mp-210 - Medical Policies - Alabama
Surgical Interruption of Pelvic Nerve Pathways for Primary and Secondary Dysmenorrhea
Policy Number: MP-210
Latest Review Date: December 2020
Category: OB/GYN Reproductive
Policy Grade: Effective October 17, 2016: Active Policy but no longer scheduled for regular literature reviews and updates.
Laparoscopic uterine nerve ablation (LUNA) or presacral neurectomy (LPSN) is considered not medically necessary and is considered investigational as a technique to treat primary or secondary dysmenorrhea.
DESCRIPTION OF PROCEDURE OR SERVICE:
Two laparoscopic surgical approaches are proposed as adjuncts to conservative surgical therapy for the treatment of primary and secondary dysmenorrhea. These approaches are laparoscopic uterine nerve ablation (LUNA) and presacral neurectomy (PSN).
Dysmenorrhea is defined as the occurrence of painful menstrual cramps. Primary dysmenorrhea occurs in the absence of an identifiable cause, while secondary dysmenorrhea is related to an identifiable pathologic condition, such as endometriosis, adenomyosis, or pelvic adhesions. First-line pharmacologic therapy typically includes non-steroidal anti-inflammatory drugs (NSAIDs), which reduce prostaglandin production, or oral contraceptives. Patients with endometriosis frequently undergo surgery to ablate, excise, or enucleate endometrial deposits or lyse pelvic adhesion. Collectively, these surgical procedures may be referred to as “conservative surgical therapy.”
Laparoscopic uterine nerve ablation (LUNA) and presacral neurectomy (PSN) are two laparoscopic surgical approaches that have been investigated as techniques to interrupt the majority of the cervical sensory nerve fibers in patients with dysmenorrhea. Uterine nerve ablation involves the transection of the uterosacral ligaments at their insertion into the cervix, while presacral neurectomy involves the removal of the presacral nerves lying within the interiliac triangle. Presacral neurectomy (PSN) interrupts a greater number of nerve pathways compared to laparoscopic uterine nerve ablation (LUNA), and is technically more demanding. There are concerns regarding the efficacy and safety of these procedures.
The literature was reviewed through December 2, 2020.
Summary of Evidence
For individuals who have primary or secondary dysmenorrhea who receive LUNA, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms and treatment-related morbidity. RCTs comparing LUNA plus conventional treatment to conventional treatment alone, and meta-analyses of these trials, have not found a consistent benefit for the addition of LUNA. In addition, sample sizes tended to be small, and there are few studies with follow-up of 12 months or longer. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have primary or secondary dysmenorrhea who receive PSN, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms and treatment-related morbidity. No trials on primary dysmenorrhea were available and there are only several trials on secondary dysmenorrhea. A pooled analysis of 2 trials with a total of 197 women with secondary dysmenorrhea associated with endometriosis found significantly greater symptom relief with PSN plus surgery versus surgery alone at 12 months. The largest and most recent trial found improvement in pain outcomes but also higher complication rates with PSN, and had some methodologic limitations which limit its interpretation. The net health benefit remains unclear and needs to be further assessed in additional trials. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
National Institute for Health and Clinical Excellence (NICE)
In 2007, NICE issued interventional procedure guidance number 234 on LUNA for chronic pelvic pain. The guidance states “The evidence on laparoscopic uterine ablation (LUNA) for chronic pelvic pain suggests that it is not efficacious and therefore should not be used.”
U.S. Preventive Services Task Force Recommendations
Dysmenorrhea, LUNA, presacral neurectomy, laparoscopic uterine nerve ablation, uterine nerve ablation, PSN, LPSN, laparoscopic presacral neurectomy, UNA
APPROVED BY GOVERNING BODIES:
LUNA and LPSN are surgical procedures and, as such are not subject to regulation by the U.S. Food and Drug Administration (FDA).
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable. The use of this device for contraceptive management is a group specific benefit.
ITS: Home Policy provisions apply
FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
There is no specific CPT code for laparoscopic uterine nerve ablation or presacral neurectomy. CPT code 58578 (unlisted laparoscopy procedure, uterus) may be used. For secondary dysmenorrhea, presacral neurectomy may be performed in conjunction with either of the following procedures:
|58660||Laparoscopy, surgical; with lysis of adhesions (salpingolysis, ovariocyesis) (separate procedure)|
|58662||Laparoscopy, surgical; with fulguration or excision of lesions of the ovary, pelvic viscera, or peritoneal surface by any method|
- American College of Obstetricians and Gynecologists (ACOG). Chronic pelvic pain. ACOG Practice Bulletin no 51, March 2004. Reaffirmed 2008. Available online at: //www.guideline.gov.
- Candiani GB, Fedele L, Vercellini P, et al. Presacral neurectomy for the treatment of pelvic pain associated with endometriosis: a controlled study. Am J Obstet Gynecol. Jul 1992; 167(1):100-103.
- Chen FP, Chang SD, Chu KK, et al. Comparison of laparoscopic presacral neurectomy and laparoscopic uterine nerve ablation for primary dysmenorrhea. J Reprod Med. 1996; 41(7):463-466.
- Daniels J. Gray R, Hills RK, et al. Laparoscopic uterosacral nerve ablation for alleviating chronic pelvic pain. JAMA. Sep 2 2009; 302(9):955-961.
- Dover RW, Pooley P, Haines P, et al. Prospective randomized double blind controlled trial of laparoscopic laser uterine nerve ablation in the treatment of pelvic pain associated with endometriosis. (Unpublished clinical trial 1999).
- El-Din Shawki H. The efficacy of laparoscopic uterosacral nerve ablation (LUNA) in the treatment of unexplained chronic pelvic pain: a randomized controlled trial. Gynecol Surg. Feb 2011; 8(1):31-39.
- Gambone JC, Mittman BS, Munro MG, et al. Consensus statement for the management of chronic pelvic pain and endometriosis: proceeding of an expert-panel consensus process. Fertil Steril. 2002; 78(5):961-972.
- Howard Fred and Barbieri Robert L. Chronic pelvic pain in women. //www.UpToDate.com.
- Johnson NP, Farquhar CM, Crossley S, et al. A double-blind randomized controlled trial of laparoscopic uterine nerve ablation for women with chronic pelvic pain. BJOG. Sep 2004; 111(9): 950-95
- Johnson NP, Farquhar CM, et al. Laparoscopic uterine nerve ablation improved non-endometriosis-associated dysmenorrheal but not other types of chronic pelvic pain. Evidenced-based Obstetrics and Gynecology. 2005; 7: 78-79.
- Latthe PM, Proctor ML, Farquhar CM, et al. Surgical interruption of pelvic nerve pathways in dysmenorrheal: A systematic review of effectiveness. Acta Obstet Gynecol Scand 2007; 86(1): 4-15.
- Lichten EM, Bombard J. Surgical treatment of primary dysmenorrhea with laparoscopic uterine nerve ablation. J Reprod Med. Jan 1987; 32(1):37-41.
- Miller LE, Bhattacharyya R, and Miller VM. Clinical utility of presacral neurectomy as an adjunct to conservative endometriosis surgery: Systemic Review and meta-analysis of controlled studies. Sci Rep. 2020; 10:6901.
- National Institute for Health and Clinical Evidence. Laparoscopic uterine nerve ablation (LUNA) for chronic pelvic pain. NICE Interventional Procedure Guidance 234. 2007. Available online at: //www.nice.org.uk/nicemedia/pdf/IPG24guidance.pdf.
- Nezhat C, Morozov V. Robot-assisted laparoscopic presacral neurectomy: feasibility, techniques and operative analysis. J Minim Invasiv Gynecol. 2010; 17(4):508-512.
- Proctor ML, Latthe PM, et al. Surgical interruption of pelvic nerve pathways for primary and secondary dysmenorrhoea. Cochrane Database System Review. 2005; (4): CD001896.
- Sutton C, Pooley AS, Jones KD, et al. A prospective, randomized, double-blind controlled trial of laparoscopic uterine nerve ablation in the treatment of pelvic pain associated with endometriosis. Gynaecol Endosc. 2001; 10(4):217-222.
- Tjaden B, Schlaff WD, Kimball A, et al. The efficacy of presacral neurectomy for the relief of midline dysmenorrhea. Obstet Gynecol. Jul 1990; 76(1): 89-91.
- Tu FF, As-Sanie S. Treatmetn of chronic pelvic pain in women. Up to Date. Available at: https://www.uptodate.com/contents/treatment-of-chronic-pelvic-pain-in-women?sectionName=When%20to%20perform%20additional%20surgery&search=presacral%20neurectomy&topicRef=16673&anchor=H269292808&source=see_link#H4112679368. Accessed 9/26/19.
- Vercellini P, Aimi G, Busacca M et al. Laparoscopic uterosacral ligament resection for dysmenorrhea associated with endometriosis: results of a randomized, controlled trial. Fertil Steril. 2003; 80(2):310-319.
- Wilson ML, Farquhar CM, Sinclair OJ, et al. Surgical interruption of pelvic nerve pathways for primary and secondary dysmenorrhoea. The Cochrane Library, Issue 1, 2004.
- Zullo F, Palomba S, Zupi E, et al. Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial. Am J Obstet Gynecol. Jul 2003; 189(1):5-10.
- Zullo F, Palomba S, Zupi E, et al. Long-term effectiveness of presacral neurectomy for the treatment of severe dysmenorrhea due to endometriosis. J Am Assoc Gynecol Laparosc. Feb 2004; 11(1):23-28.
Medical Policy Group, December 2004 (4)
Medical Policy Administration Committee, January 2005
Available for comment January 21-March 7, 2005
Medical Policy Group, December 2006 (1)
Medical Policy Group, December 2008 (1)
Medical Policy Group, March 2010 (3)
Medical Policy Group, August 2011 (3): Updated Key Points & References
Medical Policy Group, March 2012 (3): Updated Key Points & References for 2012
Medical Policy Group, April 2013 (3): Updated Key Points; No policy change
Medical Policy Group, October 2013 (3): Removed ICD-9 Diagnosis codes; Removed reference to Medical Policy Reference Manual; no change to policy statement
Medical Policy Panel, April 2014
Medical Policy Group, April 2014 (3): Reworked Key Points but no new information added; no new references; no additional info from literature; no change in policy statement
Medical Policy Panel, April 2015
Medical Policy Group, April 2015(4): Updates to Description, Key Points, Key Words and Approved Governing Bodies. No policy statement change.
Medical Policy Panel, October 2016
Medical Policy Group, October 2016 (4): Updates to Description and Key Points. No change to policy statement. Policy retired.
Medical Policy Group, September 2019 (4): Updates to Description and References. No change to policy statement.
Medical Policy Group, December 2020 (4): Updates to References. No change to policy statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.