Drugs and Biologicals – Chemotherapeutic

Article Title

Drugs and Biologicals – Chemotherapeutic – 4I-92AB-R28

Contractor’s Determination Number

4I-92AB

Contractor Name

TrailBlazer Health Enterprises

Contractor Number

04001 (04101, 04201, 04301, 04401, 04901).
04002 (04102, 04202, 04302, 04402).

Contractor Type

MAC – Part A.
MAC – Part B.

AMA CPT/ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All rights reserved. Applicable FARS/DFARS clauses apply. Current Dental Terminology (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction

Indian Health Service.
End Stage Renal Disease (ESRD) facilities.
Skilled Nursing Facilities (SNFs).
Rural Health Clinics (RHCs).

Transitioned legacy WPS providers.

Oversight Region

Region IV.
Region VI.

Original Article Effective Date

03/01/2008

03/21/2008

06/13/2008

Article Revision Effective Date

01/01/2012

Article Ending Effective Date

N/A

Article Text

Abstract

The related LCD explains the coverage criteria for drugs and biologicals used in the treatment of cancer and immune deficiency syndromes as well as certain other acute and chronic conditions. The agents discussed in the related LCD in no way constitute a complete list of drugs and biologicals covered by Medicare. The related LCD has been promulgated to establish the clinical conditions for which the included chemotherapeutic drugs are considered to be medically reasonable and necessary and thus, covered by Medicare.

Note: The related LCD and this Article do NOT describe drug and biological coverage under the Medicare Part D benefit.

The Medicare Benefit Policy Manual – Pub. 100-02, Chapter 15, Section 50, references national policy regarding Medicare coverage for drugs and biologicals as given below:

50. – Drugs and Biologicals Coverage Requirements

Generally, drugs and biologicals are covered only if all the following requirements are met:

They meet the definition of drugs or biologicals.
They are the type that has been determined to be not usually self-administered.
They meet all the general requirements for coverage of items as “incident to” a physician’s services.
They are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice.
They are not excluded as immunizations.
They have not been determined by the Food and Drug Administration (FDA) to be less than effective.

50.1 – Definition of Drug or Biological

Drugs and biologicals must be determined to meet the statutory definition. Under the statute Section 1861(t)(1), payment may be made for a drug or biological only where it is included, or approved for inclusion, in the latest official edition of the United States Pharmacopoeia–National Formulary (USP-NF), the United States Pharmacopoeia–Drug Information (USD DI), or the American Dental Association (ADA) Guide to Dental Therapeutics, except for those drugs and biologicals unfavorably evaluated in the ADA Guide to Dental Therapeutics. The inclusion of an item in the USP DI does not necessarily mean that the item is a drug or biological. The USP DI is a database of drug information developed by the U.S. Pharmacopoeia but maintained by Micromedex®, which contains medically accepted uses for generic and brand name drug products. Inclusion in such reference (or approval by a hospital committee) is a necessary condition for a product to be considered a drug or biological under the Medicare program; however, it is not enough. Rather, the product must also meet all other program requirements to be determined to be a drug or biological. Combination drugs are also included in the definition of drugs if the combination itself or all the therapeutic ingredients of the combination are included, or approved for inclusion, in any of the above drug compendia.

Drugs and biologicals are considered approved for inclusion in a compendium if approved under the established procedure by the professional organization responsible for revision of the compendium.

50.4.1 – Approved Use of Drug

Use of the drug or biological must be safe and effective and otherwise reasonable and necessary. (See the Medicare Benefit Policy Manual, Chapter 16, “General Exclusions from Coverage,” Section 20.) Drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective for purposes of this requirement when used for indications specified on the labeling. Therefore, the program may pay for the use of an FDA-approved drug or biological, if:

It was injected on or after the date of the FDA’s approval.
It is reasonable and necessary for the individual patient.
All other applicable coverage requirements are met.

The contractor will deny coverage for drugs and biologicals which have not received final marketing approval by the FDA unless it receives instructions from CMS to the contrary. For specific guidelines on coverage of Group C cancer drugs, see the Medicare National Coverage Determinations Manual. If there is reason to question whether the FDA has approved a drug or biological for marketing, the contractor must obtain satisfactory evidence of the FDA’s approval.

