• Agreement of an assignment of BU = EA per 5.5.1 of the BUS with a package size of 1 EA.

• A motion was made and seconded to classify the BU = EA per section 5.5.1 of the Billing Unit Standard^© with a package size of 1 EA. The motion carried.

• This product is regulated as a combination device/drug product
  • This product is not listed in DailyMed but is listed in GUDID
  • Billing units do not always align between CMS and NCPDP products and there is an understanding of this practice
• Each vial contains 2mL of product despite the recent 1mL indication for single use.
• Previously 2mL’s were used but, they are now transitioning to a 1 mL indication to reduce MRI artifacts
  • It was suggested that a different GUDID be assigned for the 1mL indication
• Billing discrepancies could arise from the mismatch between the 2mL vial volume and the 1mL billing unit, particularly if providers bill based on the vial size rather than the indicated dose.
• HCPCS and NCPDP billings units do not usually align, and it is not unusual for this to occur
  • This product falls under the administrative code for medical and not the pharmaceutical reimbursement codes therefore billing and payment should not be affected by the NCPDP billing unit
    • Surgical supplies are typically billed under medical benefits
      • Magtrace® is used in combination in surgical breast cancer sentinel lymph node biopsy procedures
      • Magtrace® is viewed as a “combination device/drug product” with a primary mode of action as a “device.”
• The compendia and task group currently feel the billing unit should be ML with a package size of 2mL per BUS 5.2.2 but would like to continue to discuss this product
• This QUIC Form will be adjudicated at November 2025 Work Group Meeting

• Magtrace® is classified as a medical device. Information provided by CMS is insufficient to persuade a different determination on the billing unit or package size.
• Agreement of an assignment of BU = ML per section 5.2.2 of the BUS with a package size of 2.

• Request was made by submitter to pend QF 202503 until February 2026 WG meeting.
• A motion was made and seconded to pend QF 202503 until February 2026 WG meeting.

• Daniel Tamayo, Endomag, a Hologic Company, indicated the manufacturer has changed the dosing from 2 mL to 1 mL over the past year and advised the 1 mL of remaining product after dosing be discarded.
  • The 1 mL of remaining product is considered overfill. According to the BUS, any liquid-filled vial which is used in a procedure or a device, the customary billing unit is mL and the quantity is however many mLs are in the vial, regardless of how it is used.
  • The package insert and vial do not indicate discarding a particular amount after administering the therapeutic amount.
• The work group has recommended Daniel reach out to CMS’ billing department to discuss billing issues.

• The motion was made and seconded to classify the BU = ML per section 5.2.2 of the Billing Unit Standard^© with a package size of 2 ML. The motion carried.

• This product will be provided in a single-use vial in a single carton
  • No more than two NDCs will be associated with this product
• Effective June 2025, the FDA is requiring single vials and single cartons to provide the same product code with a different package size identifier
• The package size (volume of the liquid) will be constant across all lots, and all of the product should be extracted and administered with no wastage.
  • The formulation is a fixed-dose versus weight-based variable
  • The genome factor will be the recommended dosage per FDA label and not variable.
• If the language in section 16 of the package insert states that there is a variable volume such as “not less than 3 mL” Zolgensma^® will be an assignment of BU = EA with a package size of 1 EA per section 5.1.7 of the BUS.
  • If there are any changes in the language in the package insert or label explicitly stating 3 mL and not less than 3 mL, there will be a change in the billing unit assignment.
• Agreement on the assignment of BU = EA per Section 5.1.7 of the BUS, with a package size of 1 EA for both the inner and outer NDC numbers.

• If something changes between now and when the packaging is approved by the FDA, how will that be handled? The QUIC form will be re-reviewed and re-issued if the task group feels that something needs to change. If after the product is launched and there needs to be a quantity change, there will be an e-Blast sent out.
• If the packaging does change, how will the NCPDP members be notified? Each of these manufacturers will be notified that the QUIC forms were reviewed/approved. When this product is approved by the FDA, the task group will still need to see the updated package information/artwork. The manufacturer will need to send NCPDP any updated information. Additionally, after the compendia begins entering the product into their databases, any discrepancies will be noted in the monthly billing unit discrepancy report.
• What if the outer carton quantity changes? The manufacturers would not be able to launch any package size variation that was not approved by the FDA. Since this is a gene-therapy product, there may be variable volumes from batch to batch (which is why the package size should be 1 each), the task group would need to confirm that the FDA did not remove any language regarding variable volume that would switch it from “each” to “mL.” 
• Can NCPDP issue a “conditional approval” while this product is in review with the FDA and then a “final approval” once the FDA clears this product? This should also be addressed in task group call prior to next meeting and include Margaret in the discussion.

• A motion was made and seconded to classify the BU = EA per Section 5.1.7 of the Billing Unit Standard^© with a package size of 1 EA for both the inner and outer NDC numbers. The motion carried.

• Each refill kit contains 5 sterile trays (5 Mints)
  • Each sterile tray contains:
    • A Mint reservoir, a syringe and needle for the purpose of filling the 200-unit Mint reservoir.
      • All items supplied in each tray are sterile products intended to be used together
  • Outer and inner packages (trays) have the same NDC number
• Because the contents of the sterile tray are intended to be used together and not separately, the task group agrees each tray should be counted as one unit. Section 5.5.1 of the BUS will be reviewed and updated to reflect this billing unit assignment and package size.
• Agreement of an assignment of BU = EA per section 5.5.1 of the BUS with a package size of 5 for each refill kit.

• Mint controllers are supplied once a year in the starter kit
  • Kit contains:
    • 1 mint controller with 10 Mint trays
      • Each of the sterile Mint trays includes a syringe and needle for the purpose of filling the 200-unit Mint reservoir.
• Agreement of an assignment of BU = EA per section 5.5.1 of the BUS with a package size of 1

• TAR-200 is a fixed-dose drug-device combination product designed for the treatment of bladder cancer.
  • It consists of gemcitabine and urea mini tablets embedded within a silicone tube, which is inserted into the bladder via catheter.
  • Once implanted, the device remains in the bladder for three weeks, during which time gemcitabine elutes into the urine, providing localized treatment.
• Should the package size be determined based on the total number of tablets contained within each unit?
  • Each TAR-200 system contains the same total amount of drug, the exact number of mini-tablets is not specified and, according to Johnson & Johnson representatives, will not be included on the label or package insert.
• After review and discussion, it was determined that TAR-200 does not meet the definition of a kit as outlined in Section 5.5.1 of the Billing Unit Standard (BUS).
• TAR-200 is more appropriately aligned with the definitions provided in Sections 5.1.14 and 5.1.16 of the BUS.
• BUS Section 5.1.14

• BUS section 5.1.16

• This product is not diluted and is not supplied with a separate diluent.
  • The mini tablets are embedded within a silicone tube, which is implanted into the bladder, where the tablets dissolve during the treatment.
• Agreement of an assignment of BU = EA per section 5.1.14 and 5.1.16 of the BUS with a package size of 1 for each TAR-200 system.
  • It was noted by a task group member during the call that if the quantity of tablets is ever included on the label or package insert, the product would be subject to re-review for appropriate billing unit and quantity designation.

• Miudella® is a hormone-free, low-dose copper intrauterine device or IUD (referred to as a drug device by the manufacturer).
  • An intrauterine system (IUS) is the same as an intrauterine device (IUD) which is billed as one each per section 5.1.14 of the BUS.
• Agreement of an assignment of BU = EA per section 5.1.14 of the BUS with a package size of 1.

• There is a total of 46 NDC numbers for SRP-9003
  • These NDC numbers represent the 46 distinct weight-based kits
  • Each package will contain one vial for two kilograms of body weight and an alcohol swab for each vial
    • There will be separate NDC numbers for each vial, however these vials are not intended to be individually available for sale
      • Each inner vial has the same NDC number on it which differs from the outer package NDC number
      • Each inner vial is believed to have a set volume
        • The only difference in each of the 46 NDC numbers will be the number of vials that are included in each package
• This product will be packaged and shipped similar to the way Elevidys was supplied
  • Product is shipped frozen directly to the facility where it will be administered to the patient
• Are the alcohol swabs included in sections 16 and 17 of the package insert?
  • Sarepta will refer to the Elevidys package insert as a model for how they plan on packaging SRP-9003
  • Confirmed that sections 16 (how supplied) and 17 (instructions for use) of the Elevidys include the alcohol swabs
• Agreement of an assignment of BU = EA per 5.1.7 and 5.5.1 of the BUS with a package size of 1.

• This product is an autologous product that uses the patient’s own cells which are harvested and prepared in multiple bags
  • The patient will receive a minimum of 3 bags, but can range up to 5 bags per NDC number
    • There is only one billable NDC number however there maybe multiple NDC numbers associated with each product based on the type of cells harvested
• Why would there be more than one NDC number associated with the product?
  • There could be multiple NDC numbers depending on the type of genes that are being extracted from the patient and other components such as a cassette
    • This product is a cryotherapy and must be frozen
    • This product is shipped in a dewar (metal container, packed with dry ice) which contains the cassettes in which the bags are held in
      • In some cases, the FDA may require inner NDC number for the handling of the types of cells being delineated
    • Patients receiving therapy have the same diagnosis and need the same type of therapy, so the FDA has assigned one outer NDC number regardless of the number of bags contained in the package
• What would be scanned when dispensing this therapy?
  • The inner bag cannot be scanned because of the way these types of products are packaged, the NDC code on the dewar will encompass all the information
    • The outer NDC number will be for the entire product regardless of the number of bags contained in the package.
• How will the pharmacy know which NDC number to bill?
  • This product is not shipped to the pharmacy it is delivered directly to the physician’s office or hospital so there should not be a pharmacy claim
    • This will be billed under the patient’s medical benefits
    • The physician’s office will harvest the patient’s viable cells and send them to a lab for processing
      • Once the cells are processed, they will be frozen in the bags and shipped directly to the physician’s office/hospital for administration to the patient by the physician
• Will the number of cells be on the package, and will this be submitted similar to anti-hemophilic products?
  • The details on the outer carton would identify how many bags are frozen and packaged within the dewar
  • This product is not like the anti-hemophilic factors where it is dependent on the number of cells/units packaged
    • Other products like this are referred to as a single therapy or single treatment and can consist of multiple bags
• The following update has been made to version 5 of the BUS expanding section 5.1.7 to include gene-therapy products:

• Agreement of an assignment of BU = EA per section 5.1.7 of the BUS with a package size of 1 for the outer NDC number

• A motion was made and seconded to classify the BU = EA per section 5.1.7 of the BUS with a package size of 1 EA for the outer package NDC number. The motion carried.

• This product is an insulin pump in the form of a patch and there is no long-term durable component to the product
  • There are 2 parts to the product, the bladder where the insulin goes (lasts for 3 to 4 days) and a more durable piece that the bladder clicks into (can last for up to a year)
  • The first time a patient fills the prescription they would get an introduction kit which contains the hardware which has a battery powered drivetrain (there are no buttons or screens), 10 bladders, 10 needles, and 10 syringes. (31 components)
    • The refill kit contains 5 needles, 5 syringes, and 5 bladders. (15 components)
  • If alcohol swabs were added to the packages, would it be considered a kit with a package size of 1?
• There were two new terms introduced and not understood which are causing confusion
  • Drivetrain
    • The drivetrain has an adhesive and sticks to the body (patch insulin pump)
    • The drivetrain is the transmitter that will communicate the information via Bluetooth to the application on the patient’s smartphone
      • There are no screens on the device itself
        • Data is projected to the connected Bluetooth device
      • The patient will need to have a Libre or Dexcom because the device uses the information from the glucose monitor to dose the insulin
      • The drivetrain’s application will provide how much insulin is delivered, what the CGM (Continuous Glucose Monitoring) rating is, and other information to the Bluetooth connected device
      • Everything is done through the application such as a announcing meals, suspending insulin, putting in exercise mode, etc.
      • There is no separate hardware piece that displays information
        • The information is only supplied through the connected device
      • The device is a digital therapeutic that transmits the information to the patient’s phone
  • Bladder (empty)
    • The bladder Is where the medication is stored and the patient fills this with the insulin they are taking
    • Bladders last about three days
• For a product to be considered a kit it must come with a drug or therapeutic device (such as a glucose monitoring device) adding alcohol swabs does not make supplies a kit.
  • Why does the Sequel Twiist™ have a quantity of 1 for the starter kit and refill kits? (QF 202308 Twiist™ Infusion Pump starter and refill kits)
    • The decision was made under the assumption that if the product contained alcohol pads it was automatically a kit
  • Review decision on Omnipod Introduction Kits (Package Size Verification list)
• The task group will need to review the analog products before making a decision
  • The task group will continue the discussion on the next call 10/15/2024.

• This product is similar to Jelmyto which was adjudicated in 2020 with a BU = EA and a package size of 1 per 5.5.1 of the BUS.
  • Are there any notable differences from the Jelmyto other than the size of hydrogel vial?
    • The reverse thermal gel is 60mL for the UGN-102 and is 20mL for the Jelmyto, there are no other differences.
• This product cannot be diluted with anything other than the reverse thermal gel.
  • The gel becomes liquid when it is chilled and becomes semi-solid when injected and warms up to body temperature at the tumor site.
• The hydrogel vehicle is used for the installation and release of the mitomycin and was considered as an inactive component of the dilution process.
  • This process allows for longer absorption and greater clinical benefit. This would not occur without the hydrogel.
• From QF 202005 Jelmyto
  • What was perceived to be diluent (hydrogel) and discounted is actually a clinical component as the product won’t work without it.
• Agreement of an assignment of BU = EA per section 5.5.1 and FAQ 7.49 with a package size of 1 for NDC 72493-106-03.

• A motion was made and seconded to classify the BU = EA per section 5.5.1 and FAQ 7.49 with a package size of 1 EA. The motion carried.

• Mark Hopman was on the call to review the QUIC Form and discussed the various products that will be available in the future that will follow suit with today’s decision.
• In July for 2023 the task group reviewed QF 202307 iLet Infusion kits which contained only supplies (the insulin pump was not included in these kits).
  • Agreement of a BU = EA with the package size being the total number of ConvaTec Inset, cartridges, needles, syringes, and adaptors contained in each package.
    • At the November 2023 Work Group there was agreement with the decision to count every item in the package.
• Payers, specifically Medicaid, have asked Beta Bionics to follow suit with what Insulet has done in the market with the Omnipod® product line which includes an insulin pump and the first month of supplies.
  • In this iLet Starter kit there is an insulin pump which is a quantity of 1 and the supplies which are a quantity of 50.
    • Due to the inclusion of the insulin pump is this package considered a kit with a package size of 1 or are the monthly supplies counted along with the insulin pump to create a package size of 51 without a kit designation?
• For the Omnipod® systems insulin pump (hardware) was added to the supplies, and it was considered a kit with a package size of 1 by the listing compendia.
  • It would be a little confusing if the iLet packages did not follow the same direction
• Sequel’s Twiist™ system which contains the refill kit, and their durable insulin pump is also listed as 1 EA.
• There was not a QUIC Form submitted for Omnipod® 5 however there was a QUIC Form submitted for the Sequel Twiist™ System (QF 202308).
  • For the Twiist™ Systems the package size of 1 was agreed on for both the starter kits and refill kits.
    • The refill kits were given a package size of 1 because they were supplied with alcohol pads
  • The Omnipod® contains a controller (referred to as a meter or Personal Diabetes Manager (PDM)), so it was assigned a package size of 1
    • This package doesn’t contain alcohol swabs.
• The Billing Unit Standard does not address any products which contain insulin pumps
  • BUS 5.5.1 defines a kit as meters packaged with test strips. Would this apply to an insulin pump packaged with supplies?
    • Is an insulin pump a delivery device which is an exception and should be ignored for purposes of billing or is an insulin pump more like a meter?
      • If it is considered a delivery device all items in the package should be counted.
      • The task group is leaning towards a package size of 51 per BUS 5.1.18 supported by FAQ 7.41 counting all the supplies and the insulin pump.
      • Per FAQ 7.41 all entities such as test strips, swabs, wipes etc., are billed as EA and the quantity is the actual number in the container/package.
      • Since there is no product in this package per BUS 5.5.1 all the items should be counted.
        • The task group will need to review the BUS to more clearly define what a product is in section 5.5.1 number 2.
• If a decision is made to change the Omnipod® products it would be a massive change because this product line is widely used.
  • These products are becoming very popular and evolving quickly, the task group needs to review and add these types of devices/products to the BUS for consistency among the compendia.
• The task group voted on the package size for the iLet Starter Kit Inset™ and 10 of the 20 participants voted for a package size of 51. The others did not vote.
  •  Agreement of an assignment of BU = EA per section 5.1.18 and FAQ 7.41 with a package size of 51 for each iLet starter kit.

