Are you familiar with federal regulations for screening physicians, prescribers, and distributors against various sources from the U.S. Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA)? These agencies publish information on restricted healthcare organizations and/or providers who are currently under investigation or have been convicted of crimes or violations.
To protect patients and your organization, you should be referencing and including these sources at enrollment and in your ongoing screening. In this post, we’ll take a look at each source, and how to automate screening activities.
Drug Enforcement Administration (DEA) Registration
Physicians, pharmacists, treatment facilities, distributors, nurse practitioners, and other healthcare professionals who administer, prescribe, or dispense any controlled substance must register with the federal Drug Enforcement Administration (DEA).
Those applying for a DEA number must have a valid and active or pending license from a state medical or licensing board. Some states also require a controlled substance permit prior to practice, which must be obtained before DEA Number registration. To verify a DEA Number you’ll need to provide a few details on their website.
What are the Differences Between an NPI and DEA Number?
There are some common misconceptions when identifying the distinction between DEA Numbers and National Provider Identifiers (NPIs), and whether both are required for the Centers for Medicare and Medicaid Services (CMS) enrollment process. To learn more about CMS unique identifiers, visit their site and discover more context on the relationships between government databases and provider requirements for participation. Here is a quick reminder when it comes to NPIs and DEA Numbers:
- NPIs are issued by CMS through NPPES
- DEA Numbers are issued by the U.S. Drug Enforcement Administration
- Not all Providers with an NPI will have or qualify for a DEA Registration
Do Physicians Need a DEA Number in Addition to an NPI?
Yes, physicians must register for a DEA Number if they are prescribers of a controlled or potentially dangerous substance. National Provider Identifiers (NPIs) do not replace the function of a DEA Number.
Screening DEA Registration Databases and Cases Against Doctors
The U.S. Drug Enforcement Administration publishes multiple lists to lookup physician DEA Number registration and any administrative actions or cases against doctors. Downloads and search tools are available for validating records manually, but many organizations prefer outsourcing and automating these processes given a large number of searches necessary. The following lists should be included in your ongoing monitoring for DEA requirements:
- DEA Controlled Substances Act Registration Records (CSA)
- DEA Criminal Cases Against Doctors
- DEA Registrant Actions (Administrative Actions Against Registrant)
Where Can DEA Controlled Substances Act Registration Records (CSA) be Found?
DEA Controlled Substances Act Registration Information Databases can be downloaded from NTIS.gov at multiple frequencies if you are a subscriber.
Providers are categorized by Registrant type (first letter of DEA Number):
- A/B/F/G – Hospital/Clinic/Practitioner/Teaching Institution/Pharmacy
- M – Mid-Level Practitioner (NP/PA/OD/ET, etc)
- P/R – Manufacturer/Distributor/Researcher/Analytical Lab/Importer/Exporter/Reverse Distributor/Narcotic Treatment Program
DEANumber.com – The Official DEA Authorized Database
The National Technical Information Service (NTIS) in a joint venture with Global Internet Management has created a website to maintain and provide access to the DEA database. The products from the website contain the complete official Drug Enforcement Agency database of persons and organizations certified to handle controlled substances under the Controlled Substances Act.
The DEA authorizes the use of the database, and the inclusion of any individual or organization in the database, as proof of that entity’s registration with the DEA. The Joint Commission considers the DEANumber website as a source document for DEA number verification.
What is the List for DEA Criminal Cases Against Doctors?
The DEA Criminal Cases Against Doctors is a listing of investigations of physician registrants in which DEA was involved that resulted in the arrest and prosecution of the registrant. Cases against DEA physician registrants that result in arrests and prosecutions are added to the site since 2003.
DEA Registrant Actions
Administration Actions Against Registrants can be found publicly on the DEA’s website. Actions are recorded in the Federal Register and organized annually. Documents reflect the DEA’s order to show cause for registration suspensions and revocations and the final decisions and orders from an administrative law judge (ALJ) for the physician or organization’s registration status. The DEA may deny, suspend, or revoke a practitioner’s DEA registration for the following reasons:
- A falsified DEA registration application
- A state license has been suspended, revoked, or denied
- The individual or entity is excluded from participation in Medicare or Medicaid programs
- Convicted of a felony related to a controlled substance
- Committed an act that is inconsistent with the public interest
Food and Drug Administration (FDA) Debarment List
The FDA Debarment List consists of individuals who have been convicted of a felony related to the development and/or approval of a pharmaceutical product, or any drug product under the Food, Drug and Cosmetic Act (FDCA). Monitoring individuals and parties on this list ensure you are maintaining compliance with FDA standards and no potential or current employee or provider has any convictions against them.
Best Practices for Screening Prescribers and Pharmacies
Monitoring the various lists and databases from the DEA and FDA are critical in your compliance program and ongoing provider and prescriber screening. ProviderTrust solutions help save you time and resources when it comes to verifying that none of your staff or affiliates are present in these databases. To learn more, feel free to Contact Us directly!
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Written by Michael Rosen, Esq.
Michael brings over 20 years of experience founding and leading risk mitigation businesses, receiving numerous accolades such as Inc. Magazine’s Inc. 500 Award and Nashville Chamber of Commerce Small Business of the Year.