Standards QUIC Form Resolutions

At the August 2017 WG2 meeting the form was discussed.
Requested: New Product/Package Information and FAQ Exception
Request:
Co-Packaged:
Box 1/2: (separated before shipment dry ice/kept in frozen conditions) 2 - 5ML cerliponase alfa vials and 1 - 5ML electrolyte for Intraventricular Injection.
Box 2/2: (Separated before shipment stored at room temperature/sterile conditions until administration)
Tubing/Cathether/Syringe (other) – Boxes combined prior to procedure and intraventricular procedural admin.
Why Needed:
Exception was approved: Product is only used by Physicians trained for administration, only during a procedure. Kit is co-packaged, separated during the shipment/storage (two different billing units) and re-kitted prior to the procedure/administration. This product is indicated for rare disease in pediatric patients. Request was needed due to anticipated billing issues and most importantly because implying that the package size was 15 would assume that the electrolyte & cerliponse could be combined at administration which would result in death.
Anticipated Outcome:
Committee would approve the exception, heavily document the justification as an FAQ so that other products do not compare their packaging to Brineura.
Task Group Discussion (5/23/17):

• On April 28, 2017, the billing unit and quantity was confirmed amongst the compendia via email as 15 ml per 5.2.9 of the BUS.
  • 5.2.9 For multi-component products whose components share the same billing unit, the total quantity for the product is the sum of the component sizes. For example, if a multi-component product contains 100 ML and 225 ML, the billing unit for the entire product is ML and the quantity is 325.

• A representative from BioMarin gave a presentation on the product at the May 23^rd task group meeting and requested an exception to the BUS.
• 2 vials drawn into a supplied syringe: one contains Cerliponase alfa and the other one contains an Electrolytes Solution. They are administered sequentially into an infusion pump system that must be purchased separately. Combining the two at time of administration could result in death.
• 2 boxes in a carton – one box contains the vials and the second box is the administration kit
• Transported and distributed frozen
• Hospital administration by trained clinician
• Covered by medical benefit and will be billed using HCPCS codes
• Limited pediatric population with rare disease who are primarily covered by Medicaid

• The task group agreed that a BU of a kit is appropriate for this product and an exception to the billing unit will be made because of its hospital administration and unique packaging.
• The primary reason for the exception is because of patient safety.

Work Group Discussion (8/4/17):
At this meeting, a motion was made and seconded to classify the BU=Each (Kit). The motion carried.
 

At the May 2017 WG2 meeting the form was discussed.
Requested: New Product/Package Information:
Request:
Jazz Pharmaceuticals is requesting confirmation from the NCPDP Billing Unit Standard that this product’s unit of measure (UOM) would be units per vial and to allow the NCPDP workgroup #2 attendees/members to comment on the packaging labeling attached.
Why Needed:
This request is needed to confirm the billing unit standard. The product is a lyophilized powder and is reconstituted (with 19mL’s of solution) prior to administration (infusion or injection). The item contains 100mg of Cytarabine and 44mg of daunorubicin but it is a combined dosage so the billing unit should not be for each drug but for the 100 units per vial to prevent confusion. These are single use vials sold in a 2-pack and a 5-pack. Individual vials are not commercially sold.
Anticipated Outcome:
Jazz anticipates the billing unit as 100 units per vial and that there are no concerns with the package labeling.
Task Group Discussion (04/18/17): The task group recommends a billing unit of each and a quantity based upon the amount of the package dispensed per 5.1.2 of the Billing Unit Standard.
Work Group Discussion:
At this meeting, a motion was made and seconded to classify the BU=each with a quantity based upon the amount of the package dispensed. The motion carried without opposition.

At the November 2016 WG2 meeting the form was discussed.
Requested: New Product /Package Information:
Request: Carton Label Review. Package Size and Billing Unit confirmation is needed for prefilled pens.
a.) The carton contains 2 prefilled pens, both containing 3 ML (100 MCG/ML) for 14 doses of 20 MCG.
b.) The carton contains 2 prefilled pens, one pen containing 3 ML (50 MCG/ML) for 14 doses of 10 MCG; and one pen containing 3 ML (100 MCG/ML) for 14 doses of 20 MCG
Why Needed: Package Size and Billing Unit are not clearly detailed on the carton labeling. Clarification is needed on the Package Size and Billing Unit.
Anticipated Outcome: Billing Unit = ML, Package Size = 6. (per BUS section: 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. 
Task Group Discussion (08/30/16): The task group recommends a billing unit of mL and a total quantity of 6 per 5.2.2 of the Billing Unit Standard. For the starter kit, 5.2.9 of the Billing Unit Standard applies as well.
Work Group Discussion: At this meeting, a motion was made and seconded to classify the BU=mL with a quantity of 6. The motion carried without opposition.

