(Medicare National Coverage Determinations Manual)

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)  Primary care practitioner The term primary care practitioner means an individual  (i) who  (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   All other indications remain non- covered.   D. Other   Medicare coinsurance and Part B deductible are waived for this service   (This NCD last reviewed November 2011)   210.13  Screening for Hepatitis C Virus (HCV) in Adults  (Rev. 177, Issued: 11- 19-14, Effective: 06 -02-14, Implementation: 01- 05-15 - For non -shared MAC edits and CWF analysis; 04- 06-15 - For remaining shared systems edits )  A. General   Hepatitis C Virus (HCV) is an infection that attacks the liver and leads to inflammation.  The infection is often asymptomatic and can go undiagnosed for decades.  It is difficult for the human immune system to eliminate the HCV and it is a major cause of chronic liver disease.  The presence of HCV in the liver initiates a response from the immune system which in turn causes inflammation.  Inflammation over long periods of time (usually decades) can cause scarring, called cirrhosis.  A cirrhotic liver fails  to perform the normal functions of the liver which leads to liver failure.  Cirrhotic livers are more prone to become cancerous and liver failure leads to serious complications, even death.  HCV is reported to be the leading cause of chronic hepatitis, cirrhosis and liver cancer and a primary indication for liver transplant in the Western World.   Under 1861(ddd) of the Social Security Act (the Act), the Centers for Medicare & Medicaid Services (CMS) has the authority to add coverage of additional preventive services if certain statutory requirements are met. The regulations provide:   42 CFR 410.64 Additional preventive services   (a) Medicare Part B pays for additional preventive services not described in paragraph (1) or (3) of the definition of preventive services under 42 CFR 410.2, that identify medical conditions or risk factors for individuals if the Secretary determines t hrough the national coverage determination process (as defined in section 1869(f)(1)(B) of the Act) that these services are all of the following: (1) reasonable and necessary for the prevention or early detection of illness or disability,(2) recommended wi th a grade of A or B by the United States Preventive Services Task Force (USPSTF), (3) appropriate for individuals entitled to benefits under Part A or enrolled under Part B.  (b) In making determinations under paragraph (a) of this section regarding the coverage of a new preventive service, the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such services and may take into account the results of such an assessment in making such national coverage determinations.  The scope of the review for this national coverage determination (NCD) evaluated and determined if the existing body of evidence was sufficient for Medicare coverage for screening for HCV in adults at high risk for HCV infection and one -time screening for HCV infection for adults born between 1945 and 1965, which is recommended with a grade B by the USPSTF.  B. Nationally Covered Indications   Effective for services performed on or after June 2, 2014, CMS has determined the following:   The evidence is adequate to conclude that screening for HCV, consistent with the grade B recommendations by the USPSTF, is reasonable and necessary for the prevention or early detection of an illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B, as described below.  Therefore, CMS will cover screening for HCV 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 regulation s, when ordered by the beneficiarys primary care physician or practitioner within the context of a primary care setting, and performed by an eligible Medicare provider for these services, for beneficiaries who meet either of the following conditions:   1.  A screening test is covered for adults at high risk for HCV infection.  High risk is defined as persons with a current or past history of illicit injection drug use; and persons who have a history of receiving a blood transfusion prior to 1992.  Repeat screening for high risk perso ns is covered annually only for persons who have had continued illicit injection drug use since the prior negative screening test.   2.  A single screening test is covered for adults who do not meet the high risk definition above, but who were born from 1945 through 1965.  The determination of high risk for HCV is identified by the primary care physician or practitioner who assesses the patients 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.  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 practic ing in the context of family and community.  Emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, 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.  A primary care physician and primary care practitioner will be defined consistent with existing sections of the 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   Unless specifically covered in this NCD, any other NCD, or in statute, preventive services are non-covered by Medicare.   D. Other   N/A  (This NCD last reviewed June 2014.)   