This coding analysis does not constitute a national coverage determination (NCD). It states the intent of the Centers for Medicare & Medicaid Services (CMS) to issue a change to the list of ICD-9-CM Codes Covered that are linked to one of the negotiated laboratory NCDs. This decision will be announced in an upcoming recurring update notification in accordance with CMS Pub 100-4, Chapter 16, section 120.2 and will become effective as of the date listed in the transmittal that announces the revision.
To: Administrative File: CAG-00245N
Tumor Antigen by Immunoassay CA 125 (Revision to Include Additional Personal History of Malignancy Codes)
From: Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Louis Jacques, MD
Director, Division of Items and Devices
Jackie Sheridan-Moore
Technical Advisor, Division of Items and Devices
Subject: Coding Analyses for Tumor Antigen by Immunoassay CA 125
Date: July 27, 2004
I. Decision
CMS has determined that ICD-9-CM diagnosis codes V10.41, Personal history of malignant neoplasm, cervix uteri, and V10.42, Personal history of malignant neoplasm, other parts of uterus, flow from the existing narrative for conditions for which tumor antigen by immunoassay CA 125 is reasonable and necessary. We intend to modify the list of "ICD-9-CM Codes Covered by Medicare" in the NCD for tumor antigen by immunoassay CA 125 to include these codes.
II. Background
On June 24, 2004 CMS began a coding analysis for expansion of the ICD-9-CM covered codes list for the tumor antigen by immunoassay CA 125 NCD. Immunoassay determinations of the serum levels of certain proteins or carbohydrates serve as tumor markers. When elevated, serum concentration of these markers may reflect tumor size and grade. CA 125 is a high molecular weight serum tumor marker elevated in most patients who present with epithelial ovarian carcinoma. It is also elevated in carcinomas of the fallopian tube, endometrium, and endocervix. An elevated level may also be associated with the presence of a malignant mesothelioma.
III. History of Medicare Coverage
In accordance with section 4554 of the Balanced Budget Act of 1997, CMS entered into negotiations with the laboratory community regarding coverage and administrative policies for clinical diagnostic laboratory services. As part of these negotiations, we promulgated a rule that included 23 NCDs. These NCDs included the tumor antigen by immunoassay CA 125. The rule was proposed in the March 10, 2000 edition of the Federal Register (65 FR 13082) and was made final on November 23, 2001 (66 FR 58788). The final rule called for a 12-month delay in effectuating the NCDs in accordance with the recommendations of the negotiating committee. Thus, the NCDs became effective on November 25, 2002.
In the laboratory NCDs, CMS determined that specific tests were reasonable and necessary for certain medical indications. These decisions were evidence-based, relying on scientific literature reviewed by the negotiating committee. The NCDs contain a narrative describing the indications for which the test is reasonable and necessary. We also developed a list of ICD-9-CM codes that designate diagnoses/conditions that fit within the narrative description of indications that support the medical necessity of the test. This list is entitled "ICD-9-CM Codes Covered by Medicare," and includes codes where there is a presumption of medical necessity.
In addition, we developed two other ICD-9-CM code lists. The second list is entitled "ICD-9-CM Codes Denied," and lists diagnosis codes that are never covered by Medicare. The third list is entitled "ICD-9-CM Codes that do not Support Medical Necessity," and includes codes that generally are not considered to support a decision that the test is reasonable and necessary, but for which there are limited exceptions. Tests in this third category may be covered when they are accompanied by additional documentation that supports a determination of reasonable and necessary. We determined in the tumor antigen by immunoassay CA 125 NCD that any ICD-9-CM code not listed in either of the ICD-9-CM covered or not covered sections would be categorized into this group that does not support medical necessity.
IV. Timeline of Recent Activities
On June 24, 2004, CMS open an internally generated coding analysis item regarding tumor antigen by immunoassay CA 125 after noting that the list of covered codes neglected to include the ICD-9-CM diagnosis codes for personal history of malignant neoplasm of cervix uteri and other parts of uterus. We posted a tracking sheet to the Internet site (http://cms.hhs.gov/mcd/viewtrackingsheet.asp?id=132), soliciting public comment for 30 days on the appropriateness of adding codes V10.41 and V10.42 to the list of covered diagnoses for tumor antigen by immunoassay CA 125. At the end of the public comment period, July 24, 2004, we had not received any comments.
V. General Methodological Principles
During the negotiation meetings that led to the development of the 23 clinical diagnostic laboratory NCDs, we stated our intent that the narrative of the NCDs reflect the substance of the determinations. The addition of the coding lists was intended as a convenience to the laboratories and as a means of ensuring consistency among the Medicare claims processing contractors as they interpreted the narrative conditions that support coverage. Thus, all of the codes in the covered code list must flow from the narrative indications of the NCD. We reiterated this position in the November 23, 2001 final rule (66 FR 58795) and in subsequent implementing instructions (Program Memorandum AB-02-110).
VI. CMS Analysis
As noted above, we have taken the position that the "ICD-9-CM Codes Covered by Medicare" list is intended to contain only those codes that flow from the narrative of the indication in the NCD. The tumor antigen immunoassay CA 125 NCD lists the following as an indication for testing:
The tumor antigen by immunoassay CA 125 NCD includes the following indication:
"CA 125 is a high molecular weight serum tumor marker elevated in 80% of patients who present with epithelial ovarian carcinoma. It is also elevated in carcinomas of the fallopian tube, endometrium, and endocervix. An elevated level may also be associated with the presence of a malignant mesothelioma."
We believe that the ICD-9-CM codes V10.41, Personal history of malignant neoplasm, cervix uteri, and V10.42, Personal history of malignant neoplasm, other parts of uterus, flow from the existing narrative indications statement quoted above. Consequently, we intend to issue a recurring update to the edit module implementing the NCDs to add ICD-9-CM codes V10.41 and V10.42 to the list of the ICD-9-CM codes covered for tumor antigen by immunoassay CA 125.
