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Barrett esophagus (BE) is a condition in which the normal squamous epithelium is replaced by specialized columnar-type epithelium, known as intestinal metaplasia. Intestinal metaplasia is a precursor to adenocarcinoma and may be treated with mucosal ablation techniques such as radiofrequency ablation (RFA) or cryoablation.
Barrett Esophagus and the Risk of Esophageal Carcinoma
The esophagus is normally lined by squamous epithelium. Barrett esophagus is a condition in which the normal squamous epithelium is replaced by specialized columnar-type epithelium known as intestinal metaplasia, in response to irritation and injury caused by gastroesophageal reflux disease (GERD). Barrett esophagus occurs in the distal esophagus, may be of any length, focal or circumferential, and can be seen on endoscopy as being a different color than the background squamous mucosa. Confirmation of Barrett esophagus requires biopsy of the columnar epithelium and microscopic identification of intestinal metaplasia.
Intestinal metaplasia is a precursor to esophageal adenocarcinoma, which is thought to result from a stepwise accumulation of genetic abnormalities in the specialized epithelium, which results in the phenotypic expression of histologic features of low-grade dysplasia (LGD), to high-grade dysplasia (HGD), to carcinoma. Two large epidemiologic studies published in 2011 reported the risk of progression to cancer in patients with BE. One study reported the rate of progression to cancer in more than 8000 patients with a mean duration of follow-up of 7 years (range, 1-20 years). The de novo progression to cancer from BE at 1 year was 0.13%. The risk of progression was reported as 1.4% per year in patients with LGD and 0.17% per year in patients without dysplasia. This incidence translates into a risk of 10 to 11 times that of the general population. The other study identified over 11,000 patients with BE and, after a median follow-up of 5.2 years, reported that the annual risk of esophageal adenocarcinoma was 0.12%. Detection of LGD on index endoscopy was associated with an incidence rate for adenocarcinoma of 5.1 cases per 1000 person-years, and the incidence rate among patients without dysplasia was 1.0 case per 1000 person-years. Risk estimates for patients with HGD were slightly higher.
The reported risk of progression to cancer in BE in older studies was much higher, with an annual incidence of risk of 0.4% to 0.5% per year, with risk estimated at 30 to 40 times the general population. Current surveillance recommendations have been based on these higher risk estimates.
Management of Barrett Esophagus
The current management of Barrett esophagus includes treatment of GERD, and surveillance endoscopy to detect progression to high-grade dysplasia or adenocarcinoma. The finding of high-grade dysplasia or early stage adenocarcinoma warrants mucosal ablation or resection (either endoscopic mucosal resection [EMR] or esophagectomy).
EMR, either focal or circumferential, provides a histologic specimen for examination and staging (unlike ablative techniques). One study provided long-term results for EMR in 100 consecutive patients with early Barrett-associated adenocarcinoma (limited to the mucosa). The 5-year overall survival was 98% and metachronous lesions were observed in 11% of patients after a mean of 36.7 months. In a review by Pech and colleagues, it is stated that circumferential EMR of the entire segment of Barrett esophagus leads to a stricture rate of 50%, and recurrences occur at a rate of up to 11%.
The CryoSpray Ablation™ System (formerly the SprayGenix™ Cryo Ablation System, CSA Medical, Lutherville, MD) uses a low-pressure spray for spraying liquid nitrogen through an upper endoscope. Cryotherapy allows for treatment of uneven surfaces; however, disadvantages include the uneven application inherent in spraying the cryogen.
The HALO System from Barrx™ Medical (Sunnyvale, CA, acquired by Covidien in 2012, and now known as the Barrx line of products) uses radiofrequency (RF) energy and consists of two components: an energy generator and an ablation catheter. The generator provides rapid (i.e., less than 1 second) delivery of a predetermined amount of radiofrequency energy to the catheter. The HALO90 or the HALO360 is inserted into the esophagus with an endoscope, using standard endoscopic techniques. The HALO90 catheter is plate-based and used for focal ablation of areas of Barrett esophagus up to 3 cm. The HALO360 uses a balloon catheter that is sized to fit the individual esophagus, and is inflated to allow for circumferential ablation.
Ablation with radiofrequency affects only the most superficial layer of the esophagus (the mucosa), leaving the underlying tissues unharmed. Efficacy measures of the procedure include eradication of intestinal metaplasia without leaving behind microscopic (or "buried") foci and post-ablation regrowth of the normal squamous epithelium. Reports of the efficacy of the HALO system in ablating Barrett esophagus have been as high as 70% (comparable to alternative methods of ablation [e.g., APC and MPEC]), and even higher in some reports. The incidence of leaving behind "buried" foci of intestinal metaplasia has been reported to be 20–44% with APC and 7% with MPEC; reports using the HALO system have been 0%. Another potential advantage to the HALO system is that because it is automated, it eliminates operator-dependent error that may be seen with APC and MPEC.