• On 04/05/2022 Omnipod 5 and Omnipod Dash Intro Kits were reviewed by the task group, and the decision was made to classify each kit with a BU = EA and a package size 1 EA.
  • This decision was made due to Omnipod’s controller which monitors glucose levels.
• Initially the task group thought the iLet Starter Kit Inset™ was only an insulin pump, after further review it was determined that this product also contains a continuing glucose monitoring device, which was not apparent during the original discussion.
  • iLet Starter Kit Inset™ monitors glucose levels automatically with an integrated continues glucose monitor transmitter when online, if offline information is stored.
• After further review the task group determined an assignment of BU = EA per section 5.5.1 of the BUS with a package size of 1 for each iLet Starter Kit Inset™.

• A motion was made and seconded to classify the BU = EA per section 5.5.1 of the BUS with a package size of 1 for each iLet Starter Kit Inset™. The motion carried.

• The task group reviewed 5.1.2 and 5.2.2 of the BUS.
  • The task group feels that 5.2.2 applies to only liquid products in multi-chambers
  • 5.1.2 references multi-component vials billed as a unit of "each" regardless of size or content of vial in metric decimal units.
    • Solu-Cortef Sterile NDC 0009-0016-12 is a similar product in a vial and is listed as 1 each.
    • Caverject Impulse is a single-dose, dual chamber syringe system. The system includes a cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile water for reconstitution in the rear chamber. This product is similar to the Galderma product and is listed as 1 EA.
• Agreement of an assignment of BU = EA per section 5.1.2 of the BUS with a package size of 1 EA.

• A motion was made and seconded to classify the BU = EA per section 5.1.2 of the BUS with a package size of 1 EA. The motion carried.

• Risperidone ER Injection doesn’t fit the NCPDP definition of a “kit” although kit is referenced in the labels.
• The product is a powder for suspension so according to 5.1.2 of the BUS this product would be classified as each and not the final volume once reconstituted (which is not stated on any the labels).
  • Since the final volume cannot be determined per section 5.1.17 of the BUS it would be billed as “one each”.
• Per 5.5.1 of the BUS diluents are not used in determining the kit designation.
• Agreement of an assignment of BU = EA per 5.1.2, 5.1.17 and 5.5.1 of the BUS with a package size of 1 for NDC 00480-1232-08.

• A motion was made and seconded to classify the BU = EA per 5.1.2, 5.1.17 and 5.5.1 of the BUS with a package size of 1 for NDC 00480-1232-08. The motion carried.

• This product is similar to Kitabis™ (QF201503) which was classified with a BU = ML per BUS 5.2.1 and 5.5.1 with a package size of 280mL.
  • The same approach was agreed to by the task group.
• Agreement of an assignment of BU = ML per section 5.2.1 and 5.5.1 of the BUS with a package size of 60mL for NDC 70644-210-30 and a package size of 120mL for NDC 70644-210-60.

• This product is similar to Kitabis™ (QF201503) which was classified with a BU = ML per BUS 5.2.1 and 5.5.1 with a package size of 280mL.
  • The same approach was agreed to by the task group.
• Agreement of an assignment of BU = ML per section 5.2.1 and 5.5.1 of the BUS with a package size of 60mL for NDC 70644-215-30 and a package size of 120mL for NDC 70644-215-60

• Labels for this product will be printed at the time it is ordered
• NDCs will correlate with to the patients dosing range
  • There are currently 4 NDC for this product
• All vials will have the same volume but there will be multiple vials in the package
• Agreement of an assignment of BU = EA per 5.1.7 of the BUS with a package size of 1 EA (outer carton)

• Trays are used as a separation of a product and components has nothing to do with the protection of the product.
  • Per section 5.5.1 the packages containing trays are classified as a kit because of the alcohol swabs and the quantity is determined by the number of trays if a kit contains separate, distinct trays within the kit, the billing unit is an “each,” but the quantity is the number of trays rather than “1.”
• Per section 7.4 products that meet the NCPDP definition of a kit are billed as “1 each” kit.
• Per section 7.5 Kits with multiple, distinct trays are subject to be dispensed by the tray. Thus, kits with trays would be billed as “each” with a quantity of the number of trays. 
• The concern is that if an exception was created for this product it would not only open the door to exceptions for every manufacturer who has a similarly packaged product but would add more confusion to pharmacies, PBMs rules/coding and NCPDPs Billing Unit Standard.
  • The task group agrees that the packages without dose trays should remain as 1 EA to avoid any confusion.
  • The configuration is not unique, exceptions are only granted in extremely rare circumstances due to the impact on invoicing, reimbursement, rebate adjudication and clinical evaluation per section 5.6 of the BUS.
• Agreement of an assignment of BU = EA per section 5.5.1, 5.6, 7.4 and 7.5 of the BUS with a package size of 1 EA (kit) for NDCs 0069-0325-02 and 0025-0325-02.

• Once reconstituted the product turns into a gel after 15 minutes that is not usable
• Diluent will not be provided (room temperature tap water can be used)
  • Patient or caregiver will reconstitute the product at home or where site of dosing will occur prior to administering
    • Once a week dosing – Each bottle delivers 300mg of tovorafenib
      • There will be training provided on the reconstituting of the product
        • Same amount of diluent is always added+
      • Some patients will require more than 1 bottle (max dose is 600mg)
        • 28-day supply is dispensed (4 bottles to 8 bottles each month)
  • What is leaving the pharmacy when dispensed?
    • A vial with powder similar to Golytely™
  • What does the pharmacy see on the label?
    • Each bottle delivers 300mg maximum dose (12 mL) there is overfill
  • Should the total quantity be billed as 12 mL since that is what is seen on the label?
    • Regardless of the prescribed dose the entire bottle will be reconstituted and a 12 mL dose will be extracted 
• Agreement of an assignment of BU = ML per 5.2.3 of the BUS with a package size of 12 ML.

• Marcus Farbstein. RPh, Day One Biopharmaceuticals did not agree with the decision of the task group and requested WG2 consider a different billing unit assignment because:
  • QUIC Form 201904 Gleolan is a similar product and was initially assigned to a BU = ML however the decision reconsidered and changed to EA per section 5.1.8 of the BUS.
  • Ojemda™ is a specific volume and is a single dose oral administration.
    • There is potential for confusion with the payer and use of the product because of anomalies with the dosing.
      • Some doses require two separate bottles which can cause confusion and issues with reimbursement.
• A motion was made and seconded to classify the BU = ML per 5.2.3 of the BUS with a package size of 12mL. The motion carried with one in opposition.

• Marcus Farbstein and Adelpha Abrahamson Larkin of Day One Biopharmaceuticals were present.
  • A presentation was given to reconsider the decision that was made on March 5, 2024, by the task group which was adjudicated at work group on May6, 2024.
• Ojemda™ is limited distribution and is only dispensed by two specialty pharmacies.
• The package clearly states each bottle delivers 12 mLs of product for single use.
  • Pharmacies will bill the total number of mLs that are dispensed regardless of the number of vials the patient received for the prescribed dose.
    • Pharmacies, payers and processors will bill and pay in units of 12 mLs.
    • Per section 5.2.3 of the BUS Reconstitutable non-injectable products must be billed as the total number of milliliters (mL) dispensed after reconstitution.
      • This is the same as if a child only needs 80 mLs of a 100 mL bottle of reconstituted amoxicillin. The pharmacy will bill for the 100 Mls and and not the 80 mLs prescribed for the child’s treatment.
• Gleolan® a similar product was assigned the BU of EA per 5.1.8 of the BUS
  • 5.1.8 states Powders reconstituted to a 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.
    • Variable volumes are the key words in this assignment.
  • Gleolan® directions are to add X amount of water but doesn’t mention the final volume of the product once reconstituted.
    • When reviewing the labels for Gleolan® on DailyMed there is no clear final volume on the outside carton like there is with the Ojemda™ and because of this the products present themselves differently.
      • This difference is the reason why the BU assignment is also different.
• Ojemda™ is not a variable volume the package clearly states to add 14 mLs of a diluent and extract 12 mLs.
• The compendia and task group agree with the billing unit assignment of ML with a package size of 12 mL for the Ojemda™ per section 5.2.3 of the BUS based on the differences in the labeling.  The task group has no further recommendations.

• Dosing is patient specific so the outer NDC (51167-290-09) can represent 1 or more vials (51167-290-01) for each patient specific dose.
• Agreement of assignment of BU = EA per 5.1.7 of the BUS with a package size of 1 for NDC 51167-290-09.

• Agreement of an assignment of BU = EA per section 5.5.1 of the BUS with a package size of 1 for the starter and refill kits.

• Per Section 5.1.6 of the BUS Non-drug entities, such as test strips, swabs, alcohol wipes or digital therapeutics are billed as eaches, and the quantity is the actual number in the container.
• If the infusion set were in a “tray” they would be a kit if not each item in the package would be counted

• Press release:
  • https://www.betabionics.com/beta-bionics-announces-fda-clearance-for-the-use-of-a-prefilled-insulin-cartridge-with-the-ilet-bionic-pancreas/
    • After reviewing the press release it appears iLet® may be prefilled insulin cartridges.
• The task group will continue the discussion on 07/25/2023.

• This product is packaged with an outer box and 3 inner boxes which contain the listed components.
  • Each one of the following items will be counted individually and are contained within the inner package:
    • ConvaTec Inset™
    • iLet Cartridge, Needles and Syringes
    • iLet connect adapters
      • The infusion set is packaged this way to avoid patient confusion
      • Alcohol swabs are not contained in the package
• Per 5.1.6 Non-drug entities, such as test strips, swabs, alcohol wipes or digital therapeutics are billed as eaches, and the quantity is the actual number in the container.
• The manufacturer will be sending a notification to the compendia to update files to include all components in the package count.
• Agreement of an assignment of BU = EA per 5.1.6 of the BUS with a package size of 45 for NDC 50050-0100-15, package size of 45 for NDC 50050-0101-15, package size of 30 for NDC 50050-0100-10 and a package size of 60 for 505520-0101-20.
• After the task group call it was noted that needles and syringes were not part of the discussion and may require further review.

• The needles and syringes that are listed with the iLet Cartridge will need to be added to each of the package sizes per the Billing Unit Standard.
• Agreement of an assignment of BU = EA per section 5.1.6 of the BUS with a package size of 75 for NDC 50050-0100-15, package size of 75 for NDC 50050-0101-15, package size of 50 for NDC 50050-0100-10 and a package size of 100 for 505520-0101-20.

• This product is variable in which each implant is manufactured and prepared for a specific patient.
  • Product is packaged as 1 each – implants must be done at a separate time for each eye.
• Agreement of an assignment of BU = EA per sections 5.1.7 and 5.1.14 of the BUS with a package size of 1.

• Each packet enclosed in the envelopes is measured in grams.

• Each “kit” contains 90 dose envelopes – the carton lists what each envelope contains.
• The 2gm and 3gm lists each envelope contains 1 packet of OLPRUVA™ and 1 mix-aid for a total of 180 packets.
• The 4gm, 5gm, 6gm and 6.67gm lists each envelope contains 2 packets of OLPRUVA™ and 1 mix-aid for a total of 270 packets.

• In a pharmacy how will they look at OLPRUVA™ will they only look at the envelopes or the packets? How will pharmacies know to count each packet?

• Can 5.1.11 of the BUS be used to bill the product as a therapy pack to avoid confusion and so the product can be billed correctly?

• No, according to the standard if there is a therapy pack with a bister pack and it contains 3 tablets you would count each tablet for a package size of 3 it would not be counted as a package size of 1.

• In the “How Supplied” section of the package insert you have to read above the listed NDCs to see that each envelope contains 1 packet labeled as a mix-aid.
• In 5.3.3 of the BUS, it states, “if the powder is manufactured for a single oral administration (i.e., in a “packet”), the billing unit is “each” and references 5.1.8 of the BUS.
• Additionally, the task group reviewed 5.1.18 which states “For multi-component products whose components share the same billing unit, the total quantity for the product is the sum of the component sizes.  For example, if a multi-component product contains 100 EA (tablets) and 225 EA (capsules), the billing unit for the entire product is EA and the quantity is 325”. The task group agreed that this section also fits the scenario, and each packet would be counted.
• A recommendation was made to update or add an additional bullet to BUS section 5.1.8 to accommodate this scenario.
• Agreement of an assignment of BU = EA per sections 5.3.3, 5.1.8 and 5.1.18 of the BUS with a package size of 180 for the 2gm (72542-200-09) and 3gm (72542-300-09) packages and 270 for 4gm (72542-400-18), 5gm (72542-500-18), 6gm (72542-600-18) and 6.67gm (72542-667-18) packages.

• There are 3 components to the product – This is an FDA approved product
  • This product provides multiple patient ready doses
  • Each bag is individually filled at the time of administration to the patient
    • Each bag has an NDC number that is for hospital use only and is not listed on the package insert
    • Xenon Xe 129 Gas Blend is for hospital use only
  • There is a range as to how many bags each cylinder can fill
  • Package size is 6,350,000 mL having the BU=1 EA would be appropriate due to the large size of the package
• Agreement of an assignment of BU = EA per 5.1.17 of the BUS with a package size of 1 for NDC (80534-6350-01)
  • The task group will be updating the Billing Unit Standard Implementation Guide to include large package sizes and variable amount of patient ready doses

• Agreement of an assignment of BU=EA per section 5.1.12 of the BUS with a package size of 2 for NDC (79095-003-02) and package size of 1 for each of the Inner packages NDC (75095-003-01).

• Glucose meters are counted as a kit and there is no drug product
• This product contains 300 alcohol swabs.
• This product contains 90-day access to the Rx Digital Therapeutic.
• Agreement of an assignment of BU = EA per section 5.5.1 of the Billing Unit Standard with a package size of 1.

• The artwork appears generic this is because once the physician has identified the patients factor IX deficiencies the amount of HEMGENIX® the patient needs are determined then that prescription goes to the specialty pharmacy and they will print the NDC, patient name and dose on the carton
  • Each carton is printed patient specific that is why the label looks like it is in draft or not complete
• The PI says there will be 38 NDC versions for clarification is this based on the number of vials that get dispensed?
  • This is determined by the number of vials that get dispensed and the strength and ranges
    • The minimum dispensed will be 10 vials and the maximum will be 48 vials dispensed
    • In the future there may be additional NDC numbers added
• The emphasis appears to be on the outer NDC will there be inner NDCs?
  • There is an inner NDC number per FDA requirements the NDC will not be loaded separately because the inner NDC volume is variable from lot to lot and the kits may contain different drug product lot numbers
• Each vial contains an extractable volume of no less than 10 mL is the additional volume considered overfill?
  • There cannot be less than 10 mL extracted, more can be extracted depending on the lot and quantity within it
  • Because of the number of vials in the variable strength there will be occurrences where you will have multiple lot numbers in any outer NDC number configuration therefore the appearance of some of the vials may look greater than others
• There is only one specialty pharmacy that will be dispensing this treatment
  • This product is intended to be a single infusion with no additional doses
• Agreement of each NDC as a kit with a BU assignment of 1 EA per section 5.1.7 of the BUS

• The kit contains 100 test strips, 100 pen needles, 100 lancets and 2 gauze pads it is not intended to be broken and the pharmacy is to dispense it as is
  • A glucose meter is not included in this package
  • Eli Lilly has included gauze pads in the packaging therefore per section 5.5.1 of the BUS this makes the product a kit
• This is a refill kit that will be used with the Tempo system
  • A Tempo kit was released without the gauze pads and that package is billed as 300 each
    • The new kit will be revised with a new NDC number
  • Eli Lilly recently submitted an NDC with lancets, pen needles and test strip and no gauze pads are included this package is billed as 300 EA, is this product related?
    • Eli Lilly confirmed that this is a refill kit intended to be used with Tempo smart system which includes insulin
      • This is a revised kit that will be listed as a new product with a new NDC on the kit
      • The package currently marketed with a BU of 300 EA will be revised with a new NDC to avoid confusion
• Agreement of a kit with a BU assignment of 1 EA per section 5.5.1 of the BUS.

• 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.

• 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.

• 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 

• 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.

• 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.

• 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

• 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.

• 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

• Notes from prior task group discussion on June 16, 2020 on this product:
  • Nothing on label to make it a kit
  • Each vial has a BU = EA; there are 2 vials of mitomycin
  • Reconstitute mitomycin with hydrogel
  • The gel is a diluent and a delivery vehicle
  • Agreement for 2 EA per 5.1, 5.1.2, and excluding the diluent per 5.5.1 of BUS

• A representative from the manufacturer provided the following information:
  • There are 2 inner NDCs and 1 outer NDC. The two inner NDCs are not for individual sale and they will not be separated or split from the carton.
  • The hydrogel is not really a diluent. It is a core product. It cannot be purchased separately.
    • It is highly unlikely medical personnel will try to reconstitute the mitomycin with another solution.
      • The Instructions for Pharmacy state “Must be Reconstituted with Sterile Hydrogel Before Use”
  • Patients prescribed this product are enrolled in a hub and the product is only provided through the hub. There is a specific tracking number for a specific patient to be used on a specific day. It is not a product sitting on a pharmacy shelf.
  • It is administered by a urologist through a catheter as part of a procedure. The carton is only opened to mix and administer to a single patient.
    • If for a single patient, why are their two vials of mitomycin instead of a single vial?
      • Manufacturer will check for the answer.
• In light of the special properties of the hydrogel which make it more of an active ingredient than a diluent, there is a case for qualifying this product as a kit and the package size could be 1 each.
  • There would be two distinct items with different billing units qualifying it as a kit.
  • However, we want to be sure we aren’t opening ourselves to a re-adjudication of other products with
• It was noted there is some confusion in the marketplace as to the package size. CMS is listing as 1 each.
  • The task group can reach out to our CMS contact
• Although we want to minimize discrepancies, we want to make sure we don’t create a bigger problem with legacy products.
• The task group agreed to table a final determination.
  • Need to research existing products. What is the best way to accomplish?
• Recommendation to the manufacturer: For future products, either label the hydrogel as an active ingredient or add an alcohol wipe to the carton to qualify for kit designation per the Billing Unit Standard.

