The Drug Enforcement Agency (DEA) and other agencies have strict rules to regulate how pharmacies operate. Non-compliance can lead to investigations, audits, and even hefty penalties. Our team of Dallas attorneys and compliance consultants has helped a lot of pharmacies avoid disastrous mistakes by guiding them through the right steps.
If you’re a Dallas pharmacy owner, then you know how challenging it is to stay compliant with the wide range of rules, regulations, and laws imposed on individuals in this practice. The obligations to comply with are too much, and even if you make unintended mistakes, you can still be held liable.
What should you do as a pharmacy owner who doesn’t want substantial repercussions? Prioritize compliance. You should strive to be compliant in everything your pharmacy does, and from time to time, monitor your compliance program to make sure it’s effective. That is the answer to avoiding trouble with the authorities.
Compliance with the rules and regulations established in the pharmaceutical sector may look easy when saying it, but in real sense, it’s very difficult. Sometimes it can even be hard to understand what you’re required to do. Creating, implementing, and maintaining an effective compliance program for your pharmacy is a process that requires an in-depth understanding of the regulatory authorities and comprehensive insights into the problems that may lead to federal audits and investigations.
Dallas, TX Federal Pharmacy Compliance Attorneys and Consultants
With our headquarters in Dallas, we provide legal representation to local, regional, and nationwide pharmacies in all matters concerning federal compliance. If a pharmacy is under scrutiny by the DEA or other authorities, we can also represent it. Our team comprises of highly qualified attorneys and experienced pharmacy compliance consultants, individuals who have worked in the past as diversion investigators and high ranking DEA agents. These skills in our firm are vital to helping us guide you through the challenging compliance process and represent you in audits ranging from Medicare and Medicaid billing, CBD compliance, to opioid diversion prevention.
10 Major Pharmacy Compliance Areas
As we mentioned earlier, pharmacies in Dallas have a significant compliance burden, which makes implementation complex. To simplify the whole process and make it effective, we can break it down into smaller understandable areas of need. Even though various pharmacies may have different compliance obligations, generally, there are 10 major areas of pharmaceutical compliance.
1. Pharmacy DEA Registration
One compliance obligation is registering your pharmacy with the DEA. However, care is crucial before, during, and after registering your pharmacy with this agency to ensure you’re strictly following their rules and regulations. Mistakes along the way can lead to delayed registration issuance and temporary or permanent loss of registration. And if pharmacies and their owners are found to have substantially violated provisions as established by the Controlled Substances Act, they may be significantly penalized.
2. Compliance with Electronic Prescription Regulations
This is another area that demands a lot of care from Dallas and nationwide pharmacies that allow electronic prescriptions. The U.S. Drug Enforcement Agency has well-established rules and regulations governing how pharmacies should accept electronic prescriptions. Note that in this area also, unintended mistakes and violations can lead to aggressive action by the DEA. That’s why attention is critical to ensure even unintentional shortcomings do not happen.
3. Regulations Governing the Ordering of Prescription Drugs
Pharmacies may need to regularly replenish their stock by ordering drugs from manufacturers directly or via their program benefit managers (PBMs). However, what you need to know is that this ordering process is also regulated. When making orders, pharmacies are required to get the appropriate DEA Form 222 and complete it accurately while also providing the relevant internal documentation. Documentation deficiencies in prescription drug ordering are very common, and they can lead to scrutinies, audits, and other problems with the DEA.
4. Managing Prescription Drug Inventory
The DEA also requires pharmacists to maintain comprehensive and updated inventories of all the prescription drugs they have in their facilities. They should also preserve comprehensive inventory records for a period of two years. If your pharmacy is going through an audit, you should be ready to provide these records to show your inventory management compliance. Just like in other obligations, non-compliance may lead to enforcement action.
5. Avoiding Prescription Drug Fraud
There are different types of frauds that may occur in pharmacies. For instance, pharmacists may accept invalid prescriptions and give out drugs. They may also accept illegal bribes from prescribing physicians. That’s why pharmacies are required to establish measures to ensure such kinds of frauds and others do not occur in their facilities. If any pharmacist is found to be committing prescription drug fraud deliberately, he/she may be criminally prosecuted by the U.S. Department of Justice.
6. Preventing Prescription Drug Diversion
The DEA also requires pharmacies to lay out procedures and policies that ensure prescription drug diversion doesn’t happen. Prescription drug diversion prevention is especially crucial for opioids, but to make sure you’re fully compliant, you should be keen to establish measures that ensure no diversion takes place. Don’t overlook anything; something which may look non-serious may quickly turn into a big problem with drug enforcement agents. In our team of consultants here at Oberheiden P.C., we have a former DEA Diversion Investigator and a former DEA Diversion Program Manager, which makes us suitably qualified and experienced to handle these kinds of matters.
