Standards QUIC Form Resolutions

At the August 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 units per vial and to allow the NCPDP 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 8mL’s of Sterile Water) prior to administration (infusion).  The item contains 4mg of lyophilized power in a single-dose vial sold in a 1-vial pack.  
Outcome Anticipated:
Jazz anticipates a billable unit of 1 each and 4 billable units per vial and that there are no concerns with the package labeling. 
Task Group Discussion (5/19/20):

• Per Jazz representatives, the 4 billable units correlates to number of milligrams of lyophilized powder in each vial.
• Infused product; outpatient setting
• Single patient use vial
• Lyophilized powders in a vial are considered one each for billing unit assignment
• Per 5.1.2 of BUS, recommend a BU = Each; Qty = 1 for billing
  • TG members agreed to a billing unit of EA; single vial = 1 EA; per 5.1.2 of BUS
• If trade name is approved prior to WG adjudication, it would be appreciated if it could be provided.

WG Discussion (08/06/20):
At this meeting, a motion was made and seconded to classify the BU=Each for a quantity of 1 for each single vial per Section 5.1.2 of the Billing Unit Standard. The motion carried with one in opposition.
 

At the February 2020 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
QUIC Request:
Alvogen requests NCPDP’s assistance to ensure consistent and accurate billing for Alvogen’s recently approved Bonsity (teriparatide injection). This product was approved via the 505(b)(2) pathway, using Forteo (teriparatide injection) as the RLD. Alvogen requests NCPDP to assign Bonsity the same billing unit (ML) and quantity (2.4) as Forteo for the following reasons:*
--On a unit basis, 620mcg/2.48ml Bonsity and 600mcg/2.4ml Forteo are equivalent;
--Both use a disposable pen containing a pre-determined residual amount (overfill) that remains when the pen is discarded after 28 days (per package insert directions); the residual amount should not be considered part of the volume of the unit for billing purposes;
--Both have formulations with the same teriparatide (250 mcg/ml) and excipients concentrations;
--Both provide 560 mcg of teriparatide (2.24 ml) over the 28-day life of the disposable pen;
--Both have a preset 20 mcg dose; and
--Both have the same indications.       
* Reference: FDA approved prescribing information for Forteo and Bonsity
Why Needed:
This request is needed to ensure the appropriate billing unit and quantity are used in the listing of Alvogen’s Bonsity (teriparatide injection), which should be the same used for Forteo (teriparatide injection). Both products have the same duration of therapy (28 days), package size (2.4), and billing unit (ML). The request is needed to ensure that Bonsity is listed the same across all compendia and to avoid pharmacy and payer confusion with regard to the residual (overfill) volume, which is the only difference between Bonsity and Forteo but is irrelevant for billing purposes.
Outcome Anticipated:
The artwork files provided show a Billing Unit of ML, Package Size of 2.4 in a prefilled syringe that contains overfill. We are petitioning the committee to disregard the residual (overfill) volume differences of these products per the Billing Unit Standards Implementation Guide:  Section 5.2.2 excludes overfill and Section 7.34 – “it was determined that the overfill, regardless if the product is reconstituted or not, will not be included in the billing quantity reported.” Therefore, our anticipated outcome is that the listing for Bonsity reflects the Billing Unit (ML) and Package Size (2.4) of the RLD, Forteo.
Task Group Discussion (01/14/20):
The submitter explained Bonsity is the bioequivalent of Forteo
Both products:
are 20mcg per dose
each mL contains 250 mcg teriparatide
deliver to the patient 560 mcg/2.24 ml over the 28-day period (20 mcg/0.08 ml per day; any overfill/remainder after 28 days is discarded by the patient)
The overfill is related to the machine filling the cartridge
There is a difference in the labeling for Bonsity vs Forteo
Forteo label on Dailymed:
Front and side panels: 20 mcg per dose
Back panel: Preset dose: 20 mcg teriparatide once daily. Throw pen away 28 days after first use.
Each prefilled delivery device is filled with 2.7 mL to deliver 2.4 mL.
Each mL contains 250 mcg teriparatide, …
Note: Forteo is listed as 2.4 mL
Front panel: 620 mcg/2.48mL (250mcg/mL); 20 mcg per dose
Back panel: Preset dose: 20 mcg teriparatide once daily; Each mL contains 250 mcg teriparatide…
The packaging does not mention the deliver of 2.4 mL. If it is not stated on the package, how is one to know?
The FDA dictated the labeling for Bonsity to be as it is.
The pharmacist will see 2.48 mL on the Bonsity label and use it as the quantity to bill the claim. They will use the most apparent number on the package and 2.48 is what stands out.
A product needs to stand on its own labeling; a pharmacist or a compendia representative shouldn’t have to check the Forteo label to know to use 2.4 mL as requested.
When assigning the package size/billing quantity, have to go by what is on the label.
If the compendia list 2.4 as requested and the pharmacist uses 2.48, there could be claim rejections at point of service or audits for overbilling.
Also, what is on the package is key for CMS in determining their reimbursement.
Task Group agreement on BU of mL; Quantity of 2.48mL as indicated on label; per 5.2.2 of BUS
WG Discussion (02/06/20):
At this meeting, a motion was made and seconded to classify the BU=mL for a quantity of 2.48 mL as indicated on the label per Section 5.2.2 of the Billing Unit Standard. The motion carried.
 