• Representatives from UroGen gave a presentation about their product, JELMYTO, focusing on the hydrogel and how it plays an active clinical role in the mechanism for JELMYTO and is not just a diluent.
  • It releases over an extended period of time for longer absorption of mitomycin.
  • PI says it forms a semisolid gel which dissolves releasing mitomycin for up to 4-6 hours.
• The hydrogel has its own NDC.
  • FDA typically will not assign a NDC to something that is not clinically relevant. An inactive ingredient would be given a UPC.
  • However, sterile water in kits for reconstitution have NDCs
• It was noted this product needs to be mixed in a clinical setting by someone with certification and administered to the patient within 8 hours. It is unique to the patient and ordered through a hub. The mixing process is pretty extensive.
• An outstanding question from the initial review of the QUIC form was why there are 2 vials instead of 1 vial of mitomycin. It was determined it was better to use two 40 mg vials than an 80 mg vial.
• Since the sterile hydrogel plays an active role in the mechanism for JELMYTO, Alisha recommended this be 1 each because of 2 different billing units (hydrogel (ML) and mitomycin (EA) which is in alignment with the BUS.
• Six compendia representatives agreed based on today’s presentation however 2 expressed concern about the impact on other products this package assignment will have.
  • Worried other manufacturers could or can say their diluent can play an active role. The task group doesn’t want to have to make clinical decisions.
• It was suggested we treat this an exception and draft a FAQ. It is causing disruption, billing issues, misunderstanding and possibly impact to patient safety.
• Another option was suggested was to not have an exception but clearly state in the QUIC form that the hydrogel is needed for sustained release of the mitomycin and is part of the dosage form.
• There was a recommendation for the co-leads and WG2 co-chairs have a separate discussion on the topic.
• Will also have to coordinate changing the package size from 2 to 1; this impacts more than the compendia listing.
• Some files only update monthly. October 1 was suggested but do not want a final decision on the date until we know how we are handling this product.
• We will confirm our approach and select a date on the call on 9/8.

• Concerns with creating an exception for this product
  • Unless the diluent is actually listed as an active product, it is not a separate entity. It doesn’t fit the definition of a kit.
  • Because components of a product have separate NDCs do not constitute a kit (or 1 EA).
  • What section of BUS do we cite for providing a billing unit that is different than what this looks like on the surface (2 EA).
  • There may be other products already on the market similar to this where we gave it a 2 EA.
• The presentation slides from UroGen and the product package insert, provide clinical justification to consider the Hydrogel as a key clinical component to the absorption and release of Mitomycin in the kidney, pelvis and calyces.
  • The Hydrogel is a liquid at near freezing temperatures and turns to a solid when exposed to body temperature and acts as a depot releasing mitomycin over a 4-6 hour time period. This process allows for longer absorption and greater clinical benefit. This would not occur without the hydrogel.
  • The Hydrogel doesn’t simply dilute or buffer.
• From the PI:
  • Section 11 (Description)
    • Hydrogel is clear, purple LIQUID when frozen and turns to a SOLID when instilled and at body temperature.
    • Jelmyto admixture requires certification. The mitomycin is mixed with Hydrogel, the hydrogel/mitomycin mixture turns to a solid after instillation into the bladder.
    • Normal urine flow would eliminate the mitomycin, whereas the hydrogel acts as a depot and releases the mitomycin into the kidney, pelvis and calyces over a 4-6 hour time period allowing for longer absorption and greater clinical benefit.
  • Section 12.3 (Pharmacokinetics)
    • Absorption

• Elimination

• Could support an exception as it is a unique type of product. It doesn’t fit where we would usually fit it within the BUS.
  • What was perceived to be diluent (hydrogel) and discounted is actually a clinical component as the product won’t work without it.
  • This puts the product in a different categorization and an exception is not needed.
    • Two different billing units for two different clinical components is a kit (1 EA) per BUS 5.5.1.
• Those on the call agreed to a package size of 1 EA per BUS 5.5.1.
• The compendia have it as 2 EA currently, so a change has to be coordinated.
  • Is October 1^st achievable?
    • WK would have to announce this week in order to do it for 10/1
    • Cerner cannot accommodate until mid-month (10/15)
    • Scriptpro can do 10/1
    • FDB can do 10/1
    • Elsevier can do 10/1
    • IBM is missing from call – confirm off-line (post-call they said it can be in daily and weekly deliverables by 10/1 (majority of their clients) but not the monthly file for 10/1 as the data has already been pulled. It will be available on 11/1.)
  • NCPDP Now article for this week if possible

• 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.

• "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… (Inhalation products less than 1 gm are billed as “eaches”; see section 5.1.12.)”
  • “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.”

• TG agrees that the billing unit of ProAir Digihaler should be 1 EACH per section 5.1.12 of the BUS.

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

• 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.

• On April 28, 2017, the billing unit and quantity was confirmed amongst the compendia via email as 15 ml per 5.2.9 of the BUS.
  • 5.2.9 For multi-component products whose components share the same billing unit, the total quantity for the product is the sum of the component sizes. For example, if a multi-component product contains 100 ML and 225 ML, the billing unit for the entire product is ML and the quantity is 325.

• A representative from BioMarin gave a presentation on the product at the May 23^rd task group meeting and requested an exception to the BUS.
• 2 vials drawn into a supplied syringe: one contains Cerliponase alfa and the other one contains an Electrolytes Solution. They are administered sequentially into an infusion pump system that must be purchased separately. Combining the two at time of administration could result in death.
• 2 boxes in a carton – one box contains the vials and the second box is the administration kit
• Transported and distributed frozen
• Hospital administration by trained clinician
• Covered by medical benefit and will be billed using HCPCS codes
• Limited pediatric population with rare disease who are primarily covered by Medicaid

• The task group agreed that a BU of a kit is appropriate for this product and an exception to the billing unit will be made because of its hospital administration and unique packaging.
• The primary reason for the exception is because of patient safety.

At this meeting, a motion was made and seconded to classify the Billing Unit =1 EA based upon Section 5.4.1 of the BUS. The motion carried without opposition.

A motion was made and seconded the BU=mL, with a total quantity of 280 per Sections 5.2.1 and 5.5.1 of the BUS. The motion carried with no opposition

Requested: New Product/Package Information

Request: 1 dose 600 MG IV administration (Outer NDC): 3 X 20 mL vials (200 mg/20mL) to be admixed and administered to the patient in 1 IV Infusion. (Inner Vial) 1 X 200 mg/20mL. Contents include: 1 20 mL vials, package insert.

Why Needed: Ensure the databases are in alignment (ML). Package size for OUTER NDC: 60 ML 600 MG (3 x 20 ml vials) Package Size for INNER NDC: 20 ml (1 x 20 ml vial) – Vials are filled with 21.7 ml of Peramivir solution in order to deliver 20 ml.

Outcome Anticipated: Billing Unit = ML (Per section 5.2.2 of the BUS)
OUTER NDC = Package Size 60 ML case size 1 (Considering all 3 vials are the course of therapy) INNER NDC = Package Size 20 ML (1 vial of a 3 vial IV Infusion course of therapy).

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group via email and the recommendation made that the BU=mL based upon 5.2.2 of the BUS.

• Outer NDC (carton of 3 x 20 mL vials) = 60 mL
• Inner NDC (single vial) = 20 mL

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.

At this meeting, a motion was made and seconded to classify the BU=mL per Section 5.2.2 of the BUS.

• Outer NDC (carton of 3 x 20 mL vials) = 60 mL
• Inner NDC (single vial) = 20 mL

The motion carried without opposition.

Requested: Clarification of the BUS

Request: The Medicines Company would like to clarify that the Billing Unit Standard for Orbactiv™ is "GRAM" (GM). The product is supplied in single-use vials, each containing 400 mg of oritavancin diphosphate. In accordance with section 4.2.3 of the Billing Unit Standard Implementation Guide, Orbactiv™ is "measured by its weight."

Why this request is needed: The Medicines Company would like to clarify that the dosage form of Orbactiv™ is "powders," as described in section 5.3.3 of the Billing Unit Standard Implementation Guide, and as such has an appropriate billing unit of "GRAM."

Orbactiv™ is an antibiotic used to treat patients with Acute Bacterial Skin and Skin Structure Infection ("ABSSSI"). The product received FDA approval on August 6, 2014, and the product’s labeling describes dosage as "A 1200 mg single dose treatment administered by intravenous infusion over 3 hours." The product is supplied as a sterile lyophilized powder in single-use vials containing 400 mg of oritavancin diphosphate. Orbactiv is supplied as three 400 mg vials per carton that are given as a single intravenous injection. At the time of use, physicians reconstitute each 400 mg vial with 40 mL of Sterile Water for Injection. After reconstitution, the 1200 mg of Orbactiv™ are further diluted in approximately 1000 mL of 5% Dextrose Injection ("D5W"). The patient is then administered Orbactiv™ in a single 1200 mg IV dose of 1000 mL D5W over three hours.

Because Orbactiv™ is first being marketed and commercially sold as of the date of this QUIC form, there are no current or historical CMS billing practices to take into consideration. However, assigning a billing unit of “GRAM” would be consistent with CMS’ treatment of similar products. Vibativ (J3095, Injection, telavancin, 10 mg), which is in the same class of antibiotics as Orbactiv™—lipoglycopeptide—has a billing descriptor in grams. Similarly, other antibiotics sold in the form of lyophilized powder in single-use vials and then subsequently reconstituted are also billed by CMS in grams. Examples include Sterile Vancomycin Hydrochloride, USP (J3370 Injection, vancomycin hcl, 500 mg) and Cubicin (J0878 Injection, daptomycin, 1 mg).

Outcome anticipated: As explained above, as a "powder," Orbactiv™ should be assigned a billing unit of "GRAM." See Billing Unit Standard Implementation Guide section 5.3.3. Oritavancin is not yet on the market, and The Medicines Company would like to ensure consistency between compendia listings and payors upon launch of the product, as well as between oritavancin and other, currently marketed antibiotics sold as lyophilized powders. Because oritavancin is supplied and measured by weight, a billing unit of GRAM will not cause payors to overpay or underpay. The anticipated outcome is that a billing unit standard of "GRAM" will be assigned.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of October 21st:
There was consensus from all on the call that per section 5.1.2 of the Billing Unit Standard the billing unit = one each because it is a reconstitutable powder for injection. The group also noted there are other products listed similarly that are covered by CMS for which there are no problems.

• 5.1 Dosage Forms Billed As "Each" (EA)
• 5.1.2 Injectable Powder-filled vials and multi-component containers (i.e. mix-o-vial with solution and powder within the vial) are billed as a unit of "each" regardless of size or content of vial in metric decimal units.

At this meeting, a motion was made and seconded to classify the BU=EACH (with a quantity of 3 for the box) per Section 5.1.2 of the BUS. The motion carried without opposition.

Requested: New Product/Package Information

Request: The Medi-RDT Kit (NDC 38779-7218-01) from Medisca contains the following items used to compound Rapid Dissolve Tablets. For billing purposes, is this product listed as a 1 EA Kit? Or, as 100 GM (amount of the base)?

• 1 x Medi-RDT Base, 100g
• 1 x Medi-RDT Mold, 96 Cavities x 750mg
• 1 x Medi-RDT Blister Pack w/Cold Seal & Sleeves, 160 Doses
• 1 x Hot Hand® Protector
• 1 x Sieve & Receiver Pan, 50 Meshes
• 1 x Powder Scraper

Why Needed: Clarification of billing quantity and billing unit is requested to ensure consistency.

Outcome Anticipated: The Medi-RDT Kit (NDC 38779-7218-01) contains components with 2 different billing units (GM and EA), so it is anticipated that it would be billed as a 1 EA Kit based upon section 5.5.1 of the BUS. Since it doesn’t include an active ingredient to compound a finished dosage form, it is not a compounding kit so BUS 5.5.3 does not apply.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of September 9th:
The Medi-RDT Kit (NDC 38779-7218-01) contains components with 2 different billing units (GM and EA), so it is anticipated that it would be billed as a 1 EA Kit based upon section 5.5.1 of the BUS. Since it doesn’t include an active ingredient to compound a finished dosage form, it is not a compounding kit so BUS 5.5.3 does not apply. Consensus was BU= one each kit per BUS 5.5.1.

At this meeting, a motion was made and seconded to classify the BU=EACH (kit) per Section 5.5.1 of the BUS. The motion carried without opposition.

Requested: New Product/Package Information

Request: This NDC is a grouping of devices that assist in administering the drug Varithena (60635-0118-01 =drug only). The NDC 60635-0123-01 contains no drug product. NDC 60635-0123-01 contains: 1-transfer unit to generate and dispense foam, 3-10ml silicone-free Luer syringes, 1-20” manometer tube, and 2-compression pads (plus instructions for use).

Why Needed: To determine whether this product is viewed by the BU standard as a 1 each kit or total number of separate components.

Outcome Anticipated: Unsure. I am assuming the items in the carton are not sold outside of the Administration Pack and only sold together. So, would that make this NDC 60635-0123-01 a 1 each kit or is this package considered a box of “eaches” to be counted and the total count be submitted as the billing quantity? If the latter, then Varithena Administration Pack (NDC 60635-0123-01) would be billed as 7 EA.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of September 9th:

A new box must be used for each patient
Contains:

• 1 x Varithena^™ Transfer Unit
• 3 x Low-Silicone Syringes
• 2 x Compression Pads
• 1 x Manometer Tubing

Rx only
For dosage and administration read the PI and IFU. To be used in conjuction with Varithena^™ (polidocanol injectable foam) only Sterile contents: do not resterilize. Store at controlled room temperature.

This does not cross billing units so it is not a kit. Consensus was we list as each with a billing quantity of 7. List as 7 each per BUS 5.1.6: Non-drug entities, such as test strips, swabs, or alcohol wipes, are billed as eaches and the quantity is the actual number in the container. See section "Frequently Asked Questions", question 7.41.

At this meeting, a motion was made and seconded to classify the BU=EACH per Section 5.1.6 of the BUS with a billing quantity of seven. The motion carried without opposition.

Requested: New Product/Package Information (It is a kit with a Topical Preparation with Tablet that is a Medical food).

Request: Ask WG2 to review this new item to make sure we are not missing anything needed for a successful launch. The Vascuderm Stasis Kit will be made up of:

• • 2 tubes 85 gms each of a topical preparation called Vascuderm Hydrogel Wound Dressing Product #68040-751-35
• • 1 carton Vasculera Tablets 30ct (Diosmiplex 630 mg). Product # 68040-610-14

The product # for the kit is different than the product # for the individual components. Vasculera Tablets are currently marketed and Vascuderm will be launched in the near future.

Why Needed: Want to make sure there are no issues prior to launch so we have a successful launch. Vascuderm Stasis Kit is for patients with Venous Stasis Ulcers caused by Chronic Venous Insufficiency (CVI). I am hoping the Vascuderm Stasis Kit will be listed as a billing unit of each (kit) with a quantity of 1 per section 5.5.1 KITS - BILLED AS AN EACH as it has two distinct billing units (grams and each).

Outcome Anticipated: Feedback prior to launch and listing of Vascuderm Stasis Kit as 1 each.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of July 29th:
All agreed this is a one each kit per section 5.5.1 of the BUS. A motion was made and seconded to approve as one each per section 5.5.1 of the BUS.

At this meeting, a motion was made and seconded to classify the BU=EACH (kit) per Section 5.5.1 of the BUS. The motion carried without opposition.

Requested: New Product/Package Information

Request: Ask guidance from NCPDP WG2.

Why Needed: Avoid conflicts with new product and what is in the BUS.

Outcome Anticipated: Collect guidance from WG2.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of July 15th:
Alan Ryan from Novartis was on the call. Novartis wishes to present the packaging at the WG2 meeting on August 8th to ensure there are no Billing Unit Standard concerns. This is an injectable that contains 150 mg per ml syringes. One package has 1 syringe of 1 ml and the other has 2 syringes of 1 ml each. Group agreed BU = ml with a billing quantity of one or two depending on what is in the package-per Section 5.2.2 of the BUS. All agreed.

It was suggested the company report to CMS that the smallest dispensing unit is one mL. Are there separate NDCs for inner and outer products? Alan will check but this is what NCPDP is recommending. At this meeting, a motion was made and seconded to classify the BU=mL per Section 5.2.2 of the BUS with billing quantities of one or two depending on what is in the package. The motion carried without opposition.

