This policy lists a number of higher cost drugs and biologicals used to treat cancer and other acute and chronic conditions subject to pre-pay edits.

The contractor expects the use of those drugs and biologicals not listed here to be reasonable and necessary when provided in the following circumstances:

• FDA-approved indications;
• Unlabeled uses determined per IOM 100-2, Chapter 15, Section 50.4.5

Chemotherapy services provided for unapproved off-label indications as well as other ineligible conditions will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Intravenous Fluids
Intravenous fluid administration, when administration of a chemotherapeutic agent does not require it to be administered by infusion in a volume of 250 cc or greater (i.e., codes J7030-J7050, J7060, J7070, J7120), is not medically necessary. 

Intravenous fluids used to maintain venous patency during administration of chemotherapeutic agents are considered integral to chemotherapy and is not separately billable. 

Flushing of a vascular access device will be denied if submitted on a claim on the same date of service as the administration of chemotherapy.

Off-Label Cancer Chemotherapy Use
The general utilization of any cancer chemotherapy drug will be covered for use that is not FDA approved (unlabeled) if the use is listed as acceptable in one of the Medicare approved drug compendia and the use is not listed as “not indicated” or unfavorably evaluated in any of the compendia.

A compendium is a listing of U.S. Food and Drug Administration (FDA) approved drugs and biologics. In some cases, compendia specialize in a particular subset of drugs, such as those used for anti-cancer treatment. Compendia include a summary of how each drug works in the body, as well as information for health care practitioners about proper dosing and whether the drug is recommended or endorsed for use in treating a specific disease. Medicare approved compendia for these purposes are:

• The National Comprehensive Cancer Network (NCCN) Drugs and Biologic Compendium™
• Thompson Micromedex DrugDex®
• Elsevier Gold Standard’s Clinical Pharmacology
• American Hospital Formulary Service-Drug Information (AHFS-DI)®

The off-label use of drugs and biologicals in an anti-cancer chemotherapeutic regimen will be covered when:

1. an indication is a Category 1 or 2A in NCCN; or
2. Class I, IIa, or IIb in DrugDex; or
3. the narrative text in AHFS-DI or Clinical Pharmacology is supportive.

Off-label drugs will not be covered if:

1. the indication is Category 3 in NCCN; or
2. the indication is a Class III in DrugDex; or
3. the narrative text in AHFS or Clinical Pharmacology is "not supportive."

For off-label drug indications that are Category 2B in NCCN or if there is complete absence of narrative text on a use in AHFS-DI or Clinical Pharmacology, peer-reviewed medical literature from the publications listed below must be submitted.

When an unlabeled use does not appear in any of the compendia or is listed as insufficient data or investigational, and a report regarding this use is not forthcoming from one of the compendia, the use must be supported by clinical trials published in peer reviewed medical literature.

To support off-label use of a chemotherapy drug Medicare requires the submission of full text peer-reviewed medical literature appearing in the regular periodic editions of the following publications, not to include supplemental editions that may be privately funded by parties with a vested interest in the recommendations of the authors.

• American Journal of Medicine;
• Annals of Internal Medicine;
• Annals of Oncology;
• Annals of Surgical Oncology;
• Biology of Blood and Marrow Transplantation;
• Blood;
• Bone Marrow Transplantation;
• British Journal of Cancer;
• British Journal of Hematology;
• British Medical Journal;
• Cancer;
• Clinical Cancer Research;
• Drugs;
• European Journal of Cancer (formerly the European Journal of Cancer and Clinical Oncology);
• Gynecologic Oncology;
• International Journal of Radiation, Oncology, Biology, and Physics;
• The Journal of the American Medical Association;
• Journal of Clinical Oncology;
• Journal of the National Cancer Institute;
• Journal of the National Comprehensive Cancer Network (NCCN);
• Journal of Urology;
• Lancet;
• Lancet Oncology;
• Leukemia;
• The New England Journal of Medicine; or
• Radiation Oncology

We assess the clinical evidence for: 1) the quality of the individual studies; 2) the applicability of findings from individual studies to the Medicare population; and 3) conclusions that can be drawn on potential risks and benefits. The published trials must demonstrate safety, as well as beneficial key health outcomes applicable to the Medicare population.

