Even within the heavily regulated world of healthcare, pharmacists face a substantial compliance burden. Not only must pharmacists ensure compliance with the False Claims Act, the Anti-Kickback Statute, and all of the various other laws and regulations that apply to federal program-participating healthcare providers, but they must comply with the laws and regulations that apply specifically to pharmaceutical practice as well. Add on the licensing, patient privacy, employment, and other legal aspects of operating a pharmacy, and it is not hard to see why many pharmacists end up facing substantial penalties in disciplinary proceedings, audits, and investigations.
Our firm provides comprehensive legal consulting and representation for pharmacists and pharmacies. We assist our clients with all pertinent legal matters, from billing compliance to federal healthcare fraud defense. We work with pharmacists across the country – including compounding pharmacists – and we provide personalized, detail-oriented legal services focused on protecting our clients in light of the unique aspects of their pharmacy practices.
Comprehensive Legal Compliance and Defense Representation for Pharmacists
Our pharmacy compliance team is comprised of highly-experienced lawyers, internal auditors, and consultants who all have extensive experience working with pharmacists to build and maintain legally-compliant and low-risk practices. We represent clients with regard to compliance, transactions, litigation, federal enforcement, and professional licensing, and we have a long history of successfully protecting our clients.
We regularly represent pharmacists, pharmacies, and other healthcare providers with regard to matters including:
Privacy and Patient Recordkeeping
Maintaining patient privacy and ensuring the confidentiality of patient records present unique challenges in today’s constantly evolving technological environment. We assist pharmacists and pharmacies with all aspects of privacy compliance, including compliance with the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act. In addition to addressing the specific statutory requirements that apply to pharmacies and other healthcare providers, we can assist you with negotiating IT vendor contracts and implementing appropriate internal security protocols as well.
Pharmacist Licensing and Discipline
Our attorneys represent pharmacists in state licensing board matters, including patient complaints and disciplinary proceedings. As a pharmacist, your license is one of your most-important assets, and you need to do everything in your power to ensure that it remains secure. Whether you are facing license suspension or revocation due to allegations of inadvertently dispensing the wrong drug or the wrong dosage, or you are facing more-serious allegations such as diverting opioid medications or self-dispensing, we can utilize our experience to help you execute a sound defense strategy.
Drug Enforcement Administration (DEA) Registration
As a pharmacist, you are required to register with the Drug Enforcement Administration (DEA) prior to prescribing any medications. DEA registrations are subject to regular renewal, and DEA registrants are subject to periodic audits and investigations. If you are registered with the DEA, or if you need to be registered with the DEA, our attorneys can help you establish compliance with the Controlled Substances Act (CSA), and we can defend you in an audit or investigation if necessary.
Billing and Coding Compliance
If you bill Medicaid, Tricare, Medicare, or the U.S. Department of Labor (DOL), your pharmacy is subject to comprehensive and detailed billing rules and regulations. Violations that are deemed “willful” can lead to criminal charges under the False Claims Act and other statutes, while even unintentional violations can trigger recoupments, civil fines, and other penalties. With our lawyers’ and consultants’ experience representing all types of program-participating healthcare providers, we can help you build and implement a billing compliance program that reflects the unique needs of your pharmacy practice.
Federal Audits, Investigations, and Charges
If allegations of a CSA violation, billing or coding violation, or other statutory or regulatory violation trigger an audit or investigation into your practice, executing a proactive defense strategy can significantly reduce your risk of facing federal charges. Our lawyers have extensive experience defending clients in healthcare fraud audits and investigations, and we have handled federal cases involving civil and criminal charges in jurisdictions across the country.
Professional Malpractice Claims and Litigation
Allegations of erroneously filling prescriptions, dispensing medications without a valid prescription, improperly compounding medications, and other forms of professional negligence can lead to costly and reputation-damaging claims for professional malpractice. In addition to handling federal enforcement litigation, our lawyers also provide skilled and strategic representation for pharmacists and their insurers in cases involving pharmacy malpractice claims.
