QUIC FORM 200907 ACCUTREND CHOLESTEROL CONTROL SOLUTIONS (NDC 65702025010)
Resolution Resolution
Requested clarification for the billing unit quantity. At the August 2009 WG2 meeting the form was discussed. Issue: Section 5.1.14 specified that al glucose control solutions be billed as "One Each" to eliminate confusion in the marketplace. Should this decision extend to cholesterol control solutions which also come as High/Low and listed in ML on the bottle? Because of the similarities between glucose control solutions and cholesterol control solutions, it would be useful to know if they should be billed in the same manner, i.e. "One Each". This request was reviewed by the Product Review and Billing Unit Exception TG and they reviewed the Billing Unit Standard (BUS), Section 5.1.13: Glucose Control Solutions are billed as one "each" for the entire package and section "Frequently Asked Questions", question 7.25 and determined that the BUS should be changed to include all control solutions and not just glucose. A DERF was submitted to incorporate this change into the BUS. A motion was moved and seconded to approve as a billing unit of an each. The motion carried with none in opposition.
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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.
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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.
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QUIC FORM 201102 ALSUMA (NDC 27505-0002-00) Resolution
Requested clarification for the billing unit quantity. At the February 2011 WG2 meeting the form was discussed. Issue: Since there was an exception made for Imitrex 6 mg/0.5 mL to be billed as “Kit”, we are wondering if would be the same for Alsuma 6mg/0.5ml?
Discussion: The Product Review and Billing Unit Exception Task Group discussed on their call of November 9 and December 7, 2010:
There was a previous discussion on Sumavel DosePro (sumatriptan injection) 6mg/0.5mL Needle-free delivery system (NDC 43376-106-06). The TG previously reviewed this product on 12/15/09 and decided that the Billing Unit should be ml (6x0.5ml).
From the 12/15/09 minutes:
Sumavel DosePro (43376-0106-06)
From Michelle S. McLeod: Not sure what the billing unit should be (EA or ML)? Is Sumavel DosePro included in the Billing Unit exception (bill as 1EA) that addresses Imitrex Kit Refill and generics of Imitrex Kit Refill? See Billing Unit Standard Imp Guide sections 4.3, 5.6, and FAQ 7.4. Depending upon interpretation of the standard and its exceptions, it could be 0.5ml x 6 or 1EA.
Decision: Group decided billing unit is ML.
4.2.2 BILLING UNIT OF “MILLILITER” (ML)
“ML” (milliliter) is used when a product is measured by its liquid volume.
Examples of products defined as “ML” include but are not limited to:
• Liquid non-injectable products of 1 ml or greater
• Liquid injectable products in vials/ampules/syringes
Imitrex Kit Refill and generics of Imitrex Kit Refill (one EA) are listed as Exceptions in sections 4.3 and 5.6 the BUS.
4.3 EXCEPTIONS (5.6 “Products noted as Exceptions” reads the same)
Due to the impact on invoicing, reimbursement, rebate adjudication and clinical evaluation, exceptions are rarely approved. Several products don’t fit into any of the above categories or were assigned billing units before the standard specifically addressed the product type.
The following products have been grandfathered into this standard as exceptions:
§ Imitrex™ Kit Refill and generics of Imitrex™ Kit Refill (one EA) – (see section “Frequently Asked Questions”, question 7.4)
FAQ 7.4 HOW DO I BILL KITS, SUCH AS IMITREX™ REFILLS?
In general, kits are billed as “1 each” kit. Imitrex Kit Refill, and generics of Imitrex Kit Refill, is classified as an exception to the NCPDP Billing Unit Standard because it is treated as a “kit” when it doesn’t fit the definition of a “kit” in section 5.5.1 and should be billed as a “1 each”.
There are several products that are considered exceptions within the NCPDP Billing Unit Standard. These exceptions are found in sections 4.3 and 5.6 “Exceptions” of this implementation guide.
· Imitrex Refill Kit was made an exception because the initial product was a kit and even though the refill did not qualify as a kit, the exception was made to minimize confusion. All compendia have Sumavel DosePro (NDC 43376-0106-06) listed as ML The question was asked if Imitrex Refill Kits are still on market; answer is Yes.
· One consideration is that Alsuma should be ML since it is not a generic to Imitrex. Both Alsuma and Sumavel have NDAs. These are not generics to Imitrex nor are they refills. Alsuma is an auto injector and Sumavel is a needle-free injection system.
· The BUS was reviewed for the most appropriate section to apply:
4.2.2 BILLING UNIT OF “MILLILITER” (ML)
“ML” (milliliter) is used when a product is measured by its liquid volume.
Examples of products defined as “ML” include but are not limited to:
§ Liquid non-injectable products of 1 ml or greater
§ Liquid injectable products in vials/ampules/syringes
§ Reconstitutable non-injectable products at the final volume after reconstitution except when they are in powder packets
§ Inhalers (when labeled as milliliters on the product)
A motion was moved and seconded to approve as mL. The motion carried without opposition. The compendia will change their systems by the end of March to ml if they have each. The billing unit for Alsuma and Sumavel should be mL based upon Section 4.2.2 of the BUS.
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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.
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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.
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QUIC FORM 201011 ANALPRAM ADVANCED KIT (NDC 00496-0731-64) Resolution
Requested clarification for the billing unit quantity. At the November 2010 WG2 meeting the form was discussed. Issue: We are requesting that the Analpram Advanced Kit have a billing unit of one. Analpram Advanced Kit contains the following three components:
1) Analpram HC Cream
2) Vasculara Tablets
3) AloeClean Wipes
Because the kit is made up of 3 components we need clarification of the billing unit to allow payers to pay what they should for the kit. It would be unlikely for a pharmacist to break the kit apart. Due to the components being both grams and eaches-we believe it meets the definition of a kit.
Discussion: The Product Review and Billing Unit Exception Task Group discussed on their call of October 26, 2010:
The task group determined that the products are kits and the BU should be EA (each). Section 5.5.1 of the BUS supports this decision:
5.5.1 KITS - BILLED AS AN “EACH”
Kits are defined as products that contain:
1) at least two distinct drug items with different billing units
2) one drug product packaged with medicated or unmedicated swabs, wipes, and/or cotton swabs/balls
3) meters packaged with test strips
Kits carry a single National Drug Code (NDC) for the combined items. Kits are designed with the intent to be dispensed and billed as a unit of “each”.
A motion was moved and seconded to approve this form as a billing unit of one each with a quantity of one kit. The tablets are a medical food. Does this matter? There is not an exclusion for a medical food in 5.5.1. The motion carried without opposition.
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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.
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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.
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QUIC FORM 201110 ANDROGEL METERED-DOSE PUMP 1.62% (NDC 00051-8462-33) Resolution
Requested clarification for the billing unit quantity. At the May 2011 WG2 meeting the form was discussed. Issue: Clarification is requested regarding the billing quantity for AndroGel 1.62% metered-dose pump. The outer packaging and product label state “Total contents: 88g.” The labels also state “Multi-dose pump capable of dispensing 60 metered pump actuations” and “each actuation delivers 1.25g of gel.” Based upon the latter statements, the pump is capable of delivering 75g of gel. Is the billing quantity 88 or 75?
Discussion: There was discussion on Androgel. There is a new strength of Androgel at 1.62 %. The label shows 88 grams but it only delivers 75 grams. The compendia have it listed differently and they need to be consistent. This product came out May 4th. It is anticipated that the compendia will coordinate the change to 75 grams at the end of the quarter. (note, subsequent to the meeting it was noted that all compendia changed the package size to 75 grams before the end of the quarter as the product was just launched).
Post WG Meeting Note: The Product Review and Billing Unit Exceptions Task Group discussed on their call of May 24th and it was agreed that 75 grams should be the package size
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QUIC FORM 201006 ASMALPRED PLUS (NDC 23589-0067-93) Resolution
Requested clarification for the billing unit quantity. At the November 2010 WG2 meeting the form was discussed. Issue: To determine if the Peak Flow Meter included in the package constitutes this as a kit (1 each) or is it ignored, making the BU milliliters. It is not clear how the Peak Flow Meter should be addressed under the kit exclusion list (5.5.1) unless it is to be considered as a “measuring device” (although it doesn’t measure the drug, it does measure breath volume—which is related to the drug). How supplied reads on P.I. as: Available as 8 fl oz (237ml) 23589-0058-08. Label states: Asmalpred Plus (as name). Respiratory Management System. Included inside: OpenAir Peak Flow Meter, Dosing Spoon, Patient Journal.
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of August 17, 2010:
Section 5.5.1 of the BUS lists examples of items that should be ignored for billing purposes when packaged with a drug item. Peak Flow Meters are not listed and neither are any examples of devices used to measure the efficacy of drug therapy. The Peak Flow Meter is not used in the administration of the drug and it is not a measuring device. Also, it is not on the list of items that defines a kit. A member reminded the group that the list of items to ignore for purposes of billing Section 5.5.1 is not an all inclusive list. All agreed that ML is the most appropriate billing unit for this product. The compendia will list AsmalPred Plus as ML if approved by the work group.
Are there any other products like this? What swayed the task group was Tyvaso that had everything in the box. The box shows 237 ml. A motion was moved and seconded to approve as ML for the billing unit. The motion carried without opposition.
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QUIC FORM ASMANEX NDCS 00085-1461-02. 00085-1461-07, 00085-1341-01, 00085-1341-02, 00085-1341-03, 00085-1341-04)
Resolution
Requested clarification for the billing unit quantity. At the February 2012 WG2 meeting the form was discussed. Request: Original QUIC form 200504 adjudicated Asmanex products to grams. Recently Merck changed the package size from 0.24 grams to 0.135 grams for 2 of the 220mcg/Inh Asmanex NDCs (00085-1341-03 & -04) causing an issue with FAQ 7.26 in the BUS which specifically addresses why Asmanex is billed as 0.240GM. After discussion at several WG2 Prod Review BU Exception TG calls the question arose as to whether this is an exception to the standard based on 5.2.1 and 5.1.12. The group felt that Asmanex can be considered a Unit of Use item. Section 5.1.12 of the BUS implies Unit of Use packages are self-contained single dose packages. Is this an exception of grams or does “gram” apply? Currently it appears that Asmanex listed as grams is an exception to the standard and inconsistent with other like products that are listed as each. Other similar products on the market with less than 1ml or gram have been adjudicated to list as eaches. One example is Lazanda Nasal Spray (QUIC form 20115) adjudicated to list as each. Current listings of Asmanex to be regarded as exception and changed to eaches from grams to be consistent with the standard.
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their calls of December 6, 2011 and January 3, 2012:
December 6th: Compendia representatives were alerted of the package size for 2 Asmanex NDCs change:
| NDC | Description | Current pack size | New pack size | | 00085-1341-04 | #14 inhalation unit | #30 inhalation unit | 135mg (0.135 grams) | | 00085-1341-03 | #30 inhalation unit | #30 inhalation unit | 135mg (0.135 grams) |
Originally, these were packaged as 240mg like the #60 (-1341-02) and the #120 (-1341-01). The package size was changed to 135mg for the #14 and #30 in 2010. The manufacturer did not change the NDCs.
Merck was questioned to make sure this was a change and not just an original omission. They confirmed that it changed in 2010 but the new size was not placed in the market until 8/2011. It was discussed that the manufacturer did not change the NDC because to them the package size is still one and still delivers 30 but to the compendia this is a change. The task group contacted Dr. Randy Levin of the FDA and asked if an SPL error message was generated when the manufacturer changed their product from 0.24 gm to 0.135 gm for NDCs 00085-1341-01 and 00085-1341-03. Randy responded that it would generate a validation error if they had represented the strength as 0.24 mg and changed it from 0.135 mg. However, the company described the strength as 110 ug per actuation and the package quantity as the number of inhalations in an inhaler which does not trigger an error. The group felt further review was necessary given the adjudication of the QUIC form #201115 Lazanda Nasal Spray (NDC 51772-311-01 and 51772-311-04 (100mcg) & 51772-314-01 and 51772-314-04 (400mcg)) at the November 2011 Work Group meeting to a billing unit of 1 EA for the single spray bottle and 4 EA for the box of 4 per Sections 5.2.1 and 5.1.12 of the Billing Unit Standard and proposed changes to the Billing Unit Standard based on that adjudication.
