What is the DEA?
The DEA is an arm of the U.S. Department of Justice. The DEA has the legal authority to make unannounced inspections of physician’s offices, controlled substance storage locations, laboratories, pharmacies and any location that is licensed to store or dispense controlled substances. Never forget that the DEA is a law enforcement agency with special powers. These powers include the right ability to assess civil and criminal penalties. These penalties can be a simple letter of admonition but even a letter of admonition will trigger a medical board inquiry.
What is a DEA Audit?
As the DEA regulates the prescription, storage and distribution of controlled substances an audit is a law enforcement search of premises and records for compliance with the rules and regulations. In other words, this is not just an audit. It is an audit that can be part or or grow into a criminal investigation.
The audits are often routine. In and out comparisons and record review can be both cursory and while unexpected, uneventful. However, DEA audits can be daunting if your practice is not set up for accurate tracking of distribution and prescription writing. A 2011 case is typical of an honest medical practitioner and pharmacy being fined after a DEA audit.
DEA Audit (Example)
In the case of Dr. H Aaron Blaser a dentist in Ketchum, Idaho, the DEA found a shortage of approximately 72,100 milligrams of Demerol. An audit of a nearby pharmacy revealed an inability to account for a quantity of opiates. No criminal wrongdoing was alleged but a $ 35,000 civil fine was imposed. In most states this fine would also result in a medical board investigation. Violations of this type would result in more serious sanctions in today’s opioid panic environment. While the Blaser case was a tracking issue, we have seen a significant uptick in DEA citations for storage issues. Again, fines can be imposed even without any deliberate wrongdoing. Even 12 years after the event, the DEA press release still “tags” Dr. Blaser with this citation. [If you are the subject of a criminal DEA investigation, click for our criminal defense website. For Healthcare fraud matters click for our healthcare fraud website.]
Preparing for a DEA Audit
A hostile DEA inspection will be designed to catch you off guard. If the DEA inspects late in the day or at holiday time, this is a red flag that they are looking at potentially serious violations. But regardless of whether the inspection is hostile (suggesting suspicion of criminal conduct) or truly civil or administrative, certain standards will apply.
[Note that in larger practices or practices that are at high risk, we recommend trainings to prepare for a DEA sudden audit. We make certain that staff is aware of the applicable federal and state, regulations, storage regulations and audit compliance procedures. In particular, audit related records (in/out) records in particular should be readily available and internally consistent.]
What are the DEA Rules?
You need to access accurate summaries of the DEA rules or better yet, review the rules themselves. The DEA storage Rules are found at 21 CFR 1301.71. Have you ever scanned (or even read in detail !) The rules are right there in Chapter 2 of the CFR’s (21 CFR Chapter 2) Take the time to read them and our pre-audit investigation can assist you in making sure you are compliant.
The office should have a discreet location for the inspection record review to take place and do not be shocked when the licensee/registrant of the facility is required to sign a DEA 82 form which is voluntary consent to the search/audit. Likewise do not fumble for keys or codes to access storage locations for controlled substances.
You should expect to produce
- Current usage logs
- Disposal records• Access to controlled substance storage cabinet or safe
- Purchasing records which will include invoices, packing slips, DEA Form 222 records.
Each scheduled substance should have a separate folder.
- Waste or breakage-spillage reports (DEA Form 41)
- Theft/significant loss reports (DEA Form 106)
We recommend recording the audit although this may be seen as a hostile act by some DEA investigators. In the balance however, it is useful if the audit is overly aggressive or has significant negative findings which you intend to contest.
If the audit is routine the DEA may verbally or in writing provide suggestions for improvement. This is usually done in good faith and is not an investigative tactic. Be careful however in asking questions as the question itself may open a new area of investigation.
DEA Rules Can Get Complicated
Many violations are the fault of such complex rules that the average medical practitioner or pharmacist can inadvertently step outside of the vague and often discretionary rules. The following is from a 2022 federal case where (in a footnote) the federal court summarized some of the DEA rules. It is akin to studying quantum physics. The basic rules are outlined. That part is easy – but specifically what are the rules? What are the standards? The rules describe WHAT but not HOW and not WHY.
