Overview
Retail, hospital, and specialty pharmacies, along with distributors, pharmacy benefit managers, and plan sponsors, rely on EBG Advisors to resolve government enforcement and compliance challenges related to the payment, delivery, and supply of prescription drugs.
Clients turn to EBG Advisors’ cross-functional team, which includes former clinicians as well as financial, reimbursement, and compliance professionals, to provide advice on prescription drug claims submission and payment, pharmacy benefit administration, and Medicare Part D compliance, and to prepare expert and consultative reports shared with prosecutors or used in commercial litigation. Our team has helped clients successfully resolve some of the most challenging disputes, enforcement, and compliance issues in the industry.
340B Drug Discount Program
The 340B team at EBG Advisors includes 340B independent audit and compliance consultants and highly skilled lawyers. Covered entities, pharmacies, technology vendors, and other 340B stakeholders rely on us for strategic, regulatory, and compliance counseling and consulting services. We guide clients through the 340B Drug Pricing Program’s complicated requirements while staying responsive to their needs. Our team also helps clients establish compliant and well-supported programs and effectively respond to governmental inquiries.
Covered entities, contract pharmacies, and 340B management service providers receive guidance and assistance on 340B compliance, outlook, and strategy. Clients rely on us to perform 340B eligibility and feasibility assessments and to conduct independent audits of their 340B program, including a financial and compliance review and test of internal controls. We prepare clients for, and assist them with, Health Resources and Services Administration audits, manufacturer audits, and self-disclosures, including follow-up audit responses and corrective action plans.
Our team also assists clients with developing 340B programs. We help clients prepare all necessary government contracts, draft and implement 340B compliance policies and procedures, and provide staff training.
In addition, our 340B team structures, drafts, and negotiates 340B contract pharmacy and technology vendor arrangements. Clients count on us to assist them with 340B Drug Pricing Program database registrations and re-certifications, and to advise them on registration deadlines affecting program eligibility. We also help negotiate and resolve disputes between 340B participants. And we keep covered entities and other 340B participants updated on new regulatory, industry, and enforcement guidance and developments.
Clients gain insights from members of our 340B team, who are industry thought leaders and frequent speakers on the 340B circuit and make presentations at the major 340B stakeholder and pharmaceutical conferences addressing new developments in 340B compliance and enforcement.
We provide the following services:
- Risk, regulatory, and compliance solutions for pharmacies:
- Audit and monitor operational compliance
- Create due diligence and corrective action plans
- Conduct risk assessments
- Develop monitoring measures
- Disputes and forensic solutions for pharmacies:
- Respond to claims of improper billing to government programs
- Resolve contract disputes
- Defend false claims allegations
- Data analytics:
- Perform forensic data analyses that correspond to risk and financial exposure
- Develop methodologies to test the accuracy of claims billing
- Review large volumes of claims for payment accuracy
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Insights
Insights
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Contact
EBG Advisors is prepared to assist you with undertakings ranging from launching products to obtaining regulatory approval and legal representation. Please provide us with an overview of how we may be of service, or, if you have any questions, let us know and we’ll direct them to the right consultant.
Joanna Pashos
Assistant Director EBGA
EBG Advisors, Inc.
JPashos@ebgadvisors.com
T: 202.861.1822