Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine Fibroids.
Treatment: Surgery (myomectomy or hysterectomy using power morcellation).
The insurer denied Surgery (myomectomy or hysterectomy using power morcellation).
The denial is upheld.

The patient is a female with symptomatic uterine fibroids. She underwent a laparoscopic hysterectomy and bilateral salpingo-oophorectomy. Power morcellation was performed during the procedure.

No, the health plan should not cover the proposed treatment.

Morcellation is a surgical technique used to reduce the size of the uterus or myomas by creating smaller pieces to allow the tissue to be removed through small incisions or with laparoscopic instruments. Gynecologists have performed manual morcellation to remove an enlarged uterus through the vagina or a small abdominal incision for decades. Other procedures to reduce uterine size include myomectomy, bivalving, wedge resection, or coring. Morcellation also has been performed on smaller uteri during the performance of supracervical hysterectomies. 

Electromechanical devices, commonly referred to as power morcellators, shave or cut tissue to allow tissue extraction. Open (uncontained) morcellation of the uterus and myomas has been scrutinized because of the possible spread of an unsuspected leiomyosarcoma while using a power morcellator during a hysterectomy or myomectomy for presumed symptomatic uterine leiomyomas. In response, the United States Food and Drug Administration (FDA) issued a Safety Communication warning "against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids". 

Morcellation may be performed during vaginal, laparoscopic, or abdominal surgery using a scalpel, scissors, or a power morcellator. A commonly used alternative to morcellation of an enlarged uterus is an abdominal hysterectomy. However, compared with minimally invasive approaches, abdominal hysterectomy is associated with higher morbidity and mortality and diminished quality of life. Morcellation of a malignancy is contraindicated and women should be evaluated preoperatively to identify malignancy. However, leiomyosarcoma cannot be reliably diagnosed preoperatively. There is a risk that a woman with a presumed leiomyoma may have a malignancy that may be spread through morcellation, leading to a potentially worsened prognosis. The risk of unexpected leiomyosarcoma is uncertain, but estimates range from one in 498 to less than one in 10,000. For women undergoing surgery for presumed leiomyomas, the higher procedural risk of abdominal hysterectomy or myomectomy (to avoid the risk of spreading malignant cells from an unsuspected leiomyosarcoma) must be balanced against the risk of morcellating an unanticipated malignancy and its associated morbidity and mortality. 

Based on existing data, this balance may favor a minimally invasive approach for younger women. However, because of the increasing prevalence of leiomyosarcoma with advancing age (and interpreting the age cutoff of 50 years used in the decision analyses as a proxy for menopause), for postmenopausal women, this balance may favor procedures that do not involve morcellation. The obstetrician/gynecologist and patient should engage in shared decision making, including informed consent, explaining the risks and benefits of each approach to surgery for presumed leiomyomas, the risks and benefits of morcellation, and alternatives to morcellation. 

The American College of Obstetrics and Gynecology, in its Committee Opinion, states: "More research is needed to understand the true prevalence of leiomyosarcoma at the time of surgery for presumed leiomyomas, to better define risk factors for leiomyosarcoma, and to develop preoperative diagnostic tools and methods to improve the safety and efficacy of morcellation". 

Therefore, the procedure is considered experimental/investigational.

No, the requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.

Morcellation is a surgical technique used to reduce the size of the uterus or myomas by creating smaller pieces to allow the tissue to be removed through small incisions or with laparoscopic instruments. Gynecologists have performed manual morcellation to remove an enlarged uterus through the vagina or a small abdominal incision for decades. Other procedures to reduce uterine size include myomectomy, bivalving, wedge resection, or coring. Morcellation also has been performed on smaller uteri during the performance of supracervical hysterectomies. Electromechanical devices, commonly referred to as power morcellators, shave or cut tissue to allow tissue extraction. Open (uncontained) morcellation of the uterus and myomas has been scrutinized because of the possible spread of an unsuspected leiomyosarcoma while using a power morcellator during a hysterectomy or myomectomy for presumed symptomatic uterine leiomyomas. 

In response, the FDA issued a Safety Communication warning "against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids". 

Morcellation may be performed during vaginal, laparoscopic, or abdominal surgery using a scalpel, scissors, or a power morcellator. A commonly used alternative to morcellation of an enlarged uterus is an abdominal hysterectomy. However, compared with minimally invasive approaches, abdominal hysterectomy is associated with higher morbidity and mortality and diminished quality of life. Morcellation of a malignancy is contraindicated and women should be evaluated preoperatively to identify malignancy. However, leiomyosarcoma cannot be reliably diagnosed preoperatively. There is a risk that a woman with a presumed leiomyoma may have a malignancy that may be spread through morcellation, leading to a potentially worsened prognosis. The risk of unexpected leiomyosarcoma is uncertain, but estimates range from one in 498 to less than one in 10,000. For women undergoing surgery for presumed leiomyomas, the higher procedural risk of abdominal hysterectomy or myomectomy (to avoid the risk of spreading malignant cells from an unsuspected leiomyosarcoma) must be balanced against the risk of morcellating an unanticipated malignancy and its associated morbidity and mortality. Based on existing data, this balance may favor a minimally invasive approach for younger women. However, because of the increasing prevalence of leiomyosarcoma with advancing age (and interpreting the age cutoff of 50 years used in the decision analyses as a proxy for menopause), for postmenopausal women, this balance may favor procedures that do not involve morcellation. The obstetrician/gynecologist and patient should engage in shared decision making, including informed consent, explaining the risks and benefits of each approach to surgery for presumed leiomyomas, the risks and benefits of morcellation, and alternatives to morcellation. 

The American College of Obstetrics and Gynecology, in its Committee Opinion, states: "More research is needed to understand the true prevalence of leiomyosarcoma at the time of surgery for presumed leiomyomas, to better define risk factors for leiomyosarcoma, and to develop preoperative diagnostic tools and methods to improve the safety and efficacy of morcellation". 

Therefore the procedure is considered experimental/investigational and is not more beneficial than any standard treatment.