White Paper: Balloon Sinuplasty for Chronic Sinusitis, The Latest Recommendations For Health Plans, Medical Management Organizations and TPAs Executive Summary Despite recent advances in instrumentation and technology, the management of chronic sinusitis remains challenging for both physicians and patients, especially as treatment guidelines and recommendations continue to evolve. The most commonly performed surgical procedures include functional endoscopic sinus surgery (FESS), which is currently the gold standard for the surgical treatment of inflammatory sinus disorders, and balloon sinuplasty. Balloon sinuplasty was introduced in 2005 as a less invasive alternative to endoscopic sinus surgery for patients who have failed medical management. However, balloon sinuplasty remains controversial and has not yet gained widespread acceptance as a standard of care for the treatment of patients with chronic sinusitis. Although the procedure has been shown to be safe and effective, many health insurance policies do not provide coverage, because they consider balloon sinuplasty to be experimental/investigational for the treatment of chronic sinusitis. An independent review organization (IRO) can provide ready access to specialists, which healthcare plans may lack internally, thereby allowing for the timely determination of whether the requested therapies fall under the medical necessity guidelines. Independent medical reviews facilitate the individualization and optimization of patient care by providing unbiased evaluations of the medical necessity of surgery for chronic sinusitis. Introduction Chronic Sinusitis & Surgical Options According to estimates from the Centers for Disease Control and Prevention (CDC), chronic sinusitis affects about 30 million adults in the United States. Each year, there are more than 12 million ambulatory care visits for chronic sinusitis. Chronic sinusitis may be noninfectious and may be related to allergies, cystic fibrosis, gastroesophageal reflux, or exposure to environmental pollutants. Known risk factors for chronic sinusitis include allergic rhinitis, nonallergic rhinitis, anatomic obstructions in the ostiomeatal complex, and immunological disorders. Medical treatment often involves a combination of topical or oral glucocorticoids, antibiotics, and nasal irrigation. Surgery for chronic sinusitis is usually reserved for patients who have not responded to medical therapy. The goals of surgery are to re-establish sinus ventilation and to correct mucosal opposition in order to restore the mucociliary clearance system and the functional integrity of the inflamed mucosal lining. FESS and balloon sinuplasty (also known as balloon sinus dilation) are two of the most commonly performed surgical procedures. FESS is currently the gold standard for the treatment of inflammatory sinus disorders. For this procedure, a fiber-optic nasal endoscope is used to visualize the sinus passages (the ostia), and any abnormal and obstructive tissues are removed with the use of micro-instruments. Resection of periosteal bone and tissue is often required. In 2005, the endoscopic, catheter-based system known as balloon sinuplasty was introduced as a less invasive alternative to FESS for patients who have failed medical management. The procedure involves placing a guide-wire in the sinus ostium under the direction of endoscopy and fluoroscopy, advancing a balloon dilation catheter over the guide-wire, and inflating the balloon to widen the sinus walls, without any need for sinus tissue removal or bone resection. Although the use of balloon sinuplasty has increased in recent years, the procedure remains controversial and has not yet gained widespread acceptance as a standard of care treatment of patients with chronic sinusitis. www.allmedmd.com AllMed Healthcare Management Inc. 1
Clinical Findings Chronic sinusitis is characterized by purulent nasal discharge, usually without fever, that persists for weeks to months. Symptoms of congestion often accompany the nasal discharge. There may also be mild pain and/or a headache. Thickening of mucosa may restrict or close natural openings between the sinus cavities and the nasal fossae. The location and shape of these sinus ostia vary considerably. Some cases may require surgical drainage with FESS and/or balloon sinuplasty. Patient History Symptoms of chronic sinusitis may be subtle, thereby making the diagnosis easy to miss unless an appropriate history is taken. Symptoms that are commonly associated with chronic sinusitis