CT of the thorax for lung cancer screening — registry requirements

Q.

Before January 1, 2021, when a permanent CPT^® Code 71271 replaced temporary Level II HCPCS code G0297 was there a requirement by CMS to participate in a registry where various patient data is collected and reported to CMS in order to be reimbursed for Level II code G0297?

If so, if the location that performed the Technical Component of this exam was not part of the official registry and an independent group of radiologists (i.e., a separate Radiology practice) interpreted and billed for the professional reads for these studies, is the radiology group at risk of potentially having to reimburse CMS (Medicare) for the services related to this code?

A.

Yes, the requirement for the facility to send results into a registry has been there from the beginning of coverage for this procedure. In our opinion, the radiology group will need to self-report and repay any payments to Medicare. The requirements for the interpreting physician include the requirement to furnish the service in an eligible facility, and the eligible facility requirements include sending data to the registry. 

Interpreting physician requirements: 

• 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 three years;
• Documented participation in continuing medical education in accordance with current American College of Radiology standards; and
• Furnish lung cancer screening with LDCT in a radiology imaging facility that meets the radiology imaging facility eligibility criteria described below.

Facility Requirements

• 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; and
• Collects 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 Type – Minimum Required Data Elements
Facility Identifier
Radiologist (reading) – National Provider Identifier (NPI)
Patient Identifier
Ordering Practitioner – National Provider Identifier (NPI)
CT scanner – Manufacturer, Model
Indication – Lung cancer LDCT screening absence of signs or symptoms of lung cancer
System – Lung nodule identification, classification and reporting system
Smoking history – Current 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 dose – CT Dose Index (CTDIvol)
Screening – Screen date
Initial screen or subsequent screen

This information can be found in the NCD at https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=364&ncdver=1&bc=AAAAIAAAAAAA&