January 3rd: This call was devoted solely to discussion of Lazanda and Asmanex to ensure we are consistently applying the BUS for these types of products.
Unit of Use vs. Unit Dose - the FDA regulations for Unit Dose are clear. Below is how they define Unit of Use. Source:
http://www.fda.gov
CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms
"Unit of Use" packaging which is defined as a method of preparing a legend medication in an original container, sealed and labeled, prelabeled by the manufacturer, and containing sufficient medication for one normal course of therapy. (Reference: Proceedings Unit of Use Packaging Conference, January 24-26, 1979).Section 5.1.12 of the BUS implies Unit of Use packages are self-contained single dose packages which is not how the FDA defines Unit of Use.
With the change to Asmanex from 0.24 gm to 0.135 gm, we have an issue with FAQ 7.26 which specifically addresses why Asmanex is billed as 0.24GM. The group felt that Asmanex can be considered a Unit of Use item.
Per the BUS, a non-injectable liquid product, less than one, is an each. (NOTE: This does not apply to bulk chemicals.) Two spreadsheets were created and compared for listings across the compendia: - items with a quantity less than one and a billing unit of GM or ML
- small volume nasal products (Flumist Nasal Spray, Imitrex Nasal Spray, Lazanda Nasal Spray, Sprix Nasal Spray, Sumatriptan Nasal Sprays, and Zomig Nasal Spray)
The group felt that the Billing Unit Standard should be modified to no longer show Asmanex as an exception and changes to the Billing Unit Standard were discussed.
A QUIC form for Asmanex will be submitted for WG2 review.
The manufacturer was contacted and agreed with this change. A motion was made and seconded to list as EACH per Section 5.1.7 of the Billing Unit Standard. The compendia will make the change to each for these NDCs no later than April 1, 2012. The motion carried.
The following QUIC Form 200504 was moved to avoid misinterpretation of current guidance. QUIC form shows the adjudication of Asmanex in 2005 to be grams which is no longer applicable. QUIC Form 201204 supersedes QUIC Form 200504.
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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.
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QUIC FORM AURSTAT KIT (NDC 16781-0269-96)
Resolution
Requested new product/package information. At the February 2012 WG2 meeting the form was discussed.Request: This Kit contains two separate billing units: 1 component Hylatopic Plus Cream 100gm (NDC#16781-216-96) and 2nd component Aurstat Skin & Wound HydroGel 225mL (Aurstat is Rx Only). This Kit has a separate NDC Number (NDC #16781-269-96) versus the components. Onset Dermatologics requests that the Aurstat Kit be billed as a unit of one.
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their calls of January 14 and 31, 2012:
This product meets the definition of a kit -- One item is measured in grams and the other in ml as per section 5.5.1 Kits - Billed As An “Each”. All agreed to list as one EACH (kit).
A motion was made and seconded to list as one EACH (kit) per Section 5.5.1 of the Billing Unit Standard. The motion carried.
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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.
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QUIC FORM 201108 AXIRON TOPICAL SOLUTION(NDC 00002-1975-90) Resolution
Requested clarification for the billing unit quantity. At the May 2011 WG2 meeting the form was discussed. Issue: Per Package Insert: AXIRON (testosterone) topical solution is available as a metered-dose pump containing 110 mL of solution. The pump is capable of dispensing 90 mL of solution in 60 metered pump actuations. The labels only state the 110ml and not the deliverable/dispensable 90ml. There is confusion about the package size due to the label listing the total number of MLs in the container versus the dispensable number of ML’s listed in the package insert. Per FAQ 7.34: “…the package size will be based upon the total amount of product delivered (maximum amount that can be extracted from the container, i.e. dispensed).” Based on this FAQ shouldn’t the product be listed as 90ml?
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of March 22 and 29, 2011:
This product is labeled as containing 110ml but delivers 90ml. Should the billing quantity be 110 or 90? The future BUS will state delivery volume. All compendia have this product as 90 ml. FAQ 7.34 in the DERF for May 2011 was modified to exclude reference to reconstitutable products to include this product. This product was included in the Overfill letter to the FDA sent on April 6, 2011. Lilly has called and requests discussion at the May WG meeting. They want to have the Billing Quantity as 110 and not 90. They have reported 110 to CMS.
The DERF was approved that supports the billing of 90 and not 110. A motion was moved and seconded to approve as Billing Unit of mL for a total quantity of 90 mLs, the delivered amount. The motion carried without opposition.
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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.
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QUIC FORM 201010 BARS: ORAL AND TOPICAL DOSAGE FORMS Resolution
Requested clarification for the billing unit quantity. At the November 2010 WG2 meeting the form was discussed. Issue: Medi-Span is listing Oral and Topical Bars as both each and gram. In looking at the standard, it is not really clear which is correct. A ruling from the Aug 1997 WG2 meeting for Desquam X Bar 10% states, “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. The standard will further define a bar of soap as an example under the definition of EACH.” However, the definition did not make it into the standard. Currently, there are no specific guidelines in the standard to dictate how to list a ‘Bar’ dosage form, either topical or oral.
Discussion: The Product Review and Billing Unit Exception Task Group compiled, reviewed and discussed a spreadsheet of items in the compendia’s files with the dosage form “bar” and products containing a “bar” and determined that “bars” should have a BU of EACH. Since it was questioned how this decision affects the Brevoxyl QUIC form which was adjudicated to count the bar of soap as GM, QUIC forms for dosage form of bar and for the Brevoxyls (to include BPO Creamy Wash Complete Packs) were completed for WG2 review.
A motion was moved and seconded to add bars as dosage forms with billing units of one each to the billing unit standard. The Product Review and Billing Unit Exception Task Group will review the list of bars and coordinate the date of the change by all. There should be a change to the BUS to add the “bars” as an each. The old QUIC form of #970008 for Desquam-X Bar 10% will be noted to point to the new QUIC form of #201010.
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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.
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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.
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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.
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QUIC FORM 201107 BONIVA INJ KIT (NDC 00004-0188-09) Resolution
Requested clarification for the billing unit quantity. At the May 2011 WG2 meeting the form was discussed. Issue: Boniva Injection is currently listed as a 1 each kit on all compendia. NDC contained: One prefilled syringe of Boniva injection 3mg/3ml single use, in a box with 1 needle and 2 alcohol swabs. In January 2011 the alcohol swabs were removed, technically changing the billing unit from a 1 each (kit) to 3 milliliters (ML). The NDC has not been changed. A new package insert has been issued. Should this NDC become an exception or should the compendia change the billing unit to reflect the change from Each to ML?
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of March 22 and 29, 2011:
The prescribing information was revised in March 2011 by Genentech. The changes made to the Boniva prescribing information are primarily a result of the Boniva prefilled syringes have been repackaged and no longer include the alcohol swabs. As a result, per the BUS, the BU would change from 1 EA kit to 3 ML. The FDA was contacted to determine if this change deviates from the FDA regulation: “phrase (4)(i) If any change occurs in those product characteristics that clearly distinguish one drug product version from another, the registrant shall assign a new NDC number to the new product version and submit that information to FDA.” Randy Levin was contacted and stated that the FDA does not have the new label but when received, the drug will require a new NDC.
A motion was moved and seconded to change the BU from one each kit to 3 mLs and request that the FDA request a new NDC on the product. The motion carried without opposition. A motion was moved and seconded for the compendia to make the change effective July 1, 2011. The motion carried.
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QUIC FORM 200806 BREVOXYL Resolution (SEE QUIC FORMS 201009 AND 201010 FOR UPDATE) 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.
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QUIC FORM 201009 BREVOXYL-4, BREVOXYL-8 AND BPO CREAMY WASH (COMBO PRODUCTS CONTAINING BAR SOAPS) NDCS: 00145-2564-08 (BREVOXYL-4), 00145-2594-08 (BREVOXYL-8), 42192-0110-01 (BPO 4%) AND 42192-0111-03 (BPO 8%) Resolution
Special Condition: Adjudication of this QUIC form is contingent upon the outcome of the Bar dose form QUIC FORM # 201010. If bars are ruled as an “each”, this QUIC form is necessary. If bars are ruled grams, this QUIC form is unnecessary.
Requested clarification for the billing unit quantity. At the November 2010 WG2 meeting the form was discussed. Issue: Topical and Oral Bar dose forms are under review. Brevoxyl and BPO Creamy Wash products each contain a cream-type wash and a bar soap. At the 11/08 WG2 meeting, a QUIC form (#200806) for the Brevoxyl was adjudicated as GRAMS: Cream Wash of 170.1 grams + Bar Soap of 21 grams = 212.1 grams (all 4 NDC’s have same pack size). If topical and oral bars are ruled to be eaches, this would affect all 4 of these NDC’s as they are currently listed as total number of grams. As an added note: a discussion of the Exception Task Group took place and these 4 NDC’s are the result of a project to find all combo products containing a product with a bar dose form.
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product. See QUIC form #201010 on Bars.
A motion was moved and seconded to approve these 4 products as a billing unit of one each with a quantity of one kit and that this change be made by the compendia on the last file update of the year. According to the BUS, whenever there is more than one billing unit type in a package, it is considered an each and a kit. The motion carried without opposition.
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QUIC FORM 200901 BREZE KIT 4.75% and BREZE KIT 7.75% (NDCs 14629052101 and 14629052201)
Resolution Resolution
Requested clarification for the billing unit quantity. At the February 2009 WG2 meeting the form was discussed. Issue: Compendia are not in agreement as to how this should be submitted. This difference is causing billing issues. This request was reviewed by the Product Review and Billing Unit Exception TG on their conference call of November 14th. That task group's discussion centered on how to apply the BUS and agreed to the following interpretation:
Per NCPDP guidelines (section 5.4.2), the blemish stick must be billed as "eaches" because it is less than 1 gram. The stick is counted as 1 each, in addition to the 30 pads. Therefore, the BU quantity is 31 eaches.
The task group had agreed that all compendia would make changes accordingly on December 1, 2008. Even though the packaging does not show a 31, it does not make it correct. As a dispensing pharmacist, one would think one kit but that fact should not violate the standard. Is this a rebatable product? Yes, and Breze is on the rebate list as one each. This does not fit the definition of kit because the coverage stick is less than one gram. We need to consistently apply the standard. We do not use the phrase unit of use packages anywhere in our standard. The industry norm unit of use is one time and one dispense item - not use multiple times but we will give you the whole thing. Section 5.1.1.3 is topical products less than one gram are billed as eaches - we had 30 eaches on the pads, one each on the stick and 31 eaches in the box. This has gone out to end users with a total quantity of 31 and has the billing standard applied to it. A motion was moved and seconded to approve as a billing unit of 31 eaches. The motion carried with 3 in opposition.
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QUIC FORM 201116 Bydureon NDC 66780-0226-01 Resolution
Requestedclarification for the application of the Billing Unit Standard.
At the November 2011 WG2meeting the form was discussed. Karen Biancalana of Amylin presented thisrequest.
Request: To determine how the product will bereported by the Pricing Compendia Services, dispensed by Retail Pharmacies andbilled by Payers and Processors. BYDUREONTM for weekly subcutaneousadministration is supplied in a carton containing 4 single-dose kits for use(66780-0219-01). BydureonTM single-dose kit should NOT be broken bythe Retail Pharmacist. It should bedispensed as a carton that contains four (4) Single Dose Kits. Each single dose kit contains the following:
One vial containing 2 mgexenatide (as a white to off white powder)
One prefilled syringe delivering 0.65 mL diluents
One vial connector and twocustom needles (23G, 5/16”) specific to this delivery system (one is a spareneedle) Discussion: The Product Review and Billing UnitException Task Group discussed this product on their call of October 12, 2011:
The group determined that the product is not a kit per Section 5.5.1of the BU Standard:
Kits are defined as products that contain:
1) at least two distinct drug items withdifferent billing units
2) one drug product packaged with medicated orunmedicated swabs, wipes, and/or cotton swabs/balls
3) meters packaged with test strips
Kits carry a single National Drug Code (NDC) for the combineditems. Kits are designed with the intentto be dispensed and billed as a unit of “each”. Additionally, if a kit contains separate, distinct trays within the kit,the billing unit is an “each”, but the quantity is the number of trays ratherthan “1”.
