Standards QUIC Form Resolutions

At the May 2018 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
Request:
Product contains two bottles: 1 bottle contains vancomycin powder for oral solution. The other bottle contains a flavored liquid diluent to reconstitute the powder (by the pharmacy). Powder bottle for dispensing is labeled as “150 ml final volume after reconstitution”. (there is also a 300ml as dispensed product). The outer box labeling states “…Powder for Oral Solution Kit”, also listing the contents of the two bottles.
Why Needed:
To determine if this product falls into a “1 each” kit category (2 different billing units 5.5.1) or total number of milliliters (150ml and 300ml) after constitution as dispensed (Diluents are ignored 5.1.16 and dispensing oral constituted products 5.2.3).
Anticipated Outcome:
TBD but likely MLs
Task Group Discussion (2/13/18):
The representative from the manufacturer noted there are 3 additional NDC numbers. All four NDC’s have different NDC 9’s (this is atypical; may get questions from CMS Drug Rebate program).
This is similar to an antibiotic where sterile water is added except with this product it is a flavored diluent instead of sterile water.
It is a single dose – one per patient. It goes to the patient already reconstituted.
It was noted that the PI doesn’t list the total volume in the How Supplied section. However the total volume is noted in a table under Dosage & Administration. People will use what is listed on the front of the bottle to look up the product in drug databases.
Task group agreed to BU = mL; the total quantity will be the deliverable of 150 or 300 per 5.2.3 of the BUS.
WG Discussion (05/07/18):
At this meeting, a motion was made and seconded to classify the BU=mL and the total quantity as the deliverable of either 150 or 300 per 5.2.3 of the BUS. The motion carried.

At the May 2018 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
Request:
Noctiva Nasal spray is labeled as “each spray contains 0.1ml, net content 3.8g or 30 doses”.
Why Needed:
To ensure consistency across compendia
Anticipated Outcome:
BU = GM and Pack size = 3.8 per 5.4.1
TG Discussion (2/13/18):
It is a special formulation nasal inhaler introduced a couple of weeks ago.
There may be confusion because both mL and gram are on the package. However, the full volume is 3.8g so the BU is grams. “Each spray contains 0.1mL” on the package is not a statement of package size.
TG agreed with BU = GM and package size = 3.8 per 5.4.1 of the BUS.
WG Discussion (05/07/18):
At this meeting, a motion was made and seconded to classify the BU=GM and a package size of 3.8 per BUS section 5.4.1. The motion carried.
 

At the November 2018 WG2 meeting the form was revised. 
Requested:  Clarification of Billing Unit Standard
QUIC Request:
Carton label review. Billing Unit and Package Size is needed for package that consists of:
- 28 single use vials, each containing 8.9 MLs, delivering 8.4 MLs of inhalation suspension
- 1 lead-free cloth
- 1 handset
- 4 aerosol heads
Why Needed:
Product packaging is unique. Clarification is needed on the Package Size and Billing Unit.
Anticipated Outcome:
Billing Unit: EA; Package Size: 1. Per section 5.5.1 Kits – Billed As An “Each”. This kit is defined as “One product packaged with medicated or unmedicated swabs, wipes, and/or cotton swabs/balls”.
Task Group Discussion (1/16/18):
The submitter provided the following additional information:
- Within the outer carton, ther are 4 inner cartons – one for each week
- There is no package size on the labeling; the contents are listed (as indicated above)
- Aerosol heads go on the handset
- Everything but the cloth is used in the administration of the product
- Have to order separately the nebulizer unit that connects to handset
- Vial label states each vial contains 590 mg
- The outer carton (dispensable unit) has an outer NDC – the one to use for billing
- There is an inner NDC for the weekly boxes and a NDC on the vial
- The volume will be a range
Discussion:
- Overfill situation – delivers 8.4 but contains 8.9mls; varies by vial – vials only marked as single use
- Would like to see the mL on the label; BUS addresses the nebulizers
- Without mL has to fall to number of eaches
- Swabs, wipes, etc. are counted if being used directly on the patient but not counted if used on equipment
- The task group agreed to BU = each and to count the number of vials for the quantity per BUS sections 5.1.17 and 5.2.8.For the box, it is quantity of 28; if only dispense week 1, then the quantity will be 7.
Work Group Discussion (2/2/18):
At this meeting, a motion was made and seconded to classify the BU=Each and count the number of vials for the total quantity as per sections 5.1.17 and 5.2.8 of the BUS. The motion carried.
Task Group Discussion (10/23/18):
Rereview of this form came up as a result of discrepancy between compendia listing
need to revise existing QUIC Form. Compendia would like to change to BU=mL and PS=8.4mL x 28 due to label and per section 5.2.4 of the BUS.
TG agrees to BU=mL and PS=8.4mL x 28 for Arikayce Inhalation Suspension per section 5.2.4 of the BUS. TG will also revise this QUIC form’s resolution and name on website. 
Work Group Discussion (11/8/18):
At this meeting, a motion was made and seconded to revise this QUIC Form to classify BU=mL and PS=8.4mL x 28 for Arikayce Inhalation Suspension per section 5.2.4 of the BUS. TG will also revise this QUIC form’s resolution and name on website. The motion carried.
 

