National Medical Policy Subject:

Diabetic Neuropathy, Surgical Decompression

Policy Number:

NMP341

Effective Date*:

May 2007

Updated:

May 2016

This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State’s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use

X

Source National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)*

Article (Local)* Other None

Reference/Website Link

Surgical Decompression for Peripheral Polyneuropathy: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx

Use Health Net Policy

Instructions  Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions.  Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2)

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 

If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement Health Net, Inc. considers surgical decompression not medically necessary for the treatment of diabetic neuropathy because its clinical value for this indication has not been established. No prospectively conducted randomized controlled trials using standard definitions for neuropathy and outcome measures have been completed to allow recommending this procedure.

Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets.

ICD-9 Codes 250.60 - 250.63 357.2 354.0 - 355.9

Diabetes with neurological manifestations Polyneuropathy in diabetes Mononeuritis of upper or lower limb

ICD-10 Codes E11.40-E11.9 E08.42 E09.42 E10.42 E11.42 E13.42 G56.00-G56.92 G57.00-G57.92

Type 2 diabetes mellitus with neurological complications Diabetes mellitus due to underlying condition with diabetic polyneuropathy Drug or chemical induced diabetes mellitus with neurological complications with diabetic polyneuropathy Type 1 diabetes mellitus with diabetic polyneuropathy Type 2 diabetes mellitus with diabetic polyneuropathy Other specified diabetes mellitus with diabetic polyneuropathy Mononeuropathies of upper limb Mononeuropathies of lower limb

CPT Codes 64702 64704 64708 64712 64713 64714 64716 64718

Neuroplasty; digital, 1 or both, same digit Neuroplasty; nerve of hand or foot Neuroplasty; major peripheral nerve, arm or leg, open; other than specified Neuroplasty; sciatic nerve Neuroplasty; brachial plexus Neuroplasty; lumbar plexus Neuroplasty and/or transposition; cranial nerve Neuroplasty and/or transposition; ulnar nerve at elbow

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64719 64721 64722 64726

Neuroplasty and/or transposition; ulnar nerve at wrist Neuroplasty and/or transposition; median nerve at carpal tunnel Decompression; unspecified nerve(s) Decompression; plantar digital nerve

HCPCS Codes N/A

Scientific Rationale – Update May 2016 UpToDate (December, 2015) continues to note that surgical decompression for multiple peripheral nerves as a treatment for symptomatic diabetic polyneuropathy, is not recommended. (See Scientific Rationale Update May 2014). There continues to be a paucity of peer-reviewed literature to support this.

Scientific Rationale – Update May 2015 There are three Clinical Trials that have been started on ‘Surgical Decompression for Diabetic Neuropathy in the Foot.’ However, The recruitment status of this study is unknown because the information has not been verified recently. In addition, there is a paucity of peer reviewed literature to support surgical decompression for diabetic neuropathy.

Scientific Rationale – Update May 2014 Per UpToDate (2014), surgical decompression of multiple peripheral nerves, also called the Dellon procedure, is an alternative, controversial method for treating diabetic polyneuropathy. The rationale for surgical decompression is based on the notion that the metabolic stress of diabetes renders peripheral nerves susceptible to compressive injury at sites of potential nerve entrapment, and that compressive injury of multiple peripheral nerves is what leads to symptoms in most patients. However, there are no adequately designed trials to support the use of surgical decompression of multiple peripheral nerves as a treatment for symptomatic diabetic polyneuropathy. Therefore, this treatment is not recommended.

