CRT: TVT Registry to charge providers $25K to join
“The initiation fee will go to pay for the upfront costs of the IT infrastructure that it took to build the database, link it to CMS [Centers for Medicare & Medicaid Services] data and contract with Duke Clinical Research Institute for the analytics,” he said.
While the INTERMACS registry is funded by industry, for example, the TVT registry will be funded by the users. “Currently, all the providers pay for a vendor, and societies are taking the place of that cost because it will be integrated in this TVT Registry,” Mack explained.
The annual fee of $10,000 for renewal fee is “market value for the STS and ACC database.” With TVT participation, providers will receive an annual report, benchmarking where they stand nationally and regionally.
Due to the government collaboration in creating the TVT Registry, CMS’ proposed determination—issued last week—recommended inclusion in the registry as a stipulation for reimbursement. In fact, the STS and ACC recommended that CMS “include as a condition of coverage mandatory reporting of the procedures in an STS-ACC TVT Registry which would include long-term follow-up using CMS data.” Likewise, the FDA, in their approval, included a statement recommending continued clinical study and data submission to the STS-ACC TVT Registry.
“As it stands now under the proposal, if providers want to get paid, it’s mandatory participation,” said Mack, who said that the societies spent several million dollars on creating this registry, which also will perform post-market surveillance, as stipulated in the FDA approval.
At CRT.11, the FDA sat down with STS and ACC to request this type of comprehensive registry, followed by one year of collaboration with the FDA and CMS to formulate its design.
“If Medtronic’s CoreValve gets approved, the infrastructure is in place to include their valves as well, so we won’t have to go back to the drawing board,” Mack said. “This has been an effort of federal agencies to create a national infrastructure to allow seamless post-market surveillance, so it doesn’t have to design a new post-approval structure each time a new device is approved.”