We Represent Pharmacists, Pharmacies, and Pharmacy Owners in All Federal Compliance and Defense Matters
Pharmacies are subject to extensive legal and regulatory requirements, and state and federal rules. All pharmacy owners need to prioritize pharmacy law compliance, and they must be prepared to demonstrate their compliance efforts to the U.S. Drug Enforcement Administration (DEA) and other federal government authorities when necessary. Pharmacists must give due consideration to compliance as well, and working with experienced pharmacy law attorneys is one of the best ways that pharmacists and pharmacy owners can protect their businesses, their licenses, and themselves.
Each of the pharmacy law attorneys at Oberheiden P.C. has extensive experience advising and representing pharmacists and pharmacy owners. We handle all federal compliance and defense matters involving all federal authorities and regulatory agencies. Whether you have questions about Medicare Part D or the electronic prescription requirements, or you are under investigation for billing fraud or opioid diversion, our lawyers can help you make informed decisions and our legal counsel will guide you forward.
What Pharmacy Owners Need to Know About Compliance
Like all healthcare entities, pharmacies must address compliance in all aspects of their operations. Several federal laws and regulations apply to pharmacies, and these laws and regulations govern everything from pharmacies’ drug ordering and storage practices to how they market medications to patients and consumers. Many of the laws and regulations that apply to healthcare entities more broadly apply to pharmacies as well—including (but by no means limited to) those that govern billing Medicare, Medicaid, and other federal healthcare benefit programs.
We help existing pharmacy owners manage all aspects of compliance. Our lawyers work with pharmacy owners across the country to help them develop, implement, and manage effective pharmacy compliance programs. When you engage a pharmacy lawyer at Oberheiden P.C. to help you establish and maintain compliance, your lawyer will provide assistance with matters including:
DEA Registration Compliance
All pharmacies must register with the DEA, and they must continuously maintain their DEA registrations in order to stay in business. Your pharmacy lawyer at Oberheiden P.C. will not only guide you through the DEA registration and renewal processes, but also make sure you know everything you need to know to avoid putting your pharmacy’s registration in jeopardy.
Drug Ordering, Inventory, and Disposal
The Controlled Substances Act (CSA) and Drug Supply Chain Security Act (DSCSA) impose extensive requirements regarding drug ordering, inventory, and disposal—and they impose substantial penalties for non-compliance. We guide our pharmacy clients through all aspects of CSA and DSCSA compliance management, from adopting appropriate policies to implementing effective drug management procedures.
Electronic Prescription Compliance
The DEA’s electronic prescription regulations dictate various aspects of pharmacies’ operations and interactions with other healthcare providers. They also make clear that pharmacies and their owners are directly liable for all prescriptions they fill. We provide comprehensive electronic prescription compliance guidance as well, and we provide our clients with the documentation and tools they need to accept and fill orders with confidence.
Fraud Prevention (Including Diversion Prevention)
Pharmacy owners must take several steps to ensure not only that their pharmacies avoid fraudulent prescription and billing practices, but also that they avoid falling victim to fraud. Fraud prevention is a key aspect of compliance, and it is an aspect with which each pharmacy lawyer at Oberheiden P.C. has extensive experience.
Medicare, Medicaid, Tricare, and the other federal healthcare benefit programs all have their own unique, and complicated, sets of billing rules and regulations. Pharmacy owners must ensure that their facilities strictly comply with these rules and regulations—whether they handle their billing in-house or work with a third-party administrator (TPA). We help pharmacies manage billing compliance as well, and we ensure that our clients’ TPA contracts include adequate safeguards and protections.
Drug Marketing, Employment, and Other Business Compliance Matters
Drug marketing, employment, and other business compliance matters require a detailed and custom-tailored approach. No two pharmacies are exactly alike, and this means that no two pharmacies’ compliance programs will be exactly the same. We work closely with each of our clients to ensure that we have a clear understanding of their risks and needs, and then we develop comprehensive compliance solutions that are designed to protect each individual client.
Ongoing Pharmacy Compliance Management and Documentation
When it comes to pharmacy compliance, putting a program in place is just the start of the process. Pharmacy owners must actively manage their pharmacies’ compliance programs, and they must ensure that they are generating and storing the documentation needed to prove compliance when necessary. We assist with these aspects of compliance as well, working alongside our clients on an ongoing basis to help them efficiently mitigate their compliance-related risk.
