Standards QUIC Form Resolutions

At the November 2022 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
Request: 
According to the NCPDP Billing Unit Standard, Section 7.11, Antihemophilic Products are to be billed as an Each based on the number of micrograms or units dispensed.  The packaging for Sevenfact includes a vial with powder to be reconstituted, a syringe with Sterile Water for Injection as the diluent and a vial adapter.
Why Needed:
Clarification is needed to determine if Sevenfact is to be billed based on the number of micrograms dispensed or as 1 EA for each NDC dispensed..
Outcome Anticipated:
Determine the quantity dispensed for a prescription for Sevenfact and determine if a Frequently Asked Question (FAQ) is needed for this product for the WG2 Billing Unit Standard Document.
Task Group Discussion (08/23/22):

• Clarification of the Billing Unit Standard was needed to determine if Sevenfact is to be billed based on the number of micrograms dispensed or as 1 each (EA) for each NDC dispensed.
• The task group reviewed sections 5.1.7 and 4.2.1 of the billing unit standard and FAQ 7.11 and agreed that Sevenfact be billed as 1 each per section 4.2.1 of the BUS.
  • Sevenfact is a lyophilized powder for reconstitution in a single use vial
• The task group recommendation is to continue to list Sevenfact as 1 each per section 4.2.1 of the BUS.
• No changes or updates needed to the BUS.

Task Group Discussion (10/04/22):

• Sevenfact is to be billed as the number of micrograms (mcg) dispensed where 1 mcg = 1 each per section 5.1.7. This is similar to “Alpha-1 proteinase inhibitors (such as Prolastin) are billed as an each using the number of MILLIGRAMS dispensed (each; 1 MG = 1 EA)”. The same will be true for the antihemophilic products using micrograms (each; 1 MCG = 1 EA). Section 5.1.7 will be updated to include an example of antihemophilic products.
• Additionally, BUS FAQ 7.11 was reviewed “To ensure correct reimbursement and consistency among antihemophilic products, the price per unit has been identified per unit, international unit, or mcg. The billing unit for antihemophilic products is “EA,” as in the number of micrograms or units not as in the number of “kits.”  The billing unit is each (EA). The package size is “1” and the quantity dispensed/billed is the number of units or mcg dispensed”.
• The task group recommendation is to list the SevenFact as 1 microgram equals 1 each per BUS section 5.1.7 and FAQ 7.11.

WG Discussion (11/03/22):
A motion was made and seconded to classify the BU = EA and the quantity of 1 x the number micrograms dispensed per 5.1.7 and FAQ 7.11 of the Billing Unit Standard.
 

At the August 2022 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Verrica requests NCPDP’s assistance to determine consistent and accurate billing for the single use applicator that is applied to Molluscum Contagiosum lesions. Cantharidin is a Blistering Agent that is applied to the Molluscum Contagiosum lesions and contains a dye marker to aid in physician application. This pre-filled, single use applicator contains less than 1 mL but parts of the labeling are identified as 0.45 mL. We believe that the Compendia may identify this as a package size of 1 and billing unit of EACH but would like to confirm. 
Why Needed:
The artwork files identify the quantity as 0.47 ml, but the Billing Unit Standard (BUS) identifies products that contain less than one ML as each. This request is needed because the labeling would conflict with the anticipated outcome of the NCPDP BUS.
Outcome Anticipated:
The Billing Unit Standard identifies products that contain less than one ML as each, and a package size of 1. (5.2.1) + (5.1.12) Unit-Of-Use package/self-contained single dose packages that contain less than 1 mL or GRAM should be billed as “One EACH”.
Task Group Discussion (05/17/22):

• Agreement of a BU assignment of 1 EA x the number of single dose applicators supplied in the package per 5.2.1 and 5.1.12 of the BUS
  • Quantity will be 1 each on the single dose/unit-of-use applicator NDC 71349-070-01
  • Each applicator contains approximately 0.45mL cantharidin solution
  • Quantity for package 71349-070-06 will be 6 each
  • The package contains 6 single dose applicators and 2 break tools
  • Quantity for package 71349-070-12 will be 12 each
  • The package contains 12 single dose applicators and 2 break tools
  • The break tools will be ignored and not counted in the package count for billing purposes
  • The break tool is a proprietary tool for this product and is not useful for anything other than the administration of cantharidin solution
  • Verrica is correct in saying products that contain less than one mL and are unit-of-use self-contained single dose packages should be billed as 1 each per sections 5.2.1 and 5.1.12 of the billing unit standard 

