Miami Pharmacy Compliance and Audits
The DEA and other federal authorities have strict regulations governing pharmacy operations. For pharmacies found to be non-compliant, they may be audited, investigated, and substantially penalized. Our Miami pharmacy attorneys and consultants have an impressive track record of guiding pharmacies through the compliance process to help them avoid damaging mistakes.
Pharmacy is one of the most regulated areas in Miami. There is a wide variety of laws and rules governing this practice, which can make the process of compliance difficult. And even though pharmaceutical compliance burdens are too much, unintended mistakes can still bring the risk of liability.
With all the risks associated with compliance violations, what should you do as a pharmacist or pharmacy owner? The solution lies in making insurance a priority. Take proactive steps to establish a comprehensive compliance program that takes into account all your pharmacy’s aspects of operation. You then need to monitor that program as time goes by to make sure it’s as effective as possible.
While this solution to avoid compliance violations may seem easy, actualizing it can be very challenging. You may even not know what is required of you, and for better compliance program effectiveness, you need to understand the various governing bodies in this practice as well as insights into issues that trigger federal scrutinies and audits. A qualified pharmacy compliance attorney can help you navigate this difficult process.
Federal Pharmacy Compliance Attorneys and Consultants in Miami, FL
With several offices in Miami, FL, we at Oberheiden P.C. represent pharmacies in all aspects regarding the relevant compliance obligations. We also offer legal representation to pharmacies being audited and investigated by the U.S. Drug Enforcement Administration (DEA) or other agencies. Our team is made up of local lawyers and a network of pharmacy compliance consultants countrywide, with some having worked formerly as high ranking DEA agents and drug diversion investigators.
We can be thorough to make sure your compliance is comprehensive as possible and defend you in audits involving a broad range of matters – from CBD compliance and opioid diversion prevention to Medicare and Medicaid billing compliance. Ours is an experienced and skilled team to ensure we leave no stone unturned in your situation.
10 Main Areas of Pharmacy Compliance
Pharmacy compliance is a broad term that encompasses all obligations pharmacies should observe. Trying to understand it as a whole can be hard, and that’s why we need to break it down into smaller digestible need areas. Doing this makes the process of implementation easier and effective. While the specific obligations may vary depending on each pharmacy’s operations, there are 10 general pharmacy compliance areas:
1. Pharmacy Registration With the DEA
Obtaining DEA registration is a must for Miami and countrywide pharmacies. However, care is vital before registering, during the registration process, and after to make sure all the pertinent DEA regulations are strictly followed. Mistakes before or during the process can cause delays, and if you violate any of the regulations after, you can lose your registration temporarily or even permanently. Also, significantly violating registration requirements as stipulated by the Controlled Substances Act can lead to hefty penalties in the future. Therefore, attending to all aspects regarding pharmacy DEA registration is crucial.
2. Electronic Prescription Compliance
Abiding by electronic prescription compliance is another area that requires a lot of attention from Miami and countrywide pharmacies. There are rules and laws under the DEA that regulate electronic prescription acceptance by pharmacies that allow these kinds of prescriptions. Just like in other pharmacy compliance areas, mistakes made unknowingly here can still attract aggressive enforcement action by the Drug Enforcement Agency. Care is vital to avoid any unintended deficiencies from occurring.
3. Prescription Drug Ordering
During the process of drug ordering, pharmacies are needed to obtain and accurately fill out the suitable DEA Form 222 as well as provide other relevant internal documents. All pharmacies should follow this procedure no matter whether they’re making orders directly from drug producers or via their program benefit managers (PBMs). Many pharmacies do not take the time to properly document their ongoing efforts when it comes to drug ordering compliance, and it’s an issue that can bring a lot of problems during DEA investigations and audits.
4. The Management of Prescription Drug Inventory
Inventory management another crucial area of need in pharmacy compliance. The regulatory authorities require pharmacies to keep a record of all the drugs they have in their offices and update these inventories regularly. Those records should also be maintained for two years. Pharmacy DEA audits can and will happen; and when they do, you need to have these records on hand to show your compliance with drug inventory management regulations.
5. Preventing Prescription Drug Fraud
Pharmacies are prone to different kinds of fraud daily. One is the dispensation of drugs using fake prescriptions. The other example is getting bribed by prescribing physicians. There is a wide range of ways fraud can happen in a pharmacy, and it’s a requirement for these facilities to develop procedures and policies that ensure these occurrences do not take place. If pharmacies are found to be engaging in purposeful fraudulent activities, their owners may be prosecuted criminally by the DOJ.
