Alcohol Injections for Treatment of Peripheral Neuromas

Transcription

1 MEDICAL POLICY Alcohol Injections for Treatment of Peripheral Neuromas BCBSA Ref. Policy: Effective Date: Nov. 2, 2018 Last Revised: July 10, 2018 Replaces: N/A RELATED MEDICAL POLICIES: Ablation Procedures for Peripheral Neuromas Select a hyperlink below to be directed to that section. POLICY CRITERIA CODING RELATED INFORMATION EVIDENCE REVIEW REFERENCES HISTORY Clicking this icon returns you to the hyperlinks menu above. Introduction A neuroma is a thickening or growth of nerve tissue. It can often form after an injury to a nerve. Morton s neuroma is a thickening or lump of tissue around a specific nerve in the foot. A Morton s neuroma usually forms between the third and fourth toes. It can cause sharp, burning pain in the ball of the foot, a stinging sensation, or a feeling of numbness. Often, initial treatment calls for the use of pads or inserts to relieve pressure. Other techniques are aimed at destroying the excess nerve tissue that s creating the pain. One of these methods calls for alcohol to be injected (shot) into the neuroma. The goal is to eventually destroy the neuroma by repeated injections of alcohol. Alcohol injections to try to treat Morton s neuroma are investigational. More studies are needed determine whether this technique is effective. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria

2 Procedure Alcohol injections Investigational Alcohol injections are considered investigational for treatment of peripheral neuromas (eg, Morton neuroma*). *May be referred to as intermetatarsal neuroma, interdigital neuroma, interdigital neuritis, and Morton metatarsalgia Coding Code Description CPT Destruction by neurolytic agent, plantar common digital nerve. Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS). Related Information N/A Evidence Review Description Morton neuroma is a common and painful compression neuropathy of the dorsal foot that is also referred to as intermetatarsal neuroma, interdigital neuroma, interdigital neuritis, and Morton metatarsalgia. Morton neuroma is usually treated with conservative measures, surgery, or minimally invasive procedures. Alcohol injection is a minimally invasive alternative to open surgery to treat Morton neuroma. Alcohol causes chemical neurolysis through dehydration, necrosis, and precipitation of the treated area, ultimately destroying the lesion after multiple injections. Page 2 of 8

3 Background Neuroma A neuroma is a growth or tumor consisting of nerve tissue that develops as part of a normal reparative process following nerve injury. The injury may be due to chronic irritation, pressure, stretch, poor repair of nerve lesions or previous neuromas, laceration, crush injury, or blunt trauma. 1 Neuromas typically appear 6 to 10 weeks after trauma, with most presenting within 1 to 12 months after injury or surgery. They may gradually enlarge over 2 to 3 years and may or may not be painful. Pain from a neuroma may be secondary to traction on the nerve by scar tissue, compression of the sensitive nerve endings by adjacent soft tissues, ischemia of the nervous tissue, or ectopic foci of ion channels that elicit neuropathic pain. Patients may describe the pain as low-intensity dull pain or intense paroxysmal burning pain, often triggered by external stimuli such as touch or temperature. Neuroma formation has been implicated as a contributor of neuropathic pain in residual limb pain, postthoracotomy, postmastectomy, and postherniorrhaphy pain syndromes. They may coexist with phantom pain or can predispose to it. Morton Neuroma Morton neuroma is a common and painful compression neuropathy of the common digital nerve of the foot that may also be referred to as interdigital neuroma, interdigital neuritis, or Morton metatarsalgia. 1-3 It is histologically characterized by perineural fibrosis, endoneurial edema, axonal degeneration, and local vascular proliferation. Thus, some investigators do not consider Morton neuroma to be a true neuroma; instead, they consider it to be an entrapment neuropathy occurring secondary to compression of the common digital nerve under the overlying transverse metatarsal ligament. The incidence and prevalence of Morton neuroma are not clear, but it appears 10-fold more often in women than in men, with an average age at presentation of around 50 years. 4 The pain associated with Morton neuroma is usually throbbing, burning, or shooting, localized to the plantar aspect of the foot. It is typically located between the 3rd and 4th metatarsal heads, although it may appear in other proximal locations. 1,2 The pain may radiate to the toes and can be associated with paresthesia. The pain can be severe, and the condition may become debilitating to the extent that patients are apprehensive about walking or touching their foot to the ground. It is aggravated by walking in shoes with a narrow toe box or high heels that cause Page 3 of 8

