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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.
Peyronie’s disease is caused by scar tissue that develops under the skin of the penis. Xiaflex® is a non-surgical treatment option for adult men who have a plaque (lump) in the penis that results in a curvature deformity of at least 30 degrees upon erection. It is believed to work for Peyronie’s disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity. A treatment course for Peyronie’s disease consists of a maximum of four treatment cycles. Each treatment cycle consists of two injection procedures (in which Xiaflex® is injected directly into the collagen-containing structure of the penis) and one penile modeling procedure performed by the health care professional.
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 metacarpophalangeal (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 and 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.) XIAFLEX should be used with caution in patients with coagulation disorders including patients receiving concomitant anticoagulants within 7 days prior to XIAFLEX administration (except for low-dose aspirin).
Xiaflex® is also FDA-approved for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
Xiaflex ® administered for any indications other than the indication listed above is not considered medically reasonable and necessary and, therefore, not covered by Medicare. The specialties that Medicare would expect to see billing for the treatment of Dupuytren’s contracture are rheumatology (66), orthopedic surgery (20), plastic surgery (24), hand surgery (40), or general surgery (02); and urology (34) for the treatment of Peyronie’s disease.
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
First Coast Service Options, Inc. (09101) - DME
First Coast Service Options, Inc. (09201) - DME
Auxilium Pharmaceuticals, Inc. (2010). Xiaflex® prescribing information.
Auxilium Pharmaceuticals, Inc. (revised 12/2013). 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.
U.S. Food and Drug Administration (FDA) News Release (December 6, 2013) FDA approves first drug treatment for Peyronie’s disease. Accessed at http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm377849.htm
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: For Dupuytren's contracture, 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 codes for Peyronie’s disease and Dupuytren’s contracture. 20527 26341 J0775
Any diagnosis codes not listed under ICD-9 codes that support medical necessity.