At the February 2020 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
QUIC Request:
SRPT 9001 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.
Why Needed:
Establish billing unit and quantity for SPRT-9001 with consideration that SRPT-9001 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.
Outcome Anticipated:
A billing unit of each (kit) with a billing quantity of 1 will be assigned for SRPT-9001.
Task Group Discussion (01/14/20):
Per the submitter, there will be multiple NDC’s. One was listed on the QUIC form as an example.
There is an alcohol wipe per vial. This qualifies it as a kit per BUS.
Decision: Kit designation; BU = Each; Qty = 1 per 5.5.1 of the BUS.
WG Discussion (02/06/20):
At this meeting, a motion was made and seconded to classify the BU=Each for a quantity of 1 per Section 5.5.1 of the Billing Unit Standard. The motion carried.
 

At the February 2020 WG2 Meeting the form was discussed.
New Product/Package Information
QUIC Request:
Audentes is requesting the ability to have their product presentation as a kit which would include an alcohol wipe for each vial in the kit.
AT-132 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.Multiple 10mL vials will be included in the kit based on the patient’s weight.
Why Needed:
Establish a billing unit and quantity for AT-132 with consideration that AT-132 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 alcohol wipes based on the number of vials per kit.Each kit will be prepared for just in time administration
Outcome Anticipated:
A billing unit of each (kit) with a billing quantity of 1 will be assigned AT-132.
Task Group Discussion (01/14/20):
Per the submitter, each SKU will have its own NDC based on the patient’s weight. They will provide the compendia with a master list by NDC and strength with price.
The presence of the alcohol wipe qualifies it as a kit per BUS.
Decision: Kit designation; BU = Each; Qty = 1 per 5.5.1 of the BUS.
WG Discussion (02/06/20):
At this meeting, a motion was made and seconded to classify the BU=Each for a quantity of 1 per Section 5.5.1 of the Billing Unit Standard. The motion carried.
 

At the February 2020 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
QUIC Request:
This QUIC form is being submitted to confirm the correct billing unit for CABENUVA.
 
The FDA PDUFA date is December 29, 2019 for CABENUVA, a 2-drug co-packaged kit consisting of extended-release injectable suspensions of cabotegravir (CAB ER) and rilpivirine (RPV ER). Each kit will include the two different medications in separate vials. CABENUVA is expected to be indicated as a complete regimen for the treatment of HIV-1 infection.  Note that the labeling and packaging for CABENUVA is not yet FDA-approved.
 
The two injectable medications (CAB ER and RPV ER) will not be FDA-approved for individual use, nor will they be sold individually. The products are not mixed prior to injection and are co-administered as separate gluteal intramuscular injections.
 
The lowest saleable unit of the product will be a kit – each kit containing 1 vial of CAB ER, 1 vial of RPV ER, 2 syringes, 2 needles, 2 syringe labels, and 2 vial adaptors. See below for a mock-up of the kit.
 
Two dosing kits will be available to accommodate the patient’s dosing schedule:
CABENUVA 400-mg/600-mg Kit (NDC 49702-253-15) containing:
•             One single-dose vial of cabotegravir extended-release injectable suspension containing 400 mg/2 mL (200 mg/mL) of cabotegravir.
•             One single-dose vial of rilpivirine extended-release injectable suspension containing 600 mg/2 mL (300 mg/mL) of rilpivirine
CABENUVA 600-mg/900-mg Kit (NDC 49702-240-15) containing:
•             One single-dose vial of cabotegravir extended-release injectable suspension containing 600 mg/3 mL (200 mg/mL) of cabotegravir.
•             One single-dose vial of rilpivirine extended-release injectable suspension containing 900 mg/3 mL (300 mg/mL) of rilpivirine.
Why Needed:
The request is needed because CABENUVA is one of few drugs co-packaged together as separate vials to be co-administered where the individual medications are not available for sale independently nor FDA-approved for individual use.
Outcome Anticipated:
There are two possible outcomes regarding how CABENUVA can be billed.
 