At the November 2016 WG2 meeting the form was discussed.
Requested: New Product /Package Information:
Request: Carton Label Review. Package Size and Billing Unit confirmation is needed for prefilled pens.
a.) The carton contains 5 x 3ml prefilled pens for doses from 10 to 40 Units
b.) The carton contains 5 x 3ml prefilled pens for doses from 30 to 60 Units
Why Needed: Package Size and Billing Unit are not clearly detailed on the carton labeling. Clarification is needed on the Package Size and Billing Unit.
Anticipated Outcome: Billing Unit = ML, Package Size = 15. (per BUS section: 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). 
Task Group Discussion (08/30/16): The task group recommends a billing unit of mL and a total quantity of 15 per 5.2.2 of the Billing Unit Standard.
Work Group Discussion: The submitter explained the QUIC from was submitted because 15 is not a package size listed anywhere on the labeling. The manufacturer had the number of doses as the package size on the label and not the actual quantity of the pre-filled syringes. The next round of production will include a labeling change to list five 3ml pens for a total quantity of 15.
At this meeting, a motion was made and seconded to classify the BU=mL with a quantity of 15. The motion carried without opposition.

Requested: Clarification of Billing Unit Standard
Request: To clarify the Billing Unit for PROSTASCINT® Kit for the Preparation of Indium In 111 Capromab Pendetide (NDC 57902-0817-01).  This kit contains 1 vial ProstaScint® (capromab pendetide) 0.5mg/mL (1mL); 1 vial Sodium Acetate Buffer Solution 0.5M (2mL); 1 Millex® GV Filter (0.22μm); and 1 Package insert with two identification labels.  This kit does not contain a radiopharmaceutical. 
Why Needed: To ensure consistency in billing this product with all compendia.   According to the Billing Unit Standard, ProstaScint® is not considered a Kit for billing purposes (section 5.5.1) and should not be billed as a radiopharmaceutical (section 7.39).
Anticipated Outcome: ProstaScint® should be billed as the total number of milliliters in the two vials, based on sections 5.2.2 and 5.2.9 of the Billing Unit Standard.
“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...” 
“5.2.9:  For multi-component products whose components share the same billing unit, the total quantity for the product is the sum of the component sizes. For example, if a multi-component product contains 100 ML and 225 ML, the billing unit for the entire product is ML and the quantity is 325.” 
Discussion:
This form was reviewed by the Product Review and Billing Unit Exception Task Group on July 12, 2016.
It was agreed that the billing unit is ML with a quantity of 3 per 5.2.2 and 5.2.9 of the Billing Unit Standard. There will need to be a coordinated effort amongst the compendia to change the billing unit from EA to ML. Recommending the change to occur for Quarter 3 of 2016; the compendia should change on whatever date is the quarterly update date (last week of September or first week of October)

This form was reviewed by WG2 as part of the agenda of the August Work Group meeting on Wednesday, August 3, 2016.
Anne mentioned the checklist will be followed for this billing unit change.
 
NDC 57902-0817-01 (Aytu Bioscience) was reported by the FDA as having a billing unit discrepancy (EA vs ML) amongst the Compendia after a new SPL Billing Unit Index file was generated. This QUIC form was a result of the Compendia’s review of this product on the discrepancy list. It was listed as 1 each because one of the compendia had entered it as a kit. However, it is not a kit according to the Billing Unit Standard since there is 1 vial with 1ml and another vial with 2ml and nothing else in that box makes it a kit by definition. The components have the same billing unit and no alcohol wipes so therefore you add up the total number of milliliters and it is billing unit of ML.
 
According to a representative of Jazz Pharmaceutical, which sold the water base product to Aytu, this product has to be combined with a radiopharmaceutical piece and cannot be used by itself. However, the product information says it contains no radiopharmaceutical. Because the combined product is a diagnostic it is not a rebateable product and is most likely billed with a procedure code, not a NDC. This NDC number will probably never come through on a pharmacy claim by itself.
 
