OIG Compliance Program Guidance for Pharmaceutical Manufacturers
Like all companies involved in the U.S. healthcare industry, pharmaceutical manufacturers face substantial compliance burdens. Our federal lawyers and former OIG agents provide comprehensive compliance representation for pharmaceutical companies nationwide.
Pharmaceutical manufacturers in the United States face substantial compliance burdens. Among the various federal agencies that enforce pharmaceutical manufacturers’ compliance obligations, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS) is among the most active. The OIG vigorously enforces companies’ compliance obligations through various means, and it works with the U.S. Department of Justice (DOJ) to target companies, company executives, and others suspected of fraudulent non-compliance.
At Oberheiden P.C., we assist pharmaceutical manufacturers nationwide with all aspects of OIG compliance. From developing standards of conduct to establishing billing compliance, and from avoiding issues under government supply contracts to making necessary changes in response to OIG fraud alerts, we help our clients do what is necessary to avoid unwanted OIG scrutiny.
With both highly-experienced federal compliance attorneys and former federal law enforcement agents available to serve our clients, we offer full-service compliance representation. We are able to effectively assist our clients with all aspects of compliance program development, implementation, adjustment, and enforcement. We also serve as defense counsel for OIG investigations as well, and demonstrating adherence to our clients’ compliance programs has proven to be an effective defense strategy in many cases.
Comprehensive OIG Compliance Representation for Pharmaceutical Manufacturers
Avoiding unwanted scrutiny from the OIG requires a multi-faceted approach for pharmaceutical manufacturers. In order to be effective, an OIG compliance program must address all pertinent legal and regulatory issues, and it must be tailored specifically to the manufacturer’s operations, risks, and needs. The services we provide to pharmaceutical manufacturers in the area of OIG compliance include:
Standards of Conduct
The OIG requires pharmaceutical companies (among others) to adopt and enforce internal standards of conduct that are designed to deter, prevent, and penalize actions that violate federal law. During OIG investigations, pharmaceutical companies will be asked to provide copies of their standards of conduct, and OIG agents will be looking to determine whether both (i) the company’s standards of conduct are adequate, and (ii) the company’s standards of conduct are being implemented and enforced appropriately.
Marketing compliance is an essential aspect of overall OIG compliance for pharmaceutical manufacturers. Allegations of labeling violations, unsubstantiated marketing claims, unlawful endorsement relationships, telemedicine non-compliance, and various other issues can lead to steep penalties during OIG investigations. We help our clients implement effective marketing compliance policies and procedures, and we provide assistance with evaluating proposed marketing materials and strategies as well.
Billing compliance is another essential aspect of overall OIG compliance that pharmaceutical manufacturers need to prioritize on an ongoing basis. We assist our clients with all aspects of private insurance and government healthcare benefit program billing compliance, from establishing internal billing systems and protocols to negotiating contracts with third-party billing administrators, and from maintaining necessary documentation to preparing for OIG investigations.
Government Program Compliance
In addition to government healthcare benefit program billing compliance, there are numerous other aspects to government program compliance for pharmaceutical manufacturers as well. Working closely with our clients’ executives, in-house counsel, and other key internal stakeholders, we formulate comprehensive compliance strategies and assist with the implementation of custom-tailored compliance recommendations.
Government Contract Compliance
For pharmaceutical manufacturers that enter into supply contracts with government agencies, government contract compliance is another essential area that requires its own devoted compliance focus. We have extensive experience representing government contractors throughout the healthcare industry, and our federal lawyers and former OIG agents are intimately familiar with the federal contracting requirements.
Pricing and Anti-Competitive Practices
Anti-competitive practices within the pharmaceutical industry are a particular concern for the OIG. The OIG meticulously scrutinizes pricing practices and commercial relationships that appear to raise concerns in the areas of antitrust and consumer protection, and manufacturers must be extremely careful to avoid inadvertently engaging in practices or entering into relationships that create exposure to federal enforcement action.
Financial Relationships with Healthcare Providers
Financial relationships with healthcare providers can lead to OIG scrutiny under the Anti-Kickback Statute (AKS) as well as the newer (and lesser-known) Eliminating Kickbacks in Recovery Act (EKRA). With this in mind, when entering into commercial relationships with healthcare providers, pharmaceutical manufacturers must be careful not only to avoid anti-competitive concerns, but to avoid any risk of facing allegations under the AKS or EKRA as well.
