340b Drug Discount Program Understanding The Audit Process -Books Pdf

340B Drug Discount Program Understanding the Audit Process
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Objectives,Overview of 340B Drug Discount Program,Define the purpose of the HRSA Audits. Identify key practice areas to regularly ensure,compliant programs. Describe methods to prepare a 340B entity for,internal and or external audits. Office of Pharmacy Affairs,Our Mission,To promote access. to clinically and cost effective,pharmacy services.
Clinically and Cost Effective,Pharmacy Services,Clinically Cost. Effective Pharmacy OUTCOMES,OPERATIONS,Intent of the 340B Program. Permit eligible safety net providers to stretch scarce Federal. Resources as far as possible reaching more eligible patients and. providing more comprehensive services,H R Rep No 102 384 II at 12 1992. 340B Program Overview and Benefits, Provide outpatient drug discounts to certain safety net covered. Average savings of 25 50,Savings may be used to,Reduce price of pharmaceuticals for patients.
Expand services offered to patients,Provide services to more patient. Estimated 6 billion dollars in 340B drug,purchases last year. Manufacturers that participate in Medicaid must also participate in the. 340B Program,Functions of OPA,Administrator of 340B Program. Program oversight to help maximize value of 340B,Service as Federal resource on pharmacy. 340B Program Integrity Resource,consistent,interpretation.
Federal of law policy,Transparency,in drug In all of its functions. pricing OPA prioritizes program integrity,maintains data Website FAQ. for each 340B PSSC Call,entity Annual Center,recertification PharmTA. Eligible Entities,Federal Grantees Hospital Types,Comprehensive Hemophilia Disproportionate Share. Treatment Centers Hospitals, Federally Qualified Health Critical Access Hospitals.
Centers Rural Referral Centers,Urban 638 Health Center Sole Community Hospitals. Ryan White Programs Children s Hospitals, Sexually Transmitted Free Standing Cancer Hospitals. Disease Tuberculosis,Title X Family Planning,Recent OIG Study June 2011. State Medicaid Policies and Oversight,Activities Related to 340B Purchased Drugs. OIG Recommendations, CMS to direct States to create written 340B policies.
CMS to inform States about tools they can use to,identify claims for 340B purchased drugs. HRSA to share 340B ceiling prices with States HRSA. will need to seek legislative authority to implement. HRSA in conjunction with CMS shall improve the,accuracy of the Medicaid Exclusion File. GAO FINDINGS, Manufacturer Discounts in the 340B Program Offer Benefits. but Federal Oversight Needs Improvement GAO 11 836 Sep 23 2011. Oversight of the 340B program is inadequate in providing. reasonable assurance that covered entities and drug. manufacturers are in compliance with program requirements. The 340B program has increasingly been used in settings such. as hospitals where the risk of improper purchase of 340B. drugs is greater,GAO Recommendations,GAO Recommendations include. Covered Entity Audits,Patient Definition,Nondiscrimination by Manufacturers.
Hospital eligibility,HHS RESPONSE TO RECOMMENDATIONS. I Covered Entity Audits,Continue to work with manufacturers. Target educational programs to diversion,II Patient Definition. Review and develop within context of PPACA changes. III Nondiscrimination by Manufacturers,Comprehensive education plan on existing policy. Work with manufacturers to provide clearer guidance on working with HRSA. on allocation,Continue to work with DOJ,IV Hospital Eligibility.
Publicize existing criteria,Initiate recertification process. Develop and implement comprehensive educational plan. ACA Provisions,Focus on Program Integrity, Manufacturer Integrity Civil Monetary Penalties HRSA. published Advanced Notice of Proposed Rulemaking,September 2010. Covered Entity Integrity, Pricing Changes and Transparency Regulations on line. access in 340B data system,Administrative Dispute Resolution HRSA published.
Advanced Notice of Proposed Rulemaking September 2010. Annual on line recertification of all entities,Policy Releases. February 2013,Medicaid Exclusion file,May 2012 GPO Prohibition. Non discrimination,March 2012,Covered Entity Audits.

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