The reimbursement factor in pharmaceutical regulation: rebates, cost-effectiveness, and practice guidelines

The delivery of health care services in the United States is increasingly influenced by the coverage determinations of third-party payers. This paper reviews 3 specific initiatives recently undertaken by the federal government that relate directly or indirectly to reimbursement for pharmaceuticals. The 3 initiatives, involving new conditions of coverage and incorporating language and policies that signal broader changes for the future, are the Medicaid Prudent Pharmaceutical Purchasing Program enacted as part of the Omnibus Budget Reconciliation Act of 1990, the national coverage criteria proposed by the Health Care Financing Administration, and the Agency For Health Care Policy and Research with its mandate to oversee the development of clinical practice guidelines.