Read National Medical Policy text version

Posted: January 20, 2010

National Medical Policy

Subject: Policy Number: Sclerotherapy for Vocal Cord Paralysis NMP312

Effective Date*: January 2007 Updated: January 2008, January 2010

This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document

Current Policy Statement (January 2010 - A Medline search failed to reveal any studies that would cause Health Net, Inc. to change its current position)

Health Net, Inc. considers the use of sclerotherapy for the treatment of vocal cord paralysis investigational or unproven due to lack of sufficient evidence in the published peer review literature regarding its long-term safety and efficacy.

Codes Related To This Policy ICD-9 Codes

438.10 438.19 464.00 464.01 464.20 464.21 465.0 784.40 784.49 784.5 V41.4 478.31 478.32 Acute laryngitis

Late effects of cerebrovascular disease, speech and language deficits

Acute laryngotracheitis Acute laryngopharyngitis Voice disturbance Other speech disturbance Problems with voice production Paralysis of vocal cords or larynx, unilateral, partial Paralysis of vocal cords or larynx, unilateral, complete

CPT Codes

31513

Laryngoscopy, indirect; diagnostic with vocal cord injection

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Posted: January 20, 2010 31571 31570 31599 Laryngoscopy, direct, with injection into vocal cord(s) therapeutic with operating microscope or Laryngoscopy, direct, with injection into vocal cord(s) therapeutic telescope Unlisted procedure, larynx

HCPCS Codes

N/A

Scientific Rationale Update January 2010

Review of medical literature failed to reveal available peer reviewed, evidence based medical literature studies of randomized controlled trials of sclerotherapy used to treat vocal cord paralysis. Injections of bulking agents seem to be appropriate for individuals with unilateral vocal cord paralysis using agents that are cleared by the U.S. Food and Drug Administration (FDA) for this indication. This procedure has been shown to improve vocal quality and prevent recurrent aspiration pneumonia in individuals with unilateral vocal cord paralysis. However, despite the increasing popularity and availability of permanent injection materials, laryngeal framework surgery remains the criterion standard for long-term treatment of unilateral vocal fold paralysis (UVFP). The most common implant used is a silastic block that is either sized from a variety of prefabricated implants or custom carved to address the 3-dimensional nature of the patient's unilateral vocal fold paralysis (UVFP). Gore-Tex is another thyroplasty implant option and has been long regarded as a safe, well-tolerated implant in other parts of the body. Gore-Tex has dramatically increased in popularity in recent years because of its ability to be finely adjusted easily during surgery. More advanced and recent techniques for surgical treatment of unilateral vocal fold paralysis (UVFP) using laryngeal framework surgery have involved manipulation of the arytenoid cartilage, namely arytenoid adduction. Surgical treatment of the arytenoid cartilage for unilateral vocal fold paralysis (UVFP) is important to restore optimal length/tension of the paralyzed vocal fold and to medialize the posterior glottis. The latter has become an indication for patients with severe dysphagia, especially those patients who have been identified to have aspiration pneumonia due to incompetence of the posterior glottis. These operations are more technically challenging than a medialization laryngoplasty and are not required for every patient with unilateral vocal fold paralysis (UVFP); however, combined surgical treatment of unilateral vocal fold paralysis (UVFP) with both an adduction procedure involving the arytenoid cartilage and medialization laryngoplasty has been found to yield maximal vocal rehabilitation by many leading surgeons. This is a reasonable conclusion because medialization laryngoplasty addresses the position and bulk of the membranous vocal fold while operations on the arytenoid address tension and length of the paralyzed vocal fold. Addressing all of the distinct and important features of the paralyzed vocal fold yields the best surgical result for this condition. Complications of surgical treatment for unilateral vocal fold paralysis (UVFP) include poor voice outcome, airway difficulties, and migration of the medialization implant. Given that surgical treatment for unilateral vocal fold paralysis (UVFP) involves manipulation of the airway, factors such as swelling or a hematoma from either

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Posted: January 20, 2010 laryngeal framework surgery or vocal fold injection can cause airway difficulties. Prevention of this complication involves meticulous and precise surgical technique and the use of preoperative and postoperative steroids. A greater risk exists for airway compromise and difficulties when a bilateral procedure is performed, such as bilateral medialization laryngoplasty or bilateral vocal fold injection (for unilateral vocal fold paralysis [UVFP] or contralateral vocal fold atrophy).

