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Off-Label Risks: Compliance Matters Now More Than Ever

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Manage episode 421766467 series 3506216
Content provided by Darshan Kulkarni. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Darshan Kulkarni or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.

We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.

We discuss the following:

  1. What does off-label mean from a reimbursement standpoint?
  2. Lessons from the US v. Eli Lilly 2009 case
  3. How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau
  4. How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid?
  5. How are compounded drugs reimbursed?
  6. Could a company be held accountable for off-label use of a drug due to
  7. compounded products?
  8. Are weight loss drugs exempted from reimbursement?

Support the Show.

  continue reading

101 episodes

Artwork
iconShare
 
Manage episode 421766467 series 3506216
Content provided by Darshan Kulkarni. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Darshan Kulkarni or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.

We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.

We discuss the following:

  1. What does off-label mean from a reimbursement standpoint?
  2. Lessons from the US v. Eli Lilly 2009 case
  3. How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau
  4. How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid?
  5. How are compounded drugs reimbursed?
  6. Could a company be held accountable for off-label use of a drug due to
  7. compounded products?
  8. Are weight loss drugs exempted from reimbursement?

Support the Show.

  continue reading

101 episodes

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