WG Discussion (08/04/22):
A motion was made and seconded to classify the BU 1 EA x the number of single dose applicators supplied in the package per 5.2.1 and 5.1.12 of the BUS

At the February 2022 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Eli Lilly and Company (Lilly) requests NCPDP’s assistance to determine consistent and accurate billing for a forthcoming Refill Kit for diabetes supplies. Lilly would like to confirm that NCPDP’s kit definition would be applied to their Refill Kit and also requests insight on the billing quantity that would be assigned. The Refill Kit is expected to contain 100 test strips, 100 pen needles and 100 lancets.  Lilly’s Refill Kit is not meant to be broken; the pharmacy is to dispense the package as is.
Of note, Lilly also plans to simultaneously launch a diabetes supply Starter Kit. The Starter Kit will contain a blood glucose meter, digital device product, test strips, lancets, pen needles, a lancing device, and a welcome letter. 
Why Needed:
The request is needed to ensure that a consistent and accurate billing unit and quantity are submitted to the drug pricing compendia providers at the time of product launch. Lilly wishes to avoid pharmacy, provider and payer confusion as it relates to the dispense quantity for the Refill Kit and wants to be assured that the Starter Kit and Refill kit can be prescribed in a consistent manner, i.e., both as “1 each”.  Because this combination of diabetes testing supplies has rarely been packaged together into a single kit for listing in the drug pricing compendia, Lilly found few product analogues to use as comparators. Lilly also seeks any recommendations that will help prevent confusion for NCPDP members, industry stakeholders, and patients.
Outcome Anticipated:
Lilly anticipates that each Refill Kit will be billed as “1 each”.  
It is anticipated that NCPDP can also confirm that the Starter Kit will be billed as a “1 each”, meeting NCPDP’s definition of a kit.
Task Group Discussion (11/30/21):

• Agreement of a BU assignment of 300 each on the “refill kit” per 5.1.6 and 5.1.18 of the BUS
  • Individually each of these products are billed as each.
  • Needles and lancets are the product and not to be ignored in the package count.
  • Lilly is correct in saying that the “starter kit” is 1 each as per 5.5.1 of the BUS.

WG Discussion (02/02/22):
A motion was made and seconded to classify the BU = EA per 5.1.6 and 5.1.18 of the BUS with a package size of 300.
 

At the November 2021 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Enzyvant Therapeutics, Inc. is requesting clarification to ensure accuracy in billing amongst all Compendia, we are seeking NCPDP review Allogeneic Processed Thymus Tissue-AGDC is a biological source and the strengths are variable (5.1.7 – Billed as Each).
Why Needed:
Not all Thymic tissues may be used, and they are provided with sponges and filter screens we have a kit type scenario (5.5.1 – Billed as Each).
Outcome Anticipated:
Because both segments of the Billing Unit Standard equal EACH, we anticipate the outcome to reflect the billing unit of each and a package size of 1.
Task Group Discussion (10/19/21):

• Agreement of the assignment of BU = EA per section 5.1.7 of the BUS with a package quantity of 1 due to the variable strength, single-dose unit (72359-001-01).
  • RETHYMIC® is the first of its kind; one of the first regenerative therapies in that division.
  • Product is only available from one source (a surgery center) and is not available to wholesale, retail or specialty channels and is sent directly to the surgery center.
  • RETHYMIC® is single patient use.
  • Patient type is pediatric who are born without a thymus and is indicated for immune reconstitution of patients with congenital athymia.
  • This product is processed thymus tissue from healthy infants that have a cardiac surgery. Portions of the thymus gland is processed, and the tissue is stretched on filters and placed on sponges which are an inactive ingredient but are needed to process the tissue.
  • Each package contains a single NDC number that will encompass multiple slices per polystyrene dish which contains the filters and the sponges in a single-dose unit.
  • The sponges contain fetal bovine serum that helps in processing of the allogeneic tissue
  • The components are only for the processing of the product and are not used for the administration.
  • The product is already available and converting from clinical trial to approval.

WG Discussion (11/05/21):
A motion was made and seconded to classify the BU = EA per 5.1.7 of the BUS with a package size of 1 (72359-001-01).
 