The following items included with a drug should be ignored forpurposes of billing. The billing unit ofthe drug item determines the billing unit for this product. The following table provides examples ofitems included with a drug that should be ignored for purposes of billing. Thislist is not inclusive. If you questionwhether an item is a kit, submit a QUIC form as explained in FAQ 7.1.
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- Tubing for administration
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- Applicators (including sponges)
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- Actuation devices (i.e. lancets, lancet devices)
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- Mandatory patient education information
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- Inhalation aid (i.e. spacers)
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Antihemophilic and Alpha-1 proteinase inhibitors products arenever billed as kits regardless of how they are packaged.
The billing unit is EACHper Section 5.1.2 of the Billing Unit Standard and the billing quantity for theentire carton is 4.
5.1.2 InjectablePowder-filled vials and multi-component containers (i.e. mix-o-vial withsolution and powder within the vial) are billed as a unit of "each"regardless of size or content of vial in metric decimal units. (For multi-component vials containing twoliquids, see section 5.2.2.)
Labeling of this product will be critical. Will each of thesetrays have patient instructions? Not sure if the standard needs to changebecause it is a non-drug entity. Are there other elements to the REMS thatshould be considered? If one tray was to be dispensed and not the entire box,then it would make sense that a Medguide is given to the patient. Should thebox be broken, the patient might be charged and education on the patient levelis an important consideration for the manufacturer. We cannot insure that theentire box will not be broken. Is it returnable is patient cannot tolerate? No,but samples would be available for patients to test for tolerability. The NDCassignments on the inner/outer packages are still being discussed with the FDA.Inner/Outer should have different NDCs with the same core 9. The last twodigits are the strength and it was suggested that the carton be 04 and the vialbe 01 but there is no logic applied to the 10th and 11thdigits. We ask that the company stay consistent with their assignments.
A motion was made and seconded to list as one EACH per Section5.1.2 of the Billing Unit Standard and the billing quantity for the entirecarton is 4. The motion carried withno opposition.
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QUIC FORM 201003 CAYSTON (NDC 61958-0901-01) Resolution
Requested clarification for the billing unit quantity. At the May 2010 WG2 meeting the form was discussed. Issue: Unit of use is one vial of powder (75mg) and 1 ampule of diluent (1mL). Drug is reconstituted and used with a Nebulizer. Package contains 84 vials of drug and 88 ampules of diluent (in case of spillage) which constitutes 28 days of use. Discussion: There are 88 mL in the package but only 84 doses. 88 cannot be used because of the days supply. A picture of the package was reviewed. This is not a multi-dose but a single-dose. It still requires reconstitution and you still have a solid and liquid dosage form. Which one do you count? This can be justified as 84 mL since the ultimate diluted amount of the product is 84 mL. The package say 84 single use vials and the pharmacist will interpret as 84. Regardless of what the package says, we need to be consistent with the BUS and must be able to cite the BUS when determining the correct billing unit. Is this 84 each or 84 mL? Since it is not a multi-dose, it would be mL. Since section 5.2.3 does not specify multi-dose, this is the reasoning used for 84 mL. CMS has defined as unit dose or 25 mg. Regardless of what others have decided, what is the correct billing unit of this product? Is section 5.2.3 the correct reference for application of the billing unit for this product? A motion was moved and seconded to classify as 84 mL. If it is a powder that is reconstituted, why isn’t it an each? Recall it is not injectable. This is a major issue for the Medicaid rebates. How does one reconcile the units from the different pharmacies? They will be the same. The motion carried with 3 in opposition.
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QUIC FORM 201103 CELLCEPT ORAL SUSPENSION (NDC 00004-0261-29) Resolution
Requested clarification for the billing unit quantity. At the February 2011 WG2 meeting the form was discussed. Issue: Product label has 2 different package size listings.
--Net contents after reconstitution: 175ml
--Deliverable volume after reconstitution: 160-165ml
(There is also a 225ml listing but it reads like that is the size of the bottle, not the volume contained, “contains 225ml bottle with bottle adapter…”)
Which volume after reconstitution is used when the deliverable volume is variable (a range from 160 – 165ml)?
Discussion: The Product Review and Billing Unit Exception Task Group discussed on their calls of October 26, December 7, January 4, and January 18:
Background: The dilemma associated with CellCept Oral Suspension is that its deliverable volume after constitution is stated as a range (160-165mL). If CellCept Oral Suspension remains as 175mL on the databases, then it will be an exception to the BUS. Therefore, should we change existing FAQs to include CellCept Oral Suspension, or add a new FAQ?
Concern: Are we consistent in the BUS in how we are addressing reconstitutable products? It appears we are clear on powders for injection. The non-injectable, reconstitutable products when the final volume is not expressed or the reconstituted volume is not fully delivered seem to be the most problematic.
The group reviewed the package image of the product and looked to the BUS for possible modifications.
Decision: Change Section 5.2.3 and FAQ 7.34 of the BUS as follows (changes in red).
5.2.3
Reconstitutable Non-injectable Products must be billed as the total number of milliliters (ML) dispensed after reconstitution; i.e., once the powder and added flavor packet (if applicable) have been reconstituted with diluent, according to manufacturer instructions. For example, Amoxicillin Suspension 25Ø mg/15Ø ml is billed as 15Ø ml and GolytelyÔ 4ØØØ ml bottle is billed as 4ØØØ
ml. See section “Frequently Asked Questions”, question 7.34.
For non-injectable products to be reconstituted, the package size will be based on the total amount of the product delivered (maximum amount that can be extracted from the container; i.e. dispensed). The overfill after reconstitution will not be considered. Example: Tamiflu for Oral Solution contains approximately 33 mL, after reconstitution. Each bottle can delivers up to a total of 25mL of solution.suspension. The reported quantity for dispensing should be 25mL.
For non-injectable products to be reconstituted where the deliverable volume is expressed as a range, the reported quantity for dispensing will be the lower volume of the range. Example: CellCept 200mg/mL oral suspension lists the net content after reconstitution as 175 mL and the deliverable volume after constitution as 160-165 mL. The reported quantity for dispensing should be 160mL.
Should the WG approve, the compendia will make their database changes from 175 ml to 160 ml at the end of the first quarter. Changes to the BUS will be incorporated into the DERF submitted for the May 2011 WG meeting.
When there is a range given, the least amount should be billed. The compendia have 175 mL currently. A motion was moved and seconded to approve as suggested by the task group. The motion carried without opposition. The three examples are Valcyte, Cellcept and Tamiflu. These should be sent to the FDA to shows160 mL as the volume in the SPL.
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QUIC FORM 200609 - Centany 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."
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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.
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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 opposition
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QUIC 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.
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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.
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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.
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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.
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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.
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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.
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QUIC FORM 970008 - Desquam-X Bar 10% 3.75 oz. Resolution (SEE QUIC FORM 201010 FOR UPDATE) 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.
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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.
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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.
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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.
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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.
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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.
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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.
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QUIC FORM 201012 ELESTRIN GEL (NDC 18860-0480-60) Resolution
Requested clarification for the billing unit quantity. At the November 2010 WG2 meeting the form was discussed. Issue: To clarify any confusion in the market place.
Discussion:The Product Review and Billing Unit Exception Task Group via email on October 27 and 28, 2010:
The task group agreed that this should be 26 per pump dispenser with a total of 52 grams. This also is consistent with what we’ve been saying to the FDA about the overfill in the liquids. Here we have the same situation with grams – more in the container than the device can deliver. Per the BUS:
Section 5.4.2 Topical Products - These products must be billed as the number of grams (GM) or milliliters (ML) in the container. Do not bill the number of ounces dispensed or the number of packages dispensed. (Topical products less than 1 gm are billed as “eaches”; see section 5.1.13 of this document above.)
A motion was moved and seconded to approve as a billing unit of grams and a dispensing quantity of 52. Can the package be broken apart? Yes. There are two NDCs—one on the package and one on each dispenser (same NDC on each dispenser).
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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.
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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.
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QUIC FORM EYLEA (NDC 61755-0005-02)
Resolution
Requested clarification for the billing unit quantity and new product/package information. At the February 2012 WG2 meeting the form was discussed. Request: Eylea™ was FDA approved on 11/18/2011 and entered the market on 11/21/2011. Eylea is a physician administered product indicated for the treatment of Patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD). Eylea comes as a liquid single-use vial that contains 0.278mL fill of 40 mg/mL Eylea. On the outer package it is listed as 2 mg / 0.05 mL Single-use Vial. The Unit of Measurement according to the BUS would be a mL, however, what should the Unit Package size represent? When reporting this product in the Medicaid Drug Rebate Program database (DDR) what should the mL of the unit package size represent? If we make this clean and report by the one each vial, which would also be easier in calculating the PHS price, how would this affect the Pricing Compendia reporting?
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of November 22, 2011:
Section 16 How Supplied
Each Vial is for single eye use only. EYLEA is supplied in the following presentation [see Dosage and Administration (2.3) and (2.4)].
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NDC NUMBER
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CARTON TYPE
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CARTON CONTENTS
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61755-005-02
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Vial
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one single-use, sterile, 3-mL, glass vial containing a 0.278 mL fill of 40 mg/mL EYLEA
one 19-gauge x 1½-inch, 5-micron, filter needle for withdrawal of the vial contents
one 30-gauge x ½-inch injection needle for intravitreal injection
one 1-mL syringe for administration
one package insert
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Section 3 Dosage Forms and Strengths
Single-use, glass vial designed to provide 0.05mL of 40mg/mL solution for intravitreal injection.
It was suggested that Eylea would be ml since it is injectable. It only delivers .05 ml. The task group determined: BU= ML; Package Size= 0.05 per Section 5.2.2 and FAQ 7.34
5.2.2 -- Injectables that are liquid-filled vials, including multi-chamber products, ampoules, and syringes must be billed as the total number of milliliters (ML) dispensed. If multi-chambered vials with both components are liquid, the billing unit is the sum of the milliliters of the product. If a manufacturer has labeled a product for the quantity to dispense (i.e. excluding the overfill), the reported quantity for dispensing should be total number of milliliters. See section ‘Frequently Asked Questions”, question 7.28 and 7.34. NOTE: if the product is derived from a biologic source and has a variable volume, see section 5.1.7.
FAQ 7.34 HOW DO I BILL PRODUCTS THAT HAVE AN OVERFILL?
For non-injectable products, the package size will be based on the total amount of the product delivered (amount that can be extracted from the container; i.e. dispensed). Any overfill will not be considered as part of the reported quantity. Example: Tamiflu for Oral Solution contains approximately 33 mL, after reconstitution. Each bottle delivers 25mL of suspension. The reported quantity for dispensing should be 25mL.
For non-injectable products where the deliverable volume is expressed as a range, the reported quantity for dispensing will be the lower volume of the range. Example: CellCept 200mg/mL oral suspension lists the net content after reconstitution as 175 mL and the deliverable volume after constitution as 160-165 mL. The reported quantity for dispensing should be 160mL.
NOTE: In November, 2010, it was determined that overfill, regardless if the product is reconstituted or not, will not be included in the billing quantity reported. From 2007-2010, Lucentis was an exception to the standard (see FAQ 7.28). With the change in 2010, Lucentis is now in compliance with the BUS.
All compendia were informed of this decision.
A motion was made and seconded that the BU = ML and the Package Size= 0.05 ml per Section 5.2.2 and FAQ 7.34 of the Billing Unit Standard. All the compendia have a package price that roll up to a unit price. This will be rolled up to one ml. The motion carried with no opposition.
