Pharmacies are under attack. Law enforcement agencies across the country are investigating pharmacies for alleged health care fraud and physician kick-back schemes. Compound pharmacies are facing particular scrutiny, especially those that have billed Tricare, Medicare, and Department of Labor health programs for substantial reimbursements.
Given the risks of facing an investigation – including possible criminal charges and loss of eligibility for federal reimbursement programs – pharmacies and their executives are well-advised to implement comprehensive compliance programs in order to avoid suspicion and ward off federal investigators.
The Risks of Non-Compliance
When investigators inspect pharmacies’ premises or request records through a subpoena issued by the Office of the Inspector General (OIG), one of the first things they look for is whether the pharmacy has an effective compliance program. Oftentimes, these investigators find that pharmacies either (i) do not have any compliance program, or (ii) they have a program that is nothing more than “window-dressing” – a written program with no implementation. In many fraud investigations, the difference between facing civil liability for recoupment of overcharged amounts and facing serious criminal charges is a fine line. As a result, having and implementing a thorough compliance program is well worth the investment.
Our experience has shown that implementing a professionally crafted compliance program significantly reduces pharmacies’ risk of exposure to criminal investigations. Compliance programs that establish, monitor, and enforce proper conduct help demonstrate to auditors and investigators that any mistakes are truly mistakes and not the result of bad intent. It is this bad intent (or the appearance of bad intent) that can lead to criminal charges. Without it, the most the government can seek is civil enforcement.
Elements of a Compliance Program
A pharmacy compliance program must convincingly demonstrate that the company and its key executives are not merely focused on the “window dressing,” but are actually serious about following self-imposed policies and standards in order to remain compliant with the law. Part of the program should include mechanisms designed to demonstrate the pharmacy’s zero-tolerance policy toward unlawful conduct.
Compliance programs should focus in three core areas: Policy, training, and enforcement. A comprehensive program will achieve these through:
- Written Policies and Procedures
- Compliance Officers
- Compliance Training
- Open Communication Channels
- Internal Monitoring
- Policy Enforcement
The policies and procedures that define the pharmacy’s compliance efforts should be communicated to the company’s executives and staff. Executives and staff should also receive training on the policies and procedures, and pharmacies should conduct regular compliance trainings in the areas of fraud and abuse laws, anti-kickback laws, Stark Law, HIPAA, and OSHA. Some of the documentation that pharmacies should have in place to document these communication and training efforts include:
- Company and Operating Agreement
- Employment Agreement
- Independent Contractor Agreement
- Marketing Agreement
- Review of Marketing Materials
- Code of Conduct
- Employment Manual
- Training Materials
The attorneys at Oberheiden, P.C. are former government officials, chief prosecutors for health care fraud from the Department of Justice, and team leaders and chief coordinators of the Medicare Fraud Strike Force. We have an impeccable track record when it comes to avoiding criminal charges in health care matters, and we have significant experience developing compliance programs to help pharmacies avoid and mitigate government investigations. Our team includes:
- Dr. Nick Oberheiden (Managing Partner)
- Lynette Byrd (ret. Dept of Justice, health care prosecutions)
Emergency Defense Package
We understand that, due to unfortunate circumstances, some pharmacies and their executives do not have the time to establish and implement effective compliance programs. Facing pending or imminent investigations, these companies’ and individuals’ focus is on simply completing as many compliance-related tasks as possible in the shortest possible amount of time.
In this situation, we offer our “Emergency Defense Package.” This involves quickly establishing corporate and compliance paperwork and setting up OIG-approved compliance programs within a matter of days. Our Emergency Defense Package is a proven protocol that has been featured in the media across the country.
Contact Oberheiden, P.C. for a Free Consultation
If your pharmacy’s compliance efforts are lacking, your business, your employees, and you yourself are all exposed to unnecessary risks. Oberheiden, P.C. can rectify your situation by helping you create and implement an effective compliance program. To schedule a free consultation, or to request our Emergency Defense Package, call (800) 701-7249 or contact us online today.