On June 17, 2015, HRSA proposed regulations to implement elements of the Affordable Card Act that required the agency to develop guidelines for assessing civil monetary penalties on drug manufacturers participating in the 340B program that overcharge covered entities.  The regulations also included proposed rules for calculating the 340B “ceiling price”, or the maximum price that a drug manufacturer can charge a 340B provider.  The proposed rule is here.

RWC-340B joined the 340B Coalition to submit comments on the proposed rules.  The comments, which are available here, included the following suggestions:

  • HRSA should ensure that no changes are made that could impede or hamper
    federal grantees’ ability to negotiate sub-340B or non-340B prices with
    manufacturers individually, or collectively through group purchasing
  • HRSA should clarify that a drug purchased at or below the ceiling price is a 340B
    drug only when the price is required by a pharmaceutical pricing agreement and
    that drugs which are discounted outside the 340B program are not included within
    the definition of “340B drug,” even when sold at or below the ceiling price.
  • HRSA should state its statutory authority to issue regulations governing 340B
    ceiling price calculations.
  • The 340B organizations support HRSA’s 340B ceiling price formula and efforts
    to develop a 340B ceiling price database but recommends that HRSA clarify the
    definition of “case package size.”
  • The 340B organizations support HRSA’s codification of the penny pricing policy.
  • The 340B organizations generally support HRSA’s codification of the new drug
    pricing policy with technical clarifications. HRSA should require manufacturers
    to issue refunds for all overcharges, not just overcharges on new drugs.
  • The 340B organizations support HRSA’s proposal to assess CMPs according to
    Office of the Inspector General (OIG) procedures but requests that HRSA clarify
    that key definitions from OIG regulations will be incorporated into the 340B CMP
    program. Specifically, a manufacturer should be subject to CMPs based on the
    manufacturer’s actual knowledge, deliberate ignorance, or reckless disregard of
    an overpayment.
  • The 340B organizations recommend that HRSA define “instance of
    overcharging” on a per-unit basis rather than on a per-order basis.
  • HRSA should clarify that the obligation of a manufacturer to ensure the
    availability of 340B pricing applies to a covered entity’s contract pharmacy
    arrangement with a specialty pharmacy in a manufacturer’s limited distribution
    network for a particular drug.
  • HRSA should require manufacturers to honor a covered entity’s request to
    reclassify a purchase from non-340B to 340B and to issue a corresponding refund
    if a covered entity requests such a reclassification within one year of purchase.