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National Registry to Be Created for Results from Low Dose CT Scans Paid for by CMS/Medicare

More on CMS paying for low dose CT scans for some people, as described yesterday.

As part of its announcement, CMS explained that Medicare reimbursement will be available only when the radiography facility contributes resulting data to one or more national registries that will be be put into operation. The rationale and specifics were explained as follows, and deserve careful consideration as to the short and long term implications for toxic tort litigation and precision medicine.

“Response: The primary purpose for requiring the submission of data to the registry is to document compliance with the coverage criteria that are not evidenced on the health care claim.  Furthermore, based on the public comments and the evidence reviewed, we strongly believe that the registry will serve as an aid to those seeking to study the clinical benefits of this screening.   The registry and the other criteria required in this NCD are supported by the evidence reviewed, including the NLST.  The registry will help ensure that only eligible beneficiaries will receive this screening service since only beneficiaries that meet the eligibility requirements will benefit from such screening.    

Furthermore, we recognize the impact of this criterion for imaging facilities.  We will only require production of the minimum number of data elements to carry out this payment function in an effort to reduce burdens.  Therefore, we are modifying the data registry elements, based on our review of the evidence and feedback received from commenters.  As amended, the data elements are limited to those required to determine whether an individual has met the coverage criteria for the LDCT lung cancer screening service, that is, whether their receipt of the service was “reasonable and necessary” and “appropriate.”  Data collected and submitted to a CMS-approved national 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, ModelIndicationLung 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 date    Initial Screen or     Subsequent Screen

Additionally, national registries are strongly encouraged to collect data on lung nodules (for example:  clinically significant non-lung cancer findings, the number and types of nodules, and size and location of each nodule), subsequent diagnostic testing, adverse events, and intermediate and long term health outcomes, in order to inform practices and policymakers about the ability to implement a LDCT lung cancer screening program broadly in multiple settings across the country, and achieve positive outcomes, consistent with the NLST.  We recognize that these other data elements are extremely important to establishing the benefit of these screening services and improvement in health outcomes.  We strongly encourage submission of such data elements to registries in addition to the minimum elements required under this NCD.  These data will not only verify that screening leads to improved health outcomes for the Medicare population, but will also serve as the basis to refine and improve screening in practice, and serve the quality improvement purposes of screening facilities.  We believe that multi-society stakeholders are in the best position to determine the appropriate data elements for reaching these goals, and to adjust the particular elements over time.”

About Kirk

Since becoming a lawyer in 1983, Kirk’s over 30 years of practice have focused on advising a wide range of corporations, associations, and individuals (as both plaintiffs and defendants) on both tort and commercial law issues centered around “mass torts.”

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