seconded to pend this QUIC form. The motion carried. A task group was formed to look at Nystatin and Anne volunteered to lead the task group. Update: At the May 2007 WG meetings, this form was withdrawn by the submitter and will be resubmitted once the Standard Exception Review TG has completed its work. Requested clarification for the billing unit quantity. At the November 2006 WG2 meeting discussion noted that there is no gram weights on the package. Anne Johnston of Meco provided a spreadsheet that listed all the Nystatins. Do we need to form a task group to look at the whole list of Nystantin drugs to see what we are dealing with? Is the exception in 5.6 still valid? WG2 might need to change section 5.6 of the Implementaion Guide. A motion was moved and seconded to pend this form until the task group completes its review. Should the spreadsheet be limited to just the topical? Anne will look at what is represented on the list and will segregate by route of admiinistration. Anne will do this review. Right now the compendia have these listed as:- 589-15 all listed at 26
- 589-05 10 8.7 and 10
- 589-5090, 86.6 and 90
QUIC FORM 200415 - OCTAGAM 5% VIAL Resolution
Requested clarification for the billing unit quantity for OCTAGAM 5% VIAL NDC: 67467084301, 67467084302, 67467084303, 67467084304. Fairly new product, however, there are differences in the way the FDB and Medispan determine the billing unit. It is listed as "each" by one compendia and by "ml" by the other. 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: Motion moved and seconded to adjudicate as an ml. All compendia but one who wasn't sure, have listed as ml. The motion carried.QUIC FORM 200416 - PEDIALYTE FREEZER POPS Resolution
Requested clarification for the billing unit quantity for PEDIALYTE FREEZER POPS NDC: 70074-0002-46. What should the billing unit be according to the NCPDP Billing Unit Standard? Difference in the billing unit standard between FDB and MediSpan. One compendium uses the billing unit of "each" and the other "ml". 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: A motion was moved and seconded to adjudicate as an ml. The motion carried. A suggestion was made to develop an FAQ for this regarding the liquid versus frozen state.QUIC FORM 980008 - Pedia-Pop Palsicles Resolution
There was discussion on the importance of pharmacies and states using the metric decimal quantity in billing. There was also discussion in regards to breaking up the carton of 16 and in the pharmacy arena. The assumption that a product would not be split or broken up because of the way it is packaged is incorrect. It was noted that other products have the same problem and that this issue comes up repeatedly at the Work Group meetings. The resolution was to deny the request for an exception to the standard because metric decimal quantities will alleviate the problem. A motion was made to continue to promote the value of using metric decimal quantities throughout the industry. The motion was moved and seconded. The motion carried.QUIC FORM 200308 - Prestige Smart System Resolution
QUIC Form 200308 requested clarification of the billing unit standard. It is a product that contains 2 boxes of 50 strips each, 10 additional strips, and 1 meter. The box says 110, which is what the pharmacist would enter into the computer. The product is a bonus pack. There was a motion that the product should be listed as One Kit. The motion was seconded and approved.QUIC FORM 200413 - PRETTY FEET AND HANDS Resolution
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.QUIC FORM 990001 - Prevpac Patient Pac Resolution
The QUIC Form states that First Data Bank, San Bruno and First DataBank, Indianapolis identify this product with a package size of 14, which correlates to the number of dosage cards in the package. (Each dosing card contains 8 capsules/tablets equaling one day of therapy). RedBook identifies this product with a package size of one (1) labeling Prevpac as a kit. It requests that all editorial agencies will recognize the package size of Prevpac utilizing the same number. Helidac is a product with similar packaging. This product would also need to be reviewed.The Work Group discussed what is the smallest indivisible unit that can be dispensed. The Work Group felt that utilization and product and package samples would help determine the appropriate billing unit quantity. A motion was made to table QUIC 990001 until this information could be obtained and the manufacturer could be contacted and invited to the August Work Group meeting. It was moved and seconded. The motion carried. Micromedex had already changed the quantity representing Prevpac to 14 making QUIC Form 990001 moot. This does not solve the problem of the proper way to handle these types of products in the future. The Work Group discussed what is the smallest indivisible unit that can be dispensed. After considerable discussion, they decided to create a Task Group to address the issue of multi-product therapy group packaging
QUIC FORM 200703 Pulmicort Flexhaler 180 mcg/actuation and 90 mcg/actuation (NDC#: 00186-0916-12 and 00186-0917-06) Resolution
