Clinical Trial Coverage and Billing Services
Our clinical trial billing and Medicare coverage analysis services operate as a separate line of business from Saphan Pont Law, PLLC. Our team is composed of academic medical center veterans and industry professionals with decades of hands-on experience in leading clinical trial offices and negotiating clinical research budgets, and conducting Medicare coverage determinations. We bring deep knowledge of Medicare's Clinical Trial Policy, device Investigational Device Exemption (IDE) coverage workflows, and multi-jurisdiction Local Coverage Determination (LCD) variability-expertise that comes from years of doing this work inside research institutions and alongside sponsors. We leverage AI-assisted tools to accelerate routine tasks, but every coverage determination and budget recommendation is made by experienced analysts and undergoes peer review before delivery.
For more information about our Clinical Trial Coverage and Billing services, please contact us.
Clinical Trial Billing Services
We translate your protocol and schedule of assessments into a sponsor-ready budget framework — with site payment tracking, FMV documentation support, and quarterly reporting structures that help sponsors control costs and pay sites accurately and on time.
What We Deliver:
- Site Payment Tracking & Verification — structured reporting on per-visit and per-procedure payments to confirm services were rendered and billed correctly
- Protocol-Aligned Budget Construction with transparent mapping of routine-care versus sponsor-paid items, device IDE handling, and invoiceable logic
- FMV Documentation Support — parameters and documentation practices for payments that go outside FMV, including what to collect from sites and what to retain on the sponsor side
- Document Harmonization ensuring alignment across your CTA, budget, and informed consent
Medicare Coverage Analysis
We deliver defensible Medicare Coverage Analyses grounded in the governing authorities—so you know exactly what can be billed to insurance versus sponsor before you finalize your budget or CTA.
What We Deliver:
- Medicare Coverage Analysis (MCA) with explicit authoritied and clinical guidelines where needed
- IDE Category A/B Workflows including CMS/MAC coverage approvals and proper claim elements for device trials
- Multi-Jurisdiction LCD Navigation with sponsor budgeting strategies for coverage variability across MAC jurisdictions