Oncology & Hematology Coding Alert

NCD:

Prepare for Broader Medicare Coverage of Oral 3-Drug Antiemetic Regimen

Irinotecan, oxaliplatin, and more may soon join the reasonable and necessary list.

Consider yourself on alert if your physician prescribes the oral three-drug antiemetic regimen of aprepitant, a 5HT3 antagonist, and dexamethasone. A proposed decision memo posted by CMS states coverage may soon be expanded to beneficiaries receiving moderately emetogenic chemotherapy (MEC).

Brush Up on Current Coverage

The existing National Coverage Determination (NCD) for “Aprepitant for Chemotherapy-Induced Emesis” refers only to highly emetogenic chemotherapy: “Aprepitant has been proposed to function in combination with other oral anti-emetics for a specified population of Medicare patients receiving highly emetogenic chemotherapy” (NCD Manual, Section 110.18).

The current NCD goes on to state that the three-drug combination is reasonable and necessary for patients treated with one (or more) of these anti-cancer chemotherapeutic agents (HCPCS codes aren’t included in the NCD):

·         Carmustine: J9050, Injection, carmustine, 100 mg

·         Cisplatin: J9060, Injection, cisplatin, powder or solution, 10 mg

·         Cyclophosphamide: J9070, Cyclophosphamide, 100 mg

·         Dacarbazine: J9130, Dacarbazine, 100 mg

·         Mechlorethamine: J9230, Injection, mechlorethamine hydrochloride, (nitrogen mustard), 10 mg

·         Streptozocin: J9320, Injection, streptozocin, 1 gram

·         Doxorubicin: J9000, Injection, doxorubicin hydrochloride, 10 mg

·         Epirubicin: J9178, Injection, epirubicin HCl, 2 mg

·         Lomustine: oral chemotherapy not covered by Medicare.

Note: Although lomustine is included in the NCD, lomustine is not included in the list of agents for which the three-drug regimen is considered reasonable and necessary in Medicare Claims Processing Manual (MCPM), Chapter 17, Section 80.2.

Spy What’s New in the Proposed Decision Memo

The proposed decision memo indicates the NCD could be revised so that the oral three-drug regimen “is reasonable and necessary for beneficiaries receiving moderately emetogenic chemotherapy (MEC) immediately before and within 48 hours after the administration of the anticancer treatment.”

A consequence of the proposed MEC expansion is that the list of applicable chemotherapy agents would grow to also include the ones below (HCPCS codes aren’t listed in the memo):

·         Alemtuzumab: J9010, Injection, alemtuzumab, 10 mg

·         Azacitidine: J9025, Injection, azacitidine, 1 mg

·         Bendamustine: J9033, Injection, bendamustine HCl, 1 mg

·         Carboplatin: J9045, Injection, carboplatin, 50 mg

·         Clofarabine: J9027, Injection, clofarabine, 1 mg

·         Cytarabine: J9100, Injection, cytarabine, 100 mg; J9098, Injection, cytarabine liposome, 10 mg

·         Daunorubicin: J9150, Injection, daunorubicin, 10 mg; J9151, Injection, daunorubicin citrate, liposomal formulation, 10 mg

·         Idarubicin: J9211, Injection, idarubicin hydrochloride, 5 mg

·         Ifosfamide: J9208, Injection, ifosfamide, 1 gram

·         Irinotecan: J9206, Injection, irinotecan, 20 mg

·         Oxaliplatin: J9263, Injection, oxaliplatin, 0.5 mg.

Don’t miss: CMS also proposes to allow Medicare Administrative Contractors (MACs) to determine coverage for the oral three-drug regimen with other highly or moderately emetogenic anticancer chemotherapy agents approved by the FDA.

So how will payers determine whether an agent is highly or moderately emetogenic (vomit inducing)? “CMS is defining highly emetogenic chemotherapy and moderately emetogenic chemotherapy as those anticancer agents so designated in at least two of three guidelines published by the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and European Society of Medical Oncology (ESMO)/Multinational Association of Supportive Care in Cancer (MASCC),” the proposed decision memo states.

48-hour note: The proposed decision’s reference to “immediately before and within 48 hours after the administration” is in line with current requirements outlined in the MCPM: “The three drug combination protocol requires the first dose to be administered before, during, or immediately after the anti-cancer chemotherapy administration. The second day is defined as ‘within 24 hours’ and the third day is defined as ‘within 48 hours’ of the chemotherapy administration.”

Final Decision Is Still to Come

Keep in mind that coverage will not change until CMS posts a final decision memo, and the final decision may differ from the proposed one.

Area to watch: The proposed decision memo specifically asks for comments on whether it should replace the term “aprepitant” with “NK-1 antagonists.” Aprepitant, sold under the brand name Emend, “is currently the sole NK-1 antagonist component of the three drug antiemetic regimen,” the memo states. Changing the term to NK-1 antagonists would open the way to future coverage of a class of drugs rather than a specific drug.

Fill In the Picture With a Resource Roundup

To complete your claim for the oral three-drug regimen, there are some points you need to bear in mind.

Part B coverage: Although Medicare Part B doesn’t usually cover self-administered drugs, this oral antiemetic regimen is an exception.

For the beneficiary to receive Part B coverage, the MCPM states, “The physician must indicate on the prescription that the beneficiary is receiving the oral anti-emetic drug as full therapeutic replacement for an intravenous anti-emetic drug as part of a cancer chemotherapeutic regimen.”

Keep codes together: “All three drugs in the combination oral anti-emetic regimen must be on the same claim to be eligible for Part B reimbursement,” the MCPM states. The appropriate code for aprepitant is J8501 (Aprepitant, oral, 5 mg). For dexamethasone, you should report J8540 (Dexamethasone, oral, 0.25 mg). The code for the 5HT3 antagonist will depend on the precise medication prescribed. Some possibilities include:

  • Q0162, Ondansetron 1 mg, oral, FDA approved prescription anti-emetic, for use as a complete therapeutic substitute for an IV anti-emetic at the time of chemotherapy treatment, not to exceed a 48 hour dosage regimen
  • Q0166, Granisetron hydrochloride, 1 mg, oral, FDA approved prescription anti-emetic, for use as a complete therapeutic substitute for an IV anti-emetic at the time of chemotherapy treatment, not to exceed a 24 hour dosage regimen
  • Q0180, Dolasetron mesylate, 100 mg, oral, FDA approved prescription anti-emetic, for use as a complete therapeutic substitute for an IV anti-emetic at the time of chemotherapy treatment, not to exceed a 24 hour dosage regimen.

Review the resources: For more information on coding and coverage for the oral three-drug regimen, review these resources:

·         NCD manual, Section 110.18: www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part2.pdf

·         Proposed decision memo: www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=264

·         MCPM, Chapter 17, Section 80.2: www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf

·         MLN Matters SE0910: www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE0910.pdf

·         CMS article, “Clarification on Billing for the Oral Three-Drug Combination Anti-Emetic (Aprepitant)”: www.cms.gov/Medicare/Medicare-Contracting/ContractorLearningResources/downloads/JA5655.pdf.

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