(Medicare National Coverage Determinations Manual)

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,    At average risk of developing colorectal cancer (no personal history of adenomatous  polyps, colorectal  cancer,  or inflammatory  bowel  disease,  including Crohns Disease and ulcerative colitis; no family history of colorectal cancers or adenomatous  polyps, familial adenomatous  polyposis,  or hereditary  nonpolyposis colorectal cancer).   Effective January 1, 2023, the minimum age for sDNA test is reduced to 45 years and older.    3. Blood -based  Biomarker  Tests  (effective  January 19, 2021)   Blood- based  DNA testing  detects  molecular  markers  of altered  DNA  that are contained  in the cells shed into the blood by colorectal cancer and pre -malignant colorectal epithelial neoplasia.   Effective for dates  of service on or after January 19, 2021, a blood- based  biomarker  test is covered as an appropriate colorectal cancer screening test once every 3 years for Medicare beneficiaries when performed in a Clinical Laboratory Improvement Act (CLIA) -certified laboratory, when ordered by a treating physician and when all of the f ollowing requirements are met:   The patient  is:   age 50 -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 or fecal immunochemical test), and,    at average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohns Disease and ulcerative colitis; no family history of colorectal cancers or adenomatous polyps, f amilial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).   The blood- based  biomarker  screening  test must  have  all of the following:    Food and Drug Administration (FDA) market authorization with an indication for colorectal cancer screening; and,  proven test performance characteristics for a blood -based screening test with both sensitivity greater than or equal to 74% and specificity greater than or equal to 90% in the detection of colorectal cancer compared to the recognized standard (accepted as colonoscopy at this time), as minimal threshold levels, based on the pivotal studies included in the FDA labeling.  Effective January 1, 2023, the minimum age for blood- based biomarker test is reduced to 45 years and older.   C. Nationally Non-Covered  Indications   All other  indications  for colorectal  cancer  screening  not otherwise  specified  in the Act and regulations, or otherwise specified above remain nationally non- covered. Non-  coverage specifically includes:   (1) All screening sDNA tests, effective April 28, 2008, through October 8, 2014. Effective for dates  of service on or after October  9, 2014, all other  screening  sDNA tests not otherwise specified above remain nationally non- covered.   (2) Screening  computed  tomographic  colonography (CTC),  effective May  12, 2009.   D. Other   N/A  (This  NCD was last reviewed  January  2023 and includes policy updates finalized in the Calendar Year 2023 Physician Fee Schedule final rule 87 FR 69404)   210.4 - Smoking and Tobacco-Use Cessation Counseling (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective September 30, 2015 this section is deleted and the remaining NCD entitled Counseling to Prevent Tobacco Use (210.4.1) remains effective.   210.4.1  Counseling to Prevent Tobacco Use (Effective August 25, 2010)  (Rev.202, Issued: 08-  25-17, Effective: 09 -26-17, Implementation: 09-  26-17)  A.  General   Tobacco use remains the leading cause of preventable morbidity and mortality in the U.S. and is a major contributor to the nations increasing medical costs. Despite the growing list of adverse health effects associated with smoking, more than 45 million U .S. adults continue to smoke and approximately 1,200 die prematurely each day from tobacco- related diseases. Annual smoking-attributable expenditures can be measured both in direct medical costs ($96 billion) and in lost productivity ($97 billion), but the  results of national surveys have raised concerns that recent declines in smoking prevalence among U.S. adults may have come to an end. According to the U.S. Department of Health and Human Services (DHHS) Public Health Service (PHS) Clinical Practice Guideline on Treating Tobacco Use and Dependence (2008), 4.5 million adults over 65 years of age smoke cigarettes. Even smokers over age 65, however, can benefit greatly from abstinence, and older smokers who quit can reduce their risk of death from coronary heart disease, chronic obstructive lung disease and lung cancer, as well as decre ase their risk of osteoporosis.   B.  Nationally Covered Indications   Effective for claims with dates of service on or after August 25, 2010, CMS will cover tobacco cessation counseling for outpatient and hospitalized Medicare beneficiaries   1. Who use tobacco, regardless of whether they have signs or symptoms of tobacco- related disease;  2. Who are competent and alert at the time that counseling is provided; and,  3. Whose counseling is furnished by a qualified physician or other Medicare -recognized practitioner.   Intermediate and intensive smoking cessation counseling services will be covered under Medicare Part B when the above conditions of coverage are met, subject to frequency and other limitations. That is, similar to existing tobacco cessation counseling for symptomatic individuals, CMS will allow 2 individual tobacco cessation counseling attempts per 12 -month period. Each attempt may include a maximum of 4 intermediate OR intensive sessions, with a total benefit covering up to 8 sessions per 12- month period per Medicare beneficiary who uses tobacco. The practitioner and patient have the flexibility to choose between intermediate (more than 3 minutes but less than 10 minutes), or intensive (more than 10 minutes) cessation counseling sessions for each attempt.   