6. Prescription Drug Diversion Prevention
Apart from fraud, another thing pharmacies are susceptible to is drug diversion, which mostly happens with opioid medications. Drug diversion is transferring one person’s medications to another for unlawful actions. Regulatory authorities require pharmacies to establish procedures and policies to ensure such occurrences do not happen. Our team here at Oberheiden P.C. comprises of two individuals with extensive knowledge in this area – one worked formerly as DEA Diversion Program Manager and the other as DEA Diversion Investigator. Their advice and guidance can significantly help pharmacies facing drug diversion audits.
7. Packaging of Prescription Drugs, Transfer, Disposing, and Loss Prevention
Requirements regulating the process of packaging and transferring as well as disposing of prescription drugs are broad and extensive. From keeping detailed records to the disposal process, there are various obligations, and pharmacies should strictly abide by them. Apart from pharmacy owners following these regulations, they should also train other staff regarding their roles and responsibilities for overall compliance.
8. Federal Program Billing Compliance
When it comes to federal programs like Medicare and others, billing violations can lead to potential civil and criminal prosecution. Many pharmacies hire third-party companies to help with federal program billing, but even if they do, they should establish measures to ensure no overbilling takes place. At Oberheiden P.C., we’re comprehensively experienced in all matters concerning billing compliance obligations for federal programs, having represented different pharmacies and healthcare providers in a wide range of issues. We have also effectively defended providers in Miami and countrywide in billing fraud scrutinies and audits.
9. Compliance With Record-Keeping Obligations
Preparing and maintaining all pharmacy records is critical. They can help you demonstrate your compliance during audits and investigations. When creating a compliance program, it should include steps to generate suitable records as the pharmacy continues operating and store them as necessary for easy retrieval.
10. Compliance Obligations for Compound and Specialty Pharmacies
Compliance responsibilities for specialty and compound pharmacies are unique. If you operate any of these types of pharmacies, our team here at Oberheiden can work closely with you to ensure you comply with all the pertinent obligations. Our lawyers and consultants can ensure all activities such as inventory management, drug dispensation, recordkeeping, and billing comply with the set regulations and laws.
What to Expect in the Course of a Pharmacy Audit
DEA audits can present various serious risks to non-compliant pharmacies. And even if your pharmacy has been complying with the established procedures and policies, demonstrating proof of compliance still needs skills and strategies. Apart from guiding these facilities to ensure they’re 100% compliant with their federal duties, we can also provide them with legal representation in inspections and audits. We can confidently and successfully handle:
- DEA inspections and audits
- Audits by the Pharmacy Benefit Managers (PBM)
- DHHS audits concerning HRSA 340B compliance
- Audits by the Florida State Board of Pharmacy
These audits are different because of how they’re conducted, and each one requires a unique strategic defense. We have worked with multiple Miami and nationwide pharmacies to help them avoid liabilities in these audits, and our attorneys can implement the experience plus knowledge gained to achieve a favorable outcome for you.
15 Red Flags Auditors Commonly Look For in Pharmacy Audits
Although auditors from the TSBP, DEA, PBM, and DHHS will be looking for anything and everything that indicates compliance violations, there several red flags they commonly check. Throughout the years we have been providing pharmacy compliance and audit defense, we’ve identified some of these red flags and they include the following:
- A lot of inventory mistakes
- Non-compliance with drug diversion regulations
- Dispensing controlled medications such as opioids without following the right procedures
- Unusually dispensing high-risk medications
- Inadequate validation documents concerning the prescription of narcotics
- Issues with DEA registration such as not maintaining updated information on file
- Allowing a high number of individuals to use cash for payments
- Availing dangerous drug combinations such as the Holy Trinity to various people
- A record of failed audits or letters of admonition in the past
- Inadequate staffing to run the pharmacy
- Failure to provide enough staff training
- Unusual financial relations with prescribing medical personnel
- Little or no evidence of consistent communication with prescribing medical personnel
- Availing refills often, especially without asking for documents to confirm medical necessity
- Pharmacy record disorganization, especially for prescription management and federal billing compliance
What you see here isn’t an exhaustive list of all the things auditors look when auditing your pharmacy, and therefore, you shouldn’t customize your compliance program or operations based only on this list. Instead, you should be as comprehensive as possible to address all relevant matters so that you can prove compliance and defend yourself no matter the issue raised by the TSBP, DEA, PBM, or DHHS.
Here is an evaluation of these red flags that investigators and auditors commonly check during DEA pharmacy audits in Miami, FL.
Contact Us Here at Oberheiden P.C. to Talk to a Miami Pharmacy Compliance Attorney or Consultant
If you would like to have a one on one consultation with one of our senior attorneys or consultants, get in touch with us today. We provide free consultations to learn more about your case and answer any of your pharmacy compliance questions. Call 888-680-1745 to schedule an appointment, or tell us how we can assist through this online form.