National Medical Policy

National Medical Policy Subject: Policy Number: Oxygen Therapy for Treatment of Cluster Headaches NMP14 Effective Date*: January 2004 Updated: August 2015 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 Medicaid Manuals for coverage 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 Source Reference/Website Link X National Coverage Determination (NCD) Home Oxygen Use to Treat Cluster Headache (CH) (240.2.2) http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx X National Coverage Manual Citation Local Coverage Determination (LCD)* Oxygen and Oxygen Equipment: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx X Article (Local)* Oxygen and Oxygen Equipment: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx X Other Decision Memo for Home Use of Oxygen to Treat Cluster Headache: https://www.cms.gov/medicare-coveragedatabase/details/nca-proposed-decisionmemo.aspx?ncaid=244&ver=15&ncaname=ho me+use+of+oxygen+to+treat+cluster+heada che&bc=beaaaaaaiaaa& Oxygen Therapy for Treatment of Cluster Headaches Aug 15 1

MLN Matters Number: MM7235.Revised Related Change Request (CR) #: 7235 January 14, 2011. Home Oxygen Use to Treat Cluster Headache (CH): http://www.cms.gov/outreach-and- Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/MM7235.pdf MLN Matters Number: MM7820. Related Change Request (CR) #: CR 7820. May 11, 2012. Assigned Codes for Home Oxygen Use for Cluster Headache (CH) in a Clinical Trial (ICD- 10): http://www.cms.gov/outreach-and- Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/MM7820.pdf None 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) 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 oxygen medically necessary for treatment of acute onset of a cluster headache. The inhalation of 100% oxygen, via a tight-fitting mask at a flow rate of 8-10 Liters per minute, for 10-15 minutes at the beginning of a cluster headache is effective in 80% of patients; oxygen is particularly effective for nocturnal attacks. Oxygen inhalations may be repeated up to five times per day. 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 will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this Oxygen Therapy for Treatment of Cluster Headaches Aug 15 2

transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes 339.00-339.02 Episodic cluster headache 346.2 Cluster headache ICD-10 Codes G44.001- G44.009 Cluster headache syndrome, unspecified G44.011- G44.019 Episodic cluster headache CPT Codes N/A HCPCS Codes A4616 Tubing (oxygen), per foot E0424 Stationary compressed gaseous oxygen system, rental; includes container, contents, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing. E0425 Stationary compressed gaseous oxygen system, purchase; includes container, contents, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing. E0430 Portable gaseous oxygen system, purchase; includes container, contents, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing. E0431 Portable gaseous oxygen system, rental; includes container, contents, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing. E0434 Portable liquid oxygen system, rental; includes portable container, supply reservoir, flowmeter, refill adaptor, contents gauge, cannula or mask, and tubing. E0435 Portable liquid oxygen system, purchase; includes portable container, supply reservoir, flowmeter, refill adaptor, contents gauge, cannula or mask, and tubing. E0439 Stationary liquid oxygen system, rental; includes container, contents, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing. E0440 Stationary liquid oxygen system, purchase; includes use of reservoir, contents indicator, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing. E0441 Stationary oxygen contents, gaseous, 1 month s supply = 1 unit E0442 Stationary oxygen contents, liquid, 1 month s supply = 1 unit E0443 Portable oxygen contents, gaseous, 1 month s supply = 1 unit E0444 Portable contents, liquid, 1 month s supply = 1 unit E1353 Regulator E1390 Oxygen concentrator, single delivery port, capable of delivering 85 percent or greater oxygen concentration at the prescribed flow rate Oxygen Therapy for Treatment of Cluster Headaches Aug 15 3

