Injection with clostridial collagenase is intended to provide a non-operative treatment option for fibroproliferative disorders. Fibrotic tissue disorders, characterized by excessive collagen deposits, can affect the musculoskeletal system, causing pain and limitation of movement and reduction of joint range of motion. Examples of fibroproliferative disorders include Dupuytren’s contracture, and Peyronie’s disease.
Dupuytren's contracture is a benign fibroproliferative condition characterized by excessive collagen deposition causing abnormal thickening of the fascia. This results in the formation of a ropelike cord beneath the skin of the palm, stretching from the palm into the fingers. Gradually, the progression of these cords may cause the fingers to bend into the palm resulting in permanent joint contractures. Collagenase clostridium histolyticum is the first FDA-approved nonsurgical option for the treatment of adult patients with Dupuytren's contracture with a palpable cord.
Peyronie's disease is caused by scar tissue that develops under the skin of the penis. This scar tissue causes an abnormal bend during erection and can cause problems such as bothersome symptoms during intercourse.
Collagenase clostridium histolyticum (e.g. Xiaflex®) may be considered medically necessary for ANY ONE of the following indications and their respective criteria listed below:
The use of collagenase clostridium histolyticum for any other indication is considered experimental/investigational, and therefore not covered. Scientific evidence does not support its use for any other indications.
Treatment of Dupuytren's Contracture
Treatment of Dupuytren's contracture consists of an injection of collagenase into a palpable Dupuytren's cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint. Patients may be eligible for the following treatment:
Note: *Collagenase clostridium histolyticum injections for Dupuytren's contracture should be administered by a healthcare provider experienced in injection procedures of the hand and certified in the *Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program. A copy of the REMS certification must be attached to the claim.
Treatment of Peyronie's Disease
Treatment for Peyronie's disease may be considered medically necessary for a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
The injection of the corpora cavernosa with pharmacologic agent(s) (e.g., papaverine, phentolamine) may be considered medically necessary to determine where the injection of Xiaflex should be administered on the penis. If the penis does not detumesce, then an injection of a medication to pharmacologically reduce the swelling may be considered medically necessary.
The injection of the corpora cavernosa is considered an integral part of a doctor’s medical care. Payment for the medical care performed on the same date of service includes the allowance for this procedure. A treatment course for Peyronie’s disease consists of a maximum of four (4) treatment cycles. Each treatment cycle consists of two (2) collagenase clostridium histolyticum injection procedures (in which injectable collagenase clostridium histolyticum is injected directly into the collagen-containing structure of the penis) and one penile modeling procedure.
Note: *Collagenase clostridium histolyticum injections for Peyronie’s disease should be administered by a healthcare provider experienced in the treatment of male urological diseases and certified in the *Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program. A copy of the REMS certification must be attached to the claim.
Procedure code 54235 is considered an integral part of a doctor’s medical care. Payment for the medical care performed on the same date of service includes the allowance for this procedure.
*Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program
REMS is a program to manage known or potential serious risks associated with a drug and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. Auxilium has worked with the FDA to develop materials to communicate to healthcare providers and patients, the potential serious risks associated with use of Xiaflex.
Each indication has separate REMS requirements and educational material.
Xiaflex is available only through the Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program. Required components of the Xiaflex REMS Program include the following:
Collagenase clostridium histolyticum is not reimbursable under the prescription drug benefit.
Note: Dosage recommendations per the FDA label.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