Requested clarification for the billing unit quantity. At the August 2007 WG2 meeting discussion noted that the billing unit should be maintained as an exception of 1 each..QUIC FORM 200604 - Pulmicort Inhalers Resolution
Requested clarification for the billing unit quantity. This QUIC form was pended at the March and May 2006 meeting of WG2 Product Identification. At the August 2006 meeting Kay Morgan of Gold Standard led the discussion. This was pended in order to determine how large the problem was. The total weight is not noted on the package itself - although it is on the package insert. A motion was moved and seconded to leave as is - one each. This would not meet the standard and an exception would need to be made. The BUS was reviewed - sections 4 and 5. This has been like this since 1997. The motion carried with no opposition. Do we make this an exception in the standard? Yes, the entire WG agreed. Karen Eckert of Wolters Kluwer Health will create an FAQ for the Implementation Guide and complete a DERF for review at the November WG meeting.QUIC FORM 200003 - Pulmozyme Resolution
QUIC 200003 was submitted to clarify the rounding issue on a product with a liquid metric decimal. NCPDP's standard states that the rounding should be done before the calculation of the total quantity. But EDS requires that the rounding be done after calculating the quantity, which is the direction that HCFA recommends when billing product in the Medicaid Drug Rebate Program since it more closely aligns to the number that was actually dispensed. The goal is to develop a standard of rounding that will be used by all third party processors. Tom Bizzaro pointed out that NCPDP has no power to enforce all third party processors to use NCPDP's standard.The group came to the same conclusion with this product as the others. Metric decimal is the best method to use because the bill would be based on the true amount used. A motion was made to apply the current standard as written. The motion was moved and seconded. The motion carried.
QUIC FORM 200503 - Rebif Titration Pack Resolution
Requested clarification for the billing unit quantity for Rebif Titration Pack, NDC: 44087-8822-01. Need verification of billing unit as ml and package size of 4.2 ml. Discussion at the March 2005 meeting a motion was moved and seconded to approve as 4.2 ml. The motion carried.QUIC FORM 990003 - Relenza Resolution
QUIC 990003 was submitted by the manufacturer for a new product to verify the product's dosage form and number of units and to insure that it is correct according to accepted industry standards, to avoid creating unit-based disputes. This product is packaged as 5 Rotadisks of 4 blisters each containing 5 mg of product in each blister. The Diskhaler is the activation device necessary for administration of this drug. This product follows the standard agreed upon for Flovent Rotadisk and Serevent Diskus which are similarly packaged. The outcome was to approve it for the quantity of 20, which is the total number of powder containing blisters in the package. A motion was made to approve this resolution. It was moved and seconded. The motion carried.QUIC FORM 200802 RhoGAM® Ultra-Filtered PLUS (300 µg) (1500 IU) MICRhoGAM® Ultra-Filtered PLUS (50 µg) (250 IU) (NDC#: several) Resolution
Requested clarification for the billing unit quantity. At the February 2008 WG2 meeting the form was discussed. The number of units is standard throughout every package size but the number of ml that contain those units varies. What part of the BUS should be applied? Can this be wordsmithed into the one each? Do we want it to be a one each? The product itself does not have a preservative which means it is a single-use vial. The volume for that lot is known. The Ortho representative stated that it is close to an ml but they have never put one ml on anything. The older products are listed as one ml and the situation has been the same since RhoGAM came on the market. The compendia have the old vials listed as 1 ml and the new product as 1 each. The reasoning for making the new product one each was because of the overfill issue. We need to fix this disparity. A motion was moved and seconded to categorize as 1 each. This will not change the historical value for the vials that were ml which are off the market. This motion is for the pre-filled syringes. As a follow-up to this motion, we will modify the BUS Implementation Guide accordingly. The motion carried without opposition. The way this will be handled in the Implementation Guide will be determined by the BUS Exception Review TG.QUIC FORM 200707 Rinnovi Nail System (NDC#: 23710-0050-02) Resolution
