Little Health Law Blog

Our healthcare and business law firm consistently works with physicians who are dealing with complications resulting from adverse reporting to the National Practitioner Data Bank (“NPDB”).  Certain entities, including medical licensure boards, facilities with a peer review process, and medical malpractice payers, have a duty to report specific actions or events to the NPDB. Any practitioner who has had the misfortune of having an action reported to the NPDB is likely aware of the negative impact such a report can have on his or her ability to practice.  Sometimes, however, the information reported to the NPDB is inaccurate in whole or in part or, even if accurate, inappropriately reported.  Inaccurate or inappropriate reports can have equally serious adverse impacts on a medical provider’s ability to practice as any correctly submitted NPDB report.  This post outlines the process for disputing a report that is inaccurate or inappropriately report. If you have a question about the NPDB or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

STEP 1: Dispute the Report with the Reporting Entity

The NPDB directs providers to contact the reporting organization before initiating a formal dispute with the NPDB.  Doing this is as simple as it sounds: contact the reporting entity, explain why the report is inaccurate or not reported in accordance with NPDB requirements, and request they correct or void the report.  If the report is accurate, yet a new action should have also been reported, you can also request that the reporting entity file a Revision-to-Action Report.  Although reporting entities have a duty to correctly report to the NPDB, entities can be sanctioned for not reporting.  As such, entities have an incentive to report if there is any question as to whether reporting is required.  Motivating an entity to modify a report to make it more factually accurate is a much easier feat than motivating an entity to void a report.  In our experience, entities have little incentive to void a report; they would rather the provider dispute the report to HHS and have HHS direct them to void the report. Continue reading ›

Our healthcare and business law firm works with many providers and other allied health professionals who are beginning their journeys of opening a Medical Spa.  Medical Spas have been growing in popularity across the country.  They are unique practices in that they involve many medical and non-medical procedures.  There are many factors to consider in opening a medical spa and/or IV hydration clinic, and this medical spa series focuses on key factors to consider when opening a medical spa in Georgia.  Although our healthcare law firm has assisted numerous clients in establishing a medical spa from the ground up, each client continues to present unique issues requiring our firm to research and analyze the nuances of each client’s intended setup.  This Georgia Medical Spa Series is intended to provide spas.

This post in the Georgia Medical Spa Series focuses on a newer treatment, nicotinamide adenine dinucleotide (“NAD+”), which is a newer treatment our clients have inquired about.  If you have questions regarding this blog post or would like to speak with counsel regarding opening your medical spa practice, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

1. NAD+ is a dietary supplement.

NAD+ is currently a dietary supplement (not an “approved drug” by the Food and Drug Administration (“FDA”)).  “The FDA generally does not approve dietary supplement claims or other labeling before use.”  Questions and Answers on Dietary Supplements, FDA.gov.  As such, it is on the manufacturer and distributor to “ensur[e] that the dietary supplements it manufactures or distributes are not adultered, misbranded, or otherwise in violation of federal law.”  Id.

2. NAD+ does not require a prescription in Georgia.

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As a healthcare and business law firm, many of our clients come to us with questions relating to the proper ordering and management of controlled substances.  As such, we wanted to take this opportunity to point out a recent update to the DEA’s Practitioner’s Manual.

The Drug Enforcement Administration (DEA) recently released an updated Practitioner’s Manual on June 14, 2023.  This is the first updated version of the manual since 2006. The Practitioner’s Manual provides guidance for all DEA registrants handling controlled substances—including behavioral health centers and physicians—on compliance with the Controlled Substance Act (CSA) and DEA regulations. The Practitioner’s Manual can be found here.

Some of the most significant updates include the following:

Registration Requirements

Generally, every practitioner who dispenses, which includes by definition administering and prescribing, controlled substances in schedules II through V, must be registered with DEA.  To register or reregister as a practitioner, a DEA Form 224 or Form 224a, respectively, must be completed.  The manual includes clarifying information about how practitioners can order, use, fill out, copy, store, cancel, and return the DEA Form 222 used to order, distribute and transfer Schedule I and II controlled substances. The manual also incorporates the optional Controlled Substance Ordering System (CSOS) as a viable alternative to the paper Form 222. Continue reading ›