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Attorney Spotlight

How does Jessie Zeigler anticipate the intersection of privacy and smart technology will impact the future of litigation? Find out more>

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Primary Care Providers Win Challenge of CMS Interpretation of Enhanced Payment Law

With the help and support of the Tennessee Medical Association, 21 Tennessee physicians of underserved communities joined together and retained Bass, Berry & Sims to file suit against the Centers for Medicare & Medicaid Services to stop improper collection efforts. Our team, led by David King, was successful in halting efforts to recoup TennCare payments that were used legitimately to expand services in communities that needed them. Read more

Tennessee Medical Association & Bass, Berry & Sims

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Thought Leadership

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Healthcare Private Equity Compliance Checklist

The complex and ever-changing healthcare regulatory and enforcement environment, including increased focus on the role of private equity firms in their portfolio companies, make compliance a top priority for private equity firms investing in healthcare companies. The best way to limit your exposure as a private equity firm is to avoid a compliance misstep in the first place. Additionally, an effective and robust compliance program for your portfolio healthcare company makes it much more attractive to potential buyers and helps you avoid an unexpected and costly investigation or valuation hit down the road. Download the Healthcare Private Equity Compliance Checklist to assess whether your portfolio company's compliance program is up-to-date.

Click here to download the checklist.

Danielle Sloane and Courtney Ginn Discuss FDA Enforcement Related to Labs Marketing Directly to Consumers

G2 Compliance Advisor

Publications

March 23, 2016

Bass, Berry & Sims attorneys Danielle Sloane and Courtney Ginn authored an article outlining the new FDA enforcement actions against laboratory developed tests (LDTs) that are marketed and sold directly to consumers. Although LDTs have historically been exempt from FDA regulation, as technology and testing options have developed and become more sophisticated, more regulation may be on the horizon for these types of tests. As Danielle and Courtney point out in the article, "[i]In late 2015 and early 2016, the FDA issued five warning letters to companies engaging in DTC [direct to consumers] marketing of LDTs. In several of these letters, it appears the FDA may be going beyond situations in which the consumer can order the test directly to also regulate situations in which the practitioner signing the order is affiliated with the laboratory."

The full article, "Marketing of Laboratory Tests to Consumers: Is a Practitioner Order Enough to Avoid FDA Enforcement," was published in the March 2016 issue of G2 Compliance Advisor and is available online (subscription required).


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