E1391 Oxygen concentrator, dual delivery port, capable of delivering 85 percent or greater oxygen concentration at the prescribed flow rate, each E1399 Durable medical equipment, miscellaneous Scientific Rationale Update August 2015 Petersen et al (2014) reviewed the existing literature to document oxygen's therapeutic effect on cluster headache. A PubMed search resulted in total 11 relevant studies. Six studies investigated the efficacy of oxygen treatment. One study was observational and the remaining five were RCTs. Another five studies were on hyperbaric oxygen treatment thereof two case studies. The reviewers reported oxygen therapy can be administered at different flow rates. Three studies investigate the effect of low-flow oxygen, 6-7l/min, and found a positive response in 56%, 75% and 82%, respectively, of the patients. One study investigated high-flow oxygen, 12l/min, and found efficacy in 78% of attacks. The effect of hyperbaric oxygen therapy has been investigated in a few small studies and there is evidence only for an acute, but not a prophylactic effect. The reviewers concluded, despite the fact that only a few high-quality RCT studies are available, oxygen treatment is close to an ideal treatment because it is effective and safe. However, sufferers of cluster headache do not always have access to oxygen because of logistic and financial concerns. Scientific Rationale Update February 2011 On January 4, 2011, the Centers for Medicaid and Medicare (CMS) issued a Decision Memo regarding the Home Use of Oxygen to Treat Cluster Headaches (CH). CMS determined the evidence does not demonstrate that the home use of oxygen to treat cluster headache improves health outcomes in Medicare beneficiaries with cluster headache. They noted, however, available evidence suggests that the home use of Oxygen to treat CH is promising and supports further research under 1862(a)(1) (E) of the Act through the Coverage with Study Participation (CSP) form of Coverage with Evidence Development (CED). The home use of Oxygen to treat CH is covered by Medicare only for beneficiaries with CH participating in an approved prospective clinical study comparing normobaric 100% OXYGEN (NBOT) with at least one clinically appropriate comparator for the treatment of CH. The clinical study must address one or more aspects of the following questions: 1. Prospectively, compared to individuals with cluster headache who do not receive NBOT, do Medicare beneficiaries with CH who receive NBOT have improved outcomes as indicated by: Pain relief Time to pain relief Durability of pain relief 2. Prospectively, among Medicare beneficiaries with cluster headache, which method of OXYGEN delivery provides the most benefit as indicated by: Pain relief Time to pain relief Durability of pain relief Oxygen Therapy for Treatment of Cluster Headaches Aug 15 4

3. Prospectively, among Medicare beneficiaries with cluster headache, what other factors, if any, predict the patient s response to 100% OXYGEN therapy as indicated by: Pain relief Time to pain relief Durability of pain relief Per CMS, Only those beneficiaries diagnosed with the condition of cluster headache are eligible for participation in a clinical study. CMS adopts the diagnostic criteria used by the International Headache Society to form a definitive diagnosis of CH. Therefore, the home use of OXYGEN to treat CH is covered by Medicare only when furnished to Medicare beneficiaries who have had at least five severe to very severe unilateral headache attacks lasting 15-180 minutes when untreated. The headaches must be accompanied by at least one of the following findings: Ipsilateral conjunctival injection and/or lacrimation; or Ipsilateral nasal congestion and/or rhinorrhea; or Ipsilateral eyelid edema; or Ipsilateral forehead and facial sweating; or Ipsilateral miosis and/or ptosis; or A sense of restlessness or agitation. The clinical study must adhere to the standards of scientific integrity and relevance to the Medicare population which are noted in the memo. Scientific Rationale Update November 2010 Medicare currently has a NCD for Home Use of Oxygen (240.2) that provides for coverage of home oxygen under specific conditions when the patient has significant chronic stable hypoxemia. The NCD does not address the home use of oxygen for the treatment of cluster headache. Formal and informal requestors have approached CMS and have asked them to review the evidence and reconsider the NCD to provide national coverage for the home use of oxygen to treat cluster headache. This review has been accepted and was initiated in April 2010. The expected completion date is January 2011. Cohen et al (2009) investigated whether high-flow inhaled oxygen was superior to placebo in the acute treatment of cluster headache in a double-blind, randomized, placebo-controlled crossover trial of 109 adults (aged 18-70 years) with cluster headache as defined by the International Headache Society. Patients treated 4 headache episodes with high-flow inhaled oxygen or placebo, alternately. Patients were randomized to the order in which they received the active treatment or placebo. Inhaled oxygen at 100%, 12 L/min, delivered by face mask, for 15 minutes at the start of an attack of cluster headache or high-flow air placebo delivered alternately for 4 attacks. The primary end point was to render the patient pain free, or in the absence of a diary to have adequate relief, at 15 minutes. Secondary end points included rendering the patient pain free at 30 minutes, reduction in pain up to 60 minutes, need for rescue medication 15 minutes after treatment, overall response to the treatment and overall functional disability, and effect on associated symptoms. Fifty-seven patients with episodic cluster headache and 19 with chronic cluster headache were available for the analysis. For the primary end point the difference between oxygen, 78% (95% confidence interval, 71%-85% for 150 attacks) and air, 20% (95% confidence interval, 14%-26%; for 148 attacks) was significant (Wald Oxygen Therapy for Treatment of Cluster Headaches Aug 15 5

