HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-107-013
Topic:
Injectable Collagenase Clostridium Histolyticum (Xiaflex)
Section:
Injections
Effective Date:
June 17, 2024
Issued Date:
June 17, 2024
Last Revision Date:
April 2024
Annual Review:
April 2024
 
 

Injection with collagenase clostridium histolyticum (Xiaflex®) 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 (Xiaflex) 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.

Policy Position

Treatment of Dupuytren's Contracture

Collagenase clostridium histolyticum (Xiaflex) may be considered medically necessary for the treatment of Dupuytren's contracture when ALL of the following are met:

  • Individual is 18 years of age or older; and
  • Individual has diagnosis of Dupuytren’s contracture with a palpable cord; and
  • Individual has documented metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint contracture of 20 degrees or greater at baseline; and
  • Individual will not be treated for more than two (2) joints in the same hand at the same visit; and
  • Individual will not be treated for more than a maximum of three (3) injections per cord at approximately four (4)-week intervals; and
  • Injection will 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.  

The use of collagenase clostridium histolyticum (Xiaflex) not meeting the criteria as indicated in this policy is considered not medically necessary.

J0775

 

 

 

 

 

 




Treatment of Peyronie's Disease

Collagenase clostridium histolyticum (Xiaflex) may be considered medically necessary for the following:

  • Individual is 18 years of age or older; and
  • Individual has diagnosis of Peyronie’s disease with BOTH of the following:
    • Presence of a palpable plaque; and
    • Curvature deformity of at least 30 degrees at the start of therapy; and
  • Injection will be administered by a healthcare provider experienced in injection procedures 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; and
  • Individual will not be treated with more than a total of eight (8) injections per Peyronie’s plaque per lifetime.

Note: An individual that has completed Xiaflex treatment on a previous plaque, can be treated with a full course of Xiaflex therapy (maximum 8 injections) for any new, independent plaques causing the curvature deformity.

The use of collagenase clostridium histolyticum (Xiaflex) not meeting the criteria as indicated in this policy is considered not medically necessary.

J0775

 

 

 

 

 

 




NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.


Related Policies

Refer to Medical Policy G-9, Diagnosis and Treatment of Male Sexual Dysfunction, for additional information.


Covered Diagnosis Code for Procedure Codes J0775

 M72.0

 N48.6

 

 

 

 

 

 



Place of Service: Outpatient

The use of injectable collagenase clostridium histolyticum (Xiaflex) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



Links






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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

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.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    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.