Policy Releases

Federal Register Notices | Section 340B of the Public Health Service Act (PDF - 39 KB) | Program Updates | 340B Program Regulations

2014

2014-1 Clarification of use of the Medicaid Exclusion File (PDF - 60 KB) Replaces No. 2013-2 12/12/2014

2013

2013-3 Clarification of Eligibility for Hospitals That Are Not Publicly Owned or Operated (PDF - 183 KB) 

2013-2 Clarification on Use of the Medicaid Exclusion File (PDF - 169 KB)  02/07/2013

2013-1 Statutory Prohibition on Group Purchasing Organization Participation (PDF - 194 KB) 02/07/2013

2012

2012-2 Clarification of Covered Entity Eligibility within Accountable Care Organizations (PDF - 36 KB) 05/23/2012 

2012-1.1 Clarification of HRSA Audits of 340B Covered Entities (PDF - 30 KB) 02/08/2013 replaces 2012-1

2011

2011-3 Clarification of Manufacturer Audits of 340B Covered Entities (PDF - 40 KB) 11/21/2011

2011-1.1 Clarification of Non-Discrimination Policy (PDF - 30 KB) 05/23/2012 replaces 2011-1