When reviewing clinical trials we look for:

• Use of randomization (allocation of patients to either intervention or control group) in order to minimize bias.
  
  
• Use of contemporaneous control groups (rather than historical controls) in order to ensure comparability between the intervention and control groups.
  
  
• Prospective (rather than retrospective) studies to ensure a more thorough and systematical assessment of factors related to outcomes.
  
  
• Larger sample sizes in studies to demonstrate both statistically significant as well as clinically significant outcomes that can be extrapolated to the Medicare population. Sample size should be large enough to make chance an unlikely explanation for what was found.
  
  
• Masking (blinding) to ensure patients and investigators do not know to which group patients were assigned (intervention or control). This is important especially in subjective outcomes, such as pain or quality of life, where enthusiasm and psychological factors may lead to an improved perceived outcome by either the patient or assessor.

A study’s selected outcomes are an important consideration in generalizing available clinical evidence to Medicare coverage determinations. The goal of our review process is to assess net health outcomes. These outcomes include resultant risks and benefits such as increased or decreased morbidity and mortality. In order to make this determination, it is often necessary to evaluate whether the strength of the evidence is adequate to draw conclusions about the direction and magnitude of each individual outcome relevant to the off-label treatment under study. In addition, it is important that the benefits are clinically significant and durable, rather than marginal or short-lived.

Off-label chemotherapy is not reasonable and necessary if its risks outweigh its benefits. Reported benefits must translate into improved net health outcomes actually experienced by patients, such as quality of life, functional status, duration of disability, morbidity and mortality, and less emphasis on outcomes that patients do not directly experience, such as intermediate outcomes, surrogate outcomes, and laboratory or radiographic responses. For example, stabilization is not considered a response to justify unlabeled use. The direction, magnitude, and consistency of the risks and benefits across studies are also important considerations. Based on our analysis of the strength of the evidence, we assess the relative magnitude of off-label chemotherapy in terms of benefits and risk of harm to members.

The use of cancer chemotherapy drugs in the treatment of rare malignancies for which no accepted standard treatment exists and which are unlikely to be studied due to small numbers of cases will be reviewed on a case by case basis and given individual consideration.

Services performed for excessive frequency are not medically necessary. Frequency is considered excessive when services are performed more frequently than generally accepted by peers and the reason for additional services is not justified by documentation.

Documentation Requirements

The patient's medical record must document the medical necessity of services performed for each date of service submitted on a claim, and documentation must be available on request.

Documentation of the agent, route, dose given, and the duration of administration must be in the medical record.

Document in the medical record the type of vascular access device filled or maintained.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Drugs are reported in multiples of the dosage specified in the code description. If the dosage given is not a multiple of the code, the provider rounds to the next highest unit in the description for the code.

If the full dosage is less than the dosage for the code specifying the minimum dosage for the drug, the provider reports the code for the minimum dosage amount.

Not Otherwise Classified (NOC) Drugs: When claims are submitted for HCPCS codes J9999 (not otherwise classified anti-neoplastic drugs), J3490 (unclassified drugs), and J3590 (unclassified biological drugs), the drug name, the National Drug Code (NDC) number and total dosage must be indicated in the narrative field of the claim form. The correct number of units for submitting a not otherwise classified (NOC) code is always "1" one. The reimbursement will be based on the dosage indicated in the narrative field.