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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.
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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.
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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.
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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.
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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.
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QUIC FORM 201008 FLO-PRED ORAL SUSPENSION (NDC 51672-1338-03) Resolution
Requested clarification for the billing unit quantity. At the November 2010 WG2 meeting the form was discussed. Issue: Taro Pharmaceuticals requests that Flo-Pred’s package size be coded as a 30ml dispensed unit. The total unit volume of the package is 52ml., however, due to the viscosity of the unique “Spill Resistant” suspension, only 30ml is available to the patient. This package is designed to be a unit-of-use package. This request is being made in order to avoid confusion at pharmacy level regarding the total volume of the package (52ml) vs. the actual volume available to the patient (30ml). For example: Prednisolone is often prescribed in a quantity of less than 52ml. Because only 30ml of drug is available per bottle, for prescriptions greater than 30mls and less than 52mls, two bottles of Flo-Pred must be dispensed. If the RPH is prompted that the package is actually 52mls, there is the risk that only one bottle would be dispensed and the patient would be under dosed. There is also the risk of inaccurate billing to Third Party Payers which could result in multiple co-pays and dispensing fees for prescriptions that should require a single co-pay and dispensing fee.
Discussion: The Product Review and Billing Unit Exception Task Group discussed on their call of August 17 and September 14, 2010:
The request is that the billing unit be 30 ml. Package states volume 52 ml. 30 is stated on the artwork. This is a single unit of use. All agreed that the billing quantity should be 30 ml. We should recommend to the manufacturer to take off any reference to 52 on the package because of billings errors and potential overpayment. 30 should be made more visible. A response was sent to the submitter stating that we strongly suggest that the package be changed because of overpayments.
A motion was moved and seconded that the billing unit should be 30 ML. The motion carried without opposition. It was requested that we modify the BUS to show that the FAQ 7.28 is for an exception and update FAQ 7.34. The Product Review and Billing Unit Exceptions TG will work on these modifications.
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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.
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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.
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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.
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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.
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QUIC FORM 201117 Glassia 1 gm/50 mL NDC 00944-2884-01 Resolution
Requested clarification for thebilling unit quantity. At the November 2011 WG2 meeting the form was discussed. Issue: o determine how the product will bereported by the Pricing Compendia Services, dispensed by Retail Pharmacies andbilled by Payers and Processors. This isthe first alpha-1 proteinase inhibitor with a strength that does not vary fromlot to lot. Clarification of the billing unit as it is the first standardizedpreparation of alpha-1 proteinase inhibitor. All other marketed products ofalpha-1 proteinase inhibitor vary from lot to lot.
Discussion: TheProduct Review and Billing Unit Exception Task Group discussed this product ontheir calls of October 11 and 25, 2011:
Glassia,an alpha-1-proteinase inhibitor appearing on the BU differences list. It seems to have a standardized strength.This product does not appear to vary from lot to lot. There is a standardizedstrength in liquid form and always has the same volume. Section 5.1.7 of theBUS addresses Alpha-1 proteinase inhibitors that vary from lot to lot. How do we set up an alpha-1 proteinaseinhibitor product that is not variable from lot to lot? Glassia is a solutionfor injection and solutions are typically billed per ml. Do we treat Glassiadifferently because of the drug? Compendia have different billing units.Deborah mentioned that the pricing is per mg. All agreed that the billing unit of Glassia should be ML, per 5.2.2 ofthe BU Standard.
After the Task Group meeting,Julie sent a letter that First DataBank received from Baxter stating thefollowing:
Thisproduct was discussed on our last called and determined the billing unit, per5.2.2 of the Billing Unit Standard, should be 1 gram per 50 mls since theproduct does not vary from lot to lot. After the call Julie receivedinformation that the volume does varyfrom lot to lot and the package insert was misleading. Given thisinformation, the group agreed that the billing unit, per section 5.1.7 of theBilling Unit Standard, should be each because the volume could be variable.This is not an exception to 5.1.7.
5.1.7
Products derived from biologic sources where the strength or the volumeis variable from lot to lot shall be billed as “1” each. In the casewhere strength varies from lot to lot, the number of strength units shall bethe package size. In the case where volume varies from lot to lot and the strengthremains constant, the billing unit shall be “1” each per packaged product.
A motion was made and secondedto list as EACH per Section 5.1.7 of the Billing Unit Standard. It was suggested that there should be aprimary rule that because a product is an Alpha-1 proteinase inhibitor, the BUshould be an each. The motion carried.
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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.
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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.
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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.
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QUIC FORM 201007 HUMATE-P (NDCS 63833-0615-02, 63833-0616-02, 63833-0617-02 ) Resolution
Requested clarification for the billing unit quantity. At the November 2010 WG2 meeting the form was discussed. Issue: Is this product’s billable unit (quantity) determined by the number of VWF:RCo International Units or FVIII International Units. The product contains both types of IUs and there is an approximate 2.4 to 1 ratio of VWF:RCo IUs to FVIII IUs. It is not clear which IU is the billable unit. The vials are labeled with both VWF:RCo IUs and FVIII IUs and it is not clear which should be used for billing. There is a difference between the number of IUs in each vial which could result in inaccurate reimbursement. NCPDP WG 2 should add an FAQ for this product to section 7 of the Billing Unit Standard Implementation Guide.
Discussion: The Product Review and Billing Unit Exception Task Group discussed on their call of August 17 and September 14, 2010:
This is an anti-hemophilic product. The marketer’s pricing letter should indicate which of the factors is used for pricing. The group contacted CSL Behring and found that these NDCs are priced per VWF:RCo IU. Do we add an FAQ to clarify? FAQ 7.11 shows general information on billing for anti-hemophilic as an each. Section 5.1.7 lists drugs individually that are considered as eaches. Do we add this drug to that list? What do we gain in doing so? No, we do not need to add to the list nor do we need an FAQ. The issue appears to be specific to the product and does not appear to be an appropriate addition to the BUS. This product is billed by unit—each—and price is based on each unit. The Co-Chairs will refer this issue back to the manufacturer for consideration as to why billing by VWF: RCo I.U was chosen rather than the total units per vial.
What would it hurt to add an FAQ? The billing unit is the same and the FAQ would be very specific to this drug. Terri Meredith noted that she called a hemophilia clinic in Colorado to ask about this product. Billing is based on the units of VWF because the factor VIII that is contained in it is a by-product of the VWF that cannot be purified enough to get all of the factor VIII out. A motion was moved and seconded to accept the decision of the task group. No further action is needed. The motion carried. This is a very specialty product that is billed only by specialty clinics and infrequently used.
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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QUIC FORM 200511 - Keralac Nailstik (50% Urea) NDC: 10337-648-10 Resolution
See QUIC Form 200509 Resolution.
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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.
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QUIC FORM 201115 Lazanda Nasal Spray NDC 51772-311-01 and 51772-311-04 (100mcg) & 51772-314-01 and 51772-314-04 (400mcg Resolution
Requested clarification for thebilling unit quantity. At the November 2011 WG2 meeting the form was discussed. Issue: From the PI -- Lazanda is supplied in a5.3 ml capacity clear glass bottle with an attached metered-dose nasal spraypump incorporating a visual and audible spray counter, and a protective dustcover. Each bottle contains a net fill weight of 1.57 grams and, after priming,delivers 8 sprays. The pump will remain primed for up to 5 days after primingor use. The nasal spray delivers 8 full sprays. There are 2 product strengthsand each 100 mcL spray contains either 100 mcg or 400 mcg of fentanyl. LazandaNasal Spray needs to be listed consistently across the compendia for accuratebilling and reimbursement.
Discussion: TheProduct Review and Billing Unit Exception Task Group discussed this product ontheir call of September 13, 2011:
Thesingle spray bottle is a 1 EA and the box of 4 bottles would be 4 EA based onusing the math that 1 spray=100mcL (.1mL) so 8 “delivered” sprays=.8mL which isless than 1mL. Since this is not an injectable product, then Section5.2.1 of the BUS should apply.
5.2.1 Non-Injectable LiquidDosage Forms (for example solutions and suspension, etc.) must be billed as thetotal number of milliliters (ML) dispensed, including dropperettes if thevolume is 1 ml or greater. If the volumeis less than 1 ml for a non-injectable product, the product is billed as an“each” (see section 5.1.12 above).
5.1.12Unit-of-use packages (self-containedsingle dose packages) with a quantityless than one milliliter or gram should be billed as “one each”. For example, ointment in packets of less than1 gram, eye drops in dropperettes that are less than 1 ml, or nebulizersolution in package of less than 1 ml. Thisrule does not apply to injectable products.
The task group agreed that a single Lazanda Nasal Spray isbilled as a 1 EA and the box of 4 is billed as 4 EA.
It was questioned why we wouldadjudicate this product as each but Asmanex was adjudicated as grams and it isa like product. Asmanex is an inhaler and we applied the standard for inhalers.A motion was made and seconded to list this product with a billing unit of 1 EAfor the single spray bottle and 4 EA for the box of 4 per Sections 5.2.1 and5.1.12 of the Billing Unit Standard. The motion carried with one opposition. KarenEckert stated that the BUS should be updated to add a subsection to explainthis situation. The Product Review and Billing Unit Exception Task Group willtake this change into consideration when they prepare the DERF for submissionfor the February 2012 Work Group meetings.
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QUIC FORM 201001 LIDOCAINE/PRIOLOCAINE CREAM (NDC 00168-0357-56) Resolution
Requested clarification for the billing unit quantity. At the February 2010 WG2 meeting the form was discussed. Issue: This NDC is packaged as a 5 x 5gm tube plus 12 occlusive dressings. Are the 12 occlusive dressings to be disregarded in determining whether to bill this NDC as a kit (in which case it would be billed in Grams instead of EA)? Discussion: This product was reviewed by the Product Review and Billing Unit Exception Task Group on January 19th and determined to be a kit. An exception was made on Tegaderm to be a kit. Can the product be broken up into smaller units? No. Would it be that a kit can be defined as 2 or more products that cannot be broken up into smaller units? Kay noted that birth control pills are not designed to be broken. To make these a kit would have a huge impact. Originally a kit was to be assigned when the billing unit was unclear and it crossed between the assigned three billing units—gm, ml, and each. A motion was moved and seconded to establish the BU of this product as a kit (each). The motion carried with one in opposition.
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QUIC FORM 201114 Lidocaine-Hydrocortisone Cream Kit NDC 13925-157-14 & 13925-157-20, 13925-163-20, 13925-164-20 Resolution
Requestedclarification for the billing unit quantity. At the November 2011 WG2 meetingthe form was discussed. Issue: We wouldlike to inquire how this product should be listed/billed (as 1 Kit or 20 Kits).There is no specification in NCPDP billing unit guidelines for this situation.
Discussion: The Product Review and Billing Unit Exception Task Groupdiscussed this product on their calls of September 13 and 27 and October 11,2011:
How are the following productslisted below listed-- as One Kit (PS=1, BU=EA) or 14 and 20 kits? According toBUS, in order to be listed as 14 and 20 Kits, it has to be packaged in 14 or 20separate units, each unit being a kit by itself. The manufacturer states thattheir Lidocaine products are packaged in a carton with three cells, each cellcontaining 20 tubes, 20 wipes and 20 applicators.
Kits carry a single National Drug Code (NDC) for the combineditems. Kits are designed with the intent to be dispensed and billed as a unitof “each”. Additionally, if a kit contains separate distinct trays within thekit, the billing unit is an “each”, but the quantity is the number of traysrather than “1”.
