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.
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Clinical Trial Billing Services
We transform your protocol, informed consent, and schedule of assessments into activated studies by making budgeting and Coverage Analysis clearer and more complete. Surface unbudgeted work before it becomes an amendment.
What We Deliver:
- Billing Grids with visit-by-visit items, CPT/HCPCS coding, payer designations, and authority citations
- Protocol-Aligned Budget Construction with transparent mapping of routine-care versus sponsor-paid items, device IDE handling, and invoiceable logic
- 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