1) The billing unit is an EACH, assigned to each of the 2 dosing kits available on the market.
2) The billing unit is mL. However, this could result in claims processing errors, as it is unclear as to whether the quantity would be 2 or 4 for the 2-mL dosing kit (or 3 or 6 for the 3-mL dosing kit). Additionally, the mg/mL value for CAB ER is different than that for RPV ER. The two injectable medications will not be FDA-approved for individual use nor sold separately, and a complete dose requires 2 injections: one injection of CAB ER and one injection of RPV ER.
Task Group Discussion (12/3/19):
The syringe labels are blank labels to be placed on the syringes so a physician can add the drug name and time.
In the mock-up, the prominent 3mL represents the volume for each molecule in the box for the CABENUVA 600-mg/900-mg Kit. It is intended to differentiate the two packages (CABENUVA 400-mg/600-mg vs CABENUVA 600-mg/900-mg).
Concern was expressed that it will be billed as 2mL or 3mL (instead of 4 or 6) because of the prominence of 3mL on the packaging and its presence on the vials.
Although this may be a kit to manufacturers, CMS or the public at large, it is not a kit per 5.5.1 of the Billing Unit Standard. The two vials have the same billing units and the needles, syringes and adapters are ignored per the BUS.
The manufacturer noted they expect the FDA label to call it a dosing kit.
CMS representative on the call confirmed that for rebate purposes it will be considered a kit. There will be a discrepancy between the NCPDP Billing Unit and the CMS rebate unit requiring a crosswalk.
It is anticipated that payers may set up edits to ensure claims are submitted with 4 or 6.
The task group provided recommendations to the manufacturer
Have regulatory department check with FDA on SPL listing of the product; may be a roadblock which could delay the launch
If there is a way to modify the packaging, recommend listing total mL administered.
Add to label that it is non-breakable to prevent splitting of the two vials
Ask the opinion of the Institute for Safe Medication Practice about how to list; they have been vocal about the combining of two products.
May be required to have separate NDCs for the two vials. If so, the outer NDCs in the QUIC form are the ones to report to the drug data compendia and to use for processing claims.
Task Group recommendation: Billing Unit of mL per Section 5.2.2 and 5.2.9 of the Billing Unit Standard. The quantity will be 4 for NDC 49702-253-15 and 6 for NDC 49702-240-15.
WG Discussion (02/06/20):
At this meeting, a motion was made and seconded to classify the BU=mL for a quantity of 4 for NDC 49702-253-15 and 6 for NDC 49702-240-15 per Section 5.2.2 and 5.2.9 of the Billing Unit Standard. The motion carried.
 

At the November 2019 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard and New Product/Package Information
Request:
The NS-2 Electric Patch Pouch is designed to provide non-invasive electrical stimulation of the Trigeminal nerve in the forehead. The NS-2 Electric Patch is used in conjunction with the Monarch eTNS System. Each patch can deliver 1 treatment session. The NS-2 Electric Patches are sold in pouches containing 7 patches. The purpose of this request is to standardize dosing and billing units for the NS-2 Electric Patch Pouch.
Why Needed:
Previously NeuroSigma worked with NCPDP to obtain product identifier numbers for the NS-2 Electric Patches. NeuroSigma is seeking reimbursement for these products via the pharmacy benefit. This request is needed to standardize dosing and billing units for the NS-2 Electric Patch.
Anticipated Outcome:
NeuroSigma requests that One pouch of NS-2 Electric Patch be classified in the following manner:
NCPDP Product Identifier 50218000702 (UPC 50218-00702)
Billing Unit (BU) = Each; Quantity = 1
Task Group Discussion (10/8/19):
A representative from NeuroSigma explained this QUIC form is for refill patches sold separately from the Monarch system that may be prescribed. Each sealed pouch contains 7 patches.

The pouch would not be opened to dispense individual patches because they would dry out.

Task Group recommendation: BU = Each for a quantity of 7 per Section 4.2.1 and FAQ of 7.45 of the Billing Unit Standard.
WG Discussion (11/8/19):
At this meeting, a motion was made and seconded to classify the BU=Each for a quantity of 7 per Section 4.2.1 and FAQ 7.45 of the Billing Unit Standard. The motion carried.
 

