This decision memorandum does not constitute a national coverage determination (NCD). It states CMS's intent to issue an NCD. Prior to any new or modified policy taking effect, CMS must first issue a manual instruction giving specific directions to our claims-processing contractors. That manual issuance, which includes an effective date, is the NCD. If appropriate, the Agency must also change billing and claims processing systems and issue related instructions to allow for payment. The NCD will be published in the Medicare Coverage Issues Manual. Policy changes become effective as of the date listed in the transmittal that announces the Coverage Issues Manual revision.
To: Administrative File CAG-00161N)
Home Blood Glucose Monitors
From: Jeffrey Shuren, MD, JD
Director, Division of Items and Devices
Sharon Hippler
Health Insurance Specialist, Division of Items and Devices
Subject: Coverage Determination Memorandum for Home Blood Glucose Monitors
Date: September 13, 2002
This memorandum serves the purpose of correcting a discrepancy in Coverage Issues Manual Section 60-11, Home Blood Glucose Monitors. Sec. 60-11 currently states that home blood glucose monitors are covered for use only by insulin-dependent diabetics. However, Sec. 1861(n) of the Social Security Act authorizes coverage of home blood glucose monitors for all diabetics under Medicare, both insulin dependent and non-insulin dependent.
Background
Section 4105 of the Balanced Budget Act (BBA) of 1997 (PL 105-33) provided coverage for blood glucose monitors and testing strips for all diabetics. These items were already covered for insulin-dependent diabetics. Effective July 1, 1998 coverage of home blood glucose monitors was extended to non-insulin dependent diabetics.
History of Medicare Coverage Policies and Timeline of Activities
Prior to BBA 1997, home blood glucose monitors and supplies were covered for insulin-dependent diabetics. As a result of BBA 1997, the Centers for Medicare and Medicaid Services (then the Health Care Financing Administration) issued Program Memorandums Nos.B-98-17, 26, and 33 extending coverage of home blood glucose monitors to non-insulin dependent diabetics, effective July 1, 1998. Presently, home blood glucose monitors and supplies are covered by statute and in practice by our contractors for all diabetics, insulin and non-insulin dependent. We have not received any public comments on this issue.
DECISION
This memorandum announces our intention to change Coverage Issues Manual Sec. 60-11 Home Blood Glucose Monitors to include coverage for non-insulin dependent diabetics (i.e., coverage for all diabetics) consistent with Section 1861(n) of the Social Security Act.