Vocal cord paralysis is a voice disorder that occurs when one or both of the vocal cords (or vocal folds) do not open or close properly (National Institute of Deafness and Other Communication Disorders (NIDCD, 2006). The vocal cords are two elastic bands of muscle tissue located in the larynx, directly above the trachea. The vocal cords produce voice when air held in the lungs is released and passed through the closed vocal cords, causing them to vibrate. When a person is not speaking, the vocal cords remain apart to allow normal breathing. Paralysis or paresis of the vocal cords could result from abnormal nerve input to the laryngeal muscles, occurring at any age in either males or females. Paralysis is the total interruption of nerve impulses resulting in no movement of the muscle. Paresis refers to partial interruption of nerve impulses resulting in weak or abnormal motion of the laryngeal muscle.

Scientific Rationale Initial

Symptoms of Vocal Cord Paresis or Paralysis

Paresis and or paralysis of the laryngeal muscles result in voice changes and may also result in airway problems, coughing or swallowing difficulties. These symptoms occur because the cord or cords remain open, leaving the airway passage and the lungs unprotected. This could result in food or liquids slipping into the trachea and lungs. The voice changes could result in any of the following: · · · · Hoarseness (croaky or rough voice); Breathy voice (a lot of air with the voice); Additional effort on speaking; Air wasting (excessive air pressure required to produce usual conversational voice); and diplophonia (voice sounds like a "gargle"). Shortness of breath with exertion; Noisy breathing or stridor; Ineffective or poor cough. Choking or coughing when swallowing food, drink, or even saliva; Food sticking in throat.

The airway problems could result in any of the following symptoms: · · · · ·

The swallowing difficulties could be exhibited in any of the following ways:

Nerves Involved in Vocal Cord Paresis or Paralysis

The following nerves are involved in vocal cord paresis or paralysis: 1) Superior laryngeal nerve (SLN), which carries signals to the cricothyroid muscle, located between the cricoid and thyroid cartilages.

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Posted: January 20, 2010 a. Since the cricothyroid muscle adjusts the tension of the vocal fold for high notes during singing, SLN paresis and paralysis result in abnormalities in voice pitch and the inability to sing with smooth change to each higher note. Sometimes, patients with SLN paresis/paralysis may have a normal speaking voice but an abnormal singing voice. 2) The recurrent laryngeal nerve (RLN) carries signals to different voice box muscles responsible for opening vocal folds (as in breathing, coughing), closing vocal folds for vocal fold vibration during voice use, and closing vocal folds during swallowing. a. The recurrent laryngeal nerve goes into the chest cavity and curves back into the neck until it reaches the larynx. Because the nerve is relatively long and takes a "detour" to the voice box, it is at greater risk for injury from quite different causes ­ such as infections and tumors of the brain, neck, chest, or voice box; as well as complications during surgical procedures in the head, neck, or chest regions, that directly injure, stretch, or compress the nerve. Consequently, the recurrent laryngeal nerve is involved in the majority of cases of vocal fold paresis or paralysis.

Unilateral Vocal Cord Paralysis

Unilateral vocal fold paralysis (UVFP) occurs from a dysfunction of the recurrent or vagus nerve innervating the larynx and causes a characteristic hoarseness. This type of injury typically causes the affected vocal cord to rest in the paramedian position (not fully abducted or fully adducted), although the exact position varies. In this position, the glottic airway is not significantly narrowed and airway complaints are rare; however, the opposing vocal cord may not be able to provide adequate glottic closure during speaking. This small remaining glottic gap during phonation results in air escape and a weak and breathy voice. The vocal cord surfaces are not irregular and the voice is not truly hoarse. Effective cough, which requires transient tight glottic closure, cannot be performed. The degree of vocal change depends upon the exact vocal cord position and the degree of opposite vocal cord compensation. Unilateral vocal cord paralysis can be associated with significant aspiration, depending upon the exact cord position, as the paralytic cord is unable to protect half of the glottis from saliva or ingested material, especially liquids. The degree of symptoms (breathy voice, ineffective cough, and dysphagia) varies with the degree of injury (paresis versus complete paralysis), exact position of the paralyzed vocal cord, and the degree of compensation of the opposite vocal cord. Approximately onethird of cases are ultimately diagnosed as idiopathic; several cases of herpes virus infection in association with idiopathic unilateral vocal cord paralysis have been reported.