Scientific Rationale – Update May 2013 Zhang et al (2013) analyzed the therapeutic effect of microsurgical peripheral nerve decompression for diabetic peripheral neuropathy (DPN) patients, using both clinical evaluation and electrophysiological testing. In 560 patients with DPN , the surgical nerve decompression as described by Dellon was performed. Before and 18 months after surgery, Toronto Clinical Scoring System, quantitative sensory testing, and nerve conduction velocity tests were evaluated in all cases. The control group included 40 diabetic patients in the same age range but without DPN. The scores of nerve conduction velocity, quantitative sensory testing, and Toronto Clinical Scoring System improved significantly after microsurgical decompression of the entrapped nerves, although they were still worse than in the control group. According to the Wagner classification, 208 cases (37.1%) were rated as 1 (surface ulcer, no clinical infection) before surgery, but all were rated as 0 (no surface ulcer) 18 months after surgery. Investigators concluded microsurgical decompression of entrapped peripheral nerves for DPN helped improve nerve conduction, restore lower limb feeling and motor function, and cure ulcers. Clinical trials are currently recruiting participants to evaluate surgical decompression for treatment of diabetic neuropathy.

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Scientific Rationale – Update May 2010 While it is accepted that surgical decompression of the median nerve for carpal tunnel syndrome is appropriate in the diabetic patient, application of surgical decompression to the lower extremity has not yet gained widespread recognition. A Cochrane review reported by Chaudhry et al (2008) systematically reviewed the evidence from randomized controlled trials concerning the role of decompressive surgery of lower limbs for symmetrical diabetic peripheral neuropathy. All randomized or quasi-randomized controlled human trials in which any form of decompressive surgery of the lower limbs nerves had been used to treat diabetic symmetrical distal polyneuropathy (DSDP) compared with no treatment or medical therapy were reviewed. Patients with DSDP were included if they had decompression (with or without neurolysis) of at least two of the following nerves in both lower limbs, for the treatment of DSDP: the posterior tibial nerve (including calcaneal, medial and lateral plantar nerves), deep peroneal nerve at the ankle, common peroneal nerve at the knee, lateral femoral cutaneous nerve and sural nerves in the posterior calf region. The primary outcome measure was the change in pain measured by the visual analogue scale (VAS) between the baseline and a follow-up period of greater than three months. 142 publications were identified, however, only eight were considered relevant. The review failed to identify a single randomized controlled trial or any other well designed prospective study controlling for the nonoperated limb that showed improvements in pre defined end points after decompressive surgery, thus concluding the role of decompressive surgery for diabetic symmetric distal neuropathy is unproven. Karagoz et al (2008) evaluated the effect of nerve decompression procedures on diabetic neuropathy in twenty-four patients with diabetic neuropathy who underwent surgical decompression, the following day after surgery as well as 6 months later. The common peroneal, the posterior tibial, and the deep peroneal nerves were decompressed. Visual analog scale was used for management of the pain. Patients were screened with neurosensory testing by using a Pressure-Specified Sensory Device. Preoperative values as well as values on the postoperative first day and 6 months postoperatively were compared. Pain relief rate was reported to be 80% at postoperative first day and 85% at 6 months postoperatively. Mean two-point discrimination length improvement rates were found to be 72.6% at postoperative first day and 89% at 6 months postoperatively. The authors concluded that peripheral nerve decompression can be used effectively in the treatment of diabetic neuropathy patients. According to the American Acadamy of Neurology, “The current evidence supporting the utility of decompressive surgery for the treatment of diabetic neuropathy is of poor quality and design. Although purported as a potential alternate therapy for this progressive and often debilitating condition, the data are insufficient to support or refute its benefits.” The Centers for Medicare and Medicaid Servces (CMS) do not have a NCD regarding surgical decompression for diabetic neuropathy, however, several LCD’s state there are currently no accepted indications for the surgical decompression of diabetic, other metabolic or toxic, or idiopathic polyneuropathy. Thus the procedure and related services are considered not medically necessary.