include: Nasal stuffiness Nasal discharge Postnasal drip Facial fullness, discomfort, and headache Chronic, unproductive cough Hyposmia (decreased sense of smell) Sore throat Fetid breath Malaise Easy fatigability Anorexia Exacerbation of asthma Dental pain Visual disturbances Sneezing Stuffy ears Unpleasant taste Fever of unknown origin The patient s history should focus on the following key factors, beginning with the consideration of major and minor diagnostic criteria: The presence of major symptoms: Purulent anterior nasal drainage, purulent discolored posterior nasal drainage, nasal obstruction or blockage, facial congestion or fullness, facial pain or pressure, and hyposmia or anosmia (the inability to detect odors) The presence of minor symptoms: Headache, ear pain or fullness, halitosis, dental pain, cough, fever, or fatigue Duration of symptoms Exacerbating and relieving factors History of previous nasal or paranasal sinus surgery Current medications Previous treatments and their duration Other confounding health problems: Asthma, allergy, and immunocompromising disorders Active or passive tobacco smoke www.allmedmd.com 2
Physical Examination A physical examination in a patient with chronic sinusitis may reveal various findings. It should include a complete head and neck examination to confirm the diagnosis and to rule out more serious disorders. Sinus palpation is performed to evaluate for tenderness or swelling. Pain or tenderness on palpation of the frontal or maxillary sinuses may be noted. Transillumination of the maxillary or frontal sinuses may be useful; although it lacks sensitivity, it may have value in experienced hands. An oral cavity and oropharynx examination is used to evaluate the integrity of the palate and the condition of dentition and to look for evidence of postnasal drip. Oropharyngeal erythema and purulent secretions may be noted. Dental caries may be present. Anterior rhinoscopy with the use of a nasal speculum is used to evaluate the condition of the nasal mucosa and to look for purulent drainage or evidence of polyps or other nasal masses. Other contributing factors to chronic sinusitis that can be evaluated include nasal septal deviations and turbinate hypertrophy. The nasal examination should be carried out both before and after the use of a topical decongestant. The nasal examination can be supplemented with the use of nasal endoscopy, if it is available. Endoscopic (rhinoscopic) examination findings include the following: Nasal mucosal erythema and edema Purulent secretions Nasal obstruction due to deviated nasal septum or hypertrophied turbinates Nasal polyps An ear examination is indicated for the presence of middle ear fluid, which may be the sign of a mass in the nasopharynx. An ocular examination is indicated to determine spread of disease to the orbit and to evaluate the function of the ocular musculature. A laryngeal examination is used to look for other confounding upper airway pathology, including laryngeal-pharyngeal reflux (LPR). A lung examination is performed to determine if coexisting lower airway disease is present. A cranial nerve examination is performed to look for an underlying sinus malignancy or an underlying neurological disorder. Diagnostic Criteria Symptoms of chronic sinusitis vary in severity and prevalence. According to the evidence-based recommendations of the American Academy of Otolaryngology Head and Neck Surgery (AAOHNS), the presence of two or more of the following signs or symptoms that persist for more than 12 weeks is highly sensitive for diagnosing chronic sinusitis: Anterior or posterior mucopurulent drainage Nasal obstruction Facial pain, pressure, or fullness Decreased sense of smell www.allmedmd.com 3
Symptom-based criteria alone are relatively nonspecific. The AAOHNS guidelines state that the diagnosis of chronic sinusitis requires documentation of inflammation in addition to persistent symptoms. Inflammation must be documented by demonstrating one of the following: Purulent mucus or edema in the middle meatus or ethmoid regions Polyps in the nasal cavity or middle meatus Imaging that shows inflammation of the paranasal sinuses Balloon Sinuplasty vs. FESS Balloon sinuplasty is a minimally invasive dilation procedure. It widens the sinus passages (ostia) to restore normal sinus drainage and function to patients with chronic sinusitis that is associated with inflammatory obstructions of the sinus passages. The procedure was originally envisioned as a less invasive alternative to