Requested clarification for the billing unit quantity. At the November 2007 WG2 meeting the form was discussed. There are two different dosage delivery systems within the box but they are all the same billing unit, mls. This doesn't qualify for a kit because it states, "two distinct drug items with different billing units". It should be reported as mls but it is hard to calculate the number of mls by looking at the box. This is not an exception to any of the processes that we have. This looks like the Keralac Nailstik which doesn't have the other stuff in it but determined that it would be billed as mls. Could the stick be considered an applicator? No. There is nothing in the standard that says to ignore the cleansing and protecting spray. The group also looked at the QUIC form for Coraz lotion. It is very clear through the standard that these should be billed as mls. A motion was moved and seconded to make this and Coraz (QUIC form #9) as "ml" and to send notification to the manufacturers to put total mls on the box. The motion carried without opposition. Total volume is 74.4 mls.QUIC FORM 200805 ROWASA (NDC: 68220-0066-07 & 68220-0066-28) Resolution
Requested clarification for the billing unit quantity. At the August 2008 WG2 meeting the form was discussed. Issue: Alaven Pharmaceutical has made changes to the packaging of their Rowasa products. They did not change the NDCs. The actual package sizes of 60ml x 7 and 60ml x 28 (respectively) have not changed - cleansing wipes have been added. Should the Rowasa packaging be changed from 60ml to 1ea (or 7ea etc.)? Should an exception be made? Is there another solution? Per the standard (5.5.1), these NDCs should now be listed as kits: 1 ea x qty of 1. This adversely affects adjudication as the package sizes would change from 60ml to 1 each. Discussion: Jai Will and Ed Conroy of Alaven Pharmaceutical were present to participate in the discussion. Jai presented slides that provided information on Alaven and some background on the company's negative experience when they changed NDCs in the past. For this reason, they wanted to get away from changing the NDC. How do we best handle this situation? Because the original NDC was billed as ml, it is impossible to know what is being billed - the old or the new product? Can you change to a new NDC? Yes, but how do we deal with the issue now. The issues are that we have an old product under the existing NDC that doesn't expire until 2010 and could still be on the shelf. And we have the old product followed by a new product with the same NDC but a different billing unit. We have not changed the billing unit because patients on refills who have been getting old product who either get old product again or get the new product. Additionally, on refills most pharmacy systems will not generate a new Rx number because the NDC number did not change. There is also the issue of the problems surrounding drug rebates. A motion was moved and seconded to allow an exception to the standard (the standard clearly indicates the new packaging should be billed as a kit) and keep the new drug (the kit) at ml for this NDC. It was strongly suggested that the manufacturer obtain a new NDC for the new packaging and that NDC would be identified as a kit. Karen Eckert will write the FAQ that will be added to the BUS for this exception. The motion carried.QUIC FORM 200409 - S2 Inhalant Resolution
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.QUIC FORM 200804 Salex Cream and Lotion with complimentary cleansers (NDC# 13548-0010-17 (Cream), 13548-0011-09 (Lotion)) Resolution
Requested clarification for the billing unit quantity. At the February 2008 WG2 meeting the form was discussed. From discussion by the BUS Exceptions TG: "A discussion followed regarding Salex and how it is listed differently by the compendia because it comes with a complimentary product. It was suggested that a FAQ be included to state: If a product is packaged with a complimentary or additional product, then the BUS application would consider all items/units in the package and these should be included in the final unit determinations." A motion was moved and seconded to categorize the first product that has the billing unit of grams and ml (cream) as a kit according to the billing standard and the second product that has the billing units as ml (lotion) as the total mls (as expressed on the package - regardless if it is complimentary or not) and to add an FAQ to address complimentary products that are included in the unit count. One comment noted that when one is looking on the backend at rebating with mls and are now using the unit of 20 mls, that might have implications on best pricing and rebating issues when you are including the complimentary product into the billing unit standard. Comments were that the pharmacist would not know about the complimentary products and thought it should be excluded. Kay noted that historically we have ignored the complimentary items and considered the total package. She gave examples such as birth control pills. The total package is considered in determining the billing unit and it is independent of the status of complimentary or not. The biggest concern is from a retail perspective and when does it become uncomplimentary. One of the things that was not discussed regarding this QUIC form is with the package itself. The NDC on the outside of the package represents the combination of the two. So it might be if a product becomes uncomplimentary, that a new NDC would be issued. Karen