7. Packaging, Transfering, Disposing, and Preventing Loss of Prescription Drugs
There are provisions that regulate how pharmacies should package, transfer, and dispose of prescription drugs, and they’re exceptionally detailed. There are recordkeeping rules, disposal procedures, and many other provisions, and each pharmacist must follow them strictly to avoid landing themselves in trouble. If there are several people working in the facility, each one of them should be properly trained on how to conduct their duties so that the pharmacy remains fully compliant.
8. Billing Compliance for Federal Programs (Medicare and Medicaid)
If a pharmacy violates billing compliance obligations for federal programs such as Medicaid and Medicare, it risks significant civil liabilities as well as potential criminal enforcement action. Even if they hire 3rd party billing services providers, pharmacies are the ones responsible for making sure the federal government isn’t overbilled. Here at Oberheiden P.C., we have represented different pharmacies in various issues regarding billing compliance for federal programs and gained a lot of experience. We have also effectively represented and defended providers across the country in fraud audits and scrutinies involving federal program billing.
9. Pharmacy Record-Keeping Compliance
Preserving detailed records is vital to helping you avoid liabilities during DEA audits and investigations. Apart from the areas we have discussed, pharmacies and their owners should also establish procedures and policies for any of their other compliance obligations, and these procedures and policies should include directions on how to generate and store records as the facility continues operating.
10. Compliance Duties for Specialty and Compound Pharmacies
Finally, compound and specialty pharmacies have unique obligations and responsibilities when it comes to compliance. If you operate a compound or specialty clinic in Dallas or any other part of the country, our attorneys’ and consultants’ advice can ensure you fully comply with all required federal laws and regulations. They can guide you every step of the way to ensure your recordkeeping, inventory, dispensing, and billing methods are sufficiently compliant.
What Can You Expect During a Pharmacy Audit?
If DEA comes to audit your facility and identifies inadequate compliance, you may be at the risk of serious consequences. Even if you’re fully compliant with all the relevant provisions, demonstrating compliance itself is something that requires skills and strategic approaches. Apart from representing you as you demonstrate your compliance, our attorneys and consultants here at Oberheiden P.C. can also represent you and your pharmacy in an audit or investigation. Types of audits and inspections we can handle are:
- Audits and inspections by the DEA
- Texas State Board of Pharmacy (TSBP) audits
- Audits concerning HRSA 340B compliance done by the U.S. Department of Health and Human Services (DHHS)
- Pharmacy benefit manager (PBM) audits
These audits are all unique in their own ways; none is exactly similar to the other. Therefore, handling them successfully calls for the development of unique defense strategies. We have worked with a lot of Dallas and nationwide pharmacies and produces favorable results for them in each of these audits. We can use that experience and knowledge to produce a desirable outcome for you too and help you avoid liabilities.
If you learn to learn more, here is an excellent read on what pharmacy owners and managers should know about pharmaceutical audits.
15 Common Red Flags that Auditors Check
Even though auditors from the DEA, TSBP, PBM, and DHHS will be looking for any evidence of non-compliance, several issues particularly bring trouble for pharmacies. Throughout the years we have been offering our services, our attorneys and consultants have identified some of these common issues and developed effective approaches to protect our clients from liability. Here are the 15 biggest red flags auditors tend to look for based on our decades of experience.
- A high number of inventory errors
- Outdated DEA registration information
- Insufficient documentation to show validation for narcotic prescriptions
- Refilling prescriptions frequently, especially without documents that indicate medical needs
- A suspicious dispensation of high-risk prescription drugs
- A record of previous failed audits or admonition letters
- Suspicious financial exchanges with prescribing medical practitioners
- Little or no proof of communication with prescribing doctors
- Inadequate staff to operate the pharmacy efficiently
- Unusual dispensation of known high-risk combinations such as the holy trinity.
- Undocumented policies to regulate opioid dispensing
- Undocumented policies and procedures to prevent prescription drug diversion
- Insufficient training to the pharmacy staff
- Lack of organization in pharmacy records especially for billing compliance and prescription management
- Allowing a huge percentage of patients to pay using cash
This isn’t a comprehensive list of all the things auditors look for, and you shouldn’t tailor your operations or compliance program based only on the things we have mentioned. The best course of action is making an exhaustive approach to pharmaceutical compliance to make sure you comply with all the rules and regulations. That way, you’ll be prepared to face any issue the auditors may raise.
Here is another great read to learn more about these red flags that auditors commonly look for during the investigation or audit process in Dallas, TX.
Oberheiden P.C. – Consult With Us for Free Concerning Your Pharmacy Compliance Issues
If you’re a pharmacy owner and would like to talk to a professional for proper guidance, our experienced attorneys and consultants are always available 24/7. These consultations are free. You can reach us through 214-692-2171 to schedule an appointment, or reach out to us online.