National Coverage Analysis (NCA) Tracking Sheet

Tumor Antigen by Immunoassay CA 125 (Addition of Primary Peritoneal Adenocarcinoma as a Covered Indication)

CAG-00290R

Issue

Primary Peritoneal Adenocarcinoma arises in the peritoneum and is very similar to epithelial ovarian cancer in terms of microscopic appearance, symptoms, pattern of spread, treatment and prognosis. This is because the lining of the abdomen and the surface of the ovary arise from the same embryonic tissue. Symptoms for primary peritoneal adenocarcinoma can be vague and difficult to detect, especially when the disease is in its early stages.

Primary peritoneal adenocarcinoma occurs exclusively in women. Patients with primary peritoneal adenocarcinoma are older compared to those with other epithelial ovarian cancers. Survival rates are poor with 100 percent mortality and median survival 12 -25 months.

The Medicare NCD covered indications for CA 125 include coverage of epithelial ovarian carcinoma. We have received a request to reconsider the NCD to add primary peritoneal adenocarcinoma as a covered indication due to its similarity to epithelial ovarian carcinoma. In our initial review of the literature we have found a few case studies and case series that have shown an association between the presence of primary peritoneal adenocarcinoma and an elevation in CA 125 though none of the studies has documented the accuracy of this test in this setting.

Benefit Category

Diagnostic Laboratory Tests

Requestor Information

Requestor Name Requestor Letter
Carly Elliott, RN, Rapid City Regional Hospital, Rapid City, SD View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
06/20/2005
Expected NCA Completion Date
03/20/2006
Public Comment Period
06/20/2005 - 07/20/2005
Proposed Decision Memo Due Date
Proposed Decision Memo Released
09/16/2005
Proposed Decision Memo Public Comment Period
09/16/2005 - 10/16/2005
Decision Memo Released
11/01/2005
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Jackie Sheridan-Moore
Lead Medical Officers
James Rollins, MD PhD

Medicare Benefit Category Determination Date

Actions Taken

June 20, 2005

CMS opens this reconsideration for review of addition of primary peritoneal adenocarcinoma to the covered indications for CA 125. CMS is requesting public comment before any changes are made to §190.28. After considering the public comments, we will release a proposed decision memorandum.

September 16, 2005

CMS posts a proposed decision memorandum  indicating its intent to cover CA 125 testing for the surveillance of PPC. CMS is requesting public comment on its proposal. After considering public comment, we will release a final decision memorandum.

Instructions for submitting public comments can be found here.

November 1, 2005

CMS posts a final decision memorandum  indicating its intent to cover CA 125 testing for the surveillance of PPC.