Requested: Clarification on the Billing Unit

Request: Please clarify Package Qty and billing unit; On SPL, the manufacturer has described this as a Kit which does not seem correct based on other adjudications for similar products. Item contains 60 tablets of a vitamin type preparation and 60 tablets of Doxycycline Monohydrate 100mg, to be taken concomitantly.

Why Needed: Drug wholesalers are listing as 1 each, probably based on the kit designation.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of April 8th:

Compendia show as 120 each. Per the standard, FAQ 7.6 and Section 4.2.1, the BU=each with a package size of 120. The task group also discussed Nicazel Doyx30 NDC 42783-0610-30 and determined the BU=each with a package size of 90 per the same references to the BUS. Kay will reach out to the manufacturer and let them know these should be listed as 120 each and 90 each respectively.

At this meeting, a motion was made and seconded to classify the BU=each per Section 4.2.1 for both NDCs 42783-0610-60 and 42783-0610-30. Billing quantities are 120 each and 90 each respectively. The motion carried without opposition.

Request: Reaffirm Copaxone 20mg billing unit in light of new package configuration.

Why Needed: For the past 10 years, Copaxone 20mg has been billed at 1 kit as the box of 30 prefilled 1-mL syringes also contained alcohol swabs. Starting in Q1 2014 a new package configuration will be introduced, using the same NDC, which will not contain alcohol swabs or any other prepping supplies. Simply 30 syringes. Continue forward with standard billing unit of 1 kit. Even though the new package configuration would not meet the NCPDP definition of a kit, changing the billing unit on existing product would be too disruptive.

Discussion: See QUIC #201403 Copaxone 40 mg.

The new product will be distributed mid-February. A new NDC was not required by the FDA but the BUS does state that a new NDC should be given when the package is changed. The FDA will be pointing to our new product ID standard once that is completed and approved. A motion was made and seconded to change the BU from one each kit to BU=one mL per syringe (package size of 30) per section 5.2.2 of the BUS. The motion carried without opposition. Both packages will be in the market place at the same time. Changes by the compendia will be made at the beginning of the 4th quarter, October 1, 2014. Take Change Template and apply dates for this product on the next Product Review and BU Exceptions TG call. An NCPDP NOW should be sent out soon and multiple times prior to October 1, 2014.

Request: Copaxone 40mg is a new product line extension. This is an injected product with 1 box containing 12 1-mL prefilled syringes. There are 4 3-syringe cards in blister packs with perforation between each syringe.

Why Needed: The billing unit for the current product (Copaxone 20mg, NDC 68546-0317-30) is one kit as the box of 30 1-mL syringes contained alcohol swabs. The new product packaging contains no prepping supplies. A billing unit of 1 1-mL syringe. A box of 12 syringes for 28 day supply would be counted as 12 units.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of January 28th:
Copaxone 40mg NDC 68546-0325-12 and Copaxone 20 mg NDC 68546-0317-30
Teva Pharmaceuticals current product, Copaxone 20mg, has a billing unit of 1 kit, as it contained alcohol swabs. The 40mg product they will launch will not include wipes. Additionally Barry learned that the packaging of Copaxone 20 mg has not included the alcohol swabs for a couple of years. Up to this year, the boxes (kits) have had a slot for the swabs but nothing has been in the slot. Starting this year, the package will change to just a box of 30 syringes, no empty slot.

If neither contains alcohol wipes, they are not kits and should have a BU of one ml per syringe. The group verified from package inserts that the wipes are not supplied for the 20mg. A motion was made and seconded to make the BU=one mL per syringe (package size of 12) per section 5.2.2 of the BUS. The motion carried without opposition.

Request: Crinone is packaged in applicators that contain 1.45gm of gel but deliver 1.125gm of gel containing 45mg progesterone. Per NCPDP BUS 7.34 indicates that for non injectable products the PS will be based on the total amount delivered and overfill will not be considered as part of the reported quantity. The PS should be 1.125 x the number of applicators:
Crinone 4% Gel NDC 52544-0283-24; 1.125gm x 6
Crinone 8% Gel NDC 52544-0284-12; 1.125gm x 15
Crinone 4% Gel -- NEW NDC 52544-0255-24; 1.125gm x 6
Crinone 8% Gel – NEW NDC 52544-0256-12; 1.125gm x 15

Why Needed: To ensure consistency with BUS and among compendia.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of December 17th, January 14th and 28th: Is the Package Size= 1.125gm x 15
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7def92fe-d521-41c0-b419-48e028f59f15

A list of all NDCs for Crinone and Prochieve listed by each of the compendium was compiled. This list had the billing unit and quantity for each NDC and included applicable off-market dates. The list was verified that compendia were in agreement as to which NDCs are currently active and which are no longer marketed.

Compendia agreed to the following: Crinone should be listed as the amount delivered and not the amount contained per FAQ 7.34 of the BUS.

7.34 HOW DO I BILL PRODUCTS THAT HAVE AN OVERFILL?
For non-injectable products, the package size will be based on the total amount of the product delivered (amount that can be extracted from the container; i.e. dispensed). Any overfill will not be considered as part of the reported quantity. Example: Tamiflu for Oral Solution contains approximately 33 mL, after reconstitution. Each bottle delivers 25mL of suspension. The reported quantity for dispensing should be 25mL.

Marketed Products to be listed as 1.125gm per applicator:
Crinone 4% Vaginal Gel               52544-0283-24   Watson Pharma Inc
Crinone 4% Vaginal Gel - NEW    52544-0255-24   Actavis
Crinone 8% Vaginal Gel               52544-0284-12   Watson Pharma Inc
Crinone 8% Vaginal Gel - NEW    52544-0256-12   Actavis

Those compendia needing to change BU will make the change by 2/1/2014.
The various package sizes for Crinone and Prochieve that are no longer marketed are to be left as is and not changed. There is no need to add a BUS FAQ to clarify why we did not change these off market products. An NCPDP NOW announcement will be sent to show that the change to the marketed products as 1.125 gms per applicator and will be made by February 1, 2014 for those compendia who do not have them listed as such now. The WG2 Clarification of the BUS’s Application TG will document in the Guidance Document that we conformed the newest NDCs for this product but left the old ones alone to avoid disruption to the industry.

A motion was made and seconded to classify BU=1.125 gm per applicator per FAQ 7.34 of the BUS. The motion carried without opposition. Those compendia needing to change BU made the change by 2/1/2014.

Request: Syrspend SF (Liquid) products are liquid suspending vehicles used to assist in the compounding of oral liquid dosage forms. The Manufacturer’s Website describes these products as: “All-in-one syrup-suspending vehicle” and “SyrSpend® SF (liquid) Description: hazy, white, translucent syrup.” Active pharmaceutical ingredient powders, crushed tablets or capsule contents are incorporated and mixed into the Sysrpend SF (Liquid). The products are labeled in “ML” and come in a variety of sizes. Per 5.5.2 bulk chemicals that are labeled in “ml” have a BU=ml. Bulk products are stock containers of chemicals used in compounding.

Why Needed: To ensure consistency in billing this product with all compendia.

Outcome Anticipated: Syrspend SF Liquid products should all have a BU of ml, if they are labeled as such.

Discussion: See QUIC #201401 – Syrspend SF Alka Powder and Syrspend SF Powder. A motion was made and seconded to classify the BU=mL per Section 5.5.2 of the BUS for the Syrspend Liquid products, labeled in ml. The motion carried without opposition.

Request: Syrspend powder SF & Syrspend SF Alka are powder suspending vehicles used to formulate oral liquids using active pharmaceutical ingredient powders, crushed tablets or capsule contents, which are to be mixed with Syrspend and then reconstituted to a final volume. The manufacturer makes small and very large size bottles (sizes vary from 1.1gm to 10000gm). The larger sizes are labeled only in KG. The smaller sizes are labeled in gm and in parenthesis include the final volume after reconstitution. Below are the NDCs in question, with label name and package size as listed on the label:
51553-1139-09: SYRSPEND SF ALKA DRY CHERRY, PS=10KG
51552-1201-09: SYRSPEND SF ALKA DRY, PS=10KG
51552-1201-02; SYRSPEND SF ALKA, PS=3.8GM (To Make 60mL)
51552-1139-02; SYRSPEND SF ALKA, PS=3.8GM (To Make 60mL)
51552-1201-05; SYRSPEND SF ALKA, PS=6.3GM (To make 100mL)
51552-1139-05; SYRSPEND SF ALKA, PS=6.3 GM (To Make 100mL)
51552-1123-01; SYRSPEND SF POWDER, Cherry (For Reconstitution); PS=1.1GM (To Make 30mL)
51552-1274-02; SYRSPEND SF POWDER Dry & Unflavored (For Reconstituion); PS=2.1GM (To Make 60mL)

These products are not drugs. They are powders and suspending vehicles used in compounding. The final volume of the resulting compound is that of the Syrspend plus the active ingredient, not just the Syrspend. Per 5.5.2 bulk chemicals that are labeled in “gm” have a BU=gm. Bulk products are stock containers of chemicals used in compounding. For the Syrspend SF Alka products, labeled in kg, the BU is GM - in accordance with 5.5.2. For the Syrspend SF Alka and Powder Products labeled in “..gm (to make..ml)”, the BU should also be GM for consistency with the other core 9’s listed in “gm”. Like the larger Syrspend SF Alka Products labeled in GM, these products are used in compounding and can only be dispensed after the addition of the active ingredient and sterile water. Additionally per 5.4.1 “When both milliliters and grams are supplied on the package label, use the first measurement unit listed.”

Why Needed: To ensure consistency in billing this product with all compendia.

Outcome Anticipated: Syrspend SF Alka and Syrspend SF Powder products should all have a BU of gm, if they are labeled as such.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of November 19th, December 17th, January 14th and 28th: This product was brought for discussion since it appeared on the BU discrepancy report. The group discussed at length whether the smaller size of 3.8 should be grams or mls and reviewed sections 5.5.2, 5.1.8, 5.2.3, and 5.1.17 of the BUS. A search for other similar products was made. Billing scenarios for these products were developed and reviewed. Further discussion and review were assigned to the Billing Unit subgroup who recommended the billing unit be gram on all Syrspend Powder products. Per 5.5.2 bulk chemicals that are labeled in “gm” have a BU=gm. Bulk products are stock containers of chemicals used in compounding. A motion was moved and seconded that the SyrSpend powders should be billed in grams. If the product is supplied as a powder to be reconstituted it is to be measured as grams. The motion carried. The group agreed the liquids should have a billing unit of mLs.

At this meeting, a motion was made and seconded to classify the BU=gm per Section 5.4.1 of the BUS for the Syrspend SF Alka products. For the Syrspend SF Alka and Powder Products labeled in “..gm (to make..ml)”, the BU=gm for consistency with the other core 9’s listed in “gm”. Also add an update (5.4.1) to the BUS to include other types of products besides those named. The motion carried without opposition. Those compendia needing to change BU will make the SyrSpend changes for the end of Q1 (around 4-1-14).

Request: Product package contains two blisters strips of 30 each. One strip of 30 blisters contains fluticasone furoate and other strip of 30 blisters contains vilanterol. Two blisters need to be combined for one dose. The total number of doses in the package is 30.

Why Needed: The package has a unit counter on the side indicating 30. The NCPDP work group reviewed this previously and determined that each blister should be counted and ruled that the billing unit should be 60. GSK believes that this will cause billing problems with Medicare and Medicaid and wish that the work group would reconsider changing the billing unit to 30.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of May 21, 2013 where the group agreed the BU=60 EACH per Section 5.1.3 of the BUS. Discussion also occurred on October 8^th. See discussion on QUIC #201326.

A motion was moved and seconded to approve the BU as 60 each per Section 5.1.3. The motion carried without opposition.

A motion was made and seconded to make the BU=each quantity of 60 (total number of blisters) per Section 5.1.3 of the BUS. Ask the manufacturer to clearly state the total number of blisters on the package. Kay will contact the manufacturer with this suggestion. The motion carried with one opposed.

Discussed at the August 2013 WG2 Meeting. Request Type: Clarification of the Billing Unit Standard

Request: Some Miconazole Cream products are packaged as 1 tube of cream (in grams) plus 3 pre-filled applicators of cream. There is inconsistency as to how these products are listed: 1 ea vs total number of grams.

Why Needed: Through research (the discrepancy sub task group) we have discovered that some of these products have wipes included in them, some of them do not have wipes included.

Outcome Anticipated: That Miconazole packages that include: 1 tube cream + a given number of cream pre-filled applicators be listed as total number of grams per 5.4.2. Miconazole packages that include: 1 tube cream + a given number of cream pre-filled applicators + wipes/alcohol swabs should be listed as 1 ea kit per 5.5.1 (point #2). If accepted, it is preferable to schedule a coordinated change across all compendia. It is preferable to apply only to active items on the databases.

Discussion: The Product Review and Billing Unit Exception Task Group’s subgroup on Package Size discussed this product on the TG call of May 21^st, June 4^th, and July 16^th per their review of:

Monistat-3 [3 prefilled applicators (5g/applicator) plus 9g tube of cream] and various generic/private label products

Original question = should this be listed as 24g? Currently most compendia list as 1 EA Kit.

Findings:

·        Per contact at Insight Pharmaceuticals, the only Monistat-3 package containing wipes is package with identifier 363736449803.  This package contains 3 ovule inserts and is NOT the pre-filled applicators that we are reviewing.  Contact at Insight was not responsive to providing additional information about these products.  Most compendia are not listing Monistat from Insight.

·        Some private label packages are including external wipes which make it a 1 EA kit.

o   Wipes included = Walgreens, RiteAid

o   No wipes = Kroger, Topco, CVS, Target

SubTG recommendation for pre-filled applicators + external cream:  

·        List these products per BUS. 

·        If no wipes, then list as total grams of cream [Ex. (3 applicators x5g/appl) + 9g cream = 24 g] If wipes included, then list as 1 EA Kit.

·        As a result, the private label products will not be consistent as to Pkg Size and BU.

·        As a compendium receives information that wipes are added or omitted, then communication of this information needs to occur so listings can be updated.

·        If above recommendation is accepted, then coordination of a change date is necessary.

TG Discussion: Does everyone agree with recommendation? The subgroup agreed that we either change or make an exception. All preferred to make the change. Most of these are private labels. A QUIC form is recommended.

The private labels vary as to containing wipes or not. By resolving the QUIC forms as grouped by wipes and no wipes, it would address the private label which cannot all be identified.

Are they listed as Med D products? No. Do we have utilization information on the ones that will change? No but the general sense is that there is not a lot of activity. Anne provided Express Scripts utilization of the NDCs - less than 100 prescriptions across all of the NDCs for one year. This would be a minimal impact from a processor’s perspective.

A motion was made and seconded to list the items with wipes as each (kit) per Section 5.5.1 of the BUS and those without wipes to list as grams per Section 5.4.2 of the BUS. A list of NDCs will be provided in the NCPDP NOW. The compendia will coordinate the change on October 1, 2013. The motion carried with no opposition. 

At the May 2012 WG2 meeting the form was discussed. Request: We would like to inquire how this product should be listed/billed (as GM or EACH).

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of March 13th:

This product is packaged in a pouch, net wt. 1gm. The group felt that 5.1.8 did not apply since it is not a powder for reconstitution; therefore, it is not EA. Section 5.4.2 was the most applicable which supports the billing unit of GM. All agreed that the billing unit is GM based upon 5.4.2.

A motion was made and seconded that the BU = 1 GM per packet per Section 5.4.2 of the Billing Unit Standard. The motion carried with no opposition.

Discussed at the August 2013 WG2 Meeting. Requested: Clarification of the Billing Unit Standard and New Product/Package Information

Request: INSYS Therapeutics Inc. announced that Subsys 1200 mcg and 1600 mcg have new NDCs, but the packaging remained the same. (See attached product labeling for Subsys 1200 mcg & 1600 mcg). Additionally, the following email was received on May 16^th from Dion Reimer of Insys Therapeutics:

In order to clarify the number of doses actually contained within the 1200 and 1600mcg cartons, Insys recently opted to change the last two digits of the NDC numbers for these strengths from “30” to “15” to reflect the number of doses rather than the number of spray units contained within each carton. Thus, the new NDCs for the 1200 and 1600 mcg SUBSYS strengths are 20482-012-15 and 20482-016-15 respectively.

Why Needed:  Due to the recent NDC changes to the Subsys 1200 mcg & 1600 mcg products and the changing of the last two digits of the NDC numbers for these strengths from “30” to “15”, there is the potential for confusion as to whether or not the correct package size is “15” or “30” each.

Anticipated Outcome: Subsys 1200 mcg is supplied as two (2) 600 mcg device units; and this carton contains 15 blisters which contain two 600 mcg device units in each blister.  Therefore, the billing unit and package size should be listed as “each” and “30”. 

Similarly, Subsys 1600 mcg is supplied as two (2) 800 mcg device units; and this carton contains 15 blisters which contain two 800 mcg device units in each blister.  Therefore, the billing unit and package size should be listed as “each” and “30”.

