Standards QUIC Form Resolutions

At the November 2017 WG2 meeting the form was discussed.
Requested: New Product/Package Information
QUIC Request:
Carton label review. Billing Unit and Package Size is needed for single use towelettes containing 2.4% topical solution. Carton contains 30, single use pouches, each containing a towelette in 2.8 grams of solution.
Why Needed:
Product packaging is unique. Clarification is needed on the Package Size and Billing Unit. Per NCPDP 5.1.12 “Unit-of-use packages or self-contained single dose packages with a quantity less than one milliliter or gram should be billed as “one each”. Per NCPDP 5.4.2 “Topical Products- These products must be billed as the number of grams (GM) or milliliters (ML) in the container.” However, each pouch contains a towelette with 2.8 grams of solution. Other single use towelette products with more than 1GM or 1ML of solution are listed in compendia as 1, each (reference NDCs 42192-0125-60, 42546-0016-60).
Anticipated Outcome:
Package Size: 30; Billing Unit: Each
Task Group Discussion (10/24/17):
Dosage form is a pre-saturated towelette
1 carton which contains 30 individually wrapped towelettes.
Task group agreed with recommendation of BU of each and a total quantity of 30.
Since the product doesn’t fit into section 5.1.12 of the BUS (2.8 grams of solution is greater than one gram), a FAQ will be drafted.
Work Group Discussion (11/8/17):
After the task group call, it was determined that Section 5.1.6 and 4.2.1 of the BUS applies. Has to do with how many towlettes you are counting since the towelette is the dosage form.
At this meeting, a motion was made and seconded to classify the BU=Each and total quantity of 30 per 5.1.6 and 4.2.1 of the BUS. The motion carried.
 

At the November 2017 WG2 meeting the form was discussed.
Requested: New Product/Package Information
QUIC Request:
The product is an insulin-type multi-dose insulin pen.  Typically, an insulin pen adheres to the NCPDP Billing Unit Standard as being billed in terms of mL dispensed. So, in this case 1.5mL for the first example, and 3.0mL for the second as that package will contain 2 pens per package. At issue, though is that disposable needles will be included in these packages, 6 and 4, respectively. Will this change the NCPDP Billing Unit from mL to kit?
Why Needed:
Several insulin pen-type products exist that are billed in terms of mL.
However, Example 7.25 in the NCPDP BU Guide suggest a product with a liquid, needles, and alcohol swabs becomes a “kit”, but no example exists for just product and needles. This product will NOT contain alcohol swabs.
Anticipated Outcome:
mL is expected.
Task Group Discussion (10/10/17):
Two separate NDC numbers; one for a 1 pen package and the other for a 2 pen package
The packaging will contain disposable needles but not swabs.
Patient self-administered
Since the needle is used in administration of the product, all agreed that the billing unit should be mL per 5.2.2 of the BUS. The 1 pen package = 1.5mL and the 2 pen package = 3.0mL
Work Group Discussion (11/8/17):
At this meeting, a motion was made and seconded to classify the BU=mL and the package size of 1.5mL (for 1 pen package) and 3.0mL (for 2 pen package) per 5.2.2 of the BUS. The motion carried.

At the November 2017 WG2 meeting the form was discussed.
Requested: New Product/Package Information
QUIC Request:
Carton label review to ensure that the proper Billing unit standard is established in order to minimize any billing issues 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 confirm assumption on maintaining the same unique NDC 11 for the outside box.
Why Needed:
We request the confirmation of the billing unit, Unit of Measurement (UOM) of Each carton/package per the NCPDP Billing Unit Standard, section 5.1.16.  This UOM designation will provide Intarcia with clarification on approaching the marketplace with accurate and clear billing information. We also request that the workgroup give us any additional comments on the carton/package presented.
Anticipated Outcome:
Confirmation of utilization of the Billing Unit -= Each carton/package  
Task Group Discussion (10/10/17):
The submitter provided additional information about the product:

NDC 65799-100-01 is for 2.6MG and NDC 65799-103-01 is for 14.1MG
The ITCA 650 is implanted subcutaneously in a physician’s office by a trained healthcare professional.
The same NDC will appear on the vial, the inner package and the outer package. The ITCA 650 is in a sealed glass jar which is in the inner package and then that is combined with the implant tool in the outer package. There is one unit of ITCA 650 in each outer box either 2.6 MG or 14.1 MG.

This is an implant and the device is used in the administration of the product so all agreed that the billing unit is 1 each but not a kit per 5.1.14 of BUS
Work Group Discussion (11/8/17):
At this meeting, a motion was made and seconded to classify the BU=Each (but not a kit) and the package size as 1 per BUS sections 5.1.14. The motion carried.
 