A member asked why this product is being treated differently than other kits to which a radioactive is added. Anne explained it is different because the others came to us with the radio pharmaceutical under the same NDC. The others had two different billing units for the active ingredient (powder) and the diluent as a liquid. The two different billing units make it a kit. Also, because it is radioactive the strength is a variant. And whenever the strength varies, you dispense it as 1. According to the description on DailyMed, it consists of 2 vials which contain all the non-radioactive ingredients necessary to produce the single unit dose.  Based on the fact that this product did not contain any radioactive component, it did not meet the criteria for billing unit of each/kit.
 
From a practical standpoint, by adjudicating this as ML it maintains the integrity of the standard. 
 
At this meeting, a motion was made and seconded to classify the BU=mL with a quantity of 3. The motion carried with one in opposition.

Requested: Clarification of Billing Unit Standard and New Product/Package Information
Request: NCPDP has previously incorrectly assigned a 5.0g packaging as the unit measure for the pricing compendia and wholesalers to list in their data banks.  The product is packaged in a prefilled applicator containing a net weight of 5.8g prominently displayed on the FDA approved outer carton and also listed in the package insert.
Why Needed: CMS has sent documentation to Perrigo which states the requirement to have the package unit of measure corrected for all NDC’s effected for both price reporting and reimbursement. Our patients have been denied access to our product on numerous occasions by payors and pharmacies.Mass confusion at the wholesaler/chain ordering levels.Product is disadvantaged to competitors when broken down by unit pricing.
Anticipated Outcome: Uniform package size listing of 5.8g for all NDC’s
Discussion:
This form was reviewed by WG2 as part of the agenda of the May Work Group meeting on Sunday, May 1, 2016.
Clindesse and Gynazole-1 were reviewed in August 2015 by WG2 under QUIC forms 201516 and 201517 after review by the WG2 Product Review and BU Exceptions TG on July 28, 2015. The TG reviewed because when adding the new NDC 45802004201 as 5 gm per the Billing Unit Standard, existing product billing units did no match. While the TG agreed the correct BU on these products is 5 gm, changing the billing unit of existing product posed a concern as to industry impact. Even though preliminary claim data on NDC 64011012408 showed some but not significant usage, it was agreed the BU=5 gm on the active NDCs 64011024601 (Gynazole) and 45802004201 (Clindesse) and on any new products released in the future per FAQ 7.34 of the BUS. To minimize disruption in the market place, the older products for Clindesse (NDCs 21695085805 and 64011012408) and Gynazole (NDCs 54868483800, 64011000108 and 54569545200) with obsolete dates would not change billing units and would remain with a billing unit of 5.8 grams. This recommendation applied to QUIC form #201516 for Clindesse and QUIC form #201517 for Gynazole. WG2 agreed with the recommendation of the TG. After the WG2 meeting the compendia coordinated the effective date of change to be August 20, 2015.
 
A representative of Perrigo was present at this meeting and stated CMS (Medicaid) said to change the billing unit back to 5.8 gm. He also stated patients were denied access because the product couldn’t be found.
 
The package states the applicator contains 5.8 but only delivers about 5.0. Their best price to CMS was 1 gm X 5.8 gm. One attendee noted that CMS (Med B & Med D) won’t pay for overfill. It was asked if competitors are submitting it one way and Perrigo is asked to do it differently. Both products are single source and listed as 5.0 per Walgreens, CVS, and Express Scripts.  Other same drugs are multi-dose, not single dose.
 
In July 2015, the TG pulled all the labels.  The new NDC was 5.0 and previous NDC’s were 5.8.  New label has 5.0 and 5.8.  It was suggested the manufacturer remove the reference to 5.0 grams from the package – that is what is causing the issue.  Per the Billing Unit Standard only the deliverable amount is counted.
 
It was recommended that the discussion be tabled and the QUIC form be added to the agenda for the next Product Review and Billing Unit Exception Task Group meeting on May 17^th. The QUIC form was submitted right before Work Group and the Task Group did not have an opportunity to review and research.
 
This form was reviewed by the Product Review and Billing Unit Exception Task Group on May 31, 2016.  The billing unit established for the active NDC’s (Gynazole 45802-0396-01 and Clindesse 45802-0042-01) will not change from 5.0 to 5.8.  The Billing Unit Standard was applied and per 7.34 of the Standard any overfill will not be included in the billing unit.  As long as the labeling indicates that 5.0 is delivered, we have to adhere to the Billing Unit Standard.
 
