This article contains coding and other guidelines that complement the Local Coverage Determination (LCD) for Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.
Coding Information:
General Information
Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.
A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.
The diagnosis code(s) must best describe the patient's condition for which the service was performed.
Intravenous in Lieu of Oral Formulation
When billing for an IV drug which has an available oral form, please also report an additional ICD-10-CM code to indicate that the oral route is not appropriate, for example:
| K91.2 |
POSTSURGICAL MALABSORPTION, NOT ELSEWHERE CLASSIFIED |
| K90.9 |
INTESTINAL MALABSORPTION UNSPECIFIED |
| T50.995A |
ADVERSE EFFECT OF OTHER DRUGS, MEDICAMENTS AND BIOLOGICAL SUBSTANCES, INITIAL ENCOUNTER |
| Y63.6 |
UNDERDOSING AND NONADMINISTRATION OF NECESSARY DRUG, MEDICAMENT OR BIOLOGICAL SUBSTANCE |
| Y63.8 |
FAILURE IN DOSAGE DURING OTHER SURGICAL AND MEDICAL CARE |
| Z87.19 |
PERSONAL HISTORY OF OTHER DISEASES OF THE DIGESTIVE SYSTEM |
Documentation Requirements:
The patient's medical record must contain documentation that fully supports the medical necessity for services included within the LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.
The medical record must include the following information:
- The name of the drug or biological administered;
- The route of administration;
- The dosage (e.g., mgs, mcgs, cc's or IU's);
- The duration of the administration (for CPT codes that are time based); and
When modifier –JW is used to report that a portion of the drug or biological is discarded, from single use vials, the medical record must clearly document the amount administered and the amount wasted or discarded. Effective July 1, 2023 (CR 13056) JZ Modifier is required on all claims that bill for drugs separately payable under Medicare Part B when there are no discarded amounts from single-dose containers or single-use packages.
For claims submitted to the Part B MAC:
Drugs with No Charges
Effective for dates of service on or after 05/07/2018, when a drug is purchased by the beneficiary, or when the drug was supplied without charge by the manufacturer, the drug should be billed using the appropriate HCPCS code with a billed amount of $0.01.
For dates of service prior to 05/07/2018, drugs with no charge will be accepted by Medicare even with a submitted charge of $0.00. However, the name and dosage of the drug should be listed in the narrative record of the claim, to avoid requests for additional information on the claim.
