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National Coverage Analysis (NCA) Tracking Sheet

Diabetic Peripheral Neuropathy with Loss of Protective Sensation (LOPS)

CAG-00059N

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Issue

Diabetic peripheral neuropathy with loss of protective sensation (LOPS) may place a beneficiary at risk for foot ulcers and amputations. Coverage for routine foot care may be allowed for beneficiaries with a systemic condition(s) that results in severe circulatory embarrassment or areas of diminished sensation in the individual's legs or feet. Systemic conditions are metabolic, neurologic, or peripheral vascular diseases (Medicare Carriers Manual, Part 3, §2323). Class findings are used to identify the presence of peripheral complications that place individuals at risk for infection and/or injury if non-professional foot care services are provided (Medicare Carriers Manual, Part 3, §4120.1). A presumption of coverage may be applied when the physician rendering the routine foot care has identified (1) a class A finding; (2) two of the Class B findings; or (3) one class B and two Class C findings.

The American Diabetes Association (ADA) requests that a HCFA expert panel review the scientific evidence for inclusion of diabetic peripheral neuropathy with loss of protective sensation as a Class A Finding (Q7) modifier as a presumption of coverage for routine foot care for Medicare beneficiaries. The ADA maintains that direct scientific evidence for the role of peripheral neuropathy with loss of protective sensation as an independent foot-related risk factor was lacking at the time the original class findings standards were developed.

HCFA requests that all interested parties send information on the following:

  1. What finding(s) must be present to diagnose peripheral neuropathy with loss of protective sensation?
  2. What are the minimum tests necessary to confirm a diagnosis of peripheral neuropathy with loss of protective sensation?
  3. What clinical evidence exists that demonstrates the benefit of routine foot care in preventing foot ulcers or reducing the rate of lower extremity amputations in diabetics with peripheral neuropathy?

National Coverage Determinations

Benefit Category

Physicians' Services

Requestor Information

Requestor Name Requestor Letter
American Diabetes Association N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
03/23/2000
Expected NCA Completion Date
10/17/2001
Public Comment Period
04/24/2000 - 05/24/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
10/17/2001

Contacts

Lead Analysts
Anthony Norris
Lead Medical Officers
Joseph Chin, MD

Medicare Benefit Category Determination Date

Actions Taken

February 22, 2000

Application received from the ADA.

March 23, 2000

CMS completes initial survey of other literature and determines that request is complete.

May 3, 2000

Dept. of Veterans Affairs Medical Center, Podiatry Section, Lebanon, PA submitted evidence.

May 23, 2000

Veterans Administration, Healthcare Analysis and Information Group submitted evidence.

May 24, 2000

Due date revised to August 22, 2000 in light of new evidence from Veterans Administration.

December 6, 2000

A meeting is held between CMS and officers of the ADA. The decision memorandum is to be issued 30 days following the meeting.

April 17, 2001

Decision delayed in order to accommodate request that additional evidence from a multidisciplinary group of clinicians be considered before issuing a final decision.

June 26, 2001

The due date is extended to August 8, 2001. CMS is using the additional time to consider the information presented with respect to the signs, symptoms, and diagnostic tests necessary to confirm a diagnosis of LOPS for purposes of eligibility and coverage.

August 24, 2001

The due date is extended to September 28, 2001. CMS is analyzing the statutory language on the exclusion of routine foot care and the regulatory language outlining exceptions, 42 CFR 411.15 (l)(i), and the extent to which the extension of coverage under consideration would be influenced.

October 11, 2001

The due date is extended to October 26, 2001. The document is undergoing internal review.

October 17, 2001

Decision Memorandum posted which announces CMS's intent to issue an NCD covering foot care, that would otherwise be considered routine in the absence of localized illness of the feet, for Medicare beneficiaries with peripheral neuropathy with LOPS as provided under 42 CFR 411.15(l)(1)(i).

April 2002

Claims processing instructions issued and NCD updated.
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