NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo

APPENDIX CMedicare National Coverage Determinations Manual (2014)210.14  Lung Cancer Screening with Low Dose Computed Tomography (LDCT) (Effective February 5, 2015) (Rev. 185, Issue: 08-21-15, Effective: 02-05-15, Implementation: 01-04-16)A. GeneralLung 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 150,000 deaths in 2013, with a median age at death of 72 years. Computed tomography (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.Screening for lung cancer with LDCT is not currently covered under the Medicare program. 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 certain 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 IndicationsEffective for claims with dates of service on or after February 5, 2015, CMS has determined that the evidence is sufficient to add coverage 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 CriteriaFor purposes of Medicare coverage of lung cancer screening with LDCT, beneficiaries must meet all of the following eligibility criteria:Age 55  77 years;Asymptomatic (no signs or symptoms of lung cancer);Tobacco smoking history of at least 30 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; andReceive a written order for lung cancer screening with LDCT. Written orders for lung cancer LDCT screenings must be appropriately documented in the beneficiarys medical records, and must contain the following information:Beneficiary date of birth;Actual pack  year smoking history (number);Current smoking status, and for former smokers, the number of years since quitting smoking;Statement that the beneficiary is asymptomatic (no signs or symptoms of lung cancer); andNational Provider Identifier (NPI) of the ordering practitioner.Counseling and Shared Decision-Making VisitBefore 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:Must be furnished by a physician (as defined in Section 1861(r)(1) of the Social Security Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in 1861(aa)(5) of the Social Security Act), andMust include all of the following elements:Determination of beneficiary eligibility including age, absence of signs or symptoms of lung cancer, a specific calculation of cigarette smoking pack-years; and if a former smoker, the number of years since quitting;Shared decision making, including the use of one or more decision aids, to include benefits and harms of screening, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure;Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment;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; andIf appropriate, the furnishing of a written order for lung cancer screening with LDCT.Written Orders for Subsequent Annual Lung Cancer Screenings with LDCTFor subsequent annual lung cancer LDCT screenings, the beneficiary must receive a written order for lung cancer LDCT screening. The written order may be furnished during any appropriate visit with a physician (as defined in Section 1861(r)(1) of the Social Security Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in Section 1861(aa)(5) of the Social Security Act).If a physician or qualified non-physician practitioner elects to provide a lung cancer screening counseling and shared decision-making visit before a subsequent annual lung cancer LDCT screening, the visit must meet all of the criteria described above for a counseling and shared decision-making visit.Reading Radiologist Eligibility CriteriaFor purposes of Medicare coverage of lung cancer screening with LDCT, the reading radiologist must meet all of the following eligibility criteria:Board certification or board eligibility with the American Board of Radiology or equivalent organization;Documented training in diagnostic radiology and radiation safety;Involvement in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years;Documented participation in continuing medical education in accordance with current American College of Radiology standards; andFurnish lung cancer screening with LDCT in a radiology imaging facility that meets the radiology imaging facility eligibility criteria described below.Radiology Imaging Facility Eligibility CriteriaFor purposes of Medicare coverage, lung cancer screening with LDCT must be furnished in a radiology imaging facility that meets all of the following eligibility criteria:Performs LDCT with volumetric CT dose index (CTDIvol) of  3.0 mGy (milligray) for standard size patients (defined to be 5 7 and approximately 155 pounds) with appropriate reductions in CTDIvol for smaller patients and appropriate increases in CTDIvol for larger patients;Utilizes a standardized lung nodule identification, classification and reporting system;Makes available smoking cessation interventions for current smokers; andCollects and submits data to a CMS-approved registry for each LDCT lung cancer screening performed. The data collected and submitted to a CMS-approved registry must include, at minimum, all of the following elements:Data TypeMinimum Required Data ElementsFacilityIdentifierRadiologist(reading)National Provider Identifier (NPI)PatientIdentifierOrdering PractitionerNational Provider Identifier (NPI)CT scannerManufacturer, Model.IndicationLung cancer LDCT screening absence of signs or symptoms of lung cancerSystemLung nodule identification, classification and reporting systemSmoking historyCurrent status (current, former, never).If former smoker, years since quitting.Pack-years as reported by the ordering practitioner.For current smokers, smoking cessation interventions available.Effective radiation doseCT Dose Index (CTDIvol).ScreeningScreen dateInitial screen or subsequent screenInformation regarding CMS-approved registries is posted on the CMS website at:http://www.cms.gov/Medicare/Medicare-GeneralInformation/MedicareApprovedFacilitie/Lung-Cancer-Screening-Registries.html.C. Nationally Non-Covered IndicationsUnless specifically covered in this NCD, any other NCD, in statute or regulations, preventive services are non-covered by Medicare.D. OtherMedicare coinsurance and Part B deductible are waived for this preventive service.(This NCD last reviewed February 2015.)Bibliography