Number: 0625(Replaces CPB 439) Policy
Aetna considers speech therapy for treatment of dysphagia, regardless of the presence of a communication disability, medically necessary for members who meet the criteria set forth below. Note: Some plans limit coverage of medically necessary speech therapy services. Members should check their benefit plan descriptions for any applicable benefit plan limitations and exclusions on coverage for speech therapy services.
Aetna considers therapy for the management of dysphagia medically necessary in members who meet any of the following criteria:
Aetna considers dysphagia therapy experimental and investigational for all other indications because its effectiveness for indications other than the ones listed above has not been established.
Aetna considers esophageal dilation medically necessary for the treatment of symptomatic obstruction of the esophagus.
Aetna considers esophageal dilation for the treatment of non-obstructive esophageal dysphagia experimental and investigational because its effectiveness has not been established.
Aetna considers non-biodegradable stent placement medically necessary for refractory (can not be dilated to an adequate diameter) malignant esophageal strictures.
Aetna considers the following interventions (not an all-inclusive list) experimental and investigational for the treatment of dysphagia because their effectiveness for this indication has not been established:
People with dysphagia have difficulty swallowing and may also experience pain while swallowing. Some people may be completely unable to swallow or may have trouble swallowing liquids, foods, or saliva.
Dysphagia occurs when there is a problem with any part of the swallowing process. Weak tongue or cheek muscles may make it hard to move food around in the mouth for chewing. Food pieces that are too large for swallowing may enter the throat and block the passage of air.
Other problems include not being able to start the swallowing reflex (a stimulus that allows food and liquids to move safely through the pharynx) because of a stroke or other nervous system disorder. People with these kinds of problems are unable to begin the muscle movements that allow food to move from the mouth to the stomach. Another difficulty can occur when weak throat muscles cannot move all of the food toward the stomach. Bits of food can fall or be pulled into the trachea, which may result in aspiration pneumonia.
Dysphagia may be caused by any condition that weakens or damages the muscles and nerves used for swallowing. For example, people with nervous system diseases, such as cerebral palsy or Parkinson's disease, often have problems swallowing. Additionally, cerebrovascular accident or traumatic brain injury may affect the coordination of the swallowing muscles or limit sensation in the mouth and throat. An infection or irritation can cause narrowing of the esophagus. People born with abnormalities of the swallowing mechanism may not be able to swallow normally. Infants who are born with a cleft palate are unable to suck properly, which complicates breast-feeding and drinking from a regular baby bottle. In addition, cancers of the head, neck, or esophagus may cause dysphagia. Sometimes the treatment for these types of cancers can cause dysphagia. Injuries of the head, neck, and chest may also create swallowing problems.
Physicians and speech-language pathologists who test for and treat swallowing disorders use a variety of tests that allow them to look at the parts of the swallowing mechanism, including fiber optic laryngoscopy, video fluoroscopy, and ultrasound.
Once the cause of the dysphagia is found, surgery or medication may help. If treating the cause of the dysphagia does not help, the patient may refer the patient to a speech-language pathologist who is trained in testing and treating swallowing disorders. The speech-language pathologist will test the person's ability to eat and drink and may teach the person new ways to swallow.
Oral-motor therapy is directed at correcting abnormal oral muscle behaviors that interfere with feeding. Oral-motor therapy may be focused upon inducing active suckle movements, coordinating tongue movements, or facilitating normal oral movement patterns such as lip closure.
Oral-motor therapy has also been used in developmentally delayed children to stop drooling, correct abnormal tongue thrust, and improve speech. Speech management of the developmentally delayed child has included training to improve the functioning of oral and pharyngeal muscles. This oral-motor training is usually introduced before the emergence of speech. Most Aetna plans exclude treatment of developmental delay. Please check benefit plan descriptions for details.
Electrical stimulation (ES) has been examined for the treatment of dysphagia. However, there is currently insufficient evidence to support the effectiveness of ES in treating this condition. Park et al (1997) reported a pilot study of oral ES on swallow function in post-stroke patients. They found that oral ES resulted in an improvement in swallow function in 2 of the 4 patients. The authors concluded that these early results are promising, but further research is needed. In a controlled study, Freed et al (2001) compared the effectiveness of transcutaneous ES to thermal-tactile stimulation (TS) in patients with dysphagia caused by stroke. The investigators concluded that transcutaneous ES appears to be a safe and effective treatment for dysphagia due to stroke and results in better swallow function than conventional TS treatment. However, there were no follow-up data in this study. Grill et al (2001) reviewed emerging clinical applications of ES, and concluded that functional ES has great potential for increasing life support as well as for quality of life in chronic ailments, particularly obstructive sleep apnea and dysphagia.
