Prior Authorization Review Panel MCO Policy Submission

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1 Prior Authorization Review Panel MCO Policy Submission A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review. Plan: Aetna Better Health Submission Date: 11/01/2018 Policy Number: 0527 Policy Name: Intragastric Hypothermia Effective Date: Revision Date: Type of Submission Check all that apply: New Policy* Revised Policy Annual Review No Revisions *All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below: CPB 0527 Intragastric Hypothermia Policy is new to Aetna Better Health of Pennsylvania. Name of Authorized Individual (Please type or print): Signature of Authorized Individual: Dr. Bernard Lewin, M.D.

2 Intragastric Hypothermia - Medical Clinical Policy Bulletins Aetna Page 1 of 5 Intragastric Hypothermia Number: 0527 Policy *Please see amendment forpennsylvaniamedicaid at theend of this CPB. Aetna considers gastric freezing (intragastric hypothermia) experimental and investigational for chronic peptic ulcer disease or any other indications because there is insufficient evidence to support its effectiveness for these indications. Policy History Last Review: 10/10/2018 Effective: 06/15/2001 Next Review: 05/23/2019 Review History Definitions Background Gastric freezing for chronic peptic ulcer disease is a nonsurgical treatment which was popular about 20 years ago but now is seldom performed. It has been abandoned due to a high complication rate, only temporary improvement experienced by patients, and a lack of effectiveness when tested by double-blind, controlled clinical trials. The Center for Medicare and Medicaid Services (CMS) has concluded that this procedure is obsolete. Additional Information Clinical Policy Bulletin Notes CPT Codes / HCPCS Codes / ICD-10 Codes

3 Intragastric Hypothermia - Medical Clinical Policy Bulletins Aetna Page 2 of 5 Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+": Code Code Description HCPCS codes not covered for indications listed in the CPB: M0100 Intragastric hypothermia using gastric freezing ICD-10 codes not covered for indications listed in the CPB: (not all-inclusive) : K Chronic or unspecified peptic ulcer K27.9 The above policy is based on the following references: 1. U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS). Gastric freezing. Medicare Coverage Issues Manual Baltimore, MD: CMS; Nasbeth DC, Nicholson AJ, Newman WH, et al. The influence of intragastric cooling on acute experimental pancreatitis. Surg Forum. 1960;11: Nasbeth DC, Goodale RL, Reif AE. Studies on the effect of intragastric cooling on acute experimental pancreatitis. Surgery. 1960;47: Ruffin JM, Grizzle JE, Hightower NC, et al. A co- operative double-blind evaluation of gastric 'freezing' in the treatment of duodenal ulcer. N Engl J Med. 1969;281 (1): McIntyre JA, Jalil S, Deitel M. Clinical course after gastric freezing: Long-term follow-up of 74 patients and a review of the literature. Can J Surg. 1969;12(2): Ruffin JM, Shingleton WM, McMillan WO Jr. Cold facts about gastric freezing. Postgrad Med. 1968;44(5):84-87.

4 Intragastric Hypothermia - Medical Clinical Policy Bulletins Aetna Page 3 of 5 7. Zikria BA, De Jesus RS, Cunnick WR, Ferrer JM Jr. Gastric 'freezing'--a clinical double-blind study. Am J Gastroenterol. 1967;47(3): Barner HB, Collins CH, Jones TI, Garlick TB. Clinical gastric 'freezing'. Am J Dig Dis. 1966;11(8): Marx FW Jr, Kolig G. The hazards of gastric freezing. Am J Dig Dis. 1966;11(4): Lubos MC, Viril LC, Klotz AP. A controlled study of outpatient gastric freezing. Am J Dig Dis. 1966;11(4): Wangensteen SL, Smith RB 3, Barker HG. Gastric cooling and gastric 'freezing'. Surg Clin North Am. 1966;46(2): Hitchcock CR, Ruiz E, Sutherland D, Bitter JE. Eighteenmonth follow-up of gastric freezing in 173 patients with duodenal ulcer. JAMA. 1966;195(2): Fuson RL, Shingleton WW. Technical considerations in gastric freezing. Cryobiology. 1965;2(3): Scott HW Jr, O'Neill JA Jr, Snyder HE, Shull HJ. An evaluation of the long term results of gastric freezing for duodenal ulcer. Surg Gynecol Obstet. 1965;121(4): Rose H, Fordtran JS, Harrell R, Friedman B. A controlled study of gastric freezing for the treatment of duodenal ulcer. Gastroenterol. 1964;47: Perry GT, Dunphy JV, Fruin RC, Littman A. Gastric freezing for duodenal ulcer, a double blind study. Gastroenterol. 1964:47: Goodale RL Jr, Ghanem M, Borner JW, et al. Improved technology and enhanced accomplishment of gastric freezing. An experimental study. Arch Surg. 1972;104 (3): Miao LL. Gastric freezing: An example of the evaluation of medical therapy by randomized clinical trials. In: Bunker JR, Barnes BA, Mostelloer F, eds. Cost, Risks and Benefits of Therapy. New York, NY: Oxford University Press:1977; Ch.12, pp

5 Intragastric Hypothermia - Medical Clinical Policy Bulletins Aetna Page 4 of Fineberg HV. Gastric freezing: A study of diffusion of a medical innovation. In: Medical Technology and the Health Care System. National Academy of Sciences. Washington, DC: U.S. Government Printing Office; 1979, pp Edmonson JM. Gastric freezing: The view a quarter century later. J Lab Clin Med. 1989;114(5):

6 Intragastric Hypothermia - Medical Clinical Policy Bulletins Aetna Page 5 of 5 Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change. Copyright Aetna Inc.

7 AETNA BETTER HEALTH OF PENNSYLVANIA Amendment to Aetna Clinical Policy Bulletin Number: 0527 Intragastric Hypothermia There are no amendments for Medicaid. new 11/01/2018

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