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Scientific Rationale Diabetic neuropathy (DN) is a common complication of diabetes, in which nerves are damaged as a result of hyperglycemia. People with diabetes commonly develop temporary or permanent damage to nerve tissue. Approximately one quarter of the 17 million diabetic Americans develop a peripheral neuropathy. A substantial number of such patients experience neuropathic pain, but there is no clear peripheral nerve feature distinguishing patients who have diabetic neuropathic pain from those who have nonpainful peripheral neuropathy. Injuries to the nerves are caused by decreased blood flow and high blood-sugar levels, and are more likely to develop if blood-sugar levels are not well-controlled. On average, the beginning of symptoms occurs 10 to 20 years after diabetes has been diagnosed. Approximately 50% of people with diabetes will eventually develop nerve damage. Asymmetrical neuropathies may involve cranial nerves, thoracic or limb nerves; some are of acute onset resulting from ischemic infarction of vasa nervosa. For clinical diagnosis of DN, two of the following five are recommended: (i) signs, (ii) symptoms, (iii) quantitative sensory testing, (iv) nerve conduction study, and (v) autonomic testing. Management of patients with DN entails control of hyperglycemia, other cardiovascular risk factors, alpha lipoic acid and L-carnitine. For neuropathic pain, analgesics, non-steroidal anti-inflammatory drugs, anti-depressants, and anticonvulsants are recommended. The treatment of autonomic neuropathy is symptomatic. The natural history of DN is one of progressive and irreversible loss of sensibility in the feet, which may lead to ulceration and/or amputation. Peripheral nerve injuries may affect cranial nerves or nerves from the spinal column and their branches. This type of neuropathy (nerve injury) tends to develop in stages. Early on, intermittent pain and tingling is noted in the extremities, particularly the feet. In later stages, the pain is more intense and constant. Finally, a painless neuropathy develops when pain sensation is lost to an area. This greatly increases the risk of severe tissue injury because pain no longer alerts the person to injury. Autonomic neuropathies affect the nerves that regulate vital functions, including the heart muscle and smooth muscles. Low blood pressure, diarrhea, constipation, sexual impotence, and other symptoms can be caused by autonomic neuropathies. Patients with painful diabetic neuropathy and other painful peripheral neuropathies typically complain of pain in a stocking distribution. The pain is often burning and may be sharp or lancinating. Often, the pain is worse in a recumbent position and is somewhat better with weight bearing. There may be associated allodynia, thus leading to avoidance-type behavior. Patients often have severe interruption of sleep, because the pain typically is worse at nighttime. As with all neuropathic pain syndromes, other aspects of the patient's life can be affected in a cascade in the breakdown of affect, social support, and self-esteem. Halle-Caffee (2000) reported the findings of a series of 58 operations on 36 patients who received decompression of the posterior tibial nerve for the treatment of DN. Pre-operative symptoms included lack of sensation, pain, or both. Eleven of the 36 patients had neurotrophic ulcers, which were treated simultaneously. The operation was found to be effective for relief of pain in 24 of the 28 patients with that complaint (86%). Restoration of sensation was less consistent with improvement noted in 18 of the 36 patients (50%). The mean follow-up period was 32 months with a range of 12 to 84 months, and 5 patients had some degree of recurrent symptoms. No patient has developed a new ulcer after nerve decompression. Wound complications were minimal (12%), even though ulcers were treated simultaneously. No patient required surgical treatment for the decompression incision, although 1

