Is Your Laboratory Compliant? Our Lab Compliance Consultants Assist Labs with All Aspects of Legal and Regulatory Compliance
Laboratory Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
Toxicology laboratories are subject to numerous complex compliance obligations at the federal level. While many of these compliance obligations have to do with billing, labs face other legal and regulatory burdens as well. For labs that fail to maintain strict and comprehensive compliance, the consequences can be significant—including fines, recoupments, pre-payment review, loss of program eligibility, and other civil or criminal penalties.
At Corporate Investigation Consulting, we provide full-service compliance consulting for all types of toxicology laboratories. As former agents with the Department of Health and Human Services (DHHS) and other agencies, our lab compliance consultants and specialists are intimately familiar with the expectations that labs face. The DHHS Office of Inspector General’s (OIG) Model Compliance Plan for Clinical Laboratories provides a starting point for laboratory compliance, but labs must go beyond this “model plan” and implement custom-tailored compliance policies and procedures that address their specific operations. We know what it takes for labs to be compliant, and we use our knowledge to help our clients avoid unwanted scrutiny and unnecessary penalties.
Consulting for All Aspects of Laboratory Compliance
Our consulting services for laboratories encompass all aspects of compliance. For example, we routinely consult with lab owners and executives with regard to matters such as:
- Standards of Conduct – Laboratories must adopt standards of conduct that instill a culture of compliance and reward employees’ efforts to maintain compliance, report concerns, and remedy compliance failures.
- Establishing Medical Necessity – A key aspect of compliance for laboratories is establishing the requisite medical necessity for reimbursement eligibility. DHHS has made clear that labs cannot rely solely on physicians’ orders as the basis for establishing medical necessity.
- Federal Program Billing – Medicare, Medicaid, Tricare, and the U.S. Department of Labor (DOL) health care benefit program all have unique and complex billing requirements. We have extensive experience helping all types of health care providers with federal program billing compliance.
- Private Health Insurance Billing – We consult with laboratories regarding private health care insurance billing as well, and we have experience helping labs manage billing compliance for all major health insurers.
- Physician Relationships and Standing Orders – Laboratories must carefully structure relationships with physicians to avoid anti-kickback implications, and they must be cautious not to rely too heavily on standing orders.
- Marketing – Marketing compliance is an important, and often overlooked, issue for toxicology laboratories. When promoting their testing services to physicians, labs must ensure that their marketing materials and any proposed financial arrangements comply with federal law.
Our laboratory compliance consultants assist labs with all aspects of compliance implementation as well. This includes conducting trainings, establishing record retention policies, and incorporating compliance into employee performance assessments. In its Model Compliance Plan for Clinical Laboratories, DHHS OIG advices that, “compliance programs should require that the promotion of and adherence to compliance be an element in evaluating the performance of managers and supervisors,” and that, all employees, “should be periodically trained in new compliance policies and procedures.” We assist our clients in taking these steps so that they can demonstrate the requisite level of compliance when called upon to do so.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
FAQs: Federal Health Care Law Compliance for Laboratories
Q: How can I assess whether my laboratory’s current compliance program is adequate?
In order to assess the adequacy of your laboratory’s current compliance program, it will be necessary to conduct a comprehensive internal compliance audit. This entails reviewing the lab’s policies and procedures, examining lab protocols, and reviewing billing and other records in order to determine to what extent the lab’s compliance program is being followed.
We perform internal compliance audits as part of our compliance consulting services. We can tell you definitively whether your lab’s current compliance program is working, or whether there is room for improvement.
Q: What are the steps involved in implementing a comprehensive laboratory compliance program?
Once appropriate compliance policies and procedures have been drafted, then the next step is implementation. There are several aspects to implementation, including (i) dissemination, (ii) training, (iii) testing, and (iv) ongoing compliance monitoring. At Corporate Investigation Consulting, we assist labs with compliance program implementation as well, and we document the entire implementation process in order to show federal agents and auditors that our clients are duly committed to compliance.
Q: Does my laboratory need to have a compliance officer?
Based on DHHS OIG’s guidance, all laboratories should have either a designated compliance officer or an employee with equivalent job duties. We can assist your lab in duly appointing a compliance officer, and we can provide your lab’s compliance officer with the documentation, tools, and information he or she needs in order to fulfill DHHS OIG’s expectations.
Q: What are the risks of non-compliance for laboratories?
Just like other entities in the health care sector, the risks of non-compliance for laboratories are significant. Critically, even unintentional compliance failures can lead to civil enforcement action—and penalties ranging from recoupments to program exclusion. Laboratory owners and executives cannot avoid liability for noncompliance by burying their heads in the sand. Federal authorities have made clear that ignorance is not an excuse for noncompliance, and that willful ignorance is paramount to willful noncompliance.
Q: How can I ensure that my lab remains compliant on an ongoing basis?
In order to maintain compliance on an ongoing basis, laboratories must (i) conduct periodic internal compliance audits, and (ii) implement updated compliance policies and procedures when necessary. In addition to conducting initial compliance audits, we can handle ongoing internal compliance audits for your laboratory as well, and we can keep you informed about any legal or regulatory developments that necessitate new compliance efforts.
Speak with a Senior Lab Compliance Consultant for Free
Would you like to feel more confident in your laboratory’s compliance program? If so, we encourage you to contact us for more information about our services. To speak with a senior laboratory compliance consultant at Corporate Investigation Consulting, call us at 866-352-9324 or let us know what questions you have online today.