Achalasia and Gastroesophageal Reflux Disease (GERD) - Minimally Invasive Procedures - Medical Policy
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This policy governs medical necessity, prior authorization, and coverage status for POEM, G-POEM, TIF, and other minimally invasive endoscopic or device-based procedures used for achalasia, gastroparesis, and GERD. It applies to Health New England Commercial, Medicare Advantage, and Medicaid (BeHealthy) lines of business.
The policy title and medical necessity criteria were revised.
Gastric peroral endoscopic myotomy (G-POEM) was changed from experimental or investigational to covered with prior authorization.
POEM and G-POEM were revised to be not medically necessary except in covered circumstances.
For the Medicare line of business, Health New England adopted criteria concerning select minimally invasive GERD procedures, including transoral incisionless fundoplication (TIF).
Medical Necessity and Coverage Criteria
POEM for Achalasia
POEM is considered medically necessary when ALL of the following criteria are met:
ALL of the following
- The member is 18 years of age or older.
- Achalasia type I, II, or III is confirmed by esophageal motility testing.
- The Eckardt symptom score is greater than 3.> 3
G-POEM for Refractory Gastroparesis
G-POEM is considered medically necessary for the treatment of refractory gastroparesis when ALL of the following criteria are met:
ALL of the following
- Absence of mechanical obstruction is confirmed by esophagogastroduodenoscopy (EGD).
- Gastric emptying scintigraphy (GES) confirms delayed gastric emptying with gastric retention greater than 20% at four hours.> 20% retention at 4 hours
- Chronic, intractable nausea and vomiting are secondary to gastroparesis.
- Conservative medical management has failed, including dietary modification, prokinetics, and antiemetics.
Transoral Incisionless Fundoplication (TIF)
Coverage of transoral incisionless fundoplication (TIF), including the EsophyX™ and MUSE System procedures, depends on the member's line of business:
ALL of the following
- For Commercial and MassHealth, TIF for gastroesophageal reflux disease (GERD) or any other indication is experimental/investigational and not covered.
- For Medicare, TIF is covered in accordance with Local Coverage Determination (LCD) L35080, Select Minimally Invasive GERD Procedures, and the HNE-adopted InterQual® criteria: Procedures, Select Minimally Invasive GERD Procedures Wellpoint, Transoral Incisionless Fundoplication (TIF).
Experimental and Investigational Procedures
The following procedures are considered experimental/investigational:
Any of the following procedures
- Diverticular peroral endoscopic myotomy (D-POEM).
- Zenker peroral endoscopic myotomy (Z-POEM).
- Radiofrequency energy to the gastroesophageal junction, such as the Stretta® System.
- Endoluminal gastroplasty or gastroplications, such as the Medigus Ultrasonic Surgical Endostapler (MUSE™) System or GERDx™.
- Injection or implantation of biocompatible material, such as Plexiglas, polymethylmethacrylate (PMMA), or Durasphere™.
- Magnetic sphincter augmentation, such as the LINX™ Reflux Management System.
- Resection and plication (RAP), such as Apollo Overstitch.
- EndoStim System (EndoStim Inc.) for gastroesophageal reflux disease (GERD).
Contraindications to the POEM procedure include severe erosive esophagitis; coagulation disorders; liver cirrhosis with portal hypertension; esophageal malignancy; prior therapy for achalasia that may compromise the integrity of the esophageal mucosa; and prior therapy that may lead to submucosal fibrosis, including radiofrequency ablation, radiation therapy, or endoscopic mucosal resection.
POEM is not medically necessary for any indication other than covered type I, II, or III achalasia meeting all applicable age, esophageal motility testing, and Eckardt symptom score criteria.
G-POEM is not medically necessary for any indication other than refractory gastroparesis meeting all applicable criteria, including exclusion of mechanical obstruction, documented delayed gastric emptying, chronic intractable nausea and vomiting, and failure of conservative medical management.
POEM and G-POEM are not medically necessary except in the covered circumstances described above. Procedures that do not meet the applicable medical-necessity criteria are not covered.
Coding and Clinical Thresholds
| 49999 | Unlisted procedure, abdomen, peritoneum and omentum; experimental and investigational when used to describe procedures in sections III or V. |
Prior Authorization and Provider Requirements
POEM Prior Authorization Requirements
Prior authorization is required for POEM (CPT 43497). Submit documentation showing that the member meets the applicable Medicare POEM criteria.
- Age 18 years or older.
- Achalasia type I, II, or III confirmed by esophageal motility testing.
- Eckardt symptom score greater than 3.
G-POEM Prior Authorization and CPT 43499
Prior authorization is required when CPT 43499 is used to report G-POEM. Coverage is limited to refractory gastroparesis meeting all policy criteria.
- Absence of mechanical obstruction confirmed by EGD.
- Gastric emptying scintigraphy confirms delayed emptying with gastric retention greater than 20% at 4 hours.