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subject was hospitalized for treatment of a wound infection. The author stated that the procedure appeared to be a worthwhile treatment, which should be considered for selected diabetics with symptomatic neuropathy. Wood and Wood (2003) presented the short-term results of 33 lower extremities treated with external neurolysis of the common peroneal, deep peroneal, and tarsal tunnel nerves. Mean follow-up was 3 months with a range of 1 to 6 months. The surgery was performed in an attempt to relieve pain, and to restore normal sensation in the foot. All procedures were performed under spinal or general anesthesia. Subjects for the procedure were type 1 or type 2 diabetics with symptomatic somatosensory neuropathy (e.g., pain, burning, tingling, and/or numbness) and preoperative computer-assisted neurosensory testing that confirmed the presence of elevated nerve threshold levels and axonal degeneration in the foot and leg. External neurolysis of the involved nerves provided good to excellent results in 90.0% of those patients with pre-operative neuropathic pain, and restored sensation at good to excellent levels in 66.7 % of those patients with pre-operative neuropathic numbness. The mean visual analog score (VAS) for pain assessment was 9.0 pre-operatively and 3.2 post-operatively for those patients with pain as a symptomatic complaint (n = 30). There were 4 complications (12 %) and all were early cases consisting of a non-infected wound dehiscence of the tarsal tunnel incision, which went on to heal without consequence. These initial short-term results suggested that external neurolysis of the common peroneal, deep peroneal, and tarsal tunnel nerves in selected patients with symptomatic DN and an overlying compression neuropathy as determined by using computer-assisted neurosensory testing appears to be an effective treatment for providing pain relief and restoration of sensation in the foot. Aszmann, et al (2004) studied the impact of surgical decompression on the development of ulcers and amputations in both the operated and the contralateral, non-operated limb in a retrospective analysis of 50 patients with diabetes a mean of 4.5 years (range of 2 to 7 years) from the date of surgery. No ulcers or amputations occurred in the index limb of these patients. In contrast, there were 12 ulcers and 3 amputations in 15 different patients in contralateral limbs (p < 0.001). The authors concluded that decompression of lower extremity nerves in DN changes the natural history of this disease, representing a paradigm shift in health care costs. In a prospective study, Valdivia and associates (2005) reported the findings of 100 consecutive patients (60 with diabetes and 40 with idiopathic neuropathy) operated on by 2 surgeons; with the post-operative results reviewed by someone other than these two surgeons. Each patient had neurolysis of the peroneal nerve at the knee and the dorsum of the foot, and the tibial nerve released in the four medial ankle tunnels. After at least 1 year of follow-up, 87% of patients with pre-operative numbness reported improved sensation, 92% with pre-operative balance problems reported improved balance, and 86% whose pain level was 5 or greater on VAS from 0 (no pain) to 10 (the most severe pain) before surgery reported an improvement in pain. These researchers concluded that decompression of compressed lower extremity nerves improves sensation and decreases pain, and should be recommended for patients with DN who have failed to improve with traditional medical treatment. Studies have been reported stating that surgical decompression of lower extremity peripheral nerves in patients with DN can relieve pain, restore sensation, and prevent ulceration and amputation. However, this literature consists of uncontrolled

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studies, case series, case reports, or expert opinion. Biddinger and Amend (2004) stated that while some studies reported decreased pain, others showed improved sensory function. These investigators noted that the role of surgical decompression for treating DN remains controversial. The performance of decompressive surgery in an attempt to alleviate chronic, neuropathic pain has yielded equivocal results. The use of surgical decompression of multiple peripheral nerves as an alternative approach to treatment of painful diabetic neuropathy is a contentious issue that cannot be supported. In June 2006, Chaudhry et al published The American Academy of Neurology (AAN)’s practice advisory on the “Utility Of Surgical Decompression For Treatment Of Diabetic Neuropathy”. They concluded that: “The current evidence supporting the utility of decompressive surgery for the treatment of diabetic neuropathy is of poor quality and design. Although purported as a potential alternate therapy for this progressive and often debilitating condition, the data are insufficient to support or refute its benefits……There are inadequate data concerning the efficacy of decompressive surgery for the treatment of diabetic neuropathy. Given our current knowledge, this treatment is unproven…Randomized controlled trials with standard definitions of peripheral neuropathy, control for concurrent treatments, and validated functional outcome measures with independent, blinded evaluations should be performed.”

Review History May May May May May May May May May

2007 2008 2010 2011 2012 2013 2014 2015 2016

Medical Advisory Council Initial Approval Update – no revisions Update – no revisions Update – no revisions. Added Medicare table. Code Updates. Update – no revisions Update – no revisions. Code updates Update – no revisions. Code updates Update – no revisions. Code updates. Update – no revisions. Code updates

This policy is based on the following evidence-based guidelines: 1.

2. 3.

