News & Analysis as of

Diagnostic Tests Office of the Inspector General Pharmaceutical Industry

Gardner Law

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

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Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Biopharmaceutical Company Arrangement to Provide Free Genetic Testing and...

King & Spalding on

Last week, OIG posted Advisory Opinion No. 22-06 regarding a biopharmaceutical company’s (BioPharm Co.) arrangement to provide free genetic testing and genetic counseling services to patients potentially eligible for...more

Womble Bond Dickinson

What to Expect as OIG and CMS Audits Focus on COVID-19 Testing?

Womble Bond Dickinson on

The COVID-19 pandemic has caused an enormous need for testing and has spawned the creation of new labs and specimen collection agencies to (try to) meet that need. In 2020 alone, Medicare spent $1.5 billion on COVID-19 tests....more

King & Spalding

OIG Releases Mid-Year Update to its Work Plan

King & Spalding on

On May 28, 2015, the OIG published a revised version of its Work Plan for Fiscal Year (FY) 2015. As previously reported, the original version of the FY 2015 Work Plan was published in October and summarized the OIG's ongoing...more

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