In a non-concurrent cohort study, Blumenfeld et al (2006) assessed the effectiveness of ES in treating persons with dysphagia and aspiration. The charts of 40 consecutive subjects undergoing ES and 40 consecutive persons undergoing traditional dysphagia therapy (TDT) were reviewed. Pre- and post-therapy treatment success was compared utilizing a previously described swallow severity scale. A linear regression analysis was employed to adjust for potential confounding variables. The swallow severity scale improved from 0.50 to 1.48 in the TDT group (p < 0.05) and from 0.28 to 3.23 in the ES group (p < 0.001). After adjusting for potential confounding factors, persons receiving ES did significantly better in regard to improvement in their swallowing function than persons receiving TDT (p = 0.003). The authors concluded that the findings of this non-concurrent cohort study suggested that dysphagia therapy with transcutaneous ES is superior to traditional dysphagia therapy alone in individuals in a long-term acute care facility. They also stated that confirmation of these findings with a prospective, placebo-controlled, randomized clinical trial is needed before a definitive determination regarding the effectiveness of ES dysphagia therapy can be made.
Kiger et al (2006) compared the outcomes using transcutaneous neuromuscular ES (VitalStim therapy) to outcomes using traditional swallowing therapy for deglutition disorders. A total of 22 patients had an initial and a follow-up video-fluoroscopic swallowing study or fiberoptic endoscopic evaluation of swallowing and were divided into an experimental group that received VitalStim treatments and a control group that received traditional swallowing therapy. Outcomes were analyzed for changes in oral and pharyngeal phase dysphagia severity, dietary consistency restrictions, and progression from non-oral to oral intake. Results of chi-square analysis showed no statistically significant difference in outcomes between the experimental and control groups.
Shaw and colleagues (2007) carried out a retrospective analysis of 18 patients with dysphagia who received VitalStim therapy. All subjects underwent pre-therapy evaluation by speech-language pathologists, including modified barium swallow and/or functional endoscopic evaluation of swallowing and clinical evaluation of swallowing that included assessment of laryngeal elevation, diet tolerance, and swallowing delay, and were then assigned an overall dysphagia severity score. After therapy, all patients underwent the same assessments. Twelve of the 18 subjects also underwent a functional swallowing telephone survey months (range of 1 to 21 months) after their therapy to evaluate if the improvement was worthwhile and sustained. Eleven of the 18 patients (61 %) demonstrated some improvement in their swallowing; 6 of the 18 patients (33 %) were improved enough to no longer require a feeding tube. However, of the 5 patients categorized as having "severe dysphagia" before therapy, only 2 showed any improvement, and these patients still required a feeding tube for adequate nutrition. Telephone surveys did confirm that those who improved with their therapy seemed to maintain their progress and that most patients were satisfied with their therapy. The authors concluded that VitalStim therapy seems to help those with mild-to-moderate dysphagia. However, the patients with the most severe dysphagia did not gain independence from their feeding tubes.
In a meta-analysis, Carnaby-Mann and Crary (2007) evaluated the effect of transcutaneous neuromuscular electrical stimulation (NMES) on swallowing rehabilitation. The authors concluded that this preliminary meta-analysis revealed a small but significant summary effect size for transcutaneous NMES for swallowing. Because of the small number of studies and low methodological grading for these studies, caution should be taken in interpreting this finding. These results support the need for more rigorous research in this area. This is in agreement with the observation of Steel et al (2007) who noted that although ES approaches to the restoration and rehabilitation of swallowing is an exciting area of research which holds promise for future clinically relevant technology and/or therapy, implementation of ES in clinical swallowing rehabilitation settings still remains pre-mature.
Guidelines on the use of esophageal dilation (Riley and Attwood, 2004) stated that esophageal dilation is indicated in the treatment of symptomatic obstruction of the esophagus. The guidelines explained that obstruction may develop as a consequence of a wide range of anatomical and functional esophageal disorders. Reflux-induced strictures, malignant strictures, and achalasia are the most frequent indications but patients with anastomotic, sclerotherapy, radiation, medication, and corrosive induced strictures, and those with rings and webs frequently require dilatation. The guidelines stated that patients with diffuse esophageal spasm and other motility disorders may occasionally require dilatation of the lower oesophageal sphincter when conservative measures fail.
There is inadequate evidence of the clinical utility of esophageal dilation in dysphagia not associated with obstruction. In a randomized controlled trial (n = 96), Lavu et al (2004) examined the impact of esophageal dilation with a large-diameter dilator on dysphagia and quality of life in such patients. These investigators found that most patients with esophageal dysphagia have a non-obstructing esophageal lumen. Their findings did not support the practice of empiric esophageal dilation for patients with non-obstructive esophageal dysphagia. Improvement in both treatment and control groups suggests that it occurred due to proton pump inhibitor therapy, lending credence to the hypothesis that esophageal hypersensitivity to acid contributes to symptoms in most patients with non-obstructive esophageal dysphagia, which is the predominant category of dysphagia.
