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National Coverage Determination (NCD)

Aprepitant for Chemotherapy-Induced Emesis

110.18

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Tracking Information

Publication Number
100-3
Manual Section Number
110.18
Manual Section Title
Aprepitant for Chemotherapy-Induced Emesis
Version Number
1
Effective Date of this Version
04/04/2005
Ending Effective Date of this Version
05/29/2013
Implementation Date
07/05/2005
Implementation QR Modifier Date

Description Information

Benefit Category
Oral Antiemetic Drugs


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

Chemotherapy-induced nausea and vomiting (CINV) can range from mild to severe, with the most severe cases resulting in dehydration, malnutrition, metabolic imbalances, and potential withdrawal from future chemotherapy treatments. The incidence and severity of CINV are influenced by the specific chemotherapeutic agent(s) used; dosage, schedule and route of administration; and drug combinations. Patient specific risk factors such as sex, age, history of motion sickness, and prior exposure to chemotherapeutic agents can also have an effect on CINV incidence and severity. Progress has been made in reducing CINV, although it can still be hard to control symptoms that occur more than a day after chemotherapy, during repeat cycles of chemotherapy, and when chemotherapy is given on more than one day or in very high doses. No single anti-emetic agent is completely effective in all patients. As noted above, many factors influence the incidence and severity of CINV, with the specific chemotherapeutic agent as the primary factor to consider when deciding which anti-emetic to administer. Aprepitant (Emend®) is the first Food and Drug Administration-approved drug of its type. Aprepitant has been proposed to function in combination with other oral anti-emetics for a specified population of Medicare patients receiving highly emetogenic chemotherapy.
Indications and Limitations of Coverage

B. Nationally Covered Indications

Effective for services performed on or after April 4, 2005, the Centers for Medicare & Medicaid Services makes the following determinations regarding the use of aprepitant in the treatment of reducing chemotherapy-induced emesis:

The evidence is adequate to conclude that the use of the oral anti-emetic 3-drug combination of aprepitant (Emend®), a 5-HT3 antagonist, and dexamethasone is reasonable and necessary for a specified patient population. We have defined the patient population for which the use of the oral anti-emetic 3-drug combination of aprepitant (Emend®), a 5-HT3 antagonist, and dexamethasone is reasonable and necessary as only those patients who are receiving one or more of the following anti-cancer chemotherapeutic agents:

  • Carmustine
  • Cisplatin
  • Cyclophosphamide
  • Dacarbazine
  • Mechlorethamine
  • Streptozocin
  • Doxorubicin
  • Epirubicin
  • Lomustine

C. Nationally Noncovered Indications

The evidence is adequate to conclude that aprepitant cannot function alone as a full replacement for intravenously administered anti-emetic agents for patients who are receiving highly emetogenic chemotherapy.

D. Other

N/A

(This NCD last reviewed June 2005.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
40
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R40NCD.pdf
Revision History

06/2005 - Extended coverage for use of oral anti-emetic three drug combination of aprepitant (Emend®), a 5-HT3 antagonist, and dexamethasone for specified patient population. Defined patient population only those receiving one or more anti-cancer chemotherapeutic agents of carmustine, cisplatin, cyclophosphamide, dacarbazine, mechlorethamine, streptozocin, doxorubicin, epirubicin or lomustine. Effective date 04/04/2005. Implementation date 07/05/2005. (TN 40) (CR 3831)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Aprepitant for Chemotherapy-Induced Emesis 2 05/29/2013 - N/A View
Aprepitant for Chemotherapy-Induced Emesis 1 04/04/2005 - 05/29/2013 You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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