Acceptable evidence includes:

A copy of the FDA’s letter to the drug’s manufacturer approving the New Drug Application (NDA).
A listing of the drug or biological in the FDA’s “Approved Drug Products” or “FDA Drug and Device Product Approvals.”
A copy of the manufacturer’s package insert approved by the FDA as part of the labeling of the drug, containing its recommended uses and dosage as well as possible adverse reactions and recommended precautions in using it.

Or,

Information from the FDA’s Web site.

50.4.3 – Examples of Not Reasonable and Necessary

Not for Particular Illness: Medications given for a purpose other than the treatment of a particular condition, illness or injury are not covered (except for certain immunizations). Charges for medications, e.g., vitamins, given simply for the general good and welfare of the patient and not as accepted therapies for a particular illness are excluded from coverage.
Injection Method Not Indicated: Medication given by injection (parenterally) is not covered if standard medical practice indicates that the administration of the medication by mouth (orally) is effective and is an accepted or preferred method of administration. For example, the accepted standard of medical practice for the treatment of certain diseases is to initiate therapy with parenteral penicillin and to complete therapy with oral penicillin. Contractors exclude the entire charge for penicillin injections given after the initiation of therapy if oral penicillin is indicated unless there are special medical circumstances that justify additional injections.
Excessive Medications: Medications administered for treatment of a disease and which exceed the frequency or duration of injections indicated by accepted standards of medical practice are not covered. If a medication is determined not to be reasonable and necessary for diagnosis or treatment of an illness or injury according to these guidelines, the contractor excludes the entire charge (i.e., for both the drug and its administration). Also, contractors exclude from payment any charges for other services (such as office visits) which were primarily for the purpose of administering a non-covered injection (i.e., an injection that is not reasonable and necessary for the diagnosis or treatment of an illness or injury).

50.4.5 – Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen

A. Effective January 1, 1994, off-label, medically accepted indications of Food and Drug Administration (FDA)-approved drugs and biologicals used in an anti-cancer chemotherapeutic regimen are identified under the conditions described below. A regimen is a combination of anti-cancer agents clinically recognized for the treatment of a specific type of cancer. Off-label, medically accepted indications are supported in either one or more of the compendia or in peer-reviewed medical literature. The contractor may maintain its own subscriptions to the listed compendia or peer-reviewed publications to determine the medically accepted indication of drugs or biologicals used off-label in an anti-cancer chemotherapeutic regimen. Compendia documentation or peer-reviewed literature supporting off-label use by the treating physician may also be requested of the physician by the contractor. An example of a drug regimen is: Cyclophosphamide + vincristine + prednisone (CVP) for non-Hodgkin’s lymphoma.

In addition to listing the combination of drugs for a type of cancer, there may be a different regimen or combinations which are used at various times in the history of the cancer (induction, prophylaxis of central nervous system involvement, post remission, and relapsed or refractory disease). A protocol may specify the combination of drugs, doses, and schedules for administration of the drugs. For purposes of this provision, a cancer treatment regimen includes drugs used to treat toxicities or side effects of the cancer treatment regimen when the drug is administered incident to a chemotherapy treatment.

B. Contractors must not deny coverage based solely on the absence of FDA-approved labeling for the use, if the use is supported by any of the following compendia and the use is not listed as unsupported, not indicated, not recommended, or equivalent terms, in any of the following compendia (see note at the end of this subsection):

American Hospital Formulary Services – Drug Information (AHFS-DI).

Drug monographs are arranged in alphabetical order within therapeutic classifications. Within the text of the monograph, information concerning indications is provided, including both labeled and unlabeled uses. Unlabeled uses are identified with daggers. The text must be analyzed to make a determination whether a particular use is supported.

National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium (effective June 5, 2008).

NCCN Compendium lists appropriate uses of agents as derived from the NCCN Clinical Practice Guidelines in Oncology™. Indicated uses are categorized in a systematic approach that describes the type of evidence available for and the degree of consensus underlying each recommendation. Both FDA-approved uses and appropriate uses beyond the FDA-approved label are included. Indications are categorized as “Recommended,” “Not Recommended” or “Equivocal.”

Thomson Micromedex DrugDex (effective June 10, 2008).