test, chi(5) (2) = 66.7, P <.001). There were no important adverse events. The investigators concluded treatment of patients with cluster headache at symptom onset using inhaled high-flow oxygen compared with placebo was more likely to result in being pain-free at 15 minutes. Scientific Rationale Initial Cluster headache, also known as migrainous neuralgia, is a well-defined neurovascular syndrome occurring in both episodic and chronic varieties. The more common episodic type is characterized by one to three short-lived attacks of periorbital pain per day over a 4 to 8 week period, followed by a pain-free interval that averages 1 year. The chronic form is characterized by the absence of sustained periods of remission and may begin de novo or several years after an episodic pattern has become established. A characteristic feature in about 85 percent of patients is that attacks of pain tend to recur at the same hour each day for the duration of the cluster bout; many individuals also experience additional attacks that occur randomly throughout the day. In contrast to migraine, during an attack the cluster patient prefers to pace about. The unilateral pain of a cluster headache begins quickly without, reaching a crescendo within 2 to 15 minutes. Attacks last from 30 minutes to 2 hours (mean of 45 minutes) in about 75 percent of cases. Occasionally, attacks may be as short as 10 minutes, whereas others may last as long as several hours. Attacks range in frequency from six per 24 hours to one per week, with a mean of one to two per day Agents used for acute therapy include inhalation of oxygen, sumatriptan (subcutaneous injections), and dihydroergotamine. Transitional care involves the short-term use of either corticosteroids or ergotamine derivatives. First line drug treatment for prophylaxis of the cluster syndrome is verapamil; prednisone, lithium, methysergide, and ergotamine are also useful. Lithium appears to be particularly effective for the chronic form of the disorder. Other drugs that can be considered are corticosteroids, which may induce a remission of frequent, severe attacks. Third line drugs are serotonin inhibitors (methysergide and pizotifen) and valproic acid. For a very limited group of patients with chronic cluster headache, surgery may be a last resort. Surgical options include radiofrequency rhizotomy or microvascular decompression of the trigeminal nerve. Review History January 2004 April 2006 April 2007 November 2010 February 2011 October 2011 September 2011 September 2012 August 2013 August 2014 August 2015 Medical Advisory Council Update no changes Update no changes Update no revisions. Code updates Update Added link to Medicare decision memo that states Oxygen therapy for the treatment of cluster headache would only be covered for Medicare beneficiaries enrolled in a clinical trial. Scientific rationale updated with additional information from the memo. No change to policy for commercial members. Update. Added revised Medicare table. No revisions. Update no revisions Update no revisions Update no revisions. Code updates Update no revisions. Code updates Update no revisions Oxygen Therapy for Treatment of Cluster Headaches Aug 15 6