At the February 2018 WG2 meeting the form was discussed.
Requested: New Product/Package Information
QUIC Request:
The goal of the request to accurately add RELiZORB to the NCPDP listing. Relizorb is a first of its kind digestive enzyme cartridge indicated for patients 5 years and above to hydrolyze fats in enteral formula. Pharmacists would not be breaking down into individual cartridges. Off label utilization is not a concern as product is designed with EnFit connections so can only be utilized in the enteral feeding process. The active ingredient in RELiZORB is Lipase digestive enzyme.
Why Needed:
There are currently over 1600 patients utilizing ReLIZORB. Claims for RELiZORB can be adjudicated on both pharmacy and medical benefit sides of insurance plans so an accurate description is required in order to avoid billing errors.
Anticipated Outcome:
List RELiZORB with its NDC number and billing unit as 1 box of 30 cartridges.
Task Group Discussion (1/16/18):
Background: Task Group Lead determined the product has been on the drug databases for 18 months with a BU = each and a quantity of 30. The submitter marked the product as new on the QUIC form because they were under the belief that REliZORB was not listed in the compendia as per a provider that was working on claims indicated. Submitter provided documentation of pediatric label for ages 5 and above which they received in July of 2017.
- This is not a kit and doesn’t fit as a non-drug entity
- Product fits into BUS section 5.1.17 (If the volume or weight cannot be determined fNon-injectable Liquid Dosage Forms
- Since the volume can’t be determined, count the cartridges in the box
- Task Group agreed to a BU = Each and quantity of 30
Work Group Discussion (2/2/18):
At this meeting, a motion was made and seconded to classify the BU=Each and total quantity of 30 per 5.1.17 of the BUS. The motion carried.

At the February 2018 WG2 meeting the form was discussed.
Requested: New Product/Package Information
QUIC Request:
Abilify Mycite comes in 6 tablet strengths, all w/the same package configuration: 30 tablets of aripiprazole (Abilify) and 7 patches (Mycite). Each tablet contains an IEM sensor (Ingestible Event Marker). The patch is a non-drug sensor that detects the tablet’s signal. A smartphone application is used to give the patient information. The product’s intent is to track drug ingestion.
Why Needed:
To determine whether the patches are counted in the final package size: The patches cannot be used without the tablets (they are not sold separately under a different NDC). At the same time, the tablets contain the drug and have therapeutic use but there’s no need for this particular type of tablet without the patch.
Anticipated Outcome:
Billing Unit of EACH and package size of 37.  (BUS section 5.1.18)
Task Group Discussion (12/19/17 and 1/16/18):
- What happens when the patches are used up before the tablets are? Will they ever sell just the Mycite patches? To date, there isn’t a separate product.
- Initial thought was to count 30 tablets and the 7 patches.
- The patches are what make Abilify Mycite different from Abilify. Abilify Mycite has the IEM sensor in the tablet. (FDA has assigned a new dosage form). Product is only viable with the patch.
- Unofficial images of the product on the Internet are of a box which only mentions 30 tablets and no mention of the 7 patches.
- Need to see the manufacturer’s final label before a determination is made.If it doesn’t mention patches then it will be PS = 30; with mention of patches then the PS will be 37.
- A representative from Ostuka was on the call and provided the following information:
- 30 day supply of pills
- 7 patches because anticipate a single patch being good for for about a week; additional patches are provided. In future may see less patches once technology improves.
- Outside labeling does not mention the patches; only lists the tablets with sensor
- Don’t plan to sell the patches separately from the tablets
- Don’t anticipate placing number of patches on the labeling because that number could reduce and may not need to use all of them (definitely will use 3-4 but may need extra). Confident 7 is enough to cover them for the 30 days but may not need to use all 7.
- Task Group agreed to a Billing Unit of EA with a quantity = 30 and recommends drafting a FAQ to address technology and other devices packaged with consumable drug product.
Work Group Discussion (2/2/18):
At this meeting, a motion was made and seconded to classify the BU=Each and total quantity of 30 per 5.1.6 of the BUS. The motion carried. A FAQ will be drafted to address technology and other devices packaged with consumable drug product

