Former DEA and DHHS-OIG Agents Providing Pharmacy Compliance Consulting Services Nationwide
Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
If you are a pharmacy owner, executive, or pharmacist-in-charge, compliance needs to be among your top priorities. Pharmacies are under the microscope, and those that fail to maintain compliance can face steep penalties in federal law enforcement investigations.
At Corporate Investigation Consulting, our pharmacy compliance consultants offer unique insights and expertise. Not only do our consultants have significant experience working with pharmacies in the private sector, but they also have prior experience in federal pharmacy compliance enforcement. This includes prior experience as Special Agents-in-Charge with the Drug Enforcement Administration (DEA), the U.S. Department of Health and Human Services Office of Inspector General (DHHS-OIG), and other federal law enforcement agencies.
Experienced Consultants for All Areas of Pharmacy Compliance
We assist pharmacies nationwide with all aspects of federal compliance. Whether you are opening a new pharmacy, your pharmacy’s existing compliance program needs an overhaul, or you have specific questions or concerns about pharmacy compliance, we can help. We work with our clients to address their specific needs, and we provide custom-tailored, detail-oriented and practical compliance solutions that our clients can implement immediately.
Our former DEA and DHHS-OIG agents regularly consult with pharmacy owners, executives, and pharmacists-in-charge on matters including:
DEA Registration Compliance
All pharmacies in the United States are required to maintain an active registration with the DEA. To register with the DEA, pharmacies must meet various requirements, and they must affirmatively demonstrate compliance during their DEA inspections. We help pharmacies navigate the DEA registration process, address any issues that come up during the process, and maintain compliance with the DEA’s requirements for registrants on an ongoing basis.
Electronic Prescription Compliance
The DEA has adopted extensive electronic prescription regulations. While these regulations are designed to prevent manipulation and fraud, their breadth and complexity present significant compliance burdens for pharmacies of all sizes. Crucially, beyond taking adequate steps to ensure electronic prescription compliance internally, pharmacies also have a “corresponding responsibility” to ensure that all prescriptions they fill comply with federal law.
This means that pharmacies cannot simply fill electronic prescriptions as they come in. Instead, pharmacies must implement and follow procedures designed to adequately assess the legitimacy of all electronic prescriptions before dispensing medications to patients. Pharmacies’ primary obligations appear in Part 1311 of Title 21 of the Federal Code of Regulations (CFR), titled Requirements for Electronic Orders and Prescriptions, and Subpart (C) of Part 1311 lists 21 discrete and detailed requirements for maintaining electronic prescription compliance.
CSA and DSCSA Compliance
The Controlled Substances Act (CSA) and Drug Supply Chain Security Act (DSCSA) establish numerous compliance obligations for pharmacies. Under the CSA, pharmacies have compliance obligations in areas including, but not limited to:
- Documentation and Record-Keeping
- Drug Ordering and Inventory Management
- Drug Dispensing and Diversion Prevention
- Drug Packaging and Transfers
- Loss and Theft Prevention
- Prescription Management and Fraud Monitoring
Under the DSCSA, pharmacies must take adequate steps to ensure that patients do not receive counterfeit medications. Pharmacies’ obligations under the DSCSA broadly fall into three categories: prevention, detection, and response. Among numerous other obligations, pharmacies must implement controls designed to ensure that their “trading partners” (i.e., drug manufacturers and suppliers) are federally compliant, collect and analyze drug tracing documentation, and investigate all suspected illegitimate drugs that come into their custody or possession.
Diversion Prevention
With the nation’s opioid epidemic, diversion prevention has become a key enforcement area for federal authorities. The DEA, DHHS-OIG, and other federal agencies expect pharmacies to implement exhaustive measures designed to ensure that the drugs in their inventory end up in the right hands. These measures include, but are not limited to, examining the validity of all prescriptions received from patients and healthcare providers, maintaining effective inventory controls, and verifying all patients’ identities.
When targeted in federal opioid diversion investigations, pharmacies, pharmacy owners and executives, and pharmacists-in-charge can face severe consequences. In addition to loss of DEA registration, a finding that a pharmacy has facilitated opioid diversion (whether intentionally or unintentionally) can lead to fines and other civil or criminal penalties.
Pharmacy Billing Compliance
On top of maintaining compliance with respect to their drug-related operations, pharmacies must maintain compliance with regard to billing as well. Whether dealing with pharmacy benefit managers (PBMs) or federal payors such as Medicare, Medicaid, and Tricare, pharmacies must take adequate steps to ensure that they are billing accurately—and that they will be able to prove the accuracy of their billings when necessary.