How Supplied:
Lidocaine 3% - Hydrocortisone 0.5% Cream Kit
14 Count Kit, NDC 13925-157-14
Containing: 14 single use ¼ oz (7g) Tubes (NDC 13925-157-07) ofLidocaine 3% -
Hydrocortisone 0.5% Cream (a white cream) and 14 Applicators
Lidocaine 3% - Hydrocortisone 0.5% Cream Kit
20 Count Kit, NDC 13925-165-20
Containing: 20 single use ¼ oz (7g) Tubes (NDC 13925-157-07) ofLidocaine 3% -
Hydrocortisone 0.5% Cream (a white cream) 20 Applicators and 20Moist Wipes
Lidocaine 3% - Hydrocortisone 1% Cream Kit
20 Count Kit, NDC 13925-163-20
Containing: 20 single use ¼ oz (7g) Tubes (NDC 13925-1163-07) ofLidocaine 3% -
Hydrocortisone 1% Cream (a white cream) 20 Applicators and 20 MoistWipes
Lidocaine 3% - Hydrocortisone 2.5% Gel Kit
20 Count Kit, NDC 13925-164-20
Containing: 20 single use ¼ oz (7g) Tubes (NDC 13925-164-07) ofLidocaine 3% -
Hydrocortisone 2.5% Gel (a white gel) 20 Applicators and 20Moist Wipes
The group reviewed the packagesand agreed to 1 EACH Kit for those that contain the single use tubes,applicators and moist wipes. NDC 13925-157-14 is not in questionsince this NDC has no wipes and therefore is not a kit and ismeasured by grams. This product looks very similar to AnaMantlethat were adjudicated in 2006. (See QUIC #200613) A motion was made andseconded to list this product (NDCs13925-157-20, 13925-163-20, 13925-164-20) with a billing unit of 1 EA KITand maintain the billing unit for NDC 13925-157-14 as grams. The motion carriedwithout opposition. Karen Eckert clarified that the NDC 13925-157-20 has theNDC on the individual tubes to be the same as 13925-157-14 but the outer boxhas a difference NDC so it doesn’t have the same core 9.
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QUIC FORM 200906 LIORESAL INTRATHECAL
Resolution Resolution
Requested clarification for the billing unit quantity. At the August 2009 WG2 meeting the form was discussed. Issue: We have this product in our billing unit definition spreadsheets as 1 ea kit for all, but this product does not meet the definition of a kit, as it contains only ampoules of injectable liquid. (This was verified with MedTronic) This product is not dispensed at retail, but is instead used by physicians to refill the MedTronic baclofen pain pump. This request was reviewed by the Product Review and Billing Unit Exception TG and they decided that the Lioresal Intrathecal Kits consist of ampoules and they do not meet the BUS definition of a kit. The standard states that liquid-filled ampoules are to be billed as ML. However, some compendia may have them established as 1 EA kit. Lioresal Intrathecal Kits are rebatable products and CMS lists them as ML. The compendia agreed to change the BU to ML effective 1/1/2010. A motion was moved and seconded to approve as a billing unit of ML. The motion carried without opposition.
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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
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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QUIC FORM 201104 METAMUCIL FIBER WAFERS (NDCS 37000-0029-01 AND 37000-0030-01) Resolution
Requested clarification for the billing unit quantity. At the February 2011WG2 meeting the form was discussed. Issue: OTC Product (Package Box) filed with FDA as a drug and has an NDC#. The box contains twelve (12) Single Serving (2-Wafer) Packets which could be considered 12 EACHes (oral solid packets; The data banks consider the total package equals 24 Eaches. The package does refer to weight (grams) and considers the total package weight to be 264 grams; or could also be considered 12 single servings (oral solid packets) of 22 grams.
Discussion: This form was discussed by the Product Review and Billing Unit Exception Task Group on their call of January 4th:
The task group agreed that the Billing Unit would be EA with billing quantity being the total number of wafers in the box. The decision was based on:
BUS Section 5.1.11 Convenience Packs, Therapy Packs, Starter Packs and packs of Oral Contraceptive must be billed as the number of individual tablets or capsules (EA) dispensed, not the number of boxes or packages or cavities.
A motion was moved and seconded to approve as 24 each. Could this cause a problem since the package states 12 packets? This is what the task group had a problem with and they found that Medicaids were paying as 12. Could we adjudicate this as bars? We should let the standard dictate how this is adjudicated rather than what is on the box. The motion carried with one in opposition.
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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.
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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.
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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.
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QUIC FORM 201101 NEEDLE FREE SUPPLY KITS FOR MEDI-JECTOR VISION NEEDLE FREE INSULIN INJECTION SYSTEM Resolution
Requested clarification for the billing unit quantity. At the February 2011 WG2 meeting the form was discussed. Issue: These kits consist of 4 needle free syringes plus 2 vial adapters. The kits are the same except for the size of the syringes. One data vendor has pack size listed as 4; another vendor has pack size listed as 1. Both have a billing unit of each. Request is needed to align the data. Should this product be listed as a kit of 1 ea per 5.5.1, or listed as 4 ea per 5.1.5 for empty hypodermic syringes?
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of November 9, 2010:
There is no drug in this product and it does not cross billing units so it doesn’t qualify as a kit. There are 4 syringes and 2 adapters. There was consensus reached via email before the WG meetings that it is not a kit and the billing quantity should be 4.
Decision: BUS 5.1.5 applies to the product. The BU=EA. The Billing Quantity is 4 based upon the number of needle free syringes (the sterile vial adapters with caps are ignored for purpose of billing).
5.1.5 Empty Hypodermic Syringes must be billed as the actual number of syringes and/or hypodermic needles dispensed (EA). Do not bill the number of boxes or packages.
A motion was moved and seconded to approve as a BU of each with the billing quantity of 4. The motion carried without opposition.
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QUIC FORM 200905 NEOBENZ MICRO PLUS PAC (NDC 67402002923) Resolution
Requested clarification for the billing unit quantity. At the May 2009 WG2 meeting the form was discussed. Issue: Kit contains: #7- 0.5 gm single dose applicators of NeoBenz Micro 5.5% (single dose) benzoyl peroxide 180 gm bottle-NeoBenz Micro Wash 7%. Clarification as to how this product should be listed in drug data compendia for appropriate billing unit quantity is needed. This request was reviewed by the Product Review and Billing Unit Exception TG on their conference call of March 17th. After discussion, the group decided that this product fits the definition of a kit since it contains a topical wash (BU=gm) plus 7 pads for topical application of 0.5g of benzoyl peroxide (BU=ea).
This is based on BUS section 5.5.1 KITS - BILLED AS AN "EACH":
Kits are defined as products that contain:
1)at least two distinct drug items with different billing units...
Kits carry a single National Drug Code (NDC) for the combined items. Kits are designed with the intent to be dispensed and billed as a unit of "each".
The decision was communicated to the manufacturer (Pat Hardin, SkinMedica) with a reminder that this is contingent upon WG 2's approval.
A motion was moved and seconded to approve as a billing unit of an each for the kit. The motion carried with none in opposition.
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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.
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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.
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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.
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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)
This product was reviewed by WG2 BUS Product Review and Billing Unit Exception Task Group on October 10, 2008. After a discussion of the product, the Product Review and Billing Unit Exception Task Group decided that the appropriate billing unit is 131 and that the product did not meet the definition of a Kit since each component would be considered an "each". A motion was moved and seconded to be an “each” and that this product should be established for billing as 131 eaches. The manufacturer will be informed of our decision based on the established QUIC form process. The motion carried with two in opposition.
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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
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.
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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.
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QUIC FORM 200908 OZURDEX (DEXAMETHASONE INTRAVITREAL IMPLANT) NDC 00023-3378-07
Resolution Resolution
Requested clarification for the billing unit quantity. At the November 2009 WG2 meeting the form was discussed. Issue: This newly approved product caused confusion in billing unit selection because of the labeling as the weight of dexamethasone instead of "1" insert containing the amount of drug. After discussion and investigation into this product, it was decided to add it as one. This QUIC form is requesting validation of the chosen billing unit. Discussion: This product was reviewed by the Product Review and Billing Unit Exception Task Group on September 15th. Based upon emails exchanged by the compendia during early September 2009 regarding the appropriate billing unit for this product, it was decided that the billing unit is EA and this was confirmed with all compendia. The task group discussed whether the BUS needed to be updated to address the billing of implants. The group felt an FAQ regarding the billing unit for an implant dosage form would be the appropriate solution. The labeling currently on this implant is based on the amount that is delivered—.7mL. The task group felt that the smallest measurable, dispensable quantity of this product is one implant and not .7 mL. All the other implants are listed as one each. The task group is looking to list all implants as one each. A motion was moved and seconded to establish the BU of this product and all single-use implants as EA. The motion carried without opposition.
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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.
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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.
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QUIC FORM Pico Prep Resolution
Requested new product/package information. At the February 2012 WG2 meeting the form was discussed. Cassandra Perkins, Andrew Zanga and Raheal Hussain of Ferring Pharmaceuticals, Inc. presented this request. Request: Would like to discuss Pico Prep (this is prior to our launch at the Feb workgroup meeting) to insure that we have covered all bases – we have a product that has two items inside the outer box. Two boxes have different NDC numbers. Would like to discuss potential issues with pharmacy being able to order, compendia and also reimbursement problems. Would like to explain the product and see guidance – product is kitted – has a cup, inner carton is contains packet with powder (NDC), outer carton has different NDC – want to know if there are any challenges – especially for reimbursement, etc. What are the implications if pharmacist breaks open the package? How does this impact the compendia? We would like some guidance on this to insure that we don’t have issues product being dispensed, info with compendia and reimbursement challenges. Clarification – on best practices – if there is anything we can do on our end to thwart any issues.
§ Regulatory Review
• NDA filed September 2011
• Anticipated mid-summer approval
§ Trade Stock
• Planned for late August / early September 2012
§ Data Release
• October 2012 ACG Annual Meeting
• SEE CLEAR I & II Pivotal Studies
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of January 31, 2012:
It was decided to defer this discussion until the Work Group meeting where more information would be available.
This is a prescription product. Are there any issues with how it is packaged? Is it noted that the inner NDC should not be used for billing? No, billing to a third party should not be a problem. The outer box has the number of grams. Is the smaller package size fine? Yes. No Medicaid rebate agreement is in place. The company should report this as one each packet. What does the one represent? An each represents each of the two pouches in the box. The Decision Tree was checked and the result was 2 each per box. This does not meet the definition of kit. Per Section 5.1.8 of the Billing Unit Standard this should be EACH and two each for the two packages in the box. A motion was made and seconded that the BU= EACH per Section 5.1.8 of the Billing Unit Standard and to be clearly marked on the outer box. The motion carried with no opposition. Post Meeting Note: The Product Review and Billing Unit Exception Task Group is reexamining this product to ensure the Billing Unit Standard is applied consistently.
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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.
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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.
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QUIC FORM 201005 PREVALITE (CHOLESTRYAMINE FOR ORAL SUSPENSION, USP) POWDER (NDC 0245-0036-23, 0245-0036-42, 0245-0036-60) Resolution Resolution
Requested clarification for the billing unit quantity. At the August 2010 WG2 meeting the form was discussed. Issue: Our Prevalite® product is one strength but has three different package configurations. Two are packet configurations and one is a “bulk” can with 42 doses in it. For Medicaid purposes I need a consistent approach to process these claims, and I believe gram is the universal measurement that could be used in all three cases. However, some states are requesting that they be rebate as a “1” each for the packets and this will not work for the “bulk” can.Discussion:
The BUS quoted for the packets:Dosage Forms Billed As “Each” (EA)5.1.8 Powders, reconstituted to variable volumes and intended for a single oral or topical administration, must be billed as “eaches”, not the number of boxes, packages, grams, or milliliters. This includes: - packets of cholestyramine (Questran); i.e. quantity 6Ø packets are billed as 6Ø EA),
and the BUS quoted for the bulk powderDosage Forms Billed As “Grams” (GM)5.3.3 Powders, including powders for mixing by the customer/patient on a per dose basis, must be billed as the number of grams (GM) dispensed. For example, Questran can quantity 378 gm is billed as 378 gm and Metamucil powder container quantity 538 gm is billed as 538 gm. (For Bulk powders, refer to section 5.5.2 of this document.) However, if the powder is manufactured for a single oral administration (i.e. in a “packet”), the billing unit is "each” (see section 5.1.8)
A motion was moved and seconded to indicate the packets as EACH and the bulk can as grams. The motion carried without opposition.