- Chronic, intractable nausea and vomiting secondary to gastroparesis.
- Failure of dietary modification, prokinetics, and antiemetics.
Medicare TIF Authorization Pathway
For Medicare TIF requests, follow the adopted InterQual pathway and the applicable Medicare LCD framework. TIF is covered by Medicare under LCD L35080 for Select Minimally Invasive GERD Procedures; HNE has adopted the InterQual criteria for this pathway.
- Use the Medicare InterQual criteria for Procedures, Select Minimally Invasive GERD Procedures Wellpoint, Transoral Incisionless Fundoplication (TIF).
- Refer to Medicare LCD L35080 for Select Minimally Invasive GERD Procedures.
- Health New England providers may obtain InterQual SmartSheets through the HNE provider portal or by calling (413) 787-4004.
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Document Conservative Management Failure
For G-POEM, document failure of conservative medical management before requesting authorization.
- Dietary modification.
- Prokinetic therapy.
- Antiemetic therapy.
POEM Medical Necessity Documentation
For POEM, submit documentation supporting each medical-necessity element required by the policy.
- Patient is 18 years of age or older.
- Esophageal motility testing identifies achalasia type I, II, or III.
- Eckardt symptom score is greater than 3.
G-POEM Medical Necessity Documentation
For G-POEM, document refractory gastroparesis and the objective findings required by the policy.
- EGD confirms absence of mechanical obstruction.
- Gastric emptying scintigraphy shows gastric retention greater than 20% at 4 hours.
- Chronic, intractable nausea and vomiting are secondary to gastroparesis.
- Conservative medical management has failed.
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Submit Clinical Evidence
The treating physician or primary care provider must submit clinical evidence supporting the applicable medical-necessity criteria for the requested treatment, testing, or surgical procedure.
- Submit evidence to Health New England with the prior authorization request.
- Documentation must allow Health New England to properly review the request.
POEM Outside Covered Achalasia Criteria
POEM is not medically necessary for indications other than achalasia type I, II, or III meeting the policy's age, motility-testing, and symptom-score requirements.
- Requests for other indications may be denied.
- An Eckardt symptom score of 3 or less does not meet the stated POEM criterion.
G-POEM Outside Refractory Gastroparesis Criteria
G-POEM is not medically necessary for indications that do not meet all covered refractory gastroparesis criteria.
- Requests may be denied when obstruction has not been excluded.
- Delayed gastric emptying, required symptoms, or failure of conservative management must be documented.
Experimental POEM Variants
D-POEM and Z-POEM are considered experimental and investigational under the policy.
- Diverticular peroral endoscopic myotomy (D-POEM).
- Zenker peroral endoscopic myotomy (Z-POEM).
TIF Line-of-Business Restrictions
TIF is experimental and investigational for Commercial and MassHealth. Medicare coverage follows LCD L35080 and HNE's adopted InterQual criteria.
- Commercial: TIF is experimental/investigational.
- MassHealth: TIF is experimental/investigational.
- Medicare: follow the applicable LCD and adopted InterQual pathway.
Noncovered Endoscopic Anti-Reflux Procedures
The following endoscopic anti-reflux procedures are experimental and investigational for all lines of business, including when requested for GERD or any other indication.
- Radiofrequency energy to the gastroesophageal junction, such as the Stretta System.
- Endoluminal gastroplasty or gastroplication, such as the Muse or GERDx systems.
- Injection or implantation of biocompatible material, such as Plexiglas, PMMA, or Durasphere.
- Magnetic sphincter augmentation, such as the LINX Reflux Management System.
- Resection and plication (RAP), such as Apollo Overstitch.
- EndoStim System for GERD.
POEM Contraindications
Do not approve POEM when a listed clinical contraindication is present; document that these contraindications have been assessed.
- Severe erosive esophagitis.
- Coagulation disorders.
- Liver cirrhosis with portal hypertension.
- Esophageal malignancy.
- Prior achalasia therapy that may compromise esophageal mucosal integrity.
- Prior therapy that may cause submucosal fibrosis, including radiofrequency ablation, radiation therapy, or endoscopic mucosal resection.
Insufficient Clinical Documentation
Prior authorization may not be reviewable without clinical documentation demonstrating compliance with the applicable policy criteria.
- The treating physician or primary care provider must submit the supporting clinical evidence.
- Medical necessity does not by itself guarantee benefit coverage or payment; the member's benefit program governs.
Clinical Background
Achalasia is an uncommon esophageal motility disorder involving degeneration of ganglion cells and impaired peristalsis. The resulting swallowing difficulty may be accompanied by regurgitation, aspiration, esophagitis, ulceration, and weight loss. POEM is an endoscopic myotomy that divides dysfunctional muscle fibers at the lower esophageal sphincter.
Terms and Clinical Classifications
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