Oral Antiemetic Drugs (Replacement for Intravenous Antiemetics) - Policy Article

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare 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 Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. "reasonable and necessary").

Oral Antiemetic Drugs are covered under the Oral Antiemetic Drug benefit (Social Security Act §1861(s)(2)(T)). In order for a beneficiary’s oral antiemetic drugs to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

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.

An oral antiemetic drug (J8650, J8670, Q0161, Q0162, Q0163, Q0164, Q0166, Q0167, Q0169, Q0173, Q0174, Q0175, Q0177, Q0180, Q0181) 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 practitioner 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 anti-emetic 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.

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. If all of the criteria are not met, the oral antiemetic drug will be denied as non-covered.

A 3-drug combination regimen consisting of an NK-1 antagonist, a 5HT3 antagonist and dexamethasone is covered when all of the criteria above (1-4) are met and all 3 drugs are given in combination.

If the NK-1 antagonist and/or dexamethasone is given as an oral anti-emetic outside of the 3-drug regimen, claims will be denied as statutorily non-covered, no benefit.

There are three NK-1 antagonists approved for this use, Aprepitant (J8501), rolapitant (J8670) and netupitant/palonosetron (J8655). Covered 3-drug regimens are:

• Aprepitant (J8501) or rolapitant (J8670) are covered when given as part of a 3-drug regimen that includes a 5HT3 antagonist (Q0162, Q0166, or Q0180) and dexamethasone (J8540).
• Netupitant/palonosetron (J8655) is covered when given in conjunction with dexamethasone (J8540). A separate 5HT3 antagonist is not needed. Netupitant/palonosetron has had multiple HCPCS codes assigned, depending on the date of service. Refer to the Coding Guidelines section (below) for instructions.

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 non-covered.

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 denied as incorrect coding. 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 the related 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.

REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and WOPD list is available here.

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.

The supplier must enter a diagnosis code corresponding to the beneficiary's cancer diagnosis on each claim.

The billing of an oral antiemetic 3-drug combination is accomplished by one of the following methods:

• Netupitant with its fixed combination of palonosetron (J8655) and dexamethasone (J8540), must be billed on the same claim.
• Aprepitant (J8501) or rolapitant (J8670) used with a separate 5HT3 antagonist (Q0162, Q0166 or Q0180) and dexamethasone (J8540) must be billed on the same claim.

In addition to the diagnosis code corresponding to the beneficiary’s cancer diagnosis, claims for oral aprepitant (J8501), rolapitant (J8670) or netupitant/palonosetron (J8655) must also be accompanied with a diagnosis code of an encounter for antineoplastic chemotherapy.

Claims for code Q0181 must identify the name of the drug, the manufacturer, the dosage strength dispensed, each tablet/suppository/etc and frequency of administration during the covered time period (24-48 hours) as specified on the order. This information must be entered in the narrative field of an electronic claim.

KX, GA AND GZ MODIFIERS

If dexamethasone (J8540) and either aprepitant (J8501), rolapitant (J8670) or 300mg netupitant/0.5mg palonosetron (J8655) are used in conjunction with one of the anticancer chemotherapeutic agents listed in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD, a KX modifier must be added to each code.

If dexamethasone (J8540) and either aprepitant (J8501), rolapitant (J8670) or 300mg netupitant/.5mg palonosetron (J8655) are not used in conjunction with one of the anticancer chemotherapeutic agents listed in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD the GA or GZ modifier must be added to a claim line for aprepitant, rolapitant, netupitant/palonosetron or dexamethasone. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.

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

CODING GUIDELINES

The following instructions apply to claims billed using 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.

Netupitant/palonosetron has had multiple HCPCS codes assigned.

• For claims with dates of service prior to July 1, 2015, use HCPCS code Q0181 (UNSPECIFIED ORAL DOSAGE FORM, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR A IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN)
• For claims with dates of service on or after July 1, 2015 through December 31, 2015, use HCPCS code Q9978 (NETUPITANT 300 MG AND PALONOSETRON 0.5 MG, ORAL)
• For claims with dates of service on or after January 1, 2016, use HCPCS code J8655 (NETUPITANT 300 MG AND PALONOSETRON 0.5 MG, ORAL)

The individual drugs contained in netupitant/palonosetron must not be unbundled and billed separately.

Rolapitant has had multiple HCPCS codes assigned.

• For claim on or after September 02, 2015 and before July 1, 2016 use HCPCS code Q0181 (UNSPECIFIED ORAL DOSAGE FORM, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR A IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN)
• For dates of service on or after July 1, 2016 and before January 1, 2017 use HCPCS code Q9981 (ROLAPITANT, ORAL, 1 MG).
• For dates of service on or after January 1, 2017 use HCPCS code J8670 (ROLAPITANT, ORAL, 1 MG).

Codes J8501, J8540, J8650, J8655 and Q0162, Q0163, Q0164, Q0166, Q0167, Q0169, Q0173, Q0174, Q0175, Q0177, Q0180, Q0181 or J8670 may be billed only when the oral antiemetic drug is used in the situations described in Non-Medical Necessity Coverage and Payment Rules section. The quantity of drugs billed using codes Q0162, Q0163, Q0164, Q0166, Q0167, Q0169, Q0173, Q0174, Q0175, Q0177, Q0180, Q0181 must not exceed the 24 or 48 hours of therapy specified above.

Refer to the Oral Anticancer Drugs policy for information on coding antiemetic drugs used in conjunction with oral anticancer drugs.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.