C.  Nationally Non -Covered Indications   Inpatient hospital stays with the principal diagnosis of tobacco use disorder are not reasonable and necessary for the effective delivery of tobacco cessation counseling services. Therefore, we will not cover tobacco cessation services if tobacco cessation  is the primary reason for the patients hospital stay.   D.  Other   Section 4104 of the Affordable Care Act provided for a waiver of the Medicare coinsurance and Part B deductible requirements for this service effective on or after January 1, 2011. Until that time, this service will continue to be subject to the standard M edicare coinsurance and Part B deductible requirements.    (This NCD last reviewed December 2016.)   210.5 - Diabetes Screening Tests (Effective January 1, 2005)  (Rev.)   210.6 - Screening for Hepatitis B Virus (HBV) Infection  (Rev. 198, Issued: 06- 29-17, Effective: 09 -28-16, Implementation: 10-  02- 17, October 2, 2017 -  analysis and design; January 2, 2018 -  testing and implementation)   A. General   Hepatitis B Virus (HBV) is transmitted by exposure to blood or blood- containing body fluids such as  serum, semen or saliva. HBV infection attacks the liver and leads to inflammation. An infected person may  initially develop symptoms such as nausea, anorexia, fatigue, fever and abdominal pain, or may be asymptomatic. An acute HBV infection may become a chronic infection and progress to serious and potentially life-threatening complications including cirrhosis, liver failure, hepatocellular carcinoma and death.   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 September 28, 2016, CMS has determined that the evidence is sufficient to  cover screening for HBV infection 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, when ordered by the beneficiary's primary care physician or  practitioner within the context of a primary care setting, and performed by a n eligible Medicare provider for these services, for beneficiaries who meet either of the following conditions.   1. A screening test is covered for asymptomatic, nonpregnant adolescents and adults at high risk for HBV infection. "High risk" is defined as persons born in countries and regions with a high prevalence  of HBV infection (i.e.,  2%), USborn persons not vaccinated as infants whose parents were born in  regions with a very high prevalence of HBV infection (i.e.,  8%), HIVpositive persons, men who have sex  with men, injection drug users, household contacts or sexual partners of persons with HBV infection. In addition, CMS has dete rmined that repeated screening would be appropriate annually only for beneficiaries  with continued high risk (i.e., men who have sex with men, injection drug users, household contacts or  sexual partners of persons with HBV infection) who do not receive hepatitis B  vaccination.   2. A screening test at the first prenatal visit is covered for pregnant women and then rescreening at time of delivery for those with new or continuing risk factors. In addition, CMS has determined that screening during the first prenatal visit would be appropriate for each pregnancy, regardless  of previous hepatitis B vaccination or previous negative HBsAg test  results.   The determination of "high risk for HBV" is identified by the primary care physician or practitioner who assesses the patient's history, which is part of any complete medical history, typically part of an annual  wellness visit and considered in the development of a comprehensive prevention plan. The medical record should be  a reflection of the service provided.  For the purposes of this decision memorandum, a primary care setting is defined by the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care  needs, developing a sustained partnership with patients, and practicing in the context of  family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, skilled nursing facilities, inpatient rehabilitation facilities, clinics providing a limited focus of health care services,  and hospice are examples of settings not considered primary care settings under this  definition.   For the purposes of this decision memorandum, a "primary care physician" and "primary care practitioner" will be defined consistent with existing sections of the Social Security Act (1833(u)(6), 1833(x) (2)(A)(i)(I) and  1833(x)(2)(A)(i)(II)).   1833(u)  (6) Physician Defined. For purposes of this paragraph, the term "physician" means a physician described in section 1861(r)(1) and the term "primary care physician" means a physician who is identified in the  available data as a general practitioner, family practice practitioner, general internist, or obstetrician or  gynecologist.  1833(x)(2)(A)(i)  (I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of  family medicine, internal medicine, geriatric medicine, or pediatric medicine;  or  (II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1861(aa)(5)).   C. Nationally Non -Covered Indications   Effective for claims with dates of service on and after September 28,  2016:   - Medicare beneficiaries who are symptomatic, or who have already been diagnosed with HBV infection, or who are nonpregnant and have already received a hepatitis B vaccination are non-covered.  D. Other  Medicare coinsurance and the Part B deductible are waived for this "additional preventive  service."   (NCD updated September 2016)