Entities within the pharmaceutical supply chain, including pharmacies, wholesalers and pharmacy benefit managers, face many regulatory, reimbursement and compliance challenges. In addition, they face commercial and operational challenges in dealings within the pharmaceutical distribution channels.

Arent Fox helps these companies navigate the rough waters by providing, among other things:

• Fraud and abuse assessments and counseling
• Advocacy to FDA, CMS and state agencies involving regulatory proposals that may significantly impact pharmacy and pharmacy benefit operations
• Compliance program design and implementation
• Negotiation of rebates agreements, in-network pharmacy provider agreements and pharmacy benefit management services agreements
• Counsel on commercial and statutory pricing issues, including Average Wholesale Price, Maximum Allowable Cost methodologies, Actual Acquisition Cost, National Average Drug Acquisition Cost, National Average Retail Price, Medicaid Drug Rebate Program and the Federal Upper Limit
• Assistance with formulary development and plan design in accordance with Medicare Part D, the Affordable Care Act and state statutory and regulatory requirements
• Counsel on therapeutic interchanges in long-term-care facilities and otherwise
• Consultation on the development of medication therapy management or patient adherence programs and the legal and compliance implications that are associated
• Assistance in the design of generic substitution and drug utilization management programs
• Assistance with pharmacy licensure, third party administrator and utilization review agency licensure
• Counsel on e-prescribing requirements
• Counsel on 340B program administration and requirements
• Advise on FDA, FTC and state regulatory compliance for private label products
• Counsel on state licensure issues
• Defense of enforcement actions initiated by state Boards of Pharmacy

Medicare Part D

Arent Fox advises and counsels pharmaceutical manufacturers, pharmacy benefit managers, pharmacies and others in the pharmaceutical supply chain on a wide range of complex legal, regulatory, and legislative issues, many of which stem from the Medicare Prescription Drug Improvement and Modernization Act of 2003. Our advice extends to various program requirements, including:

• Fraud, waste and abuse
• Compliance Program development
• Plan design and formulary development
• Marketing practices
• Relationships with first tier, downstream, and related entities
• Beneficiary rights and safeguards, such as appeals and grievances
• E-prescribing
• The Coverage Gap Discount Program
• Development and implementation of corrective action plans

We advocate on behalf of our clients before CMS and help clients prepare for and respond to CMS and OIG audits and inquiries.