Neotonus, Inc. v. AMERICAN MEDICAL ASS'N

554 F. Supp. 2d 1368, 2007 U.S. Dist. LEXIS 56656, 2007 WL 2258723
CourtDistrict Court, N.D. Georgia
DecidedAugust 3, 2007
DocketCivil No. 1:04-CV-2050-TTC
StatusPublished
Cited by3 cases

This text of 554 F. Supp. 2d 1368 (Neotonus, Inc. v. AMERICAN MEDICAL ASS'N) is published on Counsel Stack Legal Research, covering District Court, N.D. Georgia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Neotonus, Inc. v. AMERICAN MEDICAL ASS'N, 554 F. Supp. 2d 1368, 2007 U.S. Dist. LEXIS 56656, 2007 WL 2258723 (N.D. Ga. 2007).

Opinion

ORDER

JACK T. CAMP, District Judge.

This matter is currently before the Court on Defendant American Medical Association and Defendant American Urological Association’s motions for summary judgment [# 232, # 233].

I. Factual Background

A. The parties

Plaintiff Neotonus, Inc. is a privately-held, for-profit corporation based in Marietta, Georgia. Neotonus is in the business of developing technologies for the treatment and management of neuromus-cular disorders, including the treatment of female urinary incontinence.

*1370 ■ Defendant American Medical Association (“the AMA”), a non-profit corporation based in Chicago, Illinois, is the largest professional association of physicians and medical students in the United States, with approximately 240,000 members. The AMA’s physician members practice in all medical specialties and include, among others, urologists, gynecologists, internists, and family practitioners.

Defendant American Urological Association (“the AUA”), a non-profit corporation based in Linthicum, Maryland, is a professional association of physicians practicing urology. The AUA’s mission is to foster the highest standards of urological care by providing a wide range of services to its member urologists, including publications, research, annual meetings, continuing medical education, and the formulation of health policy.

B. Neotonus’s ExMI technology

In 1998, Neotonus began marketing a medical device referred to as “NeoCon-trol.” NeoControl is a chair intended to treat female urinary incontinence, and works using extracorporeal magnetic innervation therapy (“ExMI therapy”). Simply put, ExMI therapy utilizes a pulsed magnetic field to cause the patient’s pelvic floor muscles to intermittently contract and relax. The theory behind ExMI is that the contraction/relaxation of the pelvic floor muscles will build strength, endurance, neuromuscular control, and increased circulation in those muscles, thus improving control and continence. The NeoControl device is operated with a pre-programmed smart card that contains a physician’s prescription for the parameters of treatment, such as the frequency, duration, and number of treatments.

C. CPT and the Editorial Panel

Since 1966, the AMA has annually published a work of clinical nomenclature entitled “Current Procedural Terminology” (“CPT”). The purpose of the CPT is to provide a uniform terminology that accurately describes specific medical, surgical, and diagnostic services and procedures to facilitate efficient health care record keeping, information sharing, and efficient processing of claims for payment for services or procedures provided to patients. CPT has been adopted by both public and private health insurance programs (generally, “payors”) as the method by which physicians report the services and procedures they provide. CPT is not a reimbursement system, however, and does not constrain a payor’s decision to cover or not to cover a particular procedure. Each payor makes its own decisions regarding which services and procedures it will pay for and how much it will pay for each.

There are several different types of CPT codes. Relevant to this case are the Category I code and the Category III code. Category I codes are used to describe a service or procedure that is consistent with contemporary medical practice and performed by many physicians in clinical practice in multiple locations. There are several requirements for a Category I code: (1) the service or procedure has received the necessary clearance or approval from the Food and Drug Administration; (2) the suggested service or procedure is a distinct service performed by many physicians across the United States; (3) the clinical efficacy of the service or procedure is well-established and documented in U.S. peer-reviewed literature; (4) the suggested service or procedure is neither a fragmentation of an existing code or procedure, or currently reportable by one or more existing codes; and (5) the suggested service or procedure is not requested as a means to report extraordinary circumstances related to the performance of a service or procedure already having a specific CPT code.

*1371 Category III codes, on the other hand, are used to describe new and emerging technologies. These codes enable physicians, payors, and health services researchers to evaluate such technologies for clinical efficacy, utilization, and outcomes. Prior to the creation of Category III codes in 2000, services and procedures that did not qualify for a Category I code were identified by physicians using a generic Category I code for “unlisted” procedures.

The CPT Editorial Panel (“Editorial Panel” or “Panel”) is a group of experts convened by the AMA that meets regularly to update the CPT code set by creating, deleting, and modifying codes and related descriptors. Editorial Panel members are not employees of the AMA.; they are physicians and other health care professionals who serve on a voluntary basis. Editorial Panel members are nominated by various organizations — primarily, national medical societies and payors — but are subject to the approval of the AMLA Board of Trustees. During the relevant time period, the Editorial Panel had 17 members, none of whom was a member of the AUA.

The Editorial Panel is supported by a larger body of advisors, referred to as the CPT Advisory Committee, which is made up of more than 100 volunteer physicians and health care professionals from a broad range of medical specialties. CPT advis-ors serve the Editorial Panel by, for example, advising the panel members on procedure coding and appropriate nomenclature for a service or procedure. The advisors also provide documentation to the Editorial Panel regarding the medical appropriateness of various procedures and services under consideration for inclusion in the CPT. CPT advisors do not sit on the Editorial Panel, however, and therefore do not vote on applications to create, delete, or modify CPT codes.

D. CPT code application process

In order to request a CPT code for a new procedure or service, the applicant is required to submit an application along with certain specified information, for example, a bibliography or copies of U.S. peer-reviewed literature supporting the request. When the Editorial' Panel staff receives an application for addition, deletion, or modification of a CPT code, it reviews the application to determine whether the Editorial Panel has previously considered the request. If the change requested in the application has been previously considered, the applicant is informed of the Editorial Panel’s previous action. If an application raises a new issue, or presents significant new information regarding a previously-addressed coding issue, however, the application is disseminated for comment to those CPT advisors who are likely to be familiar with the service or procedure, at issue.

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Related

United States v. Marder
208 F. Supp. 3d 1296 (S.D. Florida, 2016)
Neotonus, Inc. v. American Medical Ass'n
270 F. App'x 813 (Eleventh Circuit, 2008)

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Bluebook (online)
554 F. Supp. 2d 1368, 2007 U.S. Dist. LEXIS 56656, 2007 WL 2258723, Counsel Stack Legal Research, https://law.counselstack.com/opinion/neotonus-inc-v-american-medical-assn-gand-2007.