Pharmacy Ownership Issues
Even setting aside the healthcare-related legal aspects of operating a pharmacy, owning and operating a pharmacy involves a number of varied and complex legal considerations. From forming business entities to structuring partner and shareholder agreements, and from dealing with contract disputes to maintaining business licenses and registrations, we can assist you with all of the legal aspects of structuring and managing your practice.
Employment-related issues can present difficult challenges for pharmacists and pharmacy owners as well. Whether you need to ensure that the terms of your employment agreement provide you with adequate rights and protections, you are dealing with a wrongful termination dispute, you have been accused of discrimination in the workplace, or you are facing a federal employment tax audit, we can help you here as well.
In healthcare, third-party contracts present compliance issues that too often go overlooked by pharmacists and other healthcare providers. If you bill Medicaid, Tricare, Medicare, or any DOL program, you must ensure that your contracts with physicians, billing administrators, marketers, and other third parties comply with the Anti-Kickback Statute. Contracts with physicians can potentially raise Stark Law implications as well, and Anti-Kickback Statute and Stark Law violations carry severe penalties for parties on both sides of the transaction at issue.
National Practitioner Data Bank (NPDB) Disputes
We also assist pharmacists with disputing reports filed with the National Practitioner Data Bank (NPDB). While unfavorable reports to the NPDB can have damaging consequences in their own right, they are also often accompanied by ethics complaints, malpractice claims, and federal enforcement audits and investigations.
FAQs: Pharmacy Compliance, Pharmacist Liability, and Federal Healthcare Fraud Defense
Q: What are some of the most-common compliance issues that lead to trouble for pharmacists?
Pharmacists can face federal penalties for a broad range of statutory and regulatory violations. This includes violations related to their prescription practices as well as violations related to their participation in federal healthcare benefit programs. In our experience, some of the types of issues that seem to be most prevalent include:
- Dispensing the wrong medication or the wrong dosage
- Improperly compounding medications
- Improperly labeling medications (including repackaging drugs)
- Dispensing contaminated or adulterated medications
- Diverting opioid medications and self-prescribing prescription drugs
- DEA registration violations
- Medicaid, Tricare, Medicare, and DOL billing and coding errors
- Entering into unlawful contracts with physicians, marketing firms, and other third parties
Q: What are the penalties for non-compliance when it comes to DEA registration and federal program billing?
DEA registration violations can be prosecuted as violations of the Controlled Substances Act. The CSA is a criminal statute that imposes years-long (if not decades-long) terms of imprisonment and substantial fines for virtually all prescription-related crimes. Federal program billing fraud can be prosecuted either civilly or criminally depending on the circumstances involved. Civil violations can lead to recoupments, fines, treble damages, program exclusion, and other penalties. Criminal violations carry the potential for substantial prison terms under the False Claims Act and other statutes.
Q: How do I know if my pharmacy’s compliance program is adequate?
The only way to determine the adequacy of your pharmacy’s compliance program is to stress test it with a comprehensive internal audit. When we represent pharmacists and pharmacies with regard to compliance, our first step is always to determine the amount of work that needs to be done. Where is your compliance program serving you well? Where is it lacking? Which shortcomings warrant immediate remediation? Are there past violations that need to be remedied? These are all questions we will look to answer quickly so that we can advise you accordingly.
Q: What do pharmacists need to know about HIPAA?
As a pharmacist, the most-important thing you need to know about HIPAA is that HIPAA compliance likely is not the most-pressing issue facing your pharmacy practice. While HIPAA compliance is certainly important (and, indeed, necessary), most pharmacies’ greatest risks lie in the areas of DEA and federal healthcare program compliance. While we can assess your pharmacy’s current patient privacy and recordkeeping practices, it will likely be most beneficial for us to devote the majority of our efforts to other areas.
Discuss Your Legal Needs with a Federal Healthcare Lawyer at Oberheiden, P.C.
For more information about our legal services for pharmacists and pharmacies, please contact us to schedule a free initial needs assessment. To speak with one of our experienced attorneys as soon as possible, call 888-680-1745 or inquire online now.