CurrentAetnaPolicy 0527

Intragastric Hypothermia

Aetna Clinical Policy Bulletin addressing coverage for intragastric hypothermia (gastric freezing). It states the procedure is considered experimental and investigational for chronic peptic ulcer disease and any other indications due to insufficient evidence.

Policy Summary

PayerAetna

PolicyIntragastric Hypothermia

Policy CodePolicy 0527

Change TypeClarified

Effective DateJun 15, 2001

Next Review DateJun 13, 2024

Key ActionClaims for gastric freezing (intragastric hypothermia) will be considered not medically necessary/experimental and investigational for chronic peptic ulcer disease and any other indications and are therefore not covered.

SourceLink

POLICY UPDATE CHANGES

Policy states intragastric hypothermia (gastric freezing) is experimental and investigational for chronic peptic ulcer disease and any other indications due to insufficient evidence.

1Primary non-covered indication listed

1Procedure HCPCS code listed

6Key policy dates present

Coverage Summary

Scope: Aetna Clinical Policy Bulletin addressing intragastric hypothermia (gastric freezing). Aetna considers gastric freezing (intragastric hypothermia) experimental and investigational for chronic peptic ulcer disease and for any other indications because there is insufficient evidence to support its effectiveness.

Experimental and Investigational

Aetna considers gastric freezing (intragastric hypothermia) experimental and investigational because there is insufficient evidence to support its effectiveness.

ALL of the following

Gastric freezing (intragastric hypothermia) is considered experimental and investigational for chronic peptic ulcer disease.
Gastric freezing (intragastric hypothermia) is considered experimental and investigational for any other indications.
Rationale: insufficient evidence to support effectiveness; high complication rate historically; temporary improvement only in some patients; obsolete per CMS.

Provider Actions

Denial Risk

Procedure considered experimental/investigational

Claims for gastric freezing (intragastric hypothermia) will be considered not medically necessary/experimental and investigational for chronic peptic ulcer disease and any other indications and are therefore not covered.

M0100

Coding

Not Covered - Procedure code listedHCPCSNot Covered

M0100

Intragastric hypothermia using gastric freezing

Not Covered - ICD-10 diagnoses (examples)ICD-10Not Covered

K27.4	Chronic or unspecified peptic ulcer
K27.5	Chronic or unspecified peptic ulcer
K27.6	Chronic or unspecified peptic ulcer
K27.7	Chronic or unspecified peptic ulcer
K27.8	Chronic or unspecified peptic ulcer
K27.9	Chronic or unspecified peptic ulcer

Background & Evidence

Background: Gastric freezing (intragastric hypothermia) was used historically as a non-surgical treatment for chronic peptic ulcer disease but is now seldom performed. It was abandoned because of a high complication rate, only temporary improvement in some patients, and a lack of effectiveness when tested in double-blind, controlled clinical trials. The Centers for Medicare & Medicaid Services (CMS) has concluded that this procedure is obsolete.

Evidence summary: CMS determination — CMS concluded gastric freezing is obsolete (Medicare Coverage Issues Manual §35-65, 2004). Clinical trials — double-blind, controlled clinical trials failed to demonstrate sustained effectiveness; historical literature documents high complication rates and only temporary benefit in some patients.

Year (effective)	Name	Number/Reference	Type
2004	Gastric freezing	Medicare Coverage Issues Manual §35-65	NCD

Revision History

2001-06-15effective

Policy effective date.

2004context

CMS concluded gastric freezing is obsolete (Medicare Coverage Issues Manual §35-65).

2023-07-21last_reviewLatest

Policy last review date.

clarified