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  The Center for Medicare and Medicaid Services (CMS) has concluded that this procedure is obsolete. 

Table: CPT Codes / HCPCS Codes / ICD-10 Codes
Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":

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) :
K27.4 - K27.9 Chronic or unspecified peptic ulcer

The above policy is based on the following references:

  1. Barner HB, Collins CH, Jones TI, Garlick TB. Clinical gastric 'freezing'. Am J Dig Dis. 1966;11(8):625-629.
  2. Edmonson JM. Gastric freezing: The view a quarter century later. J Lab Clin Med. 1989;114(5):613-614.
  3. 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.
  4. Fuson RL, Shingleton WW. Technical considerations in gastric freezing. Cryobiology. 1965;2(3):134-138.
  5. 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.
  6. 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.
  7. Lubos MC, Viril LC, Klotz AP. A controlled study of outpatient gastric freezing. Am J Dig Dis. 1966;11(4):266-271.
  8. Marx FW Jr, Kolig G. The hazards of gastric freezing. Am J Dig Dis. 1966;11(4):272-278.
  9. 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.
  10. 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.
  11. Nasbeth DC, Goodale RL, Reif AE. Studies on the effect of intragastric cooling on acute experimental pancreatitis. Surgery. 1960;47:542-547.
  12. Nasbeth DC, Nicholson AJ, Newman WH, et al. The influence of intragastric cooling on acute experimental pancreatitis. Surg Forum. 1960;11:363-364.
  13. Perry GT, Dunphy JV, Fruin RC, Littman A. Gastric freezing for duodenal ulcer, a double blind study. Gastroenterol. 1964:47:6-9.
  14. 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
  15. 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.
  16. Ruffin JM, Shingleton WM, McMillan WO Jr. Cold facts about gastric freezing. Postgrad Med. 1968;44(5):84-87.
  17. 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.
  18. 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.
  19. Wangensteen SL, Smith RB 3, Barker HG. Gastric cooling and gastric 'freezing'. Surg Clin North Am. 1966;46(2):463-475.
  20. 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.