Note: This article was revised on March 18, 2008, to add clarifying language in the “Impact to You” section and in the “Background” section.

Note: This article was revised on March 13, 2008, to correct the code for Aprepitant to show J8501 in the last paragraph of the “Background” section. All other information remains the same.

Provider Types Affected

Providers and suppliers submitting claims to Medicare fiscal intermediaries (FI) and/or Part A/B Medicare Administrative Contractors (A/B MAC) for cancer chemotherapeutic services provided to Medicare beneficiaries

Provider Action Needed

Impact to You

This article is based on Change Request (CR) 5655 which clarifies that hospital outpatient departments may bill the entire Tri-Pack of aprepitant, an oral anti-emetic drug given in conjunction w/ two other oral anti-emetic drugs to their FI or A/B MAC as part of a cancer chemotherapeutic regimen that includes the anti-emetic three drug combination.

What You Need to Know

If the three-drug anti-emetic combination (Aprepitant, a 5-HT3 antagonist (e.g., granisetron, ondansetron, or dolasetron), and Dexamethasone (a cortico-steroid)) is dispensed in a Tri-Pak in a hospital outpatient setting, the Tri-Pak may be billed to the FI as 57 units of J8501 (Aprepitant, 5 mg, Oral).

What You Need to Do

See the Background and Additional Information sections of this article for further details regarding this issue.

Background

The Centers for Medicare & Medicaid Services (CMS) states that reimbursement will be provided for oral anti-emetic drugs when used as a full therapeutic replacement for intravenous dosage forms as part of a cancer chemotherapeutic regimen when the drugs are 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 oral three drug combination is:

• Aprepitant,
• A 5-HT3 antagonist (e.g., granisetron, ondansetron, or dolasetron), and
• Dexamethasone (a cortico-steroid).

Note that 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-hour or 48-hour dosage regimen (depending upon the drug) should be prescribed/supplied for each incidence of chemotherapy treatment.

The three-drug combination protocol requires the first dose to be administered before, at, or immediately after the time of the anti-cancer chemotherapy administration. The second day, on which only aprepitant is given, is defined as “within 24 hours,” and the third day, on which only aprepitant is given, 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, or skilled nursing facility), or through a supplier, such as a pharmacy. (See the revised Medicare Claims Processing Manual, Chapter 17, Section 80.2 (Oral Anti-Emetic Drugs Used as Full Replacement for Intravenous Anti-Emetic Drugs as Part of a Cancer Chemotherapeutic Regimen which is attached to CR5655.)

It has come to the attention of CMS that some Medicare contractors are denying payment for the entire Tri-Pak because two doses of the Tri-Pak (for days two and three) are sent home with the beneficiary. This is a misinterpretation of CR 4301 (Billing for Take Home Drugs; http://www.cms.hhs.gov/Transmittals/Downloads/R882CP.pdf ) which requires billing drugs that are for take home use only to the Durable Medical Equipment Medicare Administrative Contractors (DME MAC).

The purpose of CR 5655 is to clarify that hospital outpatient departments may bill the entire Tri-Pack of aprepitant to their FI or A/B MAC as part of the three-drug combination oral anti-emetic. If the three-drug combination is dispensed with a Tri-Pak of aprepitant in a hospital outpatient setting; the entire Tri-Pak may be billed to the FI as 57 units of J8501 (Aprepitant, 5 mg, Oral), and all of the drugs in the three drug combination must be billed in the same claim.

This clarification is needed to prevent incorrect denials of claims from hospital outpatient departments for Aprepitant for Chemotherapy-Induced Emesis, as spelled out in the National Coverage Determination (NCD), CR 3831 at http://www.cms.hhs.gov/Transmittals/downloads/R40NCD.pdf a nd on the CMS Web site.

CR5655 further instructs that:

• Your FI or A/B MAC is to accept claims for 57 units of Aprepitant (J8501) when dispensed to the beneficiary by the hospital in the form of a Tri-Pak;
• Coverage of aprepitant is dependent upon the beneficiary’s receipt of a highly emetogenic anti-cancer chemotherapeutic agent;
• For dates of service on or after January 1, 2008, qualifying emetogenic anti-cancer chemotherapeutic a agents are:
• Carmustine, (J9050);
• Cisplatin, (J9060, J9062);
• Cyclophosphamide J9096, J9097);
• Dacarbazine, (J9130, J9140);
• Mechlorethamine, (J9230);
• Streptozocin, (J9320);
• Doxorubicin, (J9000, J9001); and
• Epirubicin, (J9178);

• Coverage of Aprepitant is as part of the three-drug combination of:
• Aprepitant (Emend®) (J8501),
• A 5-HT3 antagonist, e.g., Granisetron (Q0166), Ondansetron (Q0179), or Dolasetron (Q0180), and
• Dexamethasone, a cortico-steroid (J8540)

All of the drugs must be billed on the same claim.

Effective for dates of service April 4, 2005, through December 31, 2007, inclusive, the following HCPCS dispensed by non-OPPS (Outpatient Prospective Payment System) providers qualify the beneficiary to receive the three-drug combination oral anti-emetic: J9050, J9060, J9062, J9070, J9080, J9091, J9092, J9093, J9094, J9095, J9096, J9097, J9130, J9140, J9230, J9320, J9000, J9001, and J9178. For the same time period, the following HCPCS dispensed by OPPS providers qualify the beneficiary to receive the three-drug anti-emetic: J9050, J9060, J9070, J9093, J9130, J9230, J9320, J9000, J9001, and J9178.

Note that CR5655 instructs your Medicare FI or A/B MAC to adjust denied or partially denied aprepitant (J8501) claims if you bring such claims to the attention of your FI or A/B MAC within six months of the implementation date of January 2008. During this period, the timely filing requirements will be bypassed, as needed, to complete the adjustment.

Additional Information

The official instruction, CR 5655, issued to your FI and A/B MAC regarding this change may be viewed at http://www.cms.hhs.gov/Transmittals/downloads/R1281CP.pdf on the CMS Web site. CR5655 includes some billing examples.

If you have any questions, please contact your FI or A/B MAC at their toll-free number, which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

Disclaimer This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents.