Prior authorization request form Form

Effective Date

Last Reviewed

Original Document

Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the member meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request preauthorization or post-payment review. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. This clinical policy is not intended to pre-empt the judgment of the reviewing medical director or dictate to health care providers how to practice medicine. Health care providers are expected to exercise their medical judgment in rendering appropriate care. Health care providers are expected to exercise their medical judgment in rendering appropriate care.
EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary.
If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. Identification of selected brand names of devices, tests and procedures in a medical coverage policy is for reference only and is not an endorsement of any one device, test or procedure over another. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication.
EmblemHealth may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. EmblemHealth Services Company, LLC, has adopted this policy in providing management, administrative and other services to EmblemHealth Plan, Inc., EmblemHealth Insurance Company, EmblemHealth Services Company, LLC, and Health Insurance Plan of Greater New York (HIP) related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definitions EmblemHealth utilizes the definitions in the table below for this guideline. Anal incontinence Involuntary loss of solid or liquid feces or flatus Severe fecal incontinence Involuntary loss of solid or liquid feces or flatus on a weekly, or more, frequent basis Conservative medical interventions Dietary management, pharmacotherapy, strengthening exercises Guideline Any of the following treatments is considered medically necessary for severe fecal incontinence when any conservative intervention has failed:

Anal sphincter repair
Colostomy — member has failed/is not a candidate for medical interventions or surgical sphincter repair (e.g., post-anal repair, sphincteroplasty or total pelvic floor repair, biofeedback pelvic training [check member benefits])

Page 2 of 5

Acticon™ Neosphincter artificial bowel sphincter — member is ≥ 18 years of age and has failed/is not a candidate for medical interventions or surgical sphincter repair (e.g., post-anal repair, sphincteroplasty, or total pelvic floor repair)
Sacral nerve stimulation (sacral neuromodulation) for chronic fecal incontinence — member has had an inadequate response to conservative treatments and has a weak but structurally intact anal sphincter Note: A 2–3-week trial with a temporary percutaneous peripheral nerve electrode must be completed before implantation with a permanent implantable pulse generator (e.g., InterStim®) can be considered. Implantation is considered medically necessary when there is a ≥ 50 % improvement in incontinence symptoms derived from the temporary percutaneous peripheral nerve stimulation.
Limitations and Exclusions The Acticon Neosphincter is not considered medically necessary when the above criteria are not met and when its use is contraindicated. (I.e., incontinence complicated by irreversibly obstructed proximal segment of bowel, poor candidacy for surgery or anesthesia, etc.) The following interventions are not considered medically necessary due to insufficient evidence of therapeutic value:
Radiofrequency energy delivery (e.g., Secca Therapy)
Perianal electrical stimulation
Injectable bulking agents (e.g., Solesta®) (0963T)
Vaginal bowel control (e.g., eclipse system™) (A4563) (Covered for Medicare members only)
Injection of autologous myoblast cells
Injection of mesenchymal stem cells
Topical estrogen
Tibial nerve stimulation
Pudendal nerve terminal motor latency
Interna® Dermal Regeneration FENIX™ Continence Restoration System
Autologous muscle cell therapy (injection of muscle progenitor cells into the external anal sphincter) (1001T eff. 1/1/2026)
Procedure Codes
64561 Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed 64581 Incision for implantation of neurostimulator electrodes; sacral nerve (transforaminal placement) 64590 Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling 95972 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming L8680 Implantable neurostimulator electrode, each L8681 Patient programmer (external) for use with implantable programmable implantable neurostimulator pulse generator L8682 Implantable neurostimulator radiofrequency receiver

Page 3 of 5 L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver L8684 Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension L8686 Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension L8688 Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension L8689 External recharging system for battery (internal) for use with implantable neurostimulator L8695 External recharging system for battery (external) for use with implantable neurostimulator

ICD-10 Diagnoses A04.71 Enterocolitis due to Clostridium difficile, recurrent
A04.72 Enterocolitis due to Clostridium difficile, not specified as recurrent
References Alavi K, Chan S, Wise P, et al. Fecal Incontinence: Etiology, Diagnosis, and Management. J Gastrointest Surg. 2015 Oct;19(10):1910-

Barnett JL, Hasler WL, Camilleri M. American Gastroenterological Association medical position statement on anorectal testing techniques. Gastroenterology. 1999;116(3):732-760. Bharucha AE, Fletcher JG, Melton LJ, 3rd, Zinsmeister AR. Obstetric trauma, pelvic floor injury and fecal incontinence: a population- based case-control study. Am J Gastroenterol. 2012;107:902–911. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD002111. doi: 10.1002/14651858.CD002111.pub3. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Norton C1, Cody JD. Dehli T, Stordahl A, Vatten LJ et al. Sphincter training or anal injections of dextranomer for treatment of anal incontinence: a randomized trial. Scand J Gastroenterol 2013 Dis Colon Rectum. 2011 Jul;54(7):846-56. doi: 10.1007/DCR.0b013e3182148fef. Biofeedback for fecal incontinence: a randomized study comparing exercise regimens. Bartlett L1, Sloots K, Nowak M, Ho YH. Frudinger A, Kölle D, Schwaiger W, et al. Muscle-derived cell injection to treat anal incontinence due to obstetric trauma: Pilot study with 1 year follow-up. Gut. 2010;59(1):55-61. Hosker G, Norton C, Brazzelli M. Electrical stimulation for faecal incontinence in adults. Cochrane Database Syst Rev. 2000;(2). Int J Colorectal Dis. 2013 Nov;28(11):1567-77. doi: 10.1007/s00384-013-1739-0. Epub 2013 Jul 31. Electrical stimulation and biofeedback for the treatment of fecal incontinence: a systematic review. Vonthein R1, Heimerl T, Schwandner T, Ziegler A. Lam TJ, Visscher AP, Meurs-Szojda MM, Felt-Bersma RJ. Clinical response and sustainability of treatment with temperature- controlled radiofrequency energy (Secca) in patients with faecal incontinence: 3 years follow-up. Int J Colorectal Dis. 2014;29(6):755-761. Leung FW. Treatment of fecal incontinence - review of observational studies (OS) and randomized controlled trials (RCT) related to injection of bulking agent into peri-anal tissue. J Interv Gastroenterol 2011; 1(4):202-06 Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013 Feb 28;2:CD007959