Based on the actual number of spray/device units in each blister and NCPDP BUS Sections 5.1.12 and/or 5.1.17, all compendia agree with the billing unit of “each” and package size of “30” for both Subsys 1200 mcg & 1600 mcg.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of May 21^st and June 18^th

What is the Billing Unit & Billing Quantity for each of these NDCs?   

Do you interpret the NDC for the entire carton/box to be billable as 15 EA or 30 EA?  

Via email, all compendia responded with 30 EA for these 2 strengths of Subsys per Sections 5.1.12 and/or 5.1.17 of the BUS

The NDCs changed but not the packaging. All agreed that this should be 30.  The packaging might be confusing. The 1200mcg has two of the 600mcg units packaged together in a pouch so both units need to be used for the 1200mcg dose. One could be used and not both even though it would be contrary to how the package is labeled. Two blisters equal one dose and we count each blister. Additional clarification is needed regarding Insys Therapeutics’s concern/issue. Kay responded to Dion to inform him of the group’s action and to ask if he has further information. Dion was fine with the recommendation by the task group.

A motion was made and seconded that the BU = EA, quantity of 30 per Sections 5.1.12 and 5.1.17 of the BUS. The motion carried with no opposition.

Discussion:The Product Review and Billing Unit Exception Task Group via email on October 27 and 28, 2010:

The task group agreed that this should be 26 per pump dispenser with a total of 52 grams. This also is consistent with what we’ve been saying to the FDA about the overfill in the liquids.  Here we have the same situation with grams – more in the container than the device can deliver. Per the BUS:

Section 5.4.2 Topical Products - These products must be billed as the number of grams (GM) or milliliters (ML) in the container. Do not bill the number of ounces dispensed or the number of packages dispensed. (Topical products less than 1 gm are billed as “eaches”; see section 5.1.13 of this document above.)

A motion was moved and seconded to approve as a billing unit of grams and a dispensing quantity of 52. Can the package be broken apart? Yes. There are two NDCs—one on the package and one on each dispenser (same NDC on each dispenser).

Discussed at the August 2013 WG2 Meeting. Requested: Clarification on the Billing Unit

Request: According to the outer carton, the product contains 5 mini-enemas. The outer carton does not indicate the package size. Images of the enemas inside the carton show that the volume is 5 ml. This product does not contain a package insert.  This is a similar issue to Enemeez, QUIC Form 201207 and 201119. Is the BU=ml per 5.2.1?  or is the BU= ea per 5.2.8?

Why Needed: To avoid billing unit discrepancies

Outcome Anticipated: A decision for billing unit that is based on the Billing unit standard

Discussion: Via emails, the compendia representatives discussed:

There appears to be no indication of the volume on the carton or individual tube.  However, the pricing sheet states (5) 5mL tubes. If we agree that the DocuSol Plus mini-enemas do not indicate a volume, then per section 5.2.8 of the BUS and FAQ 7.38, the BU=EA and the billing quantity for the NDC would be 5.

7.38 WHY DO VACUANT AND ENEMEEZ HAVE A DIFFERENT BILLING UNIT THAN DOCUSOL?

All three products are mini-enemas containing a liquid. Docusol does not note the volume of the liquid in the container on the label. Therefore, per section 5.2.8 of the standard, the billing unit for Docusol is “ea” (5 ea). Vacuant and Enemeez have the volume of the liquid in the container identified on the label. The billing unit for Vacuant and Enemeez is ml as per section 5.2.1.

However, the volume on the individual tubes is shown as 5ml. Is it realistic to expect the pharmacist to open the box, which may be sealed, to determine a metric volume? Is the BU mL or EA? In Section 2.2: The billing unit and quantity are taken from the product labeling that is affixed to the product and is readily available to the dispensing pharmacist.  If the package size differs between the package label and the package insert, the size noted on the package label is used. While the standard would state that this is ml per the standard, there is no way the pharmacist would know the 5 ml since it only appears within the box. This is an OTC product which is typically sealed shut. Practical adjustments must be made when applying the standard.

Discussed at the August 2013 WG2 Meeting. Request Type: Clarification of the Billing Unit Standard

Request: Carton contains 1 bottle of Rezamid Lotion (56.7gm) and 1 tube of Color Matcher (2.5gm). The carton displays the package size of the lotion only. The only reference to the color matcher even being included in the package is on the bottom back of the carton, but makes no mention of package size. Should we use section 2.2 of General Rules “The billing unit and quantity are taken from the product labeling that is affixed to the product and is readily available to the dispensing pharmacist” and ignore the tube of color matcher, making the package size 56.7gm? Or do we use section 7.30 and include the complimentary item as part of the package size as 59.2gm?

Why Needed: There may be discrepancy between compendia in how this product’s package size could be reported

Anticipated Outcome: A decision for package size that is based on the Billing Unit Standard and coordination amongst the compendia as to when this change will be made.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of June 18^th.

This is an existing product on database since 1991. Currently this is listed as 60 mls by most compendia. If we ignore the color matcher it would be considered an exception even though there is nothing on the package.  An FAQ would need to be written to exclude the color matcher in the billing unit. Can we add to the exception of kit? Karen can review to find the right section within the BUS to see how the color matcher can be ignored. (Possible change to 5.1.16 as well as added to the list ignored for kits.) All agreed that this should be listed as 56.7 gm, per the updated section 5.5.1 of the BUS.

A motion was made and seconded that the BU=56.7 gms and not count the color matcher (2.5 gms) per Section 5.5.1 of the Billing Unit Standard. The motion carried without opposition. Compendia changes will occur October 1, 2013.

• items with a quantity less than one and a billing unit of GM or ML
• small volume nasal products (Flumist Nasal Spray, Imitrex Nasal Spray, Lazanda Nasal Spray, Sprix Nasal Spray, Sumatriptan Nasal Sprays, and Zomig Nasal Spray)

Discussion: The Product Review and Billing Unit Exception Task Group compiled, reviewed and discussed a spreadsheet of items in the compendia’s files with the dosage form “bar” and products containing a “bar” and determined that “bars” should have a BU of EACH. Since it was questioned how this decision affects the Brevoxyl QUIC form which was adjudicated to count the bar of soap as GM, QUIC forms for dosage form of bar and for the Brevoxyls (to include BPO Creamy Wash Complete Packs) were completed for WG2 review.

A motion was moved and seconded to add bars as dosage forms with billing units of one each to the billing unit standard. The Product Review and Billing Unit Exception Task Group will review the list of bars and coordinate the date of the change by all. There should be a change to the BUS to add the “bars” as an each. The old QUIC form of #970008 for Desquam-X Bar 10% will be noted to point to the new QUIC form of #201010.

Requested clarification for the billing unit quantity. At the November 2010 WG2 meeting the form was discussed. Issue: Topical and Oral Bar dose forms are under review. Brevoxyl and BPO Creamy Wash products each contain a cream-type wash and a bar soap. At the 11/08 WG2 meeting, a QUIC form (#200806) for the Brevoxyl was adjudicated as GRAMS: Cream Wash of 170.1 grams + Bar Soap of 21 grams = 212.1 grams (all 4 NDC’s have same pack size). If topical and oral bars are ruled to be eaches, this would affect all 4 of these NDC’s as they are currently listed as total number of grams. As an added note: a discussion of the Exception Task Group took place and these 4 NDC’s are the result of a project to find all combo products containing a product with a bar dose form.

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product. See QUIC form #201010 on Bars.

A motion was moved and seconded to approve these 4 products as a billing unit of one each with a quantity of one kit and that this change be made by the compendia on the last file update of the year. According to the BUS, whenever there is more than one billing unit type in a package, it is considered an each and a kit. The motion carried without opposition.

Request: Product package contains two blisters strips of 14 each. One strip of 14 blisters contains fluticasone furoate and other strip of 14 blisters contains vilanterol. Two blisters need to be combined for one dose. The total number of doses in the package is 14.

Why Needed: The package has a unit counter on the side indicating 14. The NCPDP work group reviewed this previously and determined that each blister should be counted and ruled that the billing unit should be 28. GSK believes that this will cause billing problems with Medicare and Medicaid and wish that the work group would reconsider changing the billing unit to 14.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of October 8^th:

Joey Pipkins and Carol Ball were in attendance to represent the QUIC forms for these products. Each medication is individually wrapped –the inhaler is 30-dose. They have concerns there could be confusion if listed as 60 for the billing unit—dispensing and reimbursement errors. Many physicians will write as one supply for 30 days.  2 blisters must be opened for a patient to receive one dose---it is a combination product.

It was explained that the billing unit is not determined by the days supply or dosing. Dosing can change which would lead to reimbursement problems. Determination by what is in the pack is the safest means to determine the billing unit. We came to 60 when seeing that this contains 2 blisters strips of 30 each.

5.1.3 Powder-filled Blisters must be billed as the number of blisters, not by weight.

Joey stated there are aware of an instance of a payer giving feedback that 60 would cause billing errors. He also noted the medications could not be included in the same blister. The payers on the phone felt that this would not be a billing issue. Joey noted that the blisters for each drug component are priced differently. The group pointed out that if that is the case, separate NDCs will need to be assigned and pricing for each provided to the compendia. Carol confirmed there would be no separate pricing submitted to the compendia nor separate NDCs assigned.

The group was asked to consider a billing unit of one for the package. The task group stated that this would be confusing whichever way you landed, the assignment should start out correctly and the standard followed. One attendee stated there is nothing on the labeling that clearly states the amount of dosing but there is great detail on the strips and the amount of strips. The labeling states that the 2 foil strips are 30 blisters each.

Helidac and Prevpac are the same as these products—different meds where are blisters are counted. There are other products on the market that contain different medications for individual doses. It would be a disservice to not follow the standard and would cause more confusion.

How supplied (that is submitted to the FDA): FDA is using the NCPDP Billing Unit on their SPL site.

16 HOW SUPPLIED/STORAGE AND HANDLING

BREO ELLIPTA is supplied as a disposable light grey and pale blue plastic inhaler containing 2 double-foil strips, each with 30 blisters. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid (NDC 0173-0859-10).

A motion was moved and seconded to approve the BU as 28 each per Section 5.1.3. The motion carried without opposition.

A motion was made and seconded to make the BU=each quantity of 28 (total number of blisters) per Section 5.1.3 of the BUS. Ask the manufacturer to clearly state the total number of blisters on the package. Kay will contact the manufacturer with this suggestion. Asmanex was .24 grams and was changed to 1 each as of April 2012 because of a quantity less than one. (See FAQ 7.26) The motion carried with one in opposition.

Request: PCCA originally submitted labeling with unit of measure as MU, FDB recently received updated labeling in MG. Manufacturer states this product has a potency of 7177 iu/mg. When asked about the potency range, the manufacturer states: “specifications for potency is >=2500 iu/mg.” This suggests that the product has a variable potency. Should the billing unit for this product be “gm” or “each”? According to EP’s definition: “Chorionic gonadotrophin is a dry preparation of placental glycoproteins which have luteinizing activity. It is extracted from the urine of pregnant women. The potency is not less than 2500 IU/mg.” EP also indicates that labeling should include the number of international units per container and per milligram.

Why Needed: To ensure consistency with BUS and among compendia.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of September 10^th:

If the label is in grams, where does that leave NCPDP? The pricing was submitted in grams. The amount of HCG varies depending upon the lot. This is a variable potency since each gram may contain a variable amount. Does anyone else supply HCG powder? Yes. We need to look at this as a bulk chemical powder billed as a one each. All agreed the BU=EACH per Section 5.5.2 of the BUS and FAQ 7.17.

A motion was made and seconded to classify BU=1 EACH per Section 5.5.2 of the BUS. The motion carried without opposition.

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of November 22, 2011:

Section 16 How Supplied

Each Vial is for single eye use only. EYLEA is supplied in the following presentation [see Dosage and Administration (2.3) and (2.4)].

Section 3 Dosage Forms and Strengths

Single-use, glass vial designed to provide 0.05mL of 40mg/mL solution for intravitreal injection.

It was suggested that Eylea would be ml since it is injectable. It only delivers .05 ml. The task group determined: BU= ML; Package Size= 0.05 per Section 5.2.2 and FAQ 7.34

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.

FAQ 7.34 HOW DO I BILL PRODUCTS THAT HAVE AN OVERFILL?

For non-injectable products, the package size will be based on the total amount of the product delivered (amount that can be extracted from the container; i.e. dispensed). Any overfill will not be considered as part of the reported quantity. Example: Tamiflu for Oral Solution contains approximately 33 mL, after reconstitution. Each bottle delivers 25mL of suspension. The reported quantity for dispensing should be 25mL.

For non-injectable products where the deliverable volume is expressed as a range, the reported quantity for dispensing will be the lower volume of the range. Example: CellCept 200mg/mL oral suspension lists the net content after reconstitution as 175 mL and the deliverable volume after constitution as 160-165 mL. The reported quantity for dispensing should be 160mL.

NOTE: In November, 2010, it was determined that overfill, regardless if the product is reconstituted or not, will not be included in the billing quantity reported. From 2007-2010, Lucentis was an exception to the standard (see FAQ 7.28). With the change in 2010, Lucentis is now in compliance with the BUS.

All compendia were informed of this decision.

A motion was made and seconded that the BU = ML and the Package Size= 0.05 ml per Section 5.2.2 and FAQ 7.34 of the Billing Unit Standard. All the compendia have a package price that roll up to a unit price. This will be rolled up to one ml. The motion carried with no opposition.

Discussion: The Product Review and Billing Unit Exception Task Group discussed on their call of August 17 and September 14, 2010:

The request is that the billing unit be 30 ml. Package states volume 52 ml. 30 is stated on the artwork. This is a single unit of use. All agreed that the billing quantity should be 30 ml. We should recommend to the manufacturer to take off any reference to 52 on the package because of billings errors and potential overpayment. 30 should be made more visible. A response was sent to the submitter stating that we strongly suggest that the package be changed because of overpayments.

A motion was moved and seconded that the billing unit should be 30 ML. The motion carried without opposition. It was requested that we modify the BUS to show that the FAQ 7.28 is for an exception and update FAQ 7.34. The Product Review and Billing Unit Exceptions TG will work on these modifications.

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of August 17, 2010:

Section 5.5.1 of the BUS lists examples of items that should be ignored for billing purposes when packaged with a drug item.  Peak Flow Meters are not listed and neither are any examples of devices used to measure the efficacy of drug therapy. The Peak Flow Meter is not used in the administration of the drug and it is not a measuring device. Also, it is not on the list of items that defines a kit. A member reminded the group that the list of items to ignore for purposes of billing Section 5.5.1 is not an all inclusive list. All agreed that ML is the most appropriate billing unit for this product. The compendia will list AsmalPred Plus as ML if approved by the work group.

Are there any other products like this? What swayed the task group was Tyvaso that had everything in the box. The box shows 237 ml. A motion was moved and seconded to approve as ML for the billing unit. The motion carried without opposition.

Requested clarification for thebilling unit quantity. At the November 2011 WG2 meeting the form was discussed. Issue: o determine how the product will bereported by the Pricing Compendia Services, dispensed by Retail Pharmacies andbilled by Payers and Processors.  This isthe first alpha-1 proteinase inhibitor with a strength that does not vary fromlot to lot. Clarification of the billing unit as it is the first standardizedpreparation of alpha-1 proteinase inhibitor. All other marketed products ofalpha-1 proteinase inhibitor vary from lot to lot.

Discussion: TheProduct Review and Billing Unit Exception Task Group discussed this product ontheir calls of October 11 and 25, 2011:

Glassia,an alpha-1-proteinase inhibitor appearing on the BU differences list.  It seems to have a standardized strength.This product does not appear to vary from lot to lot. There is a standardizedstrength in liquid form and always has the same volume. Section 5.1.7 of theBUS addresses Alpha-1 proteinase inhibitors that vary from lot to lot.  How do we set up an alpha-1 proteinaseinhibitor product that is not variable from lot to lot? Glassia is a solutionfor injection and solutions are typically billed per ml. Do we treat Glassiadifferently because of the drug? Compendia have different billing units.Deborah mentioned that the pricing is per mg. All agreed that the billing unit of Glassia should be ML, per 5.2.2 ofthe BU Standard.

After the Task Group meeting,Julie sent a letter that First DataBank received from Baxter stating thefollowing:

Thisproduct was discussed on our last called and determined the billing unit, per5.2.2 of the Billing Unit Standard, should be 1 gram per 50 mls since theproduct does not vary from lot to lot. After the call Julie receivedinformation that the volume does varyfrom lot to lot and the package insert was misleading. Given thisinformation, the group agreed that the billing unit, per section 5.1.7 of theBilling Unit Standard, should be each because the volume could be variable.This is not an exception to 5.1.7.

5.1.7

Products derived from biologic sources where the strength or the volumeis variable from lot to lot shall be billed as “1” each. In the casewhere strength varies from lot to lot, the number of strength units shall bethe package size. In the case where volume varies from lot to lot and the strengthremains constant, the billing unit shall be “1” each per packaged product.

A motion was made and secondedto list as EACH per Section 5.1.7 of the Billing Unit Standard. It was suggested that there should be aprimary rule that because a product is an Alpha-1 proteinase inhibitor, the BUshould be an each. The motion carried.

