0906-AA90 201704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0906 Health Resources and Services Administration HRSA 0900 Department of Health and Human Services HHS 340B Drug Pricing Program; Administrative Dispute Resolution Process

This proposed rule is required under the Affordable Care Act and would implement an enhancement to the 340B Program by establishing a required and binding administrative dispute resolution process to resolve claims raised by covered entities that they have been overcharged for drugs purchased under the 340B Program. This administrative dispute resolution process also is available to drug manufacturers.

]]> Other Significant Previously Published in The Unified Agenda Completed Actions No No None sec. 7102 of the Affordable Care Act Pub. L. 111-148, amending subsec(d) of sec 340B of the PHS Act No ANPRM 09/20/2010 75 FR 57233 ANPRM Comment Period End 11/19/2010 NPRM 08/12/2016 81 FR 53381 NPRM Comment Period End 10/11/2016 NPRM Withdrawn 08/01/2017 Undetermined None No No No No Bradford Lang Public Health Analyst/Health Care System Bureau 0906 Health Resources and Services Administration HRSA 301 443-2671 301 594-4982 blang@hrsa.gov 5600 Fishers Lane, Room 10C-03, Rockville MD 20857