At the February 2018 WG2 meeting the form was discussed.
Requested: New Product/Package Information
QUIC Request:
The starter pack contains 30 tabs of Cyclobenzaprine, 1- TNS unit and 20- (10 pair) electrode pads for the TENS unit. The refill pack contains 30 tabs of Cyclobenzaprine and 20- (10 pairs) electrode pads. All items, by themselves would be counted as eaches so it is likely not considered an NCPDP kit (5.5.1) and more likely considered total number of eaches (5.1.16 and 5.1.6).
Why Needed:
1)The main components to the starter pack are the tablets and the TNS device. The device requires the electrodes to work properly. Is an electrode pad a part that is counted or is it considered a delivery component? Delivery components are excluded from being counted in the standard.
2) If the electrodes are not counted in the starter pack, how is the refill pack counted? (30 tablets + 20 Electrode pads).
Anticipated Outcome:
Unsure. If the electrode is considered a countable component, for the starter pack, the result would likely be a BU = EA and Pack size of 51 (per 5.1.18). If the electrode is not counted, for the starter pack, the result would likely be a BU = EA and Pack Size of 30 (per 5.1.6 and 5.1.16).
(The same situation on the refill: electrodes counted= the BU = EA, PS = 50; if not counted BU = EA, PS = 30.)
Task Group Discussion (12/19/17):
- The compendia previously decided via email to count the tablets, TNS unit, and the electrodes to determine the package size.
- The starter pack has tablets with an active ingredient. Count the tablets and the device; don’t care about electrodes or other components.
- Task Group Recommendation: BU = EA; PS for Starter Kit is 31 (30 tablets + 1 TNS unit); PS for refill pack is 30 (tablets).
- Need coordination of change to PS from 51 to 31 for the Starter Kit and 50 to 30 for the Refill Kit on February 1^st. (Revisit date if there is a delay in identifying other products). Would like it included for monthly delivery of compendia file. Note: Change was delayed.
- A FAQ will be drafted to support how to determine the BU for TENS devices with and without drugs.
Work Group Discussion (2/2/18):
At this meeting, a motion was made and seconded to classify the BU=Each and a package size of 31 (30 tablets + 1 TNS unit) for the starter kit and a package size of 30 (tablets) for the refill pack. The motion carried. A FAQ will be drafted to support how to determine the BU for TENS devices with and without drugs.
 