Siersema (2008) stated that esophageal strictures are frequently encountered by gastroenterologists and can be caused by benign or malignant lesions. Dysphagia is the symptom experienced by all patients, regardless of the cause of their strictures. The methods most commonly employed for palliation of malignant esophageal strictures are stent placement (particularly in patients with an expected survival of 3 months or less) and brachytherapy (in patients with a life expectancy of more than 3 months). Brachytherapy has been shown to be beneficial in patients with an expected survival of longer than 3 months with regard to (prolonged) dysphagia improvement, complications and quality of life. The mainstay of benign esophageal stricture treatment is dilation. Although dilation usually results in symptomatic relief, strictures do recur. In order to predict which types of strictures are most likely to recur, it is important to differentiate between esophageal strictures that are simple (i.e., focal, straight strictures with a diameter that allows endoscope passage) and those that are more complex (i.e., over 2 cm in length, tortuous strictures with a narrow diameter). These complex strictures are considered refractory when they can not be dilated to an adequate diameter.
Verschuur and associates (2007) compared small- and large-diameter stents for improvement of dysphagia, complications, and recurrent dysphagia. These investigators prospectively followed 338 patients with dysphagia from obstructing esophageal or gastric cardia cancer who were treated with an Ultraflex stent (n = 153), a Gianturco Z-stent (n = 89), or a Flamingo Wallstent (n = 96) of either a small diameter (n = 265) or a large diameter (n = 73). Major outcome measurements included dysphagia score (on a scale from 0 [no dysphagia] to 4 [complete dysphagia]), complications, and recurrent dysphagia. Analysis was by Chi-2 test, log-rank test, and Cox regression analysis. Improvement in dysphagia was similar between patients with a small- or a large-diameter stent (p = 0.35). The occurrence of major complications, such as hemorrhage, perforation, fistula, and fever, was increased in patients with a large-diameter Gianturco Z-stent compared with those treated with a small-diameter stent (4 [40 %] versus 16 [20 %]; adjusted hazard ratio [HR] 5.03, 95 % confidence interval [CI]: 1.33 to 19.11) but not in patients with a large-diameter Ultraflex stent or a Flamingo Wallstent. Moreover, minor complications, particularly pain, were associated with prior radiation and/or chemotherapy in patients with a large- or a small-diameter Gianturco Z-stent (HR 4.27, 95 % CI: 1.44 to 12.71) but not in those with an Ultraflex stent or a Flamingo Wallstent. Dysphagia from stent migration, tissue overgrowth, and food bolus obstruction recurred more frequently in patients with a small-diameter stent than in those with a large-diameter stent (Ultraflex stent: 54 [42 %] versus 3 [13 %], adjusted HR 0.16, 95 % CI: 0.04 to 0.74; Gianturco Z-stent: 21 [27 %] versus 1 [10 %], adjusted HR 0.97, 95 % CI: 0.11 to 8.67; and Flamingo Wallstent: 21 [37 %] versus 6 [15 %], adjusted HR 0.40, 95 % CI: 0.03 to 4.79). The authors concluded that large-diameter stents reduce the risk of recurrent dysphagia from stent migration, tissue overgrowth, or food obstruction. Increasing the diameter in some stent types may, however, increase the risk of stent-related complications to the esophagus.
Conio et al (2007) stated that self-expanding metal stents (SEMS) provide effective palliation in patients with malignant dysphagia, although severe complications and mortality may result. These researchers performed a prospective controlled trial to compare a new self-expanding polyester mesh stent (Polyflex) with SEMS (Ultraflex). A total of 101 patients with unresectable esophageal carcinoma were randomized to placement of a Polyflex (n = 47) or a partially covered Ultraflex (n = 54) stent. Patients with esophagogastric junction malignancy were excluded. Placement was successful in 46 (98 %) patients with the Polyflex and 54 (100 %) patients with the Ultraflex stent. In 1 patient, the Polyflex stent could not be placed. After 1 week, dysphagia was improved by at least 1 grade in 100 % of the Polyflex group and in 94 % of the Ultraflex group. Major complications were observed in 48 % of the Polyflex group and 33 % of the Ultraflex group. Intra-procedural perforation occurred in 1 Polyflex and 1 Ultraflex patient; 2 Polyflex patients had post-procedural hemorrhage. Twenty (44 %) patients with a Polyflex stent and 18 (33 %) with an Ultraflex stent had recurrent dysphagia because of tumor overgrowth, stent migration, hyperplastic granulomatous reaction, or food bolus impaction. Multi-variate analyses showed a significantly higher complication rate with Polyflex than with Ultraflex stents (odds ratio 2.3, 95 % CI: 1.2 to 4.4). However, median survival was 134 days with Polyflex and 122 days with Ultraflex stents (p = NS). The authors concluded that no difference was seen in palliation of dysphagia between the 2 stents. Significantly more complications, especially late stent migration, were observed in the Polyflex group.