PBMs and audit contractors working with Medicare, Medicaid, and Tricare routinely inspect pharmacies’ billing records. During these inspections, they do not give pharmacies the benefit of the doubt. If there is any evidence to suggest that a pharmacy’s billings are fraudulent, or if there is no evidence to prove that a pharmacy’s billings are legitimate, this will lead to recoupment demands—and potentially other consequences as well.
Specialty Compliance Issues
Beyond the compliance obligations that apply to all pharmacies operating in the United States, certain pharmacies can face additional compliance obligations based on the nature of their operations and/or the medications they supply to patients. In addition to consulting on general pharmacy compliance matters, we also consult with clients on matters including:
- CBD Compliance for Pharmacies – As demand for CBD-based medications continues to grow, pharmacies that offer these medications have a chance to seize significant business opportunities. But, significant compliance challenges remain, and pharmacies must be extremely careful to ensure that their CBD offerings comply with the law.
- Compound Pharmacy Compliance – Compounding pharmacies face a number of unique compliance obligations. We help compounding pharmacies determine which obligations apply, and we work with them to implement comprehensive and custom-tailored compliance programs.
- Specialty Pharmacy Compliance – Specialty pharmacies face unique compliance obligations as well. Here too, we work with our clients on an individual basis to assess their compliance needs and help them implement effective compliance policies and procedures.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
Elements of an Effective Pharmacy Compliance Program
Regardless of a pharmacy’s specific compliance obligations, the pharmacy’s compliance program should consist primarily of several key elements. By implementing well-structured and comprehensive compliance programs, not only can pharmacies mitigate their risk of compliance violations, but they can also position themselves to achieve a favorable outcome in the event of a billing compliance audit or a DEA or DHHS-OIG prescription drug fraud investigation.
Some of the key elements of an effective pharmacy compliance program include:
- Initial compliance audit and documentation of the pharmacy’s compliance needs
- Written compliance policies and procedures that address all pertinent requirements
- Compliance training and certification (including Combat Methamphetamine Epidemic Act of 2005 (CMEA) self-certification)
- DEA registration
- DSCSA and electronic prescription compliance systems and protocols
- Pharmacy compliance program auditing and enforcement
- Documented procedures for remedying compliance violations
FAQs: What Pharmacy Owners, Executives, and Pharmacists-In-Charge Need to Know about Compliance
How Do I Know If My Pharmacy is DEA Compliant?
There are several aspects to DEA compliance; and, simply put, if you don’t know whether your pharmacy is DEA compliant, it probably is not. Establishing and maintaining DEA compliance requires a concerted effort, and pharmacies that don’t devote the necessary resources to DEA compliance risk facing both civil and criminal penalties.
When Can Pharmacies Be Held Liable for Filling Fraudulent Prescriptions?
Pharmacies can be held liable for filling fraudulent prescriptions under several circumstances. Even if a pharmacist is unaware that a prescription is fraudulent, this isn’t necessarily enough to avoid liability. Under the CSA and other federal laws, pharmacies must take several steps to affirmatively verify the authenticity of all prescriptions they fill.
Are Counterfeit Prescriptions a Real Concern for Pharmacies in the U.S.?
Yes, counterfeit prescriptions are a very real concern for pharmacies in the U.S. This is why Congress enacted the DSCSA in 2013. Under the DSCSA, pharmacies must examine several potential red flags before accepting prescription medications and dispensing them to patients.
What Are the Risks if My Pharmacy Isn’t Fully Compliant?
For pharmacies, pharmacy owners and executives, and pharmacists-in-charge, the risks of non-compliance are substantial. Depending on the circumstances involved, the consequences of non-compliance can include termination of DEA registration; loss of PBM contracts; loss of Medicare, Medicaid, and Tricare eligibility; recoupments; civil or criminal fines; and even federal imprisonment.
Do I Need to Engage a Consulting Firm for Pharmacy Compliance?
In today’s world, pharmacies cannot rely on off-the-shelf compliance programs. They also cannot make any assumptions when it comes to meeting (or not meeting) their compliance obligations. To ensure compliance—and to protect their patients and themselves—pharmacies and pharmacists need to work with experienced consultants who can help them understand their obligations and address them appropriately.
Speak with a Pharmacy Compliance Consultant at Corporate Investigation Consulting
If you would like more information about our pharmacy compliance consulting services, we encourage you to get in touch. One of our former DEA or DHHS-OIG agents will be happy to meet with you and discuss your pharmacy’s needs in confidence. To schedule an appointment at your convenience, give us a call at 866-352-9324 or tell us how we can reach you online today.