DrugDex ® stratifies drugs into “classes” of medically accepted indications. These “classes” are as follows:

Class I – Recommended.
Class IIa – Recommended, in Most Cases.
Class IIb – Recommended, in Some Cases.
Class III – Not Recommended.
Class Indeterminate – Evidence Inconclusive.

Clinical Pharmacology (effective July 2, 2008).

Clinical Pharmacology provides information on drugs and their indications. Notes are included regarding whether the drug is “not recommended,” the evidence is “unsupportive” or the peer-reviewed medical literature, related to an indication, is “inconclusive.”

Use of Compendia:

The listed compendia employ various rating and recommendation systems that may not be readily cross-walked from compendium to compendium. In general, a use is identified by a compendium as medically accepted if the:

1. Indication is a Category 1 or 2A in NCCN, or Class I, Class IIa or Class IIb in DrugDex.

Or,

2. Narrative text in AHFS-DI or Clinical Pharmacology is supportive.

A use is not medically accepted by a compendium if the:

1. Indication is a Category 3 in NCCN or a Class III in DrugDex.

Or,

2. Narrative text in AHFS or Clinical Pharmacology is “not supportive.”

The complete absence of narrative text on a use is considered neither supportive nor non-supportive.

C. A Use Supported by Clinical Research That Appears in Peer-Reviewed Medical Literature

Contractors may also identify off-label uses that are supported by clinical research under the conditions identified in this section. Peer-reviewed medical literature may appear in scientific, medical and pharmaceutical publications in which original manuscripts are published, only after having been critically reviewed for scientific accuracy, validity and reliability by unbiased, independent experts prior to publication. In-house publications of entities whose business relates to the manufacture, sale or distribution of pharmaceutical products are excluded from consideration. Abstracts (including meeting abstracts) are excluded from consideration.

In determining whether an off-label use is supported, the contractors will evaluate the evidence in published, peer-reviewed medical literature listed below. When evaluating this literature, they will consider (among other things) the following:

Whether the clinical characteristics of the beneficiary and the cancer are adequately represented in the published evidence.
Whether the administered chemotherapy regimen is adequately represented in the published evidence.
Whether the reported study outcomes represent clinically meaningful outcomes experienced by patients.
Whether the study is appropriate to address the clinical question.

The contractor will consider:

Whether the experimental design, in light of the drugs and conditions under investigation, is appropriate to address the investigative question. (For example, in some clinical studies, it may be unnecessary or not feasible to use randomization, double-blind trials, placebos or crossover.)
That non-randomized clinical trials with a significant number of subjects may be a basis for supportive clinical evidence for determining accepted uses of drugs.
That case reports are generally considered uncontrolled and anecdotal information and do not provide adequate supportive clinical evidence for determining accepted uses of drugs.

The contractor will use peer-reviewed medical literature appearing in the regular editions of the following publications, not to include supplement editions 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.
Radiation Oncology.

The contractor is not required to maintain copies of these publications. If a claim raises a question about the use of a drug for a purpose not included in the FDA approved labeling or the compendia, the carrier will ask the physician to submit copies of relevant supporting literature.

D. FDA-approved drugs and biologicals may also be considered for use in the determination of medically accepted indications for off-label use if determined by the contractor to be reasonable and necessary.

Note: If a use is identified as not indicated by CMS or the FDA, or if a use is specifically identified as not indicated in one or more of the compendia listed, or if the contractor determines, based on peer-reviewed medical literature, that a particular use of a drug is not safe and effective, the off-label usage is not supported and, therefore, the drug is not covered.

Note: The decision that a drug is “medically accepted” for a particular indication is a separate decision from whether that drug is “reasonable and necessary” for use in a given patient.

50.4.6 – Less-Than-Effective Drug

This is a drug that has been determined by the FDA to lack substantial evidence of effectiveness for all labeled indications. Also, a drug that has been the subject of a Notice of an Opportunity for a Hearing (NOOH) published in the Federal Register before being withdrawn from the market, and for which the Secretary has not determined there is a compelling justification for its medical need, is considered less than effective. This includes any other drug product that is identical, similar or related. Payment may not be made for a less-than-effective drug.