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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
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QUIC FORM PROCTO-PAK (NDC 64980-0302-30)
Resolution
Requested clarification of the Billing Unit Standard. At the February 2012 WG2 meeting the form was discussed. Request: This Rising NDC represents a package containing a tube of Hydrocortisone cream manufactured by Actavis under NDC 00472032126 along with an applicator and finger cots. The Actavis tube is labeled as 28.4gm (1 oz). The Rising packaging only states 1oz. and is on file with the compendia as 30gm. This request is needed to align the metric value for 1 oz on the outer package with the 1 oz value on the inner tube of cream. The Rising packaging is see-through, so the pharmacist can clearly see that the metric value on the inner tube of cream conflicts with the metric value on file for the outer package.
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their calls of January 14, 2012:
This packaging is confusing to the pharmacy. It has been on market for awhile. The Rising packaging is transparent and Actavis Hydrocortisone Cream (NDC 00472-0321-26) with quantity stated as 28.4g (1oz) is clearly visible to the pharmacist. This item is rebatable and CMS shows it as 28.4. The group agreed that Procto-Pak 1% should be changed from 30gm to 28.4gm. Compendia will make this change as of the end of February 2012—the week of February 26th.
A motion was made and seconded to list as 28.4gm and not 30gm. The motion carried.
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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..
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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.
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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.
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QUIC FORM 201118 QUILLIVANT(NDC 24478-0200-10, 24478-0200-20, 24478-0200-30) Resolution
Requested clarification for thebilling unit quantity and new product/package information. At the November 2011WG2 meeting the form was discussed. Issue: Themanufacturer wanted to confirm the Standard Unit of Measurement would meMilliliters (BUS 5.2.3). However, in researching further the core 9(NDC# 24478-0200) for all three sizes containing a different concentration/dosecould be problematic.
Producthas NOT been FDA approved awaiting on PDUFA date, estimate 2Q2012
Indication: ADHD, oral formulation. Controlled Substance, Product will be soldthrough the wholesaler channel. Quillivant will be sold in a powder vial in three sizes, each bottle contains adifferent concentration/dose. After conversation with Commercial &Regulatory Depts. Manufacturer decided to change the core 9 NDC# so that eachsize has a different code 9 NDC#. Billing Unit is still a Milliliter (BUS 5.2.3).
Discussion: TheProduct Review and Billing Unit Exception Task Group discussed this product ontheir calls of October 11, 2011:
The group agreed that since ityields different ml, the BU should be ml based on 5.2.3 of the Billing UnitStandard.
5.2.3 Reconstitutable Non-injectable Products must be billed as the totalnumber of milliliters (ML) dispensed after reconstitution; i.e., once thepowder and added flavor packet (if applicable) have been reconstituted withdiluent, according to manufacturer instructions. For example, AmoxicillinSuspension 25Ø mg/15Ø ml is billed as 15Ø ml and Golytely™ 4ØØØ ml bottle isbilled as 4ØØØ ml.
A motion was made and seconded to list as mL per Section 5.2.3of the Billing Unit Standard. Themotion carried.
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QUIC FORM 201002 QUTENZA (CAPSAICIN) 8% PATCH (NDC 49685-0928-01 AND 49685-0928-02) Resolution
Requested clarification for the billing unit quantity. At the February 2010 WG2 meeting the form was discussed. Issue: Qutenza is a new product indicated for Postherpetic Neuralgia (PHN). It will be available the first half of 2010 and be sold through Specialty Distributors as it MUST only be administered by a physician or health care professional under the close supervision of a physician. The product is supplied in 2 sizes; 1 carton containing 1 Patch and 1 tube of cleansing gel (non-medical no NDC#). 1 carton containing 2 Patches and 1 tube of cleansing gel (non-medical no NDC#). Inner Patch NDC# 49685-0920-00 (for both cartons). Why Needed: In accordance to the Billing Unit Standard and information provided to NeurogesX on 12/3/2009 from the WG2 Billing Unit Exception Task Group it was indicated that this product should be billed by the kit. NeurogesX was unable to give each carton a different core 9 NDC# because each carton needed to contain the same product code. Changing the product code and making it a different core 9 was technically incorrect according to FDA regulations. According to the manufacturer, “We need this product reported by the each patch (not as a kit). Because of the core 9 situation with this product we need the unit of measurement to reflect an EACH PATCH. This is the smallest dispensed unit. Since CMS in the drug rebate program only reads the core 9 NDC#, we need to identify and price this on an each patch.” Discussion: Linda Schock provided clarification and led discussion. The FDA approved the label that had NDCs but the SPL did not like the NDC numbers. The manufacturer had to change the NDC numbers on the box to comply with the SPL which delayed the launch. The manufacturer looked at the core 9 NDC. There is concern as to rebates on these products. The manufacturer has applied for a J code and the J Code Committee wants this priced as “per squared centimeter.” Anne noted that the standard defines this as a kit and read from the standard—“kits carry a single NDC for the combined items.” There is no NDC on the gel. The NDC on the patch is the same NDC used on the box of one patch and the two patches have the same NDC. One box has an external NDC and the 2-patch box has a different NDC. It is a reflection of the number of things within that box. Kay noted that the standard states, “two drug items”. There is only one drug item in this package—gel does not meet the definition of drug. Linda asked that the QUIC form be adjudicated as one each per the patch. Anne noted that the box that contains one patch, it is a kit of one and the box that contains two patches is also a kit of one but has a different cost associated with it. A motion was moved and seconded to list as a kit for both NDCs. The motion carried without opposition.
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QUIC FORM 201106 QUTENZA (CAPSAICIN) 8% PATCH (NDCS 49685-0928-01 AND 49685-0928-02) Resolution
Requested clarification for the billing unit quantity. At the February 2011 WG2 meeting the form was discussed. Issue: Qutenza is a new product indicated for Postherpetic Neuralgia (PHN). It was available the first half of 2010 and sold through Specialty Distributors as it MUST only be administered by a physician or health care professional under the close supervision of a physician. The product is supplied in 2 sizes; 1 carton containing 1 Patch and 1 tube of cleansing gel (non-medical no NDC#). 1 carton containing 2 Patches and 1 tube of cleansing gel (non-medical no NDC#). Inner Patch NDC# 49685-0920-00 (for both cartons)
Qutenza will be on the market for 1 year (April 2, 2011) and is indicated for Postherpetic Neuralgia (PHN). This is a pain patch that must be administered by a physician. It is applied for one hour then removed. The product is supplied in 2 sizes; 1 carton containing one patch and one tube of cleansing gel (non-medical) & 1 carton containing 2 patches with cleansing gel
Why Needed: In accordance to the Billing Unit Standard and information provided to NeurogesX on 12/3/2009 from the WG2 Billing Unit Exception Task Group it was indicated that this product should be billed by the kit. NeurogesX was unable to give each carton a different core 9 NDC# because each carton needed to contain the same product code. Changing the product code and making it a different core 9 was technically incorrect according to FDA regulations. According to the manufacturer, “We need this product reported by the each patch (not as a kit). Because of the core 9 situation with this product we need the unit of measurement to reflect an EACH PATCH. This is the smallest dispensed unit. Since CMS in the drug rebate program only reads the core 9 NDC#, we need to identify and price this on an each patch.” Currently the BUS recognizes this product as an each Kit. The Pricing Compendia have the price at each Kit. A specific J-code (J-7335) was assigned this product, beginning 1/1/2011 and the billing unit per CMS is based on A per Centimeter2. There are 28 billing units on one patch. We need to be uniform in the industry on how this product is billed. Currently, we have it by one each Kit (pricing compendia) and one each Patch.
This product needs to be recognized as a ONE EACH PATCH by the Pricing Compendia, Government Pricing. This will allow some consistency in billing. The J-code (cm2 ) does refer to the measurement of the Patch per patch.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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."
The motion was withdrawn. A motion was moved and seconded to make the unit as on the approved packages, which would be ml. The motion carried.
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QUIC FORM 201109 SPRIX INHALER(S) (NDCS 00517-8880-01 AND 00517-8880-05) Resolution
Requested clarification for the billing unit quantity. At the May 2011 WG2 meeting the form was discussed. Issue Product is an inhaler, listed as a solution in the package insert (“bottle contains a sufficient quantity of solution to deliver 8 sprays”). No milliliters are listed in the P.I. or on the label. The package size is very ambiguous. In the standard, inhalers are referenced as either ml’s or grams. This product does not list such a package size on the label or in the P.I. The index of the P.I. mentions 1.7gms but it appears to be referencing the bottle size.
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of May 10, 2011:
The How Supplied section of the PI gives some information. Multiply each spray amount (100 microliters) by 8 for a total of 0.8mL per bottle. Unfortunately, there isn’t any information on the carton to help the pharmacy do this math. If each bottle contains less than 1mL of solutions, would the billing unit be EACH? Would this fit the section for the swish and spit—no, that was an FAQ. PI states “Each 1.7 g bottle” but we believe that is the size/weight of the bottle. The entire box of 5 bottles or an individual bottle could be dispensed.
Decision: It was moved that based upon Sections 5.2.1 and 5.1.12 of the BUS, the BU is EA and the package size for the box is 5. All agreed.
5.2.1 Non-Injectable Liquid Dosage Forms (for example solutions and suspension, etc.) must be billed as the total number of milliliters (ML) dispensed, including dropperettes if the volume is 1 ml or greater. If the volume is less than 1 ml for a non-injectable product, the product is billed as an “each” (see section 5.1.12 above).
5.1.12 Unit-of-use packages (self-contained single dose packages) with a quantity less than one milliliter or gram should be billed as “one each”. For example, ointment in packets of less than 1 gram, or eye drops in dropperettes that are less than 1 ml, or nebulizer solution in package of less than 1 ml. This rule does not apply to injectable products.
This is a newly approved product and the task group discussed prior to the product coming out on the market. The manufacturer will be notified of the Work Group’s decision. A motion was moved and seconded to make this a BU of one each with a package size of 5. The motion carried without opposition.
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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.
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QUIC FORM 201111 SUMATRIPTAN INJECTION (NDC 47335-0276-41) Resolution
Requestedclarification for the billing unit quantity. At the August 2011 WG2 meeting theform was discussed. Issue: Caraco's Sumatriptan product issubstitutable by the pharmacy for Imitrex STATdose system prescription.Caraco's product is considered a generic(AB Rated) to the Imitrex STATdose System. Billing unit is tied to GCN/GCNSEQNOat FDB. Caraco’s sumatriptan injectable is not in the same GCN/GCNSEQNOas Imitrex Stat Dose because we have not changed the billing unit on ImitrexStatdose yet. The billing unit for Caraco’s Sumatriptan injectable productshould be ML so it is consistent with previous resolutions of other sumatriptaninjectables.
Discussion: The Product Review and Billing UnitException Task Group discussed this product on their call of July 19, 2011:
DeterminedCaraco’s Sumatriptan injectable product is ML so it is consistent with ourprevious resolutions of other sumatriptan injectables. Decision based on:
Section 5.2.2of the BUS applies:
Injectables that are liquid-filled vials, includingmulti-chamber products, ampoules, and syringes must be billed as the totalnumber of milliliters (ML) dispensed.
A motion was moved and seconded to list this product with abilling unit of mL. The motion carried without opposition.
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QUIC FORM 201112 SYLATRON (NDCS 00085-1388-02, 00085-1287-03, 00085-1312-02) Resolution
Requested clarificationfor the billing unit quantity. At the August 2011 WG2 meeting the form was discussed. Issue: We would like to inquire how thisproduct should be listed/billed (as 1 Kit or 4 Kits). We have both customer andmanufacturer asking for clarification whether it should be 1 or 4 kits.