During the Product Review and Billing Unit Exception Task Group on July 12, 2016, the Compendia entities, which had changed the billing unit from 5.8 to 5.0 on the NDC’s with 2016 last lot dates (Gynazole 64011-0246-01 and Clindesse 64011-0124-08), agreed to change them back to 5.8 so there is consistency across the Compendia.  Also, when these products were initially reviewed it was agreed that the change to 5.0 would only occur for active products.
 
This form was reviewed by WG2 as part of the agenda of the August Work Group meeting on Wednesday, August 3, 2016.
A member asked whether there has been a change to the package. The package indicates 5.8 grams with a delivery of 5 grams. We have communicated to the manufacturer that the only way the billing unit will change is if the package is changed to remove the reference to the delivery of 5.0 grams. As of now, they have not changed the package. 
 
There was a request to clarify what the motion for the vote was for since the pended QUIC forms are a request to change all NDC’s to 5.8 grams. Although the QUIC form requests uniform package listing for all NDC numbers, we are not able to do that if there is overfill stated on the label. In that case, the package size needs to be 5.0 to reflect the amount delivered. 
 
The QUIC forms were pended at the May Work Group meeting because a request was made to confirm that all the Compendia had updated their files to the same amount based on the QUIC forms from 2015. It was confirmed as part of the WG2 Product Review and Billing Unit Exceptions task group that all of the compendia have a billing unit of 5 grams for the active NDC numbers. We are not going back on the old obsolete NDCs and changing them to 5 grams. We are adjudicating the current QUIC forms as 5 grams for the active NDC numbers because the label indicates the amount delivered is 5 grams and per the Billing Unit Standard it should be 5 grams.
 
At this meeting, a motion was made and seconded to keep the BU=GM with a quantity of 5. The motion carried without opposition.

Requested: Clarification of Billing Unit Standard and New Product/Package Information
Request: NCPDP has previously incorrectly assigned a 5.0g packaging as the unit measure for the pricing compendia and wholesalers to list in their data banks.  The product is packaged in a prefilled applicator containing a net weight of 5.8g prominently displayed on the FDA approved outer carton and also listed in the package insert.
Why Needed: CMS has sent documentation to Perrigo which states the requirement to have the package unit of measure corrected for all NDC’s effected for both price reporting and reimbursement. Our patients have been denied access to our product on numerous occasions by payors and pharmacies.Mass confusion at the wholesaler/chain ordering levels.Product is disadvantaged to competitors when broken down by unit pricing.
Anticipated Outcome: Uniform package size listing of 5.8g for all NDC’s
Discussion:
This form was reviewed by WG2 as part of the agenda of the May Work Group meeting on Sunday, May 1, 2016.
Clindesse and Gynazole-1 were reviewed in August 2015 by WG2 under QUIC forms 201516 and 201517 after review by the WG2 Product Review and BU Exceptions TG on July 28, 2015. The TG reviewed because when adding the new NDC 45802004201 as 5 gm per the Billing Unit Standard, existing product billing units did no match. While the TG agreed the correct BU on these products is 5 gm, changing the billing unit of existing product posed a concern as to industry impact. Even though preliminary claim data on NDC 64011012408 showed some but not significant usage, it was agreed the BU=5 gm on the active NDCs 64011024601 (Gynazole) and 45802004201 (Clindesse) and on any new products released in the future per FAQ 7.34 of the BUS. To minimize disruption in the market place, the older products for Clindesse (NDCs 21695085805 and 64011012408) and Gynazole (NDCs 54868483800, 64011000108 and 54569545200) with obsolete dates would not change billing units and would remain with a billing unit of 5.8 grams. This recommendation applied to QUIC form #201516 for Clindesse and QUIC form #201517 for Gynazole. WG2 agreed with the recommendation of the TG. After the WG2 meeting the compendia coordinated the effective date of change to be August 20, 2015.
 
A representative of Perrigo was present at this meeting and stated CMS (Medicaid) said to change the billing unit back to 5.8 gm. He also stated patients were denied access because the product couldn’t be found.
 
The package states the applicator contains 5.8 but only delivers about 5.0. Their best price to CMS was 1 gm X 5.8 gm. One attendee noted that CMS (Med B & Med D) won’t pay for overfill. It was asked if competitors are submitting it one way and Perrigo is asked to do it differently. Both products are single source and listed as 5.0 per Walgreens, CVS, and Express Scripts.  Other same drugs are multi-dose, not single dose.
 
In July 2015, the TG pulled all the labels.  The new NDC was 5.0 and previous NDC’s were 5.8.  New label has 5.0 and 5.8.  It was suggested the manufacturer remove the reference to 5.0 grams from the package – that is what is causing the issue.  Per the Billing Unit Standard only the deliverable amount is counted.
 
