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Clinical Policy Bulletin:
Intragastric Hypothermia
Number: 0527


Policy

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.



Background

Gastric freezing for chronic peptic ulcer disease is a non-surgical 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  The Center for Medicare and Medicaid Services (CMS) has concluded that this procedure is obsolete. 

 
CPT Codes / HCPCS Codes / ICD-9 Codes
HCPCS codes not covered for indications listed in the CPB:
M0100 Intragastric hypothermia using gastric freezing
ICD-9 codes not covered for indications listed in the CPB: (not all-inclusive) :
530.00 - 533.91 Gastric ulcer


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 §35-65. Baltimore, MD: CMS; 2004.
  2. Nasbeth DC, Nicholson AJ, Newman WH, et al. The influence of intragastric cooling on acute experimental pancreatitis. Surg Forum. 1960;11:363-364.
  3. Nasbeth DC, Goodale RL, Reif AE. Studies on the effect of intragastric cooling
    on acute experimental pancreatitis. Surgery. 1960;47:542-547.
  4. 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):16-19.
  5. 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):210-221.
  6. Ruffin JM, Shingleton WM, McMillan WO Jr. Cold facts about gastric freezing. Postgrad Med. 1968;44(5):84-87.
  7. Zikria BA, De Jesus RS, Cunnick WR, Ferrer JM Jr. Gastric 'freezing'--a clinical double-blind study. Am J Gastroenterol. 1967;47(3):208-214.
  8. Barner HB, Collins CH, Jones TI, Garlick TB. Clinical gastric 'freezing'. Am J Dig Dis. 1966;11(8):625-629.
  9. Marx FW Jr, Kolig G. The hazards of gastric freezing. Am J Dig Dis. 1966;11(4):272-278.
  10. Lubos MC, Viril LC, Klotz AP. A controlled study of outpatient gastric freezing. Am J Dig Dis. 1966;11(4):266-271.
  11. Wangensteen SL, Smith RB 3, Barker HG. Gastric cooling and gastric 'freezing'. Surg Clin North Am. 1966;46(2):463-475.
  12. Hitchcock CR, Ruiz E, Sutherland D, Bitter JE. Eighteen-month follow-up of gastric freezing in 173 patients with duodenal ulcer. JAMA. 1966;195(2):71-75.
  13. Fuson RL, Shingleton WW. Technical considerations in gastric freezing. Cryobiology. 1965;2(3):134-138.
  14. 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):723-727.
  15. Rose H, Fordtran JS, Harrell R, Friedman B. A controlled study of gastric freezing for the treatment of duodenal ulcer. Gastroenterol. 1964;47:10-17
  16. Perry GT, Dunphy JV, Fruin RC, Littman A. Gastric freezing for duodenal ulcer, a double blind study. Gastroenterol. 1964:47:6-9.
  17. 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):314-318.
  18. 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. 198-211.
  19. 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. 173-220.
  20. Edmonson JM. Gastric freezing: The view a quarter century later. J Lab Clin Med. 1989;114(5):613-614.


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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.
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