In light of this new scrutiny and regulatory focus, 340B participants should take steps to ensure their 340B programs are properly structured to comply with the current applicable regulations and weather any future Mega Guidance impact.
Knoxville, TN (PRWEB) June 30, 2016
A new white paper from PYA, “340B Program: Mega Guidance, Mega Change,” offers an overview of the 340B Drug Pricing Program, identifies risk areas for covered entities (CEs), foreshadows operational impacts as a result of the Health Resources and Services Administration’s (HRSA) proposed “Mega Guidance,” and provides a self-assessment checklist to help providers navigate current and future risks. The paper clarifies key areas of compliance concern, as well as provides updates regarding the Orphan Drug Exclusion and specificities related to the Mega Guidance.
In an effort to eliminate unnecessary pricing, diversion, and other abuses of the 340B Program, HRSA has increased its regulatory oversight of CEs underscoring the importance of program compliance. To further augment the attention surrounding the program, the Department of Health and Human Services will address concerns via interpretive guidance, frequently referred to as Mega Guidance. While the official date of release is still unknown, the finalized Mega Guidance is expected to clarify many ambiguous interpretations of the current rule.
In addition, implications of the Mega Guidance can result in an enormous financial impact on CEs. Entities found to be non-compliant can be forced to pay back drug manufacturers and/or lose their ability to participate in the program. PYA’s new 340B white paper is designed to help entities sort through the complexities of the program, regulations, and impending guidance so that they are in compliance with program requirements.
According to the whitepaper, “In light of this new scrutiny and regulatory focus, 340B participants should take steps to ensure their 340B programs are properly structured to comply with the current applicable regulations and weather any future Mega Guidance impact. Covered entities must have in place policies, procedures, processes, and controls to ensure that they are operating within the requirements and prohibitions of the program.”
To complement the white paper and further assist providers in managing the complexities of the program, PYA has released a 340B Infographic. The infographic provides key HRSA findings, assists in identifying areas of risk, and offers recommendations for addressing critical issues.
A certified public accounting and healthcare consulting firm, PYA has years of experience assisting healthcare organizations in designing and maintaining sound internal controls, processes, and procedures. PYA’s 340B team can assist CEs in multiple areas of 340B compliance, including annual independent audits, compliance infrastructure design, policy and procedure development and testing, reimbursement and cost reporting, education and training, and corrective action plan support.
For over three decades, PYA (Pershing Yoakley & Associates, P.C.), a national healthcare consulting firm, has helped clients navigate and derive value amid complex challenges related to regulatory compliance, mergers and acquisitions, governance, business valuations and fair market value assessments, multi-unit business and clinical integrations, best practices, tax and assurance, business analysis, and operations optimization.
PYA’s steadfast commitment to an unwavering client-centric culture has served the firm’s clients well. PYA is now ranked by Modern Healthcare as the nation’s 9th largest privately owned healthcare consulting firm. PYA affiliate companies offer clients world-class data analytics, professional real estate development and advisory resources for healthcare providers, comprehensive claims audits for self-insured Fortune 500 companies, wealth management and retirement plan administration, and business transitions consulting.
For more information, please visit http://www.pyapc.com.