The Health Resources and Services Administration today  to July 1, 2018 the effective date of its  on 340B drug ceiling prices and civil monetary penalties for manufacturers. 鈥淲e are delaying the effective date of the Jan. 5, 2017, final rule to July 1, 2018, because the delay will provide stakeholders with additional time to come into compliance and provide time to consider the substantial questions of fact, law and policy raised by the rule,鈥 the agency said. AHA had any further delay of the rule, which has been subject to multiple delays since January. 鈥淭he agency鈥檚 rulemaking on these issues began seven years ago, shortly after the passage of the ACA,鈥 AHA Executive Vice President Tom Nickels said in comments submitted last week. 鈥淭his process included an advance notice of proposed rulemaking, a notice of proposed rulemaking, a final rule and now an interim final rule. Therefore, there have been extensive opportunities for stakeholders to provide feedback and ample time for HRSA to consider such feedback.鈥

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