Part A Program Instructions:

Reasons for Denial

All other indications not listed in the “Indications and Limitations of Coverage and/or Medical Necessity” section of the related LCD.
Service(s) rendered is (are) not consistent with accepted standards of medical practice.
The medical record does not verify that the service described by the CPT/HCPCS code was provided.
The medical record does not verify that the route of administration was medically necessary.
The amount of drug wasted is not reasonable or documented.
The service does not follow the guidelines of the related LCD.
The service is considered:

Investigational.
For routine screening.
A program exclusion.
Otherwise not covered.
Never medically necessary.
For cosmetic purposes.

LCD Individual Consideration Instructions

Individual consideration for coverage of a denied drug and related services may be given for that described in the LCD “Limited Coverage” section. Medical records and other supporting documents must be submitted when requesting a redetermination that describes the coding difficulty encountered and the medical necessity of the drug used in relation to the cancer being treated. The redetermination submission must have “LCD INDIVIDUAL CONSIDERATION REQUEST” indicated on the request form to receive individual consideration.

Coding Guidelines

Refer to the Correct Coding Initiative (CCI) for correct coding guidelines and specific applicable code combinations prior to billing Medicare. Provisions of this LCD do not take precedence over CCI edits.
CPT/HCPCS code J9035 must be billed with quantity one (1) for injections of bevacizumab 10 mg or less in the treatment of covered eye diseases.
When bevacizumab is used for a non-FDA-approved indication (e.g., other types of malignant neoplasms of the brain other than glioblastoma multiforme), bill CPT/HCPCS code J9035 using the GZ modifier.
Diagnosis(es) must be present on any claim submitted and coded to the highest level of specificity for that date of service.
To report these services, use the appropriate HCPCS or CPT code(s).
All coverage criteria must be met before Medicare can reimburse this service.
The diagnosis code(s) must be representative of the patient’s condition.
Use of oxaliplatin (CPT/HCPCS code J9263) or irinotecan (CPT/HCPCS code J9206) for the treatment of metastatic carcinoma of the pancreas (ICD-9-CM diagnosis codes 157.0, 157.1, 157.2, 157.8 and 157.9) must occur in conjunction with leucovorin and 5-FU.
When billing for this service in a non-covered situation (e.g., does not meet indications of the related LCD), use the appropriate modifier (see below). To bill the patient for services that are not covered (investigational/experimental or not reasonable and necessary) will generally require an Advance Beneficiary Notice (ABN) be obtained before the service is rendered.

Modifiers:

GA: Waiver of liability statement issued as required by payer policy, individual case. (Use for patients who do not meet the covered indications and limitations of this LCD and for whom an ABN is on file.) (ABN does not have to be submitted but must be made available upon request.)
GZ*: Item or service expected to be denied as not reasonable and necessary. (Use for patients who do not meet the covered indications and limitations of this LCD and who did not sign an ABN and the provider expects the item/service to be denied. All claim line items submitted with the GZ modifier will be denied automatically and will not be subject to complex medical review.)
GY: Item or service is statutorily excluded or does not meet the definition of any Medicare benefit.

*Note: Do not place the GZ modifier on the related claim line(s) of a drug that is anticipated will be covered on an individual consideration basis (see “Individual Consideration” section described in the LCD for details).

· See also Bill Type and Revenue Code sections below.

Coding Services Not Separately Billable

Flushing of a vascular access port prior to administration of chemotherapy, port access, portal exit, chemotherapy planning and chemotherapy management (not an all-inclusive list) is integral to the chemotherapy administration and is not separately billable. If a special visit is made to a physician’s office just for the port flushing, use code 99211 (brief office visit). Do not use code 96522 (refilling and maintenance of implantable pump or reservoir) to report port flushing.

Coding Drug Wastage (JW Modifier)

Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug and made good faith efforts to minimize the unused portion of the drug in how it is supplied, then the program will cover the amount of drug discarded along with the amount administered. If after taking the above measures a portion of the single-use vial must be discarded, CPT/HCPCS modifier JW may be used to indicate the drug amount discarded/not administered to any patient. The amount administered and the amount wasted must be billed on the same claim. The amount administered must be on a separate detail line from the amount wasted, indicated with the modifier JW (when applicable). The modifier JW would not be used for claim billings when the actual dose of the drug/biological administered is less than the billing unit established by CPT/HCPCS description (e.g., the description of the CPT/HCPCS code already includes the amount administered along with the amount wasted. Example: 75 mg of meperidine HCl (J2175, meperidine hydrochloride, per 100 mg) is administered. Bill CPT/HCPCS code J2175 quantity “1.” Payment will be provided for J2175, 100 mg, which includes the amount administered (75 mg) and the amount discarded (25 mg)). Please reference “Drug Wastage” at http://www.trailblazerhealth.com/Publications/Job%20Aid/Drug%20Wastage.pdf for examples of determining the correct way of billing drug wastage to Medicare.

