Highmark Medicare Services

12102, 12202, 12302, 12501, 12301, 12201

MAC Part A & B

L27477

Cancer Chemotherapeutic Agents

L27477

CPT codes, descriptions and other data only are copyright 2007 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.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare 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 1862(a)(7). This section excludes routine physical examinations.

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.

CMS On-line Manual Pub. 100-4, Chapter 12, Section 30.5F

Pennsylvania, Maryland, District of Columbia, Delaware

Central Office

For services performed on or after 07/11/2008

N/A

For services performed on or after 08/01/2008

08/31/2008

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

Several cancer chemotherapeutic agents and regimes have been developed and approved by the Food and Drug Administration (FDA) to treat various types of cancer. The intended mechanism of action is to interfere with or prevent the growth of malignant (cancerous) cells.

FDA-approved Use for Chemotherapeutic Agents

Generally, cancer chemotherapeutic agents are covered only if all of the following requirements are met:

• Documentation is present to support that the drug is safe and effective and is being administered for an approved indication.
• Documentation in the patient’s medical record supports the medical necessity of administering the chemotherapy drug to that individual patient.
• Documentation in the patient’s medical record supports that the chemotherapy drug was administered as billed.

Therefore, payment may be made for an FDA-approved chemotherapeutic 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; and
• All other applicable coverage requirements are met.

FDA Unlabeled Use for Chemotherapeutic Agents

There are many reasons to consider an unlabeled use for a cancer chemotherapy agent. Some of these are:

• Drugs may be effective for many other cancers in addition to the ones that were considered in the primary labeling of the drug.
• Many chemotherapeutic agents are given in combinations. Any one of the drugs in the combination may not have been approved in the initial labeling of the products. In addition the combination of effective chemotherapeutic agents changes over time.
• Cancer chemotherapeutic agents are always changing and improving over time
• Oncologists are often left with few approved treatment options if initial treatment regimens have failed.

If a physician is contemplating the use of an FDA-unlabeled anti-cancer drug or biological the following steps should be followed.

1. Initially, one of the following drug compendia should be consulted to find a list approved chemotherapeutic agents and their list of indications.

• American Hospital Formulary Service Drug Information
• American Medical Association Drug Evaluations
• United States Pharmacopoeia Drug Information (USP DI)

In review of these compendia if the use of the chemotherapeutic agent is supported by any one of these three compendia AND the use is NOT listed as “not indicated” in any of the other two compendia, the agent may be approved.

2. In those circumstances when the unlabeled use of the chemotherapeutic agent is not listed in any of the compendia or is listed as insufficient data or investigational its use, the use of the drug may be supported by clinical research that appears in peer reviewed medical literature. Peer reviewed medical literature includes 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. This does not include in-house publications of pharmaceutical manufacturing companies or abstracts (including meeting abstracts).

Coverage will be determined based on the results of peer reviewed medical literature published 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

3. Unlabeled uses of cancer chemotherapeutic agents may also be considered medically accepted if determined to be the community standard of care and to be medically accepted as safe and effective for the particular use. In order to determine if a chemotherapeutic agent meets the level of community standard of care, the following may be used:

Peer reviewed medical literature in journals other than those journals cited above also can be used to establish a community level standard of care. Again this literature includes 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. This does not include in-house publications of pharmaceutical manufacturing companies or abstracts (including meeting abstracts). Furthermore, the level of evidence in each article must be determined.

Levels of evidence as defined below will be used use to assess research and to determine a grade of recommendation for a particular medical treatment. These levels are described below:

Level 1: Randomized controlled trials/meta analyses

Level 2: Cohort studies

Level 3: Case controlled studies

Level 4: Cross sectional surveys, case reports, or case series

Level 5: Expert opinion

If the peer-reviewed literature is a Level 1 study, the use of that specific chemotherapeutic agent is considered to be the community standard and the agent is covered. However, if the peer-reviewed literature is a Level 2, 3, or 4 study two or more articles by different authoring groups are required to establish the use of the chemotherapeutic agent as the community standard before the agent will be covered. If the literature is only Level 5 then the chemotherapeutic agent has not been established as a community standard and will not be covered.

4. If the provider decides to use a chemotherapeutic agent that does not have FDA-approved labeling, the evidence used to make that decision (information in the compendia, established guidelines [for example guidelines developed by the National Comprehensive Cancer Network, Association of Community Cancer Center Compendia, American Society of Clinical Oncology], research studies in approved peer-reviewed medical journals, etc.) must be retained. This information must be retained in the patient’s record either as a hard copy of the reference material itself or citations of the reference material. This information must be submitted whenever requested.

Note: Payment for the administration of a chemotherapy injection or infusion may be paid when provided on the same day as an E and M service, other than 99211, if the E and M service represents a separate and significantly identifiable service. Modifier 25 must be used. A different diagnosis code is not required.

For Additional Drug and Biological Coverage, see L27473

Chemotherapy (Inpatient), Chemotherapy (Outpatient), Oral Anticancer Drugs

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.

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.

N/A

Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.

1. All documentation must be maintained in the patient’s medical record and available to the contractor upon request.
   
   
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
   
   
3. The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed.
   
   
4. Physicians or suppliers must be able to produce copies of relevant supporting full-text articles, guidelines, and/or supporting literature when an unlabeled use does not appear in at least one of the three major compendia mentioned or is listed as insufficient data or investigational. Abstracts, opinions, or book chapters are not acceptable. Availability of this specifically required documentation is indicated by use of the KX modifier on the submitted claim. This material must be submitted whenever requested.

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

American Society of Clinical Oncology Web Site. Available at http://www.asco.org/portal/site/ASCO. Accessed May 15, 2007.

Centre for Evidence Based Medicine Web Site. Available at http://www.cebm.net. Accessed May 15, 2007

Levels of Evidence in AFP. American Family Physician. 2007. Available at http://www.aafp.org/online/en/home/publications/journals/afp/afplevels.html. Accessed May 15, 2007.

National Comprehensive Cancer Network Web Site. 2007. Available at http://www.nccn.org. Accessed on May 15, 2007.

National Guideline Clearinghouse Web Site. 2007. Available at http://www.guideline.gov. Accessed May 15, 2007.

U.S. Food and Drug Administration. "Off-Label" and Investigational Use

Of Marketed Drugs, Biologics, and Medical Devices. Available at http://www.fda.gov/oc/ohrt/irbs/offlabel.html. Accessed May 9 2007.

Other Contractors' Policies

Highmark Medicare Services Contractor Medical Directors

This policy does not reflect the sole opinion of the contractor or Contractor Medical Directors. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from the appropriate specialty (ies).

CAC/IAC Distribution:  04/01/2008

05/15/2008

05/23/2008

L27477

07/31/2008

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