Page 4 of 5 Maslekar S, et al. Injectable collagen for the treatment of fecal incontinence: long-term results. Dis Colon Rectum 2013 Mar;56(3):354-

Nandivada P, Nagle D. Surgical therapies for fecal incontinence. Curr Opin Gastroenterol. 2014;30(1):69-74. National Institute for Clinical Excellence (NICE). Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence.
https://www.nice.org.uk/guidance/ipg393. Accessed June 18, 2025. National Institute for Health and Clinical Excellence (NICE). Injectable bulking agents for faecal incontinence. 2007. https://www.nice.org.uk/guidance/ipg210 . Accessed June 18, 2025. National Institute for Health and Clinical Excellence (NICE). Percutaneous tibial nerve stimulation for faecal incontinence. 2011. https://www.nice.org.uk/guidance/ipg395. Accessed June 18, 2025. Park EJ, Kang 1, Baik SH. Treatment of faecal incontinence using allogeneic-adipose-derived mesenchymal stem cells: A study protocol for a pilot randomised controlled trial. BMJ Open. 2016;6(2):e010450. Paquette IM, Varma MG, Kaiser AM, et al. The American Society of Colon and Rectal Surgeons' Clinical Practice Guideline for the Treatment of Fecal Incontinence. July 2015. https://www.fascrs.org/sites/default/files/downloads/publication/clinical_practice_guideline_for_the_treatment_of_fecal_inconti nence.pdf. Accessed June 18, 2025. Robson K, Lembo AJ. Fecal incontinence in adults: Etiology and evaluation. UpToDate Inc., Waltham, MA. Last reviewed April 2015. Ruiz D, Pinto RA, Hull TL et al. Does the radiofrequency procedure for fecal incontinence improve quality of life and incontinence at 1-year follow-up? Dis Colon Rectum 2010; 53(7):1041-6. Satish S, Rao M. Diagnosis and management of fecal incontinence. Practice Guidelines. American Journal of Gastroenterology 2004; doi:10.1111/j.1572-0241.2004.40105.x Treatments for Fecal Incontinence [Internet]. Editors Forte ML, Andrade KE, Butler M, Lowry AC, Bliss DZ, Slavin JL, Kane RL. Source Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Mar. Report No.: 15(16)-EHC037-EF. AHRQ Comparative Effectiveness Reviews. Up to Date. Fecal incontinence in adults: Etiology and evaluation. Authors: Kristen M Robson, MD, MBA, FACGAnthony J Lembo, MDSection Editor:Nicholas J Talley, MD, PhDDeputy Editor:Shilpa Grover, MD, MPH. August 10, 2016. Wald A, Bharucha AE, Cosman BC, Whitehead WE. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol 2014 Aug;109(8):1141-57. Findlay JM, Maxwell-Armstrong C. Posterior tibial nerve stimulation and faecal incontinence: A review. Int J Colorectal Dis. 2011;26(3):265-273. National Institute for Health and Care Excellence (NICE) Website. Percutaneous tibial nerve stimulation for faecal incontinence. May 25, 2011. Thomas GP, Dudding TC, Rahbour G, et al. A review of posterior tibial nerve stimulation for faecal incontinence. Colorectal Dis. 2013;15(5):519-526. Horrocks EJ, Thin N, Thaha MA, et al. Systematic review of tibial nerve stimulation to treat faecal incontinence. Br J Surg. 2014;101(5):457-468. Edenfield AL, Amundsen CL, Wu JM, et al. Posterior tibial nerve stimulation for the treatment of fecal incontinence: A systematic evidence review. Obstet Gynecol Surv. 2015;70(5):329-341. Horrocks EJ, Bremner SA, Stevens N, et al. Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial). Health Technol Assess. 2015;19(77):1-164. FDA. Humanitarian Device Exemption (HDE) Fenix Continence Restoration System. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=H130006. Accessed June 18, 2025. Specialty matched clinical peer review.

Page 5 of 5 Revision History Company(ies)

  DATE

REVISION EmblemHealth Dec. 8, 2025 Added autologous muscle therapy as investigational EmblemHealth Jun. 13, 2025 Transferred policy content to individual company branded template EmblemHealth ConnectiCare May 13, 2022 ConnectiCare adopts clinical criteria of its parent corporation EmblemHealth ConnectiCare Jul. 14, 2017 Added Interna® Dermal Regeneration FENIX™ Continence Restoration System as investigational

Book a walkthrough

Walk through this policy with us

Review how this policy can be converted into cited criteria, prior authorization checks, and operational automation.

GenHealth is the best way to run RCM including eligibility, prior auth, billing, and denials with AI that works like a teammate in your EMR and billing systems.

Prior authorization request form Form

Previewing the first 5 questions