At the August 2021 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
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 mL and to allow the NCPDP members to comment on the packaging label attached. Also attached is the RYLAZE™ package insert.

Why Needed:
This request is needed to confirm the billing unit standard. RYLAZE™’s has one carton containing 3 single dose vials. Each single dose vial contains 10 mg/0.5 mL asparaginase erwinia chrysanthemi (recombinant)-rywn. When replacing a long-acting asparaginase product, the recommended dosage of RYLAZE™ is 25 mg/m² administered intramuscularly every 48 hours.
Outcome Anticipated:
Jazz anticipates a BU= mL. This anticipated outcome is based on Section 5.2.2 (Dosage Forms Billed as “Milliliters) of the Billing Unit Standard.
Task Group Discussion (07/13/21):
Agreement of an assignment of BU = ML per 5.2.2 of BUS with a package size of .5 x number of vials dispensed. 1.5 mL for 3 vials (68727-900-03).
WG Discussion (08/04/21):
A motion was made and seconded to classify the BU = ML per 5.2.2 of BUS with a package size of .5 x number of vials dispensed. 1.5 mL for 3 vials (68727-900-03).

At the May 2021 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Takeda Pharmaceuticals is requesting confirmation from the NCPDP Billing Unit Standard on this product’s unit of measure would be ml. In addition, Takeda would welcome any additional considerations that should be taken for this packaging format.

• 1 Carton (64764-105-60) contains #60 Single-dose stick packs (64764-105-10)
• Artwork of the Carton and Single-dose stick packs have been included with submission

Why Needed:
Takeda anticipates a PDUFA sometime in April with product launch taking place shortly thereafter. Takeda would like to confirm the proper billing unit for this product and be advised of any recommended action that will help prevent confusion for NCPDP members, industry partners, and patients.
Outcome Anticipated:
Takeda anticipates a BU = ml which would mean one Carton has a billing unit quantity of 600 ml and one Single-dose stick pack has a billing unit quantity of 10 ml
Task Group Discussion (03/09/21):
Agreement of an assignment of BU = ML per 4.2.2 and 5.2.1 of the BUS with a package size of 10ml (64764-105-10) or 600ml (64764-105-60).
WG Discussion (05/03/21):
A motion was made and seconded to classify the BU = ML per 4.2.2 and 5.2.1 of the BUS with a package size of 10ml (64764-105-10) or 600ml (64764-105-60).
 

At the February 2021 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
We would like to verify that the billing unit would be each (pills) with a quantity of 24.  We do not believe this would be considered a kit.  The package contains two bottles of 12 pills each for a total of 24 pills.  Administration of two doses of SUTAB® (24 tablets) are required for a complete preparation for colonoscopy.  Twelve (12) pills are equivalent to one dose.  The package cannot be broken because all 24 tablets are required for a proper colon prep.
Why Needed:
This is a new product launch (approved 11/10/2020).  We want to confirm that our understanding of the billing unit is correct and that the package will not be broken.
Outcome Anticipated:
Billing unit of each, quantity of 24. Package cannot be broken.
Task Group Discussion (11/17/20):

• An expedited billing unit confirmation was requested via email in advance of the task group call. There was agreement from the compendia representatives of the task group co-leads’ recommendation of: BU = each and a Quantity = 24 based on BUS section 5.1.18.
• The task group agreed to BU = each and a Quantity = 24 based on BUS section 5.1.18.

WG Discussion (02/03/21):
A motion was made and seconded to classify the BU=Each for a quantity of 24 per Section 5.1.18 of the Billing Unit Standard. The motion carried.
 

At the November 2020 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
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 mLs per bottle and to allow NCPDP members to comment on this request.
Why Needed:
This request is needed to confirm the billing unit standard. 
Outcome Anticipated:
Jazz anticipates a billable unit of 1mL and 180 billable units per bottle.
Task Group Discussion (9/22/20):

• Product received FDA approval in July; planning to launch in the next month or so
• 1 commercial NDC
• Liquid; 180 mL in bottle
• Comes as a liquid; not reconstituted
• Recommendation: BU = mL; package size 180 per BUS Section 5.2.1
• Task group agreed with the recommendation

WG Discussion (11/04/20):
A motion was made and seconded to classify the BU=ML for a package size of 180 per Section 5.2.1 of the Billing Unit Standard. The motion carried.