(Medicare Claims Processing Manual)

When a billing provider or supplier must discard the remainder of a single -dose container or single -use package after administering a dose to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dos e administered, up to the amount of the drug or biological as indicated on the vial or package label.   Effective January 1, 2017 when processing claims for drugs and biologicals local contractors shall require the use of the JW modifier to identify unused and discarded amounts (hereafter, discarded amounts) of drugs or biologicals from single -dose containers or single -use packages.   The discarded amount is any amount that is not part of the prescribed dose and not intended to have a therapeutic effect in the patient. Even if certain amounts are extracted from the vial or are required to be in the vial to administer the prescribed dose , we do not consider them to be used if they are not intended for therapeutic effect as part of the prescribed dose.  Generally, the discarded amount is the labeled amount on the single -dose container (or containers if more than one is required) minus the dose (the dose being the prescribed amount of drug administered to the patient).  The JW modifier, billed on a separate line, provides payment for the amount of discarded drug or biological. For the administered amount, one claim line shall include the billing and payment code (such as a HCPCS code) describing the given drug, no modifie r, and the number of units administered in the unit field. For the discarded amount, a second claim line shall include the same billing and payment code as used for the administered amount, the JW modifier, and the number of units discarded in the units field.   For example, if a provider or supplier uses a single -dose container that is labeled to contain 100 units of a drug to administer 95 units to the patient and 5 units are discarded. The 95-unit dose is billed on one line, while the discarded 5 units shall be  billed on another line with the JW modifier. Both line items would be processed for payment. Providers must record the discarded amounts of drugs and biologicals in the patients medical record.   Effective July 1, 2023, local contractors shall require the use of the modifier JZ to attest that there are no amounts of drugs or biologicals from single -dose containers or single -use packages were unused and discarded. For the administered amount, the cl aim line should include the billing and payment code (such as HCPCS code) describing the given drug, the JZ modifier (attesting that there were no discarded amounts), and the number of units administered in the units field.   The JW modifier is only applied to the amount of drug or biological that is discarded. A situation in which the JW modifier is not permitted is when the actual dose of the drug or biological administered is less than the billing unit. For example, one bill ing unit for a drug is equal to 10mg of the drug in a single use vial. A 7mg dose is administered to a patient while 3mg of the remaining drug is discarded. The 7mg dose is billed using one billing unit that represents 10mg on a single line item. The singl e line item of 1 unit would be processed for payment of the total 10mg of drug administered and discarded. Billing another unit on a separate line item with the JW modifier for the discarded 3mg of drug is not permitted because it would result in overpayme nt. Therefore, when the billing unit is equal to or greater than the total actual dose and the amount discarded, the use of the JW modifier is not permitted. For dates of service beginning July 1, 2023, the JZ modifier shall be used in this circumstance.   In general, the JW and JZ modifier policy applies to all drugs separately payable under Medicare Part B that are described as being supplied in a single -dose container or single -use package based on FDA -approved labeling.  The use of these modifiers is  not appropriate for drugs that are from multiple -dose containers.  The JW and JZ modifier policy does not apply for drugs that are not separately payable, such as packaged OPPS or ASC drugs, or drugs administered in the FQHC or RHC setting.   The JW and JZ modifiers are not required for vaccines described under section 1861(s)(10) of the Act that are furnished from single -dose containers. Since the influenza, pneumococcal, and COVID 19 vaccines specified in section 1861(s)(10) of the Act are of ten roster billed by mass immunizers, and roster billing cannot accommodate modifiers, it would be impractical to require the JW and JZ modifiers for such vaccines. Such a requirement would likely result in substantial operational issues for mass immunizers and impair patient access to these vaccines.   The JW modifier is not used on claims for CAP drugs. For CAP drugs, see subsection 100.2.9 - Submission of Claims With the Modifier JW, Drug or Biological Amount Discarded/Not Administered to Any Patient, for additional discussion of the discarded remainder of a vial or other packaged drug or biological in the CAP. Note that the CAP is postponed effective January 1, 2009.   40.1 - Discarded Erythropoietin Stimulating Agents for Home Dialysis  (Rev. 1581; Issued:  08- 29-08; Effective/Implementation Date:  12 -01-08)  Multiuse vials are not subject to payment for discarded amounts of drug or biological, with the exception of self administered erythropoietin stimulating agents (ESAs) by Method I home dialysis patients.  The renal facility must bill the program using the modifier JW for the amount of ESAs appropriately discarded if the home dialysis patient must discard a portion of the ESA supply due to expiration of a vial, because of interruption in the patients plan of care, or unused ESAs on hand after a patients de ath.  Specific instructions are found in chapter 8 of this manual, 60.4.4.1 Self Administered EPO Supply, and 60.7.4 Darbepoetin Alfa (Aranesp) Furnished to Home Patients.  