4 excessive pronation and excessive forefoot pressure; removal of tight shoes typically relieves the pain. Diagnosis Although a host of imaging methods are used to diagnosis Morton neuroma, including plain radiographs, magnetic resonance imaging, and ultrasonography, objective findings are unique to this condition and are primarily used to establish a clinical diagnosis. 1 Thus, a patient s toes often show splaying or divergence. Patients may describe the feeling of a lump on the foot bottom or a feeling of walking on a rolled-up or wrinkled sock. Clinical examination with medial and lateral compression may reproduce the painful symptoms with a palpable click on interspace compression (Mulder sign). 5 Treatment Management of patients diagnosed with Morton neuroma typically starts with conservative approaches, such as the use of metatarsal pads in shoes and orthotic devices that alter supination and pronation of the affected foot. 3 These approaches are aimed at reducing pressure and irritation of the affected nerve. They may provide relief, but they do not alter the underlying pathology. There is little evidence supporting the effectiveness or comparative effectiveness of these practices. 2,6,7 In a case series, Bennett et al (1995) evaluated a 3-stage protocol of private practice patients (N=115) who advanced from stage I (education plus footwear modifications, and a metatarsal pad) to stage II (steroid injections with local anesthetic or local anesthetic alone) and into stage III (surgical resection) if treated while in stages I and II did not bring relief within 3 months. 8 Overall, 97 (85%) of 115 patients believed that pain had been reduced with the treatment program. However, twenty-four (21%) patients eventually required surgical excision of the nerve and 23 (96%) of those had satisfactory results. Ablation Techniques Alternative approaches to treat refractory Morton neuroma include minimally invasive procedures aimed at in situ destruction, including intralesional alcohol injections. 2 Dehydrated ethanol has been shown to inhibit nerve function in vitro, has high affinity for nerve tissue, and causes direct damage to nerve cells via dehydration, cell necrosis, and precipitation of protoplasm, leading to neuritis and a pattern of Wallerian degeneration. Technically, ethanol is a sclerosant that causes chemical neurolysis of the nerve pathology but is considered an ablative Page 4 of 8

5 procedure for this evidence review. The use of ultrasound guidance during this procedure has been shown to increase surgical accuracy, improve outcomes, and shorten procedure duration. Summary of Evidence For individuals who have Morton neuroma who receive intralesional alcohol injection(s), the evidence includes retrospective case series. Relevant outcomes are symptoms, resource utilization, and treatment-related morbidity. The body of evidence is limited, consisting of case series reporting on the treatment response of patients with refractory Morton neuroma. The available series have generally reported that some patients experience pain relief and express satisfaction with the procedure. Some evidence has suggested that surgery after failed cases of alcohol injections is more complex and challenging than in untreated patients due to the presence of fibrosis. There is a lack of controlled trials comparing alcohol injections with alternative therapies, and there are no controlled studies comparing outcomes for alcohol injections with those for surgery in surgical candidates. The evidence is insufficient to determine the effects of the technology on health outcomes. Ongoing and Unpublished Clinical Trials A search of ClinicalTrials.gov in May 2018 did not identify any ongoing or unpublished trials that would likely influence this review. Clinical Input Received from Physician Specialty Societies and Academic Medical Centers While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. In response to requests, input was received from 2 specialty societies and 5 academic medical centers while this policy was under review in Input was consistent that the use of alcohol injections to treat Morton neuroma is investigational. Page 5 of 8

6 Practice Guidelines and Position Statements American College of Foot and Ankle Surgeons The American College of Foot and Ankle Surgeons (2009) released a clinical practice guideline on the diagnosis and treatment of forefoot disorders. 3 The statement reported that 3 to 7 injections of dilute 4% alcohol administered at 5- to 10-day intervals had been associated with an 89% success rate, with 82% of patients achieving complete relief of symptoms. The statement s pathway for treatment of intermetatarsal space neuroma listed decompression, excision, and cryogenic neuroablation under surgical management options. Association of Extremity Nerve Surgeons The Association of Extremity Nerve Surgeons issued practice guidelines (2014), which drew the following conclusions about alcohol injections 16 : The literature regarding alcohol injections is equivocal. There may be some short-term positive effect, but long-term effect is poor for this therapy. Some of the literature recommends using 30% alcohol solution to get effective results. However, there is not enough data to support the use of alcohol. As a general rule, we do not advocate the use of alcohol injections. Medicare National Coverage There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers. Regulatory Status Alcohol injection for Morton neuroma is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration. References Page 6 of 8

