(Medicare National Coverage Determinations Manual)

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 perfor med).  Screening digital rectal examination means a clinical examination of an individuals 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 beneficiarys medical condition, and would be responsible for using the results of any examination performed in the overall management of the beneficiarys 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 beneficiarys physician or by the beneficiarys 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 beneficiarys medical condition, and who would be responsible for using the results of any examination (test) performed in the overall management of the beneficiarys specific medical problem.   210.2 - Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical 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 physicians 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 beneficiarys 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 covera ge 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.)   210.3  Colorectal Cancer Screening Tests  (Rev. 12299; Issued:10- 12-23; Effective:01 -01-23; Implementation:11 -13-23)  A. General   Sections  1861(s)(2)(R) and 1861(pp)  of the Social  Security  Act (the Act) and regulations at 42 CFR 410.37 authorize Medicare coverage for screening colorectal cancer tests under Medicare Part B. The statute and regulations authorize the Secretary to add other tests and procedures (and modifications to tests and procedures for color ectal cancer screening) as the Secretary finds appropriate based on consultation with appropriate organizations.   B. Nationally Covered  Indications   1. Fecal  Occult  Blood  Tests  (FOBT)  (effective  January 1, 2004)   Fecal  occult  blood tests  (FOBTs)  are generally  divided into  two types:  immunoassay and guaiac types. Immunoassay (or immunochemical) fecal occult blood tests (iFOBT) use antibodies directed against human globin epitopes. While most iFOBTs use spatulas to collect  stool  samples,  some  use a brush to collect  toilet water  surrounding the stool. Most iFOBTs require laboratory processing.  Guaiac fecal  occult  blood tests (gFOBT)  use a peroxidase  reaction  to indicate  presence of the heme portion of hemoglobin. Guaiac turns blue after oxidation by oxidants or peroxidases  in the presence of  an oxygen donor  such  as hydrogen peroxide.  Most  FOBTs use sticks to collect stool samples and may be developed in a physicians office or a laboratory. In 1998, Medicare began reimbursement for guaiac FOBTs, but not immunoassay type tests for colorectal cancer screening. Since the fundamental process is  similar for other iFOBTs, the Centers for Medicare & Medicaid Services evaluated colorectal cancer screening using immunoassay FOBTs in general.   Effective for dates of service on and after January 1, 2004, Medicare covers one screening FOBT per annum for the early detection of colorectal cancer. This means that Medicare will cover  one gFOBT  or one iFOBT  at a frequency  of every  12 months;  i.e., at least 11 months have passed following the month in which the last covered screening FOBT was performed, for beneficiaries aged 50 years and older. The beneficiary completes the existing gFOBT by taking samples from two different sites of three consecuti ve stools; the beneficiary completes the iFOBT by taking the appropriate number of stool samples according to the specific manufacturers instructions. This screening requires  a written  order from  the beneficiarys  attending physician. (Attending physician means a doctor of medicine or osteopathy (as defined in 1861(r)(1) of the Act) who is fully knowledgeable about the beneficiarys medical condition, and who would be responsible for using the results of any examination performed in the overall management o f the beneficiarys specific medical problem.)   Effective January 1, 2023, the minimum age for FOBT is reduced to 45 years and older.   2. The CologuardTM  Multi -target  Stool  DNA (sDNA)  Test (effective October 9, 2014)   Screening stool or fecal DNA (deoxyribonucleic acid, sDNA ) testing detects molecular markers of altered DNA that are contained in the cells shed by colorectal cancer and pre-  malignant colorectal epithelial neoplasia into the lumen of the large bowel. Through the use of selective enrichment and amplification tec hniques, sDNA tests are designed to detect very small amounts of  DNA markers  to identify colorectal cancer or  pre-malignant colorectal neoplasia. The CologuardTM  multi- target sDNA test is a proprietary in vitro diagnostic  device  that incorporates  both sDNA and fecal  immunochemical test techniques and is designed to analyze patients stool samples for markers associated with the presence of colorectal cancer and pre- malignant colorectal neoplasia.   Effective for dates of service on or after October 9, 2014, The Cologuard  test is covered  once every  three  years  for Medicare beneficiaries  that meet  all of the following criteria:    Age 50 to 85 years, and,    Asymptomatic (no signs or symptoms of colorectal disease including but not limited  to lower  gastrointestinal pain, blood in stool,  positive  guaiac fecal  occult blood test (gFOBT) or fecal immunochemical test (iFOBT)), and,