210.14  Lung Cancer Screening with Low Dose Computed Tomography (LDCT)  (Rev. 11388; Issued:04- 29-22; (Effective: 02 -10-22; Implementation:10 -03-22)  A. General   Lung cancer is the third most common cancer and the leading cause of cancer deaths in the United States. Cancer of the lung and bronchus accounted for over 130,000 deaths in 2021 (more than the total number of estimated deaths from colon, breast and prostate cancer combined) with a median age at death of 72 years. Computed tomogra phy (CT) is an imaging procedure that uses specialized x -ray equipment to create detailed pictures of areas inside the body. Low dose computed tomography (LDCT) is a chest CT scan performed at settings to minimize radiation exposure compared to a standard chest CT. Under 1861(ddd) of the Social Security Act (the Act), the Centers for Medicare & Medicaid Services(CMS) has the authority to add coverage of additional preventive services through the Medicare national coverage determination (NCD) process if c ertain statutory requirements are met: (1) reasonable and necessary for the prevention or early detection of illness or disability, (2) recommended with a grade of A or B by the United States Preventive Services Task Force (USPSTF), and (3) appropriate for  individuals entitled to benefits under Part A or enrolled under Part B.  B. Nationally Covered Indications   Effective for claims with dates of service on or after February 10, 2022, CMS has determined that the evidence is sufficient to cover, under Medicare Part B, a lung cancer screening counseling and shared decision- making visit, and for appropriate beneficiaries, annual screening for lung cancer with LDCT, as an additional preventive service benefit under the Medicare program, only if all of the following eligibility criteria are met.   Beneficiary Eligibility Criteria   Beneficiaries must meet all of the following eligibility criteria:  Age 50  77 years;   Asymptomatic (no signs or symptoms of lung cancer);   Tobacco smoking history of at least 20 pack- years (one pack -year = smoking one pack per day for one year; 1 pack =20 cigarettes);   Current smoker or one who has quit smoking within the last 15 years; and,   Receive an order for lung cancer screening with LDCT.   Counseling and Shared Decision -Making Visit   Before the beneficiarys first lung cancer LDCT screening, the beneficiary must receive a counseling and shared decision- making visit that meets all of the following criteria, and is appropriately documented in the beneficiarys medical records:    Determination of beneficiary eligibility;   Shared decision -making, including the use of one or more decision aids;   Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment; and,  Counseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions.     Reading Radiologist Eligibility Criteria   The reading radiologist must have board certification or board eligibility with the American Board of Radiology or equivalent organization.    Radiology Imaging Facility Eligibility Criteria   Lung cancer screening with LDCT must be furnished in a radiology imaging facility that utilizes a standardized lung nodule identification, classification, and reporting system.  C. Nationally Non -Covered Indications   Preventive services are non -covered by Medicare unless specifically covered in this NCD, any other NCD, or in statute or regulations.   D. Other   Medicare Part B coinsurance and deductible are waived for this preventive service.   (This NCD last reviewed February 2022.)   220 - Radiology  (Rev.)   220.1 - Computed Tomography (CT)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General   Diagnostic examinations of the head (head scans) and of other parts of the body (body scans) performed by computerized tomography (CT) scanners are covered if medical and scientific literature and opinion support the effective use of a scan for the condition, and the scan is: (1) reasonable and necessary for the indi vidual patient; and (2) performed on a model of CT equipment that meets the criteria in C below.   The CT scans have become the primary diagnostic tool for many conditions and symptoms.  CT scanning used as the primary diagnostic tool can be cost effective because it can eliminate the need for a series of other tests, is noninvasive and thus virtually e liminates complications, and does not require hospitalization.  B. Determining Whether a CT Scan Is Reasonable and Necessary   Sufficient information must be provided with claims to differentiate CT scans from other radiology services and to make coverage determinations.  Carefully review claims to ensure that a scan is reasonable and necessary for the individual patient; i.e., the use must be found to be medically appropriate considering the patients symptoms and preliminary diagnosis.  There is no general rule that requires other diagnostic tests to be tried before CT scanning is used.  However, in an individual case the A/B MAC (A) or (B) medical staff may determine that use of a CT scan as the initial diagnostic test was not reasonable  and necessary because it was not supported by the patients symptoms or complaints stated on the claim form; e.g., periodic headaches."   Claims for CT scans are reviewed for evidence of abuse, which might include the absence of reasonable indications for the scans, an excessive number of scans, or unnecessarily expensive types of scans considering the facts in the particular cases.   C. Approved Models of CT Equipment   1. Criteria for Approval   In the absence of evidence to the contrary, the A/B MAC (A) or (B) may assume that a CT scan for which payment is requested has been performed on equipment that meets the following criteria: