340B Program Ceiling Price and CMP Final Rule Delayed Until May 22

On 20 March 2017, the Health Resources and Services Administration (HRSA) published an Interim Final Rule (IFR) delaying the effective date of the 340B Ceiling Price and Civil Monetary Penalties (CMP) Rule (the Final Rule) until 22 May 2017. The delay is effective immediately.

HRSA also asked for comments on whether the effective date of the rule should be delayed further, until 1 October 2017. Comments are due on or before 19 April 2017.

As a reminder, the Final Rule established:

  • CMPs for manufacturers who knowingly and intentionally charge covered entities more than the ceiling price for a covered outpatient drug.
  • A methodology for calculating the 340B ceiling price, including:
    • The codification of HRSA's penny pricing policy, which requires manufacturers to charge $0.01 for a drug whose ceiling price calculates to less than $0.01.
    • A ceiling price estimation methodology for new drugs.
  • Requirements for refunding covered entities in connection with truing up estimated ceiling prices and revised ceiling prices resulting from routine restatements of CMS Medicaid data.

For more details, read more.


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