In 2004, the National Association of Boards of Pharmacy (NABP) established the Verified-Accredited Wholesale Distributors (VAWD) process in order to keep the country’s supply of prescription drugs and medical devices safe from counterfeit products. The NABP process is a rigorous one. In order to receive VAWD-certification, a drug wholesale company must show that they have a legitimate operation, their license is in good standing, they have employees, and utilize best practices when it comes to handling, storing, and shipping prescription drugs and medical devices.

It is in a pharmacy’s best interests – as well as their customers’ – to always purchase medications and devices from a VAWD-certified company. Although it may be tempting to purchase from a secondary wholesaler because it has lower prices than an accredited company, you have no idea where the products are coming from or how the company operates since there is no oversight. Recent events emphasize just how dangerous this can be.

Owner Indicted on Federal Charges

Last month, federal prosecutors announced they had indicted the owner of a Plainfield, IL wholesale drug company for purchasing unregulated prescription drugs and then reselling these medications to unsuspecting pharmacies. The man was charged with six counts of mail fraud, four counts of wire fraud, and three counts of money laundering.

The role of a pharmacy benefit manager (PBM) is one that is quite important in the health industry. PBM’s serve as the middleman between pharmacies and insurance companies and are necessary for a pharmacy to operate. Every once in a while, your PBM will contact you to inform you of an audit to ensure rules are being followed and business is being conducted as it should be. Being audited by anyone can be a nerve-wracking experience, especially if that audit is conducted by your PBM. A catastrophic PBM audit could leave lasting effects on your business. If you have been notified of an upcoming PBM audit, here are a few tips to help you prepare for your audit:‘

• Ensure you are there for the audit. When you receive notice of the audit, the exact date and time will also be mentioned. Make sure you are in the pharmacy at that time and that you are free to work with the auditor while they are there.
• Review the audit rules. Once you have received notification of the audit, you should review the audit section of the PBM’s manual. This section will contain information about the auditor’s procedures that you should be familiar with.
• Begin to organize your documents. In the audit notice, there should be a date range that the auditor will be focusing on. In some cases, actual prescription numbers will be provided. Be sure to have all records pertaining to the prescriptions filled within those dates and keep them in one place.
• Conduct a staff meeting. Not only should you be prepared for the audit, but your staff should also be prepared. Hold a meeting to inform your staff members of the date and time of the audit and of your expectations of them during the audit.

Concerned About an Upcoming Audit? Contact a Knowledgeable Illinois PBM Audit Lawyer

When it comes to any audit, especially a PBM audit, preparation is key for a successful outcome. If you have gotten notice of an upcoming PBM audit, you should contact a skilled Illinois PBM audit attorney. The Law Offices of Joseph J. Bogdan, LLC has been helping clients prepare for PBM audits and advising clients of their next steps after PBM audits for more than 16 years. Being both an attorney and a registered pharmacist, Attorney Joseph Bogdan has the legal and medical knowledge needed to help you make the best decisions for your pharmacy. Call our office today at 630-310-1267 to schedule a consultation.

Wholesale drug distributors are actually pretty strictly regulated in the United States. To be a wholesale drug distributor, you have to be properly accredited and licensed and you must also pass a series of tests and inspections. The Verified-Accredited Wholesale Distributors (VAWD) was created by the National Association of Boards of Pharmacy (NABP) and helps ensure the quality of drugs that are in the U.S. marketplace. This is accomplished by requiring distributors to pass a variety of tests and criteria in order to receive the accreditation. Here are a few mistakes you should avoid making if you are trying to receive VAWD accreditation.

Not Properly Preparing

The accreditation process is one that is extremely thorough and often complicated. There are various documents that you must have on hand when you apply for your VAWD accreditation and you even have to have a complete business plan and Standard Operating Procedures (SOP) written out that prove that you will be compliant with all federal and state laws and requirements. Not having proper planning before you even begin the process can spell disaster.

Using Business Policies and Plans That Are Not Unique

One of the major requirements in the VAWD accreditation process is having an SOP and business plan that outlines the company’s practices and that proves that the company can meet each specific set of criteria put forth by the VAWD. The VAWD does not accept SOP’s that are cookie cutter or the same as other wholesale drug distribution companies. Your business plan and SOP has to be unique and tailor to your company, or you risk your application being canceled or straight up denied.

Audits to your pharmacy can be made by insurance companies, pharmacy benefit managers and third-party payers. Many pharmacy owners view audits as a threat to their business and with good reason.

The outcome of an audit can mean that a pharmacy is required to pay large sums of money that the auditing agency says it is owed. This could be taken out of what would be payments from future money that would be paid to the pharmacy.

Audits should be taken seriously, and often an attorney can safeguard a pharmacy’s rights as well as negotiate issues that may come up in the course of an audit.

Being a pharmacy owner can be a rewarding and profitable career. However, all careers must come to an end, and at some point, you will likely wish to sell your pharmacy. Pharmacy owners decide to sell for many reasons. The technology is ever-changing, and margins seem to become thinner with each year. However, the most common reason for the sale of a pharmacy is that the owner seeks to retire.

It is estimated that two-thirds of pharmacy owners are at or nearing retirement age. In the coming years, many pharmacies will experience a change in ownership. If you are looking to sell your pharmacy, there are a host of steps you can take to ease the process and to get top dollar for your business.

The selling process -- planning and executing the sale -- can take two to three years. In fact, many of the most successful sellers begin planning the sale when the pharmacy is bought. However, if you have a shorter timeline, many successful sales are prepared for in less time.