||CMS National Guidelines
||Prostatic Specific Antigen (PSA) and Prostate Cancer Screening - NCD 190.31
||November 9, 2009
||November 9, 2009
PSA, a tumor marker for adenocarcinoma of the prostate, can predict residual tumor in the post-operative phase of prostate cancer. Three to six months after radical prostatectomy, PSA is reported to provide a sensitive indicator of persistent disease. Six months following introduction of antiandrogen therapy, PSA is reported as capable of distinguishing patients with favorable response from those in whom limited response is anticipated.
PSA when used in conjunction with other prostate cancer tests, such as digital rectal examination, may assist in the decision making process for diagnosing prostate cancer. PSA also serves as a marker in following the progress of most prostate tumors once a diagnosis has been established. This test is also an aid in the management of prostate cancer patients and in detecting metastatic or persistent disease in patients following treatment.
A digital rectal examination is a clinical examination of an individual’s prostate for nodules or other abnormalities of the prostate.
A digital rectal examination or PSA test is considered "screening" when performed on an individual without signs or symptoms of prostatic disease.
Coverage of prostate cancer screening tests includes screening digital rectal examination and screening prostate specific antigen blood test furnished for the early detection of prostate cancer.
Indications and Limitations of Coverage
Prostate Specific Antigen (PSA); Total (84153)
PSA is of proven value in differentiating benign from malignant disease in men with lower urinary tract signs and symptoms (e.g., hematuria, slow urine stream, hesitancy, urgency, frequency, nocturia and incontinence) as well as with patients with palpably abnormal prostate glands on physician exam, and in patients with other laboratory or imaging studies that suggest the possibility of a malignant prostate disorder. PSA is also a marker used to follow the progress of prostate cancer once a diagnosis has been established, such as in detecting metastatic or persistent disease in patients who may require additional treatment. PSA testing may also be useful in the differential diagnosis of men presenting with as yet undiagnosed disseminated metastatic disease.
Generally, for patients with lower urinary tract signs or symptoms, the test is performed only once per year unless there is a change in the patient's medical condition.
Testing with a diagnosis of in situ carcinoma is not reasonably done more frequently than once, unless the result is abnormal, in which case the test may be repeated once.
Any diagnosis other than those listed under the "Diagnosis Codes" section as covered for code 84153 will be denied as not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.
- 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 a diagnosis code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. Also, 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.
Screening Digital Rectal Examination (G0102)
- Screening digital rectal examinations are covered at a frequency of once every 12 months for men who are age 50 or older (at least 11 months have passed following the month in which the last 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, or by a physician assistant nurse practitioner, clinical nurse specialist, or certified nurse midwife who is authorized under State law to perform the examination, fully knowledgeable about the member’s medical condition, and would be responsible for using the results of any examination performed in the overall management of the member’s specific medical problem.
- Payment may be made for a screening digital rectal examination when it is the only service provided. However, when a screening digital rectal examination is provided on the same day as a covered E&M service, payment for the digital rectal examination should be combined into the payment for the E&M service. Separate payment should not be made for the rectal examination in this case.
- Screening tests that do not meet all the criteria will be denied.
Screening Prostate Specific Antigen Test (G0103)
- 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 covered screening prostate specific antigen test was performed).
- Screening prostate specific antigen tests (PSA) means a test to detect the marker for adenocarcinoma of the prostate. PSA is a reliable immunocytochemical marker for primary and metastatic adenocarcinoma of the prostate. This screening must be ordered by the member’s physician or by the member’s physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife, who is fully knowledgeable about the member’s medical condition, and who would be responsible for using the results of any examination (test) performed in the overall management of the member’s specific medical problem.
- Screening tests that do not meet the listed criteria will be denied. The provider can bill the member for the denied service.
Failure to provide documentation of the medical necessity of tests may result in denial of claims. Such 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.
- This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
CMS On-Line Pub. 100-3, Chapter 1, Section 210.01
CMS On-Line Pub. 100-4, Chapter 18, Section 50
National Coverage Determination - 190.31
National Coverage Determination Coding Policy Manual and Change Report
Transmittal 1676, CR 1252
Transmittal AB-02-110, CR 2130
Transmittal 17, CR 2130
Transmittal 651, CR 4005
Transmittal 758. CR 4161
Transmittal 864, CR 4328
Transmittal 1050, CR 5293
Transmittal 1606, CR 6213
Transmittal 1645, CR 6304
Transmittal 1766, CR 6548
MedLearn Matters, SE 0709
Procedure Code Attachments
Covered Diagnosis Codes for code 84153:
Covered Diagnosis Codes for codes G0102 and G0103:
Noncovered Diagnosis Codes for code 84153
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.
Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Medicare Advantage plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.
Medicare Advantage retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Medicare Advantage. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.