Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A56395 (Billing and Coding: Endoscopic Treatment of GERD) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A56395: Billing and Coding: Endoscopic Treatment of GERD (Billing and Coding, effective 2026-06-16)
- Covered ICD-10-CM codes
- 3
- 1 group
- Non-covered ICD-10-CM codes
- 1
- Procedure codes listed
- 5
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| K21.00 | — |
| K21.01 | — |
| K21.9 | — |
Procedure codes: 43210, 43257, 43499, 43999, 49999.
Coverage indications, limitations and medical necessity
Benefits are not available for endoluminal treatment for Gastroesophageal Reflux Disease (GERD) using the Stretta® procedure, the Bard EndoCinch™ Suturing System, Plicator™, or similar treatments as these procedures are not considered reasonable and necessary for the diagnosis or treatment of an injury or disease.
Currently, these procedures are considered non-covered due to the fact that current peer-reviewed literature does not support the efficacy of the services. Claims will be denied as "not proven effective."
The Stretta® procedure is an endoluminal treatment for GERD in which radiofrequency energy is delivered to smooth muscle of the lower esophageal sphincter (LES). A flexible catheter equipped with special needle electrodes for precise energy delivery is placed by mouth into the esophagus and carefully controlled radiofrequency energy is then delivered to the LES and gastric cardia, creating thermal lesions. The manufacturer maintains that the changes that occur immediately, and over time, result in a "tighter" LES and a less compliant gastric cardia. Additionally, the interruption of nerve pathways in the LES area is believed to reduce the incidence of inappropriate LES "relaxations," leading to an improvement in GERD symptoms. Substantial peer-reviewed evidence to fully support these assumptions remains to be published.
The Bard EndoCinch™ Suturing System and the Plicator™ are intended for use in endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for approximation of tissue for treatment of symptomatic gastroesophageal reflux disease.
Clinical data from various studies are emerging. Currently, open-label studies or patient registries with short-term follow-ups are the dominant source of data. The overwhelming preponderance of reviewers remains equivocal in their support and have called for randomized controlled trials with long-term follow-ups. In the absence of evidence from such studies, and in the absence of wide acceptance, endoscopic treatments for GERD are not proven effective.
Therefore, they are not reimbursable even though some of the treatments may have associated CPT™ or OPPS codes.
Coverage for the TIF (Transoral Incisionless Fundoplication) procedure is for treatment of patients in whom proton pump inhibitor therapy fails. An example of the device used in TIF is EsophyX™. TIF using EsophyX™ for performing surgery for treating gastroesophageal reflux disease (GERD) reconstructs the valve at the top of the stomach that helps prevents acid reflux.
Indications
Coverage is appropriate for TIF if done by a well-trained surgeon for the following indications:
1. Symptomatic chronic gastroesophageal reflux (chronic being defined as > 6 months of symptoms), and
2. Symptoms must not be completely responsive to Proton Pump Inhibitors (PPIs) as judged by GERD HRQL scores of or equal to 20 when off for 14 days (also acceptable would be the difference of > or equal to 10 of the scores between off and on therapy), and
3. Hiatal hernia TIF procedure. (Based on (FDA) approval).
Limitations
Coverage is not extended:
1. For those patients who may have recurrent symptoms or may fail this procedure. No literature has been submitted for repeat TIF use. These procedures (repeat TIF) would be considered investigational at this time.
Summary of evidence (opening)
Summary of evidence for TIF: June 2020
• Chang CG, Thackeray L. Laparoscopic Hiatal Hernia Repair in 221 Patients: Outcomes and Experience. JSLS . 2016;20(1):e2015.00104. doi:10.4293/JSLS.2015.00104. The article addresses the common condition of hiatal hernia, which is often associated with symptomatic gastroesophageal reflux disease (GERD). The article supported the studies outcomes of the efficacy and safety of laparoscopic hiatal hernia repair (LHHR) with biologic mesh to reduce and/or alleviate GERD symptoms and associated hiatal hernia recurrence. The greatest GERD-HRQL score decrease (20.5 ± 13.4) was observed in patients who underwent LHHR with a fundoplication procedure (Nissen/TIF).
• Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg . 2011; 202(6):740-747. doi:10.1016/j.amjsurg.2011.06.035. The study supports the safety of TIF and the procedure’s ability to significantly reduce the symptoms. The technology represents a suitable alternative treatment option to patients with chronic GERD not satisfied with their current management of the disease. The use of laparoscopic HHR can augment the use of transoral fundoplication without introducing the side effects of laparoscopic Nissen fundoplication (LNF).
• Ihde GM 2nd, Pena C, Scitern C, Brewer S. pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication. JSLS . 2019;23(1):e2018.00087. doi:10.4293/JSLS.2018.00087. This article supports that hiatal hernia repair combined with transoral incisionless fundoplication significantly improved outcomes in patients with gastroesophageal reflux disease in both subjective Gastroesophageal Reflux Disease Health Related Quality of Life and Reflux Symptom Index measurements as well as in objective pH scores.
The contractor cites 16 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2015-10-01
- Current revision effective
- 2026-07-30
- Last reviewed by the contractor
- 2026-06-25
- MCD version
- 32
- Derived from
- L30473
The contractor lists 2 National Coverage Determinations as related: NCD 100.2 Endoscopy, NCD 100.3 24-Hour Ambulatory Esophageal pH Monitoring. Where an NCD speaks, it controls; the LCD can only address what the NCD leaves open.
Other related documents: A58568 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Wisconsin Physicians Service Insurance Corporation hub lists every other active policy from the same contractor.
Frequently asked questions
What does LCD L34659 cover?
Benefits are not available for endoluminal treatment for Gastroesophageal Reflux Disease (GERD) using the Stretta® procedure, the Bard EndoCinch™ Suturing System, Plicator™, or similar treatments as these procedures are not considered reasonable and necessary for the diagnosis or treatment of an injury or disease. The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L34659 apply to?
Wisconsin Physicians Service Insurance Corporation applies it to Medicare claims in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L34659?
The companion billing and coding article A56395 lists 3 ICD-10-CM codes in 1 group that support medical necessity and 1 that do not; the first 3 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L34659?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.