National Coverage Analysis (NCA) Tracking Sheet

Warm-Up Wound Therapy® a/k/a Noncontact Normothermic Wound Therapy (NNWT)

CAG-00114N

Issue

Chronic skin wounds and ulcers result in serious morbidity to Medicare and Medicaid beneficiaries each year. In the United States, there are 6.5 million chronic wounds per year. The Warm-up Wound Therapy® was developed to raise the temperature in a wound to core body temperature to promote healing, reduce rates of infection, and reduce complications. The apparatus consists of a noncontact, domed wound cover into which a flexible infrared heating card is inserted. A battery pack powers the device and warms the wound to a predetermined temperature. The inside of the wound cover contains a foam ring, which acts as a wick to drain away exudate. The requestor is asking for Medicare coverage of this device for pressure ulcers, diabetic/neuropathic ulcers, venous ulcers, complicated non-healing surgical incisions/wounds, and chronic wounds.

It is our intention to review this matter to determine if a national coverage determination (NCD) would be appropriate. Therefore, we invite any interested party to submit scientific evidence to assist us in this review.

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
Augustine Medical N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
09/25/2001
Expected NCA Completion Date
01/14/2002
Public Comment Period
10/25/2001 - 11/25/2001
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
01/14/2002

Contacts

Lead Analysts
Lorrie Ballantine
Joyce Eng
Lead Medical Officers
Ron Dei Cas, MD

Medicare Benefit Category Determination Date

Actions Taken

August 23, 2001

CMS met with Augustine Medical to review existing evidence and clarify details concerning NCD request. Following the meeting, additional information was provided by the requestor.

October 4, 2001

CMS officially accepts NCD request from Augustine Medical. The current due date of the decision memorandum is January 2, 2002.

December 28, 2001

CMS received request from Augustine Medical to withdraw its request for a national coverage determination.

January 14, 2002

CMS denies Augustine Medical's request for withdrawal. Decision memorandum posted which announces CMS's intent to issue a national noncoverage decision.

February 14, 2002

In an effort to ensure the accuracy of our decision memorandum, we have posted a revised version of our Decision Memorandum  to reflect minor technical corrections made to this document.

February 2002

Claims processing instructions issued and NCD updated.