Toxicology and Clinical Laboratory Compliance
Toxicology laboratories and clinical laboratories that bill Medicare and other government benefit programs must adopt comprehensive compliance programs in order to avoid violations and mitigate their risk of federal prosecution. Our federal attorneys bring centuries of combined experience to representing labs in compliance matters nationwide.
For toxicology laboratories and clinical laboratories that bill Medicare, Medicaid, Tricare, or the Department of Labor (DOL) health care benefit program, billing compliance is a constant concern. From billing for tests deemed “medically unnecessary” under the applicable program guidelines to making errors when coding requests for reimbursement, all types of mistakes – both intentional and unintentional – have the potential for costly consequences. An effective compliance program can substantially mitigate the risk of these kinds of errors, and serve as a strong defense to liability in the event of a federal health care fraud investigation.
A “Cookie-Cutter” Compliance Policy Is Not Going to Cut It
When it comes to federal health care compliance, there is no “one-size-fits-all” approach. While most compliance programs will generally consist of the same basic elements, in order to be effective, a compliance program must be carefully tailored to the particular needs of the lab for which it is designed. When federal agents and prosecutors are reviewing labs’ compliance efforts, they are looking to see whether real and significant efforts have been made to avoid billing errors and other unlawful practices. A set of “cookie-cutter” policies and procedures simply is not going to cut it.
There are many other important considerations as well. For example, beyond simply having compliance policies and procedures, it is necessary to actually (and effectively) put these policies and procedures into practice. This is a multi-step and multi-phase process, and it is one that requires constant attention, effort, and re-evaluation. When program billing regulations or other circumstances change, toxicology laboratories and clinical laboratories must adapt their compliance efforts accordingly.
Our Team of Highly-Experienced Federal Health Care Lawyers Provides Compliance Representation for Labs Across the Country
Oberheiden, P.C. is a team of talented and highly-experienced federal health care lawyers who work collaboratively to help toxicology laboratories, clinical laboratories, and other health care clients develop and implement comprehensive compliance programs. Our attorneys have represented clients, including the U.S. government, in thousands of federal health care fraud audits, investigations, and trials. With centuries of combined experience on both sides of federal health care fraud cases, our attorneys offer extensive knowledge, deep insights, and practical solutions for all aspects of federal health care compliance.
About the OIG’s “Model Compliance Plan for Clinical Laboratories”
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) has published a “Model Compliance Plan for Clinical Laboratories.” While this document has informational value, it should not be viewed as a definitive guide with regard to compliance. As the OIG explains in its Introduction:
“This information is being supplied to assist laboratory providers in crafting and refining their own compliance plans. Elements of these guidelines can be used by all laboratories, regardless of size, to establish a compliance program. . . . [T]hese guidelines represent the government’s suggestions on how to correct and prevent fraudulent activity, and they can be tailored to fit the individual needs and financial realities of any clinical laboratory, be it an independent national laboratory, a hospital laboratory, or a small, regional laboratory. We expect variations reflecting the specific factual context in which each individual laboratory operates.
“This . . . model laboratory compliance plan is not all inclusive as to subject matter. . . . We see this model compliance plan as a dynamic document, and therefore, one that may be modified or expanded as we gather more information and knowledge about best practices and successful compliance plans. . . . All providers should be aware that the development and implementation of compliance programs can raise a host of sensitive and complex legal issues. Nothing stated herein should substitute for or be used in lieu of legal advice from competent, experienced counsel.”
In fact, rather than constituting a sample compliance policy, the OIG’s Model Compliance Plan for Clinical Laboratories consists of a list of “Compliance Elements” to be considered when developing and implementing a customized compliance program. These basic elements include:
1. Written Procedures and Policies
Clear, customized, and comprehensive written documentation is at the core of any effective federal health care compliance program. In order to be effective as a tool for risk management, a lab’s policies and procedures must address all aspects of billing, regulatory, and statutory compliance. As highlighted by the OIG, some of the key issues to be addressed in toxicology and clinical laboratories’ written policies and procedures include:
- Standards of Conduct – Labs should adopt standards of conduct that are appropriately suited to all employees, and they must communicate and provide training on these standards of conduct as well.
