Government Programs

Government Program participation is a complex topic in today’s Pharmaceutical Manufacturing environment. The “Government business,” including by Medicaid, Medicare (Parts B and D), VA program purchases and Public Health Services (PHS) purchases can be a key market segment, and must be managed and administrated effectively and efficiently like any segment of the “commercial business.” The Government business, however, differs from the commercial business in that it is regulated by laws and regulations, as well as guidance published by each applicable agency. Additionally, data reported to the government under the Federal Programs is based almost entirely on commercial sales activity, meaning that a company has to establish coordination and communication between its Government operations and its commercial operations in order to ensure that information is being captured and reported accurately.

Underpinning the management and administration of the Government programs is the broadly applicable provisions of the False Claims Act (FCA). The Office of Inspector General (OIG), in its April, 2003 guidance, Recommendations to Pharmaceutical Manufacturers, listed integrity of information reported to the government as one of its 3 key risk areas. Recent investigative activity by the Federal Government has established that there does not have to be intent of wrong doing for a potential False Claims Act violation, that there could be a potential violation if a manufacturer fails to have sufficient systems, procedures and documentation in place to ensure that information provided to the government is accurate. This position is now being extended to State Attorney Generals, as under provisions of the Deficit Reduction Act of 2005 (DRA), states are being encouraged to enact their own False Claims Acts. Also under the DRA, the OIG is now being funded for “proactive audits,” and will begin to proactively and routinely audit the Medicaid operations of pharmaceutical manufactures. Due to this, it is imperative that a company establish its Government Program policies and procedures correctly up front, establishing systems and procedures, as well as adequate documentation, that meet the needs of the business as well as ensure compliance with the Federal Programs that it participates in.

CIS has experience in both the commercial and government sides of pharmaceutical manufacturing, and has worked closely with small and mid-market companies in developing compliance programs. Our goal is to develop a practical strategy, that puts effective and meaningful procedures in place, and that can be implemented over time. CIS has experience in both the audit environment, as well as experience working directly with the various government agencies, including the OIG. We understand what an auditor would look for, and the critical importance of being able to demonstrate that. Our goal is to establish and maintain compliance within your organization and remaining committed to ensuring that you have the appropriate documentation in place that will guide your day-to-day operations.

Our services include:

  • Defining Information Technology Requirements for Price Reporting
      • CIS can define the requirements, not only for what must get done, but for how efficiently and reliably it must be done, so that our clients can acquire and develop systems that are truly helpful.

  • Coordinating Data Gathering Among Departments
      • CIS helps ensure that the systems, policies and procedures consistently gather accurate information, ensuring that programs are efficient and reliable.

  • Augmenting Management Resources to Implement Price Reporting, IT and Documentation Projects
      • CIS ensures that programs are integrated with existing processes, enabling out clients to complete projects they would not otherwise have the time and available resources.

  • Writing Policies, Procedures, Instructions and Process Diagrams to Instruct Employees and Ensure Compliance
      • CIS’s program development takes the baseline of industry practice, considers the particulars of the company, and develops methods that fit our clients while improving efficiency, rationality and adaptability of operations.

  • Developing and Providing Training for Price Reporting
      • CIS training programs teach a broad range of employees an appreciation for compliance and teach targeted employees the specific skills they need.

  • Assessing Programs to Determine the Costs and Benefits of IT, Personnel, Procedural and Training Solutions
      • By providing an unbiased review of our clients’ programs without any particular software of program to sell, CIS assesses the improvements that can be made and the costs of implementing various information technology projects, personnel additions and restructurings, changes in process and training possibilities.