Big news for heart care: Medicare will now cover transcatheter tricuspid valve replacement (TTVR) — but only under strict conditions. The March 2025 CMS ruling requires the procedure to be part of agency-approved studies, with rigid tracking of patient outcomes for at least two years. For hospitals, this isn’t just about cutting-edge care. It’s a billing maze.
To get paid, providers must:
- Use TTVR for FDA-approved cases (like severe symptomatic tricuspid regurgitation).
- Assemble a specialized heart team — surgeons, cardiologists, imaging experts — all experienced in treating TR.
- Enroll patients in CMS-backed studies that compare results against standard care and track mortality, hospitalizations, and subgroups.
Edwards Lifesciences’ Evoque system, approved in 2024, drove this decision. Trials showed it nearly eliminated TR and boosted quality of life. But here’s the catch: One missed paperwork step or incomplete data could mean denied claims.
Imagine a hospital’s billing team. They’re juggling study enrollment logs, heart team sign-offs, and 24-month outcome tracking — all while ensuring every code matches CMS’s evidence-development rules. A single error? Unpaid claims. Lost revenue. Administrative chaos.
This is where Pyramids Global, steps in.
- Study Compliance Checks: They verify every TTVR case meets CMS’s research criteria, so claims aren’t rejected for technicalities.
- Heart Team Coordination: Their system tracks mandatory sign-offs from surgeons, cardiologists, and imaging experts, ensuring no gaps.
- CED Documentation: They organize outcome data for the required 24-month follow-up, aligning with subgroup analysis demands.
- Audit Prep: With reimbursement tied to active studies, their team preps records for CMS scrutiny — minimizing financial risk.
Reimbursement hinges on “coverage with evidence development.” That means hospitals aren’t just treating patients — they’re running research projects. Billing teams must now act like clinical trial managers. Pyramids Global bridges this gap, turning regulatory hurdles into streamlined workflows.
TTVR is a leap forward for heart care. But without precise billing, providers lose revenue. Partnering with Pyramids Global lets hospitals focus on innovation, not paperwork.