Standards QUIC Form Resolutions

At the February 2019 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
Request:
This product contains a gammaCore Refill Card, product information, and tubes of conductive gel
Why Needed: 
Based on the prescription from their Health Care Provider, a Refill Card Kit is provided to the user along with two additional tubes of conductive gel. On receipt of the Refill Card Kit, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on) for several seconds.  The device will display “rd” and the "refill" icon as the device reads the Card.  The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment.  Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away
Anticipated Outcome:
Confirm gammaCore Refill Card, and its box contents are classified as BU=Each and total quantity of one (1)
TG Discussion (1/22/19):
*Because there are two distinct items with different billing units (each for the card and grams for the gel), it was recommended the billing unit is each with a quantity of 1 per section 5.5.1 of the BUS.
* The task group agreed with the recommendation of BU=Each with a quantity of 1 per section 5.5.1 of the BUS.
WG Discussion (2/7/19):
* At this meeting, a motion was made and seconded to classify BU=EA and PS=1 per section 5.5.1 of the Billing Unit Standard. The motion carried.
 

At the February 2019 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
Request:

This product contains a gammaCore Sapphire Device (non-invasive nerve stimulator), a gammaCore RFID Card, tubes of conductive gel, charging station/storage case, ISI, and power adapter.   gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation(nVNS) on the side of the neck. gammaCore is indicated for:   • Adjunctive use for the preventive treatment of cluster headache in adult patients. • The acute treatment of pain associated with episodic cluster headache in adult patients. • The acute treatment of pain associated with migraine headache in adult patients

Why Needed: 
The gammaCore Sapphire device is currently adjudicated under both Medical and Pharmacy coverage. Therefore, a valid standard is required to avoid billing unit assumptions and/or mistakes. gammaCore Sapphire is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case, connected to a power adapter, to charge the device as necessary by the end user.  The device will be provided to the patient/user with an initial 31-day RFID card, based on the health care provider’s prescription. It can be refilled / reloaded for additional 31-day periods, via a "Refill Card" encoded and provided by electroCore or its authorized agent. (Once the maximum number of daily doses has been reached, the device will not deliver any more doses until the following 24-hour period.). On receipt of the RFID Card the user loads the therapy on the gammaCore device by placing the Card across the face of the device (with the device turned on) for several seconds.  The device will display “rd” and the "refill" icon as the device reads the Card.  The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment.  Each RFID Card can only be used for one fill; upon completion of loading the therapy, the card may be thrown away
Anticipated Outcome:
Confirm gammaCore Sapphire device, and its box contents are classified as BU=Each and total quantity of one (1)
TG Discussion (1/22/19):
Because there are two distinct items with different billing units (each for the device and grams for the gel), it was recommended the BU= Each with a quantity of 1 per section 5.5.1 of the BUS. The task group agreed with the recommendation of BU= Each with a quantity of 1 per section 5.5.1 of the BUS.
WG Discussion (2/7/19):
At this meeting, a motion was made and seconded to classify BU=EA and PS=1  per section 5.5.1 of the Billing Unit Standard. The motion carried.

 

At the February 2019 WG2 meeting the form was discussed. 
Requested: Clarification of Billing Unit Standard and New Product/Package Information
Request:
Jazz Pharmaceuticals is requesting confirmation from the NCPDP Billing Unit Standard that this products unit of measure would be an EACH.  We would like comments on the packaging, labeling and UOM from the NCPDP workgroup #2
Why Needed: 
This request is needed to confirm the billing unit standard.  The product is a tablet that will be commercially available in 30 and 100 count bottles in three different strengths.  It will be sold to the wholesalers and they will sell through to the pharmacy for individual patient dispense.
Anticipated Outcome:
Jazz anticipates the billing unit standard to be an Each
TG Discussion (1/8/19):
* Labeling is not available at this time.
* Explained the process of assignment of billing unit and package size determinations to submitter. They also provided a background of the Billing Unit Standard and its use in making these determinations.
* Task group agrees to BU= EACH per section 5.1.1 of the BUS. Will update QUIC Form with product name when it is received.
WG Discussion (2/7/19):
* At this meeting, a motion was made and seconded to classify BU=EA and PS of either 30 or 100 depending on the bottle size per section 5.1.1 of the Billing Unit Standard. The motion carried.

