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CMS Announces Policy on Medicare Secondary Payer Insurer Reporting Requirements for Clinical Trial Sponsors and CMS also Addresses 'Risk Management Write-Offs'

June 2010

Health Alert

The Centers for Medicare & Medicaid Services (CMS) announced its policy on application of the Medicare secondary payer (MSP) reporting requirements under section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) to sponsors of clinical trials. During the May 27, 2010, teleconference for liability insurance (including self-insurance), no-fault insurance, and workers' compensation responsible reporting entities (RREs), CMS staff announced that the agency would issue a policy alert regarding clinical trials. This policy is dated May 26, 2010, was posted on the CMS website on June 10, 2010, and is quoted in this Alert. CMS also released a new policy alert on risk management write-offs. These policies will be of interest to providers and manufacturers.

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The team

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