Transcription of Review of the 340B Drug Pricing Program
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Review of the 340B. drug Pricing Program Table of Contents I. Executive 2. II. Table of Acronyms .. 6. III. Findings .. 7. IV. Background .. 9. A. Overview of the 340B Program 's Development and Growth .. 9. B. Types of Covered Entities .. 13. C. Background on the Committee's 15. D. GAO and HHS OIG Reports on the 340B Program .. 18. V. HRSA Administration and Oversight of the 340B Program .. 20. A. HRSA's Implementation of 340B 20. B. HRSA's Authority to Clarify Program Requirements .. 25. C. HRSA's Audits of Covered Entities .. 30. i. Audit Findings .. 35. ii. Duplicate Discounts .. 36. iii. Diversion .. 38. iv. Incorrect Reporting .. 40. v. GPO Prohibition and Program Termination .. 40. D. HRSA's Audits of Manufacturers .. 42. E. Program Growth and HRSA's Ability to Keep Up .. 43.
2 I. Executive Summary The 340B Drug Pricing Program (340B program) was established by Congress in 1992, and mandates that, to remain eligible for participation in the Medicaid program, drug
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