National Coverage Analysis (NCA) Tracking Sheet

Lymphedema Pumps

CAG-00016N

Issue

HCFA has received inquiries on the national coverage policy on lymphedema pumps. Based on this request and our initial analysis, we have decided to review certain aspects of our current national coverage policy. Our intent is to review the current clinical evidence on the use of lymphedema pumps for the treatment of lymphedema.

We ask that any interested party or anyone knowledgeable in this matter send to HCFA evidence on the use of lymphedema pumps addressing:

1. Lymphedema pumps as a treatment of lymphedema in the lower extremity associated with venous insufficiency.

2. Lymphedema pumps as a treatment for edema that is secondary to conditions other than disease of or injury to the lymphatic vessels.

3. Lymphedema pumps in the treatment and prevention of skin ulcers in limbs with primary or secondary lymphedema.

4. Current policy requires attempts to treat with less intensive modalities, such as elevation and stockings or sleeves, prior to use of pneumatic compression devices. We are interested in evidence that the primary treatment with lymphedema pumps is significantly superior to custom fabricated and graded pressure stockings or sleeves.

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
HCFA Coverage and Analysis Group N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
04/28/2000
Expected NCA Completion Date
05/03/2001
Public Comment Period
05/30/2000 - 06/30/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
05/03/2001

Contacts

Lead Analysts
Lorrie Ballantine
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

July 27, 2000

Due date is extended to October 25, 2000. We have received additional information that may materially affect our determination. Therefore, we are extending our due date to allow us to fully consider this information.

October 25, 2000

After a review of the evidence, we identified 2 primary and distinct indications for the use of the pump. or this reason, we found it necessary to divide our review and subsequent decision into 2 separate parts. The use of pneumatic compression pumps for the treatment of lymphedema, both primary and secondary in nature and the use of the pumps to treat venous insufficiency.

We plan to issue a revision to the National Coverage Policy in the near future detailing the use of these pumps to treat primary or secondary lymphedema.

We have requested that AHRQ perform a review and assessment of peer reviewed literature dealing with the use of pneumatic compression pumps for the treatment of lymphedema in the home setting for venous insufficiency and ulceration of the lower extremities. Therefore, we are continuing our review of pneumatic compression pumps for venous insufficiency. The technology assessment is due in approximately 5 months.

November 30, 2000

We met with representatives from a manufacturer of pneumatic compression pumps to obtain additional information and to discuss medical evidence. We expect a final decision memo by January 15, 2001.

May 3, 2001

January 2002

NCD updated.