As DEA registrants in the closed-delivery system established by the CSA and its implementing regulations for the flow of controlled substances through the pharmaceutical supply chain, see 21 U.S.C. §§ 801 et seq.; 21 C.F.R. §§ 1301 et seq., participants in each of these sectors bear significant and independent responsibilities to ensure the safety and integrity of the supply of prescription opioids to the public, including the essential duty to provide effective controls and procedures to guard against diversion of these controlled substances. See CT1 MSJ Order re CSA Duties at 14–19 (docket no. 2483) (In re Opiate, 2019 WL 3917575, at *7-9 (N.D. Ohio Aug. 19, 2019)) (the CSA and its implementing regulations require manufacturers and distributors to: design and operate a system to identify suspicious orders of controlled substances, inform the DEA of suspicious orders when discovered, and not ship such orders unless due diligence reasonably dispels the suspicion); Order Denying MTD at 15 (docket no. 3403), In re Opiate, 477 F. Supp.3d 613, 624-25 (N.D. Ohio 2020) (21 C.F.R. § 1301.71(a) requires all DEA registrants, including manufacturers, distributors, and pharmacies, to provide effective controls and procedures to guard against diversion of controlled substances); Daubert Order re Rafalski at 3–5 (docket no. 3929), In re Opiate, 2021 WL 4060359, at *2-3 (N.D. Ohio Sept. 7, 2021) (citing Rafalski CT3 Rpt. at 8–9).
In re National Prescription Opiate Litigation (N.D. Ohio, Aug. 17, 2022, No. 18-OP-45032) 2022 WL 3443614, at *29, judgment entered (N.D. Ohio, Aug. 22, 2022, No. 1:17-MD-2804) 2022 WL 4099669
The courts are completely aware of the ambiguity. Another federal lcourt in City of Huntington v. AmerisourceBergen Drug Corporation (S.D.W. Va., July 4, 2022, No. CV 3:17-01362) 2022 WL 2399876, at *11 outlined the subjectivity of the rules:
Substantial compliance with the relevant security requirements may be deemed sufficient by the DEA. 21 C.F.R. § 1301.71(b). “A registrant’s regulatory obligations under the CSA, … and [its] implementing regulations do not require strict compliance. Only substantial compliance is required.” In re Nat’l Prescription Opiate Litig., No. 1:17-MD-2804, 2021 WL 3917174, at *3 (N.D. Ohio Sept. 1, 2021). “A determination of substantial compliance … is a fact-intensive inquiry … and whether a defendant has substantially complied with the CSA is a question of fact.” Id.; see also In re Nat’l Prescription Opiate Litig., No. 1:17-MD-2804, ––– F.Supp.3d ––––, ––––, 2022 WL 671219, at *6 (N.D. Ohio Mar. 7, 2022) (“[T]he ultimate determination of whether a defendants’ compliance was substantial, or whether it falls somewhere short of that mark, is best left to a jury.”).
City of Huntington v. AmerisourceBergen Drug Corporation (S.D.W. Va., July 4, 2022, No. CV 3:17-01362) 2022 WL 2399876, at *11
Our office has serious constitutional concerns regarding these vague rules. We believe that these vague rules violate the constitution. We look at the decision of the U.S. Supreme Court in Connally v. General Construction Co. (1926). In Connally the court held that a law is unconstitutionally vague when people “of common intelligence must necessarily guess at its meaning.” Whether or not the law regulates free speech, if it is unduly vague it raises serious problems under the due process guarantee, which is applicable to the federal government by virtue of the Fifth Amendment and to state governments through the Fourteenth Amendment.
In Kolender v. Lawson (1983), the Supreme Court explained that “the void-for-vagueness doctrine requires that a penal statute define the criminal offense with sufficient definiteness that ordinary people can understand what conduct is prohibited and in a manner that does not encourage arbitrary and discriminatory treatment.”
This void for vagueness defense works with many aspects of medical regulation because the rules are often political and sometimes not clearly expressed. We have used this defense in medical board cases and criminal cases as well.
Electronic Prescriptions – Be Careful
DEA audits, rule violations and controlled substance prescription abuse are a constant threat to practices that rely significantly on controlled substances for proper patient care. Changing opioid prescription rules, underground regulations and political pressures can lead to a DEA audit or medical board investigation. It is important to ensure that your electronic practices are consistent with current rules.
Telemedicine or electronic prescriptions are addressed by DEA regulations which specify the conditions under which controlled substance prescriptions may be issued electronically.Before any electronic prescription or pharmacy application may be used to transmit prescriptions, a third party must audit the application for compliance with the requirements of 21 CFR part 1311. Alternatively a certifying organization whose certification process has been approved by DEA must verify and certify that the application meets the requirements of 21 CFR part 1311.