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HRSA 340B AUDIT FINDINGS
You’ve Been Sanctioned – Now What?
 
The importance of covered entities being compliant is becoming more critical with the growth of the 340B program.  HRSA audit findings are showing increased non-compliance.  Unfortunately, you were one of those entities – what can you do to make sure that it doesn’t happen again?
 
The Section 340B Drug Pricing Discount Program has been under intense scrutiny by HRSA, the pharmaceutical industry and members of Congress.  The programs’ intent is to provide a safety net for the most vulnerable members of the population.  Section 340B sales have increased to approximately $10 billion since its inception in 1992 with a substantial portion of this growth occurring in the last 10 years.  Contemporary Health Care, Inc. worked extensively on 340B issues since 1999 and is very familiar with is requirements.  Executive’s team of professionals have conducted and performed compliance reviews, prepared action plans, worked with qualified 340B counsel and assisted in the development of policies and procedure manuals.  Executive will work with clients to make the process transparent.
 
Contemporary Health Care, Inc. has been involved with assisting our clients and covered entities participating in the Section 340B Drug Pricing Program over the past two decades. We have developed an expertise and program templates that are used to assist covered entities in complying with regulatory and guidance issues.  Further, we assist our clients relative to the 340B Drug Pricing Program in developing strategies for revenue expansion by innovative program analysis, and site expansion potential through collaboration and partnership contractual relationships.
 
In response to the needs of our clients Contemporary Health Care, Inc. developed a series of products that are used to assist clients in identifying those areas of compliance and potential areas of non-compliance that may require additional review and/or change.
 
Contemporary Health Care has developed the following products to assist covered entities in complying with the 340B Drug Pricing Program guidelines and to prepare for HRSA audits:
 
• Contemporary Health Care’ Compliance Assessment Review Program (EXCARP-340B) © 2015 v.2 focuses on two specific areas of review that we believe should address concerns of HRSA. These areas are:
     - Covered Entity Review; and
     - Contract Pharmacy Review.

• The Compliance Assessment Program (EXCAP-340B) © 2015 v.2 was developed to obtain a better understanding of a client’s compliance with the Section 340B Drug Pricing Program requirements and to identify potential areas of weakness and deficiencies that will be used in developing a focused program of review.
 
• Contemporary Health Care’ Policies and Procedures Manual (EXCoPP-340B) © 2015 v.2 was developed to assist 340B covered entities demonstrating to HRSA auditors that it understands the requirements and intent of the 340B guidelines, as required by HRSA.
 
• Contemporary Health Care’ 340B Checklist Program (EXCK-340B) © 2015 v.2 was designed to assist 340B covered entities who recently received approval to participate in the Section 340B Program or for those covered entities who would like to check that they meet the necessary documentation requirements for participation.
 
For more detailed information on the HRSA Audit Findings or our 340B Products and Services, click on our "Services" tab  at www.execresources.net.
 
 

Contact us, and we'll be happy to tell you exactly how we can address your particular institutional situation.