Discussion: The Product Review and Billing UnitException Task Group discussed this product on their call of July 5, 2011:
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Each SYLATRON PACK 4 Contains: |
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A box containing four 296 mcg vials of SYLATRON powder and four 1.25 mL vials of Sterile Water for Injection, USP, 8 B-D Safety Lok syringes with a safety sleeve and 8 alcohol swabs. |
(NDC 0085-1388-02) |
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A box containing four 444 mcg vials of SYLATRON powder and four 1.25 mL vials of Sterile Water for Injection, USP, 8 B-D Safety Lok syringes with a safety sleeve and 8 alcohol swabs. |
(NDC 0085-1287-03) |
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A box containing four 888 mcg vials of SYLATRON powder and four 1.25 mL vials of Sterile Water for Injection, USP, 8 B-D Safety Lok syringes with a safety sleeve and 8 alcohol swabs. |
(NDC 0085-1312-02) |
Product photos were obtained and distributed to the group priorto the conference call. Based upon these photos, the product is not packaged intrays or similar, distinct inner packages for dispensing. Product is packagedsimilar to Copaxone which was addressed by the TG previously and determined tobe 1 EA Kit for the entire box. Sylatron Pack 4 is not packaged in dose trayslike Humira. Concern was expressed that Sylatron single vial and Pack 4presentations share the same core 9 NDC which is an issue for CMS rebates. The group agreed that based uponsection 5.5.1 of the BUS, Sylatron Pack 4 should be listed as 1 EA Kit. No effective date is needed since thisproduct has only been on market a few months. Randy Levin of the FDA statedthat he would follow-up with the manufacturer.
Kits aredefined as products that contain:
1) at least two distinct drug items with different billing units
2) one drug product packaged with medicated or unmedicated swabs,wipes, and/or cotton swabs/balls
3) meters packaged with test strips
Kits carry a single National Drug Code (NDC) for the combineditems. Kits are designed with the intentto be dispensed and billed as a unit of “each”. Additionally, if a kit contains separate, distinct trays within the kit,the billing unit is an “each”, but the quantity is the number of trays ratherthan “1”.
The following items included with a drug should be ignored forpurposes of billing. The billing unit ofthe drug item determines the billing unit for this product. The following table provides examples ofitems included with a drug that should be ignored for purposes of billing. Thislist is not inclusive. If you questionwhether an item is a kit, submit a QUIC form as explained in FAQ 7.1.
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- Tubing for administration
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- Applicators (including sponges)
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- Actuation devices (i.e. lancets, lancet devices)
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- Mandatory patient education information
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- Inhalation aid (i.e. spacers)
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Antihemophilic and Alpha-1 proteinase inhibitors products arenever billed as kits regardless of how they are packaged.
A motion was moved and seconded that Sylatron Pack 4 should belisted as 1 EA Kit as this does not meet the tray exception. The motioncarried. Randy noted that the FDA has talked to the manufacturer since theinner NDC is the same as on the outside package. This product was describedincorrectly in the SPL saying all were in one box. The FDA pointed out to themanufacturer what is wrong and the manufacturer is working on this. The QUICforms are posted to the website and all the compendia will have the samebilling unit for this product.
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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.
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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.
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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.
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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.
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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.
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QUIC FORM 200909 TYVASO STARTER KIT AND TYVASO REFILL KIT (NDC 66302-0206-01 AND 66302-0206-02)
Resolution Resolution
Requested clarification for the billing unit quantity. At the November 2009 WG2 meeting the form was discussed. Issue: Both Tyvaso Starter Kit and Tyvaso Refill Kit are listed by the manufacturer as “Kit”. The starter Kit includes the drug, the ultrasonic nebulizer device plus its own accessories. The Refill Kit includes the drug, plus accessories for the nebulizer only (no nebulizer). Clarification is needed to determine if these two products should be billed as “Kit” or just “mL”. Discussion: This product was reviewed by the Product Review and Billing Unit Exception Task Group on August 18th and on September 1st. The Tyvaso Starter and Refill Kits are listed as kits by the manufacturer but do not fit the definition of a kit per the BUS. There are many components within the package in addition to the drug but none qualify as part of a kit per the BUS standard. Using the Billing Unit Decision Tree, the billing unit = mL. Concern is that it will be difficult for pharmacists to understand that these should be billed as mLs when there are so many components in the box. The only way to make these a kit is through an exception. Most likely this will be a CMS rebatable product but they aren’t on the CMS list yet. The task group did not want to create an exception or revise the BUS for these 2 items and determined that the Billing Unit = mL for all 3 NDCs. Input from payers and practitioners was asked for regarding what the pharmacist would most likely bill as. It is most likely what is written on the outside of the box unless their pharmacy system says otherwise. This product was approved in 2002. The primary concern is that one box has the same billing unit as the crate with the only differentiation being the name field. Is there a separate entry for all the stuff together or just the nebulizer? They all have the same core 9 NDC---crate is 01, refill is 02, and the product itself is a 03. If pharmacy system are core 9 based, there is a problem because you cannot differentiate. For quantity, the NDC 01=28 X 2.9, 02=28 X 2.9, and 03=4 X 2.9. Would the 03 ever be dispensed by the pharmacy? Only if the patient’s dosing regimen deviates from what is provided by the other two. The section on kits in the BUS was reviewed and it showed that this product does not meet the kit definition. A motion was moved and seconded to bill as mL. The motion carried without opposition.
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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.
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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.
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QUIC FORM 201119 VACUANT MINI ENEMA (NDC 58980-0401-05)
Resolution
Requested new product packageinformation. At the November 2011 WG2 meeting the form was discussed. Issue: Vacuant is a newer mini enema in themarket. According to the package label, the box contains 30 x 5cc disposabletubes. There are two other mini enemas in the market: Docusol Mini (17433-9878-05),labeled as “5 mini-enemas” and Enemeez Mini Enema (17433-9876-05), labeled as“30 disposable tubes”. The internal literature for Enemeez Mini Enema lists“Each Disposable 5cc Single Use Tube…: We currently list Enemeez & Docusolas eaches in the absence of a milliliter listing on the label (30 ea & 5ea, respectively). Vacuant clearly has an ‘ml’ listing on its label so we arelisting as ‘ml’. This causes a difference in how these 3 products arelisting—I’m sure this is causing confusion. (WG2 Product Review and BUException TG discussed through email and several compendia are listing theseproducts as described above.)
1) Are we listing these correctly?
2) Guidance in listing items without clear MLor GM listing on the packaging regardless of dose form
Discussion: The Product Review andBU Exceptions task group discussed via email.
WG2 Product Review TG files and found this information in our TGMinutes, January 5, 2010:
Enemeez(Mini NDC 17433-9876-03 and Plus 17433-9877-03) --We agreed that both Enemeez products and the Docusol would be billed as “each”.Confirmed all have made the change.
It sounds like we’re interpreting the same way: on the ones thatdo not show a size listing on the label we’re listing as EACH and where thereis a size listing on the label we went with ML.
A motion was made and secondedthat per the standard this should be adjudicated as 150 ml per Section of 5.2.1of the standard.
5.2.1 Non-Injectable Liquid Dosage Forms (for example solutionsand suspension, etc.) must be billed as the total number of milliliters (ML)dispensed, including dropperettes if the volume is 1 ml or greater. If the volume is less than 1 ml for anon-injectable product, the product is billed as an “each” (see section 5.1.12above).
We need to add clarification tothe standard when we do not know the volume. The motion carried with one inopposition.
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QUIC FORM 201004 VALCYTE ORAL SUSPENSION (NDC 00004-0039-09) Resolution Resolution
Requested clarification for the billing unit quantity. At the August 2010 WG2 meeting the form was discussed. Issue: The bottle is supplied as 100 mL, but only delivers 88 mL. This is causing confusion in the industry. This product cannot clearly be assigned a billing unit based on the wording in the current Billing Unit Standard.Discussion: The Product Review and Billing Unit Exception Task Group discussed on their call of May 11, 2010. If 100mL is used as billing quantity, more doses would be expected. For oral liquids with overfill there is nothing in the BUS to address. The 7.19 FAQ comes close but is not totally applicable. A new FAQ will be added to the BUS and FAQ 7.19 deleted. The BU is MLs and the billing unit quantity should be 88 mls. Notification will be sent to the manufacturer and a copy of the overfill letter will be sent to them. A motion was moved and seconded to approve as 88 ml as the billing unit quantity. The motion carried.
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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.
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QUIC FORM 200902 VANOXIDE HC LOTION KIT
(NDC: 11086004501)
Resolution Resolution
Requested clarification for the billing unit quantity. At the February 2009 WG2 meeting the form was discussed. Issue: New product-Need consensus on how to list this product. Packaging states the following- KIT CONTAINS:1. Vanoxide® HC Lotion Base 25g (as dispensed); 2. Benzoyl-Pak™ 3.8g (to be added to Vanoxide® Lotion Base); 3. ABC Lotion-A Balancing Cleanser formulated to offer remarkable gentle, effective cleansing of the skin. (If you look at the label inside the box, it states that this is 60G) ;4. Product Information Brochure) Packaging indicates 3 items all in grams. However, one item doesn't list number of grams on the outside of the package and one item is mixed in the other before it is dispensed. How should this be billed? 25g (qty of dispensed cream) or 85G (total qty of dispensed cream and cleanser even though qty of cleanser is not listed on the outside of the box)? Or, should this be listed as something else?
This request was reviewed by the Product Review and Billing Unit Exception TG on their conference call of December 12th. It was decided that for now the compendia would establish the billing unit/quantity as 85 grams. Additionally, the following information was received from the Summers, the manufacturer via Mike Lock:
This product is the same identical pharmaceutical product as the previous Vanoxide HC Lotion but with an added complimentary bottle of ABC Lotion. There has been no price adjustment upward by Summers Labs with the inclusion of the ABC Lotion. Vanoxide HC Lotion (the principle pharmaceutical product in this Kit), a combination Rx acne regimen is gaining steady momentum within the prescribing dermatology community. Vanoxide HC Lotion is the ONLY Rx combination of a topical steroid and benzoyl peroxide. This Rx combination allows Dermatologist and other prescribers to reduce the number of prescriptions written without compromising results. This advantage along with increased awareness is driving unit usage quarter after quarter.
The old product is still out in the market. A review of the language in our proposed changes to the BUS was shown regarding how to handle complimentary products.
7.31 How do I bill for Complimentary Items as part of the NDC?
It depends. If the complimentary item carries a different billing unit of the main drug component, the item is treated as a "kit". If the billing unit of the complimentary item is the same billing unit as the main drug component, sum the quantities for the billing unit and report per the billing unit.
Diluents whether complimentary or not, are not to be considered when making a determination of a kit. See section 5.5.1
There is nothing on the outside of the box to show that it is 60 grams but the label on the cleanser does say 60 grams. We should go back to the manufacturer to ask that they put the quantity on the outside of the box to make it clearer of the quantity being dispensed. The ABC Lotion does not have a separate NDC. This item is not a kit since a kit requires two different billing units. Mike Lock was invited to attend but could not. A motion was moved and seconded to approve as a billing unit of 85 grams. This is not a rebatable product that we are aware of. The motion carried with one in opposition.
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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.
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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.
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QUIC FORM 200406 - Vfend Resolution
Requested clarification for the billing unit quantity and unit for Vfend. The product contains a 100 ml bottle of powder containing 75 mil of voriconazole liquid when reconstituted. The bottle is supplied with a dispenser that will deliver 70 ml liquid to the patient. A motion was made to remain consistent with the decision on the QUIC forms for Follistim AQ and make the billing quantity and units to be 75 ml. A motion was made and to accept as presented. Motion was approved unanimously.
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QUIC FORM 201113 V-GO Resolution
Requestedclarification for the application of the Billing Unit Standard.
Matt Nguyen of Valeritas presented this request. This is aunique device for delivering insulin that will be launched this fall. Itis already FDA approved but the company requests NCPDP review prior tolaunch.
Request: V-Go is a prescription insulindelivery device treating diabetes
WhyNeeded: Packagingwill consist of 30 daily V-Go devices and 1 filling accessory (i.e. 31components). It is anticipated thatpayers will pay for 30 V-Go devices for each prescription submitted.