Coding Colorectal Anti-Cancer Drug Claims Included in Clinical Trials (J9035, J9055, J9190, J9201, J9206, J9263)

Use ICD-9-CM from code ranges 153.0–154.8 or V10.05 – V10.06 on claim.
Use ICD-9-CM V70.7 in the second diagnosis code position on claim and CPT/HCPCS code with modifier J9XXX-Q0 on all claims to indicate used in a clinical research study (claims will be returned if both are not on claim).

Part B Program Instructions:

Reasons for Denial

All other indications not listed in the “Indications and Limitations of Coverage and/or Medical Necessity” section of the related LCD.
Service(s) rendered is (are) not consistent with accepted standards of medical practice.
The medical record does not verify that the service described by the CPT/HCPCS code was provided.
The medical record does not verify that the route of administration was medically necessary.
The amount of drug wasted is not reasonable or documented.
The service does not follow the guidelines of the related LCD.
The service is considered:

Investigational.
For routine screening.
A program exclusion.
Otherwise not covered.
Never medically necessary.
For cosmetic purposes.

LCD Individual Consideration Instructions

Coding Guidelines

Refer to the Correct Coding Initiative (CCI) for correct coding guidelines and specific applicable code combinations prior to billing Medicare. Provisions of this LCD do not take precedence over CCI edits.
CPT/HCPCS code J9035 must be billed with quantity one (1) for injections of bevacizumab 10 mg or less in the treatment of covered eye diseases.
When bevacizumab is used for a non-FDA-approved indication (e.g., other types of malignant neoplasms of the brain other than glioblastoma multiforme), bill CPT/HCPCS code J9035 using the GZ modifier.
Diagnosis(es) must be present on any claim submitted and coded to the highest level of specificity for that date of service.
To report these services, use the appropriate HCPCS or CPT code(s).
All coverage criteria must be met before Medicare can reimburse this service.
The diagnosis code(s) must be representative of the patient’s condition.
Use of oxaliplatin (CPT/HCPCS code J9263) or irinotecan (CPT/HCPCS code J9206) for the treatment of metastatic carcinoma of the pancreas (ICD-9-CM diagnosis codes 157.0, 157.1, 157.2, 157.8 and 157.9) must occur in conjunction with leucovorin and 5-FU.
When billing for this service in a non-covered situation (e.g., does not meet indications of the related LCD), use the appropriate modifier (see below). To bill the patient for services that are not covered (investigational/experimental or not reasonable and necessary) will generally require an Advance Beneficiary Notice (ABN) be obtained before the service is rendered.

Modifiers:

GA: Waiver of liability statement issued as required by payer policy, individual case. (Use for patients who do not meet the covered indications and limitations of this LCD and for whom an ABN is on file.) (ABN does not have to be submitted but must be made available upon request.)
GZ*: Item or service expected to be denied as not reasonable and necessary. (Use for patients who do not meet the covered indications and limitations of this LCD and who did not sign an ABN and the provider expects the item/service to be denied. All claim line items submitted with the GZ modifier will be denied automatically and will not be subject to complex medical review.)
GY: Item or service is statutorily excluded or does not meet the definition of any Medicare benefit.

Bill Type and Revenue Codes below DO NOT apply to Part B.

Coding Services Not Separately Billable

Coding Drug Wastage (JW Modifier)

Coding Colorectal Anti-Cancer Drug Claims Included in Clinical Trials (J9035, J9055, J9190, J9201, J9206, J9263)

Use ICD-9-CM from code ranges 153.0–154.8 or V10.05 – V10.06 on claim.
Use ICD-9-CM V70.7 in the second diagnosis code position on claim and CPT/HCPCS code with modifier J9XXX-Q0 on all claims to indicate used in a clinical research study (claims will be returned if both are not on claim).

