Medicare Claims Processing Manual (Pub. 100-04), Ch. 17 § 60.1
Prescription Drugs Billed by Suppliers Not Licensed to Dispense Them
60.1 - Prescription Drugs Billed by Suppliers Not Licensed to Dispense Them
(Rev. 3721, Issued: 02-24-17, Effective: 05-25-17, Implementation: 05-25-17)
Medicare does not cover a drug used as a supply with DME or a prosthetic device if the drug is
dispensed by an entity that is not licensed to dispense the drug. The drug is not considered to be
reasonable and necessary because CMS cannot be assured of its safety and effectiveness unless it is
dispensed by an entity that has a State license that qualifies it to dispense the drug. The equipment used
with the drugs dispensed by a nonlicensed entity is also considered to be not reasonable and necessary
because of the related safety and efficacy concerns. Physicians are considered to have been “deemed”
the right to dispense prescription drugs, and therefore do not require a pharmacy license.
The DME MACs should deny claims for a prescription drug (and related equipment when billed on the
same claim as the drug) when the National Supplier Clearinghouse’s (NSC’s) files show the supplier is
or was not licensed to dispense the drugs on the date of service (DOS).
An exception to this general policy is oxygen claims.
Messages for Assigned Claims:
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: 8.50
Messages for Nonassigned Claims:
MSN: “This item or service is not covered when performed or ordered by this provider.”
(MSN #12.18)
Appeals should be addressed according to the instructions in Chapter 29.