Clinical Trials Sponsors are required to report under Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA). The penalty for not reporting is $1,000 per day per test subject and the risk of double damages under Title 42 U.S.C. 1395y(b)(8), MSP laws.
CMS Probes Sponsor Billing Practices
In a joint meeting brokered by Piatt Consulting to discuss reporting, CMS asked pointed questions about leading Pharma’s billing practices
For leading pharmaceutical firms the debate over whether Title 42 U.S.C. 1395y(b)(8) of the Medicare Secondary Payer (MSP) law is applicable to Clinical Trials has ended.
There has been some confusion about when to report -- payment or adverse event.
David Piatt formed Piatt Consulting, Medicare Consul Services LLC (MCS), an independent business dedicated to Mandatory Insurer Reporting services and Piatt Claims Resolution LLC to provide Medicare Claims Resolution and Medicare Set-Asides. He is the former Program Director of the Medicare Secondary Payer Recovery Contract (MSPRC) where he managed Medicare's national recovery ("liens") efforts.