Treating high-grade dysplasia or mucosal cancer solely with ablative techniques risks undertreating the approximately 10% of patients who have undetected submucosal cancer, in whom esophagectomy would have been required.
The HALO360 (now Barrx™ 360 RFA Balloon Catheter) received FDA 510(k) clearance for marketing in 2005 and the HALO90 (now Barrx™ 90 RFA Focal Catheter) received clearance in 2006. The FDA-labeled Indications are for use in coagulation of bleeding and nonbleeding sites in the gastrointestinal tract, and include the treatment of Barrett esophagus.
The CryoSpray Ablation™ System received FDA 510(k) marketing clearance in December 2007 for use as a “cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.”
In July 2002, the Polar Wand® device (Chek Med Systems, Willington, CT), a cryosurgical device that uses compressed carbon dioxide, was cleared for marketing by FDA through the 510(k) process. Indications for use are, “ablation of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and gastroenterology.”
Radiofrequency ablation may be considered medically necessary for treatment of Barrett esophagus with high-grade dysplasia (see Policy Guidelines).
Radiofrequency ablation may be considered medically necessary for treatment of Barrett esophagus with low-grade dysplasia, when the initial diagnosis of low-grade dysplasia is confirmed by 2 physicians (see Policy Guidelines).
Radiofrequency ablation is considered investigational for treatment of Barrett esophagus when the above criteria are not met, including but not limited to Barrett esophagus in the absence of dysplasia.
Cryoablation is considered investigational for Barrett esophagus, with or without dysplasia.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Radiofrequency ablation for Barrett esophagus with high-grade dysplasia may be used in combination with endoscopic mucosal resection of nodular/visible lesions. The diagnosis of high-grade dysplasia should be confirmed by two pathologists prior to radiofrequency ablation.
There is considerable interobserver variability in the diagnosis of low-grade dysplasia (LGD), and potential for overdiagnosis of LGD by nonexpert pathologists. This is due primarily to the difficulty in distinguishing inflammatory changes from low-grade dysplasia. There is literature evidence that expert GI pathologists will downgrade a substantial portion of biopsies that are initially read as low-grade dysplasia by nonexperts. As a result, it is ideal that two experts in GI pathology agree on the diagnosis to confirm low-grade dysplasia; this may result in greater than 75% of initial diagnoses of low-grade dysplasia being downgraded to nondysplasia. A review by a single expert GI pathologist will also result in a large number of low-grade dysplasia being downgraded, although probably not as many downgrades as achieved by two expert pathologists.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
POLICY HISTORY3/3/2009: Policy added
04/27/2010: “Cryoablation” added to the policy title. Policy description updated regarding disease progression, dysplasia criteria, cryoablation, and devices. Policy statement revised to indicate that radiofrequency ablation may be considered medically necessary for high-grade dysplasia. Based on this revised policy statement, moved CPT code 43257 to the Covered table and added ICD-9 code 530.85 as a covered diagnosis. Radiofrequency ablation for low-grade dysplasia or Barrett’s esophagus in the absence of dysplasia is considered investigational. New policy statement added that cryoablation is considered investigational. FEP verbiage added to the Policy Exceptions section. Corrected the typo of CPT code 43288; correct code is 43228.
02/23/2011: Policy reviewed; no changes.
07/12/2012: The policy statement regarding low-grade dysplasia was changed from investigational to medically necessary as follows: Radiofrequency ablation may be considered medically necessary for treatment of Barrett’s esophagus with low-grade dysplasia, when the initial diagnosis of low-grade dysplasia is confirmed by a second pathologist who is an expert in GI [gastrointestinal] pathology. Policy guidelines updated regarding diagnosing low-grade dysplasia.
06/13/2013: Policy reviewed; no changes.
07/15/2014: Policy reviewed; description updated regarding Barrett's Esophagus and the Risk of Esophageal Carcinoma. Added "(see Policy Guidelines)" to the first policy statement. Policy statement on radiofrequency ablation for treatment of Barrett's esophagus with low-grade dysplasia revised to change "a second pathologist who is an expert in GI [gastrointestinal] pathology" to "2 physicians (see Policy Guidelines)." Third policy statement revised to change "as a" to "for." It previously stated: Radiofrequency ablation is considered investigational as a treatment of Barrett's esophagus in the absence of dysplasia. Policy Guidelines updated regarding low-grade dysplasia.
08/18/2015: Medical policy revised for ICD-10.
11/11/2015: Policy description updated. First investigational policy statement updated to clarify that radiofrequency ablation is considered investigational for treatment of Barrett esophagus when the medically necessary criteria are not met, including but not limited to Barrett esophagus in the absence of dysplasia. Policy guidelines updated to add medically necessary and investigative definitions.
01/11/2016: Policy description updated regarding devices. Policy statements unchanged.
06/01/2016: Policy number added.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 2.01.80
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.