Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis.

The U.S. Department of Justice (DOJ), Department of Health and Human Services (HHS) Office of Inspector General (OIG), Drug Enforcement Agency (DEA), and numerous other state and federal agencies, have ramped up efforts to audit, investigate, and prosecute physicians, pharmacists, and others who fraudulently administer prescription drugs.

As a pharmacist, how can you defend yourself in the face of an audit or investigation?

What Should You Do If You Are Contacted By A Pharmacy Fraud Investigator?

The Federal Bureau of Investigation (FBI), DEA, Texas Attorney General’s Office, Texas’ Medicaid Fraud Control Unit (MFCU), the U.S. Postal Service Office of Inspector General (USPS-OIG), HHS-OIG, the DOJ, and other agencies all play roles in collecting evidence and prosecuting fraud allegations.

If you are contacted by an agent or officer with any of these agencies – or if you receive a Civil Investigative Demand or subpoena – contact an attorney immediately.

An attorney can help you by:

• Opening lines of communication with regulators to define scope and establish credibility;
• Intervening before prescription drug fraud charges are filed;
• Resolving or disputing overpayment and recoupment efforts;
• Managing costs and effort while meeting demands for documentation and other requests made by authorities;
• Preserving evidence and ensuring compliance;
• Preparing for interviews;
• Crafting tailored defense strategies;
• Exploring options for ending enforcement efforts as soon as possible; and
• Negotiating resolutions or settlements.

Even if you believe you are not the subject of an investigation or believe you can smooth things over after making prescription errors, the aggressiveness with which prescription drug fraud, and any healthcare fraud matter, is pursued may demand legal representation to protect your rights.

How Are Prescription Fraud Cases Initiated & Investigated?

Investigations target all types of providers involved in prescribing and supplying prescription medications – including physicians, pharmacists, compounding pharmacies, nurse practitioners, psychiatrists, orthopedic surgeons, pain management specialists, chiropractors, and others.

Prescription drug fraud investigations may begin in a few ways:

• DEA, DOJ, or state-level data analysis and drug monitoring designed to identify patterns of unusual or disproportionate amounts of prescriptions.
• Anonymous tips filed with authorities or other government agencies by the public or insiders.
• Lawsuit filed by whistleblowers under the qui tam provisions of the False Claims Act.
• Complaints or reports filed by patients, including complaints filed with a state medical licensing agency (i.e. the Texas Medical Board).
• Audits or investigations conducted by the Texas Department of Insurance (TDI).
• Audits that detect billing errors, overpayment, and suspicious patterns performed by Recovery Audit Contractors (RACs), Medicare Administrative Contractors (MACs), or Unified Program Integrity Contractors (UPICs).
• “Strike Force” collaboration and data sharing between any number of agencies and federal payors, including Medicare & Medicaid, TRICARE, the Texas Attorney General’s Office, the Medicaid Fraud Control Unit (MFCU), DOJ, DEA, and others.

What Is Considered Prescription Drug Fraud?

Prescription drug fraud may involve acts, arrangements, or other fraudulent and unlawful schemes that violate the federal Anti-Kickback Statute, False Claims Act, the Stark Law, the Controlled Substances Act, or state-law equivalents. This can include improper business relationships and telemedicine schemes designed to induce referrals or remuneration, kickback arrangements, and more.

State and federal regulatory agencies commonly target the following practices involving fraud and prescription medications:

• Dispensing more medication than prescribed;
• Filling prescriptions for controlled substances that do not meet legal requirements (lacked a legitimate medical purpose, were not for a medically accepted indication, or were not issued in the usual course of professional practice);
• Fake or fraudulent prescriptions;
• Billing Medicare for an expensive prescription drug and dispensing a less expensive version to patients;
• Misbranded drugs or medical devices;
• Unlawful distribution and dispensing of controlled substances;
• Improperly reporting evaluations / tests to prescribe medically unnecessary prescription drugs;
• Prescribing drugs without performing in-person evaluations, including failures to meet standards of telemedicine in absence of a real physician-patient relationship;
• Diverting prescription medications to unauthorized end users;
• Sales of false or fraudulent prescriptions;
• Increasing prescriptions for certain drugs, including compounded drugs, when there are commercially available drugs that serve the same purpose;
• Unauthorized prescription refills;
• Prescribing, dispensing, or distributing controlled substances that are not medically necessary; and
• Paying kickbacks to doctors to write prescriptions.

Avoiding Prescription Drug Fraud Investigations

Pharmacists are the last line of defense against prescription fraud. To improve detection and prevent fraud, the DOJ urges pharmacists to “always check the patient’s identification, verify the doctor’s information when it is not familiar, and use [your] experience and knowledge to judge when a patient’s behavior is suspicious, or a prescription may be fraudulent.”

Use these techniques to recognize prescription drug fraud and misuse:

• Know the prescriber and his or her signature.
• Know the prescriber’s DEA number.
• Know the patient (or get a profile if you do not).
• Check the date on the prescription. Ensure it has been presented within a reasonable time.
• Telephone the prescriber for verification or clarification if you have any questions. The patient should give a plausible reason for any discrepancy before you dispense the drug.
• If you are in doubt, request proper identification; doing so increases an offender’s risk of getting caught.
• If you believe a prescription is forged or altered, do not dispense it – call the local police.
• If you believe that you have discovered a pattern of prescription misuse, contact your state pharmacy board or the DEA.

An investigation can create exposure to not only costly and time-consuming interviews, records requests, and other demands, but also brings the threat of civil penalties, disciplinary actions, provider exclusion, and criminal charges. Enlist the help of a healthcare law firm with experience handling prescription error audits and fraud investigations to help achieve the best possible outcome.