Verschuur and collegues (2008) noted that stents are often used for the palliation of inoperable esophageal or gastric cardia cancer. One of the drawbacks of the currently used stents is the high percentage of recurrent dysphagia due to stent migration and tissue growth. New stents have been designed to overcome this unwanted sequela of stent placement. In this randomized trial, these investigators examined if results of stent placement could be improved with newer stent designs. A total of 125 patients with dysphagia from inoperable carcinoma of the esophagus or gastric cardia were randomized to placement of an Ultraflex stent (n = 42), Polyflex stent (n = 41), or Niti-S stent (n = 42). Patients were followed by scheduled telephone calls at 14 days after treatment, and then monthly for 6 months or until death. Technical and functional outcome, complications, recurrent dysphagia, and survival were analyzed with,Chi(2) tests, Kaplan-Meier curves, and log-rank tests. Stent placement was technically successful in all patients with an Ultraflex stent, in 34/41 (83 %) patients with a Polyflex stent, and in 40/42 (95 %) patients treated with a Niti-S stent (p = 0.008). Dysphagia score improved from a median of 3 (liquids only) to 1 (ability to eat some solid food) in all patients. There were no differences in complications among the 3 stent types. Recurrent dysphagia, caused by tissue ingrowth or overgrowth, migration, or food obstruction, was significantly different between patients with an Ultraflex stent and patients with a Polyflex stent or Niti-S stent (22 [52 %] versus 15 [37 %] versus 13 [31 %], p = 0.03). Stent migration occurred more frequently with Polyflex stents, whereas tissue ingrowth or overgrowth was more frequently seen with Ultraflex stents, and to a lesser degree, Niti-S stents. No differences were found in survival (median survival: Ultraflex stent 132 days versus Polyflex stent 102 days versus Niti-S stent 159 days) among the 3 stent types. The authors concluded that all 3 stents are safe and offer adequate palliation of dysphagia from esophageal or gastric cardia cancer. Nonetheless, Polyflex stents seem the least preferable in this patient group, as placement of this device is technically demanding and associated with a high rate of stent migrations.
In a pilot study, Terre et al (2008) evaluated the effectiveness of botulinum toxin (BTX-A) injection in the cricopharyngeus muscle in patients with neurological dysphagia caused by alteration in the upper esophageal sphincter (UES) opening and with preserved pharyngeal contraction. A total of 10 patients (7 brain lesions and 3 cervical spinal cord injuries), with a minimum time-lapse of 6 months from neurological lesion received BTX-A injection. Dysfunction of the UES opening and the presence of pharyngeal contraction were diagnosed by videofluoroscopy (VDF) and esophageal manometry (EM). The BTX-A (100 U) injection was guided by endoscopy. Clinical, VDF, and EM follow-ups were carried out at 3 weeks, 3 and 6 months, and at 1 year post-injection. Prior to treatment, 6 patients were fed by naso-gastric tube; VDF showed impairment of the UES opening, residue in pyriform sinuses, and aspiration in all cases. During follow-up, there was a decrease in the number of patients who had aspiration: 3 patients at 1 year. During swallowing, EM showed a mean UES relaxation of 90 % (range of 74.5 to 100 %), residual pressure 3.2 mm Hg (range of 0 to 13 mm Hg) and pharyngeal amplitude 52 mm Hg (range of 25 to 80 mm Hg). At follow-up, a significant improvement in UES relaxation (98 % [89 % to 100 %]) and pharyngeal contraction (97 mm Hg [35 mm Hg to 165 mm Hg]) was observed. At 3 months, 6 patients were eating exclusively by mouth. The authors concluded that 1 single injection of BTX-A in the UES has long-lasting effectiveness in patients with neurological dysphagia caused by alteration in the UES opening and with pharyngeal contraction. Nevertheless, they stated that a randomized control trial should be done to confirm these results and rule out the effect of potential spontaneous improvement of neurological injury.
Khedr and Abo-Elfetoh (2010) examined the effect of repetitive transcranial magnetic stimulation (rTMS) applied to the motor area of both hemispheres in patients with acute lateral medullary infarction (LMI) or other brainstem infarctions. The study included 22 patients with acute ischemic stroke who had severe bulbar manifestation -- 11 patients had LMI, and 11 had another brainstem infarction. They were randomly allocated to receive active (n = 11) or sham (n = 11) rTMS of the esophageal motor cortex. Each patient received 300 rTMS pulses at 3 Hz and an intensity of 130 % resting motor threshold to each hemisphere for 5 consecutive days. Clinical ratings of dysphagia and motor disability were assessed before and immediately after the last session, and then again after 1 and 2 months. There were no significant differences in baseline clinical assessment of swallowing between active and sham groups. Active rTMS improved dysphagia compared with sham rTMS in both groups of patients, (p = 0.001 for both); the LMI group also improved the scores in the Barthel Index. All improvements were maintained over 2 months of follow-up (p = 0.001). The authors concluded that these findings suggested that rTMS could be a useful adjuvant strategy in neurorehabilitation of dysphagia due to LMI or other brainstem infarction, although further assessment is needed in multi-center clinical trials.
