Clinical Trials Compliance

Client Situation 1

In response to a government inquiry, McAllister Consulting reviewed over 300 medical records and corresponding UB-92 and HCFA-1500 claim forms to determine compliance with CMS billing regulations for experimental and investigational cardiology devices. Subsequently, we were engaged to conduct a system-wide risk assessment of the entire clinical trials life-cycle process.

Core Competency: Regulatory, Operations Review & Strategy Development

Consulting Objectives:

• Conduct a comprehensive, system-wide risk assessment for this 13-hospital system in a cost-effective and efficient manner.
• Assess various operational and compliance activities of a centralized IRB-administrative office responsible for multiple IRBs.
• Establish a multi-disciplinary team for conducting Medicare / Medicaid coverage analyses on a prospective basis.
• Review pre- and post-award compliance for federal grants administered in a centralized accounting office.

Approach:

• Using a combination of interviews, document review and sample audit techniques, assess clinical operating departments (e.g., cath lab, OR etc.) and functional areas (e.g., pharmacy, materials management, etc.) at three of the client’s thirteen hospitals.
• Review IRB meeting minutes, study files and study-tracking database.
• Audit sample study files and federal grants.

Outcomes:

• By implementing our recommendations, the client was able to achieve accreditation of its IRBs by the Association for the Accreditation of Human Research Protections (AAHRP).
• Increased staffing levels for understaffed operating departments (e.g., pharmacy) in order to improve compliance activities and internal controls.
• Client’s net income from commercially-sponsored research activities increased from a multi-million dollar deficit to a profit sufficient to support additional staffing levels and compliance activities.
• Enhanced awareness, support and participation in compliance activities by independent physician group practices.

Client Situation 2

The external auditors of a leading Midwestern AMC noted several deficiencies in its OMB Circular A-133 audit, primarily related to time and effort reporting. McAllister Consulting was engaged to conduct an assessment of accounting practices, procedures and internal control systems to determine the level of compliance with all federal regulations governing the receipt and use of federal funds.

Core Competency: Regulatory (National Institutes of Health (NIH), Departments of Defense and Energy (DOD and DOE), Defense Advanced Research Projects Agency (DARPA), Center for Disease Control (CDC) etc.) & Audit Plan Development

Consulting Objectives:

• Develop a cost-effective and efficient audit methodology that will provide maximum coverage of grants from multiple federal agencies and compliance activities of individual principal investigators in a highly decentralized environment.
• Identify “best practices” among principal investigators.
• Conduct an operations review / risk assessment of centralized pre- and post-award offices.
• Provide recommendations for improvement in a detailed corrective action plan ranked by level of risk and costs to implement.

Approach:

• Select audit sample of federal grants from various federal agencies in ten clinical specialty areas (e.g., Neurology, Infectious Diseases).
• Using our proprietary life-cycle approach, conduct an operations review / compliance risk assessment from pre-award activities through post-award / account close-out.

Outcomes:

• Implementation of our recommendations resulted in a long overdue replacement of the client’s antiquated fund accounting system.
• More timely submissions of financial status reports (FSRs) which can be reconciled with and supported by information in the underlying general ledger and sub-ledgers.
• Streamlined process for allocating allowable direct costs among grants and identifying costs reimbursed through the indirect F&A rate.
• Improved processes and procedures for sub-recipient monitoring.
• Identification of “best practices” and enhanced administrative support for researchers.

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