OAR 410-122-0525: External Insulin Infusion Pump

(1) Indications and limitations of coverage and medical appropriateness: (a) The Division may cover an external insulin infusion pump for the administration of continuous subcutaneous insulin for the treatment of diabetes mellitus when criterion (A) or (B) is met and criterion (C) or (D) is met: (A) C-peptide testing requirement: (i) The C-peptide level is less than or equal to 110 percent of the lower limit of normal of the laboratory’s measurement method; or (ii) For a client with renal insufficiency and a creatinine clearance (actual or calculated from age, weight, and serum creatinine) less than or equal to 50 ml/minute, a fasting C-peptide level is less than or equal to 200 percent of the lower limit of normal of the laboratory’s measurement method; and (iii) A fasting blood sugar obtained at the same time as the C-peptide level is less than or equal to 225 mg/dl. (B) Beta cell autoantibody test is positive; (C) The client has: (i) Completed a comprehensive diabetes education program; and (ii) Been on a program of multiple daily injections of insulin (i.e., at least three injections per day) with frequent self-adjustments of insulin dose for at least six (6) months prior to initiation of the insulin pump; and (iii) Documented frequency of glucose self-testing an average of at least four (4) times per day during the two (2) months prior to initiation of the insulin pump and meets one (1) or more of the following criteria while on the multiple injection regimen: (I) Glycosylated hemoglobin level (HbA1C) greater than seven (7) percent; (II) History of recurring hypoglycemia; (III) Wide fluctuations in blood glucose before mealtime; (IV) Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL; (V) History of severe glycemic excursions; (D) The client has: (i) Been on an external insulin infusion pump prior to enrollment in the medical assistance program, and; (ii) Documented frequency of glucose self-testing an average of at least four times per day during the month prior to medical assistance program enrollment; (b) For continued coverage of an external insulin pump and supplies, the client shall be seen and evaluated by the treating practitioner at least every three (3) months; (c) The external insulin infusion pump shall be ordered and follow-up care rendered by a practitioner who manages multiple clients on continuous subcutaneous insulin infusion therapy and who works closely with a team including nurses, diabetic educators, and dieticians who are knowledgeable in the use of continuous subcutaneous insulin infusion therapy; (d) The Division may cover supplies (including dressings) used with an external insulin infusion pump during the period of covered use of an infusion pump. These supplies are billed with codes A4224 or A4225; (e) Code A4224 includes catheter insertion devices for use with external insulin infusion pump infusion cannulas and are not separately payable; (f) A4224 is limited to one (1) unit of service per week. (2) Coding guidelines: (a) Code A4224 includes all cannulas, needles, dressings, and infusion supplies (excluding the insulin reservoir) related to continuous subcutaneous insulin infusion via external insulin infusion pump (E0784); (b) Refer to the product classification list on the Medicare Pricing, Data Analysis and Coding (PDAC) contractor website for appropriate Healthcare Common Procedure Coding System (HCPCS) codes; (c) Insulin delivery devices and related supplies other than those identified in this rule and coverage table 122-0525 are not considered to be medically necessary or medically appropriate. (3) Documentation requirements: (a) With the request for PA, the DMEPOS provider shall submit medical justification that supports the criteria in this rule are met; (b) When billing and dispensing for an item in Table 122-0525, the DMEPOS provider shall ensure that medical records corroborate all criteria in this rule are met; (c) The DMEPOS provider shall keep medical records on file and make them available to the Division upon request. (4) Table 122-0525. [ED. NOTE: To view attachments referenced in rule text, click here to view rule.]