Michou et al (2012) examined the behavioral and neurophysiological effects of a new neurostimulation technique (paired associative stimulation [PAS]), applied to the pharyngeal motor cortex, on swallowing function in healthy individuals and patients with dysphagia from stroke. These researchers examined the optimal parameters of PAS to promote plasticity by combining peripheral pharyngeal (electrical) with cortical stimulation. A virtual lesion was used as an experimental model of stroke, created with 1-Hz repetitive transcranial magnetic stimulation over the pharyngeal cortex in 12 healthy individuals. Theye tested whether hemispheric targeting of PAS altered swallowing performance before applying the technique to 6 patients with severe, chronic dysphagia from stroke (mean of 38.8 +/- 24.4 weeks post-stroke). Ten minutes of PAS to the unlesioned pharyngeal cortex reversed (bilaterally) the cortical suppression induced by virtual lesion (lesioned: F(1,9) = 21.347, p = 0.001; contralesional: F(1,9) = 9.648, p = 0.013; repeated-measures analysis of variance) compared with sham PAS. It promoted changes in behavior responses measured with a swallowing reaction time task (F(1,7) = 21.02, p = 0.003; repeated-measures analysis of variance). In patients with chronic dysphagia, real PAS induced short-term bilateral changes in the brain; the unaffected pharyngeal cortex had increased excitability (p = 0.001; 95 % CI: 0.21 to 0.05; post-hoc paired t test) with reduced penetration-aspiration scores and changes in swallowing biomechanics determined by videofluoroscopy. The authors concluded that the beneficial neurophysiological and behavioral properties of PAS, when applied to unlesioned brain, provide the foundation for further investigation into the use of neurostimulation as a rehabilitative approach for patients with dysphagia from stroke.
In a meta-analysis, Long and Wu (2012) examined the effect of acupuncture for treatment of dysphagia in patients affected by a stroke. Randomized controlled trials (RCTs) comparing acupuncture treatment with non-acupuncture treatment of dysphagia in patients with a stroke were identified from the databases of PubMed, Embase, Cochrane Library and CBM disc (China Biological Medicine Database). Eligible investigations were included and data on the effectiveness of acupuncture were extracted and synthesized by meta-analysis using RevMan 5.1.4. Results were expressed as odds ratio (OR) for dichotomous data; 95 % CIs were also calculated. A total of 72 RCTs (3,208 patients in the treatment group and 2,926 patients in the control group) were identified. Details of randomization and blinding were not reported and information on withdrawals and drop-outs was missing in most of included reports. Meta-analysis showed that the effectiveness of treatment in the group receiving acupuncture was higher than that in the non-acupuncture group (OR = 5.17, 95 % CI: 4.18 to 6.38; p < 0.00001). However, the study quality was generally low and of insufficient quality to make recommendations about using acupuncture in the rehabilitation of patients with dysphagia due to stroke. The authors concluded that acupuncture might be beneficial in the rehabilitation of patients with dysphagia caused by stroke, and the evidence justifies future high-quality studies.
Griffiths et al (2012) noted that biodegradable (BD) esophageal stents have been available commercially only since 2008 and previous published research is limited. These researchers reviewed the use of BD stents to treat dysphagia in benign or malignant esophageal strictures. Patients were identified from a prospective interventional radiological database. Biodegradable stents were inserted radiologically under fluoroscopic control. Between July 2008 and February 2011, a total of 25 attempts at placing SX-ELLA BD esophageal stents were made in 17 males and 5 females, with a median age of 69 (range of 54 to 80) years. Two patients required more than 1 BD stent. Indications were benign strictures (n = 7) and esophageal cancer (n = 17). One attempt was unsuccessful for a technical success rate of 96 % with no immediate complications. Clinical success rate was 76 %. Median dysphagia score before stent insertion was 3 (range of 2 to 4) compared to 2 (range of 0 to 3) after stent insertion (p = 0.0001). The authors concluded that BD stents provide good dysphagia relief for the life time of the stent. They may help avoid the use of feeding tubes in patients having radical chemoradiotherapy or awaiting esophagectomy. They do not require removal or interfere with radiotherapy planning via imaging. However, the re-intervention rate was high after the stent dissolves.
Krokidis et al (2013) evaluated the clinical results of the use of BD esophageal stents in malignant strictures. A total of 11 patients were included in this prospective analysis in which a woven polydioxanone BD esophageal stent was used. The inclusion criterion was that the patient underwent neoadjuvant treatment or radical radiotherapy after the stent insertion. Primary end points were dysphagia score at discharge, stent patency, and complication rate. Secondary end points were overall survival and surgical outcome of surgery. There was a 100 % procedure technical success rate. Early complications occurred in 3 patients resulting in failure to restore oral nutrition. In the remaining 8 patients, dysphagia was significantly improved at discharge. Mean stent patency rate in this group was 71.5 days. Stent dysfunction occurred in 5 of 8 patients (62.5 %); in 2 of 5 patients this was due to local inflammatory reaction, and in 3 of 5 patients it was due to tumor growth after a mean time of 97.8 days, and a new metallic stent was consequently placed in 4 of 5 patients. One patient was successfully treated with esophagectomy. At the end of follow-up (mean time of 102.1 days), 3 of 8 stents were patent. The overall patient survival rate was 81.8 %. The authors concluded that although short-term dysphagia scores improved, BD stents do not appear to offer a clear beneficial effect in most cases of malignant strictures, particularly due to a local inflammatory reaction that may be induced. Technical improvement of the device and delineation of the patient group that would benefit from its use is necessary if further studies are to be conducted in the future.