Discussion: The Product Review andBilling Unit Exception Task Group discussed this product on their call of July19, 2011 to make all aware that it will be discussed at the August WG meeting.The compendia needs to list consistently.
Matt gave a presentation on this product. The V-Go package comeswith no insulin and is fully disposable. There are 3 dosing options of 20, 30and 40 that are based on the basal rate. The filling accessory is used to fillinsulin into the V-Go. Each package contains one easy fill and 30 V-Gos. Thereare no plans to package either separately.
This does not meet our definition of kits. This can be comparedto lancets—where we count only the lancets. A previous QUIC form wasadjudicated to ignore the adapters in the package. Randy asked if we would liketo see this sort of information in the SPL file. Terri will look at this in hergroup. The FDA has a pilot for creating SPL files for devices and Randy askedValeritas to participate. A motion was moved and seconded to bill as 30 each andto modify the Billing Unit Standard Section 5.1 to show that adapters, devices,etc. are not counted and should be excluded. Karen Eckert will complete a DERFfor review at the November WG meetings. The motion carried.
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QUIC FORM 200001 - Videx Pediatric Solution Resolution
QUIC 200001 was submitted to clarify how Videx Pediatric Solution is to be billed. This product is reconstituted in two steps, first with water and then further diluted with Mylanta or Maalox. Confusion exists as to whether it should be billed for the amount in the bottle after the initial reconstitution, or for the amount after the second dilution. A motion was made to bill it based on 100 or 200 ml (amount after the initial reconstitution). The motion was moved and seconded. The motion carried.
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QUIC FORM Viread Oral Powder NDC 61958-0403-01 Resolution
Requested new product/package information. At the February 2012 WG2 meeting the form was discussed. Request: 60 g bottle of oral powder with 40 mg scoop. Designed for pediatric use to be mixed with food, such as apple sauce. Indicated for ages 2 to <6 years old and weight >10 kg and < 17 kg. Need a uniform unit of measure for compendia and Medicaid.
Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of December 6, 2011:
The group agreed that the billing unit should be GM per Section 5.3.3 of the Billing Unit Standard:
5.3.3 Powders, including powders for mixing by the customer/patient on a per dose basis, must be billed as the number of grams (GM) dispensed. For example, Questran™ can quantity 378 gm is billed as 378 gm and Metamucil™ powder container quantity 538 gm is billed as 538 gm. (For Bulk powders, refer to section 5.5.2 of this document.) However, if the powder is manufactured for a single oral administration (i.e. in a “packet”), the billing unit is “each” (see section 5.1.8)
A motion was made and seconded that the BU = GM (60 GM) per Section 5.3.3 of the Billing Unit Standard. The motion carried with no opposition.
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QUIC FORM 200903 AND 200904 WELCHOL POWDER
Resolution Resolution
Requested clarification for the billing unit quantity. At the February 2009 WG2 meeting the form was discussed. A new formulation of a product that we currently marketed, Welchol tablets has been marketed since 2000 and Daiichi Sankyo now seeks to market 2 new versions of this product in powder form dispensed via packets. Additional documentation attached. Current - Welchol 625mg Tablet 180 count Bottle 65597-0701-18 New - Welchol 1.875 gram packets (pouch) 60 count box and New - Welchol 3.75 gram packets (pouch) 30 count box
Why Needed: To ensure that the proper Billing unit standard is established in order to minimize any billing issues in the market place (especially with a tablet already in the market place). To ensure that pharmacies and claims processors indicate the quantity dispensed and billed/reimbursed is accurate. To avoid any reimbursement problems that might occur at the pharmacy level. To determine whether we should have a unique NDC 11 for the outside box (30 count) and the individual packets. Additionally, to determine if we can request separate NDC 9's for each of the strengths (3.75 gram packet and the 1.875 gram packet.)
Depending on the recommendation of the NCPDP; anticipate having unique NDC 9's for the current offering indicated above as well as the 3.75 gram and 1.875 gram packet. To have the same NDC on the outer box as each individual packet (3.75 gram pack and 1.875 gram packet each having their unique NDC 11 on the outside box and packet of their respective offerings). We believe that such an approach would alleviate the billing of incorrect amounts and reimbursement issues. This would ensure consistent and accurate billing of our products at the pharmacies.
This request was reviewed by the Product Review and Billing Unit Exception TG on their conference call of December 12th. That task group felt that the billing unit/quantity is addressed in Section 4.2.1 of the Billing Unit Standard. Therefore, the products would be 60 eaches and 30 eaches respectively. The group felt that they could not respond to the questions regarding NDC numbers. Anne contacted Paula Martins and Edward McAdam, the submitters of the form and representatives from the manufacturer Daiichi Sankyo, regarding the Billing Unit determination, notified them that the QUIC forms would be presented to WG2 during the February 2009 meeting for adjudication, and invited them to attend. Paula attended and assisted with the discussion. Paula asked if a new separate NDC should be given because of the tablet to powder and the response was yes. Also, does a separate NDC go on the box versus the packets or is the same NDC on the box as the packets or just refer to the box-"total quantity of 60 contains each packet of NDC xxxxxxxxxxx"? Will this be on a hospital formulary? No. You would not want a different NDC on the packet that is on the bottle. Is the 3.75 gram and 1.875 gram the actual weight of the packet or the actual medication? This is weight of the content of the packets. Per the BUS: Powders, reconstituted to variable volumes and intended for a single oral or topical administration, must be billed as "eaches", not the number of boxes, packages, grams, or milliliters. This includes:
- packets of cholestyramine (Questran™; i.e. quantity 60 packets are billed as 60 EA),
- pouches of Moviprep™
- the individual 2 GM dose bottle of azithromycin (Zmax?) for reconstitution (i.e. quantity of 1 EA) and
- Thrombin that is a powder that is reconstituted for a one-time spray topical administration.
There are two packages for the different sizes. One has 60 and the other has 30. Technically, there are 4 11 digit NDCs here-two separate strengths at 60 and 30 each. Recommend the same NDC on the packet and box. A motion was moved and seconded that the packets have a separate core-9 NDC than the tablets for each strength. The motion carried without opposition. A motion was moved and seconded to assign a billing unit of eaches to each of those products. The motion carried without opposition. We recommend the same NDC is on the packet as on the box. HDMA will be recommending different NDCs on the packets and box. FDA is recommending different NDCs on the packets and the box (due to pedigree). We are recommending one NDC but there are other forces within the industry that would require 2 NDCs and the manufacturer should be aware of this.
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QUIC FORM 200417 - XOLAIR Resolution
Requested clarification for the billing unit quantity for XOLAIR NDC: Not assigned. We are considering new package configurations for our product Xolair. In the new packaging we would have two carton sizes described below:
1) Xolair 225mg carton will contain: 1- 150mg vial and 1- 75mg vial of Xolair
2) Xolair 375mg carton will contain: 2- 150mg vials and 1- 75mg vial of Xolair
Currently Genentech only markets the Xolair 150mg vial which is billed as a one each (not a kit).
Discussed at the November 2004 Meeting: It was noted that Genetech would like to launch a 75 mg unit with the 150 mg unit in a kit in order to minimize wastage and to not economically disadvantage the patient because it would be one claim with one co-pay. Outside of package shows as a kit not to be broken apart and will show one NDC. The NDCs on the inside will be different. Motion moved and a seconded to classify each product as a one based on the one NDC on the outside package and the recommendation that the manufacturer should indicate do not break on the outside package. Is this an exception to the standard? Karen read the definition of a kit from the BUS version 2.0, and it did not appear to be an exception. The motion carried.
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QUIC FORM 200507 - ZMAX Resolution
Requested clarification for the billing unit quantity for ZMAX. Discussion at August 2005 Meeting: This is a noninjectable powder for reconstitution. 60 mls of water is added but the final volume is not stated, but it is a single dose product. Final volume is 75 ml. One participant noted that this is strictly defined in the standard. This can be dispensed as a powder as well - there are specific instructions to the patient as to how to mix it. This can go out as a powder or a liquid. This is in a bottle rather than a packet. Pfizer prefers that it be an each. It was asked if this were dispensed by ml, what happens if you had the package before it is reconstituted? Reconstituted antibiotics are dispensed this way today - one would still bill it as 75 mls. The problem is that it does not show 75 on the package insert. Until this is indicated on the package, what do we use? It was noted again that this is clearly defined in the standard as dispensing by ml. Pfizer could in the interim send out a "Dear Pharmacist" letter and the compendia would have mls so that the pharmacist sees the dispensing by ml is correct. Right now, as of August 1st, all the compendia have as one each - changed before this discussion. It was asked if there would be value in supplying a unit of ml on the fact sheet. One attendee thought it would be better to have the final volume be on the bottle and/or box - additionally it should be on the package insert. There was a motion moved and seconded to make this ml - 75 - to follow the standard. If we do that, will there be information going out to the pharmacists that says this should be 75? Can we use a Dear Pharmacist letter - a letter to the pharmacists from Pfizer? When was the launch date of this product? Not sure of the lunch date but it was on payers' files from June 15-Aug 1st as ml. It was changed to each after August 1 and now we are recommending another change. Explicit dates and advanced warning is needed if we go to 75. Pfizer will need to contact the compendia and communicate to the pharmacies that there is a change and the date of change. The motion carried with two in opposition. The change to 75 ml needs to be coordinated with the notification to the pharmacies. Can we wait to get feedback from Pfizer before we make that decision? We will wait for word from Ross and the Co-chairs will make a decision of the change - it should be on the quarterly compendia updates based on rebates. The compendia will leave as is until we get word from Ross. All compendia would change on the same quarterly update. Ross has no idea at this time as to how long this will take. There was a motion moved and seconded to coordinate the change according to Pfizer's guidance - either the end of Sept/early October or end of December. The dropdead date is December and the compendia will make the change if they have not gotten what they need from Pfizer. NCPDP Now or News Flash article to tell when the date of change will occur. The motion carried with no opposition.
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QUIC FORM 200603 - ZMAX ( 2gm) NDC: 00069-4170-21 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. It is a antibiotic for reconstitution. It is a unit of use - single dose product. Pharmacist or patient may add the water. The final volume is not clinically relevant and should not be used. There is nothing on the carton that reflects 75 anywhere and the concern is confusion to the pharmacy on this if listed as 75. Is this on the Medicaid rebate program? David did not know---but most Medicaids use FDB and they have it as one each. This can be reconstituted by the patient - like powder in the vial. Nothing that says it has to be reconstituted as 75ml. Very clear from the packaging that the dose is 2 grams - should be marketed as a single dose. The labeling should be changed to indicate a single dose pack. Since the product was launch there have been no questions on the adjudication of this product. The packaging says one bottle per two grams. Tom Bizzaro noted that we have avoided using dose as a measure. Represented as 33 mg per ml in RxNorm. SPL has it as one. A motion was moved and seconded to approve as one each. If we approve this, we need to change the standard to allow this to happen - it is not a multi-component vial. Clarify 5.1.9 for the Powder Packets to single use products. As a pharmacist, it would make more sense to be as 2 grams. There is nothing on the label to show what you got---because there is nothing clear as to how much the final represents. Ross felt that it is important to make a change to the standard on this since this could be a sign of things to come. Are we saying, "Convenient packs of single dose products regardless of dosage form or packaging will be considered as one each"? Can take a lot of products that are grams and mls and put into the new category and that is a problem. Is this a new exception? There are products out there like this but you are just not really aware of them(dietary supplements) and we have forced them to fit the standard and end of with disasters. If it is written sufficiently, it should be ok. The exceptions are mainly the single unit of use - so if we word it correctly we might be able to clear up the exceptions. Could be "individual doses of powder" - something that doesn't address the container. Golytely is very similar too where is a bulk container that the patient reconstitutes and it is listed as ml. Wording will be tricky. One approach would be to say "Where final volume is not relevant" and to use as an example. Shouldn't be addressed that because it is convenient that it is an each. Must do some coordination with SPL - we have a how supplied quantity. SPL should have the same rules that the BUS has. The definition of gram is a weight and this is the strength. The packaging is confusing. Motion carried with one in opposition.
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