Medical Device Go-to-Market Guide: Hospital VAC Dossiers and Reimbursement Planning
How MedTech teams prepare hospital Value Analysis Committee dossiers and plan coding, Medicare coverage and payment. Companion guide to the Cahir MedTech VAC Dossier Pack and Reimbursement & Coding Roadmap.
Why does FDA clearance not guarantee sales?
FDA decides whether a device can be marketed. Hospitals decide whether to buy it, and payers decide whether to cover and pay for its use. Medicare covers items that are reasonable and necessary under Social Security Act §1862(a)(1)(A), a separate test from FDA review.
Plan regulatory, hospital and payer evidence together so one clinical program serves all three audiences.
Sources: CMS Medicare Coverage Database
What does a hospital Value Analysis Committee review?
A Value Analysis Committee (VAC) is a hospital group, often clinicians, supply chain and finance, that reviews new products before purchase. Typical requests cover regulatory status, clinical evidence, safety, cost impact, coding, workflow and contracting.
The VAC Dossier Pack gives a ten-part checklist for these elements, with evidence and owner fields for each one.
How should I estimate budget impact for a hospital?
Use the hospital's own annual volumes and per-case costs. For each cost element, annual impact equals current cost per case minus new cost per case, multiplied by annual cases. Positive values are savings.
Include device price, length of stay and complication costs where your evidence supports them, and state the data source for each number. Keep every claim within your cleared or approved indications.
How do medical device codes get created?
CPT codes are maintained by the AMA CPT Editorial Panel, which reviews applications on a published meeting calendar. Category III codes track emerging technologies. HCPCS Level II codes are maintained by CMS, which reviews applications on published cycles.
Check whether existing codes already describe the service before applying for a new one, and confirm current deadlines on the official pages.
Sources: AMA CPT Editorial Panel · CMS HCPCS
What Medicare coverage routes are available?
Medicare coverage can come from National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs) issued by Medicare Administrative Contractors, or claim-by-claim review where no policy exists.
Transitional Coverage for Emerging Technologies (TCET) is a voluntary pathway for certain FDA-designated Breakthrough devices. CMS accepts a limited number of candidates each year.
Sources: CMS TCET final notice
What are NTAP and transitional pass-through payment?
New Technology Add-on Payment (NTAP) can add payment for qualifying new technologies in the inpatient setting; applications follow the annual IPPS rulemaking cycle. Transitional pass-through payment can apply to qualifying devices in the hospital outpatient setting; CMS reviews applications quarterly.
Both require evidence of cost and clinical improvement. The Reimbursement & Coding Roadmap tracks each step alongside your FDA decision date.
Sources: CMS NTAP · CMS OPPS pass-through
Planning aid, not legal, coding or reimbursement advice. Confirm current cycles and requirements on official CMS, AMA and FDA pages. Get the workbooks in your toolkit dashboard.