National and Local Coverage Determinations (NCDs and LCDs) are two of the most important aspects of Medicare coverage. Both NCDs and LCDs are released by Centers for Medicare and Medicaid Services (CMS) to standardize Medicare coverage for certain medical tests and procedures. These determinations outline the conditions in which a service is considered to be covered by Medicare.
NCDs, which are developed through an evidence-based process, are applicable nationwide and to US territories. Conversely, LCDs are released by Medicare contractors, and apply only to the contractor’s region. While LCDs cannot contradict NCDs, LCDs are often released to clarify an NCD or address common coverage issues.
NCDs and LCDs guide healthcare providers in submitting correct claims for reimbursement. As such, these determinations are a crucial aspect of clinical research, and furthermore, to the process of coverage analysis. Coverage analysis is the review of events listed in a study protocol to determine which events are billable, and if so, to whom those services should be billed. It is important for institutions and other healthcare providers to perform a coverage analysis on each study to ensure billing compliance, particularly in today’s environment of heightened scrutiny.
One of the most important determinations in this context is NCD 310.1, the National Clinical Trial Policy. NCD 310.1 was enacted in 2000 after an executive memorandum was issued by the President of the United States requesting standardization of Medicare payment with regard to clinical trial costs. CMS updated the policy in July of 2007 to address several issues, which was the first and only update since its inauguration.
NCD 310.1 provides coverage for routine costs of qualifying clinical trials, as well as items and services used to diagnose and treat complications resulting from participation in a clinical trial. A qualifying clinical trial must evaluate an item or service that is included in a Medicare benefit category, have therapeutic intent for the patient, and enroll patients with a diagnosed disease. Clinical trials must also be "deemed" to qualify, meaning they are being conducted under an IND, are IND exempt, or are funded by a cooperative group or government agency.
Not all costs incurred in a clinical trial are covered by NCD 310.1. Some items that are not covered include the investigational item itself (e.g. the study drug), or items required solely for data collection. Additionally, NCD 310.1 does not apply to device studies. That said, NCD 310.1 does cover items and services considered to be conventional care, items related to the administration of the investigational drug, and items used to monitor side effects of the study drug.
A full database of NCDs and LCDs is available on cms.gov. Because of frequent changes and updates to NCDs and LCDs, search engines often contain old information, and thus are not recommended when researching this topic.