CMS Pub. 100-03, ch. 1, § 210.2

or Vaginal Cancer

(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, Implementation: Upon Implementation of ICD-10)

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 Social Security Act (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 seven 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 diagnosis code 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 3 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 meatus (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 & Medicaid Services and the American Medical

Association.

210.2.1 - Screening for Cervical Cancer with Human Papillomavirus (HPV) Testing

(Effective July 9, 2015)

(Rev. 189, Issued: 02-05-16, Effective: 07-05-16; Implementation: 03-07-16 - for non-shared MAC edits; 07-05-16 - CWF analysis and design; 10-03-16 - CWF Coding, Testing and Implementation, MCS, and FISS Implementation; 01-03-17 - Requirement BR9434.04.8.2)

A. General

Medicare covers a screening pelvic examination and Pap test for all female beneficiaries at 12 or 24 month

intervals, based on specific risk factors. See 42 C.F.R. §410.56; Medicare National Coverage

Determinations Manual, §210.2.1 Current Medicare coverage does not include the HPV testing. Pursuant to

§1861(ddd) of the Social Security Act, the Secretary may add coverage of "additional preventive services" if

certain statutory requirements are met.

B. Nationally Covered Indications

Effective for services performed on or after July 9, 2015, CMS has determined that the evidence is sufficient

to add Human Papillomavirus (HPV) testing once every five years as an additional preventive service benefit

under the Medicare program for asymptomatic beneficiaries aged 30 to 65 years in conjunction with the Pap

smear test. CMS will cover screening for cervical cancer with the appropriate U.S. Food and Drug

Administration (FDA) approved/cleared laboratory tests, used consistent with FDA approved labeling and in

compliance with the Clinical Laboratory Improvement Act (CLIA) regulations.

C. Nationally Non-Covered Indications

Unless specifically covered in this NCD, any other NCD, by statute or regulation, preventive services are

non-covered by Medicare.

D. Other

(This NCD last reviewed July 2015.)