This applies only to home dialysis patients who meet the Method I conditions described in Pub 100- 2 Benefits Policy Manual, chapter 11, 90 Epoetin (EPO), and does not apply to Method II home dialysis patients.   Supplies of ESAs for self administration are billed according to the pre -determined plan of care schedule provided to home dialysis patients that meet the criteria for self administered ESAs discussed in chapter 8 of this manual, 60.4 Epoetin Alfa (EPO) For ESRD Patients and 60.7 Darbepoetin Alfa (Aranesp) for ESRD Patients.  The renal facility, through the amounts prescribed in the plan of care, shall ensure the patients ESA on hand at any time does not exceed a 2 -month supply.  CMS expects the faci lity to minimize excess dispensing of the ESAs for self administration based on the patients plan of care.   50 - Assignment Required for Drugs and Biologicals  (Rev. 3721, Issued: 02- 24-17, Effective: 05 -25-17, Implementation: 05- 25-17)  A. A/B MACs (B)   Under 114 of the Benefits Improvement Act of 2000, effective for claims with dates of service on or after February 1, 2001, payment for any drug or biological covered under Part B of Medicare may be made only on an assignment -related basis.  Therefore, no  charge or bill may be rendered to anyone for these drugs and biologicals for any amount except for any applicable unmet Medicare Part B deductible and coinsurance amounts.  All entities (including physicians, nonphysician practitioners, pharmacies and suppliers) that bill Medicare for drugs and biologicals must take assignment on all claims for drugs and biologicals furnished to any beneficiary enrolled in Medicare Part B.  Contractors apply this policy to all items paid based on the lower of the actual charge on the claim or 95 percent of the AWP.  See 20 for a description of the AWP.  Mandatory assignment does not apply to HCPCS code E0590, which represents the dispensing fee for nebulizer drugs.   A/B MACs (B) process all claims for drugs and biologicals with a date of service on or after February 1, 2001, as though the physician or nonphysician practitioner had taken assignment.  If only drugs and biologicals are billed on the claim, and the claim was submitted as unassigned, contractors change the claim to assigned and process as an assigned claim.  If a physician or nonphysician practitioner submits an unassigned claim that contains both codes for drugs or biologicals and codes for other services, A/B MACs (B) split the claim into two claims.  The first claim will be an unassigned claim for services other than drugs or biologicals, and the second will be an assigned claim for drugs or biologicals furnished on or after February 1, 2001.  The followi ng messages apply when an A/B MAC (B) has changed the claim to assigned status (regardless of whether the contractor had to split the claim):   The contractor shall use the following remittance advice messages and associated codes when adjusting payment under this policy. The RARC below is not included in the CAQH CORE Business Scenarios.  Group Code: N/A  CARC: N/A  RARC: MA72  MSN: 16.50  Additional appropriate message for physicians, suppliers, and beneficiaries should be added as necessary.   B. DME MACs   Under 114 of BIPA, DMEPOS suppliers must accept assignment on all claims for drugs and biologicals that they bill to the DME MACs.  A supplier may not render a charge or bill to anyone for these drugs and biologicals for any amount other than the Medicare  Part B deductible and coinsurance amounts.  Mandatory assignment does not apply to HCPCS code E0590, which represents the dispensing fee for nebulizer drugs.   The DME MACs must inform suppliers on their Web sites and in their next bulletins that they must accept assignment on claims for drugs and biologicals furnished on or after February 1, 2001.   The DME MACs must deny any claims a beneficiary submits for drugs and biologicals with dates of service on or after February 1, 2001.  The DME MACs must notify beneficiaries that suppliers must accept assignment on claims for drugs and biologicals, and the refore, the beneficiaries may not submit claims for drugs and biologicals.  When denying beneficiary- submitted claims, DME MACs use the following Medicare Summary Notice (MSN) messages:   MSN 16.6 (English):  This item or service cannot be paid unless the provider accepts assignment.   MSN 16.6 (Spanish):  Este artculo o servicio no se pagar a menos de que el proveedor acepte asignacin.   MSN 16.7 (English):  Your provider must complete and submit your claim.   MSN 16.7 (Spanish):  Su proveedor debe completar y someter su reclamacin.   MSN 16.34 (English):  You should not be billed for this service.  You do not have to pay this amount.   MSN 16.34 (Spanish):  Usted no debera ser facturado por este servicio.  Usted no tiene que pagar esta cantidad.   MSN 16.36 (English):  If you have already paid it, you are entitled to a refund from this provider.   MSN 16.36 (Spanish):  Si usted ya lo ha pagado, tiene derecho a un reembolso de su proveedor.   If a supplier submits an unassigned claim with a date of service on or after February 1, 2001, to the DME MAC for a drug or biological, the DME MAC must process the claim as though the supplier accepted assignment.  It is possible that a supplier may bill drugs and other items on the same claim, which would result in a claim with some assigned and some nonassigned items.  In the event that a supplier bills an unassigned claim to a DME MAC that contains both codes for drugs or biologicals and codes for other items, the DME MACs must replicate the claim.  This will result in two claims in the DME MAC system: an unassigned cla im for items other than drugs or biologicals, and an assigned claim for drugs and biologicals furnished on or after February 1, 2001.  When a DME MAC changes an unassigned drug claim to an assigned claim, the contractor shall use the following remittance advice messages and associated codes when adjusting payment under this policy. The RARC below is not included in the CAQH CORE Business Scenarios