- Medical Necessity – While the OIG, “recognize that laboratories do not and cannot treat patients or make medical necessity determinations,” it also takes the position that, “there are steps that [labs] can and should take,” in order to prevent the medically-unnecessary testing.
- Billing – Billing and coding errors are among the most-common triggers for federal investigations targeting toxicology and clinical laboratories. Compliance programs must be designed to facilitate accurate billing with respect to the varying requirements of Medicare, Medicaid, Tricare, and the DOL health care benefit program.
- Reliance on Standing Orders – Standing orders for laboratory testing, while not inherently illegal, will often be viewed by federal authorities as red flags for fraudulent and abusive practices.
- Compliance with Applicable HHS OIG Fraud Alerts – According to the OIG, “[l]aboratory compliance plans should require that any and all fraud alerts issued by the OIG are carefully considered by the legal staff, chief compliance officer, or other appropriate personnel.”
- Marketing – Marketing efforts targeting physicians, relationships with marketing groups, and other related issues can lead to scrutiny under the Anti-Kickback Statute and other federal laws. As a result, labs must structure any commercial relationships with compliance in mind, and they must remain cognizant of potential compliance issues when conducting marketing campaigns.
- Prices Charged Physicians for Profiles – Outside of the marketing realm, other types of financial relationships with physicians can raise compliance concerns as well. “The prices that laboratories charge, particularly to physicians and especially for profiles, raise compliance issues that should be addressed in a laboratory’s written compliance policies.”
- Retention of Records – Records retention is a critical component of compliance. In the event of an audit or investigation, being able to present records confirming strict adherence to a comprehensive compliance program can provide a strong defense to liability.
- Compliance as an Element of a Performance Plan – The OIG recommends, “[t]o ensure that corporate integrity rises to the level of importance required of laboratories participating in Medicare or other federally funded health care programs, compliance programs should require that the promotion of and adherence to compliance be an element in evaluating the performance of managers and supervisors.”
2. Designation of a Compliance Officer (or Equivalent)
Unless and until a compliance program is put into practice, it is worth no more than the paper on which it is printed. One of the first steps toward implementing a compliance program is to designate an internal compliance officer (or equivalent).
3. Education and Training
Personnel at all levels of the organization should be educated and trained on the laboratory’s compliance obligations and the specifics of its compliance program. This includes initial and refresher trainings, as well as additional trainings as issues or changes arise.
Once employees have been educated and trained, they should be encouraged to report any apparent compliance issues they encounter. The OIG recommends, “an open door, complete anonymity, non-retribution policy available to all employees to encourage communication.”
5. Auditing and Monitoring
While relying on employees reporting is one method of identifying compliance issues, it is not independently sufficient. Toxicology and clinical laboratories should adopt structured auditing and monitoring programs designed to identify compliance issues as quickly as possible.
6. Disciplinary Actions
Laboratories’ compliance policies should work in tandem with their employment policies to facilitate appropriate disciplinary action in the event of a compliance violation by an individual employee.
7. Corrective Action
If an issue is identified, the lab’s compliance documentation should establish clear and executable steps for taking corrective action. This includes addressing the issue, preventing similar issues in the future, and reporting the issue as required by law.
Key Compliance Considerations for Toxicology and Clinical Laboratories
In our experience, while these are indeed fundamental components of an effective compliance plan, the OIG’s recommendations are by no means exhaustive. Remember, the OIG is not the only federal agency that conducts federal health care fraud investigations, and the OIG itself acknowledges that further action may be required. In order to protect themselves to the greatest extent possible, toxicology laboratories and clinical laboratories must critically examine their particular compliance needs in light of their unique business and operational characteristics, and they must structure and implement compliance programs that take all relevant sources of federal authority into consideration.
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If you have questions or would like more information about Oberheiden, P.C.’s federal health care compliance practice, we encourage you to get in touch. To schedule a free initial consultation with one of our highly-experienced attorneys, please call 888-519-4897 or inquire online today.