Key facts for NCD 190.28
- Benefit category
- Diagnostic Laboratory Tests
- Effective date
- 01/01/2006
- Implemented 01/03/2006
- Transmittal
- Transmittal 47
- Versions published
- 2
- Manual chapter
- 190
- NCD Manual (Pub. 100-03)
- Lab edit list
- 47 covered ICD-10
- 245 non-covered
TL;DR
NCD 190.28 sets Medicare's national policy for tumor antigen by immunoassay - ca 125 under the benefit category "Diagnostic Laboratory Tests", effective 01/01/2006 and implemented 01/03/2006. 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… As a laboratory NCD it carries a national ICD-10 edit list: 47 diagnosis codes support medical necessity and 245 are denied, applied automatically by every Medicare contractor to 1 procedure code.
Item or service described
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.
This policy specifically addresses tumor antigen CA 125.
Indications and limitations of coverage
Indications
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 or primary peritoneal carcinoma .
A CA125 level may be obtained as part of the initial pre-operative work-up for women presenting with a suspicious pelvic mass to be used as a baseline for purposes of post-operative monitoring. Initial declines in CA 125 after initial surgery and/or chemotherapy for ovarian carcinoma are also measured by obtaining three serum levels during the first month post treatment to determine the patient's CA 125 half-life, which has significant prognostic implications.
The CA 125 levels are again obtained at the completion of chemotherapy as an index of residual disease. Surveillance CA125 measurements are generally obtained every 3 months for 2 years, every 6 months for the next 3 years, and yearly thereafter. CA 125 levels are also an important indicator of a patient's response to therapy in the presence of advanced or recurrent disease. In this setting, CA 125 levels may be obtained prior to each treatment cycle.
Limitations
These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy. The service may be ordered at times necessary to assess either the presence of recurrent disease or the patient's response to treatment with subsequent treatment cycles.
The CA 125 is specifically not covered for aiding in the differential diagnosis of patients with a pelvic mass as the sensitivity and specificity of the test is not sufficient. In general, a single "tumor marker" will suffice in following a patient with one of these malignancies.
(This NCD last reviewed November 2005)
Note: Scroll down for links to the quarterly Covered Code Lists (including narrative).
Text reproduced from the CMS Medicare Coverage Database record for NCD 190.28 version 2. View the original on cms.gov.
Laboratory NCD code lists (January 2026)
Medicare contractors apply this NCD through a national edit: the procedure codes below are paid only when the claim carries a covered diagnosis. The January 2026 list holds 47 covered and 245 non-covered ICD-10-CM codes plus 7 codes with other resolution rules.
1 procedure code are edited against this NCD's diagnosis list. CPT codes are shown as numbers only; descriptors are licensed by the AMA.
| Code | Code set |
|---|---|
| 86304 | CPT (descriptor licensed by AMA) |
The first 40 of 47 covered diagnosis codes, with FY2027 ICD-10-CM descriptions. A claim with any covered code on the line supports medical necessity under the national edit.
| ICD-10-CM | Description | Effective |
|---|---|---|
| C451 | Mesothelioma of peritoneum | 2015-10-01 |
| C481 | Malignant neoplasm of specified parts of peritoneum | 2015-10-01 |
| C482 | Malignant neoplasm of peritoneum, unspecified | 2015-10-01 |
| C488 | Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum | 2015-10-01 |
| C518 | Malignant neoplasm of overlapping sites of vulva | 2015-10-01 |
| C530 | Malignant neoplasm of endocervix | 2015-10-01 |
| C541 | Malignant neoplasm of endometrium | 2015-10-01 |
| C542 | Malignant neoplasm of myometrium | 2015-10-01 |
| C543 | Malignant neoplasm of fundus uteri | 2015-10-01 |
| C549 | Malignant neoplasm of corpus uteri, unspecified | 2015-10-01 |
| C561 | Malignant neoplasm of right ovary | 2015-10-01 |
| C562 | Malignant neoplasm of left ovary | 2015-10-01 |
| C563 | Malignant neoplasm of bilateral ovaries | 2021-10-01 |
| C569 | Malignant neoplasm of unspecified ovary | 2015-10-01 |
| C5700 | Malignant neoplasm of unspecified fallopian tube | 2015-10-01 |
| C5701 | Malignant neoplasm of right fallopian tube | 2015-10-01 |
| C5702 | Malignant neoplasm of left fallopian tube | 2015-10-01 |
| C574 | Malignant neoplasm of uterine adnexa, unspecified | 2015-10-01 |
| C577 | Malignant neoplasm of other specified female genital organs | 2015-10-01 |
| C578 | Malignant neoplasm of overlapping sites of female genital organs | 2015-10-01 |
| C7960 | Secondary malignant neoplasm of unspecified ovary | 2015-10-01 |
| C7961 | Secondary malignant neoplasm of right ovary | 2015-10-01 |
| C7962 | Secondary malignant neoplasm of left ovary | 2015-10-01 |
| C7963 | Secondary malignant neoplasm of bilateral ovaries | 2021-10-01 |
| C7982 | Secondary malignant neoplasm of genital organs | 2015-10-01 |
| D390 | Neoplasm of uncertain behavior of uterus | 2015-10-01 |
| D3910 | Neoplasm of uncertain behavior of unspecified ovary | 2015-10-01 |
| D3911 | Neoplasm of uncertain behavior of right ovary | 2015-10-01 |
| D3912 | Neoplasm of uncertain behavior of left ovary | 2015-10-01 |
| D392 | Neoplasm of uncertain behavior of placenta | 2015-10-01 |
| D398 | Neoplasm of uncertain behavior of other specified female genital organs | 2015-10-01 |
| D399 | Neoplasm of uncertain behavior of female genital organ, unspecified | 2015-10-01 |
| G893 | Neoplasm related pain (acute) (chronic) | 2015-10-01 |
| M3303 | Juvenile dermatomyositis without myopathy | 2017-10-01 |
| M3313 | Other dermatomyositis without myopathy | 2017-10-01 |
| M3393 | Dermatopolymyositis, unspecified without myopathy | 2017-10-01 |
| R1901 | Right upper quadrant abdominal swelling, mass and lump | 2021-10-01 |
| R1902 | Left upper quadrant abdominal swelling, mass and lump | 2021-10-01 |
| R1903 | Right lower quadrant abdominal swelling, mass and lump | 2021-10-01 |
| R1904 | Left lower quadrant abdominal swelling, mass and lump | 2021-10-01 |
245 diagnosis codes deny automatically under this NCD; the first 20 are shown.
