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National Coverage Determination (NCD)

Screening for Cervical Cancer with Human Papillomavirus (HPV)

210.2.1

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Tracking Information

Publication Number
100-3
Manual Section Number
210.2.1
Manual Section Title
Screening for Cervical Cancer with Human Papillomavirus (HPV)
Version Number
1
Effective Date of this Version
07/09/2015
Ending Effective Date of this Version
Implementation Date
03/07/2016
Implementation QR Modifier Date

Description Information

Benefit Category
Additional Preventive Services


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

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.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
189
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R189NCD.pdf
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)
Other

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 for Cervical Cancer with Human Papillomavirus (HPV) 1 07/09/2015 - N/A You are here
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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.
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