As medical breakthroughs occur, policies must change to accommodate them.

Powell Goldstein has extensive experience developing and implementing strategies for expanding public and private markets for new medical products, technologies and services. These efforts include work to shape policies promulgated by the Centers for Medicare and Medicaid Services (CMS); the Food and Drug Administration (FDA); the DMERCs, SADMERC and other Medicare carriers; the U.S. Departments of Defense (DoD) and Veterans Affairs (VA); and state Medicaid agencies and state legislatures.

Representative Matters:

• Developed and implemented strategies at the national, regional and local levels to establish and protect Medicare policies involving the coverage, reimbursement and coding of new medical products, technologies and services
• Established and operated coalitions and associations to leverage our clients' resources and to establish grassroots support on Medicare policy issues
• Worked with our clients to ensure that clinical studies performed to secure FDA clearance are also useful in seeking coverage by public and private payers
• Guided products from start to finish through the FDA's pre-market clearance process beginning with product development strategies designed to minimize FDA regulatory costs and avoid time delays
• Designed and implemented effective, globally focused strategies to protect the intellectual property assets of U.S. and multinational companies