L28841

 

FLOXURIDINE (FUDR)

 

02/16/2009

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Floxuridine (FUDR)–J9200

• Floxuridine is FDA approved for the following indications:

o In the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means.

o Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.

• Medicare will consider the use of Floxuridine medically reasonable and necessary for the FDA approved uses, as well as for the treatment of the following off-labeled indications:

o Epithelial ovarian carcinoma.

o Renal carcinoma.

o Primary peritoneal carcinoma.

o Fallopian tube carcinoma.

o Carcinoma of the ovary and kidney not responsive to other antimotabolites.

o Palliative management of colorectal carcinoma metastatic to the liver that has not responded to other treatment, when given by continuous regional intra-arterial infusion.

• In addition to the above FDA approved uses and off-label indications, Medicare will cover Floxuridine for the treatment of the following off-labeled indications when there is documentation to support the failure of standard chemotherapy regimens:

o Advanced, metastatic pancreatic carcinoma.

o Esophageal and gastric cancer when given in combination with cisplatinum, taxol, and leucovorin.

Coding Information

 

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.

 

 

 

13x Hospital Outpatient

21x Skilled Nursing - Inpatient (Including Medicare Part A)

22x Skilled Nursing - Inpatient (Medicare Part B only)

23x Skilled Nursing - Outpatient

85x Critical Access Hospital

 

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.

 

 

 

0636 Pharmacy - Drugs Requiring Detailed Coding

 

 

CPT/HCPCS Codes

 

 

 

J9200 INJECTION, FLOXURIDINE, 500 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

 

 

150.0 MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS

150.1 MALIGNANT NEOPLASM OF THORACIC ESOPHAGUS

150.2 MALIGNANT NEOPLASM OF ABDOMINAL ESOPHAGUS

150.3 MALIGNANT NEOPLASM OF UPPER THIRD OF ESOPHAGUS

150.4 MALIGNANT NEOPLASM OF MIDDLE THIRD OF ESOPHAGUS

150.5 MALIGNANT NEOPLASM OF LOWER THIRD OF ESOPHAGUS

150.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED PART OF ESOPHAGUS

150.9 MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

151.0 MALIGNANT NEOPLASM OF CARDIA

151.1 MALIGNANT NEOPLASM OF PYLORUS

151.2 MALIGNANT NEOPLASM OF PYLORIC ANTRUM

151.3 MALIGNANT NEOPLASM OF FUNDUS OF STOMACH

151.4 MALIGNANT NEOPLASM OF BODY OF STOMACH

151.5 MALIGNANT NEOPLASM OF LESSER CURVATURE OF STOMACH UNSPECIFIED

151.6 MALIGNANT NEOPLASM OF GREATER CURVATURE OF STOMACH UNSPECIFIED

151.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF STOMACH

151.9 MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

153.0 MALIGNANT NEOPLASM OF HEPATIC FLEXURE

153.1 MALIGNANT NEOPLASM OF TRANSVERSE COLON

153.2 MALIGNANT NEOPLASM OF DESCENDING COLON

153.3 MALIGNANT NEOPLASM OF SIGMOID COLON

153.4 MALIGNANT NEOPLASM OF CECUM

153.5 MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS

153.6 MALIGNANT NEOPLASM OF ASCENDING COLON

153.7 MALIGNANT NEOPLASM OF SPLENIC FLEXURE

153.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE

153.9 MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

154.0 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION

154.1 MALIGNANT NEOPLASM OF RECTUM

154.2 MALIGNANT NEOPLASM OF ANAL CANAL

154.3 MALIGNANT NEOPLASM OF ANUS UNSPECIFIED SITE

154.8 MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

155.0 MALIGNANT NEOPLASM OF LIVER PRIMARY

155.1 MALIGNANT NEOPLASM OF INTRAHEPATIC BILE DUCTS

155.2 MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY

157.0 MALIGNANT NEOPLASM OF HEAD OF PANCREAS

157.1 MALIGNANT NEOPLASM OF BODY OF PANCREAS

157.2 MALIGNANT NEOPLASM OF TAIL OF PANCREAS

157.3 MALIGNANT NEOPLASM OF PANCREATIC DUCT

157.4 MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS

157.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF PANCREAS

157.9 MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED

158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM

158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

183.0 MALIGNANT NEOPLASM OF OVARY

183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE

183.3 MALIGNANT NEOPLASM OF BROAD LIGAMENT OF UTERUS

183.4 MALIGNANT NEOPLASM OF PARAMETRIUM

183.5 MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS

183.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA

183.9 MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE

189.0 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS

189.1 MALIGNANT NEOPLASM OF RENAL PELVIS

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

197.7 MALIGNANT NEOPLASM OF LIVER SECONDARY

230.8 CARCINOMA IN SITU OF LIVER AND BILIARY SYSTEM

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

 

 

Documentation Requirements

• Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used.

o This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy.

o This documentation is usually found in the history and physical or in the office/progress notes.

• If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug.

o The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

Treatment Logic

• Floxuridine (FUDR) is an antimetabolite of the pyrimidine analog type.

• The monophosphate of the drug, 5-fluoro-2’-deoxyuridine-5’-phosphate (FUDR-MP), inhibits thymidylate synthetase, thus inhibiting methylation of deoxyuridylic acid to thymidylic acid, thereby, interfering with the synthesis of DNA.

 

Sources of Information and Basis for Decision

 

AHFS Drug Information (2002). American Society of Hospital Pharmacists, Inc.: Bethesda, MD. This source provided the description and outlined the covered indications for this drug.

 

Compendia-Based Drug Bulletin. (May 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

 

FCSO LCD 29175, Floxuridine (FUDR), 02/16/09. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

National Comprehensive Cancer Network (2007). Colon Cancer. Clinical Practice Guidelines in Oncology – V.1.2007.

 

Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch

 

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, July 2007.

 

 

AMA CPT 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.

 

CMS LCD FLOXURIDINE (FUDR)