L31223-LCD

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Local Coverage Determination (LCD) for Collagenase clostridium histolyticum (Xiaflex ®) (L31223)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L31223

LCD Title Collagenase clostridium histolyticum (Xiaflex ®)

Contractor's Determination Number AXiaflex ®

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 09/30/2010

Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/01/2012

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: N/A

Indications and Limitations of Coverage and/or Medical Necessity

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.

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. 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: 1.) 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 2.) a positive “table top” test defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top. 3.) 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 4.) 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.

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.

012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient

085x 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

0940 Other Therapeutic Services - General Classification

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

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity

Any diagnosis codes not listed under ICD-9 codes that support medical necessity.

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations 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. There must be evidence in the medical record of the proper training maintained and made available to Medicare upon request. 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. The medical record should document successful treatment of one cord prior to proceeding to the treatment of another. 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 ®. 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.

Appendices

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

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

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. 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. 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.

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 This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies including

rheumatology, orthopedic surgery and plastic surgery.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2011

Revision History Number 2

Revision History Explanation Revision Number:2 Start Date of Comment Period:N/A

Start Date of Notice Period:01/01/2012 Revision Effective Date: 01/01/2012

LCR A2012-020

December 2011 Connection

Explanation of Revision: Annual 2012 HCPCS Update. CPT code 26989 was removed and replaced with CPT codes 20527 and 26341. The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2011 Revision Effective Date 01/01/2011

LCR A2011-022

December 2010 Bulletin

Explanation of Revision: Annual 2011 HCPCS Update. Deleted HCPCS code C9266 and replaced with HCPCS code J0775. The effective date of this revision is based on date of service.

Revision Number Original

Start Date of Comment Period:05/28/2010 Start Date of Notice Period:08/16/2010 Original Effective Date 09/30/2010

LCR A2010-043

August 2010 Bulletin

8/1/2010 - The description for Bill Type Code 12 was changed 8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0636 was changed 8/1/2010 - The description for Revenue code 0940 was changed

11/21/2010 - The following CPT/HCPCS codes were deleted:

C9266 was deleted from Group 1

Reason for Change