Retired - Coverage and Coding – New Oral Antiemetic Drug Varubi® – Revised – Effective Date July 1, 2016

Joint DME MAC Publication

The U.S. Food and Drug Administration approved Varubi® (rolapitant) on September 2, 2015. Rolapitant is a substance P/neurokinin1 (NK-1) receptor antagonist used to treat nausea and vomiting in patients undergoing emetogenic cancer chemotherapy.

The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have evaluated rolapitant and determined that it is eligible for inclusion in the DME MAC Oral Antiemetic Drugs (Replacement for Intravenous Antiemetics) Local Coverage Determination (LCD).

For dates of service on or after September 2, 2015 and before July 1, 2016, claims for rolapitant must be billed using 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, claims for rolapitant must be billed using HCPCS Code:

Q9981-  ROLAPITANT, ORAL, 1 MG

Q9981 must be billed on the same claim with dexamethasone (J8540) and an oral 5HT3 antagonist.

The use of the oral anti-emetic 3-drug combination of an FDA-approved oral NK-1 antagonist and an oral 5HT3 antagonist, in combination with dexamethasone, is covered if in addition to meeting the statutory coverage criteria specified in the related Policy Article, they are administered to beneficiaries who are receiving one or more of the anti-cancer chemotherapeutic agents listed in the LCD regarding oral anti-emetic coverage.

If the three drug combination of an oral 5HT3 antagonist, rolapitant (Q9981) and dexamethasone (J8540) are used in conjunction with one of the anticancer chemotherapeutic agents listed in the Coverage Indications, Limitations and/or Medical Necessity section of the LCD regarding oral antiemetics, a KX modifier must be added to each code. In addition to the diagnosis code corresponding to the beneficiary's cancer diagnosis, claims for these drugs must also be accompanied with a diagnosis code of an encounter for antineoplastic chemotherapy (Z51.11).

If the three drug combination of rolapitant (Q9981), an oral 5HT3 antagonist and dexamethasone (J8540) are not used in conjunction with one of the anticancer chemotherapeutic agents listed in the Coverage Indications, Limitations and/or Medical Necessity section of this policy, the GA or GZ modifier must be added to the claim lines for Q9981 and J8540 and the 5HT3 antagonist. 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.

Please refer to the DME Oral Antiemetic Drugs (Replacement for Intravenous Antiemetics) Local Coverage Determination, related Policy Article and Supplier Manual for further information on coverage, documentation and coding requirements.

For questions about correct coding, contact the Pricing, Data Analysis, and Coding contractor (PDAC) at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or e-mail the PDAC by completing the DME PDAC Contact Form.