At the November 2019 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard and New Product/Package Information
Request:
The Monarch eTNS System is the first-ever medical device to receive FDA clearance for treating pediatric ADHD. The Monarch is a non-invasive medical device that delivers external Trigeminal Nerve Stimulation (eTNS) to the V1 branch of the trigeminal nerve just under the skin of the forehead. This innovative device is prescribed and used daily, just like a pharmaceutical, and has a daily disposable component. The purpose of this request is to standardize dosing and billing units for the Monarch eTNS System.
Why Needed:
Previously NeuroSigma worked with NCPDP to obtain product identifier numbers for the Monarch eTNS System. NeuroSigma is seeking reimbursement for these products via the pharmacy benefit. This request is needed to standardize dosing and billing units for the Monarch eTNS System.
Anticipated Outcome:
NeuroSigma requests that the Monarch eTNS Systems be classified in the following manner:
NCPDP Product Identifier 50218000700 (UPC 50218-00700)
Billing Unit (BU) = Each; Quantity = 1
TG Discussion (10/8/19)
A representative from NeuroSigma explained this QUIC form is for the system unit which also includes 4 pouches, each containing 7 patches.

The box also contains a suitcase with the pump generator, lead wires, battery system, plug, rechargeable batteries and a user manual.

It was noted by a task group member that none of these contents allow for classification as a kit per the Billing Unit Standard.

Task Group recommendation: BU = Each for a quantity of 29 per Section 4.2.1 and FAQ 7.45 of the Billing Unit Standard.
WG Discussion (11/08/19):
At this meeting, a motion was made and seconded to classify the BU=Each for a quantity of 29 per Section 4.2.1 and FAQ 7.45 of the Billing Unit Standard. The motion carried.
 

At the February 2020 WG2 Meeting the form was discussed.
Production Identification Code Questions/Issues
Request:
1.) Request for Billing Unit of EACH
2.) Package Size Request for 1 (EACH Rescue Dose Administration)
Product X is a nasal spray being developed as an acute rescue medication to be given outside the medical setting for seizure emergencies that have the potential to result in significant morbidity or even mortality if allowed to continue. Each commercial carton contains 2 doses: a primary dose and a back-up dose, which is customary for rescue treatments
Why Needed:
While the 5mg and 10mg dose packs contain a single sprayer, which delivers the complete dose, the 15mg and 20mg blister dose packs contain two sprayers in which both must be delivered (one in each nostril) for the complete dose. We are requesting that the Package Size reflect the Dose and not the number of sprayers to avoid confusion and an emergency situation where the patient receive an unintended dose.
Outcome Anticipated:
We are anticipating that these rescue meds will be listed with a Billing Unit of EACH and that the quantity will reflect the amount of Rescue Doses instead of the total number of sprayers. We understand this is an exception, but there is no clear guidance on “Doses” within the Billing Unit and the other Rescue Meds requiring immediate administration (EpiPen, Narcan) all have a package size of the amount of Rescues
Task Group Discussion (12/17/19):
The labels in the presentation are redacted because not FDA approved yet
Rescue medication similar to Narcon in presentation and packaging; nasal spray administration
For Epilepsy patients in an emergency situation
Product is packaged in a blister and labeled as “per dose
4 different strengths available
Higher strengths (15mg and 20 mg) of product require the administration of two nasal spray devices for a single rescue (dose); the lower strengths (5 mg and 10 mg) require only one nasal spray device
The higher doses had to be divided between two nasal spray devices because of volume limit of a nose.
Each blister pack has a full dose; each box has 2 blister packs
1 blister = 1 rescue dose regardless of dosage strength and number of nasal spray devices to be used
Requesting BU assignment per rescue dose instead of per nasal spray device
Concerned that medication could be administered incorrectly if listed as 4 units instead of 2 units.
Epilepsy community is accustomed to seizure rescue medications coming in cartons of TWO DOSES
The second dose is in case something happens to the first one; it serves as a back-up
Packaging does indicate the blister packs are not for individual sale.
Task group agreed the Billing Unit is an each and to count the discrete blister packs in each box for a quantity of 2 for each strength. BUS 4.2.1 and 5.1.3 are the closest to being applicable. Need a FAQ, similar to the one for epi-pen to explain the exception on the quantity.
Alisha will write the FAQ and Dave to review
WG Discussion (02/06/20):
At this meeting, a motion was made and seconded to classify the BU=Each for a quantity of 2 for each strength per Section 4.2.1 and 5.1.3 of the Billing Unit Standard. The motion carried.