At the November 2018 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
Request:
Label Review. Billing Unit and Package Size are needed for breath-actuated multi-dose dry powder inhaler metering 400 mcg of active ingredient A and 12 mcg of active ingredient B, for 30 and 60 actuations. The actuation device is the same device used for single active ingredient Tudorza (PS: 1; BU: Each)
Why Needed: 
Clarification is needed: BUS 5.4.1: Multi-dose inhalers, inhaler refills and aerosols should be represented as the metric decimal quantity contained in the packaging in grams (GM) or milliliters (ML) as specified by the manufacturer on the labeling. When both milliliters and grams are supplied on the package label, use the first measurement unit listed. For example, Alupent™ inhaler includes “14 gms (10ml) on its label. Thus, the billing unit for Alupent™ inhaler is 14 GM. (Inhalation products less than 1 gm are billed as “eaches”; see section 5.1.12.) BUS 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”. For example, ointment in packets of less than 1 gram, eye drops in dropperettes that are less than 1 ml, or nebulizer solution in package of less than 1 ml. This rule does not apply to injectable products.
Anticipated Outcome:
BU=EA ; PS=1
TG Discussion (10/23/18):
Product is similar to Tudorza
Task group agrees to on BU=EA with PS=1 per BUS 5.1.17 for Circassia Inhalation Powder for package sizes 30 and 60.
WG Discussion (11/8/18):
At this meeting, a motion was made and seconded to to classify BU=EA with PS=1 per section 5.1.17 of the Billing Unit Standard. The motion carried.
 

At the November 2018 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
Request:
AZEDRA® is supplied as a 30-mL single-dose vial containing 555 MBq/1 mL (15 mCi/1 mL) of I-131 (as iobenguane I 131).  Product is supplied as an intravenous solution in Dosimetric (30 mCi/2 mL; NDC 71258-015-02) and Therapeutic (337.5 mCi/22.5 mL; NDC 71258-015-22) presentations.
Why Needed: 
The manufacturer is requesting a billing unit assignment of millicuries (mCi) as that is how this product is dosed, and the volume at administration is variable due to degradation.

Background received from Progenics on how the product is dosed:

As patients are identified, physicians will complete a dosimetry scan to identify the amount of radioactive product a patient will require based on the scan of the tumor.

Given that AZEDRA is a radiologic with approximately a 6-day shelf-life window prior to administration and degrades during shipment and preparation, Progenics will ship the number of vials that will be needed to ensure the prescribed amount of product can be calibrated appropriately for administration. Depending on the scheduled day of administration, the number of vials will vary in some cases. This is the reason that we Progenics chose to charge by the mCi prescribed, so hospitals are not paying for vials simply because the product is degrading.

​Further complicating the situation, low weight patients (those below 62.5 kg) are also dosed by weight, but the same issue with degradation still exists.  For all of these reasons, Progenics’ chose to price according to the amount of drug prescribed. Progenics felt it is the most responsible way to price.
Anticipated Outcome:
EA.  Per FAQ 7.39 of the Billing Unit Standard.
TG Discussion (8/21/18):
It is a radiologic drug that decays (8 day half-life, 8 hours to be administered), and in hospital setting is prescribed in millicuries. Due to product degradation multiple vials may be sent.
Strength or dose does not relate to billing unit. Millicuries are not part of the NCPDP Billing Unit Standard. Only mL, EA and GM.
Refer to FAQ 7.39 HOW ARE RADIOPHARMACEUTICALS TO BE BILLED? 
Task Group members agreed to BU = each per vial and the quantity of  ‘1’ per vial supplied per 5.1.2 of BUSTG agreed with BU = GM and package size = 3.8 per 5.4.1 of the BUS.
WG Discussion (11/8/18):
A motion was made and seconded to classify BU=Each per vial and PS=’1’ per vial supplied per section 5.1.2 of the Billing Unit Standard.  The motion carried.

