Pharmaceuticals, Prescription Drugs & Medical Devices
Entities within the pharmaceutical supply chain, including pharmacies, wholesalers and pharmacy benefit managers, face many regulatory, reimbursement and compliance challenges. In addition, they must deal with commercial and operational challenges within pharmaceutical distribution networks.
Arent Fox helps these companies navigate the rough waters by providing:
- Fraud and abuse risk assessments related to the sales and marketing of prescription drugs and medical devices under both federal and state fraud and abuse laws.
- Compliance program development, monitoring, auditing, and training tailored for the drug and device arena.
- “Sunshine Act” compliance, both under the federal Physician Sunshine Act and under state laws mandating reporting of advertising and marketing costs.
- Patient assistance programs, including free goods, charities, and manufacturer-sponsored “coupon” or co-payment assistance programs.
- Tracking of state law developments relating to price reporting, registering of clinical trials and reporting of trial results, limitations on prescription data-mining and licensing or other oversight of field sales representations.
Prescription Drug Pricing
Arent Fox is one of only a handful of US firms that provides sophisticated counsel to the prescription drug industry on the full range of complex pricing issues, including:
- Average Wholesale Price (AWP) and Wholesale Acquisition Cost (WAC) reporting to the compendia.
- Average Sales Price (ASP) reporting to Medicare.
- Average Manufacturer Price (AMP) and Best Price reporting to Medicaid.
- Ceiling and sub-ceiling price reporting to support the Public Health Service 340B program.
- Non-FAMP and FCP reporting to FA/FSS.
We also assist pharmaceutical manufacturers in navigating the Coverage Gap Discount Program under Medicare Part D, NADAC, and the AAC methodologies currently being adopted by state Medicaid programs. Our advice reflects experience gained from supervising government pricing systems audits, handling restatements and voluntary disclosures with the Centers for Medicare and Medicaid Services (CMS), the Office of Pharmacy Affairs (OPA) at HRSA and the US Department of Veterans Affairs (VA), and representing clients facing enforcement actions tied to their price reporting obligations.
How We Help
- Prescription drug pricing
- Fraud and abuse assessments and counseling
- Advocacy to Food and Drug Administration (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, 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
- 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, Federal Trade Commission (FTC), and state regulatory compliance for private label products.
- Counsel on state licensure issues
- Defense of enforcement actions initiated by state Boards of Pharmacy