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NON-MEDICAL
NECESSITY COVERAGE AND PAYMENT RULES
For an item to be covered by Medicare, a written signed and dated order
must be received by the supplier before a claim is submitted. If the
supplier bills for an item addressed in this policy without first receiving
the completed order, the item will be denied as non-covered.
Oral Anticancer Drugs
An oral anticancer drug is covered if all of the following criteria (1-4)
are met:
1) It is a drug or biological that has been approved by the Food and Drug
Administration (FDA), and
2) It has the same ingredients as a non-self-administrable anticancer
chemotherapeutic drug or biological that is covered when furnished incident
to a physician's service. The oral anticancer drug and the
non-self-administrable drug must have the same chemical/generic name as
indicated by the FDA's Approved Drug Products (Orange Book), Physician's
Desk Reference (PDR), or an authoritative drug compendium, or it is a prodrug which, when ingested, is metabolized into the
same active ingredient which is found in the non-self-administrable form of
the drug, and
3) It is used for the same indications, including unlabeled uses, as the
non-self-administrable form of the drug
- For busulfan, capecitabine, cyclophosphamide, etoposide,
melphalan, methotrexate,
or temozolomide, it is prescribed for the
treatment of cancer (ICD-9 codes 140.0-208.91, 230.0-239.9, 259.2,
273.3, V58.11);
- For topotecan, it is prescribed for the treatment of
relapsed small cell lung (ICD-9 codes 162.2-162.9); and
4) It is prescribed by a physician or other practitioner licensed under
state law to prescribe such drugs as anticancer chemotherapeutic agents.
A drug that is not available in an injectable
form does not meet criterion 2. If an oral anticancer drug is used for immunosuppression (rather than the treatment of
cancer), criterion 3 is not met, and the drug cannot be covered under the
oral anticancer drug benefit. (If the drug is used for immunosuppression
following organ transplant, refer to the Immunosuppressive Drugs policy.)
If criteria 1-4 are not met, the drug will be denied as non-covered.
The quantity of oral anticancer drugs that is dispensed should be limited
to a 30-day supply. Prescriptions may be refillable.
Antiemetic drugs used with oral
anticancer drugs
A self-administered antiemetic drug billed with
code J8498 or J8597 is covered if all of the following criteria are met:
1) It is used in conjunction with a covered oral anticancer drug, and
2) It is likely that administration of the covered oral anticancer drug
will induce emesis if the antiemetic drug is not
administered, and
3) The antiemetic drug is administered within 2
hours before the covered oral anticancer drug is administered.
Antiemetic drugs are covered under the oral
anticancer drug benefit for the sole purpose of allowing the absorption of
the covered oral anticancer drug. Therefore, coverage is limited to doses
of antiemetic drugs, which are administered
during the two hours before administration of the covered oral anticancer
drug. Doses of antiemetic drugs administered
after the administration of the oral anticancer drug (e.g., to treat nausea
or vomiting which is caused by the oral anticancer drug or other etiology)
are non-covered.
If all of the criteria are not met, the antiemetic
drug will be denied as non-covered.
For information on the coverage of oral antiemetic
drugs when they are used as a full replacement for intravenous antiemetic drugs used in conjunction with intravenous
cancer chemotherapeutic regimens, refer to the Oral Antiemetic
Drugs (Replacement for Intravenous Antiemetics)
policy.
Supply Fee
One unit of service of supply fee code Q0511 is covered for the first
covered oral anticancer drug that is dispensed in a 30-day period. If
covered drugs are dispensed by more than one pharmacy during a 30-day
period, one unit of Q0511 is covered for each pharmacy. One unit of service
of supply fee code Q0512 is covered for each subsequent covered oral
anticancer drug that is dispensed in that 30-day period. If two dosage
strengths of the same drug are dispensed on the same day, one unit of
service of the appropriate supply fee is payable for each one. If more than
one unit of service of code Q0511 is billed per 30 days by a single pharmacy,
the excess units of service will be paid comparable to code Q0512. If the
billed units of service of Q0511 or Q0512 exceed the number of drugs on the
claim, the excess units will be denied as not separately payable.
Supply fees are eligible for coverage only for drugs that are covered under
this LCD. If the drug on the claim is denied as non-covered, the supply fee
will be denied as non-covered.
The supply fee code must be billed on the same claim as the drug(s). If it
is not, the supply fee will be denied as incorrect billing.
J8498 is not eligible for payment of a supply fee.
CODING GUIDELINES
For the instructions below that apply to J codes, when claims are billed in
NCPDP format using NDC numbers, different instructions may apply. Refer to
the NCPDP Companion Document available through the CMS web site.
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.
For all NDC numbers, 1 unit of service = 1 tablet or 1 capsule.
For codes J8498 and J8597, 1 unit of service = 1 mg.
National Drugs Codes (NDCs) may be billed only when
the drug is used as an oral anticancer drug. If cyclophosphamide
or methotrexate is prescribed as an oral
immunosuppressive drug following an organ transplant, code J8530 or J8610
respectively must be used. (Refer to the Immunosuppressive Drugs policy for
additional information.) If cyclophosphamide or methotrexate are prescribed as an oral
immunosuppressive drug for other conditions (e.g., lupus, rheumatoid
arthritis, etc.), a claim should not be submitted to Medicare (unless
requested by the beneficiary) because there is no statutory benefit for
oral immunosuppressive drugs in these conditions.
Code J8498 or J8597 may be billed only when the antiemetic
drug is used in conjunction with a covered oral anticancer drug. Suppliers
may bill only for quantities of antiemetic drugs
that are to be used within 2 hours before the covered oral anticancer drug.
Refer to the Oral Antiemetic Drugs (Replacement
for Intravenous Antiemetics) policy for
information on billing oral antiemetics used in
conjunction with intravenous cancer chemotherapeutic regimens.
A list of valid NDC numbers for covered oral anticancer drugs can be found
on the SADMERC web site. Until a new NDC number is added to the list,
suppliers must submit claims using code J8999.
Oral anticancer drugs which are not covered under the oral anticancer drug
benefit (i.e., those that are not specifically listed in this policy) must
be billed using code A9270 (noncovered item or
service) if the supplier chooses to submit a claim.
Suppliers should contact the Statistical Analysis Durable Medical Equipment
Regional Carrier (SADMERC) for guidance on the correct coding of these
items.
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