noted a concern where it states 12 fluid ounces but when you bring up a picture of the product on its own, you can tell that it is a different number of mls. This is fine but since it is not stated on the package insert this way, do we want to go through the research to find out if it is really whatever it is less than 360 as the total number of mls? Do any of the compendia have the lotion and the cleanser listed as total mls? And is it 237 plus 360 or is it another number? It is 597 mls. One compendia has it listed as 355 but has agreed to add together. The compendia had agreed to one each for the cream and 597 ml for the lotion. That is the motion on the floor. The standard is clear but how are we going to treat complimentary products? Do we ignore them or include them? Thought the manufacturer may call them complimentary, the product that they put in the box might not be available outside of that particular packaging. The motion is: In products such as Salex with a complimentary product where 2 distinctly different units (gms and mls), that the product be listed as one, a kit, in accordance with the BUS. On the second NDC, Salex Lotion, with the complimentary cleanser, they are the same billing unit and according to the BUS, the total number of same billing units are counted. If one were distilled water, would you still add them together? If you read the standard, it says a "drug item" and the complimentary stuff is not a drug item. Would depend on how the water is described but it is normally considered a diluent and is not counted. For the second item where we said mls, why are we assuming that it is 360 rather than 355 when the first example is 237 for 8 ounces rather than 240? Doesn't the standard state that if it is listed as 8 ounces (237ml) it should be billed as 237 ml but if it is listed as 8 ounces then it is billed as 240 ml. Anne called for a vote. If it is multiple billing units, express it as a kit for the first NDC and if it is the same billing units, it is the total number of expressed units on the package, regardless of whether it is a complimentary product or not. The motion carried. We need to contact manufacturers to stop putting complimentary products in a package because of rebate and DUR issues. We need to notify the manufacturer of the receipt and review of this QUIC form, the outcome and express our concerns regarding the complimentary products within the package. Suggest that complimentary products be accounted for in the total dispensed. Kay noted that how we came to the decision on the Salex lotion was the numbers on the box - it has the fluid ounces for the one component and the specific ml for the other. The way this will be handled in the IG will be determined by the BUS Exception Review TG.QUIC FORM 200803 SALICEPT SUS (NDC#: 53303001108) Resolution
Requested clarification for the billing unit quantity. At the February 2008 WG2 meeting the form was discussed. From discussion by the BUS Exceptions TG: "The package does give a gm weight but it is a powder for reconstitution and should be expressed as "ml". It was suggested that the product be expressed as 9.4 gm until this issue is resolved since that is the only thing listed on the bottle. The compendia will make the change as of April 1 and the WG will address the issue with the manufacturer." Section 5.1.9 of the BUS Implementation Guide was reviewed. It is not used in a single dose and does not fit that part of the standard. This does not appear to be an FDA approved product. Section 5.4.2 of the Implementation Guide was reviewed and could be applied to this product. A claim's analysis was done and the volume is very small but the quantities were all multiples of 9.4 and 210. A motion was moved and seconded to make this 9.4 gms based on Section 5.4.2 of the IG. The motion carried with no opposition. Do we need to change the Implementation Guide? Anne asked for a list of oral topicals that are reconstitutable for swish and spit so that we can determine the impact of the decision for Salicept has on these other products. The BUS Exception Review TG will review the other products.QUIC FORM 200508 - Sidekick Blood Glucose Monitoring Strips (NDC: 56151-0880-50) Resolution
Requested clarification for the billing unit quantity for Sidekick. At the November 2005 WG2 meeting Dino J. Dibella R.Ph. with Home Diagnostics, Inc. was present. Home Diagnostics is a blood/glucose manufacturing company for meters and strips. This is not a kit and should be listed as the number of strips in the vial. Home Diagnostics has had such a strong response for this product from state medicaids and private insurers. HDI is currently working on a 100 count SideKick, so resolution on this will help resolve any issues upon its release. The outcome anticipated is that this product, SideKick, be listed as the number of test strips which is 50. Dino provided examples to the participants. This product was introduced in July. It is a vial of strips that has a cap with the meter built into the cap.This was submitted as a 50 count to the compendia. This is a disposal 50 test strips. This