At the February 2018 WG2 meeting the form was discussed.
Requested: New Product/Package Information
QUIC Request:
This product contains a Cefaly device (nerve stimulator), a Cefaly electrode, and assorted other items that would not normally be counted as part of a kit (storage box, power adaptor, instructions.
Why Needed:
The product is a device. It requires the electrode to work properly but the main product is the nerve stimulator device. Is the electrode a part that is counted or considered a delivery component? Delivery components are excluded from being counted in the standard.
Anticipated Outcome:
Unsure. If the electrode is considered a countable component the result would likely be a BU = EA and Pack size of 2 (per 5.1.18). If the electrode is not counted, the result would likely be a BU = EA and Pack Size of 1 (per 5.1.6 and 5.1.16).
Task Group Discussion (12/19/17):
- These are devices which make them non-drug. Propose BU = Each with package size of 1.
- How to count what is in a kit when there is no drug? This is a machine.
- After eliminating the storage box, power adaptor and cable, and the instruction manual, left with the device and the electrodes. The task group agreed to not count electrodes since they are administration stuff.
- Count as 1 similar to diabetic testing systems.
- As pharmacist dispensing, first inclination would be 1.
-Task Group Recommendation: BU = Each. Package size of 1. A FAQ will be drafted to support how to determine the BU for TENS devices with and without drugs
- FAQ for how to determine the BU for TENS devices with and without drugs
- For devices that do not contain an active drug component and the package has multiple distinct items that are not active drug components then count as 1.
- Jenny B. will consult with Karen E. about the wording of the FAQ
- Coordination of change for Cefaly from 2 PS to 1 PS on February 1^st. (Revisit date if there is a delay in identifying other products). Would like it included for monthly delivery of compendia file. Note: Change was delayed.
Work Group Discussion (2/2/18):
At this meeting, a motion was made and seconded to classify the BU=Each and the package size as 1. The motion carried. A FAQ will be drafted to support how to determine the BU for TENS devices with and without drugs.

At the February 2018 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
Request:
AstraZeneca would like to challenge the billing unit of mL that has been assigned to BYDUREON BCise. It is AstraZeneca’s position that based on section 5.1.12 BCise billing unit should be an EACH. Section 5.1.12 of the Billing Unit Standard states, a unit-of-use or self-contained single dose packages with a quantity less than one milliliter or gram should be billed as “one each”. Furthermore, an individual autoinjector contains a product that is dispensed in a discreet unit and has a quantity of less than one milliliter, therefore a billing unit of EACH would be applicable. Furthermore, in 5.2 of the billing standards, it identifies a suspension of less than 1ml should be billed as an “each”.
Why Needed:
The packaging indicates a 2g dose on the autoinjector. A patient can only administer the full dose due to the fact that the device is an autoinjector, there is not an ability to take less or more than the 2g/0.85mL dose.  Therefore, billing by an ML is not possible. 
Anticipated Outcome:
Agreement from all pricing compendium to change the billing unit from mL to Each ensuring appropriate reimbursement. AstraZeneca would like to have this changed as soon as possible to minimize any reimbursement already initiated as the product will be first shipped into the market on 12/4/17.
Task Group Discussion (12/5/17):
Note: Confirmation amongst the data compendia via email on 11/8/17 resulted in the assignment of BU = ML, PS = 0.85 per 5.2.2 of the BUS. Other Bydureon products are listed as each due to being powders for injectables or suspension per BUS 5.1.2.
Astra-Zeneca representatives noted:
- Auto-injector is different than a syringe because one discreet unit is dispensed.
- Feel this fits in with 4.2.1 of the BUS which states “”EA” (each) is used when the product is dispensed in discreet units.”
- It is a mechanical device used once and disposed. Pharmacies may submit 1 as the quantity on the claim.
- Set pricing and reimbursement at .85 ml but claims come through as a 1 then not priced correctly
- 1 dose = 1 pen
- Dispensing 1 unit (1 auto-injector device)
- The BUS doesn’t specifically call out auto-injectors.
- The result of the NCPDP Billing Unit Decision Tree was inconclusive but indicated probably billed as Each.
Task Group members noted:
- The sections of the BUS mentioned in the QUIC form do not apply to injectable products.
- Billing Unit is not based on dosing. Be careful to not confuse dosing with dosage form.
- If all compendia list as BU=mL and PS = .85, then the pharmacies and PBM’s will receive those data files and should not be submitting claims as a quantity of 1.
- Not comfortable granting an exception for this product. All similar products within the marketplace would have to be reviewed.
- There are other products in the marketplace that are the same drug but have two different billing units.
- Other auto-injector products have been listed as mL including Trulicity and Victoza
- The task group agreed to BU=mL and PS = .85 per 5.2.2 of the BUS.
Work Group Discussion (2/2/18):
At this meeting, a motion was made and seconded classify the BU=mL and a package size of .85 per BUS section 5.2.2. The motion carried.