• packets of cholestyramine (Questran); i.e. quantity 6Ø packets are billed as 6Ø EA),

Why Needed: Helidac is now packaged in 224 individual blisters making its exception status obsolete. There are new products to the market such as Omeclamox (40 Amoxicillin caps, 20 each Omeprazole Caps and Clarithromycin tabs = 80 total, individually blistered) represented as 80 each per 5.1.11: Convenience Packs, Therapy Packs, Starter Packs and packs of Oral Contraceptive must be billed as the number of individual tablets or capsules (EA) dispensed, not the number of boxes or packages or cavities. Expected outcome: Change in pack size from 56 each to 224 each and removal of the exceptions to Sections 4.3, 5.6 and FAQ 7.6.  (provided Prevpac is also overturned as an exception. The other drug in the exception is Pravigard which is no longer in the marketplace)

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of July 17^th and July 31^st.

During the discussion of Omeclamox-Pak, the task group determined that the exceptions listed in the BUS (section 4.3, 5.6, and FAQ 7.6) for Helidac, Prevpac, and Pravigard required review to ensure they are still exceptions. Current product packaging images/labels for Helidac and Prevpac were reviewed which indicated that the tablets and capsules are individually blistered.  (NOTE: Pravigard is no longer marketed.)

Decision:  All agreed that the products as currently packaged are not exceptions to the BUS.

If the QUIC Forms are adjudicated, a DERF will be submitted at the November 2012 WG meeting for changes to the BUS for Sections 4.3, 5.6 and FAQ 7.6. 

A motion was made and seconded that the BU = Each (quantity of 224), removal of the exception to Sections 4.3, 5.6 and FAQ 7.6 of the Billing Unit Standard and compendia to make the change in the future depending on the approval of the DERF to remove the exception. It was noted that the compendia would make the change at the first of a quarter. The motion carried with no opposition.

Qutenza will be on the market for 1 year (April 2, 2011) and is indicated for Postherpetic Neuralgia (PHN). This is a pain patch that must be administered by a physician.  It is applied for one hour then removed. The product is supplied in 2 sizes; 1 carton containing one patch and one tube of cleansing gel (non-medical) & 1 carton containing 2 patches with cleansing gel

Why Needed: In accordance to the Billing Unit Standard and information provided to NeurogesX on 12/3/2009 from the WG2 Billing Unit Exception Task Group it was indicated that this product should be billed by the kit. NeurogesX was unable to give each carton a different core 9 NDC# because each carton needed to contain the same product code.  Changing the product code and making it a different core 9 was technically incorrect according to FDA regulations. According to the manufacturer, “We need this product reported by the each patch (not as a kit). Because of the core 9 situation with this product we need the unit of measurement to reflect an EACH PATCH. This is the smallest dispensed unit. Since CMS in the drug rebate program only reads the core 9 NDC#, we need to identify and price this on an each patch.” Currently the BUS recognizes this product as an each Kit. The Pricing Compendia have the price at each Kit. A specific J-code (J-7335) was assigned this product, beginning 1/1/2011 and the billing unit per CMS is based on A per Centimeter². There are 28 billing units on one patch.  We need to be uniform in the industry on how this product is billed. Currently, we have it by one each Kit (pricing compendia) and one each Patch.

This product needs to be recognized as a ONE EACH PATCH by the Pricing Compendia, Government Pricing.  This will allow some consistency in billing.  The J-code (cm2 ) does refer to the measurement of the Patch per patch.  

Discussion: Linda Schock provided clarification and led the discussion. This is intended for single use. This product would be billed under the J Code. This product currently has the correct billing unit assigned as a kit because it is two different types of billing units in the package. An exception to the standard is being requested since it is dosed excluding the cleansing agent. Do we add a section to the BUS for physician-dispensed drugs? This is not an issue of how the physician views the drug but rather how a government agency made an arbitrary decision without knowledge of how the world looks at the product. There would need to be a different billing unit for physicians as opposed to the Telecommunication Standard and caution was given to avoid such an approach. There is no other area within the BUS to apply this product and it was have to be an exception to the kit assignment. Other patches in the market are based on the patch and this product is based on dosing where a part of a patch could be used. Linda knew of no way to appeal the assignment of the J code. Linda stated that the issue is the assignment of kit on the two patches. When one is being billed, it could be one patch or one kit. A motion was moved and seconded to make this an exception to the kit within the BUS and to bill as an each patch rather than as an each kit. One attendee stated that he could not support an exception. Would LTC pharmacy dispense this product? There is a need to have the physician present while the application is being put on—so there would be challenges and there has not been any billing of such since it has been on the market. There are no REMS on this product. Some shared concerns that we are making an exception to our standard based on an error made by a government agency. If we make this exception based on the J code status does it muck up the 99.9% of the other kit products? This would set a precedent. The 6 exceptions in the Billing Unit Standard were reviewed and none were given for this reason and were adjudicated per the current status of the standard at the time. It was noted that as we look at our definition of kit, we should consider the non-NDC ancillary items in kits. The motion failed by a vote of 5 approves and 21 opposed.

Pen - Total Quantity: 4 single dose Pen packages, each containing 1 Pen and 1 extra needle in the carton

Each Pen Package includes supplies to deliver a 2-mg dose -Use 1 Pen package per week.

BYDUREON Vial Carton - Total Quantity: 4 single dose trays – Each tray includes supplies to deliver a 2 mg dose Use 1 tray every week.

Why Needed: The following outlines the anticipated outcome of BYDUREON^TM:

How will it be listed in the Pricing Compendia Systems (each, mL or kit)?

How will Pharmacies dispense (each, mL or kit)?

How will Payers and Processors bill (each, mL or kit)?

Consider modifying Pen Carton Wording to match the BYDREON Vial

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their calls of April 10^th with Karen M. Biancalana of Amylin Pharmaceuticals, Inc. attending the call:

·        How the product is currently represented in the different compendia? Drug is not yet approved.

·        Is a picture of the package available as it would be stored on the shelf in a pharmacy? See Below

·Does this product set a precedent, is it accepted, or is there another similar product? No precedent. Similar to BYDUREON Vial

·        What is indicated on the package regarding "package size" and/or "units"? 2 mg /pen

·        How would CMS/Medicaid bill this product currently and historically? Anticipate to be billed as a Each

·        Would the requested billing unit cause Payers to underpay or overpay for the product? No

·        If applicable, does the product meet "kit" requirements? Possibly

·        Is the package meant to be broken? No

·        Would a pharmacist be LIKELY or ABLE to break the package despite the recommendations in the package insert? Yes, pharmacist is able, but not likely

·        Is off-label utilization a concern? No

·        If applicable, does the product have NDCs on each individual component? Yes

·        What would be the implications of changing billing units? Drug is not yet approved.

Does this apply to Section 5.1.2 - Injectable Powder-filled vials and multi-component containers (i.e. mix-o-vial with solution and powder within the vial) are billed as a unit of "each" regardless of size or content of vial in metric decimal units.  (For multi-component vials containing two liquids, see section 5.2.2.)

Staying away from the tray as everything in the tray is not counted as a billable unit. Each pen is a single dose used once a week. There are four pens and only one extra needle in the carton. Is this the first product that has a powder and a liquid? Yes. The pens are activated and there is no need to transfer the liquid to the powder. Is this like Gentropin? Gentropin is listed as an each.  What is the volume? This is a unit of use product and a one-time dose. All agreed that this should be an each per pen based on Section 5.1.2—4 eaches for the box. The carton is a 220-04 and an individual NDC on each pen, 222-01. Same core nine. The group recommended that the pen package should be 220-01. Proposed Bydureon^TM Pen Carton wording: Pen - Total Quantity: 4 single dose Pen packages, each containing 1 Pen and 1 extra needle in the carton. Each Pen Package includes supplies to deliver a 2-mg dose -Use 1 Pen package per week. The group suggested the removal of the word “packages” since it is confusing. Suggested verbiage to state: Total Quantity: 4 single dose Pens: one carton containing 4 Pens and 1 extra needle. Each Pen to deliver a 2-mg dose – Use 1 Pen per week.

QUIC form to be presented at the WG2 May 2012 meeting with anticipated outcome of one each per pen based on Section 5.1.2 of the BUS—4 eaches for the box.

Request: The Marqibo Kit (NDC #20536-0322-01) contains the following:

• • Vial Containing VinCRIStine Sulfate Injection, USP 5mg/5mL (1mg/mL)  Inner NDC #20536-0323-01
• • Vial Containing Sphingomyelin/Cholesterol Liposome Injection 103mg/mL  Inner NDC# 20536-0324-01
• • Vial Containing Sodium Phosphate Injection 355mg/25mL (14.2mg/mL) Inner NDC# 20536-0325-01
• • Flotation Ring / Overlabel for Sodium Phosphate Injection vial containing Marqibo / Infusion Bag Label

Why Needed: This request is needed to provide clarity in the industry on the Unit of Measurement (UOM) for this physician administered Oncology product. The J-code to be assigned in October 2013 will be based on 1 mg.

Outcome Anticipated: To maintain the Unit of Measurement as an EACH KIT as all of these components currently contained in the Kit make up the product that will be administered to the patient.

Discussion: Thomas Tarloid of Talon (purchased by Spectrum Pharmaceuticals) was present by conference call. The product will be commercially launched by Spectrum in the September 2013 timeframe. Approval of the product Marqibo was received August 2012. This product is indicated for Adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia. It is an injection that is prepared mostly in a clinic setting. It does carry a black box warning. It did receive approval for a J-code which will be assigned in Oct. and the UOM 1mg. No components may be purchased separately. This is not a retail pharmacy dispersible product and would be administered within the physician office or an infusion clinic.

Following are the components in the Marqibo KIT that are within the box:

16, HOW SUPPLIED/STORAGE AND HANDLING

The Marqibo Kit (NDC # 20536-322-01) contains:

• • Vial containing VinCRIStine Sulfate Injection, USP 5 mg/5 mL (1 mg/mL) – NDC # 20536-323-01
• • Vial containing Sphingomyelin/Cholesterol Liposome Injection 103 mg/mL – NDC # 20536-324-01
• • Vial containing Sodium Phosphate Injection 355 mg/25 mL (14.2 mg/mL) – NDC # 20536-325-01
• • Flotation Ring
• • Overlabel for Sodium Phosphate Injection vial containing constituted Marqibo (vinCRIStine sulfate LIPOSOME injection), 5 mg/31 mL (0.16 mg/mL)
• • Infusion Bag Label

Reference ID: 3172211 1.14 Labeling

This drug was discussed by the Product Review and Billing Unit Exception Task Group in August of last year. They determined the BU=mL, quantity of 31 mls.  Thomas explained that the product is comprised of 3 vialed components with appropriate labels for preparation of the final drug product and a kit container. On delivery to the pharmacy, where the drug is prepared, the pharmacy will have previously received from Spectrum a water bath, a calibrated thermometer and a calibrated timer. The pharmacy follows the instructions for combining the components after which the vial of the final product is placed in 65 degrees centigrade water for 10 minutes affixing the floatation ring to the vial. The vial is removed, the patient dose calculated and injected into a 100 ml bag containing saline or sucrose. The dose is delivered to the patient as a one hour infusion.

A motion was made and seconded to classify as a 1 EACH kit per Section 5.5.1 of the BUS. There was concern that the floating device is not used to administer the drug even though it is not on the list within the BUS. It is not part of the administered product. The motion carried with 16 for and 8 against the motion.

Discussed at the August 2013 WG2 Meeting. Requested: Clarification on the Billing Unit

Request: Each unit carton contains three individual trays. Each individual tray: 2 single-use prefilled syringes (200 mg/1 ml) and 2 alcohol swabs. Therefore, the billing unit would be each and the package size=3. Pursuant to Section 7.5 of the NCPDP Billing Unit Standard Implementation Guide: Kits with multiple, distinct trays are subject to be dispensed by the tray. Thus, kits with trays would be billed as “each” with a quantity of the number of trays.

Why Needed: To ensure that the product is listed with the correct package size and billing unit among the compendia.

Outcome Anticipated: Package size of 3 each based on Billing Unit standard 7.3

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of June 18^th and July 16^th:

Request to confirm if the PS for 50474-710-81 would change from 1 to 3.

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b4c2c9dc-a0bb-4d64-a667-a67ebe88392d

Bu=ea                  

Should the PS for this product be 3? All are listed today as one kit.

PRINCIPAL DISPLAY PANEL - 200 mg/mL Syringe Carton

NDC 50474-710-81

Rx ONLY

Do not accept if seals on top and bottom of carton are missing.

Dispense the enclosed Medication Guide to each patient.

cimzia® (certolizumab pegol) STARTER KIT

3 cartons of 2 × 200 mg/mL prefilled syringes FOR SUBCUTANEOUS INJECTION USE ONLY

The entire carton is to be dispensed as one unit.

Each unit carton contains three individual cartons (doses). Each individual carton (dose) contains: 2 single-use prefilled syringes (200 mg/1 mL) and 2 alcohol swabs.

store in refrigerator

Prefilled Syringe Starter Kit NDC 50474-710-81 6 alcohol swabs and 6 single use prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle. The Starter Kit contains 3 sets of 2 prefilled syringes to provide sufficient drug supply for the initial 3 induction doses at the start of treatment. Each prefilled syringe contains 200 mg (1 mL) of CIMZIA.

NDC 50474-0710-79

50474-0710-79 is a kit with:

•                  two prefilled syringes each containing 200 mg/mL Cimzia

•                  two alcohol swabs

•                  we list as PS =1 and CSP = 1 (which conforms to NCPDP)

•                  Prefilled Syringe NDC 50474-710-79 2 alcohol swabs and 2 single use prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle, each containing 200 mg (1 mL) of CIMZIA.

According to the Billing Unit Standard, the -81 NDC appears to be 3:

7.5 HOW DO I BILL KITS THAT HAVE MULTIPLE TRAYS?

Kits with multiple, distinct trays are subject to be dispensed by the tray. Thus, kits with trays would be billed as “each” with a quantity of the number of trays. For example, Avonex™ contains 4 distinct trays. It’s billing quantity and unit is “4 ea”.

• packets of cholestyramine (Questran™; i.e. quantity 60 packets are billed as 60 EA),
• pouches of Moviprep™
• the individual 2 GM dose bottle of azithromycin (Zmax?) for reconstitution (i.e. quantity of 1 EA) and
• Thrombin that is a powder that is reconstituted for a one-time spray topical administration.

Requestedclarification for the application of the Billing Unit Standard.

At the November 2011 WG2meeting the form was discussed. Karen Biancalana of Amylin presented thisrequest. 

Request: To determine how the product will bereported by the Pricing Compendia Services, dispensed by Retail Pharmacies andbilled by Payers and Processors. BYDUREON^TM for weekly subcutaneousadministration is supplied in a carton containing 4 single-dose kits for use(66780-0219-01). Bydureon^TM single-dose kit should NOT be broken bythe Retail Pharmacist.  It should bedispensed as a carton that contains four (4) Single Dose Kits.  Each single dose kit contains the following:

One vial containing 2 mgexenatide (as a white to off white powder)

One prefilled syringe delivering 0.65 mL diluents

One vial connector and twocustom needles (23G, 5/16”) specific to this delivery system (one is a spareneedle)

Discussion: The Product Review and Billing UnitException Task Group discussed this product on their call of October 12, 2011:

The group determined that the product is not a kit per Section 5.5.1of the BU Standard:

Kits - BilledAs An “Each”

Kits are defined as products that contain:

1)    at least two distinct drug items withdifferent billing units

2)    one drug product packaged with medicated orunmedicated swabs, wipes, and/or cotton swabs/balls

3)    meters packaged with test strips

Kits carry a single National Drug Code (NDC) for the combineditems.  Kits are designed with the intentto be dispensed and billed as a unit of “each”. Additionally, if a kit contains separate, distinct trays within the kit,the billing unit is an “each”, but the quantity is the number of trays ratherthan “1”.

The following items included with a drug should be ignored forpurposes of billing.  The billing unit ofthe drug item determines the billing unit for this product. The following table provides examples ofitems included with a drug that should be ignored for purposes of billing. Thislist is not inclusive.  If you questionwhether an item is a kit, submit a QUIC form as explained in FAQ 7.1.

Antihemophilic and Alpha-1 proteinase inhibitors products arenever billed as kits regardless of how they are packaged.

 The billing unit is EACHper Section 5.1.2 of the Billing Unit Standard and the billing quantity for theentire carton is 4.

5.1.2     InjectablePowder-filled vials and multi-component containers (i.e. mix-o-vial withsolution and powder within the vial) are billed as a unit of "each"regardless of size or content of vial in metric decimal units.  (For multi-component vials containing twoliquids, see section 5.2.2.)

