LCD/NCD Portal

L11559 ORAL ANTICANCER DRUGS

 

Region IV

DME

Jurisdiction C

 

08/05/2011

 

• For any item to be covered by Medicare, it must

o be eligible for a defined Medicare benefit category

o be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

o Meet all other applicable Medicare statutory and regulatory requirements.

o For the items addressed in this medical policy, the criteria for reasonable and necessary are defined by the following indications and limitations of coverage and/or medical necessity.

• Statutory coverage criteria for oral anticancer drugs are specified in the related Policy Article.

o In addition, the drug must be reasonable and necessary for the individual patient.

o If the statutory coverage criteria are met but the drug is not reasonable and necessary for the individual patient it will be denied as not medically necessary.

• Drugs may be covered only if dispensed and billed to Medicare by the entity that actually dispenses the drug to the Medicare beneficiary, and that entity must be permitted under all applicable federal, state, and local laws and regulations to dispense drugs.

o Only entities licensed in the state where they are physically located may bill the DME MAC for oral anticancer and oral antiemetic drugs.

o Physicians may bill the DME MAC for drugs if all of the following conditions are met:

 The physician is

• enrolled as a DMEPOS supplier with the National Supplier Clearinghouse

• dispensing the drug(s) to the Medicare beneficiary

• Authorized by the state to dispense drugs as part of the physician's license.

 Claims submitted by entities not licensed to dispense drugs will be denied for lack of medical necessity.

• If the drug on the claim is denied as not medically necessary, the related supply fee will also be denied as not medically necessary.

 

 

Bill Type Codes:

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

Revenue Codes:

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

 

CPT/HCPCS Codes

• The appearance of a code in this section does not necessarily indicate coverage.

 

HCPCS MODIFIERS:

 

• EY - No physician or other licensed health care provider order for this item or service

 

NATIONAL DRUG CODES (NDC):

 

• The National Drug Code (NDC) is a number, which uniquely identifies a manufacturer's product in terms of the strength of each tablet/capsule, quantity of tablets/capsules in a package, and other packaging details. Suppliers must use the NDC that matches the product dispensed.

• The oral anticancer drugs that are addressed in this policy are:

o Busulfan

o Capecitabine

o Cyclophosphamide

o Etoposide

o Fludarabine phosphate

o Melphalan

o Methotrexate

o Temozolomide

o Topotecan

 

 

HCPCS CODES:

 

A9270 NON-COVERED ITEM OR SERVICE

J8498 ANTIEMETIC DRUG, RECTAL/SUPPOSITORY, NOT OTHERWISE SPECIFIED

J8597 ANTIEMETIC DRUG, ORAL, NOT OTHERWISE SPECIFIED

J8999 PRESCRIPTION DRUG, ORAL, CHEMOTHERAPEUTIC, NOS

Q0511 PHARMACY SUPPLY FEE FOR ORAL ANTI-CANCER, ORAL ANTI-EMETIC OR IMMUNOSUPPRESSIVE DRUG(S); FOR THE FIRST PRESCRIPTION IN A 30-DAY PERIOD

Q0512 PHARMACY SUPPLY FEE FOR ORAL ANTI-CANCER, ORAL ANTI-EMETIC OR IMMUNOSUPPRESSIVE DRUG(S); FOR A SUBSEQUENT PRESCRIPTION IN A 30-DAY PERIOD

 

 

Documentations Requirements

• Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider".

o It is expected that the patient's medical records will reflect the need for the care provided.

o The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports.

o This documentation must be available upon request.

• An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request.

o Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

• A new detailed written order is required whenever there is a change in dosage or in the directions for administering the drug.

• The ICD-9 diagnosis code describing the condition for which the drug is used must be included on each claim.

• Claims for codes J8498 or J8597 must identify the name of the drug, the manufacturer, and the dosage strength of each tablet/suppository/etc.

o Only quantities of these drugs which meet the coverage criteria listed in the related Policy Article may be billed using these codes.

o The claim must also indicate which oral anticancer drug is being used and the prescribed frequency of administration of the anticancer drug.

o This information should be entered in the narrative field of an electronic claim.

• Claims using code J8999 must include the name of the drug, the manufacturer, the NDC number, and the number of tablets or capsules dispensed.

o This information must be entered in the narrative field of an electronic claim.

• Refer to the Supplier Manual for more information on documentation requirements.

 

Sources of Information and Basis for Decision

 

A25619 - Oral Anticancer Drugs - Policy Article - Effective June 2011

 

Local Coverage Determination (LCD) for Oral Anticancer Drugs (L11559)