HRSA FINAL RULE FOR 340B- NEW REQUIREMENTS FOR CALCULATING CEILING PRICES & THE NEW REALITY OF CIVIL MONETARY PENALTIES

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After much discussion and debate, on January 6 HRSA finalized its Final Rule (340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation), which supersedes all subparts of 42 C.F.R. Part 10. The revised regulations and preamble language address key issues in the calculation of 340B ceiling prices (with particular emphasis on new drugs) and outline the rules under which civil monetary penalties (CMPs) for “knowing and intentionally” overcharging covered entities will be imposed.

  • Key elements and definitions in the Final Rule, including the potential for retroactive application of penalties
  • Methods for calculating 340B ceiling prices, including the codification of penny pricing
  • Situational analysis of how new drug pricing will work in practice
  • The threat of CMPs, how they will be calculated, and under what circumstances they will be imposed by OIG
  • Other important takeaways for manufacturers’ compliance in 340B

Speaker:
John D. Shakow
Partner
King & Spalding

Brooke AkinsContact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 
bakins@q1productions.com