Chaudhry V, Stevens JC, Kincaid J, So YT. Practice advisory: Utility of surgical decompression for treatment of diabetic neuropathy. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2006;66(12):1805-1808. Argoff CE, Backonja MM, Belgrade MJ, et al. Consensus guidelines: Treatment planning and options. Diabetic peripheral neuropathic pain. Mayo Clin Proc. 2006;81(4 Suppl):S12-S25. Bril V, England J, Franklin GM, et al. Evidence-based Guideline: Treatment of Painful Diabetic Neuropathy Report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. PM R. 2011 Apr;3(4):345-352.e21. Available at: http://www.neurology.org/content/early/2011/04/08/WNL.0b013e3182166ebe.f ull.pdf

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References – Update May 2016 1.

Nickerson DS. Rationale, Science, and Economics of Surgical Nerve Decompression for Diabetic Neuropathy Foot Complications. Clin Podiatr Med Surg. 2016 Apr;33(2):267-82. doi: 10.1016/j.cpm.2015.12.004. Epub 2016 Jan 30.

References – Update May 2015 1. 2. 3.

Clinicaltrials.gov. Surgical Decompression for Diabetic Neuropathy in the Foot. ClinicalTrials.gov Identifier: NCT01006915. April 2013. Clinicaltrials.gov. Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow After Nerve Decompression in Diabetic Neuropathy Patients (OMNIFICENT). ClinicalTrials.gov Identifier:NCT01735903. November 2012. Clinicaltrials.gov. Study on the Role of Decompression of Lower Extremity Nerves for the Treatment of Patients With Symptomatic Diabetic Neuropathy With Chronic Nerve Compression. ClinicalTrials.gov Identifier: NCT00703209. August 2011.

References – Update May 2014 1.

Feldman EL, McCulloch DK. Treatment of diabetic neuropathy. UpToDate. January 14, 2014. Updated January 15, 2015. Updated December 10, 2015.

References – Update May 2013 1.

Zhang W, Li S, Zheng X. Evaluation of the clinical efficacy of multiple lower extremity nerve decompression in diabetic peripheral neuropathy. J Neurol Surg A Cent Eur Neurosurg. 2013 Mar;74(2):96-100.

References – Update May 2012 1. 2. 3. 4.

Ducic I, Felder JM 3rd, Iorio ML. The role of peripheral nerve surgery in diabetic limb salvage. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:259S-269S. Knobloch K, Gohritz G, Vogt PM. Surgical decompression of the lower leg in painful diabetic polyneuropathy. Oper Orthop Traumatol. 2012 Feb;24(1):74-9. German. Pinzur MS. Diabetic peripheral neuropathy. Foot Ankle Clin. 2011 Jun;16(2):345-9. Ziegler D. Current concepts in the management of diabetic polyneuropathy. Curr Diabetes Rev. 2011 May;7(3):208-20.

References – Update May 2011 1. 2. 3.

Ducic I, Felder JM 3rd, Iorio ML. The role of peripheral nerve surgery in diabetic limb salvage. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:259S-269S Thomsen NO, Rosén I, Dahlin LB. Neurophysiologic recovery after carpal tunnel release in diabetic patients. Clin Neurophysiol. 2010 Sep;121(9):1569-73. Thomsen NO, Cederlund R, Rosén I, et al. Clinical outcomes of surgical release among diabetic patients with carpal tunnel syndrome: prospective follow-up with matched controls. Hand Surg Am. 2009 Sep;34(7):1177-87.

References – Update May 2010 1. 2.

Centers for Medicare and Medicaid Services. LCD for Surgical Decompression for Peripheral Polyneuropathy. (L25271) Centers for Medicare and Medicaid Services. LCD for Surgical Decompression for Peripheral Polyneuropathy. (L25271)

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3. 4. 5. 6. 7. 8.

