National Coverage Analysis (NCA) Tracking Sheet

Cryosurgical Salvage Therapy for Recurrent Prostate Cancer

CAG-00064N

Issue

Cryosurgical salvage therapy is a method that may be used as a treatment for recurrent prostate cancer. Currently Medicare coverage, effective July 1, 1999, is limited to cryosurgical ablation for a patient with clinically localized prostate cancer. (Coverage Issues Manual 35-96).

We currently do not have enough scientific data to make a medically sound; evidence based determination on this issue.

Endocare, Inc. has requested that the current non-coverage policy for prostate cryoablation as salvage therapy for recurrent prostate cancer be reconsidered. HCFA must reevaluate whether current literature supports that cryosurgical salvage therapy is a "reasonable and necessary" prostate cancer treatment.

National Coverage Determinations

Benefit Category

Inpatient Hospital Services
Outpatient Hospital Services Incident to a Physician's Service
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Endocare, Inc., Galil Medical USA N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
07/05/2000
Expected NCA Completion Date
12/05/2000
Public Comment Period
08/04/2000 - 09/04/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
12/05/2000

Contacts

Lead Analysts
Samantha Richardson
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

June 15, 2000

Met with Endocare.

July 5, 2000

Accepted formal reconsideration request.

September 5, 2000

Accepted a subsequent formal request from Galil Medical USA in which Galil Medical USA included additional evidence on cryosurgery.

November 16, 2000

American Urological Association submitted a position statement on salvage cryosurgical ablation of the prostate.

November 21, 2000

Conference call with Galil Medical to discuss any outstanding issues concerning information they submitted.

December 05, 2000

National coverage decision determined.

December 12, 2000

Final national Coverage Decision posted on internet site.