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The Medicaid Drug Rebate Program

Since the establishment of the Medicaid Drug Rebate Program by the Omnibus Budget Reconciliation Act (OBRA) of 1990, pharmaceutical manufacturers have faced challenges in understanding, interpreting, and complying with laws, regulations and guidance set forth to support this program. Expansion of the Medicaid program has driven rapid growth in Federal and State government related expenditures, as a result, the calculations used to derive rebate amounts are under increasing scrutiny by various regulatory enforcement and oversight agencies. In the past decade alone, the Medicaid eligible population has risen over 30%. Today, the government continues to refine and redefine Medicaid drug reimbursement components including calculations such as AMP and BP, thereby making compliance an even greater struggle.

As a manufacturer, compliance within the changing Medicaid drug reimbursement environment is critical not only to a company’s own commitment to compliance, but also to avoid potential civil and criminal penalties. In order to support price reporting within your company while upholding regulatory requirements you will need policies, procedures, and systems in place that are designed to utilize data to calculate accurate prices. These systems need to prevent underpayment to the government and also overpayment for the company’s best interest. Recent government investigative activity has demonstrated the position that the lack of sufficient policies, procedures and systems can be a potential False Claims Act violation.

CIS understands the complex challenges pharmaceutical manufacturers face in developing, implementing and maintaining government pricing systems and supporting documentation. Our price reporting experts bring practical, hands-on industry experience to help guide and/or assess your company’s Medicaid Drug Rebate Program adherence. Furthermore, CIS price reporting experts are at the forefront of change, with knowledge of new or proposed changes to the Medicaid Drug Rebate Program and helping clients assess the impact of these changes on their business.

Let CIS help your company evaluate your current compliance with the Medicaid Program. See how your current policies, procedures, and systems rate on a compliance “scorecard,” and put together a practical roadmap for improvement and growth.