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

11X, 12X, 13X, 18X, 21X, 22X, 23X, 71X, 72X, 73X, 74X, 75X, 77X, 83X, 85X

Bill Type Note: Code 73X end-dated for Medicare use March 31, 2010; code 77X effective for dates of service on or after April 1, 2010.

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with CPT/HCPCS codes included in this policy. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.

0250, 0636

CPT/HCPCS Codes

LIST A:

Note: Limited coverage is being established for the drugs included in List A.

Note:	Providers are reminded to refer to the long descriptors of the CPT codes in their CPT books. The American Medical Association (AMA) and CMS require the use of short CPT descriptors in policies published on the Web.
C9257	Injection, bevacizumab, 0.25 mg (OPPS and ASC)
J0894	Injection, decitabine, 1 mg
J9001	Injection, doxorubicin hydrochloride, all lipid formulations, 10 mg
J9010	Injection, alemtuzumab, 10 mg
J9015	Injection, aldesleukin, per single use vial
J9017	Injection, arsenic trioxide, 1 mg
J9025	Injection, azacitidine, 1 mg
J9033	Injection, bendamustine hcl, 1 mg
J9035	Injection, bevacizumab, 10 mg
J9041	Injection, bortezomib, 0.1 mg
J9043	Injection, cabazitaxel, 1mg
J9171	Injection, docetaxel, 1 mg
J9179	Injection, eribulin mesylate, 0.1 mg
J9201	Injection, gemcitabine hydrochloride, 200 mg
J9206	Injection, irinotecan, 20 mg
J9207	Injection, ixabepilone, 1 mg
J9214	Injection, interferon alfa-2B, recombinant, 1 million units
J9228	Injection, ipilimumab, 1mg
J9263	Injection, oxaliplatin, 0.5 mg
J9264	Injection, paclitaxel protein-bound particles, 1 mg
J9265	Injection, paclitaxel, 30 mg
J9302	Injection, ofatumumab, 10 mg (for DOS on or after January 1, 2011; for DOS before 2011, use CPT/HCPCS code J9999 to identify ofatumumab)
J9305	Injection, pemetrexed, 10 mg
J9310	Injection, rituximab, 100 mg
J9330	Injection, temsirolimus, 1 mg
J9351	Injection, topotecan, 0.1mg
J9355	Injection, trastuzumab 10 mg
J9395	Injection, fulvestrant, 25 mg
J9999	Not otherwise classified, antineoplastic drug

LIST B:

Note: The contractor expects that the use of these drugs will be reasonable and necessary.

J9000	Injection, doxorubicin hydrochloride [Adriamycin], 10 mg
J9020	Injection, asparaginase, 10,000 units
J9027	Injection, clofarabine, 1 mg
J9031	BCG live (intravesical), per installation
J9040	Injection, bleomycin sulfate, [Blenoxane], 15 units
J9045	Injection, carboplatin, [Paraplatin], 50 mg
J9050	Injection, carmustine, [BiCNU], 100 mg
J9055	Injection, cetuximab, 10 mg
J9060	Injection, cisplatin, [Platinol], powder or solution, 10 mg
J9065	Cladribine, per 1 mg
J9070	Cyclophosphamide, 100 mg
J9098	Injection, cytarabine liposome, 10 mg
J9100	Injection, cytarabine, 100 mg
J9120	Injection, dactinomycin, 0.5 mg
J9130	Dacarbazine, 100 mg
J9150	Injection, daunorubicin HCl, 10 mg
J9151	Injection, daunorubicin citrate, liposomal formulation, 10 mg
J9160	Injection, denileukin diftitox 300 micrograms
J9165	Injection, diethylstilbestrol diphosphate, 250 mg
J9178	Injection, epirubicin HCl, 2 mg
J9181	Injection, etoposide, [VePesid], 10 mg
J9185	Injection, fludarabine phosphate, 50 mg
J9190	Injection, fluorouracil, 500 mg
J9200	Injection, floxuridine, 500 mg
J9208	Injection, ifosfamide, per 1 gram
J9209	Injection, mesna, 200 mg
J9211	Injection, idarubicin HCl, 5 mg
J9215	Injection, interferon alfa-N3, (human leukocyte derived), 250,000 IU
J9230	Injection, mechlorethamine HCl, (nitrogen mustard), 10 mg
J9245	Melphalan HCl, 50 mg
J9250	Methotrexate sodium, 5 mg
J9260	Methotrexate sodium, 50 mg
J9261	Injection, nalarabine, 50 mg
J9266	Injection, pegaspargase, per single dose vial
J9268	Injection, pentostatin, 10 mg
J9270	Injection, plicamycin, 2.5 mg
J9280	Mitomycin, 5 mg
J9293	Injection, mitoxantrone HCl, per 5 mg
J9300	Injection, gemtuzumab ozogamicin, 5 mg
J9303	Injection, panitumumab, 10 mg
J9320	Injection, streptozin, 1 gram
J9340	Injection, thiotepa, 15 mg
J9357	Injection, valrubicin, intravesical, 200 mg
J9360	Injection, vinblastine sulfate, 1 mg
J9370	Vincristine sulfate, [Oncovin]; 1 mg
J9390	Injection, vinorelbine tartrate, per 10 mg
J9600	Injection, porfimer sodium, [Photofrin], 75 mg

