LCD/NCD Portal

L31243

 

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (XIAFLEX ®)

 

01/01/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Indications

• Per the Food and Drug Administration (FDA) label, Xiaflex ® is indicated for the treatment of adult patients with Dupuytren’s contractures with a palpable cord.

o Therefore, Medicare will cover Xiaflex ® for its FDA approved indication of Dupuytren’s contracture with palpable cord.

• Study criteria submitted to the FDA included the following:

o a finger flexion contracture with a palpable cord of at least one finger (other than thumb) of 20 degrees to 100 degrees in a metacarpophangeal (MP) joint or 20 degrees to 80 degrees in a proximal interphalangeal (PIP) joint and

o A positive “table top” test defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.

o Could not have received a surgical treatment (e.g., fasciectomy, fasciotomy) on the selected primary joint within 90 days before the first injection of study medication and

o Could not have received anticoagulation medication (except for up to 150 mg of aspirin per day) within 7 days before the first injection of study medication.

Limitations

• Xiaflex ® administered for any indication other than the indication listed above is not considered medically reasonable and necessary and, therefore, not covered by Medicare.

 

 

CPT/HCPCS Codes

 

 

Note: HCPCS code J0775 represents the use of Xiaflex® on day 1 of treatment. CPT code 20527 represents the injection of the cord on day 1 of treatment and CPT code 26341 represents the stretching of the cord on day 2 of treatment. Please see the attached coding guideline for a more detailed discussion on the appropiate billing of these codes.

20527 INJECTION, ENZYME (EG, COLLAGENASE), PALMAR FASCIAL CORD (IE, DUPUYTREN’S CONTRACTURE)

26341 MANIPULATION, PALMAR FASCIAL CORD (IE, DUPUYTREN’S CORD), POST ENZYME INJECTION (EG, COLLAGENASE), SINGLE CORD

J0775 INJECTION, COLLAGENASE, CLOSTRIDIUM HISTOLYTICUM, 0.01 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

728.6 CONTRACTURE OF PALMAR FASCIA

 

 

Documentation Requirements

• Because of the specific training requirements needed to identify and inject the cords associated with Dupuytren’s contracture, Medicare would only expect to see Xiaflex ® administered by physicians with specialized training in treating and injecting Dupuytren’s contracture.

o There must be evidence in the medical record of the proper training maintained and made available to Medicare upon request.

o See the Utilization Guidelines below for specific specialties allowed to perform this service.

• It is expected that these services are preformed within the parameters of acceptable standards of medical practice.

o The medical record should document successful treatment of one cord prior to proceeding to the treatment of another.

o The medical record must support that cord treatment follows the protocol and time frames outlined below and in the FDA label.

• The FDA approval label does not place restrictions on the presence of certain dysfunctions or degrees of flexion in order to treat patients with Xiaflex ®.

o The medical record must support the medical necessity of treating with Xiaflex ®, if the patient is outside the study criteria noted under the Indications Section of the LCD.

 

 

Utilization Guidelines

• It is expected that the services associated with the administration of Xiaflex® and associated treatment of Dupuytren’s contracture are performed by providers who have specialized training and expertise in treating diseases of the hand, specifically Dupuytren’s contracture.

o Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in rheumatology, orthopedic surgery, plastic surgery or hand surgery.

o If this skill has been acquired as continuing medical education, the courses must be comprehensive, offered or sponsored or endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.

• The specialties that Medicare would expect to see billing for these services are rheumatology (66), orthopedic surgery (20), plastic surgery (24), and hand surgery (40).

• Dosage and administration for Day 1 and Day 2

o Day 1: Inject Xiaflex® 0.58 mg into one palpable cord with contracture of the MP or PIP joint.

o Day 2: Approximately 24 hours after the cord is injected, the physician may perform a finger extension procedure if a contracture persists, to facilitate cord disruption.

• Approximately 4 weeks after the Xiaflex® injection and finger extension procedure, if a MP or PIP joint contracture remains, the cord may be repeated per the protocol outlined above.

o Injections and finger extension procedures may be administered and performed up to 3 times per cord at approximately 4 week intervals.

• It is expected that only one cord is injected and treated at a time.

o If other palpable cords are present, they must be treated in sequential order, once the previous cord has been treated per the FDA label protocol.

 

 

Treatment Logic

• Dupuytren’s contracture affects the palmer fascia of the hands.

• It is characterized by a thickening of the fibrous tissue underneath the skin of the hand, with resulting nodule and contracture formation.

• These contractures cause the finger(s) to flex forward.

• The contractures are usually painless, but they can cause disability of the hand as the disease progresses.

• The two joints most commonly affected by Dupuytren’s contracture are the metacarpophalangeal (MCP) joints and the proximal interphalangeal (PIP) joints.

 

 

Sources of Information and Basis for Decision

 

Auxilium Pharmaceuticals, Inc. (2010). Xiaflex® prescribing information.

 

Badalamente, M.and Hurst, L., (2007). Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren’s contracture. The Journal of Hand Surgery 32A (6), 767-774.

 

Badalamente, M., Hurst, L. and Hentz,V. (2002). Original communication. Collagen as a clinical target: non-operative treatment of Dupuytren’s disease. The Journal of Hand Surgery 27A (5), 788-798.

Advisory Committee Meeting Notes

 

01/01/2012

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

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.

 

 

CMS LCD COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (XIAFLEX ®)