For any item to be covered, it must:

1. be eligible for a defined benefit category;
2. be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; and
3. meet all other applicable statutory and regulatory requirements.

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.

Aprepitant (J8501) and dexamethasone (J8540) are covered if, in addition to meeting the statutory coverage criteria, they are administered to patients who are receiving one or more of the following anti-cancer chemotherapeutic agents:

Carmustine
Cisplatin
Cyclophosphamide
Dacarbazine
Mechlorethamine
Streptozocin
Doxorubicin
Epirubicin
Lomustine

If aprepitant and dexamethasone meet the statutory coverage criteria, but are not used with one of the preceding chemotherapeutic agents, they will be denied as not medically necessary. 

The supplier may dispense only a single course of oral antiemetic drugs at one time.

Refer to Medicare Advantage Medical Policy Bulletin G-51, Oral Anticancer Drugs, for information on coverage of antiemetic drugs used in conjunction with oral anticancer drugs.

An oral antiemetic drug billed with a procedure code listed in the policy is covered if all of the following criteria (1-4) are met:

1. The drug has been approved by the Food and Drug Administration (FDA) for use as an antiemetic; and
   
   
2. The drug has been ordered by the treating physician as part of a cancer chemotherapy regimen; and
   
   
3. The drug is used as a full therapeutic replacement for an intravenous antiemetic drug that would otherwise have been administered at the time of the chemotherapy treatment; and
   
   
4. Oral antiemetic drugs administered with a particular chemotherapy treatment must be initiated within two hours of the administration of the chemotherapeutic agent and may be continued for a period not to exceed 48 hours from that time.

If all of the criteria are not met, the oral antiemetic drug will be denied as not medically necessary. Criterion 3 is not met when the chemotherapy drug is an oral drug or when the chemotherapy drug is administered intravenously in the home setting because the type and dosage of chemotherapy drugs administered in these situations do not require intravenous antiemetic drugs.

Aprepitant (J8501) and dexamethasone (J8540) are covered only if, in addition to the general criteria listed above, they are administered as part of an oral antiemetic 3-drug regimen which includes a 5-HT3 antagonist [i.e., granisetron (Q0166), ondansetron (Q0179), or dolasetron (Q0180)]. If aprepitant and/or dexamethasone are not used as part of this 3-drug regimen, they will be denied as not medically necessary. 

If all of the above criteria (1-4) are met, the quantity of oral antiemetic drugs covered for each episode of chemotherapy cannot exceed the initial loading dose plus 48 hours of therapy. However, for the drugs granisetron (Q0166) and dolasetron (Q0180), the quantity of drugs covered for each episode of chemotherapy is limited to the initial loading dose plus 24 hours of therapy. Quantities of drugs in excess of these amounts are considered not medically necessary.

More than one oral antiemetic drug may be covered for concurrent use if more than one oral drug is needed to fully replace the intravenous drugs that would otherwise have been given.

The quantity of oral antiemetic drugs that is dispensed should be limited to a 30-day supply. Orders may be refillable.

Supply Fee
One unit of service of supply fee code Q0511 is covered for the first covered oral antiemetic 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 antiemetic 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 policy. If the drug on the claim is denied as not medically necessary, the supply fee will be denied as not medically necessary.

The supply fee code must be billed on the same claim as the drug(s).

Reasons for Noncoverage

Payment for the services will be denied as not medically necessary when used for indications or in circumstances other than those listed in this policy. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation 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." It is expected that the patient's medical records will reflect the need for the care provided. 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. 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. 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 procedure code.

The supplier must enter a diagnosis code corresponding to the patient's cancer diagnosis on each claim.
The oral antiemetic 3-drug combination of aprepitant (J8501), a 5-HT3 antagonist (Q0166, Q0179, Q0180), and dexamethasone (J8540) should be submitted on the same claim.

If aprepitant (J8501) and dexamethasone (J8540) are used in conjunction with one of the anticancer chemotherapeutic agents listed in the "Indications and Limitations of Coverage" section of this policy, a KX modifier should be added to each code.

Claims for code Q0181 must be accompanied by the name of the drug, the manufacturer, the dosage strength dispensed, the number of tablets and frequency of administration during the covered time period (24-48 hours) as specified on the order.

KX, GA and GZ Modifiers
If aprepitant (J8501) and dexamethasone (J8540) are used in conjunction with one of the anticancer chemotherapeutic agents listed in the Indications and Limitations of Coverage section of this policy, a KX modifier must be added to each code.

If aprepitant and dexamethasone are not used in conjunction with one of the anticancer chemotherapeutic agents listed in the Indications and Limitations of Coverage section of this policy, the GA or GZ modifier must be added to a claim line for aprepitant or dexamethasone. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Pre-Service Denial Notice or the GZ modifier if they have not obtained a valid Pre-Service Denial Notice. The provider can bill the member if a GA modifier is entered on the claim. A provider cannot bill the member if a GZ modifier is entered on the claim.

Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Codes J8501, J8540, J8650 and Q0163-Q0181 may be billed only when the oral antiemetic drug is used in the situations described in the "Indications and Limitations of Coverage" section. The quantity of drugs billed using codes Q0163-Q0181 must not exceed the 24 or 48 hours of therapy specified above.

Code Q0181 is a miscellaneous code, which may be used only when all the requirements of the policy are met, but the drug administered does not have a specific code (J8501, J8540, J8650, and Q0163-Q0180).