At the November 2017 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
QUIC Request:
Pending FDA approval for a frozen suspension of a genetically modified autologous T cell product supplied in one or more infusion bags labeled for a specific recipient.Product will be shipped directly to the cell lab associated with the infusion center in a liquid nitrogen Dewar.Product and patient specific labels are located in the Dewar.
Why Needed:
Product is recipient-specific.  Number of bags and volume in bags will vary by recipient.  Only 1 NDC will be associated with this product, therefore, a need to confirm a billing unit to account for a product based on variance in volume and number of bags (it is specifically manufactured on demand for each recipient). 
Anticipated Outcome:
A billing unit of each with a billing quantity of 1 will be assigned to product (BUS 5.1.7)
Task Group Discussion (8/29 & 30/17):
This form was reviewed by the Product Review and Billing Unit Exception Task Group on August 29, 2017 and agreement on the BU recommendation was reached via email on August 30, 2017.

The submitter was not available to answer questions during the August 29^th task group call so the QUIC form was deferred to the next task group meeting.

However, on August 30, 2017, FDA announced its approval of the product. Because of the product shipping shortly, the QUIC form was adjudicated via email.

The task group members agreed via email to: Billing Unit = Each; Quantity = 1 based on Section 5.1.7 of the Billing Unit Standard.
5.1.7 Products derived from biologic sources where the strength or the volume is variable from lot to lot shall be billed as “1” each. In the case where strength varies from lot-to-lot, the number of strength units shall be the package size. In the case where volume varies from lot-to-lot and the strength remains constant, the billing unit shall be “1” each per packaged product.
Work Group Discussion (11/8/17):
At this meeting, a motion was made and seconded classify the BU=Each and quantity of 1 per BUS section 5.1.7. The motion carried.
 

At the August 2017 WG2 meeting the form was discussed.
Requested: New Product/Package Information
QUIC Request:
AVXS -101 Gene therapy candidate proposed commercial product will have multiple SKUs that will be prepared and manufactured based on patient’s weight.The gene therapy will not be inventoried in the channel, but will be manufactured and prepared for a specific patient and sent to the requesting hospital for just in time administration via intravenous infusion.The goal is to have each SKU be considered an each with a NDC based on vector genome volume.The 50mL vial will be filled with the appropriate volume of vector genomes based on the patient’s weight.
Why Needed:
Establish billing unit and quantity for AVXS -101 with consideration that AVXS-101 is gene therapy that is prepared specifically for the patient when ordered based on the patient’s weight.  Each shelf keeping unit (SKU) will be supplied with an alcohol wipe.
Anticipated Outcome:
A billing unit of each (kit) with a billing quantity of 1 will be assigned for AVXS-101.
Task Group Discussion (7/18/17):
A billing unit of each (kit) with a billing quantity of 1 will be assigned for AVXS-101 per 5.5.1 of the Billing Unit Standard.
Work Group Discussion (8/4/17):
At this meeting, a motion was made and seconded to classify the BU=Each (Kit) and the package size of 1. The motion carried.
 

At the August 2017 WG2 meeting the form was discussed.
Requested: New Product/Package Information
QUIC Request:
Carton Label Review. Package Size and Billing Unit confirmation is needed for emergency epinephrine pre-filled syringes:
-Carton with NDC ending in -01 contains 1 pre-filled syringe, containing 0.8 ML for 1 single dose of 0.3 ML (0.3 MG/0.3 ML). Syringe contains overfill that cannot be reused.
-Carton with NDC ending in -02 contains 2 pre-filled syringes, each containing 0.8 ML for 2 single doses of 0.3 ML (0.3 MG/0.3 ML). Syringes contain overfill that cannot be reused.
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.
-Product is a pre-filled injector syringe, not an auto-injector like other emergency epinephrine products.
Anticipated Outcome:
Billing Unit = EA, Package size = 1 (for NDC ending in -01) and 2 (for NDC ending in -02)
Per BUS section: 4.3 & 5.6 Exceptions, “Epinephrine single dose injection devices (one EA)”
Per BUS section: 7.21 Why Are EpiPen and Twinject Exceptions?, “In 2009, the exception was broadened to include all epinephrine single dose injection devices.”
Task Group Discussion (6/20/17):
Billing Unit = EA, Package size = 1 and 2 as per BUS sections 4.3, 5.6, and 7.21.
Work Group Discussion (8/4/17):
At this meeting, a motion was made and seconded to classify the BU=Each and the package size as 1 (for NDC ending in -01) and 2 (for NDC ending in -02). The motion carried.
 

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.