was made to make it very simple and easy to test. There are no lancets included and was never intended as a kit. The meter must be thrown away and cannot be reused. Refills of this product are being rejected because billing shows that the patient received one meter - drug benefits will limit the number of meters per specified periods of time. Does the controlled solution have to be part of the kit? The package cannot be broken and there is no NDC on it. Many payers will not pay for diabetic kits because of the existence of the meter. This parallels with the Sharps Container and is this really just a packaging attribute. A proposal was made to make this an exception to 5.1 Dosage Forms Billed As Each (Ea) - particularly 5.1.6---Non-drug entities, such as test strips, swabs, or alcoholwipes, are billed as eaches and the quantity is the actual number in the container. For Medicare there are implications on the Part B, as meters and test strips are Part B . (This is only a Part B issue ...as strips nor meters will be covered under Part D). Discussion followed on what "reusable" actually means.Reusable beyond that fill. When one kit is billed to a third part plan, they assume it is a meter. One member viewed as a kit because it has all the components. Many times when this comes across as a one it is viewed as a kit with one meter that is reusable. Payers have their limits to being paid as one time. There is a billing unit issue and a therapy classification problem which has it listed as a meter with test strips. If we change this to 50 will the GPI be changed? One compendia noted that this product differs from other systems because it does not have the lancets. The compendia will do whatever is decided here. Even if the lancets were included in this product, that would be ignored and it would not be considered a kit. Is there a need for a new categorization for an identification of the billing unit? The other systems have a reusable life beyond that fill and this is assumed to be why the payers would not pay beyond the original fill. Even if you change the product to 50 you would still have the same problem. This is a payer issue. The compendia have nothing to do with the rules that the payers place around this product. With a new categorization, the payers could place new rules around that categorization. It was noted that we needed to be cautious when we talk about making this a new therapuetic class. This is not a new therapuetic class. What we are talking about here is an identifier that the compendia may use for groupings of pharacueticals entites or products. This work group reviewed a product in the past that was listed as 110 and the group changed it to one as the billing unit because the meter was reusable. The rules are clear - a meter with test strips is considered a kit. Every kit up til now has had a reusable meter. This does not. A motion was moved and seconded to pend this form until we get more information from the payers. We could also determine if we need to make a categorization change. This would be part of the investigation and we can find out if the work group has any influence on this. This could outstretch what this work group can do and this work group has never done that. This is not a billing unit issue and could be resolved before this group meets again. The motion did not carry. One attendee felt that this is a kit and a payer issue not a BU standard issue. A motion was moved and seconded to consider this a kit. Dino noted that if this is not determined to be 50 - they will continue to have problems. It was felt that this is a payer issue as to how they look at this as a meter. A friendly amendment was suggested and asked that we deal with the payer issues outside of this work group. It was accepted. It is not a therapuetic class issue but an identifier that identifies this product as a meter with strips. Is the issue getting the product covered? Yes. If so it was asked that Dino get with Dan Hardin who volunteered to help and who might have some answers for him. The motion carried. Is the control solution the issue with this product or is it the meter? A straw poll showed that it was not the control solution but the meter. What is it that makes the plan say that they are not covering beyond this fill? Work with the payers needs to be done.QUIC FORM 200708 Somatuline Depot Inj (NDC#: 15054-0060-01, 15054-0090-01, 15054-0120-02) Resolution
Requested clarification for the billing unit quantity. At the November 2007 WG2 meeting the form was discussed. The way they are packaging, the only way to bill this is by each. But there is a letter from the FDA to the manufacturer asking that they list the total volume on the package. A motion was moved and seconded to pend this form, send a letter to the manufacturer asking that they comply with the FDA request, and review the form again once the manufacturer has complied. The FDA actually approved the application and requested two of the following from the manufacturer:- Revise the product strength of each label to read in terms of total mg/total mL (e.g., 60 mg/XX mL).