What Pharmacists Need to Know About Compliance
As a pharmacist, not only must you be familiar with your pharmacy’s compliance obligations, but you must be familiar with your own personal compliance obligations as well. From reviewing prescriptions for signs of fraud to supervising staff members and ensuring that you meet your professional obligations as a licensed pharmacist, you face a variety of compliance risks on a daily basis.
But, while these risks exist, they don’t have to jeopardize your career. Pharmacists can—and should—effectively manage their professional risks through a proactive approach to compliance management. Along with advising pharmacy owners and representing pharmacies, we advise and represent pharmacists as well, and a pharmacy lawyer at Oberheiden P.C. can explain everything you need to know to practice with confidence. We routinely assist pharmacists throughout the United States with compliance matters such as:
- Anti-Kickback Statute compliance
- Patient privacy and recordkeeping compliance
- State licensing board compliance
- DEA registration and compliance
- Drug diversion prevention and anti-fraud compliance
These are just examples. As a pharmacist, you cannot rely solely on your pharmacy for compliance purposes. Pharmacists have obligations that do not exist at the pharmacy level, and managing these obligations effectively is critical for avoiding disciplinary action, audits, and investigations. If you want to make sure that you are not exposing yourself to risk unnecessarily, we encourage you to contact us for more information.
Audit and Investigation Defense for Pharmacists, Pharmacies, and Pharmacy Owners
Along with providing pharmacy and pharmacist compliance services, we also defend pharmacies, pharmacists, and pharmacy owners in federal audits and investigations. We defend pharmacists in state licensing board matters as well.
Depending on the specific allegations and circumstances involved, these legal matters can present substantial risks. While most audits and investigations present risks for professional disciplinary action and civil fines, federal authorities can (and will) pursue criminal fraud in some cases. Cases prosecuted under the Controlled Substances Act, False Claims Act, and other federal statutes can expose pharmacists and pharmacy owners to both criminal fines and prison time.
Within our pharmacy defense practice, we handle all types of administrative, civil, and criminal matters nationwide. This includes defending licensed pharmacists, pharmacies, operators of retail pharmacies, and pharmacy owners in matters such as:
- DEA registration and renewal inspections
- Medicare, Medicaid, and Tricare billing audits
- Pharmacy benefit managers (PBM) and private insurance audits
- Compounding pharmacies audits
- Prescription drug fraud and diversion investigations
Here, too, these are just examples. If you or your pharmacy is facing any level of scrutiny from any governmental authority or third-party payor, we can help. We can arrange for you to speak with a pharmacy lawyer at Oberheiden P.C. immediately, and our pharmacy lawyers can use their experience to steer the matter toward a favorable and cost-effective resolution.
FAQs: Risk Management for Pharmacies, Pharmacy Owners, and Pharmacists
Do I need to engage a pharmacy lawyer for compliance?
Yes, all pharmacy owners and pharmacists should engage a pharmacy lawyer for compliance. Effectively managing compliance requires a comprehensive understanding of all pertinent laws and regulations, and it requires the ability to craft custom-tailored policies and procedures focused on your (or your pharmacy’s) specific risks and needs.
What are the risks of non-compliance for pharmacists and pharmacy owners?
The risks of non-compliance for pharmacists and pharmacy owners are substantial. In addition to the risk of disciplinary action (for pharmacists) and loss of DEA registration, compliance issues can also lead to federal audits and investigations with the potential for civil or criminal penalties.
What should I do if my pharmacy is being audited?
If your pharmacy is being audited, you should engage an experienced pharmacy lawyer promptly. An experienced lawyer will be able to intervene in the audit on your behalf and guide you through the process of avoiding unnecessary recoupments and penalties.
What should I do if I am under investigation for pharmacy billing fraud or drug diversion?
If you are under investigation for pharmacy billing fraud or drug diversion, you need an experienced pharmacy lawyer on your side. These types of allegations can lead to serious criminal charges, and you will need to execute a proactive defense in order to avoid a federal indictment.
Should I hire a pharmacy lawyer to deal with the DEA on my (or my pharmacy’s) behalf?
Yes, if you need to deal with the DEA in any respect, you should hire a pharmacy lawyer to communicate with federal agents on your behalf. When dealing with the DEA, mistakes can be costly, and you can quickly find yourself facing intensive scrutiny if you aren’t careful.
Speak with a Pharmacy Lawyer at Oberheiden P.C.
If you would like to speak with a pharmacy layer at Oberheiden P.C., we invite you to get in touch. Please call 888-680-1745 or contact us online to arrange a complimentary initial consultation.