FESS, which often requires resections of periosteal bone and tissue. However, the use of balloon sinuplasty as a stand-alone procedure remains controversial; some practitioners feel that the procedure does not address the underlying issues of sinusitis. Currently, no randomized studies have compared balloon sinuplasty with FESS. A recent Cochrane review found one unpublished small study, which did not find evidence for using balloon sinuplasty over FESS. However, the existing data gathered from retrospective chart reviews, as well as small, prospective uncontrolled multicenter studies and short-term studies, suggest that balloon sinuplasty, either alone or in combination with conventional surgical treatment, is a viable option for sinus surgery in patients with chronic sinusitis that has been unresponsive to medical management. Studies have demonstrated the procedure s safety and efficacy, along with improved quality of life for patients. Indications The indications for balloon sinpulasty are identical to those for FESS, which include chronic sinusitis that is refractory to medical treatment. Endoscopic surgery is typically reserved for patients with documented rhinosinusitis, based on a thorough history and a complete physical examination, including CT scans if appropriate, and for patients in whom appropriate medical treatment has failed. Balloon sinuplasty is used solely for dilation of obstructed ostia, with its use limited to the frontal, sphenoid, and maxillary (extranasal) sinuses. Contraindications Balloon sinuplasty alone should not be considered for patients with pansinus polyposis, extensive fungal disease, advanced connective tissue disease, or suspected neoplasms. In addition, balloon sinuplasty is not appropriate for use in patients who require revision surgery or in patients with severe disease in which bony thickening or dehiscence of the orbital wall or skull base bone has occurred. Evolution of Balloon Sinuplasty Balloon sinuplasty remains an evolving technology despite its introduction in 2005 as a less invasive alternative to FESS. It has been suggested that opening up the sinus is not enough to resolve chronic sinusitis. Some physicians believe that inflammation of the bone contributes to the disease and that simply pushing the bone aside with a balloon may lead to continued problems. Recently, there has been an increase in the use of balloon dilation devices as an adjunct to conventional FESS. In complex cases, many physicians use the balloon to initially open the sinuses and then use more traditional surgical tools to remove diseased bone and tissue. The effects of removing the bone fragments in conjunction with balloon sinuplasty have not been studied to date. www.allmedmd.com 4
Health Plan Coverage Many health plans consider the stand-alone use of balloon sinuplasty to be experimental/investigational and do not provide coverage for the procedure. Balloon sinuplasty is sometimes covered as an adjunct to FESS, and some plans state: When performed on the same sinus in conjunction with another surgical procedure, such as functional endoscopic sinus surgery, balloon sinuplasty is considered inclusive/incidental to the surgical procedure and is not eligible for separate reimbursement by the company. Position Statements on Balloon Sinuplasty In 2007, the AAOHNS issued their first position statement on balloon sinuplasty. It declared that the evidence regarding the safety of sinus balloon catheterization has been supportive and that balloon catheterization is a promising technique for the treatment of selected cases of rhinosinusitis. These include those patients without polyposis involving the frontal, sphenoid, or maxillary sinuses, either in conjunction with or in place of conventional instrumentation. Based on the currently available scientific medical evidence, endoscopic balloon dilation technology is accept able and safe for use in the management of sinus disease Endoscopic balloon dilation technology is a tool, not a procedure, available to the operating surgeon at his/her discretion for the surgical management of sinus disease Patients who are treated with this technology may require concurrent conventional endoscopic sinus surgery especially in the ethmoid sinuses, much like any surgical instrument that may be used in some parts of the sinus and not others or in combination with other technologies In a group of selected patients, the use of balloon catheter dilation technology alone may eliminate need for other surgical techniques