Compliance with Applicable OIG Fraud Alerts
The OIG occasionally issues Fraud Alerts that identify current areas of enforcement focus based on current events in the healthcare sector. For example, in 2020, the OIG raised various specific concerns related to COVID-19 testing and vaccination fraud. Pharmaceutical manufacturers (among others) are expected to remain up-to-date on the OIG’s Fraud Alerts and implement any compliance program modifications that are necessary in order to mitigate against the risk of fraud.
Internal Compliance Monitoring and Enforcement
When it comes to OIG compliance, establishing standards of conduct and an internal compliance program are just the beginning. Pharmaceutical companies must effectively implement their standards of conduct and internal compliance programs, and they must also implement measures to assess compliance (and remedy any compliance failures) on an ongoing basis. At Oberheiden P.C., we work with our clients on an ongoing basis to help ensure that they are consistently meeting their OIG compliance obligations.
Maintaining effective recordkeeping practices is an essential element of OIG compliance as well. In order to favorably respond to inquiries during an OIG investigation, pharmaceutical companies must have ready access not only to their standards of conduct and internal compliance program documents, but to documentation of ongoing compliance and enforcement efforts as well.
In addition to OIG compliance, we assist pharmaceutical manufacturers nationwide with other areas of compliance as well. This includes, but is not limited to, compliance with the laws and regulations enforced by the U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission (FTC).
FAQs: What Do Pharmaceutical Manufacturers Need to Know about OIG Compliance?
Q: How important is it for pharmaceutical manufacturers to develop and implement OIG compliance programs?
Developing and implementing an OIG compliance program is extremely important for pharmaceutical manufacturers. The OIG (among other federal agencies) pays particular attention to the pharmaceutical industry, and it vigorously enforces manufacturers’ compliance obligations. Implementing an effective compliance program not only mitigates the risk of facing OIG scrutiny, but it mitigates the risk of facing civil or criminal enforcement action in the event of an OIG investigation as well.
Q: Does an OIG compliance program need to be separate and distinct from a pharmaceutical manufacturer’s other compliance documentation?
No, not necessarily. When developing an OIG compliance program, form is far less important than substance. The key to avoiding scrutiny and penalties is to implement a custom-tailored compliance program that comprehensively addresses all areas of concern. While there may be certain benefits to having stand-alone OIG documentation (i.e. having this documentation available and easily retrievable without the need to disclose impertinent corporate information), pharmaceutical manufacturers can develop their OIG compliance documentation in any format that makes sense in light of the circumstances at hand.
Q: Can pharmaceutical manufacturers effectively manage OIG compliance in-house?
While there are many aspects of OIG compliance that pharmaceutical manufacturers will need to manage in-house, it is important to work with experienced legal counsel in order to ensure comprehensive compliance. For most companies, this means engaging an outside law firm. At Oberheiden P.C., we serve as outside OIG compliance counsel to healthcare companies and providers throughout the United States, and we are experienced in providing custom-tailored, effective, and cost-conscious compliance representation.
Q: As a pharmaceutical manufacturing company executive or in-house lawyer, what should I do if I am aware of past compliance violations?
If you are aware of past compliance violations, it will be important to discuss the issue with your company’s outside OIG compliance counsel. Generally speaking, the most-appropriate course of action is to address known compliance failures proactively. However, in doing so, caution must be exercised, and appropriate confidentiality and privileges must be maintained. We have extensive experience representing clients in direct communications with the OIG, and we can represent your company in developing and executing a strategy to come into compliance while mitigating (or avoiding) any potential penalties.
Q: What are the risks of OIG non-compliance for pharmaceutical manufacturers?
For all companies, the risks of OIG non-compliance can be substantial. Compliance failures can lead to both civil and criminal prosecution, with potential ramifications including:
- Loss of government program eligibility
- Loss of government contracts
- Recoupments, payment denials, and prepayment review
- Civil monetary penalties (CMP)
- Criminal fines
- Incarceration of company owners and executives
Speak with an OIG Compliance Lawyer or Consultant at Oberheiden P.C.
Do you have questions about OIG compliance for pharmaceutical manufacturers? If so, we encourage you to schedule a complimentary consultation at Oberheiden P.C. To speak with one of our senior compliance lawyers or consultants in confidence, please call 888-680-1745 or inquire online today.