It was recommended that the discussion be tabled and the QUIC form be added to the agenda for the next Product Review and Billing Unit Exception Task Group meeting on May 17^th. The QUIC form was submitted right before Work Group and the Task Group did not have an opportunity to review and research.
 
This form was reviewed by the Product Review and Billing Unit Exception Task Group on May 31, 2016.  The billing unit established for the active NDC’s (Gynazole 45802-0396-01 and Clindesse 45802-0042-01) will not change from 5.0 to 5.8.  The Billing Unit Standard was applied and per 7.34 of the Standard any overfill will not be included in the billing unit.  As long as the labeling indicates that 5.0 is delivered, we have to adhere to the Billing Unit Standard.
 
During the Product Review and Billing Unit Exception Task Group on July 12, 2016, the Compendia entities, which had changed the billing unit from 5.8 to 5.0 on the NDC’s with 2016 last lot dates (Gynazole 64011-0246-01 and Clindesse 64011-0124-08), agreed to change them back to 5.8 so there is consistency across the Compendia.  Also, when these products were initially reviewed it was agreed that the change to 5.0 would only occur for active products.
 
This form was reviewed by WG2 as part of the agenda of the August Work Group meeting on Wednesday, August 3, 2016.
A member asked whether there has been a change to the package. The package indicates 5.8 grams with a delivery of 5 grams. We have communicated to the manufacturer that the only way the billing unit will change is if the package is changed to remove the reference to the delivery of 5.0 grams. As of now, they have not changed the package. 
 
There was a request to clarify what the motion for the vote was for since the pended QUIC forms are a request to change all NDC’s to 5.8 grams. Although the QUIC form requests uniform package listing for all NDC numbers, we are not able to do that if there is overfill stated on the label. In that case, the package size needs to be 5.0 to reflect the amount delivered. 
 
The QUIC forms were pended at the May Work Group meeting because a request was made to confirm that all the Compendia had updated their files to the same amount based on the QUIC forms from 2015. It was confirmed as part of the WG2 Product Review and Billing Unit Exceptions task group that all of the compendia have a billing unit of 5 grams for the active NDC numbers. We are not going back on the old obsolete NDCs and changing them to 5 grams. We are adjudicating the current QUIC forms as 5 grams for the active NDC numbers because the label indicates the amount delivered is 5 grams and per the Billing Unit Standard it should be 5 grams.
 
At this meeting, a motion was made and seconded to keep the BU=GM with a quantity of 5. The motion carried without opposition.

At the May 2016 WG2 meeting the form was discussed.
Requested: New Product /Package Information:
Request: This is a non-resin product pending FDA approval for the treatment of hyperkalemia. The unit of use is a one-dose oral powder packet to be suspended in water. Amounts of water can be variable.
Why Needed: Need a uniform unit of measure for compendia and Medicaid use.
Anticipated Outcome: I believe the unit of measure should be an each. Per the Implementation Guide v3.1 (7/31/15), Section 4.2.1 Billing Unit of “Each” (EA) includes oral powder packets as a category billed as eaches. Section 5.1.8 states that “Powders, reconstituted to variable volumes and intended for single oral or topical administration, must be billed as “eaches”, not the number of boxes, packages, grams, or milliliters” and 5.3.3 Dosage Forms Billed As “Grams” (GM) states “if the powder is manufactured for a single oral administration (i.e. in a “packet”) the billing unit is ‘each’.” It also refers to Section 5.1.17, which states “If the volume or weight cannot be determined for a product, it will be billed as “one each”.
Discussion: This form was reviewed by the WG2 Product Review and BU Exceptions TG on their call of April 19, 2016. Cynthia Foy of ZS Pharma and Alisha Nielsen of Two Labs Marketing were on the call to answer questions. The product has not been approved yet so there is no labeling. It will launch sometime in the summer. The powder is added to water and patient drinks it. There is a recommended amount of water but it can vary. Product comes in 5 gram and 10 grams. There are 30 packets per box. There are different NDCs on the packet and on the box. Same core-9NDC except one on packet ends in 01 and one on box ends in 30. The Billing Unit Standard was reviewed and all agreed the BU=EACH with a quantity of 30 per Section 5.1.8.
At this meeting, a motion was made and seconded to classify the BU = each with a quantity of 30 per Section 5.1.8 of the BUS. The motion carried without opposition.