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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.
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.
Xiaflex ® administered for any indication other than the indication listed above is not considered medically reasonable and necessary and, therefore, not covered by Medicare.
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:
Contractor Name(Contractor Number) - Contractor Info
Start Date of Comment Period:N/A
Start Date of Notice Period:01/01/2012
Revision Effective Date: 01/01/2012
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.
Start Date of Comment Period:N/A
Start Date of Notice Period:01/01/2011
Revision Effective Date 01/01/2011
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
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
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.
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.
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.12 - Hospital Inpatient (Medicare Part B only)
13 - Hospital Outpatient
85 - Critical Access Hospital
0636 - Pharmacy - Drugs Requiring Detailed Coding
0940 - Other Therapeutic Services - General Classification
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 26341 J0775
Any diagnosis codes not listed under ICD-9 codes that support medical necessity.