CHICAGO – As the epidemic of opioid addiction and overdose deaths continues to surge, state and federal authorities are keeping a close eye on physicians who prescribe controlled substances.
Experts offer the following guidance on how well-meaning doctors can avoid coming under scrutiny for prescribing opioids and successfully manage investigations and audits.
1. Know who’s on the radar: The Drug Enforcement Agency (DEA) compiles a “black list” yearly of physicians and health care providers they plan to target for audits, said, a San Francisco–based attorney who specializes in health and pharmacy law. For 2017, the list includes physicians who have prior noncompliance records, providers who specialize in pain management, and those who dispense or administer large quantities of controlled substances.
In addition, family physicians, psychiatrists, and other specialists who come under investigation by a state medical board because of suspected inappropriate prescribing or reporting violations may also come under the purview of federal authorities, Ms. Mazina said.
“If they come on the medical board radar, they may come on the [DEA’s] radar as well,” she said during the interview. “They just have to watch how many prescriptions they write for controlled substances and make sure they are legitimate prescriptions.”
2. Maintain proper records: Poor record keeping is a top reason that the DEA investigates health care providers for potential prescribing violations, said Dennis A. Wichern, a DEA agent with the Chicago Field Division.requires that registered practitioners who store or dispense controlled substances keep records of controlled substances coming in and out of the practice. That includes physicians who hand out samples of controlled substances to patients and also pertains to samples provided to doctors by pharmaceutical companies.
Records should include whether the inventory was taken at the beginning or close of business, names of controlled substances, each finished form of the substances, the number of dosage units of each finished form in the commercial container, the number of commercial containers of each finished form, and disposition of the controlled substances.
Law requires that physicians take a new inventory of all controlled substances on hand every 2 years. Doctors are not required to keep records of controlled substances that are merely prescribed, unless such substances are prescribed in the course of maintenance or detoxification treatment.
Ms. Mazina notes that there are many software platforms that can assist practices with proper inventory and record keeping for opioids and other drugs.
3. Check the state database: Before prescribing opioids, check your state’s prescription drug monitoring program (PDMP) database, advises Ms. Mazina. At least 37 states have operationalthat receive and distribute controlled substance prescription information to authorized users. About 11 states have enacted legislation to establish a PDMP, but some databases are not fully operational.
A state’s PDMP can reveal whether patients may be obtaining multiple controlled substance prescriptions from different doctors or doctor-shopping, Ms. Mazina said. Such due diligence helps inform treatment decisions and can assist a doctor’s case if a medical board or DEA investigation later arises.
“Even if your state law does not require you to check a patient’s history prior to prescribing, you have to check it to protect yourself,” she said. “If you want to avoid controlled substances problems, PDMP is the way to go.”
4. Establish an audit response plan: Have an audit response plan ready to roll should an inquiry arise, experts advise. The policies ensure that only approved information is released to authorities, and that all staff members are on the same page about how to react to audits, Ms. Mazina said.
Plans should clearly state what information can be collected and what data should be kept confidential. Financial information, for example, should be off limits, she said. Government agents are entitled to inventory, dispensary data, and records of receipts.
“Agents very often do the mirror image of the database, and they get too much information,” she said. “You don’t want to [allow] that.”
Train staff members how to respond to government authorities seeking audit information, and explain they have the right to refuse being interviewed, Ms. Mazina said.
“Train your employees on what’s going to happen if the DEA comes in,” she said. “If I don’t have clear policies and procedures, and I’m not trained, I might disclose everything and blame someone. That puts everyone in a [bad] position, because [authorities] will record everything and use it against [the practice].”
5. Confer with the experts: It doesn’t hurt to consult with other medical professionals, such as emergency physicians or pain management specialists, for practical advice on inventory policies or software suggestions. But when it comes to staying updated on new drug laws and regulations, confer with a health law attorney or compliance officer, Ms. Mazina said. The DEAalso includes useful information about recent laws and rules pertaining to prescription drugs, as does the Centers for Disease Control and Prevention .
If an investigation or audit emerges, work with an attorney as early as possible. Often, practices wait until too late after an investigation begins to contact legal counsel, Ms. Mazina noted. The earlier an attorney gets involved, the sooner that person can build a strong case for the practice and work toward the best resolution.
“Very often, the physician thinks they are right, and there’s nothing for them to fear,” she said. “There is something for you to fear. There’s a lot at stake.”