From health care to financial services, and from automotive manufacturing to resource extraction, numerous types of companies face industry-specific compliance obligations at the federal level. Our federal compliance attorneys help clients nationwide avoid investigations and penalties due to statutory and regulatory non-compliance.
If your business is subject to industry-specific compliance obligations at the federal level, maintaining a comprehensive and effective corporate compliance program presents unique challenges. Not only does your business face the same compliance burdens as other companies with regard to things like data security and employee rights, but it faces additional compliance burdens as well. Furthermore, when it comes to industry-specific compliance, federal authorities often expect companies to be subject-matter experts. As a result, enforcement standards are often extremely high, and federal prosecutors tend to have very little sympathy for companies’ shortcomings.
At Oberheiden, P.C., we provide industry-specific compliance representation for companies in a broad array of industry sectors. Our federal compliance attorneys, many of whom are former U.S. Department of Justice (DOJ) prosecutors and trial attorneys with the U.S. Attorney’s Office, have extensive experience in all areas of compliance, and we also routinely represent clients in compliance-related investigations. Whether your company is seeking to break into a new industry or you need experienced legal guidance for establishing, updating, maintaining, or overhauling the industry-specific aspects of a compliance program, our attorneys can skillfully guide you through the entire process.
Industries We Serve
With centuries of combined experience on both sides of federal civil and criminal statutory and regulatory enforcement matters, our attorneys are able to provide insightful, practical, and cost-effective representation for compliance matters in all industries. Over the past several decades, our attorneys have worked with all major federal law enforcement agencies, both as prosecutors and as defense counsel advocating for our clients. This includes assisting with compliance and enforcement matters involving:
- Centers for Medicare and Medicaid Services (CMS)
- Drug Enforcement Administration (DEA)
- Federal Trade Commission (FTC)
- U.S. Department of Defense (DOD)
- U.S. Department of Health and Human Services (DHHS)
- U.S. Department of Homeland Security (DHS)
- U.S. Department of Labor (DOL)
- U.S. Department of Transportation (DOT)
- U.S. Department of Veterans Affairs (VA)
- U.S. Food and Drug Administration (FDA)
- U.S. Securities and Exchange Commission (SEC)
Our clients range from private doctor’s offices to large multinational corporations. Regardless of the scope and immediacy of your business’s needs, our federal compliance lawyers can help you. We have particular experience with federal compliance and enforcement in the following industries:
- Automotive and Transportation
- Construction and Real Estate
- Consumer Products
- Design, Engineering, and Manufacturing
- Energy and Utilities
- Financial Services
- Government Contracting
- Health Care
- Pharmaceuticals and Medical Devices
- Professional Services
- Tourism, Hospitality, Sports and Entertainment
What Does it Take to Establish Industry-Specific Compliance?
While specific compliance obligations vary greatly from one industry to the next, generally speaking, the fundamental components of all industry-specific compliance programs are largely the same. Thorough documentation is key; and, beyond simply establishing policies and procedures, businesses must effectively implement these policies and procedures on an organization-wide scale.
Developing a Stand-Alone Industry-Specific Compliance Program
Due to the unique aspects of industry-specific compliance, many businesses will find it beneficial to establish stand-alone compliance programs rather than incorporating industry-specific statutory and regulatory compliance efforts into their general corporate compliance programs. Not only can this provide additional clarity and facilitate making updates and modifications when necessary, but it can also make it far more efficient to demonstrate compliance when faced with an inquiry from one of the federal agencies listed above.
Several of these agencies have published industry-specific guidance. While this guidance helps to provide certainty when it comes to understanding businesses’ compliance obligations, the fact that this information is publicly available also means that businesses have no excuse for anything less than full compliance. At Oberheiden, P.C., we can use our experience in federal compliance and enforcement matters to make favorable use of the available guidance and ensure that it does not act as a source of liability.
When it comes to industry-specific compliance (and, indeed, all aspects of federal compliance), the importance of developing and implementing a custom-tailored compliance program cannot be overstated. A generic, non-specific compliance program that overlooks key issues while addressing issues that are irrelevant to your business is going to be a red flag for federal authorities. Our attorneys understand the importance of customized compliance, and we work with our clients to gain an intimate understanding of their specific compliance needs. The more directly your compliance program addresses your business’s needs, the less likely you are to face unfavorable consequences in the event that federal authorities come calling.