7 1. Rajput K, Reddy S, Shankar H. Painful neuromas. Clin J Pain. Sep 2012;28(7): PMID Jain S, Mannan K. The diagnosis and management of Morton's neuroma: a literature review. Foot Ankle Spec. Aug 2013;6(4): PMID Clinical Practice Guideline Forefoot Disorders Panel, Thomas JL, Blitch EL, et al. Diagnosis and treatment of forefoot disorders. Section 3. Morton's intermetatarsal neuroma. J Foot Ankle Surg. Mar-Apr 2009;48(2): PMID Wu KK. Morton's interdigital neuroma: a clinical review of its etiology, treatment, and results. J Foot Ankle Surg. Mar-Apr 1996;35(2): ; discussion PMID Mulder JD. The causative mechanism in Morton's metatarsalgia. J Bone Joint Surg Br. Feb 1951;33-B(1): PMID Adams WR, 2nd. Morton's neuroma. Clin Podiatr Med Surg. Oct 2010;27(4): PMID Thomson CE, Gibson JN, Martin D. Interventions for the treatment of Morton's neuroma. Cochrane Database Syst Rev. Jul 2004(3):CD PMID Bennett GL, Graham CE, Mauldin DM. Morton's interdigital neuroma: a comprehensive treatment protocol. Foot Ankle Int. Dec 1995;16(12): PMID Pasquali C, Vulcano E, Novario R, et al. Ultrasound-guided alcohol injection for Morton's neuroma. Foot Ankle Int. Jan 2015;36(1): PMID Perini L, Perini C, Tagliapietra M, et al. Percutaneous alcohol injection under sonographic guidance in Morton's neuroma: follow-up in 220 treated lesions. Radiol Med. Jul 2016;121(7): PMID Musson RE, Sawhney JS, Lamb L, et al. Ultrasound guided alcohol ablation of Morton's neuroma. Foot Ankle Int. Mar 2012;33(3): PMID Hughes RJ, Ali K, Jones H, et al. Treatment of Morton's neuroma with alcohol injection under sonographic guidance: follow-up of 101 cases. AJR Am J Roentgenol. Jun 2007;188(6): PMID Fanucci E, Masala S, Fabiano S, et al. Treatment of intermetatarsal Morton's neuroma with alcohol injection under US guide: 10- month follow-up. Eur Radiol. Oct 2004;14(3): PMID Morgan P, Monaghan W, Richards S. A systematic review of ultrasound-guided and non-ultrasound-guided therapeutic injections to treat Morton's neuroma. J Am Podiatr Med Assoc. Jul 2014;104(4): PMID Dockery GL. The treatment of intermetatarsal neuromas with 4% alcohol sclerosing injections. J Foot Ankle Surg. Nov-Dec 1999;38(6): PMID Barrett SL, Nickerson DS, Elison P, et al. Clinical Practice Guidelines 2014, Edition 1. Wimberley, TX: Association of Extremity Nerve Surgeons; History Date Comments 08/01/18 New policy, approved July 10, 2018, effective November 2, Policy created with literature review through April Alcohol injections are considered investigational for treatment of peripheral neuromas (eg, Morton neuroma). Page 7 of 8

8 Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA) Premera All Rights Reserved. Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage. Page 8 of 8