Miller et al (2014) performed a systematic literature search in the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, the DAHTA database, the Health Technology Assessment Database and MEDLINE or PubMed considered studies on the use of neuromuscular electrostimulation (NMES) in otorhinolaryngology that have been published in German or English. The search identified 180 studies. These were evaluated and relevant studies were included in the further evaluation. The authors concluded that in the fields of otorhinolaryngology and phoniatry/pediatric audiology, clinical studies investigating the effects of NMES on facial and laryngeal paresis, as well as dysphonia and dysphagia have been carried out. The evidence collected to date is encouraging; particularly for the treatment of certain forms of dysphagia and laryngeal paresis.
Von Renteln et al (2013) stated that pilot studies have indicated that per-oral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. These investigators performed a prospective, international, multi-center study to determine the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months after POEM, 97 % of patients were in symptom remission (95 % CI: 89 % to 99 %); symptom scores were reduced from 7 to 1 (p < 0.001) and lower esophageal sphincter (LES) pressures were reduced from 28 to 9 mm Hg (p < 0.001). The percentage of patients in symptom remission at 6 and 12 months was 89 % and 82 %, respectively. The authors concluded that POEM was found to be an effective treatment for achalasia after a mean follow-up period of 10 months. The main drawbacks of this study were the lack of a control group and the short-term follow-up.
In a prospective trial, Verlaan et al (2013) evaluated the effect of POEM on esophagogastric function. Patients were greater than 17 years of age with achalasia and an Eckardt score of greater than or equal to 3. Before and 3 months after POEM, 10 consecutive patients underwent esophageal manometry, timed barium esophagograms, and EndoFLIP as well as an esophago-gastro-duodenoscopy (EGD). Main outcome measures were Eckardt symptom score, LES resting pressure, centimeters of barium stasis, esophagogastric junction (EGJ) distensibility, and reflux esophagitis. Compared with scores before POEM, patient symptom scores were significantly reduced (1, interquartile range [IQR 0 to 1] versus 8 [IQR 4 to 8]; p = 0.005). Lower esophageal sphincter pressure decreased significantly (6.0 mm Hg [IQR 2.6 to 7.4] versus 19.0 mm Hg [IQR 13.0 to 28.0]; p = 0.008). Esophageal emptying increased significantly, and a 5-min barium column measured 2.3 cm (IQR 0 to 3.2 cm) versus 10.1 cm (IQR 5.7 to 10.8 cm; p =0 .005). Esophagogastric junction distensibility increased significantly (6.7 mm(2)/mm Hg [IQR 3.8 to 16.6] versus 1.0 mm(2)/mm Hg [IQR 0.4 to 2.3]; p = 0.02) at 50 ml. In 6 of 10 patients, reflux esophagitis was seen. Of these patients, 3 reported reflux symptoms. The authors concluded that POEM improves esophagogastric function and suggested favorable long-term results based on Eckardt score, esophageal manometry, esophageal emptying, and EGJ distensibility. Moreover, they stated that long-term follow-up of larger series will determine whether the high rate of reflux esophagitis affects the clinical application of POEM. The main drawbacks of this study were small number of patients, and short-term follow-up.
Onimaru et al (2013) evaluated the safety and effectiveness of POEM for surgical myotomy failure as a rescue second-line treatment, and discussed the treatment options adapted in achalasia recurrence. A total of 315 consecutive achalasia patients received POEM from September 2008 to December 2012 in the authors’ hospital. A total of 11 (3.5 %) patients, who had persistent or recurrent achalasia and had received surgical myotomy as a first-line treatment from other hospitals, were included in this study. Patient background, barium swallow studies, EGD, manometry, and symptom scores were prospectively evaluated. In principle, all patients in whom surgical myotomy failed received pneumatic balloon dilatation (PBD) as the first line "rescue" treatment, and only if PBD failed were patients considered for rescue POEM. The PBD alone was effective in 1 patient, and in the remaining 10 patients, rescue POEM was performed successfully without complications. Three months after rescue POEM, significant reduction in LES resting pressures (22.1 ± 6.6 mm Hg versus 10.9 ± 4.5 mm Hg, p < 0.01) and Eckardt symptom scores (6.5 ± 1.3 versus 1.1 ± 1.3, p < 0.001) were observed. The authors concluded that short-term results of POEM for failed surgical myotomy were excellent; long-term results are awaited.
