LCD L34540

Coverage Guidance

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publications:

CMS Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1:

100.9 Implantation of Anti-Gastroesophageal Reflux Device

Indications and Limitations of Coverage

Abstract:

The Stretta procedure delivers radiofrequency thermal energy to the lower esophagus as a treatment for gastroesophageal reflux disease (GERD). CGS Administrators considers the Stretta procedure to be investigational and therefore non-covered.

Limitations:

An extensive literature review documented the following information:

• efficacy based on objective physiologic measurements has not been shown;

• a clear mechanism of action has not been determined, and;

• significant long-term studies confirming efficacy and safety have not been carried out. The Stretta procedure is considered investigational and is not covered.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Not applicable

Not applicable

Bibliography

N/A