Coverage Requirements from USPSTF
The United State Preventive Services Task Force (USPSTF) has designated annual screening for lung cancer with LDCT as category ‘B’. The screening requirements for this include adults who meet the following criteria:
- Age between 50 and 80 years.
- No current signs or symptoms of lung cancer (asymptomatic),
- A history of tobacco smoking of at least 20 pack-years (pack-years are calculated by multiplying the number of packs smoked per day by number of years smoked).
- Current or former smokers who have quit within the last 15 years.
Medicare
While Medicare mostly follows the USPSTF lung cancer screening guidelines, coverage is only for patients agesd 50-77 years.
To receive a lung cancer screening under Medicare, a beneficiary must first receive a counseling and shared decision-making visit that meets all the following criteria, and is documented in the beneficiary’s medical records:
- Determination of the beneficiary’s eligibility.
- Shared decision-making, including the use of one or more decision aids*.
- Counseling on the importance of annual lung cancer LDCT screenings, considering the impact of any comorbidities, and discussing the beneficiary’s ability or willingness to undergo diagnosis and treatment.
- Counseling on the importance of maintaining abstinence from cigarette smoking if the beneficiary is a former smoker, or the significance of smoking cessation if the beneficiary is a current smoker. If appropriate, information about tobacco cessation interventions should also be provided.
* Many Medicare coverage denials for lung cancer screening arise from insufficient documentation of shared decision-making. It is crucial that this step is properly recorded in the patient chart.
Medicare Advantage (MA)
MA organizations may impose additional requirements beyond those of traditional Medicare, including requiring beneficiaries to use in-network providers for specific services, prior authorization, or referrals for specialty care.
Medicaid
Traditional Medicaid fee-for-service programs cover lung cancer screening, but programs vary in eligibility criteria and barriers to screening, including prior authorization and cost-sharing. Coverage may also vary between fee-for-service and managed care plans within a state’s Medicaid program. The American Lung Association’s online State Lung Cancer Screening Coverage Toolkit provides updated coverage information about each state’s fee-for-service Medicaid program.
States that have expanded Medicaid are required to provide lung cancer screening at no cost.
Private Insurance
Lung cancer screening coverage changes depending on the type of private insurance plan patients have.
- Employer-sponsored: Most private insurance plans are required to cover lung cancer screening at no cost to the member. However, for employer-sponsored plans purchased before March 23, 2010, LDCT screening may not be covered without cost sharing.
- Individual Plans: Many individual plans do not have to follow ACA standards and thus may not cover lung cancer screening or may impose cost-sharing if it is covered.
- State Health Insurance Marketplace Plan: Individual insurance plans sold on the state health insurance marketplace must cover lung cancer screening without cost-sharing.
Prior Authorization Delays
While the Medicare guidance allows the shared decision-making visit to be on the same day as the LDCT scan, if a health plan requires prior authorization, it may need to be completed before that date. This has been particularly challenging for facilities that have established a workflow to have shared decision-making on the same day as the LDCT scan. The shared decision-making visit includes eligibility determination, which may be the first time the lung cancer screening program is alerted to the need for prior authorization. Some prior authorization decisions are received the same day, but they may take longer for approval.
Understanding which payers will require the prior authorization and if it is completed as an automated authorization if the patient meets standard criteria (vs. clinical reviewer) may assist the screening program in developing a workflow to include one or two visits per patient, depending on the payer. The need for two visits creates additional patient barriers (time off work, transportation, childcare, etc.) so communication with payers may be necessary.
How mobile units work around issues concerning prior authorization delays depends on the unit’s funding mechanisms and coordination efforts. For example, the Breathe Easy unit in Chattanooga, TN, provides grants for those who are uninsured and a self-pay option of $150 for those who do not meet the screening criteria or would not be able to receive prior authorization approval while on the coach. These fees can vary depending on available resources. Many other mobile units schedule their lung cancer screening visits in advance so that patients can get prior authorization approval before entering the unit.
Legal and Regulatory Requirements
Starting a mobile screening unit involves navigating various state and federal regulations and licensing requirements. Here are some key considerations:
Federal Regulations
Health Insurance Portability and Accountability Act (HIPAA):
- Any mobile unit that electronically transmits health information is subject to HIPAA regulations and must keep patient records confidential. HIPAA compliance requires mobile health units to have physical, network, and process security measures that include:
- Special policies regulating the use and access of electronic media where patient data is stored.
- Restrictions on handling electronic media and electronic protected health information (ePHI).
- A system for reviewing requests for protected health information (PHI)
- A system for immediate patient notification in the event of a data breach .
- Maintaining data storage with access limited to authorized personnel.
- Implementation of cybersecurity measures.
State Regulations
Healthcare Facility Licensure:
- Some states require a healthcare facility license for mobile units, especially if providing diagnostic services. Most states require mobile medical services to comply with the same licensing requirements as brick-and-mortar offices. Check with your state health department.
Operational Considerations
Vehicle Compliance:
- Mobile medical vehicles are required to have commercial vehicle insurance coverage. Typically, this coverage encompasses liability, property, and auto insurance to safeguard against potential accidents or damages. Both the vehicle and any drivers need to be covered. The cost of insurance will vary based on factors such as the driver’s experience, the types of vehicles in the fleet, and the number of trips completed daily.