| ICD-10-CM | Description |
|---|---|
| R99 | Ill-defined and unknown cause of mortality |
| Z0000 | Encounter for general adult medical examination without abnormal findings |
| Z0001 | Encounter for general adult medical examination with abnormal findings |
| Z00110 | Health examination for newborn under 8 days old |
| Z00111 | Health examination for newborn 8 to 28 days old |
| Z00121 | Encounter for routine child health examination with abnormal findings |
| Z00129 | Encounter for routine child health examination without abnormal findings |
| Z005 | Encounter for examination of potential donor of organ and tissue |
| Z006 | Encounter for examination for normal comparison and control in clinical research program |
| Z0070 | Encounter for examination for period of delayed growth in childhood without abnormal findings |
| Z0071 | Encounter for examination for period of delayed growth in childhood with abnormal findings |
| Z008 | Encounter for other general examination |
| Z020 | Encounter for examination for admission to educational institution |
| Z021 | Encounter for pre-employment examination |
| Z022 | Encounter for examination for admission to residential institution |
| Z023 | Encounter for examination for recruitment to armed forces |
| Z024 | Encounter for examination for driving license |
| Z025 | Encounter for examination for participation in sport |
| Z026 | Encounter for examination for insurance purposes |
| Z0271 | Encounter for disability determination |
Revision history
02/2006 - Changes to the Covered Indications for Tumor Antigen by Immunoassay CA 125 to Add Primary Peritoneal Carcinoma. Effective Date: 01/01/2006. Implementation Date: 01/03/2006. ( TN 47 ) (CR 4257)
07/2004 - Published NCD in the NCD Manual without change to narrative contained in PM AB-02-110. Coding guidance now published in Medicare Lab NCD Manual. Effective and Implementation dates NA. ( TN 17 ) (CR 2130)
07/2002 - Implemented NCD. Effective date 11/25/02. Implementation date 1/01/03. ( TN AB-02-110 ) (CR 2130)
How this NCD shows up on remittances
A service denied under a National Coverage Determination returns CARC 50 (not deemed medically necessary) with remark N386 (decision based on an NCD); a denial citing a local policy instead carries N115. Because NCDs bind nationally, the appeal path is documentation that the patient meets the indications above, not a contractor-policy argument.
How QuickIntell applies NCD 190.28
QuickAuth checks the ordered service and diagnosis against NCD and LCD criteria before the encounter, QuickCode validates the diagnosis pairing on the claim, and QuickRCM routes CARC 50 denials with the policy text and the covered-code list attached so the appeal starts with evidence.
Frequently asked questions — NCD 190.28
What does NCD 190.28 cover?
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 or primary peritoneal carcinoma . The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database.
When did NCD 190.28 take effect?
The current version (2) is effective 01/01/2006, implemented 01/03/2006, published in transmittal 47. CMS lists 2 versions of this NCD.
Does a Local Coverage Determination override NCD 190.28?
No. A National Coverage Determination binds all Medicare Administrative Contractors; an LCD can only address services or circumstances the NCD leaves open. Claims denied under this NCD typically return CARC 50 with remark N386 (NCD) rather than N115 (LCD).
Which diagnosis codes are covered under NCD 190.28?
The January 2026 laboratory NCD edit list contains 47 ICD-10-CM codes that support tumor antigen by immunoassay - ca 125 (for example C451 Mesothelioma of peritoneum; C481 Malignant neoplasm of specified parts of peritoneum; C482 Malignant neoplasm of peritoneum, unspecified) and 245 codes that deny. The list applies to 86304.
How often does the lab NCD code list for 190.28 change?
CMS updates the laboratory NCD edit module quarterly, with the January release carrying the annual ICD-10-CM code changes. Codes added or deleted mid-year appear in the quarterly change spreadsheets on the Lab NCDs page.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database NCDs via the CMS Coverage APIVersion API snapshot 2026-09-27 · effective 2026-09-20 · file national-coverage-ncd.jsonSHA-256 a90fadfd264b9ef4…
- Laboratory NCD ICD-10 code lists, January 2026Version January 2026 · effective 2026-01-01 · file 2026100-Initial-ICD10-NCD-Spreadsheet-20250721-508.xlsxSHA-256 57ff5cd37ba523d3…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
This page reproduces the CMS National Coverage Determination text and, for laboratory NCDs, the CMS ICD-10 edit lists, as an operational reference. Coverage decisions depend on the full policy, the claim and the contractor; nothing here is legal, clinical or billing advice. CPT codes are shown as numbers only; CPT descriptors are copyright AMA.