Aprepitant for Chemotherapy-Induced Emesis

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 gender, 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 antiemetic 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 antiemetic 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 antiemetics for a specified population of Medicare patients receiving highly emetogenic chemotherapy and/or moderately emetogenic chemotherapy.

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 inclusive examples are: NCCN plus ASCO, NCCN plus ESMO/MASCC, or ASCO plus ESMO/MASCC.

B. Nationally Covered Indications

Effective for services performed between April 4, 2005, and May 28, 2013, 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 antiemetic three-drug combination of oral aprepitant (Emend®), an oral 5HT₃ antagonist, and oral dexamethasone is reasonable and necessary for a specified patient population. We have defined the patient population for which the use of the oral antiemetic three-drug combination of oral aprepitant (Emend®), an oral 5HT₃ antagonist, and oral 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

Effective for services performed on or after May 29, 2013, the oral three-drug regimen of oral aprepitant, an oral 5HT₃ antagonist and oral dexamethasone is reasonable and necessary for beneficiaries receiving, either singularly or in combination with other drugs the following anticancer chemotherapeutic agents:

• Alemtuzumab
• Azacitidine
• Bendamustine
• Carboplatin
• Carmustine
• Cisplatin
• Clofarabine
• Cyclophosphamide
• Cytarabine
• Dacarbazine
• Daunorubicin
• Doxorubicin
• Epirubicin
• Idarubicin
• Ifosfamide
• Irinotecan
• Lomustine
• Mechlorethamine
• Oxaliplatin
• Streptozocin

The oral three drug regimen must be administered immediately before and within 48 hours after the administration of these chemotherapeutic agents.

C. Nationally Noncovered Indications

The evidence is adequate to conclude that aprepitant cannot function alone as a full replacement for intravenously administered antiemetic agents for patients who are receiving highly emetogenic chemotherapy and/or moderately emetogenic chemotherapy. Medicare does not cover under Part B for oral antiemetic drugs in antiemetic drug combination regimens that are administered in part, via an oral route and in part, via an intravenous route. Medicare does not cover under Part B aprepitant when it is used alone for anticancer chemotherapy related nausea and vomiting.

D. Other

Medicare Administrative Contractors may determine coverage for other all-oral three-drug antiemesis regimens of aprepitant or any other FDA approved oral NK-1 antagonist in combination with an oral 5HT₃ antagonist and oral dexamethasone with the chemotherapeutic agents listed above, or any other anticancer chemotherapeutic agents that are FDA approved and are defined as highly or moderately emetogenic.

(Last revised May 2013)

02/2024 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. (TN 12493) (CR13507)

01/2024 - Transmittal 12318 issued October 19, 2023, is being rescinded and replaced by Transmittal 12441, dated January 3, 2024, to add FISS to BR 13390.11 and to add clarifying verbiage to business requirement 13390.12. All other information remains the same. (TN 12441) (CR13390)

10/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. (TN 12318) (CR13390)

10/2022 - Transmittal 11546, dated August 4, 2022, is being rescinded and replaced by Transmittal 11636, dated, October 5, 2022, to remove ICD-10 dx codes added in error to NCD 150.3, business requirement 12842.4, and restore ICD-10 dx C91.92 removed in error to NCD 110.23, business requirement 12842.3. All other information remains the same. (TN 11636) (CR12842)

08/2022 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. (TN 11546) (CR12842)

01/2022 - Transmittal 11068, dated October 21, 2021, is being rescinded and replaced by Transmittal 11179, dated, January 12, 2022 to revise the attachment for NCD 110.24, CAR-T, to add business requirement 12480.10.1 by adding generic unspecified procedure codes, to clarify coverage and claims processing in the policy section and to review the implementation date. All other information remains the same. (TN 11179) (CR12480)

10/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 11068) (CR12480)

09/2019 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 2362) (CR11392)

05/2019 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process.(TN 2298) (CR11229)

11/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process.(TN 2200) (CR10859)

09/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process.(TN 2138) (CR10859)

08/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding to feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2122) (CR10859)

05/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. (TN 2076) (CR10622)

02/2018 - Transmittal 2033, dated February 16, 2018, is being rescinded and replaced by Transmittal 2039, dated, February 28, 2018 to correct instructions in business requirement 7, NCD210.3, Colorectal Cancer Screening, and its accompanying spreadsheet. All other information remains the same. (TN 2039) (CR10473)

02/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2033) (CR10473)

01/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2005) (CR10318)

11/2017 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 1975) (CR10318)

02/2017 - This change request (CR) is the 10th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. Previous NCD coding changes appear in ICD-10 quarterly updates as follows: CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, CR9631, and CR9751, as well as in CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1792) (CR9861)

06/2016 - Transmittal 1665, dated May 13, 2016, is being rescinded and replaced by Transmittal 1672 to: (1) 9631.1: Remove FISS responsibility and 1st sentence; (2) 9631.2: Remove additional procedure codes, including 0075T, 0076T; (3) 9631.4: Revise descriptor of dx L59.8; (4) 9631.6: Add deletion of dx C49.10, C65.9, remove deletion of dx C54.9, remove deletion of invalid dx C47.90; (5) 9631.8: Remove deletion of invalid dx C51.29, replace with deletion of dx C50.029; (6) 9631.9: Add deletion of 0V504ZZ, 0V500ZZ, override capability, and contractor discretion verbiage. All other information remains the same. (TN 1672) (CR9631)

05/2016 - This change request (CR) is the 7th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, and CR9540. Some are the result of revisions required to other NCD-related CRs released separately. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1665) (CR9631)

04/2016 - Transmittal 1630, dated February 26, 2016, is being rescinded and replaced by Transmittal 1658 to (1) remove duplicate spreadsheet NCD210.3, (2) add missing spreadsheet NCD20.33, (3) add B/MAC to requirement 3 at request of WPS/B, (4) rename the spreadsheet titles, and, (5) provide a link to the attached spreadsheets for more efficient ease of reference and accessibility. All other information remains the same. (TN 1658) (CR9540)

04/2014 - Transmittal 163, dated February 21, 2014, is being rescinded and replaced by Transmittal 165, dated April 15, 2014, to correct language for the title of the NCD Manual. All other information remains the same. (TN 165) (CR8418).

02/2014 - Effective for claims with dates of service May 29, 2013, and later, CMS extends coverage of the oral antiemetic three-drug regimen of oral aprepitant, an oral 5HT3 antagonist and oral dexamethasone to beneficiaries who are receiving one or more of the following anti-cancer chemotherapeutic agents. Effective date: 05/29/2013. Implementation date: 07/07/2014. (TN 163) (CR8418).

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)