Standards QUIC Form Resolutions

At the August 2019 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard; Product Identification Code Questions/Issues
Request:

reSET® is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to increase abstinence from a patient’s substances of abuse during treatment, and increase retention in the outpatient treatment program. reSET-O® is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.   Patient users download the PDTs through the Apple App store on iOS devices or the Google Play store on Android devices. In order to access app content, patient users must redeem an access code specific to the prescribed product that is distributed by a licensed pharmacist after a review of the user's prescription.   Pear Therapeutics is requesting a billing unit determination for reSET and reSET-O applications. Pear Therapeutics also would like NCPDP to verify the above converted UDI to NCPDP Reimbursement Identifiers is correct.

Why Needed: 

Payers and processors have asked Pear Therapeutics for the ability to adjudicate the reSET and reSET-O PDTs under both Medical and Pharmacy coverage. Pear Therapeutics would like a billing unit determination made for both products so that they can be listed consistently within the compendia and minimize confusion in the pharmacies.

Anticipated Outcome:

reSET is dispensed as a 12 week (90 day) treatment and reSET-O is dispensed as a 12 week treatment. A unit of one is expected for reSET, and a unit of one is expected for reSET-O.

TG Discussion (7/23/19):
* The patient is given a prescription for the product, are provided an access code and download the application. When the claim comes through it is representative that the patient has received the access code.
* NOTE: Draft verbiage for the Product Identifier Standard that converted product identifiers do not following the traditional CORE 9 as they may be uniquely different products.                           * TG agrees that the following NCPDP Reimbursement identifiers are properly converted

• • reSET DI: 10851580008071 reSET NCPDP Reimbursement Identifier: 51580000807
  • reSET-O DI: 10851580008101 reSET-O NCPDP Reimbursement Identifier: 51580000810 

TG agrees to BU= EACH with a quantity of 1 per BUS section 5.1.6
WG Discussion (8/8/19):
At this meeting, a motion was made and seconded to classify this product with a BU= EACH with a quantity of 1 per BUS Section 5.1.6

At the August 2019 WG2 meeting the form was discussed.
Requested: New Product/Package Information
Request:

Xeris is hoping for FDA Approval of two drug candidates that are under review with a PDUFA date of June 10th. The drug candidates are both Glucagon for treatment of severe hypoglycemia – a rescue drug.  One is Glucagon HypoPen for single use Injection via an auto-injector and the other is Glucagon Pre-Filled Syringe for single use Injection via prefilled syringe.  All current Glucagon for Injection products that are currently on the market carry a billing unit of EA and we’d like the same for our product once approved.

Why Needed: 

Glucagon is a rescue drug for treatment of severe hypoglycemia.  To avoid industry confusion and billing errors across payers and to achieve prescriber parity, we request that Xeris drug candidates, when approved, carry the same billing unit of EA like all other Glucagon for Injection products.

Anticipated Outcome:

Xeris Glucagon billing units expressed in EA which is uniform with all current Glucagon for single use Injection products marketed by Novo Nordisk, Eli Lilly, and Fresenius Kabi.  Also, the Glucagon for Injection via Auto-Injector administration device is comparable to the EpiPen which carries a billing unit of EA.  There are no other components in the package to constitute a kit and it cannot be broken apart by a pharmacist.

TG Discussion (6/11/19):
* 0.5mg is for pediatric (0.1mL); 1mg is for adults (0.2mL)
* Per section 5.2.2; Injectables that are liquid-filled vials, including multi-chamber products, ampoules, and syringes must be billed as the total number of milliliters (ML) dispensed. If multi-chambered vials with both components are liquid, the billing unit is the sum of the milliliters of the product. If a manufacturer has labeled a product for the quantity to dispense (i.e. excluding the overfill), the reported quantity for dispensing should be total number of milliliters. See section ‘Frequently Asked Questions”, question 7.28 and 7.34. NOTE: if the product is derived from a biologic source and has a variable volume, see section 5.1.7.
* Other glucagon products are listed as one each because they are comprise of lyophilic powders, whereas this product is not.
* Manufacturer believes that there may be confusion since this is the first glucagon product listed as mL. Compendia and payers can work together to communicate this information to the industry so the pharmacies know to submit the correct billing unit.
* TG agrees that in order to ensure consistency, the NCPDP Billing Unit for this product should be listed as mL per section 5.2.2. (0.1mL for 0.5mg and 0.2mL for 1mg)
WG Discussion (8/8/19):
At this meeting, a motion was made and seconded to classify this product with a BU=mL per section 5.2.2. (0.1mL for 0.5mg and 0.2mL for 1mg respectively).
 

At the May 2019 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard; New Product/Package Information; Product Identification Code Questions/Issues
Request:

SIM card that is used for the sTMS device for activation of device each month.

Why Needed: 

Product will be billed under pharmacy benefit and we want to ensure consistency compendia

Anticipated Outcome:

BU=EA and PS=1  per section 5.5.1 of the Billing Unit Standard

TG Discussion (4/30/19):
* Looking to be covered under the pharmacy benefit
* Used for renewals/refills
* Manufacturer will obtain UDI for lone SIM card
* Product is currently in the marketplace.
* TG agrees to BU=EACH with PS=1 per section 5.5.1 per the BUS

WG Discussion (5/6/19):
There was a comment as to why both QUIC Forms for the Device/MicroSIM Rx Card and the lone MicroSIM Rx Card had the same Unique Device Identifier (UDI) listed. Anne explained this was discussed during the task group call and the submitter was informed they would need to obtain a separate UDI for the lone SIM Card.
 
