Dallas Pharmacy Compliance and Audits
Pharmacies are subject to strict regulation by the DEA and other authorities, and compliance deficiencies can lead to audits, investigations, and steep penalties. Our Dallas pharmacy lawyers and compliance consultants have a proven record of success helping pharmacies avoid costly mistakes.
If you are a pharmacist or you own a pharmacy in Dallas, you know just how difficult it is to maintain pharmacy compliance with the myriad laws, rules, and regulations that apply to pharmaceutical practice. The compliance burden is substantial, and even unintentional mistakes have the potential for significant consequences.
So, what do you do? The answer is simple: You need to make compliance a priority. Compliance should be an affirmative consideration in all aspects of your pharmacy’s operations, and you need to monitor the effectiveness of your pharmacy’s compliance program on an ongoing basis.
Of course, while the answer is simple in concept, establishing and maintaining pharmacy compliance is easier said than done. Even understanding what is necessary can be challenging, and implementing an effective pharmacy compliance program requires comprehensive knowledge of the regulatory regime as well as deep insights into the types of issues that lead to federal scrutiny.
Federal Pharmacy Compliance Lawyers and Consultants in Dallas, TX
Headquartered in Dallas, TX, our firm represents pharmacies in all aspects of federal compliance. We also represent pharmacies in audits and investigations conducted by the U.S. Drug Enforcement Administration (DEA) and other agencies. With local attorneys and a nationwide network of pharmacy compliance consultants that includes former senior DEA agents and diversion investigators, we offer comprehensive compliance and audit defense representation for matters ranging from opioid diversion prevention and CBD compliance to Medicare and Medicaid billing compliance management.
10 Key Areas of Pharmacy Compliance
Due to the volume of compliance obligations pharmacies in Dallas face, in order to manage compliance effectively, it is necessary to break down the broader issue of “pharmacy compliance” into discrete areas of need. While different pharmacies will have different compliance burdens, generally speaking, the 10 key areas of pharmacy compliance are as follows:
1. DEA Registration Compliance
All pharmacies are required to register with the DEA, and pharmacies must be careful before, during, and after the registration process to ensure that they are strictly adhering to the DEA’s rules and requirements. Any shortcomings can potentially lead to delays and temporary (or permanent) loss of registration, and significant violations of the Controlled Substances Act’s registration provisions can expose pharmacists and pharmacy owners to substantial penalties.
2. Electronic Prescription Compliance
For pharmacies in Dallas that accept electronic prescriptions, electronic prescription compliance is itself an area that demands significant care and attention. The DEA has established extensive regulations that govern pharmacy’s acceptance of electronic prescriptions; and, here too, even unintentional oversights and mistakes that result from being “overwhelmed” can lead to aggressive DEA enforcement.
3. Prescription Drug Ordering
When ordering prescription drugs through their program benefit managers (PBMs) or from drug manufacturers directly, pharmacies must make appropriate of DEA Form 222, and they must accurately complete the form while also generating appropriate internal documentation. Inadequate documentation of prescription drug ordering compliance is a common issue, and it is one that routinely leads to issues during DEA audits and inspections.
4. Prescription Drug Inventory Management
Pharmacies are required to maintain complete and up-to-date inventories of the prescription medications that they have on hand at all times. They must also maintain complete historical inventory records for two years. When audited by the DEA, pharmacies must be prepared to present these records promptly in order to demonstrate compliant inventory management.
5. Prescription Drug Fraud Prevention
From dispensing medications under invalid prescriptions to accepting unlawful kickbacks from prescribing physicians, pharmacies must have comprehensive policies and procedures in place to prevent all forms of prescription drug fraud. If accused of intentional prescription drug fraud, pharmacists and pharmacy owners can face criminal prosecution by the U.S. Department of Justice (DOJ).
6. Prescription Drug Diversion Prevention
Pharmacies also need to take all necessary and appropriate measures to prevent prescription drug diversion. This is particularly important with respect to opioid medications, but no diversion risks can be overlooked when it comes to pharmacy compliance. With a retired DEA Diversion Program Manager and a retired DEA Diversion Investigator in our consultant network, we offer deep expertise in this area.
7. Prescription Drug Packaging, Transfer, Disposal, and Loss Prevention
The prescription drug packaging, transfer, and disposal requirements for pharmacies are extraordinarily detailed and comprehensive. From recordkeeping requirements to disposal protocols, pharmacies must establish and adhere to strict compliance protocols, and they must ensure that all staff members are adequately trained with regard to their individual roles in maintaining compliance.
