CMS Pub. 100-04, ch. 17, § 80.2

Emetic Drugs as Part of a Cancer Chemotherapeutic Regimen

(Rev. 2931, Issued: 04-15-14, Effective: 05-29-13, Implementation: 07-07-14)

See the Medicare Benefit Policy Manual, Chapter 15, and the National Coverage Determination (NCD)

Manual, Section 110.18, for detailed coverage requirements.

Effective for dates of service on or after January 1, 1998, Medicare Part B (including institutional

claims processed by A/B MACs (A) and physician/supplier claims processed by DME MACs) pays for

oral anti-emetic drugs when used as full therapeutic replacement for intravenous dosage forms as part

of a cancer chemotherapeutic regimen when the drug(s) is administered or prescribed by a physician for

use immediately before, at, or within 48 hours after the time of administration of the chemotherapeutic

agent.

The allowable period of covered therapy includes day 1, the date of service of the chemotherapy drug

(beginning at the time of treatment), plus a period not to exceed 2 additional calendar days, or a

maximum period up to 48 hours. Some drugs are limited to 24 hours; some to 48 hours. The hour limit

is included in the narrative description of the Health Care Common Procedure Coding System

(HCPCS) code.

The oral, 3-drug combination is aprepitant, a 5HT3 antagonist, e.g. granisetron, ondansetron, or

dolasetron, and dexamethasone, a corticosteroid.

The oral anti-emetic drug(s) should be prescribed only on a per chemotherapy treatment basis. For

example, only enough of the oral anti-emetic(s) for one 24- or 48-hour dosage regimen (depending

upon the drug) should be prescribed/supplied for each incidence of chemotherapy treatment. The 3-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. These drugs may be

supplied by the physician in the office, by an inpatient or outpatient provider (e.g., hospital, critical

access hospital (CAH), skilled nursing facility (SNF), or through a supplier (e.g., a pharmacy).

The physician must indicate on the prescription that the beneficiary is receiving the oral anti-emetic

drug(s) as a full therapeutic replacement for an intravenous anti-emetic drug as part of a cancer

chemotherapeutic regimen. Where the drug is provided by a facility, the beneficiary’s medical record

maintained by the facility must be documented to reflect that the beneficiary is receiving the oral anti-emetic drug(s) as full therapeutic replacement for an intravenous anti-emetic drug as part of a cancer

chemotherapeutic regimen. All other indications or combinations for the use of oral aprepitant that are

not noted in the NCD Manual Pub. 100-03 chapter 1, section 110.18, are non-covered under Medicare

Part B, but may be considered for payment under Medicare Part D.

Payment for drugs used as a full replacement for intravenous anti-emetic drugs is made under Part B.

Beginning January 1, 2005, the payment allowance limit for these Part B drugs (the term “drugs”

includes biologicals) will be based on the Average Sales Price (ASP) plus 6%. Hospital outpatient

department providers may either:

(1) Bill all doses of the 3-drug oral regimen that will be given in a 3-day period, including the entire

Tri-Pak (3 days of aprepitant, 57 units of J8501) as well as the oral dexamethasone and oral 5HT3

antagonist to the A/B MAC (A), or (2) Bill the first day’s supply of aprepitant along with an oral 5HT3

antagonist and oral dexamethasone to their A/B MAC (A), and give a prescription for remaining doses

of the regimen, for example the second and third days’ supply of aprepitant and oral dexamethasone,

which must be billed to the DME MAC.

When billed to the A/B MAC (A), all three drugs in the combination oral anti-emetic must be on the

same claim. Providers subject to the hospital outpatient PPS will be paid on the basis of an APC. If the

hospital outpatient department dispenses the aprepitant for days two and three to the beneficiary and

bills the DME MAC for the take home drugs, the hospital’s billing department should review all

instructions for billing oral anti-emetics. Follow this link to reach the local coverage determination

(LCD) for oral anti-emetics:

http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=5058&lcd_version=27&show=all

In the case of IV Emend (HCPCS code J1453 - injection, fosaprepitant, 1 mg) provided on day 1,

payment for days 2 and 3 would not be made under Part B.

Payment allowances for these drugs dispensed in physician offices will be based on the lower of the

submitted charge or the ASP file price. These drugs continue to be priced based on the date of service.

The drug payment allowance limit pricing file is distributed to contractors by the Centers for Medicare

& Medicaid Services (CMS) on a quarterly basis.

The HCPCS codes shown in section 80.2.1 are used.

The common working file (CWF) edits claims with these codes to assure that the beneficiary is

receiving the oral anti-emetic(s) as part of a cancer chemotherapeutic regimen by requiring a diagnosis

code of an encounter for antineoplastic chemotherapy (V58.11/Z51.11).

Most drugs furnished as an outpatient hospital service are packaged under OPPS. However,

chemotherapeutic agents and the supportive and adjunctive drugs used with them are paid separately.

Effective for dates of service on or after April 4, 2005, coverage for the use of the oral anti-emetic 3-drug combination of aprepitant (Emend®), a 5-HT3 antagonist, and dexamethasone is considered

reasonable and necessary for 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 on or after May 29, 2013, the following anti-cancer chemotherapeutic agents have

been added to the list of anticancer chemotherapeutic agents for which the use of the oral antiemetic 3-drug combination of oral aprepitant, an oral 5HT3 antagonist and oral dexamethasone is deemed

reasonable and necessary:

• Alemtuzumab

• Azacitidine

• Bendamustine

• Carboplatin

• Clofarabine

• Cytarabine

• Daunorubicin

• Idarubicin

• Ifosfamide

• Irinotecan

• Oxaliplatin

MACs may determine coverage for other all-oral 3-drug anti-emesis regimens of aprepitant or any other

Food and Drug Administration (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 anti-cancer chemotherapeutic agents that are FD- approved and are defined as highly or moderately

emetogenic. See the Medicare NCD Manual, Section 110.18, for detailed coverage requirements.