HRSA Takes its First Steps on 340B Rules

June 22, 2015

Health Law & Policy Matters (Sternfield, Wiley) reported that on June 17, the Health Resources and Services Administration (HRSA) issued proposed rules that "address two ACA provisions:  (i) the requirement that HRSA adopt regulations penalizing manufacturers for overcharging ceiling prices, and (ii) a separate requirement that HRSA 'develop and publish through an appropriate policy or regulatory issuance, precisely defined standards and methodology for the calculation of [340B] ceiling prices.' Because the statutory language does not specifically authorize rulemaking on calculation of ceiling prices, this portion of the rule may be the subject of comments or future legal challenges.  Comments to the proposed rules must be submitted by Monday, August 17, 2015."