Causes of Unilateral Vocal Cord Paralysis

Tumor at the base of skull, in the neck (usually thyroid), or in the mediastinum can injure the vagus or recurrent laryngeal nerve; Neck and chest trauma; Laryngeal trauma (as with endotracheal tube intubation); Thoracic aneurysm;

Iatrogenic injury during surgery, particularly with thyroid and parathyroid surgery, carotid endarterectomy, and anterior cervical approaches to the cervical spine for disk surgery;

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Posted: January 20, 2010 Inflammatory disorders of the neck base and mediastinum including radiation-induced fibrosis; Degenerative neural disorders including bulbar palsies (eg, polio), demyelinating disease, vascular syndromes (eg, Wallenberg's syndrome); Lung malignancy, followed by surgically-induced injury.

Bilateral Vocal Cord Paralysis

Bilateral vocal cord paralysis causes very different symptoms as compared with unilateral paralysis. The bilaterally denervated vocal cords typically come to rest in the midline, demonstrating very little abduction ability. Voice is usually good, but respiratory function is compromised. Such patients can present with respiratory distress in the recovery room after bilateral thyroidectomy and may require urgent tracheotomy. Unrecognized respiratory distress without change in voice in a patient with bilateral vocal cord paralysis can result in hypoxia, respiratory arrest, brain anoxia, and death. Intraoperative recurrent laryngeal nerve EMG monitoring during thyroidectomy and other surgeries that risk the recurrent laryngeal or vagus nerve allow a surgeon to assess the functional integrity of the nerve at the end of surgery. This type of monitoring allows the surgeon to defer contralateral surgery if there is a loss of significant EMG activity during evoked stimulation of the dissected nerve on the first side. Bilateral vocal cord paralysis could also occur as a result of neurologic events.

Treatments For Vocal Cord Paralysis

In nerves that are bruised, stretched, but not transected (neurapraxic), function generally returns within six months and almost definitely by one year. Laryngeal EMG can offer prognostic information regarding the likelihood of resumption of function. A recurrent laryngeal nerve that has been transected at surgery or infiltrated with malignancy will not resume function, but voice or speech therapy can be helpful by facilitating the patient's own contralateral cord compensation. If surgery is needed, the goal is generally to change the position of the paralyzed vocal cord to improve the voice. Medialization involves surgery to push the paralyzed vocal fold closer toward the middle. This type of procedure allows the non-paralyzed cord to make better contact with the paralyzed cord, thus improving the voice. Surgery involves adding bulk to the paralyzed vocal cord or changing its position. To add bulk, an otolaryngologist injects a substance, commonly collagen, a structural protein; silicone, a synthetic material; and body fat, into the paralyzed cord. The added bulk also reduces the space between the vocal cords. The National Institute for Clinical Excellence (NICE, 2005) issued an Interventional Procedure Guidance overview of collagen injection for vocal cord augmentation. The author's state, "Not many good-quality studies have been carried out on collagen injections into the vocal cord, but NICE considers that there is enough evidence to support use of these injections in people who need short-term relief of problems affecting the vocal cords." Laryngeal framework surgery is considered the gold standard for the long-term treatment of unilateral vocal cord paralysis (UVCP). Studies have concluded that in carefully selected patients, some injection materials may be beneficial for short-term treatment. Long-term clinical studies are needed to assess the safety and efficacy of

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Posted: January 20, 2010 the materials used for injection laryngoplasty. Outcome studies that compare the injection materials are needed. If both left and right nerves are damaged, an immediate tracheotomy may be required to help the patient breathe, followed by definitive surgery at a later date. Reinnervation involves surgery to connect another nerve to the larynx to replace the nerve that was damaged. The National Institute on Deafness and Other Communication Disorders (NIDCD) supports research studies that may help provide new clinical measurements to diagnose vocal cord paralysis. For instance, computer software is being developed that can describe important aspects of the health of a person's larynx by analyzing the sounds it produces. By measuring instabilities in the motion of the vocal cords, the software may allow scientists and treatment clinics to relate these measurements to the study of the misuse of the voice and help diagnose disorders such as muscle paralysis and tissue loss. Recent studies show that another feasible approach to laryngeal rehabilitation may be using an electrical stimulation device to activate the reflexes of the paralyzed muscles that open the airway during breathing.