This policy is based on the following evidence-based guidelines: 1. Biondi D, Mendes P. Treatment of primary headache: cluster headache. In: Standards of care for headache diagnosis and treatment. National Headache Foundation; 2004. p. 59-72. 2. May A, Leone M, Afra J, et al. EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias. Eur J Neurol 2006 Oct; 13(10):1066-77. References Update August 2015 1. Hardinge M, Annandale J, Bourne S, et al. British Thoracic Society guidelines for home oxygen use in adults. Thorax. 2015 Jun;70 Suppl 1:i1-43. 2. Martelletti P. Cluster headache management and beyond. Expert Opin Pharmacother. 2015 Jul;16(10):1411-5. 3. Petersen AS, Barloese MC, Jensen RH. Oxygen treatment of cluster headache: a review. Cephalalgia. 2014 Nov;34(13):1079-87 References Update August 2014 1. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia 2013; 33:629. 2. Morgan A, Jessop V. Best BETs from the Manchester Royal Infirmary. BET 2: should intranasal lidocaine be used in patients with acute cluster headache? Emerg Med J 2013; 30:769. References Update August 2013 1. Becker WJ. Cluster headache: conventional pharmacological management. Headache. 2013 Jul;53(7):1191-6. 2. Haane DY, de Ceuster LM, Geerlings RP, et al. Cluster headache and oxygen: is it possible to predict which patients will be relieved? A prospective crosssectional correlation study. J Neurol. 2013 Jul 14. 3. Lambru G, Matharu M. Management of trigeminal autonomic cephalalgias in children and adolescents. Curr Pain Headache Rep. 2013 Apr;17(4):323. 4. Rozen TD, Fishman RS. Demand valve oxygen: a promising new oxygen delivery system for the acute treatment of cluster headache. Pain Med. 2013 Apr;14(4):455-9. References Update September 2012 1. Bajwa ZH, Sabahat A. Headache syndromes other than migraine. UpToDate. December 3, 2011. 2. Matharu MS, Cohen AS. SUNCT and SUNA headache syndromes: Clinical features and diagnosis. UpToDate. January 26, 2011. References Update October 2011 1. Fontaine D, Lazorthes Y, Mertens P, et al. Safety and efficacy of deep brain stimulation in refractory cluster headache: a randomized placebo-controlled double-blind trial followed by a 1-year open extension. J Headache Pain 2010; 11:23. 2. Francis GJ, Becker WJ, Pringsheim TM. Acute and preventive pharmacologic treatment of cluster headache. Neurology 2010; 75:463. 3. Law S, Derry S, Moore RA. Triptans for acute cluster headache. Cochrane Database Syst Rev 2010. Oxygen Therapy for Treatment of Cluster Headaches Aug 15 7

