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Pharmacy Compliance

Regulations and Compliance Programs for Pharmacies Across the United States

Introduction

Pharmacies are under attack. Law enforcement agencies across the country are investigating pharmacies for compliance and alleged healthcare fraud and physician kick-back schemes. Of particular scrutiny are compound pharmacies that have billed high amounts to Tricare, Medicare, and the Department of Labor health programs. In light of this climate of dangerous investigations, pharmacies and their executives are well advised to pursue a strong and effective pharmacy compliance program to obviate impressions of any wrongdoing. How that can be done is subject of this brief overview.

Dennis A. Wichern

Dennis A. Wichern

Former Special Agent-in-Charge, DEA, Chicago Field Office

Joe Lewis

Former Chief of Investigations, Texas State Board of Pharmacy & Former Chief Drug Diversion Control Office


Dr. Nick Oberheiden, Esq.
Direct: (214) 469-9009
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The Risk of No Compliance

When investigators inspect premises or request records from pharmacies by way of OIG subpoenas, one of the first things they look for is the existence of an effective pharmacy compliance program. In a great number of cases, OIG and FBI agents in charge of pharmacy investigations find either no compliance program or, what they call “window-dressing,” that is a program merely on paper. Because in many fraud investigations the difference between civil recoupment of overcharged amounts and actual criminal charges is just a fine line, pharmacy owners are silly not to have the safety net of a compliance program in place.

Without any doubt, a realistic and professionally set up compliance program will significantly reduce the risk of criminal exposure. Compliance programs are designed to establish, monitor, and enforce proper conduct and to demonstrate to auditors and the government that no bad intent— which is needed for criminal prosecutions— ever existed among the pharmacy’s owners and decision-makers.

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Elements of a Pharmacy Compliance & Regulation Program

A healthcare compliance program must convince the government or auditor that the company and its key executives not just have a program in place, but that they are actually serious about following its self-imposed policies and standards. It is of critical importance to properly document each compliance effort and to set up mechanisms designed to demonstrate the company’s zero tolerance against unlawful behavior and operations. Each compliance program should consist of the following three features: policy, training, and enforcement.

  • Written Policies and Procedures
  • Compliance Officers
  • Compliance Training
  • Open Communication Channels
  • Internal Monitoring
  • Policy Enforcement

With respect to policies, the company should have waterproof documentation of its policies and standards of ethics. Such a collection may include Employment Manuals, Code of Conducts, and other corporate documents that outline the company’s expectation of its employees and affiliates.

  • Company & Operating Agreement
  • Employment Agreement
  • Independent Contractor Agreement
  • Marketing Agreement
  • Review of Marketing Materials
  • Code of Conduct
  • Employment Manual
  • Training Materials

The policies that define company’s ethical goals must be conveyed to company’s executive and staff. Regular compliance training on topics such as fraud and abuse laws, anti-kickback laws, Stark Law, or HIPAA and OSHA are mandatory elements of any serious compliance program in the healthcare industry.

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Your Pharmacy Compliance Attorneys

Oberheiden, P.C. offers effective pharmacy compliance programs to avoid or to mitigate government investigations. Our compliance attorneys bring in the experience of former government officials, former chief prosecutors for healthcare 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 healthcare matters.

Emergency Defense Package

We understand that some clients simply do not have the time to set up long-term compliance programs. Due to pending or imminent investigations, the goal of these clients is to accomplish as many compliance efforts as possible in a short amount of time.

We serve these clients with our “Emergency Defense Package”, by which we turn around corporate and compliance paperwork and set up OIG approved compliance programs within days from our engagement. The Emergency Defense Package is a proven protocol that summarizes decades of experience in healthcare investigations and it has been featured by news stations across the country.

This information has been prepared for informational purposes only and does not constitute legal advice. This information may constitute attorney advertising in some jurisdictions. Reading of this information does not create an attorney-client relationship. Prior results do not guarantee similar future outcomes. Oberheiden, P.C. is a Texas LLP with headquarters in Dallas. Mr. Oberheiden limits his practice to federal law.

Tag: Pharmacy Compliance & Regulatory Law Firm – Oberheiden P.C.

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