Sclerotherapy

Sclerotherapy is a procedure used primarily to eliminate varicose veins and "spider veins." This procedure involves an injection of a solution (generally sodium chloride known as Heparsol or Sotradecol) directly into the vein. The solution irritates the lining of the blood vessel, causing it to swell, stick together, and the blood to clot. The vessel eventually turns into scar tissue. Sclerotherapy is also one of the methods used to destroy internal hemorrhoids by removing or causing sloughing of excess hemorrhoidal tissue. In addition, esophageal varices and gastric varices in direct continuity with esophageal varices are treatable by endoscopic sclerotherapy. Review of medical literature failed to reveal available peer reviewed medical literature studies of randomized trials of sclerotherapy used to treat vocal cord paralysis. Randomized controlled trials are needed that compare this therapy to the current more conventional treatment now being used, such as laryngeal fat injections or other bulking agents, including collagen, gelfoam or surgery when required. There is a lack of data regarding the functional results of sclerotherapy on vocal cord paralysis. Long term outcomes data regarding its safety and effectiveness has not been validated. There is a need for high quality, randomized controlled trials with large patient samples and data on long term effects. In summary, due to lack of sufficient evidence in the published peer review literature regarding the long term safety and efficacy of sclerotherapy for vocal cord paralysis, it is at this time considered investigational.

Review History

January 2007 January 2008 January 2010

Medical Advisory Council initial approval Update. No revisions. Codes reviewed. Update. No revisions. Codes reviewed.

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Posted: January 20, 2010

English 1. National Institute on Deafness and Other Communication Disorders (NIDCD). Vocal cord paralysis. Updated 2006 March 18. Available at: http://www.nidcd.nih.gov/health/voice/vocalparal.asp 2. American Academy of Otolaryngology. 2004 Fact Sheet on Vocal Cord Paralysis. Available at: 3. http://www.entnet.org/healthinfo/throat/Vocal-Cord-Paralysis.cfm Spanish 1. National Institute on Deafness and Other Communication Disorders. Cuidando su voz. Acesso en: http://www.nidcd.nih.gov/health/spanish/takingcare_span.asp 2. University Health Care. Otorrinolaringologia Enfermedades del Oido, Los Desordenes de las Cuerdas Vocales. Acesso en: 3. http://uuhsc.utah.edu/healthinfo/spanish/ent/vocal.htm

Patient Education Websites

1. National Institute for Clinical Excellence (NICE) Collagen injection for vocal cord augmentation. Interventional procedural consultation document. March 2005. http://www.nice.org.uk/page.aspx?o=244152 2. American Academy of Otolaryngology Head and Neck Surgery. Fact sheet: vocal cord paralysis. 2004. Available at: http://www.entnet.org/healthinfo/throat/Vocal-Cord-Paralysis.cfm 3. Medicare Coverage Issues Manual Transmittal 122, Feb 2000, HCFA Publ 6, 3573: http://www.cms.hhs.gov/mcd/viewarticle.asp?article_id=23776&article_version= 5&basket=article%3A23776%3A5%3ASclerotherapy+for+Varicose+Veins+of+th e+Lower+Extremities+With+or+Without+Doppler%2FDuplex+Guidance%3ACarr ier%3AHealthNow+++%2800801%29 4. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES): The role of endoscopic sclerotherapy. http://www.sages.org/sg_asgepub1019.html

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

1.

References Update January 2010

2.

Benjamin JR, Goldberg RN, Malcolm WF. Neonatal Vocal Cord Paralysis. NeoReviews Vol.10 No.10 2009, American Academy of Pediatrics. Carroll TL, Rosen CA. Vocal Fold Paralysis, Unilateral. Medscape, eMedicine. November 6, 2008.

1. 2. 3. 4. 5.

References ­ Initial

Rakel: Conn's Current Therapy 2006, 58th ed. Sclerotherapy Treatment. Sanyal S. Sclerotherapy. Prevention of recurrent variceal hemorrhage in patients with cirrhosis. September 2006. Sasai H, Watanabe Y, Muta H, et al. Long-term histological outcomes of injected autologous fat into human vocal folds after secondary laryngectomy. Otolaryngol Head Neck Surg. 2005 May; 132(5): 685-8. Umeno H, Shirouzu H, Chitose S, et al. Analysis of voice function following autologous fat injection for vocal fold paralysis. Otolaryngol Head Neck Surg. 2005 Jan;132(1):103-7. Cummings CW. Otolaryngology: Head & Neck Surgery, 4th ed.,2005. Vocal Cord paralysis.

