Reimbursement
National and Local Coverage Determinations(NCD / LCD)
In one line
Medicare coverage policies issued nationally (NCD) or by individual MAC contractors (LCD).
Definition
An NCD is a binding nationwide Medicare coverage decision; an LCD is a coverage decision by a Medicare Administrative Contractor applicable in its jurisdiction. Both define when an item or service is reasonable and necessary.
NCDs are developed by CMS through a public process with a proposed decision, a comment period and a final decision. LCDs follow the process in the Medicare Program Integrity Manual, including open meetings and comment periods. Where no NCD or LCD exists, contractors decide claims individually. Coverage criteria often require specific diagnoses, physician qualifications or documentation.
Why it matters
Many device coverage paths begin as LCDs that influence later national policy. Manufacturers engage MACs early on evidence requirements and coverage gaps.
Common pitfalls
- •A common pitfall is failing to engage with MACs early in the product development lifecycle to understand evidence requirements for LCDs.
- •Another mistake is assuming that an LCD in one jurisdiction will automatically translate to an NCD or coverage in other MAC jurisdictions.
- •Companies sometimes underestimate the significant financial and time investment required to generate the clinical evidence needed to support NCD or LCD approval.
- •Ignoring the nuances of "reasonable and necessary" criteria, which can vary between NCDs and LCDs, can lead to unfavorable coverage decisions.
- •A pitfall is neglecting to monitor updates and revisions to NCDs and LCDs, which can impact existing coverage for MedTech products.
Sources