Discarded portions – CMS encourages physicians to schedule patients in such a way that they can use drugs or biologicals most efficiently, in a clinically appropriate manner. However, if a physician must discard the remainder of a single use vial or other single use package after administering it to a patient, the program covers the amount of drug or biological discarded along with the amount administered, up to the amount of the drug or biological as indicated on the vial or package label. When submitting a claim for situations when a portion of the drug is supplied is unused (discarded) include the total of both the unused and the used portion in the days/units field when reporting the dosage.

The coverage of discarded drugs or biologicals applies only to single use vials. Multi-use vials are not subject to payment for discarded amounts of drugs or biologicals.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Internet-Only Manual (IOM)Publication 100-2, Medicare Benefit Policy, Chapter 15, Section 50.4.5

Use of these code does not guarantee reimbursement. The patient’s medical record must document that the coverage criteria in this policy have been met.

The following drugs are covered for the following specific indications:

Aldesleukin; Proleukin, Interleukin II (IL-2)
J9015–Aldesleukin, per single use vial

Bevacizumab; Avastin
J9035-Bevacizumab, 10 mg

Cetuximab; Erbitux
J9055-Cetuximab, 10 mg

Decitabine; Dacogen™
J0894-Decitabine, 1 mg

*Effective 12/01/2010

Denileukin Diftitox; Ontak
J9160-Denileukin diftitox, 300 mcg

Docetaxel; Taxotere
J9171-Docetaxel, 1 mg

Doxorubicin, Liposomal; Doxil, Caelyx
J9001-Doxorubicin hydrochloride, all lipid formulations, 10 mg

Gemtuzumab Ozogamicin; Mylotarg
J9300-Gemtuzumab ozogamicin, 5 mg

Histrelin acetate; Vantas
**J9226-Histrelin implant, 50 mg

**Effective 01/01/2011

Ibritumomab Tiuxetan; Zevalin
A9542-Supply of radiopharmaceutical diagnostic imaging agent

Indium-111; Ibritumomab
A9543-Supply of radiopharmaceutical therapeutic imaging agent, Yttrium 90 Ibritumomab

Note: Zevalin use is approved as part of a therapeutic regimen with Rituximab. Rituximab must be administered on the same date of service as either Indium-111 Ibritumomab or Yttrium 90 Ibritumomab.

Infliximab; Remicade
J1745-Infliximab, 10mg

Leuprolide acetate implant; Lupron implant
J9219-Leuprolide acetate implant, 65 mg

Oxaliplatin; Eloxatin
J9263-Oxaliplatin, 0.5 mg

Paclitaxel protein-bound particles; Abraxane
J9264-Injection, paclitaxel protein-bound particles, 1 mg

Panitumumab; Vectibix™
J9303-panitumumab

Pemetrexed; Alimta
J9305-Pemetrexed, 10 mg

Porfimer Sodium; Photofrin
J9600-Porfimer sodium, 75 mg

Rituximab; Rituxan
J9310-Rituximab, 100 mg

Topotecan; Hycamtin
J9351-Topotecan, 0.1 mg

**Effective 01/01/2011

Trastuzumab; Herceptin
J9355-Trastuzumab, 10mg

Eculizumab; Soliris
J1300-Eculizumab 300mg

Ixabepilone; Ixempra
J9207-Ixabepilone Injection

Ranibizumab; Lucentis
J2778-Ranibizumab Intraocular Injection 0.1 mg

Bendamustine hydrochloride; Treanda
J9033-Bendamustine hydrochloride; Injection

Pralatrexate
J9307 - Pralatrexate; Folotyn; Injection 1 mg

**Effective 01/01/2011

Sipuleucel-T
J9999 - Sipuleucel-T; Provenge; Injection

Cabazitaxel; Jevtana
J9999 - Cabazitaxel; Jevtana; Injection

Ofatumumab; Arzerra
J9302 - Ofatumumab; Arzerra; Injection

**Effective 01/01/2011

Eribulin Mesylate; Halaven
J9999 - Eribulin Mesylate; Halaven; Injection

**Effective 01/01/2011