This local coverage determination (LCD) outlines general coverage criteria for drugs approved for marketing by the Food and Drug Administration (FDA) labeled use, as well as the off-labeled use in the absence of a National Coverage Determination (NCD) or a Medicare Administrative Contractor(MAC) LCD addressing a specific drug. The related billing and coding article emphasizes documentation requirement that support the administration of a drug meets the Benefit category and the threshold of medically reasonable and necessary for the given patient.
An item or service maybe covered by a contractor LCD if it is reasonable and necessary. Please refer to CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 for reasonable and necessary provision in an LCD.
Drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective when used for indications specified on the labeling. Please refer to CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1 for the approved use of an FDA approved drug or biological.
The Medicare program provides limited benefits for outpatient drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually self-administered by the patients who take them. Please refer to CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50 for coverage requirements for drugs provided in an outpatient setting “incident to” a physician’s service.
Off Label Use of Drugs:
For unlabeled use of drug, please refer to CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.2.
For off-label use of drugs and biologicals in an anti-cancer chemotherapeutic regimen and the list of compendia that will support this indication, please refer to CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.5.
In the absence of a NCD, LCD or coverage article from the contractor, coverage for an off-label indication must be requested in writing and must include data or documentation to support the request of coverage. Supporting documentation should include, but is not limited to the following (also refer to the documentation requirements section of this LCD):
- Published recommendations from specialty societies or other authoritative evidence-based guidelines
- At least one of the Centers for Medicare & Medicaid Services (CMS) approved compendium
- Phase ll or phase llI trials that have been published in national or international peer reviewed journals. The trials should be from different centers, and should not include publications from the pharmaceutical manufacturing companies.
If the contractor determines that the evidence, as supported by the criteria listed above, is supported, then off-label coverage will be outlined in an LCD or article.
Limitations
If an off-labeled use is determined to be not indicated by CMS or the FDA, or if the use is identified as not indicated by one of the above listed compendium, or if the use is determined not safe and effective based on peer reviewed medical literature, the off-labeled use will be considered by this contractor as not meeting the reasonable and necessary threshold, and therefore not covered. Regardless of the supporting evidence for coverage for an off-labeled use of a drug, payment may only be allowed if the contractor determines the use is reasonable and necessary for the treatment of an illness or injury of a patient receiving the drug.
Self-Administered Drugs
For determining whether a drug or biological is considered to be usually self-administered, and its limitation of use, please refer to CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.2 Determining Self-Administration of Drug or Biological.
As indicated previously in this LCD, the use of a drug must meet the medical necessity requirements as outlined by CMS, which also includes the route of drug administration. Contractors must continue to apply the policy that not only the drug is medically reasonable and necessary for any individual claim, but also that the route of administration is medically reasonable and necessary. That is, if a drug is available in both oral and injectable forms, the injectable form of the drug must be medically reasonable and necessary as compared to using the oral form. Medication given by injection (parenterally) is not covered if standard medical practice indicates that the administration of the medication by mouth (orally) is effective and is an accepted or preferred method of administration.
In cases where intravenous (IV) versus oral (PO) equivalent is an issue, the physician should clearly address in the medical record, the medical rational/justification for the IV choice for a given patient when the PO form would have sufficed. Examples of when medical necessity for using the IV route include but are not limited to a patient with esophageal cancer and cannot swallow; a patient who had had recent head and neck irradiation and has severe mucositis and cannot swallow; a patient who is already suffering from severe nausea and vomiting when the medication is needed.
Medical necessity of an IV equivalent is not demonstrated in the cases where a patient has not taken the prescribed oral medication or for patient or provider convenience purposes.
This LCD summarizes coverage information “incident to” and not self-administered when there is not an active NCD or LCD or applicable CMS manual language.
Services related to non-covered services or drugs are also not covered (e.g., administration services).
As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.
