Press Releases
MEDICARE PROPOSES EXPANDED INSULIN PUMP USE
MEDICARE PROPOSES EXPANDED INSULIN PUMP USE
The Centers for Medicare & Medicaid Services (CMS) announced today that it intends to expand Medicare coverage for insulin infusion pumps. CMS will accept public comments on the draft decision memorandum for 30 days, and will make the decision final within 90 days.
"This draft decision is part of Medicare's ongoing commitment to provide new medical technology to its beneficiaries," said CMS Administrator Mark B. McClellan, M.D., Ph.D.
Insulin infusion pumps have been covered for some Medicare Beneficiaries with diabetes since 1999. CMS developed this new draft decision in response to Medtronic MiniMed's request to remove the C-Peptide testing requirement for insulin pump coverage. C-peptide in blood demonstrates insulin release in diabetic patients.
CMS proposes several modifications to the C-peptide requirement for the insulin pump coverage.
First, CMS would allow an alternative test, called beta cell autoantibody, to identify beneficiaries with type 1 diabetes (T1DM) who would benefit from the insulin pump.
Second the decision would increase the number of beneficiaries with type 2 diabetes (T2DM) who qualify for insulin pumps by standardizing the C-peptide testing and relaxing the criteria for those with kidney disease. CMS would not change the remaining criteria for insulin pump therapy dealing with diabetic control and side effects.
The decision would make it more equitable for some Medicare beneficiaries with diabetes to qualify for continuous subcutaneous insulin infusion (CSII). It also may promote future practical clinical trials to evaluate the health benefit laboratory tests to select diabetic patients for insulin pumps.
Diabetes is comprised of two major types: T1DM, which accounts for 5 to 10 percent of diabetic patients and results from immune-mediated destruction of the pancreatic beta cells; and T2DM, which accounts for 90 to 95 percent of diabetic patients and is generally characterized by insulin resistance.
The goals of intensive therapy can be achieved by either multiple daily injections (MDI) of insulin or (CSII) using an insulin pump. The health benefits of intensive insulin therapy are substantial in T1DM, but they are less clear in T2DM.
CMS is publishing its draft decision memorandum on this National Coverage Determination today in accordance with the coverage decision timeline mandated by the Medicare Modernization Act of 2003 (MMA). The draft decision memorandum appears on the CMS on its web site at http://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center.html
CMS invites public comments on this draft and specifically on the clinical criteria proposed to identify patients eligible for coverage of continuous subcutaneous insulin infusion.