NCD 210.2.1

Item/Service Description

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.

Indications and Limitations of Coverage

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

N/A

(This NCD last reviewed July 2015.)

Revision History

02/2016 - The purpose of this this Change Request (CR) is that CMS has determined that for dates of service on or after effective July 9, 2015, evidence is sufficient to add HPV testing under specified conditions. Effective date: 07/09/2015 Implementation date: 03/07/2016 (TN 189) (CR9434)