Labeling of this product will be critical. Will each of thesetrays have patient instructions? Not sure if the standard needs to changebecause it is a non-drug entity. Are there other elements to the REMS thatshould be considered? If one tray was to be dispensed and not the entire box,then it would make sense that a Medguide is given to the patient. Should thebox be broken, the patient might be charged and education on the patient levelis an important consideration for the manufacturer. We cannot insure that theentire box will not be broken. Is it returnable is patient cannot tolerate? No,but samples would be available for patients to test for tolerability. The NDCassignments on the inner/outer packages are still being discussed with the FDA.Inner/Outer should have different NDCs with the same core 9. The last twodigits are the strength and it was suggested that the carton be 04 and the vialbe 01 but there is no logic applied to the 10^th and 11^thdigits. We ask that the company stay consistent with their assignments.

A motion was made and seconded to list as one EACH per Section5.1.2 of the Billing Unit Standard and the billing quantity for the entirecarton is 4. The motion carried withno opposition.

Discussion: The Product Review and Billing Unit Exception Task Group discussed on their call of August 17 and September 14, 2010:

This is an anti-hemophilic product. The marketer’s pricing letter should indicate which of the factors is used for pricing. The group contacted CSL Behring and found that these NDCs are priced per VWF:RCo IU. Do we add an FAQ to clarify? FAQ 7.11 shows general information on billing for anti-hemophilic as an each. Section 5.1.7 lists drugs individually that are considered as eaches. Do we add this drug to that list? What do we gain in doing so? No, we do not need to add to the list nor do we need an FAQ. The issue appears to be specific to the product and does not appear to be an appropriate addition to the BUS. This product is billed by unit—each—and price is based on each unit. The Co-Chairs will refer this issue back to the manufacturer for consideration as to why billing by VWF: RCo I.U was chosen rather than the total units per vial.

What would it hurt to add an FAQ? The billing unit is the same and the FAQ would be very specific to this drug. Terri Meredith noted that she called a hemophilia clinic in Colorado to ask about this product. Billing is based on the units of VWF because the factor VIII that is contained in it is a by-product of the VWF that cannot be purified enough to get all of the factor VIII out.  A motion was moved and seconded to accept the decision of the task group. No further action is needed. The motion carried. This is a very specialty product that is billed only by specialty clinics and infrequently used.

1)     Analpram HC Cream

2)     Vasculara Tablets

3)     AloeClean Wipes

Because the kit is made up of 3 components we need clarification of the billing unit to allow payers to pay what they should for the kit. It would be unlikely for a pharmacist to break the kit apart. Due to the components being both grams and eaches-we believe it meets the definition of a kit.

Discussion: The Product Review and Billing Unit Exception Task Group discussed on their call of October 26, 2010:

The task group determined that the products are kits and the BU should be EA (each). Section 5.5.1 of the BUS supports this decision:

 5.5.1 KITS - BILLED AS AN “EACH”

Kits are defined as products that contain:

1) at least two distinct drug items with different billing units

2) one drug product packaged with medicated or unmedicated swabs, wipes, and/or cotton swabs/balls

3) meters packaged with test strips

Kits carry a single National Drug Code (NDC) for the combined items. Kits are designed with the intent to be dispensed and billed as a unit of “each”.

A motion was moved and seconded to approve this form as a billing unit of one each with a quantity of one kit. The tablets are a medical food. Does this matter? There is not an exclusion for a medical food in 5.5.1. The motion carried without opposition.

• 589-15 all listed at 26
• 589-05 10 8.7 and 10
• 589-5090, 86.6 and 90

Requested: Clarification of the BUS. At the May 2013 WG2 meeting the form was discussed.

Request: When this product was originally launched it contained HPR Plus Emollient labeled as 100 grams and MB Hydrogel labeled as 225ml. Per 5.5.1 of the BUS this NDC met the definition of a 1 EACH kit. In March 2013, Prugen changed the MB Hydrogel to 225 grams on the kit label. With this change, as both products included in the box are listed as grams this NDC no longer meets the definition of 5.5.1—EACH kit.  The NDC was not changed.

Why Needed:  To get consensus that this NDC needs a package size/size unit of measure (BU) change from 1 each to 325 grams. If consensus is reached, it is advisable to coordinate the change among all the databases for the same time.

Anticipated Outcome: A change from 1 each to 325 grams with a coordinated change date.

Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of April 23^rd.

There was a label change (with no NDC change) that will affect the billing unit of this NDC.

The original label received is described on the label as:

1 Canister (100g) of HPR Plus Emollient Foam

1 Bottle (225ml) of MB Hydrogel

Pack size is listed as 1 each kit

PruGen sent a new label showing:

1 Canister (100g) of HPR Plus Emollient Foam

1 Bottle (225g) of MB Hydrogel

The BU should be changed from EACH to GM. Rebates could be impacted so we will need to notify the membership and make the change on the quarter. Not covered by Medicare Part D (considered a device).

A motion was made and seconded that the BU = GM, quantity of 325. Compendia will make the change on July 1.  The application of more than one tube in a box requiring all the grams are added is not specifically stated in the BUS. Recommend we adjudicate the QUIC form and update the standards section 5.3 and/or the FAQ—like units are the total quantity of all those units.  A DERF will be submitted for the August work group meeting. Karen Eckert will make the changes to the BUS and submit to the task group. The motion carried with no opposition.

Requested clarification for thebilling unit quantity. At the November 2011 WG2 meeting the form was discussed. Issue: From the PI -- Lazanda is supplied in a5.3 ml capacity clear glass bottle with an attached metered-dose nasal spraypump incorporating a visual and audible spray counter, and a protective dustcover. Each bottle contains a net fill weight of 1.57 grams and, after priming,delivers 8 sprays. The pump will remain primed for up to 5 days after primingor use. The nasal spray delivers 8 full sprays. There are 2 product strengthsand each 100 mcL spray contains either 100 mcg or 400 mcg of fentanyl. LazandaNasal Spray needs to be listed consistently across the compendia for accuratebilling and reimbursement.

Discussion: TheProduct Review and Billing Unit Exception Task Group discussed this product ontheir call of September 13, 2011:

Thesingle spray bottle is a 1 EA and the box of 4 bottles would be 4 EA based onusing the math that 1 spray=100mcL (.1mL) so 8 “delivered” sprays=.8mL which isless than 1mL.  Since this is not an injectable product, then Section5.2.1 of the BUS should apply. 

 5.2.1 Non-Injectable LiquidDosage Forms (for example solutions and suspension, etc.) must be billed as thetotal number of milliliters (ML) dispensed, including dropperettes if thevolume is 1 ml or greater. If the volumeis less than 1 ml for a non-injectable product, the product is billed as an“each” (see section 5.1.12 above).

5.1.12Unit-of-use packages (self-containedsingle dose packages) with a quantityless than one milliliter or gram should be billed as “one each”.  For example, ointment in packets of less than1 gram, eye drops in dropperettes that are less than 1 ml, or nebulizersolution in package of less than 1 ml.  Thisrule does not apply to injectable products.

The task group agreed that a single Lazanda Nasal Spray isbilled as a 1 EA and the box of 4 is billed as 4 EA.  

It was questioned why we wouldadjudicate this product as each but Asmanex was adjudicated as grams and it isa like product. Asmanex is an inhaler and we applied the standard for inhalers.A motion was made and seconded to list this product with a billing unit of 1 EAfor the single spray bottle and 4 EA for the box of 4 per Sections 5.2.1 and5.1.12 of the Billing Unit Standard. The motion carried with one opposition. KarenEckert stated that the BUS should be updated to add a subsection to explainthis situation. The Product Review and Billing Unit Exception Task Group willtake this change into consideration when they prepare the DERF for submissionfor the February 2012 Work Group meetings.

Requestedclarification for the application of the Billing Unit Standard.

Matt Nguyen of Valeritas presented this request. This is aunique device for delivering insulin that will be launched this fall. Itis already FDA approved but the company requests NCPDP review prior tolaunch.  

Request: V-Go is a prescription insulindelivery device treating diabetes

WhyNeeded: Packagingwill consist of 30 daily V-Go devices and 1 filling accessory (i.e. 31components).  It is anticipated thatpayers will pay for 30 V-Go devices for each prescription submitted.

Discussion: The Product Review andBilling Unit Exception Task Group discussed this product on their call of July19, 2011 to make all aware that it will be discussed at the August WG meeting.The compendia needs to list consistently.

Matt gave a presentation on this product. The V-Go package comeswith no insulin and is fully disposable. There are 3 dosing options of 20, 30and 40 that are based on the basal rate. The filling accessory is used to fillinsulin into the V-Go. Each package contains one easy fill and 30 V-Gos. Thereare no plans to package either separately. 

This does not meet our definition of kits. This can be comparedto lancets—where we count only the lancets. A previous QUIC form wasadjudicated to ignore the adapters in the package. Randy asked if we would liketo see this sort of information in the SPL file. Terri will look at this in hergroup. The FDA has a pilot for creating SPL files for devices and Randy askedValeritas to participate. A motion was moved and seconded to bill as 30 each andto modify the Billing Unit Standard Section 5.1 to show that adapters, devices,etc. are not counted and should be excluded. Karen Eckert will complete a DERFfor review at the November WG meetings. The motion carried.

Requested clarificationfor the billing unit quantity. At the August 2011 WG2 meeting the form was discussed. Issue: We would like to inquire how thisproduct should be listed/billed (as 1 Kit or 4 Kits). We have both customer andmanufacturer asking for clarification whether it should be 1 or 4 kits.

Discussion: The Product Review and Billing UnitException Task Group discussed this product on their call of July 5, 2011:

Product photos were obtained and distributed to the group priorto the conference call. Based upon these photos, the product is not packaged intrays or similar, distinct inner packages for dispensing. Product is packagedsimilar to Copaxone which was addressed by the TG previously and determined tobe 1 EA Kit for the entire box. Sylatron Pack 4 is not packaged in dose trayslike Humira. Concern was expressed that Sylatron single vial and Pack 4presentations share the same core 9 NDC which is an issue for CMS rebates. The group agreed that based uponsection 5.5.1 of the BUS, Sylatron Pack 4 should be listed as 1 EA Kit.  No effective date is needed since thisproduct has only been on market a few months. Randy Levin of the FDA statedthat he would follow-up with the manufacturer.

Section 5.5.1 Kits - Billed As An “Each”

Kits aredefined as products that contain:

1)    at least two distinct drug items with different billing units

2)    one drug product packaged with medicated or unmedicated swabs,wipes, and/or cotton swabs/balls

3)    meters packaged with test strips

Kits carry a single National Drug Code (NDC) for the combineditems.  Kits are designed with the intentto be dispensed and billed as a unit of “each”. Additionally, if a kit contains separate, distinct trays within the kit,the billing unit is an “each”, but the quantity is the number of trays ratherthan “1”.

The following items included with a drug should be ignored forpurposes of billing.  The billing unit ofthe drug item determines the billing unit for this product. The following table provides examples ofitems included with a drug that should be ignored for purposes of billing. Thislist is not inclusive.  If you questionwhether an item is a kit, submit a QUIC form as explained in FAQ 7.1.

Antihemophilic and Alpha-1 proteinase inhibitors products arenever billed as kits regardless of how they are packaged.

A motion was moved and seconded that Sylatron Pack 4 should belisted as 1 EA Kit as this does not meet the tray exception. The motioncarried. Randy noted that the FDA has talked to the manufacturer since theinner NDC is the same as on the outside package. This product was describedincorrectly in the SPL saying all were in one box. The FDA pointed out to themanufacturer what is wrong and the manufacturer is working on this. The QUICforms are posted to the website and all the compendia will have the samebilling unit for this product.

--Net contents after reconstitution: 175ml

--Deliverable volume after reconstitution: 160-165ml

(There is also a 225ml listing but it reads like that is the size of the bottle, not the volume contained, “contains 225ml bottle with bottle adapter…”)

Which volume after reconstitution is used when the deliverable volume is variable (a range from 160 – 165ml)?

Discussion: The Product Review and Billing Unit Exception Task Group discussed on their calls of October 26, December 7,  January 4, and January 18:

Background:  The dilemma associated with CellCept Oral Suspension is that its deliverable volume after constitution is stated as a range (160-165mL).  If CellCept Oral Suspension remains as 175mL on the databases, then it will be an exception to the BUS.  Therefore, should we change existing FAQs to include CellCept Oral Suspension, or add a new FAQ? 

Concern:  Are we consistent in the BUS in how we are addressing reconstitutable products?  It appears we are clear on powders for injection.  The non-injectable, reconstitutable products when the final volume is not expressed or the reconstituted volume is not fully delivered seem to be the most problematic.

The group reviewed the package image of the product and looked to the BUS for possible modifications.

Decision: Change Section 5.2.3 and FAQ 7.34 of the BUS as follows (changes in red).

5.2.3

Reconstitutable Non-injectable Products must be billed as the total number of milliliters (ML) dispensed after reconstitution; i.e., once the powder and added flavor packet (if applicable) have been reconstituted with diluent, according to manufacturer instructions.   For example, Amoxicillin Suspension 25Ø mg/15Ø ml is billed as 15Ø ml and GolytelyÔ 4ØØØ ml bottle is billed as 4ØØØ

ml. See section “Frequently Asked Questions”, question 7.34.

7.34 How do I bill reconstitutable products that have an overfill ?

For non-injectable products to be reconstituted, the package size will be based on the total amount of the product delivered (maximum amount that can be extracted from the container; i.e. dispensed). The overfill after reconstitution will not be considered. Example: Tamiflu for Oral Solution contains approximately 33 mL, after reconstitution. Each bottle can delivers up to a total of 25mL of solution.suspension. The reported quantity for dispensing should be 25mL.

For non-injectable products to be reconstituted where the deliverable volume is expressed as a range, the reported quantity for dispensing will be the lower volume of the range. Example: CellCept 200mg/mL oral suspension lists the net content after reconstitution as 175 mL and the deliverable volume after constitution as 160-165 mL. The reported quantity for dispensing should be 160mL.

Should the WG approve, the compendia will make their database changes from 175 ml to 160 ml at the end of the first quarter. Changes to the BUS will be incorporated into the DERF submitted for the May 2011 WG meeting.

When there is a range given, the least amount should be billed. The compendia have 175 mL currently. A motion was moved and seconded to approve as suggested by the task group. The motion carried without opposition. The three examples are Valcyte, Cellcept and Tamiflu. These should be sent to the FDA to shows160 mL as the volume in the SPL.

Why Needed: Prevpac is now packaged in 112 individual blisters making its exception status obsolete. There are new products to the market such as Omeclamox (40 Amoxicillin caps, 20 each Omeprazole Caps and Clarithromycin tabs = 80 total, individually blistered) represented as 80 each per 5.1.11: Convenience Packs, Therapy Packs, Starter Packs and packs of Oral Contraceptive must be billed as the number of individual tablets or capsules (EA) dispensed, not the number of boxes or packages or cavities. Expected outcome: Change in pack size from 14 each to 112 each and removal of the exception to Sections 4.3, 5.6 and FAQ 7.6.  (provided Helidac is also overturned as an exception. The other drug in the exception is Pravigard which is no longer in the marketplace)

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of July 17^th and July 31^st.

During the discussion of Omeclamox-Pak, the task group determined that the exceptions listed in the BUS (section 4.3, 5.6, and FAQ 7.6) for Helidac, Prevpac, and Pravigard required review to ensure they are still exceptions. Current product packaging images/labels for Helidac and Prevpac were reviewed which indicated that the tablets and capsules are individually blistered.  (NOTE: Pravigard is no longer marketed.)

Decision:  All agreed that the products as currently packaged are not exceptions to the BUS.

If the QUIC Forms are adjudicated, a DERF will be submitted at the November 2012 WG meeting for changes to the BUS for Sections 4.3, 5.6 and FAQ 7.6. 

A motion was made and seconded that the BU = Each (quantity of 112), removal of the exception to Sections 4.3, 5.6 and FAQ 7.6 of the Billing Unit Standard and compendia to make the change in the future depending on the approval of the DERF to remove the exception. It was noted that the compendia would make the change at the first of a quarter. The motion carried with no opposition.

The Pravigard will be removed from Sections 4.3, 5.6 and FAQ 7.6. FAQ 7.6 would end after the first paragraph and numbers 2, 3, and 4 of Section 5.6 would be removed. A motion was made and seconded to approve the changes to 4.3, 5.6 and FAQ 7.6. The motion carried without opposition. The previous QUIC forms on these products will be noted that they are superseded by the newer QUIC forms.

Why Needed: There is no specification in NCPDP billing unit guidelines for this situation. Decision on billing unit: either 10 EA (# DOSE CARDS) OR 20 EA (# ADMINISTRATIONS)

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of July 17^th.  

The compendia are listing this product differently and it was requested to list like Prevpac (PrevPac is an exception.) NCPDP FAQ 7.6 – states that “Prevpac - This product, and generics of this product, should be billed as eaches equal to the number of blister cards dispensed.”  Omeclamox- Pak contains omeprazole (a different PPI from Prev Pak) along with clarithromycin and amoxicillin and is supplied in 10 daily cards.

Generics should be billed as cards so you do not have different counts

HOW SUPPLIED/STORAGE AND HANDLING

Omeclamox-PakTM is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs:

·        Omeprazole Delayed-Release Capsules, USP, 20 mg

Two opaque hard gelatin lavender and grey capsules, with ‘R 158’ and ‘OMEPRAZOLE 20 mg’ imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets.

