Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-11-036
Topic: Botulinum Toxin (Chemodenervation)
Section: Injections
Effective Date: June 25, 2018
Issue Date: June 25, 2018
Last Reviewed: May 2018

Chemodenervation is a procedure whereby small amounts of botulinum toxin are injected into excessively contracted muscles. Botulinum toxin prevents the release of the chemical signal, which leads to muscle relaxation.

Botulinum toxin type A and B are chemically, pharmacologically, and clinically distinct products and are not interchangeable.

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 circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

OnabotulinumtoxinA (Botox®) may be considered medically necessary when it's used in the treatment of ANY of the following conditions:

All other uses of onabotulinumtoxinA (Botox) are not medically necessary.

Procedure Codes
52287, 53899, 64611, 64612, 64615, 64616, 64617, 64642, 64643, 64644, 64645, 64646, 64647, 64999, 67345, 92265, 95873, 95874, J0585


OnabotulinumtoxinA (Botox) and other medically accepted non-FDA approved indications, Class IIB or higher grade recommendation.

OnabotulinumtoxinA (Botox) may be considered medically necessary for the following medically accepted non-FDA approved indications when it's used in the treatment of ANY of the following conditions:

All other uses of onabotulinumtoxinA (Botox) are considered not medically necessary.

Procedure Codes
46505, 64611, 64616, 64617, 95873, 95874, J0585, S2340, S2341


AbobotulinumtoxinA (Dysport™) may be considered medically necessary for the following FDA approved conditions:

All other uses of abobotulinumtoxinA (Dysport) are considered not medically necessary.

Procedure Codes
64615, 64616, 64642, 64643, 64644, 64645, 95873, 95874, J0586


IncobotulinumtoxinA (Xeomin®) may be considered medically necessary for adult individuals for the treatment of:

All other uses of incobotulinumtoxinA (Xeomin) are considered not medically necessary.

Procedure Codes
64612, 64616, 64642, 64643, 64644, 64645, 95873, 95874, J0588


RimabotulinumtoxinB (Myobloc®) may be considered medically necessary for adult individuals for the treatment of:

All other uses of rimabotulinumtoxinB (Myobloc) are considered not medically necessary.

Procedure Codes
64616, 95873, 95874, J0587


RimabotulinumtoxinB (Myobloc) for other medically accepted non-FDA approved indications, Class IIB or higher grade recommendation.

RimabotulinumtoxinB (MYOBLOC®) may be considered medically necessary for adult individuals for the treatment of:

All other uses of rimabotulinumtoxinB (Myobloc) are considered not medically necessary.

Procedure Codes
64611, 64616, 95873, 95874, J0587


Refer to medical policy S-178, Treatment of Hyperhidrosis, for additional information.

Dosage recommendations per the FDA label.

Dosage recommendations per DRUGDEX® Evaluations (non-FDA approved indications, Class IIb or higher grade recommendation).


Professional Statements and Societal Positions

American Academy of Neurology (AAN).  Botulinum neurotoxin should be offered as a treatment option for the treatment of cervical dystonia, blepharospasm, focal upper extremity dystonia, adductor laryngeal dystonia, upper extremity essential tremor, and may be considered for hemifacial spasm and focal lower limb dystonia.

American Urological Association (AUA).  Intradetrusor onabotulinumtoxinA should be offered as third-line treatment in the carefully-selected and thoroughly-counseled individual who has been refractory to first and second-line OAB treatments. The individual must be able and willing to return for frequent post-void residual evaluation and able and willing to perform self-catheterization if necessary.


Place of Service: Outpatient

Botulinum Toxin (Chemodenervation) 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


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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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.

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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 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.

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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.