- Revise the statement on the back panel of the carton labeling to read "CONTENTS: This box contains one (1) pre-filled syringe. Each syringe contains lanreotide acetate corresponding to XX mg of lanreotide base per XX mL solution, which is the equivalent of XX mg lanreotide per syringe."
QUIC FORM 980004 - STIMATE Resolution
This QUIC form was reviewed in the August 1998 meeting, Baltimore, MD. The manufacturer and HCFA show the NDC for this product as "EACH" or "1" spray but the states formulary files along with the pricing compendia show the quantity as 2.5 milliliters, which is correct in regards to the NCPDP billing unit standard. The two unit of measurements out in the industry is causing rebate and pharmacy errors. During the Kansas City, MO meeting the work group continued to feel strongly about contacting the manufacturer, Rhone Poulenc Rorer and making them aware of this problem. The changing of a unit of measurement to comply with the NCPDP billing unit standard must be initiated by the manufacturer.QUIC FORM 200710 and 200711 SymlinPen TM 120 and 60 (pramlintide acetate) pen-injector (NDC#: 66780-0111-09 and 66780-0111-08) Resolution
Requested clarification for the billing unit quantity. At the November 2007 WG2 meeting the form was discussed. Karen M. Biancalana of Amylin Pharmaceuticals, Inc. presented both forms. These products have not been launched. Are there overfills in these pens and if so, is that overfill mentioned in the package insert somewhere? On the 120 it says two 2.7 mls disposable multi-dose injectors. So that is real clear that it would be a total of 5.4 mls. The 60 shows two 1.5 mls for a total of 3. There is not a different NDC on the syringe. The NDCs will change on both of these forms. Is there a bar code on the pen? The pharmacist might think that the pen is an individual billing unit. A bar code that does not match the NDC will be a problem for administration within an institution. The motion and second was to bill as mls for both QUIC forms. The motion carried. The 60 is a total of 3 mls and the 120 is a total of 5.4.QUIC FORM 200309 - Synalgos-DC Resolution
QUIC Form 200309 requested clarification on the billing unit standard. Attendees were not sure if the product was 3 cards of 12 capsules within one box or three boxes of 1 card each. A copy of the box was not available to view. There was a motion to pend this QUIC Form until a copy of the box was available to view at the meeting. The motion was seconded and approved.QUIC FORM 200705 Torisel (NDC#: 00008-1179-01 kit containing 00008-1125-01 and 0008-1179-05) Resolution
Requested clarification for the billing unit quantity. At the August 2007 WG2 meeting discussion noted that this does not qualify as a kit because it does not have two billing units and a cotton ball (see 5.5.1 of the BUS). Is this a physician based product? Yes, but we must still review and not exclude review because it is physician based. This is a very expensive product and would recommend a billing unit of one because it cannot be converted to the right number. This would be considered an exception to the standard. A motion was moved and seconded to approve as a 1. Is that a 1 ml or 1 each? The motion was amended to 1 ml. It should not be referred to as a kit. The administered amount is 1 ml. The motion carried with no opposition. There are no changes that need to be made to the standard at this time.QUIC FORM 200602 - Tretin-X NDC: 14290-0351-97 Resolution