At the February 2019 WG2 meeting the form was discussed.
Requested: Product Identification Code Questions/Issues
Request:
Glenmark recently sent notification to Medicaid agencies (attached) stating the product has a new revised units per package size of 6 GM. Previously in the CMS system the drug was listed as 24 GM. The new 6 GM package size has been revised back to June 2012. The drug compendia have the product listed as EACH with a package size of 24.
Why Needed:
The imiquimod product was previously listed in the CMS DDR & MDRP with a units per package of 24 GM. A new units per package of 6 GM was recently entered and backdated to 2012. Drug compendia list the product as 24 EACH. When the CMS systems and drug compendia units per package size do not match and are changed frequently, it creates problems with rebate conversion.
Anticipated Outcome:
To determine if the CMS systems should also reflect the NCPDP Billing Unit Standard for units per package size – in this case the system would show 24 EACH, not 6 GM.
Task Group Discussion (8/21/18):
- Per BUS 4.2.1 if less than 1 is counted as EA.
“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”. For example, ointment in packets of less than 1 gram or eye drops in dropperettes that are less than 1 ml. This rule does not apply to injectable products.”
- Need to have a conversation with CMS. TG feels that should not go against BUS and change. If changed, would have to go back and look at numerous products.
- Submitter asked if they were supposed to change in their system in accordance with the notice, Kay advised that we cannot dictate what is done, can only advise what the Billing Unit should be.
- Product should remain as BU= EA with a quantity of 24 sachets per section 4.2.1 of the BUS. Task Group will reach out to CMS to work together on a resolution to these issues going forward.
Work Group Discussion (2/7/19):
A motion was made and seconded to classify BU=EA with PS=24 sachets per section 4.2.1 of the Billing Unit Standard. The motion carried.
 

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At the August 2018 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
Request:
The packaging presentation for this proposed product is designed to allow for weight-based dosing and patient safety and ease-of-use. It will be available in multiple outer boxes, with each box containing a series of inner carton aluminum blister packs consisting of either 1 or 2 tablets. Each blister pack provides a patient one day of therapy. Each outer box will provide a patient with one week of therapy.  The internal configuration of the inner carton blister packs will be unique to each outer box, allowing the outer boxes to address all possible patient weight -based dosing options. Each tablet contained in the inner carton blister packs is identical (same strength) across all packaging configurations. Each of the outer boxes will be a different commercialized NDC11 intended for sale. Though the two inner carton blister packs will each have an inner NDC11, the number will not be visible on the inner carton packaging (however, there will be bar codes which can be scanned to retrieve the NDC11 code for the inner carton blister packs). The two inner carton blister packs are not intended for individual sale.  A dispense will be a single outer box, though a patient may require multiple dispenses to complete a treatment course.
Why Needed: 
Submitter seeks to understand whether and how the market will treat the inner carton if CMS/Medicaid determines the pill to be the billable unit.  Particularly, Submitter seeks guidance regarding whether pharmacists are likely and able to break the outer box, especially if the package insert is silent as to breaking up an outer carton

Anticipated Outcome:
Submitter anticipates NCPDP to provide guidance as to whether the best suited billable unit to support proper dosing and administration would be (i) the outer box, (ii) the inner carton, or (iii) the pill. If the billable unit is not the outer box, what changes would be necessary for NCPDP to make the outer box the billable unit? Additionally, Submitter anticipates that after resolution of the best billable unit type, NCDPD will provide guidance as to of the likelihood of pharmacies breaking up the outer boxes given the billable unit type.
TG Discussion (7/17/18):
In assigning a billing unit, we do not look at it from the dosing perspective but from a dispensing, labeling and packaging perspective
The product will be packaged as a combination of tablets in blister packets in a box inside of another box. There are no other items in the box. The final package will contain all the same tablets of the same strength.
Normally tablets are countable as eaches
Per the submitter, for weight-based dosing the dispensing mentality is to make it as easy to dispense and provide the patient with an experience which is as simple as possible.
It was noted patient safety is a concern because of the weight-based dosing.
Would like to define a certain number of units as the base units and then create any permeation to create the weight dosing.
For example, have a 1 pill pack, 3 pill pack and 5 pill pack and then create any needed combination. These individual smaller packs would go into a single box for the entire dose.
They desire to have only the outer box have a NDC but we advised it won’t make it through FDA
There is a risk that the outer box (intended for one patient) will be broken up and used to treat two patients.
This will not be a high volume product and will be a specialty pharmacy product. It doesn’t change the billing unit but may put the manufacturer on the hot seat for making it cost effective.
The recommended billing unit will not impact flat copayments – it will be the same whether 4 each or 6 each.
The submitter inquired if there was any configuration to have the outer box as the billable unit instead of each tablet. Since the strength does not vary from lot to lot nor is there a range, it doesn’t qualify. Also, if we allowed that type of BU assignment for this product, existing products in the marketplace would want to have their BU changed as well.
From Billing Unit perspective, the task group members agreed to BU = each and the quantity is the total number of tablets in box dispensed (going to patient).
WG Discussion (8/2/18):
At this meeting, a motion was made and seconded to classify the BU = each and the quantity is the total number of tablets in box dispensed (going to patient).

