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National Coverage Determination (NCD)

Prostate Cancer Screening Tests

210.1

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Tracking Information

Publication Number
100-3
Manual Section Number
210.1
Manual Section Title
Prostate Cancer Screening Tests
Version Number
2
Effective Date of this Version
06/19/2006
Ending Effective Date of this Version
Implementation Date
06/19/2006
Implementation QR Modifier Date

Description Information

Benefit Category
Prostate Cancer Screening Tests


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 50-55

Covered

A. General

Section 4103 of the Balanced Budget Act of 1997 provides for coverage of certain prostate cancer screening tests subject to certain coverage, frequency, and payment limitations. Medicare will cover prostate cancer screening tests/procedures for the early detection of prostate cancer. Coverage of prostate cancer screening tests includes the following procedures furnished to an individual for the early detection of prostate cancer:

  • Screening digital rectal examination; and
  • Screening prostate specific antigen blood test

B. Screening Digital Rectal Examinations

Screening digital rectal examinations are covered at a frequency of once every 12 months for men who have attained age 50 (at least 11 months have passed following the month in which the last Medicare-covered screening digital rectal examination was performed). Screening digital rectal examination means a clinical examination of an individual's prostate for nodules or other abnormalities of the prostate. This screening must be performed by a doctor of medicine or osteopathy (as defined in §1861(r)(1) of the Act), or by a physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife (as defined in §1861(aa) and §1861(gg) of the Act) who is authorized under State law to perform the examination, fully knowledgeable about the beneficiary's medical condition, and would be responsible for using the results of any examination performed in the overall management of the beneficiary's specific medical problem.

C. Screening Prostate Specific Antigen Tests

Screening prostate specific antigen tests are covered at a frequency of once every 12 months for men who have attained age 50 (at least 11 months have passed following the month in which the last Medicare-covered screening prostate specific antigen test was performed). Screening prostate specific antigen tests (PSA) means a test to detect the marker for adenocarcinoma of prostate. PSA is a reliable immunocytochemical marker for primary and metastatic adenocarcinoma of prostate. This screening must be ordered by the beneficiary's physician or by the beneficiary's physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife (the term "attending physician" is defined in §1861(r)(1) of the Act to mean a doctor of medicine or osteopathy and the terms "physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife" are defined in §1861(aa) and §1861(gg) of the Act) who is fully knowledgeable about the beneficiary's medical condition, and who would be responsible for using the results of any examination (test) performed in the overall management of the beneficiary's specific medical problem.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
48
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R48NCD.pdf
Revision History

01/2024 - Transmittal 12355 issued November 09, 2023, is being rescinded and replaced by Transmittal 12444, January 4, 2024 to add clarifying verbiage to NCD 90.2, business requirement 13278.2, and related edits to NCD 90.2, Next Generation Sequencing, attached spreadsheet. All other information remains the same. (TN 12444) (CR13278)

11/2023 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 12355) (CR13278)

08/2023 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. (TN 12184) (CR13278)

05/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determination (NCDs). No policy is being changed as a result of these updates. (TN 12017) (CR13166)

04/2023 - Transmittal 11884 issued March 01, 2023, is being rescinded and replaced by Transmittal 11952, dated, April 12, 2023, to remove the A/B MACs (Part A) and FISS from BR 13070.1 and to revise the NCD 20.4 Implantable Automatic Defibrillators (ICDs) spreadsheet. All other information remains the same. (TN 11952) (CR13070)

02/2023 - The purpose of the Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 11832) (CR13070)

05/2014 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/06/2014 Effective date: 10/1/2015. (TN 1388) (TN 1388) (CR 8691)

01/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 04/01/2013 Effective date: 10/1/2015. (TN 1165) (CR 8109)

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

04/1999 - Provided coverage for certain prostate cancer screening tests as mandated by section 4103 of the BBA of 1997. Effective date 01/01/2000. (TN 109).  Conforming regulations found at 42 CFR  §410.39 (http://www.gpo.gov/nara/cfr/index.html)
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
Prostate Cancer Screening Tests 2 06/19/2006 - N/A You are here
Prostate Cancer Screening Tests 1 01/01/2000 - 06/19/2006 View
CPT Copyright Statement
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.
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