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Medicare Coverage Criteria for Oral and Intravenous Antiemetics

IV antiemetics that are administered in a physician's office under the "incident-to" rules are considered covered by Medicare. The incident-to rules have specific requirements that include the following:

• Physical presence of a physician. Because the service is being performed incident to a physician's service, a physician must be present in the office suite and must be immediately available to provide assistance while the service is being performed.
  
• Expense to the physician. The cost of the service must represent a cost to the physician.
  
• Employment status of the staff. This means that the nonphysician staff furnishing the service (as incident to a physician's service) must be a part-time, full-time, or leased employee of the physician (or group practice or entity that employs the physician) who is supervising the service.
  

Under the coverage criteria for IV antiemetics, the drug itself would need to be approved by the FDA. Medicare will generally cover off-label uses; however, the off-label use must be supported by one of Medicare's recognized compendia or by peer-reviewed literature in certain journals recognized by Medicare.

The criteria for Medicare Part B coverage of oral antiemetics are more specific than for IV antiemetics. In general, Medicare Part B covers oral antiemetics if the following are met:

• The oral form is a full replacement for IV antiemetics.
  
• The oral antiemetic(s) are initiated within 2 hours of the chemotherapy agent.
  
• The use of the medication does not extend more than 48 hours after initiation.
  
• The drug is approved by the FDA as an antiemetic.
  

Even though Medicare requires that the oral form be a full replacement for the IV antiemetics, it will provide coverage for the IV form should the patient experience treatment failure on the oral medication.

Oral and IV antiemetics may also be covered under Medicare Part D, which is the program's prescription drug plan. Generally speaking, all drugs are covered under Part D unless they are covered under Parts A or B. If some or all of the Part B requirements specified above are not met, a beneficiary should be able to obtain coverage of an antiemetic through his or her Part D plan. It is important to note that Part D plans can impose formulary, prior authorization, or other management controls on medicine.

Coverage for Aprepitant Top Coverage for Aprepitant   Aprepitant (Emend; Merck, Whitehouse Station, NJ) is an antiemetic currently available in both oral and intravenous (IV) forms (as described in related article on page 130). There has been some confusion regarding Medicare coverage when both forms of the drug are administered during one episode. In 2005, Medicare established a national coverage determination for aprepitant that outlines the coverage of the drug when it is used in a three-drug oral combination consisting of aprepitant, a 5-HT3 antagonist, and dexamethasone. (Medicare does not cover the aprepitant if used by itself.) The oral combination is covered when used in conjunction with the following chemotherapy agents: carmustine, cisplatin, cyclophosphamide, dacarbazine, mechlorethamine, streptozocin, doxorubicin, epirubicin, and lomustine. Medicare does not believe aprepitant is effective when administered by itself and will not provide coverage when administered outside of the three-drug combination. Physicians may wish to use the IV form of aprepitant on the first day, which would replace the first of three oral doses of aprepitant. However, the IV administration on day one is not consistent with the Medicare national coverage determination, which specifically identifies use of the oral antiemetic. Administering the IV form on the first day would also not conform to Medicare's policy that the oral antiemetic be a full replacement of the IV form. Some local Medicare contractors are reviewing the use of the IV form of the drug on the first day and providing clarifying language to address the multiple forms of aprepitant.

 

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