There was another comment questioning whether section 5.5.1 of the Billing Unit Standard was indeed the correct reference. Anne explained the referenced section was the most applicable to this product. The current version of the Billing Unit Standard does not explicitly address these types of non-drug therapies. Anne suggested this be placed on the Product Review and Billing Unit Exceptions Task Group agenda to formulate an FAQ to address these types of products.

At this meeting, a motion was made and seconded to classify this product with a BU=EA and PS=1 per section 5.5.1 of the Billing Unit Standard. The motion carried
 

At the May 2019 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard; New Product/Package Information; Product Identification Code Questions/Issues
Request:
The sTMS mini™ by eNeura^® is the first sTMS device indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults
Why Needed: 
Product will be billed under pharmacy benefit and we want to ensure consistency compendia
Anticipated Outcome:
U=EA and PS=1 per section 5.5.1 of the Billing Unit Standard
TG Discussion (4/30/19):
* Looking to be covered under the pharmacy benefit
* Product has a UDI number that will be converted to an NCPDP reimbursement number per the Billing Unit Standard
* Device and refill card have the same UDI – The device is activated by the SIM card, without it the product will not operate. The pharmacy would initially dispense the device and the initial SIM card. For refills, just the SIM would be dispensed. The device with SIM and lone SIM card would need two different UDI numbers (device and SIM; SIM only).
* UDI 81614002-0071 = NCPDP Identifier 16140-0020-07 (drop the first and last digit from the 12 digits and add a zero after the first 5 digits)
* Product is currently in the marketplace.
* TG agrees to BU=Each with PS=1 per section 5.5.1 per the BUS
WG Discussion (5/6/19):
At this meeting, a motion was made and seconded to classify this product with a 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:
Gleolan is an oral powder for reconstitution, once reconstituted is meant as a single dose. The label reads, “Dissolve contents of 1 vial in 50ml of drinking water” but there is no stated final volume. However, the concentration after reconstitution is listed on the label as 30mg/ml—if the vial contains 1500mg, that would be a total of 50ml
Why Needed: 

To determine which rule most applies:  5.1.8 Powders, reconstituted to variable volumes and intended for a single oral or topical administration, must be billed as “eaches”, not the number of boxes, packages, grams, or milliliters. Or 5.2.3 Reconstitutable Non-injectable Products must be billed as the total number of milliliters (ML) dispensed after reconstitution;

Anticipated Outcome:
Discussed vial email among Prod Review & Exception TG members: outcome was “ML”. Discussed again during Prod Review & Exception TG in Jan: “Each” was the outcome

TG Discussion (1/22/19):
* This product is similar to ZMAX which is listed as 1 each.
* For consistent application of the BUS, recommend using the same for Gleolan.
* Gleolan is single dose.
* Label states 1 vial; in tiny print it does mention the 50 mL
* On DailyMed, in section 3 of the drug label it does mention the result of the reconstitution but have to hunt for this information. It would not be readily available to the pharmacy.
* Recommend BU= EACH with PS=1 per section 5.1.8 of Billing Unit Standard so there is consistent application of the BUS. (Powders, reconstituted to variable volumes and intended for a single oral or topical administration, must be billed as “eaches”, not the number of boxes, packages, grams, or milliliters). The task group agreed.
WG Discussion (2/7/19):
At this meeting, a motion was made and seconded to classify BU=EA and PS=1 per section 5.1.8 of the Billing Unit Standard. The motion carried.
 

At the February 2019 WG2 meeting the form was discussed.
Requested: Clarification of Billing Unit Standard; New Product/Package Information
Request:
The QUIC form is being submitted to validate the milliliter billing unit (NCPDP Billing Unit Standard) for this product which is a pre-filled syringe.  This is an oncology-based product that is physician administered in a hospital/clinic/physician office setting.  The commercial launch date of this product was January 3, 2019
Why Needed: 
Acknowledge and confirm that this product is on the market and reported in the Data Compendia as a UOM of Milliliter
Anticipated Outcome:
A Voice:  In a “perfect world” the UOM would be one each pre-filled syringe.   CMS Medicaid would request this be reported on the Medicaid Rebate Program by a one each syringe.  However, this can only work if the NCPDP Billing Unit changes to a one each syringe and the Data Compendia report as a one each syringe. Pharmaceutical Manufacturers with pre-filled syringes are challenged by the UOM of milliliter. FYI the Q-code (Q5111) is based on 0.5mg (12 units need to be billed for One prefilled syringe
TG Discussion (1/22/19):
* It was confirmed there is no alcohol swab in the package with the syringe.
* Per section 5.2.2 of the BUS: “Injectables that are liquid-filled vials, including multi-chamber products, ampoules, and syringes must be billed as the total number of milliliters (ML) dispensed.”
* Recommendation of a BU= mL with a quantity of 0.6mL per 5.2.2 of the BUS.  The task group agreed with the recommendation.
WG Discussion (2/7/19):
At this meeting, a motion was made and seconded to classify BU=mL and quantity of 0.6mL per section 5.2.2 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 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.