Yang and Wagh (2013) stated that achalasia is a motility disorder of the esophagus, characterized by a peristalsis of the esophageal body and incomplete relaxation of the LES. Treatment of achalasia is currently aimed at decreasing the resting pressure in the LES. Per-oral endoscopic myotomy is an emerging novel endoscopic procedure for the treatment of achalasia with initial data suggesting an acceptable safety profile, excellent short-term symptom resolution, low incidence of post-procedural gastro-esophageal reflux (GER), and improvement in manometric outcomes. The authors concluded that further prospective randomized trials are needed to evaluate the long-term effectiveness of this promising technique compared to other treatment modalities for achalasia.
Friedel et al (2013) stated that the volume of POEMs performed worldwide has grown exponentially. In fact, surgeons who have performed Heller myotomy have embraced POEM as the preferred intervention for achalasia. However, the authors stated that the niche of POEM remains to be defined and long-term results are awaited.
Pescarus et al (2014) stated that POEM is a new minimally invasive endoscopic treatment for achalasia. Since the first modern human cases were published in 2008, around 2,000 cases have been performed worldwide. This technique requires advanced endoscopic skills and a learning curve of at least 20 cases. Per-oral endoscopic myotomy is highly successful with over 90 % improvement in dysphagia while offering patients the advantage of a low impact endoscopic access. The main long-term complication is GER with an estimated incidence of 35 %, similar to the incidence of GER post-laparoscopic Heller with fundoplication. The authors concluded that although POEM represents a paradigm shift in the treatment of achalasia, more long-term data are needed to further define its role in the treatment algorithm of this rare disease.
Bredenoord et al (2014) noted that treatment of achalasia is complicated by symptom recurrence and a significant risk for severe complications. Endoscopic myotomy was developed in the search for a highly effective treatment with lower risks. Since its introduction in 2010, several centers have adopted the technique and published excellent short-term results of open label series. These researchers stated that randomized trials with long-term end-point comparing POEM with the established treatments such as balloon dilation and surgical myotomy are now warranted, before POEM can be regarded as the routine clinical care for achalasia patients.
Furthermore, an UpToDate review on “Overview of the treatment of achalasia” (Spechler, 2014) states that “Long-term data from randomized trials are necessary to compare POEM with laparoscopic surgical myotomy and pneumatic dilation before POEM can be recommended”.
|CPT Codes / ICD-9 Codes / HCPCS Codes|
|Therapy for the management of dysphagia other than esophageal dilation or stent placement:|
|CPT codes covered if selection criteria are met:|
|92526||Treatment of swallowing dysfunction and/or oral function for feeding|
|92610||Evaluation of oral and pharyngeal swallowing function|
|92611||Motion fluoroscopic evaluation of swallowing function by cine or video recording|
|92612||Flexible fiberoptic endoscopic evaluation of swallowing by cine or video recording|
|92613||physician interpretation and report only|
|CPT codes not covered for indications listed in the CPB:|
|64550||Application of surface (transcutaneous) neurostimulator|
|64612||Chemodenervation of muscle(s); muscle(s) innervated by facial nerve, unilateral (eg, for blepharospasm, hemifacial spasm)|
|64616||Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (eg, for cervical dystonia, spasmodic torticollis)|
|90867||Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; initial, including cortical mapping, motor threshold determination, delivery and management|
|90868||subsequent delivery and management, per session|
|90869||subsequent motor threshold re-determination with delivery and management|
|95873||Electrical stimulation for guidance in conjunction with chemodenervation (List separately in addition to code for primary procedure)|
|95874||Needle electromyography for guidance in conjunction with chemodenervation (List separately in addition to code for primary procedure)|
|97014||Application of a modality to one or more areas; electrical stimulation (unattended)|
|97032||Application of a modality to one or more areas; electrical stimulation (manual), each 15 minutes|
|97810 - 97814||Acupuncture|
|HCPCS codes covered if selection criteria are met:|
|G0153||Services performed by a qualified speech-language pathologist in the home health or hospice setting, each 15 minutes|
|S9128||Speech therapy, in the home, per diem|
|HCPCS codes not covered for indications listed in the CPB:|
|E0720||Transcutaneous electrical nerve stimulation (TENS) device, two lead, localized stimulation|
|E0730||Transcutaneous electrical nerve stimulation (TENS) device, four or more leads, for multiple nerve stimulation|
|E0745||Neuromuscular stimulator, electronic shock unit|
|G0283||Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care|
|J0585||Botulinum toxin type A, per unit|
