Oral Anticancer & Antiemetic Drugs

Affected Providers

Treating practitioners and DME suppliers who bill for oral anticancer drugs and antiemetic drugs.

HCPCS & CPT Codes

Local Coverage Determination (LCD): Oral Anticancer Drugs (L33826) and Article: Oral Anticancer Drugs (A52479) have the current HCPCS and CPT codes.

Background

According to the 2024 Medicare Fee-for-Service Supplemental Improper Payment Data, the improper payment rate for oral anticancer drugs is 37.7%, with a projected improper payment amount of $3.2 million.

We cover oral anticancer drugs under the oral anticancer drug benefit. You must also meet the specific statutory payment policy requirements detailed below.

Denial Reasons

Insufficient documentation accounted for 86% of improper payments for oral anticancer drugs during the 2024 reporting period, while other errors (14%) also caused improper payments. Other errors include duplicate payment, non-covered or unallowable service, or ineligible Medicare patient errors.

Preventing Denials

Oral Anticancer Drugs Coverage Criteria

Under Article A52479, you must meet all these criteria (1–4) for us to cover an oral anticancer drug:

1. It’s an FDA-approved drug or biological.
2. It has the same active ingredients as a non-self-administrable anticancer chemotherapeutic drug or biological that’s covered when given “incident to” a practitioner’s service. The oral anticancer drug and the non-self-administrable drug must have the same chemical or generic name as shown by the FDA’s Approved Drug Products (Orange Book), Physician’s Desk Reference (PDR), or an authoritative drug compendium, or the oral drug must be a prodrug which, when ingested, is metabolized into the same active ingredient found in the non-self-administrable form of the drug.
3. It’s used for the same anticancer chemotherapeutic indications, including unlabeled or off-label uses, as the non-self-administrable form of the drug.
4. It’s prescribed by a practitioner licensed under state law to prescribe these drugs as anticancer chemotherapeutic agents.

Medicare Claims Processing Manual, Chapter 17, Section 80.1 has more information.

Antiemetic Drugs Used with Oral Anticancer Drugs

We cover a self-administered antiemetic drug billed with code J8498 or J8597 if you meet these criteria:

• It’s used with a covered oral anticancer drug
• It’s likely the administered covered oral anticancer drug will induce emesis if you don’t administer the antiemetic drug
• You administer the antiemetic drug in the 2 hours before you administer the covered oral anticancer drug

We deny the antiemetic drug as non-covered if you don’t meet all criteria.

For DMEPOS items and supplies provided on a recurring basis, base your billing on prospective, not retrospective use.

Documentation Requirements

To justify payment, you must meet specific requirements when ordering DMEPOS.

Example of Improper Payments Due to Insufficient Documentation for Antiemetic Drugs in Conjunction with Anticancer Drugs

A supplier bills the claim for HCPCS J8498 (Antiemetic drug, rectal/suppository, not otherwise specified) and submits the following documentation per the review contractor’s request:

• Standard written order with correct HCPCS coding
• Treating practitioner’s medical record that doesn’t have complete documentation of continued use
• Proof of delivery

What Documentation Was Missing?

The patient’s medical documentation doesn’t support the requirement of continued use of the anticancer or antiemetic drug.

What Happens Next?

The review contractor completes the claim as an insufficient documentation error, and the Medicare Administrative Contractor recoups payment.

Recommendation

To prevent claim denials and improper payments, the certifying physician must collect and submit proper documentation, including the need for continued use, in the treating practitioner’s medical record for DMEPOS.

For specific policy requirements, see LCD L33826.