Endoscopic balloon catheter dilation as a tool for dilating the opening of the maxillary sphenoid and frontal sinuses is not investigational or experimental and should not be viewed as such In a recent public letter, the AAOHNS expressed disagreement with the experimental assignation of balloon sinuplasty. According to the letter, the AAOHNS not only believes that using the balloon as a tool in a standard approach to sinus ostial dilation along with other indicated endoscopic surgery is acceptable but also disagrees with policies designating stand-alone sinus ostial dilations as investigational/not medically necessary. Determining Medical Necessity for Balloon Sinuplasty: The Role of Independent Medical Review An independent medical review looks at whether or not a specific therapy or procedure is medically necessary. Effective care for patients with chronic sinusitis who have failed medical management requires an in-depth understanding of the continually evolving technologies for sinus surgery. An IRO provides ready access to specialists, which healthcare plans may lack internally, thereby allowing for unbiased and timely determinations of whether the requested treatment falls under the medical necessity guidelines. The board-certified physician specialists who work with IROs keep up-to-date with the latest medical research literature and the latest standard of care, staying on top of continually evolving technical advances as they are studied more extensively and potentially accepted into the clinical guidelines. 5
Conclusions Currently, there is limited peer-reviewed literature that has evaluated the outcome of patients undergoing balloon sinuplasty, and no randomized studies have compared balloon sinuplasty to FESS. The existing data show that balloon sinuplasty by itself or as an adjunct to FESS is safe and effective for the treatment of chronic sinusitis that is unresponsive to medical management. Although FESS remains the gold standard for surgical treatment of inflammatory sinus disorders, balloon sinuplasty may gain more widespread acceptance and may eventually become accepted as a standard of care as more randomized studies are conducted and longer-term data become available. Sources Ahmed J, Pal S, Hopkins C, Jayaraj S. Functional endoscopic balloon dilation of sinus ostia for chronic rhinosinusitis. Cochrane Database Syst Rev. 2011 Jul 6;7:CD008515. AAO-HNS issues position statement on balloon sinuplasty [press release]. Alexandria, Va: American Academy of Otolaryngology Head and Neck Surgery; March 19, 2007. Available at: http://www.newswise.com/articles/view/528170/. Accessed June 10, 2012. American Rhinologic Society. Balloon sinuplasty. Available at: http://www.american-rhinologic.org/position_balloon_sinuplasty?print. Accessed June 10, 2012. Bolger WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg. 2007;137:10-20. Brown C, Bolger W. Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006:115:293-299. Fink J. Balloon sinuplasty use continues to evolve: procedure may complement traditional sinus surgery. ENT Today. Nov 2011. Levine H, Rabago D. Balloon sinuplasty: a minimally invasive option for patients with chronic rhinosinusitis. Postgrad Med. 2011;123:112-118. NICE. IPG 273 Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis. September 2008. Available at: http://www.nice.org.uk/nicemedia/pdf/ipg273guidance.pdf. Accessed June 10, 2012. Rosenfeld RM. Clinical practice guideline on adult sinusitis. Otolaryngol Head Neck Surg. 2007;137:365-377 Stewart AE, Vaughan WC. Balloon sinuplasty versus surgical management of chronic rhinosinusitis. Curr Allergy Asthma Rep. 2010 May;10(3):181-187. U.S. Department of Health and Human Services; Centers for Disease Control and Prevention National Center for Health Statistics. Ambulatory Medical Care Utilization Estimates for 2007. Data From the National Health Care Surveys. April 2011. DHHS Publication No. (PHS) 2011-1740. Available at: http://www.cdc.gov/nchs/data/series/sr_13/sr13_169.pdf. Accessed June 10, 2012. U.S. Department of Health and Human Services; Centers for Disease Control and Prevention National Center for Health Statistics. Summary Health Statistics for U.S. Adults: National Health Interview Survey, 2010. Data From the National Health Interview Survey. January 2012. DHHS Publication No. (PHS) 2012-1580. Available at: http://www.cdc.gov/nchs/data/series/sr_10/sr10_252.pdf. Accessed June 10, 2012. www.allmedmd.com 621 SW Alder St., Suite 740 Portland, OR 97205 800-400-9916 www.allmedmd.com 6