|J0587||Botulinum toxin type B, per 100 units|
|ICD-9 codes covered if selection criteria are met:|
|438.82||Late effect of cerebrovascular disease, dysphagia|
|787.20 - 787.29||Dysphagia|
|CPT codes covered if selection criteria are met:|
|43196||Esophagoscopy, rigid, transoral; with insertion of guide wire followed by dilation over guide wire|
|43213||Esophagoscopy, flexible, transoral; with dilation of esophagus, by balloon or dilator, retrograde (includes fluoroscopic guidance, when performed)|
|43214||with dilation of esophagus with balloon (30 mm diameter or larger) (includes fluoroscopic guidance, when performed)|
|43220||Esophagoscopy, rigid or flexible; with balloon dilation (less than 30 mm diameter)|
|43226||with insertion of guide wire followed by dilation over guide wire|
|43229||Esophagoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)|
|43233||Esophagogastroduodenoscopy, flexible, transoral; with dilation of esophagus with balloon (30 mm diameter or larger) (includes fluoroscopic guidance, when performed)|
|43249||Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with balloon dilation of esophagus (less than 30 mm diameter)|
|43253||Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic ultrasound-guided transmural injection of diagnostic or therapeutic substance(s) (eg, anesthetic, neurolytic agent) or fiducial marker(s) (includes endoscopic ultrasound examination of the esophagus, stomach, and either the duodenum or a surgically altered stomach where the jejunum is examined distal to the anastomosis)|
|43266||Esophagogastroduodenoscopy, flexible, transoral; with placement of endoscopic stent (includes pre- and post-dilation and guide wire passage, when performed)|
|43270||Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)|
|43450||Dilation of esophagus, by unguided sound or bougie, single or multiple passes|
|43453||Dilation of esophagus, over guide wire|
|ICD-9 codes covered if selection criteria are met:|
|530.3||Stricture and stenosis of esophagus|
|750.3||Tracheoesophageal fistula, esophageal atresia and stenosis|
|ICD-9 codes not covered for indications listed in the CPB:|
|438.82||Late effect of cerebrovascular disease, dysphagia|
|787.20 - 787.29||Dysphagia|
|CPT codes covered if selection criteria are met:|
|43212||Esophagoscopy, flexible, transoral; with placement of endoscopic stent (includes pre- and post-dilation and guide wire passage, when performed)|
|43256||Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with transendoscopic stent placement (includes predilation)|
|Other HCPCS codes related to the CPB:|
|C1876||Stent, noncoated/noncovered, with delivery system|
|C1877||Stent, noncoated/noncovered, without delivery system|
|ICD-9 codes covered if selection criteria are met:|
|150.0 - 150.9||Malignant neoplasm of esophagus|
|Other ICD-9 codes related to the CPB:|
|141.0 - 149.9||Malignant neoplasm of tongue, major salivary glands, gum, floor of mouth, other and unspecified parts of mouth, oropharynx, nasopharynx, hypopharynx, other ill-defined sites within the lip, oral cavity, and pharynx|
|161.0 - 162.0||Malignant neoplasm of larynx and trachea|
|260, 261, 262||Kwashiorkor, nutritional marasmus or other severe, protein-calorie malnutrition|
|263.0 - 263.9||Other and unspecified protein-calorie malnutrition|
|306.4||Physiological malfunction arising from mental factors, gastrointestinal|
|314.1||Hyperkinesis with developmental delay|
|315.31 - 315.39||Developmental speech or language disorder|
|332.0 - 332.1||Parkinson's disease|
|343.0 - 343.9||Infantile cerebral palsy|
|430 - 438.81, 438.83 - 438.9||Cerebrovascular disease|
|478.30 - 478.34||Paralysis of vocal cords or larynx|
|507.0||Pneumonitis due to inhalation of food or vomitus|
|527.7||Disturbance of salivary secretion|
|530.0 - 530.2, 530.4 - 530.9||Diseases of the esophagus|
|748.2||Web of larynx|
|748.3||Othe anomalies of larynx, trachea, and bronchus|
|749.00 - 749.25||Cleft palate and cleft lip|
|750.21 - 750.29||Other specified anomalies of mouth and pharynx|
|750.3||Tracheoesophageal fistula, esophageal atresia and stenosis|
|750.4||Other specified anomalies of esophagus|
|779.3||Feeding problems in newborn|
|781.0||Abnormal involuntary movements|
|783.21||Loss of weight|
|783.3||Feeding difficulties and mismanagement|
|783.41||Failure to thrive|
|783.7||Adult failure to thrive|
|800.00 - 804.99||Fracture of skull|
|850.00 - 854.19||Intracranial injury, excluding those with skull fracture|
|905.0||Late effect of fracture of skull and face bones|
|906.0||Late effect of open wound of head, neck, and trunk|
|907.0||Late effect of intracranial injury without mention of skull fracture|
|907.1||Late effect of injury to cranial nerve|
|V10.00||Personal history of malignant neoplasm of gastrointestinal tract, unspecified|
|V10.01||Personal history of malignant neoplasm of tongue|
|V10.02||Personal history of malignant neoplasm of other and unspecified oral cavity and pharynx|
|V10.03||Personal history of malignant neoplasm of esophagus|
|V10.12||Personal history of malignant neoplasm of trachea|
|V10.21||Personal history of malignant neoplasm of larynx|
|V41.6||Problems with swallowing and mastication|
|V43.81||Organ or tissue replaced by other means, larynx|