Who is affected and how:

• Medicare beneficiaries: May gain access to new multi-cancer screening tests through Medicare coverage if tests meet the statutory definition and an NCD finds them reasonable and necessary; out-of-pocket costs will depend on Medicare cost-sharing and whether tests are covered under Part B or other Medicare rules.

• Health care providers and clinical laboratories: Will have a route to bill Medicare for qualifying MCED tests, but must meet the definition, coding, and claims requirements; providers may need to update ordering, documentation, and billing processes.

• Test manufacturers and diagnostic developers: Stand to benefit from a clear coverage and payment pathway; must ensure tests are available and furnished on/after Jan 1, 2028 and pursue evidence and administrative processes (NCD) to secure coverage and payment.

• Medicare program finances and administrators (CMS): Will need to process NCDs specific to MCED tests, implement coding and payment rules, and manage potential utilization increases and budget impacts; CMS must also reconcile payment changes effective Jan 1, 2031.

• Clinical practice and public health: Could see increased early detection of multiple cancers if tests are accurate and widely adopted; also raises issues around downstream diagnostic follow-up, possible false positives, and care pathways that could increase use of diagnostic procedures.

Risks and operational considerations:

• Evidence and utilization uncertainty: Coverage hinges on NCDs and USPSTF recommendations—if evidence is limited or mixed, coverage may be narrow or conditional.
• Budgetary effects: Broader coverage could increase Medicare spending for screening and follow-up care; phased payment rules attempt to manage those effects.
• Implementation work: CMS, providers, and payers will need to update coding, claims systems, and clinical guidance before 2028 and again before the 2031 payment change.