Suppliers and distributors of pharmaceutical products, medical devices, and durable medical equipment (DME) are confronted with a wide range of regulatory and other legal requirements addressing contracting, pricing, billing, marketing, and delivering health care products. These businesses are subject to scrutiny by federal and state regulators, third-party payors, and the customers with whom they deal. With the current emphasis on both cost containment and legal compliance, suppliers and distributors must be alert to existing obligations and respond to changes from a variety of public and private sources in order to minimize their risks.
We have extensive experience representing health care suppliers and distributors as well as group purchasing organizations (GPOs), which are purchasing agents authorized to act for their members. Due to the size of their member base, GPOs are able to negotiate more favorable prices with suppliers for a particular item or service than individual providers could on their own.
Services/Scope of Practice
Epstein Becker Green counsels health care suppliers, distributors, and GPOs (as well as the health care providers contracting with suppliers, distributors, and GPOs), on a wide range of compliance, reimbursement, and transactional issues. Our services include the following:
- Providing comprehensive fraud and abuse counseling relating to contracting and pricing arrangements
- Counseling on government pricing programs, such as Medicaid Best Price, Average Sales Price, the Competitive Acquisition Program, the Federal Supply Schedule, and the Public Health Service Act, and VA pricing issues
- Structuring patient assistance program agreements for drugs, devices, and DME
- Providing HIPAA privacy and security counseling relating to use of manufacturing, research, and marketing issues
- Structuring agreements with manufacturers and customers
- Representing suppliers and distributors in administrative appeals and litigation
- Providing counsel in connection with audits and investigations by federal and state government agencies and government contractors