HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
S-179-019
Topic:
Treatment of Abnormal Uterine Bleeding and Fibroids
Section:
Surgery
Effective Date:
September 17, 2018
Issued Date:
September 17, 2018
Last Revision Date:
September 2018
Annual Review:
April 2018
 
 

Uterine fibroids are one of the most common conditions affecting women in the reproductive years; symptoms include menorrhagia, pelvic pressure, or pain. Surgery, including hysterectomy and various myomectomy procedures, is considered the criterion standard treatment for symptom resolution. However, there is the potential for surgical complications and, in the case of hysterectomy, the uterus is not preserved. In addition, in the case of multiple uterine fibroids, myomectomy can be a time-consuming procedure. Treatment options include hysterectomy, myomectomy, uterine artery embolization and endometrial ablation.

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

Treatment of uterine fibroids is considered experimental/investigational and therefore non-covered for ANY ONE of the following procedures/services:

  • Laparoscopic and percutaneous techniques for myolysis (e.g., laser and bipolar needles, cryomyolysis); or
  • Laparoscopic uterine power morcellation in hysterectomy and myomectomy; or
  • MRI guidance performed in conjunction with percutaneous myolysis of uterine fibroids. 

The published data regarding techniques of myolysis are inadequate to permit scientific conclusions due to the lack of randomized trials and therefore safety and effectiveness has not been established.

0404T

58578

58999

77022

 

 

 


C1782



Transcatheter uterine artery embolization (UAE) of uterine arteries may be considered medically necessary for the treatment of uterine fibroids when ANY ONE of the following criteria is met: 

  • The individual is experiencing the following symptoms:
    • Menorrhagia (excessive menstrual bleeding lasting more than eight (8) days) as a direct result of the fibroid (i.e., not resulting from hyperplasia, atypia, or cancer) that interferes with daily activities or causes anemia; or 
    • Pelvic pain or pressure as a direct result of the fibroid; or
    • Lower back pain as a direct result of the fibroid; or
    • Urinary symptoms (e.g., urinary frequency, urgency )related to compression of the bladder as a direct result of the fibroid; or
    • Gastrointestinal symptoms related to compression of the bowel (e.g., constipation, bloating) as a direct result of the fibroid; or
    • Dyspareunia (painful or difficult sexual relations) as a direct result of the fibroid; or
    • An abdominally palpable fibroid.

Or 

  • The individual is asymptomatic with an abdominally palpable fibroid or significantly enlarged fibroid on abdominal/vaginal examination and ANY ONE of the following:
    • The use of anesthesia places the individual at high surgical risk; or
    • The individual has medical contraindications to hysterectomy (e.g., morbid obesity); or
    • The use of hormonal therapy is contraindicated, or the individual is intolerant to or has previously failed a course of hormone therapy; or
    • The individual wishes to avoid hysterectomy; or
    • The individual may want to become pregnant; or
    • The individual has hydronephrosis. 

One repeat transcatheter embolization of uterine arteries may be considered medically necessary to treat persistent symptoms of uterine fibroids after an initial uterine artery embolization when ANY ONE of the following criteria is met: 

  • Documentation of continued symptoms such as bleeding or pain; or
  • Individual has persistent symptoms in combination with findings on imaging of an incomplete initial procedure, as evidenced by continued blood flow to the treated regions.  

UAE may be considered medically necessary for the treatment of postpartum uterine hemorrhage.

UAE is considered experimental/investigational for all other indications and therefore non-covered because the safety and/or effectiveness have not been established by the available published peer-reviewed literature.

36245

36246

36247

36248

37243

37244

75894


Laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa™) for the treatment of uterine fibroids may be considered medically necessary when the individual is experiencing ANY ONE of the following symptoms:

  • Menorrhagia (excessive menstrual bleeding lasting more than eight (8) days) as a direct result of the fibroid (e.g., not resulting from hyperplasia, atypia, or cancer) that interferes with daily activities or causes anemia; or 
  • Pelvic pain or pressure as a direct result of the fibroid; or
  • Lower back pain as a direct result of the fibroid; or
  • Urinary symptoms (e.g., urinary frequency, urgency )related to compression of the bladder as a direct result of the fibroid; or
  • Gastrointestinal symptoms related to compression of the bowel (e.g., constipation, bloating) as a direct result of the fibroid; or
  • Dyspareunia (painful or difficult sexual relations) as a direct result of the fibroid; or
  • An abdominally palpable fibroid.

Laparoscopic ultrasound-guided radiofrequency ablation is considered experimental/investigational for all other indications not listed above and therefore non-covered because the safety and/or effectiveness have not been established by the available published peer-reviewed literature.

58674



Endometrial ablation with or without hysteroscopic guidance, using an FDA-approved device, may be considered medically necessary in women who would otherwise be considered candidates for hysterectomy when ANY ONE of the following criteria are met:

  • In women with menorrhagia who are not candidates for hormone therapy; or
  • Decline hormone therapy; or
  • Who are unresponsive to hormone therapy.

Endometrial ablation with or without hysteroscopic guidance for all other indications is considered not medically necessary. 

58353

58356

58563


Professional Statements and Societal Positions Guidelines

In November 2014, the U.S. Food and Drug Administration (FDA) published a safety communication on laparoscopic power morcellators used for myomectomy and hysterectomy in most women. FDA recommended that manufacturers of these devices include in their product labels a boxed safety warning and wording on contraindications.

In November 2012, the Acessa™ System (Acessa Health, Austin, TX, formerly Halt Medical) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for percutaneous laparoscopic coagulation and ablation of soft tissue and treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The technology was previously approved in 2010, at which time it was called the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System. The intended use of the Halt 2000GI system was for percutaneous laparoscopic coagulation and ablation of soft tissue. Unlike FDA clearance of the Acessa System, the intended use statement for the Halt 2000GI system does not specifically mention the treatment of uterine fibroids.


Covered Diagnosis Codes for Procedure Code 37243 and 58674

D25.0

D25.1

D25.2

D25.9

 

 

 

 

Covered Diagnosis Codes for Procedure Codes 37244 and 75894

O43.211

O43.212

O43.213

O43.221

O43.222

O43.223

O43.231

O43.232

O43.233

O44.30

O44.31

O44.32

O44.33

O44.50

O44.51

O44.52

O44.53

O72.0

O72.1

O72.2

 

 

Non-Covered Diagnosis Codes for Procedure Codes 58578, 58999, 77022, C1782

D25.0

D25.1

D25.2

D25.9

 

 

 

 

Covered Diagnosis Codes for Procedure Codes 58353, 58356, and 58563

N92.0

N92.1

N92.4

 

 

 

 


Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Treatment of Uterine Fibroids 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.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree 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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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.

    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:

  • 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.