National Coverage Determination (NCD)

Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical or Vaginal Cancer


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Tracking Information

Publication Number
Manual Section Number
Manual Section Title
Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical or Vaginal Cancer
Version Number
Effective Date of this Version
Ending Effective Date of this Version
Implementation Date
Implementation QR Modifier Date

Description Information

Benefit Category
Screening Pap Smear
Screening Pelvic Exam

Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description
Indications and Limitations of Coverage

CIM 50-20.1

Screening Pap Smear

A screening pap smear and related medically necessary services provided to a woman for the early detection of cervical cancer (including collection of the sample of cells and a physician's interpretation of the test results) and pelvic examination (including clinical breast examination) are covered under Medicare Part B when ordered by a physician (or authorized practitioner) under one of the following conditions:

  • She has not had such a test during the preceding two years or is a woman of childbearing age (§1861(nn) of the Act).
  • There is evidence (on the basis of her medical history or other findings) that she is at high risk of developing cervical cancer and her physician (or authorized practitioner) recommends that she have the test performed more frequently than every two years.

High risk factors for cervical and vaginal cancer are:

  • Early onset of sexual activity (under 16 years of age).
  • Multiple sexual partners (five or more in a lifetime).
  • History of sexually transmitted disease (including HIV infection).
  • Fewer than three negative or any pap smears within the previous 7 years.; and
  • DES (diethylstilbestrol) - exposed daughters of women who took DES during pregnancy.

NOTE: Claims for pap smears must indicate the beneficiary's low or high risk status by including the appropriate ICD-9-CM on the line item (Item 24E of the Form CMS-1500).


  • A woman as described in §1861(nn) of the Act is a woman who is of childbearing age and has had a pap smear test during any of the preceding three years that indicated the presence of cervical or vaginal cancer or other abnormality, or is at high risk of developing cervical or vaginal cancer.
  • A woman of childbearing age is one who is premenopausal and has been determined by a physician or other qualified practitioner to be of childbearing age, based upon the medical history or other findings.
  • Other qualified practitioner, as defined in 42 CFR 410.56(a) includes a certified nurse midwife (as defined in §1861(gg) of the Act), or a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in §1861(aa) of the Act) who is authorized under State law to perform the examination.

Screening Pelvic Examination

Section 4102 of the Balanced Budget Act of 1997 provides for coverage of screening pelvic examinations (including a clinical breast examination) for all female beneficiaries, subject to certain frequency and other limitations. A screening pelvic examination (including a clinical breast examination) should include at least seven of the following eleven elements:

  • Inspection and palpation of breasts for masses or lumps, tenderness, symmetry, or nipple discharge.
  • Digital rectal examination including sphincter tone, presence of hemorrhoids, and rectal masses. Pelvic examination (with or without specimen collection for smears and cultures) including:
  • External genitalia (for example, general appearance, hair distribution, or lesions).
  • Urethral maetus (for example, size, location, lesions, or prolapse).
  • Urethra (for example, masses, tenderness, or scarring).
  • Bladder (for example, fullness, masses, or tenderness).
  • Vagina (for example, general appearance, estrogen effect, discharge lesions, pelvic support, cystocele, or rectocele).
  • Cervix (for example, general appearance, lesions, or discharge).
  • Uterus (for example, size, contour, position, mobility, tenderness, consistency, descent, or support).
  • Adnexa/parametria (for example, masses, tenderness, organomegaly, or nodularity).
  • Anus and perineum.

This description is from Documentation Guidelines for Evaluation and Management Services, published in May 1997 and was developed by the Centers for Medicare and Medicaid Services and the American Medical Association.

Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
Revision History

03/2006 - Delete coding information. Effective/Implementation date: 06/19/2006. (TN 48) (CR4278)

12/2002 - Section 101 of Benefits Improvement and Protection Act of 2000 (P.L. 106-554) changed the screening frequency from once every three years to once every two years.  This section of the manual has not been updated to reflect the change.  The conforming regulation at 42 CFR § 410.56 has been updated.  Effective date of change 07/01/2001.

03/1998 - Reflected changes mandated by section 4102 of the Balanced Budget Act of 1998 and listed high risk factors for developing cervical or vaginal cancer. Effective date 01/01/1998.  (TN 103)

07/1990 - Provided coverage instructions authorized by section 6115 of OBRA 1989. Effective date 07/01/1990. (TN 43)


National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical or Vaginal Cancer 3 06/19/2006 - N/A View
Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical or Vaginal Cancer 2 06/19/2006 - 06/19/2006 You are here
Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical or Vaginal Cancer 1 07/01/2001 - 06/19/2006 View
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CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.