Centers for Medicare and Medicaid Services. LCD for Surgical Decompression for Peripheral Polyneuropathy (L27594). Available at: Chaudhry V, Russell J, Belzberg A. Decompressive surgery of lower limbs for symmetrical diabetic peripheral neuropathy. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006152 Dellon AL. The Dellon approach to neurolysis in the neuropathy patient with chronic nerve compression. Handchir Mikrochir Plast Chir. 2008 Dec;40(6):35160. Hruby S, Dellon L, Ebmer J, et al. Sensory recovery after decompression of the distal pudendal nerve: anatomical review and quantitative neurosensory data of a prospective clinical study. Microsurgery. 2009;29(4):270-4. Karagoz H, Yuksel F, Ulkur E, Celikoz B. Early and late results of nerve decompression procedures in diabetic neuropathy: a series from Turkiye. J Reconstr Microsurg. 2008 Feb;24(2):95-101 Nickerson DS. Low recurrence rate of diabetic foot ulcer after nerve decompression. J Am Podiatr Med Assoc. 2010 Mar-Apr;100(2):111-5.

References – Update May 2008 1. 2.

3. 4. 5.

Dellon AL. Neurosurgical prevention of ulceration and amputation by decompression of lower extremity peripheral nerves in diabetic neuropathy: update 2006. Acta Neurochir Suppl. 2007;100:149-51. Nelson SC, Little ER Jr. The 36-item Short-Form Health Survey outcome evaluation for multiple lower-extremity nerve decompressions in diabetic peripheral neuropathy: a pilot study. J Am Podiatr Med Assoc. 2007 MarApr;97(2):121-5. Siemionow M, Alghoul M, Molski M, Agaoglu G. Clinical outcome of peripheral nerve decompression in diabetic and nondiabetic peripheral neuropathy. Ann Plast Surg. 2006 Oct;57(4):385-90. Centers for Medicare and Medicaid Services. National Government Services. LCD for Surgical Decompression for Peripheral Polyneuropathy. Centers for Medicare and Medicaid Services. First Coast Service Options, Inc. LCD for Surgical Decompression for Peripheral Polyneuropathy.

References 1. 2. 3. 4. 5. 6. 7.

Bansal V, Kalita J, Misra UK. Diabetic neuropathy. Postgrad Med J. 2006;82(964):95-100. eMedicine. Quan D, Soliman E. Diabetic Neuropathy. September 28, 2006. Available at: http://www.emedicine.com/neuro/topic88.htm Baravarian B. Surgical decompression for painful diabetic peripheral nerve compression and neuropathy: a comprehensive approach to a potential surgical problem. Clin Podiatr Med Surg. 2006 Jul;23(3):621-35. Rader AJ. Surgical decompression in lower-extremity diabetic peripheral neuropathy. J Am Podiatr Med Assoc. 2005 Sep-Oct;95(5):446-50. Valdivia JM, Dellon AL, Weinand ME, Maloney CT Jr. Surgical treatment of peripheral neuropathy: Outcomes from 100 consecutive decompressions. J Am Podiatr Med Assoc. 2005;95(5):451-454. Boulton AJ, Vinik AI, Arezzo JC, et al. Diabetic neuropathies: A statement by the American Diabetes Association. Diabetes Care. 2005;28(4):956-962. Aszmann O, Tassler PL, Dellon AL. Changing the natural history of diabetic neuropathy: Incidence of ulcer/amputation in the contralateral limb of patients with a unilateral nerve decompression procedure. Ann Plast Surg. 2004;53(6):517-522.

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8.

Dellon AL. Diabetic neuropathy: review of a surgical approach to restore sensation, relieve pain, and prevent ulceration and amputation. Foot Ankle Int. 2004 Oct;25(10):749-55. 9. Biddinger KR, Amend KJ. The role of surgical decompression for diabetic neuropathy. Foot Ankle Clin. 2004;9(2):239-254. 10. Wood WA, Wood MA. Decompression of peripheral nerves for diabetic neuropathy in the lower extremity. J Foot Ankle Surg. 2003;42(5):268-275 Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. states, prior notice or website posting is required before an amendment is deemed effective.

In some

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other relevant terms and conditions of coverage. In the event the Member’s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member’s contract shall govern. The Policies do not replace or amend the Member’s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. “Reconstructive surgery” means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean “cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation.

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