By: Dean Viskovich
The Office of Inspector General (OIG) and other Federal agencies charged with responsibility for enforcement of Federal law have emphasized the importance of voluntarily developed and implemented compliance plans. The government, especially the OIG, has a zero- tolerance policy towards fraud and abuse and uses its extensive statutory authority to reduce fraud in Medicare and other federally funded health care programs. The OIG believes that through a partnership with the private sector, significant reductions in fraud and abuse can be accomplished. Compliance plans offer a vehicle to achieve that goal. The OIG has provided a model compliance plan for clinical laboratories to assist laboratory providers in crafting and refining their own compliance plans.
The OIG suggests that the comprehensive compliance program should include the following elements:
- Written Procedures and Policies
- Designation of a Compliance Officer
- Education and Training
- Auditing and Monitoring
- Disciplinary Actions
- Corrective Action
The OIG is critical of compliance plans and programs that exist on paper but are not implemented or enforced. A compliance program should require the thorough monitoring of its implementation and regular reporting to senior executives and members of the Board of Directors. An effective monitoring tool to ensure enforcement with compliance is the performance of regular and periodic audits. The audits should cover laboratory operations with particular attention paid to billing, sales, marketing, notices and disclosures to physicians, requisition forms, pricing, and activities of phlebotomists and others involved in the ordering of laboratory services. The audits should be designed and implemented to ensure compliance with the laboratory compliance policies, the laboratory’s compliance plan, and all applicable Federal and State laws. In addition, auditing should address issues related to contracts, competitive practices, marketing materials, CPT/HCPCS coding and billing, test information, reporting and record keeping.
Quality assurance and zero tolerance of fraud and abuse are compliance goals and auditing are a good tool to use to reach that goal. Compliance audits should be conducted in accordance with established comprehensive audit procedures and should include 1) on-site visits; 2) interviews with personnel involved in management, operations, billing, sales, marketing, and other related activities; 3) review of written materials and documentation used by the laboratory; and 4) trend analysis studies. Audit reports should be prepared and submitted to the chief compliance officer and the Board of Directors or other governing body to ensure laboratory management is aware of the results and can take whatever steps necessary to correct past problems and deter them from recurring. Audits and analytical reports should identify areas where corrective action is needed. At times, additional audits are recommended to ensure that the previously conducted corrective action plan was implemented and was successful.
The ability of a clinical laboratory to self- audit is a cornerstone of an effective compliance program. The implementation of an effective compliance program plan will allow the laboratory to achieve better quality control of claim submission and reduce the risk of future criminal and civil liabilities.
A laboratory that does not have an OIG comprehensive compliance program is a red flag for regulatory agencies (CLIA, CAP and COLA), venture capitalists and purchasers. Many a deal has fallen by the wayside after the investors due diligence audit procedure has found and documented inconsistencies in various lab policies and procedures. The lab that self- audits all the processes prior to a third- party audit will be able to stay ahead of the curve. The firm is uniquely qualified to implement a laboratory compliance plan, educate, train, and conduct regularly schedule audits. We look forward to assisting your lab.