At the August 2018 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard
Request:
Aimovig™ is supplied as a 1-mL SureClick® Autoinjector containing 70 mg/1 mL of erenumab-aooe.  Product is packaged as one 1-mL autoinjector (NDC 55513-0841-01) for a 70-mg dose, or two 1-mL autoinjectors (NDC 55513-0841-02) for a 140-mg dose.  Product labeling indicates “1 x 70 mg/mL Prefilled Autoinjector” and “2 x 70 mg/mL Prefilled Autoinjectors”, respectively.
Why Needed: 
To determine if the billing unit should be EA, rather than ML, as the package with two autoinjectors is meant to be dispensed as a whole, single unit and is not intended to be divided.  The manufacturer feels there could be FDA compliance issues if the billing unit suggests the packaging contains multiple units within it.  Each NDC is intended to be a single unit.
Anticipated Outcome:
ML.  Per section 5.2.2 of the Billing Unit Standard.
TG Discussion (6/5/18):
Representatives from Amgen provided some background on the product and some concerns:

• Product was approved on 5/17/18 with two different dosages available.Product is packaged as one 1-mL autoinjector for a 70-mg dose or two 1-mL autoinjectors for a 140-mg dose (2 x 70-mg dose)
• A concern was expressed about the unit price in the compendia and Kay explained that we have to be careful about mentioning pricing because of competitors and NCPDP’s anti-trust statement.
• Both are intended to be used as described on the PI. If prescribed 70-mg, supposed to take the 70-mg at one time. If prescribed 140 mg, supposed to take two 70-mg at one time.
• Concern with the package size of 2 for the 140-mg NDC for the potential for dispensing behavior contradictory to the FDA label. Pharmacy might break apart the 140-mg package and dispense the 70-mg separately. Want to insure the 140 is not broken apart.
• NCPDP does not base Billing Unit on doses. It is based on “what is 1”?
• Have to consistently apply the BUS for all products in the marketplace. To assign a package size of 1 to the 140mg NDC as Amgen desires would require revisiting all products on the market.
• It was questioned whether at the pharmacy level a claim could be billed for 1 for the 140-mg NDC. It would be up to the payers to determine if they would reject a claim for a unit of 1 on that NDC.
• Although a package (even one labeled a kit) is designed not to be broken, a pharmacist may still break it (for example, patient cannot afford the full supply). There is nothing to stop a pharmacist from breaking it up.
• Suggestion to communicate with pharmacy corporate offices and payers and request they only allow a dispensed quantity of 2 or multiples of 2 for the 140 mg NDC.
• Suggestion to present the product to WG2 at our next Work Group meeting in August and stress the importance of dispensing the 140 mg package as an entire unit. It is a wider audience and includes more representation from pharmacy and payers. However, the pricing concern should not be mentioned.
• Task Group agreed to BU of mL quantity of 1 for 70 mg NDC and 2 for 140 mg NDC per section 5.2.2 of the BUS.

WG Discussion (8/2/18):
At this meeting, a motion was made and seconded to classify the BU=mL with quantity of 1 for 70 mg NDC and 2 for 140 mg NDC per section 5.2.2 of the BUS. The motion carried.