CT Screening for Lung Cancer in Heavy Smokers Policy Number: PG0049 ADVANTAGE | ELITE

CT Screening for Lung Cancer in Heavy Smokers Policy Number: PG0049 ADVANTAGE | ELITE | HMO Last Review: 04/01/2021

INDIVIDUAL MARKETPLACE | PROMEDICA MEDICARE PLAN | PPO GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder terms, conditions, exclusions and limitations contract. It does not constitute a contract or guarantee regarding coverage or reimbursement/payment. Self-Insured group specific policy will supersede this general policy when group supplementary plan document or individual plan decision directs otherwise. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This medical policy is solely for guiding medical necessity and explaining correct procedure reporting used to assist in making coverage decisions and administering benefits.

SCOPE X Professional X Facility

DESCRIPTION In the United States, lung cancer is the most commonly occurring noncutaneous cancer in men and a woman combined, and is the leading cause of cancer deaths. The most important risk factor for lung cancer is tobacco use. Other risk factors are small compared with cigarette smoking—these causal factors include exposures to environmental and occupational substances and family history of lung cancer. Currently, most lung cancer is diagnosed clinically when patients present with symptoms such as persistent cough, pain and weight loss; unfortunately, patients with these symptoms usually have advanced lung cancer. Due to the prevalence and the mortality associated with lung cancer, detecting the disease and initiating treatment at an early stage, in particular, for at-risk individuals is important for improving survival. Chest x-ray (CXR) and sputum cytology have been the most common methods used for screening for lung cancer.

More recently, low-dose computed tomography (LDCT) has been proposed as a method of screening asymptomatic, high-risk individuals for lung cancer. The goal of screening is to detect disease at a stage when it is not causing symptoms and when treatment will be most successful. It has been suggested that spiral CT may be an improved early lung cancer detection tool based on the greater sensitivity for detecting early-stage cancer it appears to have over CXR and sputum cytology to detect lung cancer at an earlier stage. However, questions remain as to whether screening with spiral CT can reduce lung cancer mortality. This is the subject of ongoing randomized controlled clinical trials. Potential disadvantages associated with this test include false-positive results and over-diagnosis.

The United States Preventive Services Task Force (USPSTF) recommends annual screening for lung cancer with LDCT in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.

POLICY

PG0049 – 04/01/2021  Low dose CT scan (LDCT) for lung cancer screening in heavy smokers (71271 effective 1/1/2021/G0297 deleted 12/31/2020) does not require prior authorization for HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage

 Counseling visit to discuss need for lung cancer screening (LDCT) using low dose CT scan (G0296) does not require prior authorization for HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage

 When the services are provided as Preventive Services procedures (G0296, G0297, 71271) must be billed with the medically indicated/supported screening ICD-10 diagnosis codes F17.210, F17.211, F17.213, F17.218, F17.219, Z87.891 (nicotine dependence)

COVERAGE CRITERIA HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage The use of low-dose, non-contrast spiral (helical) multi-detector CT imaging as a screening technique for lung cancer is considered medically necessary when used to screen for lung cancer for certain high-risk individuals when ALL of the following criteria are met: 1. Individual has no signs or symptoms suggestive of underlying lung cancer which includes, but is not limited to the following: unexplained cough, hemoptysis, or unexplained weight loss of more than 15 pounds in the past year 2. Individual has NO health problems that substantially limit life expectancy or the ability or willingness to have curative lung surgery a. Congestive heart failure b. Advanced cancer from another site c. COPD with the use of oxygen 3. Individual is between 55-80 (effective 3/09/2021) 50-80 years of age 4. There is at least a 30 (effective 3/09/2021) 20 pack-year smoking history and currently smoking 5. If the individual is a former smoker, that individual had quit smoking within the previous 15 years 6. Screening will occur no more often than annually

These services (G0296, G0297, 71271) must be billed with the medically indicated/supported screening ICD-10 diagnosis codes F17.210, F17.211, F17.213, F17.218, F17.219, Z87.891 (nicotine dependence).

The use of CT scanning as a screening technique for lung cancer in asymptomatic individuals is considered investigational and therefore not medically necessary. Low dose CT scan (LDCT) for lung cancer screening is non- covered when the above criteria are not met and for all other indications.

Paramount considers LDCT experimental and investigational as a screening test for all other indications (e.g., asbestos-exposed individuals).

Paramount considers computer-aided detection for chest radiographs experimental and investigational for screening or diagnosis of lung cancer and for all other indications. There is presently inadequate evidence in the medical literature that population-based mass lung cancer screening with computer-aided detection for chest radiographs will contribute substantially to the detection of smaller cancers, or decreases mortality.

Lung cancer screening for asymptomatic individuals is non-covered utilizing the following tests for any indication:  Chest x-ray  EarlyCDT-Lung test  PAULAs test  PET scan  Sputum cytology

These tests are considered experimental and investigational for lung cancer screening because their effectiveness for this indication has not been established.