4. May A. Cluster headache: Acute and preventive treatment. UpToDate. January 14, 2011. Updated January 25, 2012. Updated November 20, 2013. 5. Matharu M, Khan U, McCulloch S, et al. POH05 Efficacy and safety of greater occipital nerve blocks in cluster headache. J Neurol Neurosurg Psychiatry 2010; 81:e52. 6. Prakash S, Shah ND, Chavda BV. Cluster headache responsive to indomethacin: Case reports and a critical review of the literature. Cephalalgia. 2010; 30(8):975. References Update November 2010 1. Backx AP, Haane DY, De Ceuster L, Koehler PJ. Cluster headache and oxygen: is it possible to predict which patients will be relieved? A retrospective crosssectional correlation study. J Neurol. 2010 Sep; 257(9):1533-42. 2. Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009 Dec 9; 302(22):2451-7. 3. Francis GJ, Becker WJ, Pringsheim TM. Acute and preventive pharmacologic treatment of cluster headache. Neurology. 2010 Aug 3;75(5):463-73 4. Halker R, Vargas B, Dodick DW. Cluster headache: diagnosis and treatment. Semin Neurol. 2010 Apr; 30(2):175-85. 5. van Kleef M, Lataster A, Narouze S, et al. Evidence-based interventional pain medicine according to clinical diagnoses. 2. Cluster headache. Pain Pract. 2009 Nov-Dec; 9(6):435-42. References 1. Bigal ME, Rapoport AM, Camel M. Cluster headache as a manifestation of intracranial inflammatory myofibroblastic tumour: a case report with pathophysiological considerations. Cephalalgia. 2003 Mar; 23(2):124-8. 2. Chervin RD, Zallek SN, Lin X, Hall JM, Sharma N, Hedger KM. Sleep disordered breathing in patients with cluster headache. Neurology. 2000 Jun 27; 54(12):2302-6. 3. Di Sabato F, Rocco M, Martelletti P, Giacovazzo M. Hyperbaric oxygen in chronic cluster headaches: influence on serotonergic pathways. Undersea Hyperb Med. 1997 Jun; 24(2):117-22. 4. Dodick DW, Capobianco DJ. Treatment and management of cluster headache. Curr Pain Headache Rep 2001 Feb;5(1):83-91 5. Dodick DW, Capobianco DJ. Treatment and management of cluster headache. Curr Pain Headache Rep. 2001 Feb; 5(1):83-91. 6. Ekbom K, Hardebo JE. Cluster headache: aetiology, diagnosis and management. Drugs 2002;62(1):61-9 7. Fogan L. Treatment of cluster headache. A double-blind comparison of oxygen v air inhalation. Arch Neurol. 1985 Apr; 42(4):362-3. 8. Franzini A, Ferroli P, Leone M, and Broggi G. Stimulation of the posterior hypothalamus for treatment of chronic intractable cluster headaches: first reported series. Neurosurgery. 2003 May; 52(5):1095-9; discussion 1099-101. 9. Green MW. The emergency management of headaches. Neurolog. 2003 Mar; 9(2):93-8. 10. Kudrow L. Response of cluster headache attacks to oxygen inhalation. Headache. 1981 Jan; 21(1):1-4. 11. Leone M, Franzini A, Broggi G, Bussone G. Hypothalamic deep brain stimulation for intractable chronic cluster headache: a 3-year follow-up. Neurol Sci. 2003 May; 24 Suppl 2:S143-5. Oxygen Therapy for Treatment of Cluster Headaches Aug 15 8

12. Levy MJ, Matharu MS, Bhola R, Lightman S, Goadsby PJ. Somatostatin infusion withdrawal: a study of patients with migraine, cluster headache and healthy volunteers. Pain. 2003 Apr; 102(3):235-41. 13. May A, Leone M. Update on cluster headache. Curr Opin Neurol. 2003 Jun; 16(3):333-40. 14. Mayo Clinic, 13400 E Shea Boulevard, Scottsdale, AZ 85259, USA. dodick.dav id@m ayo.edu 15. McGeeney BE. Topiramate in the treatment of cluster headache. Curr Pain Headache Rep. 2003 Apr; 7(2):135-8. 16. Nilsson Remahl AI, Ansjon R, Lind F, Waldenlind E. Hyperbaric oxygen treatment of active cluster headache: a double-blind placebo-controlled crossover study. 17. Riess CM, Becker WJ, Robertson M. Episodic cluster headache in a community: clinical features and treatment. Can J Neurol Sci. 1998 May; 25(2):141-5? 18. Salvesen R. Cluster Headache. Curr Treat Options Neurol 1999 Nov;1(5):441-449 19. Weintraub JR. Cluster headaches and sleep disorders. Curr Pain Headache Rep. 2003 Apr; 7(2):150-6. 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. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Oxygen Therapy for Treatment of Cluster Headaches Aug 15 9

No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and 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. Oxygen Therapy for Treatment of Cluster Headaches Aug 15 10