Injectable drugs and their administration are subject to limitation of liability and refund requirements. The assignment of the claim determines whether this applies to only the drug or the drug and its administration.
Limitation of Liability
- Limitation of liability applies to injectable drugs and their administration when denied as not being reasonable and necessary
- Charges for injectable drugs and their administration cannot be billed to a beneficiary unless the beneficiary signed an Advance Beneficiary Notice (ABN)
- The CMS-approved ABN and instructions for its use are available on the CMS Beneficiary Notices Initiative Web page
Mandatory Assignment
Under the Benefits Improvement and Protection Act of 2000 (BIPA), payment for any drug or biological covered under Part B of Medicare must be made only on an assigned basis. Therefore, no charge or bill may be rendered to anyone for drugs and biologicals for any amount except the Medicare Part B deductible and coinsurance amounts.
Effective July 1, 2001, for dates of service on or after February 1, 2001, physicians and non-physicians practitioners must accept assignment on claims for drugs and biologicals.
Claims submitted as 'Unassigned' ('N' in the assignment field of electronic claims or Item 27 of the CMS-1500 claim form marked 'NO') or when assignment is not indicated, will be processed as follows:
- If the only service on the claim is a drug or biological, the claim assignment will be changed to Assigned
- If the claim contains charges for drugs or biologicals in addition to other services, the drugs and biologicals will be split onto a separate claim and processed as Assigned
- The beneficiary’s Medicare Summary Notice will reflect the following remark (N71) if the claim assignment was changed:
"Your assigned claim for a drug or biological was processed as an assigned claim. The law requires that you must take assignment on all claims for drugs and biologicals."
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