Pharmacy Compliance Consulting

Pharmacies do not necessarily need separate compliance programs for Medicare, Medicaid, and Tricare; however, they must ensure that their programs address all pertinent billing rules and regulations. Each federal benefit program has its own unique set of requirements, and pharmacies that bill more than one program need to maintain program-specific compliance in order to avoid liability for fraudulent practices.

When we work with pharmacies that bill multiple programs, we structure their policies and procedures in such a way that they are integrated, comprehensive, and easy to follow. A compliance program is useless if it cannot be implemented effectively, so we make sure our clients have practical resources that they can efficiently deploy across all aspects of their pharmacy operations.

No, it is not. Unfortunately, there are a lot of these products out there, and they are often marketed as a “quick” solution to pharmacy compliance. However, the reality is that compliance programs need to be custom-tailored to pharmacies’ operations, and off-the-shelf products simply do not offer the flexibility or comprehensiveness that is required.

If your pharmacy is audited by the DEA or any other federal agency, simply having some compliance documents will not be enough to protect you. Instead, you will need to be able to demonstrate that both: (i) your pharmacy’s compliance program is fully comprehensive in light of its specific operations; and, (ii) you have effectively implemented the program so as to avoid billing errors, drug-related violations, and other compliance deficiencies.

The answer to this question depends on a few different factors. Your pharmacy’s compliance officer should be intimately familiar with your pharmacy’s legal and regulatory obligations, and he or she should be in a position to monitor and enforce compliance without bias or self-interest. Additionally, serving in the compliance officer position takes time, so it is important to choose someone who can devote the time necessary. As we work to develop your pharmacy’s compliance program, we will also work with you evaluate your options and choose an appropriate compliance officer.

Monitoring compliance on an ongoing basis is just as important as developing your pharmacy’s compliance program. You need to be confident that your pharmacists and billing personnel (or third-party billing agency) are maintaining compliance, and you need to be able to promptly address any compliance deficiencies before they lead to exposure to civil or criminal enforcement proceedings.

Compliance monitoring involves various measures that are designed to identify billing violations or Controlled Substances Act violations as soon as they occur. This includes (but is not limited to) measures such as:

• Regular reviews of billing records
• Regular reviews of paper and electronic prescription records
• Inspections to confirm pill counts
• Periodic reviews of pharmacists’ and billing administrators’ day-to-day practices
• Periodic in-depth audits of billing and prescription records

If your pharmacy’s monitoring efforts uncover a compliance deficiency (or if an employee or patient reports a potential issue), it will be necessary to remedy the issue as soon as possible. What is necessary in terms of remediation will depend on the nature and extent of the violation.

If there has been an isolated incident, then correcting the error and re-training the implicated employee may be sufficient. However, if there is a systemic issue, then more substantial action will be necessary. In all cases, taking remedial action (or failing to take all necessary remedial action) can have significant legal implications, so it is important to act on the advice of legal counsel.

Yes, absolutely. When federal laws and regulations change, pharmacies must update their compliance programs in order to ensure that they are not adhering to outdated requirements. Likewise, when pharmacies expand their operations or begin working with new payors, they must carefully review their compliance policies and make any necessary additions or revisions.

When choosing pharmacy compliance counsel, the most important factor is relevant experience. Federal healthcare compliance is a complex and nuanced area of legal practice, and pharmacy compliance is a subniche with its own unique and complicated requirements. At Oberheiden P.C., we pair our pharmacy clients with senior attorneys, former DEA agents, and other professionals who have devoted their careers to understanding the laws and regulations that apply to pharmacies and other providers, and we offer custom-tailored compliance solutions backed by extensive experience on both sides of federal pharmacy compliance enforcement matters.