Other Comments

Requests to establish coverage for a new FDA-approved drug must include:

1. A letter addressed to “Medicare Medical Director” from a Medicare provider/physician currently practicing within the TrailBlazer Health Enterprises (TrailBlazer) service area.

2. A copy of the FDA approval letter.

3. A copy of the package insert.

Or,

4. A Medicare claim submitted with an NOC code (e.g., J3490 for Part B; C9399 for Part A) used to indicate the new FDA-approved drug. The name of the drug, amount administered and route of administration must be given in CMS-1500 claim form Item 19 or electronic equivalent. The ICD-9-CM diagnosis code used on the claim must indicate the condition treated with the drug billed.

Note: All claims will be reviewed internally for appropriateness of use per the above referenced criteria.

Requests to expand coverage for an additional indication(s) or off-label use of an FDA-approved anti-neoplastic drug must include:

1. A letter addressed to “Medicare Medical Director” from a Medicare provider/physician currently practicing within the TrailBlazer service area.

2. A copy of the approved drug indication information from at least one of the following drug compendia:

American Hospital Formulary Services – Drug Information (AHFS-DI).
National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium (effective June 5, 2008).
Thomson Micromedex DrugDex (effective June 10, 2008).
Clinical Pharmacology (effective July 2, 2008).

Or,

3. A copy of current scientific or peer-reviewed literature.

Note: Trial studies submitted should definitively demonstrate safety and effectiveness supporting the request and must have been published in one of the CMS-approved journals (see list in the CMS Medicare Benefit Policy Manual – Pub. 100-02, Chapter 15, Section 50.4.5.D). Do not submit abstracts or summary materials obtained from the manufacturer.

When the Medicare contractor is requested by a physician or physician group to cover an unlabeled use for a non-self-administered drug, the request should be accompanied by evidence that the unlabeled use is listed in one of the drug compendia listed above or by pertinent peer-reviewed literature that meets the specifications listed above. Note that evidence from Phase I or limited Phase II studies does not qualify a drug for coverage by Medicare. After such evidence is received, the contractor will, with the help of specialty-specific consultants, make a coverage determination for the unlabeled use of the drug.

Contractor Use of Compendia: The listed compendia employ various rating and recommendation systems that may not be readily cross-walked from compendium to compendium. In general, a use is identified by a compendium as medically accepted if the:

1. Indication is a Category 1 or 2A in NCCN, or Class I, Class IIa or Class IIb in DrugDex.

Or,

2. Narrative text in AHFS-DI or Clinical Pharmacology is supportive.

A use is not medically accepted by a compendium if the:

1. Indication is a Category 3 in NCCN or a Class III in DrugDex.

Or,

2. Narrative text in AHFS or Clinical Pharmacology is “not supportive.”

The complete absence of narrative text on a use is considered neither supportive nor non-supportive.

Mail requests to:

Medicare Medical Directors

Executive Center III

8330 LBJ Freeway

Dallas, TX 75243-1213

Fax: (469) 372-2649

All requests will be handled in date order. Requests can be handled more rapidly if information from all four compendia is received. Action on a request can usually be expected within 30 days.