·        Clarithromycin Tablets, USP, 500 mg

Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with ‘54 312’ on one side and plain on the other side.

·        Amoxicillin Capsules, USP, 500 mg

Four opaque hard gelatin peach and orange capsules marked ‘WC 731’. Each capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin.

NDC 65224-707-11 Carton containing 10 daily administration cards

NDC 65224-707-00 Daily administration card

The manufacturer (Pernix) thinks it should be listed as 10 ea, but it looks like 5.1.11 applies: “Convenience Packs, Therapy Packs, Starter Packs and packs of Oral Contraceptive must be billed as the number of individual tablets or capsules (EA) dispensed, not the number of boxes or packages or cavities.”  Per 5.1.11, the billing quantity for Omeclamox-Pak would be 80 each since each card has 8 tablets or capsules in separate blisters.

Omeclamox-Pak is not the same as Helidac.  It appears the packaging of Helidac has changed since it was originally marketed and included as a BUS exception.  Helidac(ndc 65483-495-14) contains 56 dose units (1 dose unit = 3 tablets + 1 capsule = 4 EA) which is a total of 224 EA (168 tablets and 56 capsules)

The group agreed that all new products should adhere to 5.1.11 of the BUS thus all tablets and capsules would be counted for billing purposes.

Decision: All agreed that Omeclamox-Pak should be 80 EA and each compendium that has 10 should follow their process for file updates and notifications. The manufacturer was informed of the decision.

A motion was made and seconded that the BU = Each (quantity of 80) per Section 5.1.11 of the Billing Unit Standard. The motion carried with no opposition.

Why Needed: Development process is at the stage where significant packaging decisions need to be made.  Will the package configuration impact the likely billing unit for this product?  Will a package containing an inhaler and cartridges packed together impact billing units?  Will different strength cartridges packed together impact billing units? We would like guidance on what the billing unit standard will be for this product, and the rationale behind that decision.

Discussion:

The Product Review and Billing Unit Exception Task Group discussed this product on their call of May 22^nd and had questions of the manufacturer. 

The WG2 Co-Chairs met with MannKind representatives on June 7^th and 28^th:

Combined Notes on both calls – new product by Mannkind Corporation

Attendees: Saumil Pandya, Consultant with Kantar Health, Joy Dickery and Todd Easley with MannKind. Anne Johnston, Julie Suko, Kay Morgan, and Patsy McElroy

This product is a novel, ultra rapid-acting mealtime insulin therapy in late stage clinical investigation for the treatment of adult patients with Type 1 and Type 2 diabetes mellitus for the control of hyperglycemia. It is a drug-device combination product, consisting of a inhalation powder pre-metered into single use dose cartridges and the light, discreet and easy-to-use inhaler. The Inhalation Powder is available as 4 unit and 8 unit single use cartridges. The cartridge strengths are color-coded, blue signifying the 4 unit strength and green signifying the 8 unit strength. The inhaler is included free in the box and each is good for two weeks. It is not packaged separately and there is not a plan for the company to market it separately.

Example: 30 days supply (sig=3 times per day). Contains:

90 cartridges

2 inhalers (each good for 15 days)

4 Units and 8 Units = dose that is delivered. Represents a certain number of insulin units—not 1 to 1.  Unit=amount of drug in the cartridge. The 8 units contain more medication than the 4 units—represents a higher dose.

Container = a certain # of cartridges, each one delivers a single use dose via an inhaler that is in the same container.

The BUS determines the BU and not dosing. Since each cartridge is individual use, is it less than 1 or greater than 1? The amount of powder in each cartridge is not listed anywhere.

Will the 4 and 8 units be contained in one box? Manufacturer is still looking at this but most likely. Since there is such a wide dosing regimen, the manufacturer wants to have one box for as many combos in order to allow the patient to pay only one co-pay.

The manufacturer does not recommend that the box be broken for use.

Recommendation:

·        There should be a different core 9 NDC for boxes of all 4s, for boxes of all 8s, and for each combo of mixed 4s and 8s.

·        This is not related to the LTC short cycle fill since it is not oral

·        This is not a kit as it doesn’t cross billing units

·        Devices (inhalers) used to administer drugs are not considered/counted.

·        Suggested they market a start pack and possibly a replacement inhaler—inhaler would have a billing unit of each.

·        Billing Unit=Each (per cartridge)

Is the inhaler reusable? Yes, for 15-days and then it is disposed of. A motion was made and seconded that the BU = Each (per cartridge). The motion carried with no opposition.

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their calls of January 14, 2012:

This packaging is confusing to the pharmacy. It has been on market for awhile. The Rising packaging is transparent and Actavis Hydrocortisone Cream (NDC 00472-0321-26) with quantity stated as 28.4g (1oz) is clearly visible to the pharmacist. This item is rebatable and CMS shows it as 28.4. The group agreed that Procto-Pak 1% should be changed from 30gm to 28.4gm. Compendia will make this change as of the end of February 2012 - the week of February 26^th.

A motion was made and seconded to list as 28.4gm and not 30gm. The motion carried.

Request: Gemcitabine Hydrocholoride for injection is a powder filled vial that was commercially launched in July 2011.  At the time of launch the Billing Unit was reported to CMS under the Medicaid Drug Rebate Program as a milliliter (10mL and 50mL).  The pricing reported to CMS was also based on the milliliter.  The Pricing Compendia (data bases) reported this product as a one each vial, per the NCPDP Billing Unit Standard (BUS).  The State Medicaid programs have billed in various Unit of Measurements (UOM) (i.e. milliliter, vial) which has been confusing.

Why Needed: Dr. Reddy would like to be compliant with the NCPDP Billing Unit Standard and is requesting that the UOM be changed from a milliliter in the Medicaid Drug Rebate Program to reflect the correct industry BUS of a ONE EACH VIAL.  Dr. Reddy has notified CMS Medicaid Rebate Operations and intends to also notify the Pricing Compendia as well as the State Medicaid Programs of this change.

Outcome Anticipated: Approval by the workgroup committee acknowledging that a ONE EACH VIAL is the correct Billing Unit Standard to assist in the further communication to the State Medicaid’s of this change to be effective 4^th Quarter 2013, which will be reported by 1/30/2014.

Discussion: A motion was made and seconded to approve the BU=1 EACH per Section 5.1.2 of the Billing Unit Standard. The motion carried without opposition. All compendia present has this product listed as 1 Each. Compendia not present will be contacted to verify their lilsting. If that compendium has a billing unit different than 1 Each, a date of change will be identified for that compendium.

Discussed at the August 2013 WG2 Meeting. Request Type: Clarification of the Billing Unit Standard

Request: Some Miconazole Cream products are packaged as 1 tube of cream (in grams) plus 3 pre-filled applicators of cream. There is inconsistency as to how these products are listed: 1 ea vs total number of grams.

Why Needed: Through research (the discrepancy sub task group) we have discovered that some of these products have wipes included in them, some of them do not have wipes included.

Outcome Anticipated: That Miconazole packages that include: 1 tube cream + a given number of cream pre-filled applicators be listed as total number of grams per 5.4.2. Miconazole packages that include: 1 tube cream + a given number of cream pre-filled applicators + wipes/alcohol swabs should be listed as 1 ea kit per 5.5.1 (point #2). If accepted, it is preferable to schedule a coordinated change across all compendia. It is preferable to apply only to active items on the databases.

Discussion: The Product Review and Billing Unit Exception Task Group’s subgroup on Package Size discussed this product on the TG call of May 21^st, June 4^th, and July 16^th per their review of:

Monistat-3 [3 prefilled applicators (5g/applicator) plus 9g tube of cream] and various generic/private label products

Original question = should this be listed as 24g? Currently most compendia list as 1 EA Kit.

Findings:

·        Per contact at Insight Pharmaceuticals, the only Monistat-3 package containing wipes is package with identifier 363736449803.  This package contains 3 ovule inserts and is NOT the pre-filled applicators that we are reviewing.  Contact at Insight was not responsive to providing additional information about these products.  Most compendia are not listing Monistat from Insight.

·        Some private label packages are including external wipes which make it a 1 EA kit.

o   Wipes included = Walgreens, RiteAid

o   No wipes = Kroger, Topco, CVS, Target

SubTG recommendation for pre-filled applicators + external cream:  

·        List these products per BUS. 

·        If no wipes, then list as total grams of cream [Ex. (3 applicators x5g/appl) + 9g cream = 24 g] If wipes included, then list as 1 EA Kit.

·        As a result, the private label products will not be consistent as to Pkg Size and BU.

·        As a compendium receives information that wipes are added or omitted, then communication of this information needs to occur so listings can be updated.

·        If above recommendation is accepted, then coordination of a change date is necessary.

TG Discussion: Does everyone agree with recommendation? The subgroup agreed that we either change or make an exception. All preferred to make the change. Most of these are private labels. A QUIC form is recommended.

The private labels vary as to containing wipes or not. By resolving the QUIC forms as grouped by wipes and no wipes, it would address the private label which cannot all be identified.

Are they listed as Med D products? No. Do we have utilization information on the ones that will change? No but the general sense is that there is not a lot of activity. Anne provided Express Scripts utilization of the NDCs - less than 100 prescriptions across all of the NDCs for one year. This would be a minimal impact from a processor’s perspective.

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their calls of January 14 and 31, 2012:

This product meets the definition of a kit -- One item is measured in grams and the other in ml as per section 5.5.1 Kits - Billed As An “Each”. All agreed to list as one EACH (kit).

A motion was made and seconded to list as one EACH (kit) per Section 5.5.1 of the Billing Unit Standard. The motion carried.

Why Needed: FAQ 7.5 of the Billing Unit Standard states “Kits with multiple, distinct trays are subject to be dispensed by the tray. Thus, kits with trays would be billed as “each” with a quantity of the number of trays. For example, Avonex contains 4 distinct trays. It’s billing quantity and unit is ‘4 ea’.” However, the packaging for these 2 NDCs doesn’t indicate distinct trays since the alcohol wipes, gauze pads and adhesive bandages are in the accessory pouch. QUIC FORM 960005 Avonex Administration Pack was adjudicated as 4 EA but may only reflect NDC59727-001-03. The Avonex Prefilled Syringe and Avonex Prefilled Autoinjector packaging meets the definition of a kit and 1 EACH seems appropriate as the billing quantity and unit for the entire carton.

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their callsarch 27ling Unit of Gram (GM):  this product. shown. The spreadsheet has been posted to the WG2 webpage and compendia will make of March 27^th and April 10th:

Anne provided a summary. There was a request to discuss the quantity and billing unit since there was new packaging of this product. In 2005, the manufacturer added a pre-filled syringe packaging in addition to the powder for injection. The packaging for the powder for injection remained the same, but when the prefilled syringe was added, alcohol swabs were included in an accessory pack. So rather than being one each they should be a kit according to the standard. The task group questioned if the AVONEX Lyophilized Powder Vial had been or was going to be changed as it would make it easier to apply the billing unit standard. In the BUS Implementation Guide, FAQ 7.5 references Avonex –

                    HOW DO I BILL KITS THAT HAVE MULTIPLE TRAYS?

Kits with multiple, distinct trays are subject to be dispensed by the tray. Thus, kits with trays would be billed as “each” with a quantity of the number of trays. For example, Avonex™ contains 4 distinct trays. It’s billing quantity and unit is “4 ea”.

This FAQ was applicable when the alcohol wipes were in the tray and not the accessory pouch. Now we have the trays and the pouch with the wipes. After much discussion, it was decided that 59627-0002-05 (Prefilled Syringe) 59627-0003-04 (Prefilled Autoinjector) are kits and one each. The AVONEX Lyophilized Powder Vial will not be touched and remains the same. The existing NDC (59627000205), the original syringe kit that is counted as 4 eaches, will now become one each. This will result in a quantity change that needs to be communicated to our downstream retail partners and coordinated amongst the compendia.  The CMS rebate for the only listed NDC is one. The manufacturer cannot tell us when a change was made to move the alcolhol wipes to the pouch for the existing NDC (59627000205).  All three NDCs are staying on the market.

1.                NDC ending in 002-05 is currently listed with all compendia as 4 each.

2.                NDC ending in 003-04 is currently listed with all the compendia as 1 each.

3.                Both NDCs have 4 trays plus one accessory pouch containing alcohol.

4.                There is only one med guide per box.

Recommendation:

Change the BU for NDC 59627-0002-05 (PFS) from 4 each to 1 each (kit) as it meets the current BU Standard. The BU for 59627-0003-04 will be 1 each (kit). If this is accepted, the FAQ 7.5 of the BUS will require the following modification:

FAQ 7.5:  How Do I Bill Kits That Have Multiple Trays?

Kits with multiple, distinct trays are subject to be dispensed by the tray.  Thus, kits with trays would be billed as “each” with a quantity of the number of trays.  For example, Avonex contains 4 distinct trays.  It’s billing quantity and unit is “4 ea”.

Additionally, since this product has been on the database since 2005 as 4 each; ample customer notification will be required. No change to NDC 59627-001-03 AVONEX Lyophilized Powder Vial.

Summary:  Avonex lyophilized powder remains as 4 eaches

Avonex Single-Use Prefilled Syringe and PEN Single-Use Prefilled Autoinjector are 1  each (kit)

Why Needed: Lilly is making this request WG2 because of the complexity and uniqueness of this product, as well as our goal to appropriately report price and provide clear guidance for reimbursement purposes. Amyvid currently has NDCs in our label on the 3 multi-dose vials, which represent the “batches” created by our CMOs.  These vials will not be “active” in the marketplace and consequently Lilly will not list these vials nor will these vials be billed by imaging centers.  Lilly proposes listing this product as above with the WAC on an inner NDC. This inner NDC will not be on the Lilly FDA approved label.

According to the NCPDP BILLING UNIT OF “EACH” (EA):“EA” (each) is used when the product is dispensed in discreet units.  These products are not measured by volume or weight.  The Billing Unit of “EA” is also used to address exceptions where “GM” and “ML” are not applicable……. We expect the billing unit to be “EACH” (EA) to represent the 10mCi dose at time of calibration, which will have a corresponding Inner NDC as noted.

Discussion:

Joe Fine noted that Medicaid is looking to bill for rebates on products that are dosed in millicuries. The WG2 Co-Chairs held a conference call prior to the WG2 meeting with Lilly representatives regarding this product. They thanked the company for bringing this product forward before there is an issue in the market place. Compendia are not to list the NDCs in the package insert but list only the NDC that is the dispensable products. It was asked if we could propose a billing unit of millicurie, Is it difficult to do this? It is in that it requires an addition to the Billing Unit Standard and the Telecommunication Standard and would require a significant amount of work. But if it becomes an issue, it is certainly something that NCPDP would entertain. Kay noted that the billing unit was recommended as one each because it fit with the Billing Unit Standard’s definition of a powder for reconstitution/activation.

The dosage is 10 millicuries but the ml and millicuries (when it first starts out) are variable within the dosage. Due to this variability it was proposed as one each. Karen stated that she looked at other radioactive products currently on file and they are listed by concentration but she has a feeling that they have the same sort of variability. Two of those products are listed as ml but those were never adjudicated by WG2. The recommendation by the task group to list as a BU of one each (each syringe) was made because the product is dispensed in discreet units and not measured by volume or weight. It is also used to address exceptions where gram and ml are not applicable.  A motion was made and seconded to make the BU = 1 each. It was reiterated that the compendia are not to list the NDCs in the package insert. This fits the one each variable within the standard. The Product Review and BU Exceptions task group will reinforce the compendia listing of the dispensed NDC and not the other NDCs listed and will draft a new FAQ. The task group will also look at the other radiopharmaceutical like products to make sure we are consistent. The motion carried.

Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of December 6, 2011:

 The group agreed that the billing unit should be GM per Section 5.3.3 of the Billing Unit Standard:

5.3.3 Powders, including powders for mixing by the customer/patient on a per dose basis, must be billed as the number of grams (GM) dispensed. For example, Questran™ can quantity 378 gm is billed as 378 gm and Metamucil™ powder container quantity 538 gm is billed as 538 gm. (For Bulk powders, refer to section 5.5.2 of this document.) However, if the powder is manufactured for a single oral administration (i.e. in a “packet”), the billing unit is “each” (see section 5.1.8)

Requested: Clarification of the Billing Unit Standard. At the February 2013 WG2 meeting the form was discussed.

Request: BlueStar (Diabetes Management Medical Software) is an FDA approved Class II Medical Device for use over mobile phones and computers in the home or professional setting.  It is not specific to any one device.  BlueStar is prescribed by a Health Care Professional to adult type 2 diabetic patients to help with the management of diabetes. Patient and physician engagement will be active for one month per Rx.  

WellDoc requests confirmation that BlueStar is a Medical Device with a standardized unit designation.

Why Needed: In order for standardization, we request a billing unit decision on this FDA approved Class II Medical Device. BlueStar may be considered a unique medical software device now but similar products will soon arrive on the market that should necessitate direction from the committee.

Anticipated Outcome: Request direction from NCPDP that will confirm BlueStar as a Class II Medical Device (per FDA approval) with a unit of one (1) designated as 30 days.