Substance and Structure are Both Important
While the substance of a business’s industry-specific compliance program needs to be custom-tailored, in many respects, the structure of a compliance program can be just as important. Federal agencies’ guidance often specifies the recommended components of an effective compliance program, and adopting each of these components in the manner prescribed can be crucial to warding off potentially undesirable lines of questioning.
Our federal compliance attorneys are familiar not only with the guidance that is available, but also with how federal agencies interpret this guidance in the context of assessing the sufficiency of businesses’ compliance efforts. We utilize this knowledge to develop effective industry-specific compliance programs comprised of the recommended components, which in most cases minimally include:
1. Industry-Specific Compliance Documentation
As with all aspects of federal compliance, thorough documentation is key. Once all pertinent compliance obligations have been identified, then companies must develop thorough policies, procedures, and protocols that address the specific requirements of all applicable industry-specific laws and regulations.
2. Internal Dissemination and Training
Effective implementation is a key aspect of compliance as well. This involves disseminating compliance documentation to all relevant personnel and conducting appropriate training programs to ensure that all employees are aware of their respective roles in maintaining corporate compliance.
3. Auditing, Monitoring, and Refinement
Once implemented, businesses must audit and monitor the effectiveness of their industry-specific compliance programs. In addition, agency rulemaking, statutory amendments, and federal court decisions can quickly and substantially modify businesses’ compliance obligations. As a result, regularly reviewing and updating policies, procedures, and protocols is a key aspect of effective compliance as well.
4. Internal Investigations, Enforcement, and Employee Discipline
Compliance programs must include appropriate measures and protocols for promptly launching internal investigations at the first warning signs of an actual or potential compliance deficiency. If an issue is identified during an investigation, then appropriate steps must be taken to enforce the business’s compliance program and discipline the employee(s) who are responsible for statutory and regulatory violations.
5. Adverse Event Response and Reporting
Several federal agencies require businesses to report known or suspected compliance violations. Whether through direct communication to the relevant agency or disclosure in a public filing, this reporting must be both accurate and compliant; however, it must also be done extremely carefully in order to avoid unnecessary exposure to federal civil or criminal prosecution.
Examples of Industry-Specific Compliance Obligations
While federal authorities hold business owners, executives, and professionals to extremely high standards when it comes to industry-specific compliance, the reality is that the compliance obligations in many industries are so voluminous and complex that most individuals only have a very basic understanding of the types of burdens to which they are subject. At Oberheiden, P.C., we rely on our federal compliance attorneys’ centuries of combined experience to help our clients understand their obligations; and, when you come to us, we do not expect you to know what the federal government expects of you. Acknowledging that businesses in the industries listed above are subject to hundreds of pages of dense rules and regulations, the following is a brief overview of some of the types of issues that will generally need to be addressed:
- Health Care Compliance – Compliance with Medicare, Medicaid, Tricare, VA, and DOL billing rules and regulations; Anti-Kickback Statute and Stark Law compliance; False Claims Act compliance; CMS contractor audits; compliance with rules regarding telemedicine, compound medications, and other health care practice issues.
- Food and Drug Compliance – FDA approval; DEA registration; agency inspections and audits; recalls and consumer notifications; labeling and marketing compliance.
- Financial Services and Investment Brokerage Compliance – SEC and Financial Industry Regulatory Authority (FINRA) registration and compliance; FTC compliance; consumer finance disclosure and marketing compliance; securities rules and regulations; private placement compliance; cryptocurrency compliance; investor fraud compliance.
- Government Contracting Compliance – Bidding compliance; contract compliance, including use of appropriate labor and materials; False Claims act compliance; cost allocation and cross-charging compliance; quality control testing fraud; Truth-in-Negotiations Act (TINA) compliance; re-bidding and contract renewal compliance; anti-bribery and corruption compliance.
These lists are far from exhaustive, and businesses in other industries face a host of unique federal compliance obligations. If you have questions about your company’s federal responsibilities, we encourage you to contact us for a free initial consultation.
Contact the Federal Compliance Lawyers at Oberheiden, P.C.
If you would like to speak with one of our federal compliance lawyers about industry-specific compliance, please contact us to arrange a complimentary and confidential needs assessment. Our attorneys are available to speak with prospective clients nationwide 24/7, so call (214) 692-2171 or inquire online now.