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10 日本語 (Japanese): この通知には重要な情報が含まれています この通知には Premera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があります この通知に記載されている可能性がある重要な日付をご確認ください 健康保険や有料サポートを維持するには 特定の期日までに行動を取らなければならない場合があります ご希望の言語による情報とサポートが無料で提供されます (TTY: ) までお電話ください 한국어 (Korean): 본통지서에는중요한정보가들어있습니다. 즉이통지서는귀하의신청에관하여그리고 Premera Blue Cross 를통한커버리지에관한정보를포함하고있을수있습니다. 본통지서에는핵심이되는날짜들이있을수있습니다. 귀하는귀하의건강커버리지를계속유지하거나비용을절감하기위해서일정한마감일까지조치를취해야할필요가있을수있습니다. 귀하는이러한정보와도움을귀하의언어로비용부담없이얻을수있는권리가있습니다 (TTY: ) 로전화하십시오. ລາວ (Lao): ແຈ ງການນ ມ ຂ ມ ນສ າຄ ນ. ແຈ ງການນ ອາດຈະມ ຂ ມ ນສ າຄ ນກ ຽວກ ບຄ າຮ ອງສະ ໝ ກ ຫ ຄວາມຄ ມຄອງປະກ ນໄພຂອງທ ານຜ ານ Premera Blue Cross. ອາດຈະມ ວ ນທ ສ າຄ ນໃນແຈ ງການນ. ທ ານອາດຈະຈ າເປ ນຕ ອງດ າເນ ນການຕາມກ ານ ດ ເວລາສະເພາະເພ ອຮ ກສາຄວາມຄ ມຄອງປະກ ນສ ຂະພາບ ຫ ຄວາມຊ ວຍເຫ ອເລ ອງ ຄ າໃຊ ຈ າຍຂອງທ ານໄວ. ທ ານມ ສ ດໄດ ຮ ບຂ ມ ນນ ແລະ ຄວາມຊ ວຍເຫ ອເປ ນພາສາ ຂອງທ ານໂດຍບ ເສຍຄ າ. ໃຫ ໂທຫາ ភ ស ខមរ (Khmer): សចកត ជ នដ ណ ង ន ម នព ត ម នយ ងស ខ ន សចកត ជ នដ ណ ង ន រប ហល ជ ម នព ត ម នយ ងស ខ ន អ ព ទរមង បបបទ ឬក ររ ប រងរបស អនកត មរយ Premera Blue Cross រប ហលជ ម ន ក លបរ ចឆទស ខ ន ន កន ង សចកត ជ ន ដ ណ ង ន អនករប ហលជ រត វក រប ញច ញសមតថភ ព ដល ក ណត ថងជ ក ចប ស ន ន ដ មប ន ងរកស ទ កក រធ ន រ ប រងស ខភ ពរបស អនក ឬរប ក ជ ន យ ចញ ថល អនកម នស ទធ ទទ លព ត ម ន ន ន ងជ ន យ ន កន ងភ ស របស អនក ដ យម នអស ល យ ឡ យ ស មទ រស ពទ (TTY: ) ਪ ਜ ਬ (Punjabi): ਇਸ ਨ ਟਸ ਵਚ ਖ ਸ ਜ ਣਕ ਰ ਹ. ਇਸ ਨ ਟਸ ਵਚ Premera Blue Cross ਵਲ ਤ ਹ ਡ ਕਵਰ ਜ ਅਤ ਅਰਜ ਬ ਰ ਮਹ ਤਵਪ ਰਨ ਜ ਣਕ ਰ ਹ ਸਕਦ ਹ. ਇਸ ਨ ਜਸ ਜਵਚ ਖ ਸ ਤ ਰ ਖ ਹ ਸਕਦ ਆ ਹਨ. ਜ ਕਰ ਤ ਸ ਜਸਹਤ ਕਵਰ ਜ ਰ ਖਣ ਹ ਵ ਜ ਓਸ ਦ ਲ ਗਤ ਜ ਵ ਚ ਮਦਦ ਦ ਇਛ ਕ ਹ ਤ ਤ ਹ ਨ ਅ ਤਮ ਤ ਰ ਖ਼ ਤ ਪ ਹਲ ਕ ਝ ਖ ਸ ਕਦਮ ਚ ਕਣ ਦ ਲ ੜ ਹ ਸਕਦ ਹ,ਤ ਹ ਨ ਮ ਫ਼ਤ ਵ ਚ ਤ ਆਪਣ ਭ ਸ਼ ਵ ਚ ਜ ਣਕ ਰ ਅਤ ਮਦਦ ਪ ਰ ਪਤ ਕਰਨ ਦ ਅ ਧਕ ਰ ਹ,ਕ ਲ (Farsi): فارسی اين اعالميه حاوی اطالعات مھم ميباشد.اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم تقاضا و يا پوشش بيمه ای شما از طريق Premera Blue Cross باشد. به تاريخ ھای مھم در اين اعالميه توجه نماييد.شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه ھای درمانی تان به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد.شما حق اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد. برای کسب اطالعات با شماره (کاربران TTY تماس باشماره ) تماس برقرار نماييد. Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do Premera Blue Cross. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter esta informação e ajuda em seu idioma e sem custos. Ligue para Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону Fa asamoa (Samoan): Atonu ua iai i lenei fa asilasilaga ni fa amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa asilasilaga o se fesoasoani e fa amatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Fa amolemole, ia e iloilo fa alelei i aso fa apitoa olo o iai i lenei fa asilasilaga taua. Masalo o le a iai ni feau e tatau ona e faia ao le i aulia le aso ua ta ua i lenei fa asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo o e iai i ai. Olo o iai iate oe le aia tatau e maua atu i lenei fa asilasilaga ma lenei fa matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni Español (Spanish): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de Premera Blue Cross. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa ไทย (Thai): ประกาศน ม ข อม ลส าค ญ ประกาศน อาจม ข อม ลท ส าค ญเก ยวก บการการสม ครหร อขอบเขตประก น ส ขภาพของค ณผ าน Premera Blue Cross และอาจม ก าหนดการในประกาศน ค ณอาจจะต อง ด าเน นการภายในก าหนดระยะเวลาท แน นอนเพ อจะร กษาการประก นส ขภาพของค ณหร อการช วยเหล อท ม ค าใช จ าย ค ณม ส ทธ ท จะได ร บข อม ลและความช วยเหล อน ในภาษาของค ณโดยไม ม ค าใช จ าย โทร (TTY: ) Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số