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

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).

Definitions

• 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.

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

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)

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.

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