PG0049 – 04/01/2021

Counseling and Shared Decision-Making Visit Before the first lung cancer LDCT screening occurs, the member must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision-making visit that includes the following elements and is appropriately documented in the beneficiary’s medical records:

 Must be furnished by a physician or qualified non-physician practitioner (meaning a Physician Assistant (PA), Nurse Practitioner (NP), or Clinical Nurse Specialist (CNS); and  Must include all of the following elements: o Determination of member 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 o 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 o Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of co- morbidities, and ability or willingness to undergo diagnosis and treatment o 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 o If appropriate, the furnishing of a written order for lung cancer screening with LDCT

Written orders for subsequent annual LDCT screens may be furnished during any appropriate visit with a physician or qualified non-physician practitioner (PA, NP, or CNS).

The U.S. Preventive Services Task Force (USPSTF) recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.

CODING/BILLING INFORMATION The inclusion or exclusion of a code in this section does not necessarily indicate coverage. Codes referenced in this clinical policy are for informational purposes only. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. CPT CODES 71271 Computed tomography, thorax, low dose for lung cancer screening, without contrast materials(s) HCPCS CODES G0296 Counseling visit to discuss need for lung cancer screening (LDCT) using low dose CT scan (service is for eligibility determination and shared decision making) G0297 Low dose CT scan (LDCT) for lung cancer screening Deleted 12/31/2020 ICD-10-CM CODES REQUIRED FOR COVERAGE F17.210 Nicotine dependence, cigarettes, uncomplicated F17.211 Nicotine dependence, cigarette, in remission F17.213 Nicotine dependence, cigarettes, with withdrawal F17.218 Nicotine dependence, cigarettes, with other nicotine-induced disorders F17.219 Nicotine dependence, cigarettes, with unspecified nicotine-induced disorders Z87.891 Personal history of nicotine dependence

Paramount reserves the right to review and revise our policies periodically when necessary. When there is an update, we will publish the most current policy to https://www.paramounthealthcare.com/services/providers/medical-policies/ .

PG0049 – 04/01/2021

REVISION HISTORY EXPLANATION ORIGINAL EFFECTIVE DATE: 01/11/2012 Date Explanation & Changes  Removed codes 71260 and 71270  ICD-10 Codes added from ICD-9 conversion  CT screening for lung cancer in heavy smokers is now covered for all members per TAWG review 03/21/2014 with prior authorization following the USPSTF recommendations  Procedure S8092 is non-covered for Advantage per The Ohio Department of Medicaid.  Policy reviewed and updated to reflect most current clinical evidence per TAWG  Added codes S8032 & 76497  Removed codes 71250 & S8092 11/10/2015  Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee  Added HCPCS codes G0296 & G0297, ICD-9 code V15.82 and ICD-10 code Z87.891  Removed CPT code 76497, HCPCS code S8032, ICD-9 code V76.0 and ICD-10 code Z12.2  CT screening for lung cancer in heavy smokers (G0296, G0297) covered with prior authorization for 01/12/2016 HMO, PPO, Individual Marketplace, & Elite  Procedures G0296 & G0297 are non-covered per The Ohio Department of Medicaid  Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee  Added code S8032 as covered for Advantage only with prior authorization 06/14/2016  Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee  HCPCS code S8032 deleted effective 09/30/16  Effective 01/01/17 code G0297 is now covered for Advantage per ODM guidelines 01/10/2017  Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee  Effective 10/01/17 code G0296 is now covered with prior authorization for Advantage per ODM guidelines 06/13/2017  Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee  Added ICD-10 diagnosis codes F17.210, F17.211, F17.213, F17.218, F17.219 per CMS guidelines  Prior authorization requirement removed for Elite for low dose CT scan (LDCT) for lung cancer screening in heavy smokers (G0296, G0297)  These services (G0296, G0297) must be billed with ICD-10 diagnosis codes F17.210, F17.211, 10/09/2018 F17.213, F17.218, F17.219, Z87.891 per CMS guidelines  ICD-9 code removed  Removed effective 09/30/16 deleted code S8032  Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee  Effective 1/1/2019: Procedure G0296 no longer requires a prior authorization for HMO, PPO, 01/01/2019 Individual Marketplace, & Advantage, per Administrative Medial Review/Determination  Effective 1/1/2019: Procedures G0296 and G0297 no longer require a prior authorization for all 02/01/2019 product lines, per Administrative Medical Review/Determination 01/01/2021  Medical policy placed on the new Paramount Medical Policy Format  Added new CPT code 71271-effective 1/1/2021 01/06/2021  Deleted code G0297-as of 12/31/2020  Medical Policy updated to the latest March 09, 2021 USPSTF Lung Cancer Screening 04/01/2021 Recommendations. The age populations’ span changed to 50-80 and the number of pack-year requirement decreased to 20. The USPSTF grade is a B.

REFERENCES/RESOURCES

Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services

Ohio Department of Medicaid

PG0049 – 04/01/2021

American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services

Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets

U.S. Preventive Services Task Force, http://www.uspreventiveservicestaskforce.org/ Industry Standard Review

Hayes, Inc.

PG0049 – 04/01/2021