8. Federal Program (i.e. Medicare and Medicaid) Billing Compliance
Billing violations under federal benefit programs such as Medicare and Medicaid can lead to substantial civil liability and the potential for criminal prosecution. Even when pharmacies hire third-party billing administrators, they ultimately remain responsible for ensuring that they do not overbill the federal government. We have extensive experience representing pharmacies and other healthcare providers with respect to federal program billing compliance, and we have successfully defended providers nationwide in federal billing fraud audits and investigations.
9. Pharmacy Record-Keeping Compliance
When it comes to avoiding risks during DEA audits and inspections, having comprehensive records on hand can be absolutely critical. In addition to all of the various areas of compliance discussed above, pharmacies must adopt comprehensive policies and procedures that address any other compliance needs they may have, and these policies and procedures must include provisions for generating and storing appropriate records on an ongoing basis.
10. Specialty Pharmacy and Compound Pharmacy Compliance
Finally, specialty pharmacies and compound pharmacies have unique compliance obligations. If you own or run a specialty pharmacy or compound pharmacy in Dallas, our federal defense attorneys and compliance consultants can work with you to ensure that your inventory, dispensing, billing, and recordkeeping practices are fully compliant with all federal laws and regulations.
What to Expect in a Pharmacy Audit
If your pharmacy is not 100% compliant, an audit can present serious risks. Even if your pharmacy has fully implemented all requisite policies and procedures, demonstrating compliance during an audit still requires a skilled and strategic approach. In addition to representing pharmacies with regard to compliance, we also represent pharmacies during audits and inspections, including specifically:
- DEA audits and inspections
- HRSA 340B compliance audits conducted by the U.S. Department of Health and Human Services (DHHS)
- Pharmacy benefit manager (PBM) audits
- Texas State Board of Pharmacy (TSBP) audits
Each of these audits follows its own unique progression, and each requires its own unique tactical defense. We have helped pharmacies in Dallas and across the country avoid liability in each of these types of audits, and we can use our experience to achieve a favorable result in your case.
15 Red Flags During Pharmacy Audits
While DEA, DHHS, PBM, and TSBP auditors will be looking for any and all reasons to hold your pharmacy accountable for compliance shortcomings, there are a number of issues in particular that tend to lead to trouble for pharmacies in Dallas. We have identified these recurring issues over decades of experience on both sides of pharmacy audits, and we have developed proven strategies for protecting pharmacies, pharmacy owners, and pharmacists against liability for these (and other) issues. In our experience, some of the biggest “red flags” for pharmacy auditors include:
- Failure to maintain up-to-date DEA registration information on file
- Failure to adopt written policies on opioid dispensing
- Failure to adopt written policies on diversion control
- Inadequate documentation of validation for narcotics prescriptions
- Limited or no evidence of regular communication with prescribing physicians
- Serving a large number of patients who pay with cash
- Providing frequent refills, particularly without documentation of confirmed medical necessity
- Disorganized pharmacy records, particularly with regard to prescription management and billing compliance
- Above-normal inventory error rates
- A pattern of dispensing high-risk prescription medications (i.e. Oxy 30mg)
- A pattern of dispensing known dangerous drug combinations (i.e. the “Holy Trinity”)
- A history of past failed inspections or letters of admonition
- Financial relationships with prescribing physicians
- A staffing level that is insufficient to maintain pharmacy operations while also devoting the necessary time and effort to compliance
- Inadequate staff training by the supervising pharmacist in charge (PIC)
This list is not exhaustive, and pharmacy owners should not try to tailor their compliance programs to specific hot-button issues or red flags. Instead, they must take a truly comprehensive approach so that they are prepared to demonstrate compliance regardless of the issues raised by the DEA, DHHA, PBM, or TSBP.
Learn more about each of these concerns for pharmacies facing DEA audits in Dallas, TX: What are Red Flags for DEA Investigators During a Pharmacy Audit?
Speak with One of Our Dallas Pharmacy Compliance Lawyers or Consultants for Free
Would you like to speak with one of our Dallas pharmacy lawyers or compliance consultants? If so, we encourage you to schedule a complimentary initial consultation. Call 888-680-1745 to request an appointment, or tell us how we can help online and we will respond promptly.