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DEA Rule Lets EPs Skip Costly Fee

Newdow, Michael MD, JD

Emergency Medicine News 44(9):p 3, September 2022. | DOI: 10.1097/01.EEM.0000874660.38159.cd
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    Code of Federal Regulations, controlled substances, DEA, medical law

    The Drug Enforcement Agency ensures compliance with controlled substances laws and regulations, one of which requires physicians to pay a hefty fee, $888, for a registration certificate to cover each location where they dispense controlled substances.

    The law considers prescribing a part of dispensing, and the certificate is valid for only three years. Surprisingly, and it seems few are aware of this, A federal law exempts emergency physicians (and other licensed professionals who dispense only in a hospital) from paying this fee.

    The exemption is found in the Code of Federal Regulations, the body of rules created by federal agencies. These are not strictly statutes, but they essentially have the same effect. Section 1301.22(c) of title 21 contains the prose that can save those of us working exclusively in hospitals from ever having to pay the fee. It basically says an individual practitioner who is an agent or employee of a hospital or another institution may, in the normal course of employment, administer, dispense, or prescribe controlled substances under the registration of the hospital in lieu of being registered himself.

    It has a few provisos, including that the prescribing is done as part of professional practice, that the physician is authorized to do so by his practice jurisdiction, and that the hospital has verified each physician is permitted to prescribe. Hospitals are also required to designate a code number for each practitioner that includes the institution's DEA registration number.

    The requirements are rather minimal. The hospital and its pharmacy merely have to keep a list of practitioners working in the ED. The other obligations are done anyway when a hospital credentials a physician.

    But this exemption is virtually never used, probably because few physicians know about it and bureaucracies often resist change. But it has essentially no downsides and an $888 upside, and it should be the new standard of DEA registration for emergency physicians and other hospital-based professionals.

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    Dr. Newdowis an emergency physician who has worked locum tenens for most of his 42-year career. He is also the medical director and chief of staff at the Jerold Phelps Community Hospital in Garberville, CA.

    Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
    • Michael Newdow, MD, JD8:01:11 AMI tried to contact Mr. Crouch, but he is on an extended leave. I am highly doubtful that he contended (or that anyone else in the DEA would contend) that “very few emergency physicians will qualify for this $888 exemption.” The code is clear: Any physician who prescribes controlled substances in a hospital setting (which I think describes the overwhelming majority of EPs) may do so using that hospital’s DEA registration. As for only prescribing within the confines of the hospital, I can only say that you and I must come from different worlds. I can’t recall the last time (if ever) that I prescribed a controlled substance outside of my role as a hospital-based physician. Assuming that you are, like I am, using an n of 1, I guess we will need to see some decent data to determine if that has any basis in fact. If you have those data, I would love to see them. Similarly, I would expect that the vast majority of EPs who moonlight do so in other EDs, where the $888 registration fee can still be avoided by simply having a numerical suffix assigned under the other hospitals’ registrations. Despite my skepticism regarding the accuracy of your first sentence, the question still remains about whether hospital administrators and the other powers-that-be will agree to allow their EPs to take advantage of this law. As my article concluded, “But this exemption is virtually never used, probably because few physicians know about it and bureaucracies often resist change. But it has essentially no downsides and an $888 upside, and it should be the new standard of DEA registration for emergency physicians and other hospital-based professionals.”
    • Michael Newdow, MD, JD1:51:49 PMI’m unaware of any reason why physicians employed by the federal government would not be able to take advantage of 21 CFR § 1301.22(c). There certainly is nothing in that provision’s text that makes a distinction between federal and other practitioners.
    • Michael Newdow, MD, JD1:51:38 PMYou wrote, “That I would purchase a separate number for $888 (plus credit card fee) for each different practice location makes no financial sense.” Whether it makes financial sense or not, it’s the law. 21 CFR § 1301.12(a) states that, “A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person.” That said, there is a caveat that may allow you to get by with only one registration: 21 CFR § 1301.12(b)(3) notes that an additional registration is not required for “An office used by a practitioner (who is registered at another location in the same State in which he or she practices) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.” However, if there are controlled substances kept at that additional office, this provision would not apply, and you would need another DEA registration. Note also that even if you work in a facility where you only write prescriptions and no controlled substances are present, you would still need an additional DEA registration if the additional office is not in the same state as the office for which your current DEA registration is being used. As for the registration fee being “extortion,” I’m not certain why that’s different from any of the other fees and taxes that our legislators—elected by “the people”—have implemented. Moreover, as the original article makes clear, you don’t have to pay anything if you are prescribing only during your regular work in an ED. Either way, I submit that knowingly violating the law probably makes the least financial sense of all.
    • Michael Newdow, MD, JD1:51:15 PMI’m not certain what is behind your statement that “The fee is now more than $888.” The fee is provided in 21 CFR § 1301.13(e)(1). It is $888 for a three-year registration.
    • John C. Gill, MD11:48:05 AMI called the DEA and spoke with their representative Kenneth Crouch, and it turns out that very few emergency physicians will qualify for this $888 exemption. To qualify, you must be using your hospital pharmacy's DEA number. That means no moonlighting and no prescribing controlled substances outside of the hospital, even Lomotil. Very few of us use our DEA license only within the confines of the hospital setting. This exemption sounds wonderful, but it doesn't help the vast majority of EPs. Too bad. Thanks for listening. ​<br>
    • lbandrew10:51:15 AMI practiced for more 35 years not knowing about this provision except as a resident, when we all used the hospital DEA number. I can certainly see that a locums doc or someone working multiple clinical sites could benefit from this information. The fee is now more than $888, and it was knowing that my DEA fee was funding raids on fellow (office-based) physicians, sometimes based on little or no evidence of misdoing, that prompted me to quit the system. If you are quite sure of this provision&#160;and perhaps have a legal opinion or hospital-vetted policy that confirms its workability, it would seem to me that some very intensive education of hospital and ED administrators is in order. In addition, NOT having DEA registration would help to stem the oft-quoted misstatement that EPs are among the physicians with the highest rates of SUD, which was based on some research dating back to the '80s (when most EPs were recycled into the field, having failed in other specialties sometimes due to SUD). Thanks for bringing this to the attention of EPs.
    • jaysigel10:20:11 AMA DEA number is required by pharmacies and hospitals (in addition to the NPI) as validation. Not getting one is not an option. Every application form for privileges requires it. I've worked in many small EDs, hospitals, and clinics in several states, and I only had one DEA number ever. I never obtained a separate number for each practice location. It was the same number I used when I was in private practice. That I would purchase a separate number for $888 (plus credit card fee) for each different practice location makes no financial sense. I consider having to pay that amount for a silly piece of paper extortion. Keeping them all straight and renewing them would be a silly and costly challenge. The government only needs to know who prescribed the controlled substance. From which location it was prescribed, the government would have a bit more difficulty finding out unless they were specifically investigating me. If the DEA planned to enforce that, it would create major complaints and staffing hardships, and I would predict that the regulation would be quickly changed or not enforced. In the meantime, I plan on keep using my single DEA number.
    • drmsr12:35:51 PMInteresting and probably of use to many emergency&#160;physicians. However, physicians who work for the federal government generally need to maintain a DEA registration, such as the National Disaster Medical System. Same probably for those with the X waiver?