Do you have a compliance system in place in your pharmacy? If not, you’re potentially at risk for huge audit fines or even, in extreme situations, civil and criminal fines.
Complying with all of the regulations that govern the business operations of your pharmacy can be tricky. The regulations themselves come from multiple organizations—the federal government, Medicare, State Boards of Pharmacy—and the penalties that enforce them continue to evolve and increase each year.
This audit phenomenon is fairly new in pharmacy. “Back in the 70s and 80s, even into the 90s, audits were not in pharmacists’ vocabulary,” said Tim Gregorius, vice president of operations at PRS Pharmacy Services.
“Then, you could have survived for a long time never caring about being audited. That’s no longer true today. It is now a reality of doing business.”
In 2015, experts agree that every pharmacy should be prepared for an audit. Because of this, daily compliance is more important than ever. Discover why you need to pay attention to compliance, and how building a culture of compliance can make all the difference in your pharmacy.
Compliance confusion
It’s easy to see why compliance is difficult for pharmacists. “There’s no single source of information for regulations and compliance,” Gregorius said. “It’s hard to even understand all the ABCs of what you need to comply with and what regulations you need to be meeting. And because of that confusion, most pharmacies believe they are compliant even though they’re not familiar with the details.”
That mistake, however, can be costly, as auditors won’t be forgiving. “When it comes to HIPAA, for example, the Office for Civil Rights has said that ignorance of the requirements of the law, or of the law itself, is going to be dealt with severely. They’re going to go with the maximum fine they can possibly levy for someone who’s ignorant
of the law,” said Joshua Potter, director of compliance at PRS Pharmacy Services.
“There are still a lot of business owners who think that if they hand out a notice of privacy document and whisper in a consultation area, that they’re HIPAA- compliant and that’s just not true today,” he said.
A culture of compliance
As the role of the pharmacist expands today, it’s difficult to make compliance a priority. “Pharmacists are focused on patient care. They make sure medicines get out safely and that patients are being dealt with appropriately,” Potter said. “They don’t necessarily always have time to focus on compliance.”
While it’s true that compliance may require a lot of work upfront, beyond that, it’s not as difficult as it seems.
“You need to make sure you set up a whole culture of compliance. Once everybody is trained appropriately and your policies and procedures are written well enough, you don’t really need to be doing anything different on a day- to-day basis,” Potter said. “Once you have everything in place, being compliant is very easy.”
This means, as a start, you should put a system into place and educate your employees to ensure that your records, forms and documents are always accessible, up- to-date and used when needed.
And while it may seem more cost-efficient to manage compliance on your own, your time is valuable. There are options available to help you manage compliance, so that you can devote your time to other aspects of your business. You might consider partnering with a company that offers a compliance solution, such as ComplianceTrack from PRS Pharmacy Services, which consolidates all compliance standards into one program for pharmacies.
“We’ve tried to take the confusion out of compliance and make it simple and effective in real time. We know the battles that go on at the pharmacy counter and we’ve really tried to look at that and make our ComplianceTrack service work for pharmacists,” Gregorius said. “We look at it as an insurance policy for their pharmacy.”
With a little diligence, compliance can be easy to manage, and you can get back to what’s most important—your patients.
3 regulations you should know
Looking to 2015, Joshua Potter, director of compliance at PRS Pharmacy Services, identified three regulations you should always be aware of, and what can’t be overlooked as you work to comply.
1. HIPAA
One of the important things to understand about HIPAA training is that your training has to be based on your policies and procedures, not on the regulation itself, Potter said. If auditors find that your training and your policies don’t mesh together, that’s going to be a ding.
2. Fraud, Waste and Abuse
When it comes to Fraud, Waste and Abuse, it’s important to have your pharmacy’s Code of Conduct and Code of Ethics in place, and to know if your third party plan requires you to be compliant with the Compliance Program Guidelines, Chapter 9 of the Medicare Prescription Drug Manual.
3. Exclusion verifications
Any pharmacy that’s involved in receiving any sort of public funds, whether it’s Medicaid or Medicare, needs to make sure they’re checking their employees on the Office of Inspector General (OIG) and System for Award Management (SAMS) exclusion databases on a monthly basis. If they find that any employees are on that list, they need to remove them from being involved in any provision of care services.
