US · guidance
CMS Pub. 100-04, ch. 17, § 50
Assignment Required for Drugs and Biologicals
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 following 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 therefore, 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 artículo o servicio no se pagará a menos de que el proveedor acepte
asignación.”
MSN 16.7 (English): “Your provider must complete and submit your claim.”
MSN 16.7 (Spanish): “Su proveedor debe completar y someter su reclamación.”
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 debería 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 claim 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
Group Code: N/A
CARC: N/A
RARC: MA72
MSN: N/A
Suppliers that bill the DME MACs for drugs for use with DMEPOS must have a pharmacy license to
dispense drugs. When a DME MAC denies a claim for a drug because the National Supplier Clearing
House (NSC) records do not show that the supplier has a pharmacy license, the DME MAC must also
deny any equipment, accessories, and supplies related to the drug, when the supplier bills the drug on
the same claim as the equipment. (Suppliers should bill drugs for use with DMEPOS on the same
claim as the equipment itself, if they are also providing and billing for the equipment.) In situations
when a supplier bills unassigned drugs and equipment, accessories, or supplies on the same claim, the
DME MAC and VMS Shared System Maintainer must ensure that they apply nonlicensed pharmacy
equipment, accessory and supply edits and denials before they replicate the claim. Even if the system
denies a line due to the nonlicensed pharmacy edit prior to replicating the claim, the system must still
replicate any unassigned claims for drugs and biologicals and change the assignment indicator.
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: N/A
OR
The contractor shall use the following remittance advice messages and associated codes when
rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH
CORE Business Scenario Three.
Group Code: CO
CARC: B7
RARC: M143
MSN: N/A
Or
The contractor shall use the following remittance advice messages and associated codes when
rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH
CORE Business Scenario Two.
Group Code: CO
CARC: 107
RARC: N/A
MSN: N/A
The DME MACs must work together to create and maintain a list of HCPCS drug codes that suppliers
must bill on an assigned basis. This will enable VMS shared system maintainer and the DME MACs to
implement the necessary edits in their systems. Finally, the four DME MACs must work together to
create a list of drug and equipment codes to which the nonlicensed pharmacy edit would apply in this
situation. For this second list, the DME MACs need add only drugs that are used with equipment, and
the equipment, and related supplies and accessories, that use those drugs, as opposed to all drugs that
are subjected to the licensure edit. The DME MACs must share these lists with VMS shared system
maintainer and CMS Central Office.
History
(Rev. 3721, Issued: 02-24-17, Effective: 05-25-17, Implementation: 05-25-17)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
8d842b1fd9e9e405e42c2978817977168afd57b4de7b9faf192fc80c41bd24e1
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