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Posted: January 20, 2010 6. 7. 8. 9. 10. 11. Sadick N. Advances in the Treatment of Varicose Veins: Ambulatory Phlebectomy, Foam Sclerotherapy, Endovascular Laser, and Radiofrequency Closure. Dermatol Clin 23 (2005) 443 ­ 455. Rosen, CA. Vocal cord paralysis, unilateral. 2006 June 16. Hartl DM, Travagli JP, Leboulleux S. et al. Current concepts in the management of unilateral recurrent laryngeal nerve paralysis after thyroid surgery. J Clin Endocrinol Metab. 2005 May;90(5):3084-8. Zapanta PE, Bielamowicz SA. Laryngeal abscess after injection laryngoplasty with micronized AlloDerm. Laryngoscope. 2004 Sep;114(9):1522-4. Lorenz RR, Netterville JL, Burkey BB. Vocal Cord Paralysis. Sabiston Textbook of Surgery. The Biological Basis of Modern Surgical Practice. 17th ed. St Louis, MO. W.B. Saunders; 2004. Ch 31. U.S. Food and Drug Administration (FDA). Center for devices and radiological health (CDRH). Hylaform (hylan B gel). Summary of safety and effectiveness. Updated May 10, 2004. Available at: http://www.fda.gov/cdrh/PDF3/P030032.html Kwon TK, Buckmire R. Injection laryngoplasty for management of unilateral vocal fold paralysis. Curr Opin Otolaryngol Head Neck Surg. 2004 Dec;12(6):538-42. Unusual cases and review of the literature. J Voice. 2004 Sep;18(3):392-7. Belafsky PC, Postma GN. Vocal fold augmentation with calcium hydroxylapatite. Otolaryngol Head Neck Surg. 2004 Oct;131(4):351-4. Zealear DL, Billante CR. Neurophysiology of vocal fold paralysis. Otolaryngol Clin North Am. 2004 Feb;37(1):1-23. Courey MS. Injection laryngoplasty. Otolaryngol Clin North Am. 2004 Feb;37(1):121-38. Anderson TD, Sataloff RT. Complications of collagen injection of the vocal fold: report of several unusual cases and review of the literature. J Voice. 2004 Sep;18(3):392-7. Rosen CA, Thekdi AA. Vocal fold augmentation with injectable calcium hydroxylapatite: short-term results. J Voice. 2004 Sep;18(3):387-91. Miller S. Voice therapy for vocal fold paralysis. Otolaryngol Clin North Am. 2004;37(1):105-119. Parsons M. Sclerotherapy Basics. Dermatol Clin 22 (2004) 501­508. Karpenko AN, Dworkin JP, Meleca RJ. et al. Cymetra injection for unilateral vocal fold paralysis. Ann Otol Rhinol Laryngol. 2003;112(11):927-934. Lowe DA, Hoare TJ. Surgery for vocal cord paralysis and paresis. Protocol for Cochrane Review. 2003;(2):CD004164. Pearl AW, Woo P, Ostrowski R, et al. A preliminary report on micronized AlloDerm injection laryngoplasty. Laryngoscope. 2002 Jun;112(6):990-6. Ramelett AA. Sclerotherapy, old- or new-fashioned. J Cosmet Dermatol 2002;1:113­ 4. Yousem DM, Tufano RP. Laryngeal imaging. Magn Reson Imaging Clin North Am 2002; 10:451. Sclafani AP, Romo T 3rd, Jacono AA, et al. Evaluation of acellular dermal graft in sheet (AlloDerm) and injectable (micronized AlloDerm) forms for soft tissue augmentation. Clinical observations and histological analysis. Arch Facial Plast Surg. 2000 Apr-Jun;2(2):130-6. Barnstetter BF, Weissman JL. Normal anatomy of the neck with CT and MR imaging correlation. Radiol Clin N Am 2000; 38:925. Kamholz, J, Menichella, D, Jani, A, et al. Charcot-Marie-Tooth disease type 1: molecular pathogenesis to gene therapy. Brain 2000; 123 ( Pt 2):222.

12.

13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25.

26. 27.

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Posted: January 20, 2010 28. Mersiyanova IV, Ismailov SM, Polyakov AV, et al. Screening for mutations in the peripheral myelin genes PMP22, MPZ and Cx32 (GJB1) in Russian CharcotMarie-Tooth neuropathy patients. Hum Mutat 2000; 15:340. 29. Laccourreye O, Paczona R, Ageel M. et al. Intracordal autologous fat injection for aspiration after recurrent laryngeal nerve paralysis. Eur Arch Otorhinolaryngol. 1999;256(9):458-61.

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, new or revised policies require prior notice or posting on the website 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, new or revised policies require prior notice or website posting 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. 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. 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. Coverage decisions are the result of the terms and conditions of the

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Posted: January 20, 2010

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