Requested clarification for the billing unit quantity. At the March 2006 WG2 meeting Peter Volk of Triax Pharmaceuticals L.L.C. was present to discuss this form. NDC for the combination pack is different than the individual tube - currently not selling the tube separately. A motion was moved and seconded to approve as a kit. There are different strengths. Problem with the package - shows 35 grams quite visibly. Peter said that they would consider changing the labeling of the package. Free syringe dispenser that is not included -the sharps container. Kay noted that the syringes was called "the box or container" and was not considered part of the product. Complimentary does not come into this so it is not considered part of the product. Billing unit as part of the SPL not recommended because it is complicated but we will work through that. Medi-Span changed from grams. There is nothing on the box that says do not split - they will change that. What definition of kit does this meet? Two of the tubes show ml and one shows grams. The motion carried without opposition.QUIC FORM 200506 - Twinject auto-injector Resolution
Requested clarification for the billing unit quantity for Twinject. (For 0.15 mg, 13436-0701-01 and 13436-0701-02 (Two-Pack). For 0.3 mg 13436-0700-01 and 13436-0700-02 (Two-Pack)) It is different from Epi-Pen in that it delivers two doses rather than one dose. It is packaged exactly as Epi-Pen. Twinject hit the market on August 10, 2005. After discussion with the compendia, it was felt that this be dispensed as an each to avoid confusion with Epi-Pen that has been on the market for years. There was a motion moved and seconded to make Twinject an each. The motion carried with no opposition.QUIC FORM 200505 - Ultiguard Resolution
Requested clarification for the billing unit quantity for Ultiguard, NDC: Numerous. Product contains 100 syringes in a Container for disposal of the syringes. Requesting determination of the correct package size to be listed for the product. Should product be listed as 1 kit since it contains more than one distinct item or should it be listed as 101 eaches for the 100 syringes and 1 Container or should it be listed as 100 syringes and the container for disposal ignored. At the May 2005 meeting a motion was moved and seconded to bill this as 100 each syringes without regard to the packaging. The motion carried with no opposition.QUIC FORM 200301 - Ultra TLC Resolution
QUIC Form #200301 requesting clarification of the billing unit standard. The product includes 50 lancets and a device. There was a motion to list this product as One Kit. The motion was seconded and carried.QUIC FORM 990004 - Vanceril DS Convenience Resolution
QUIC 990004 was submitted to clarify the inconsistency in rounding the metric decimal quantity. The product consists of three separate 5.4gm inhalers that are boxed together. First Data Bank, San Bruno considers the package size 16.2gm with additional information that describes the product as containing three 5.4gm inhalers, and First DataBank, Indianapolis considers the package size 5.4gm with a package quantity of 3 for a total package size of 16.2gm. Tom Bizzaro stated that the method of rounding is causing the confusion. Some round the quantity to "17" and others to "18," depending if they are rounding before or after multiplying 5.4 X 3.The work group noted that the basic problem is the inability of some users to represent metric decimal quantity. Those users who require the use of metric quantity must round up using the billing unit standard method. The group discussed how the product is used in the industry. The outcome was that the quantity of 5.4 should be rounded to "6" and then multiplied by three for a total metric quantity of 18, the metric decimal quantity is 16.2. A motion was made to approve this resolution. It was moved and seconded. The motion carried.
QUIC FORM 200607 - Vaprisol NDC: 00469160104 Resolution
Requested clarification for the billing unit quantity. At the May 2006 WG2 meeting Kay Morgan of Gold Standard led the discussion. Review of the package insert showed that it is supplied in 4 ml clear glass, one-pt cut ampules. A motion was moved and seconded to approve as a ml with 4 ml by package size. The motion carried without opposition.QUIC FORM 200414 - VARIOUS GLUCOSE METER CONTROL SOLUTIONS Resolution
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.