Neurotron Inc v. Medical Serv Assoc

CourtCourt of Appeals for the Third Circuit
DecidedJune 19, 2001
Docket00-1516
StatusUnknown

This text of Neurotron Inc v. Medical Serv Assoc (Neurotron Inc v. Medical Serv Assoc) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Neurotron Inc v. Medical Serv Assoc, (3d Cir. 2001).

Opinion

Opinions of the United 2001 Decisions States Court of Appeals for the Third Circuit

6-19-2001

Neurotron Inc v. Medical Serv Assoc Precedential or Non-Precedential:

Docket 00-1516

Follow this and additional works at: http://digitalcommons.law.villanova.edu/thirdcircuit_2001

Recommended Citation "Neurotron Inc v. Medical Serv Assoc" (2001). 2001 Decisions. Paper 132. http://digitalcommons.law.villanova.edu/thirdcircuit_2001/132

This decision is brought to you for free and open access by the Opinions of the United States Court of Appeals for the Third Circuit at Villanova University School of Law Digital Repository. It has been accepted for inclusion in 2001 Decisions by an authorized administrator of Villanova University School of Law Digital Repository. For more information, please contact Benjamin.Carlson@law.villanova.edu. Filed June 19, 2001

UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

NO. 00-1516

NEUROTRON INC., Appellant

v.

MEDICAL SERVICE ASSOCIATION OF PENNSYL VANIA, INC., t/a Pennsylvania Blue Shield; HIGHMARK, INC.

On Appeal From the United States District Court For the Middle District of Pennsylvania (D.C. Civil Action No. 98-cv-00157) District Judge: Honorable Yvette Kane

Argued December 14, 2000

BEFORE: NYGAARD and STAPLETON, Circuit Judges, and DEBEVOISE,* District Judge

(Opinion Filed: June 19, 2001)

_________________________________________________________________ * Honorable Dickinson R. Debevoise, United States District Judge for the District of New Jersey, sitting by designation. Andrew W. Barbin Gleason & Barbin 123 State Street Harrisburg, PA 17101 and Charles I. Artz (Argued) Charles Artz and Associates 207 State Street Harrisburg, PA 17101 Attorneys for Appellant

Thomas E. Wood (Argued) Keefer, Wood, Allen & Rahal 210 Walnut Street P.O. Box 11963 Harrisburg, PA 17108 Attorney for Appellees

OPINION OF THE COURT

STAPLETON, Circuit Judge:

Neurotron, Inc. ("Neurotron") is a Maryland corporation which manufactures an electrodiagnostic medical testing device known as the Neurometer CPT ("Neur ometer"). Highmark, Inc. ("Highmark")1 is a Pennsylvania corporation engaged in the operation of nonprofit health care plans. Neurotron alleges that a passage in Highmark's newsletter, Policy Review and News ("PRN"), commer cially disparaged the Neurometer. Highmark successfully moved for summary judgment. Neurotron appeals. We will affirm. _________________________________________________________________

1. At the time of the disputed events, Medical Services Association of Pennsylvania operated under the trade name "Pennsylvania Blue Shield." "Highmark, Inc." is the Pennsylvania corporation formed in 1996 by the consolidation of the former Pennsylvania Blue Shield and Blue Cross of Western Pennsylvania. The parties have stipulated that Highmark is the successor-in-interest to all of its pr edecessor corporations' rights and obligations.

2 I.

The Neurometer tests a patient's ability to per ceive small electrical currents through a procedure known as "current perception threshold" testing ("CPT"). CPT involves connecting electrodes to the surface of the patient's skin and then delivering a series of low-voltage electrical shocks and recording whether the shocks wer e perceived. Through a series of shocks at decreasing voltages, the Neurometer establishes the lowest level of current that the patient is able to feel. It then compares these readings to a database of "normal" readings and delivers a printout that states whether the patient's sensory perception of electrical current is either elevated ("hyperesthesia"), normal, or depressed ("hypoesthesia"). Hyper esthesia and hypoesthesia can be symptoms of numerous medical problems. Neurotron contends that the Neurometer is a useful diagnostic tool because it can detect these symptoms at a very early stage.

Highmark provides nonprofit health insurance programs which cover the medical expenses of Highmark members. Among the services that Highmark excludes fr om payment are services that are experimental or investigational. Its agreement with its members and health car e providers stipulates that Highmark "does not cover services which it determines are Experimental or Investigative in nature because those services are not accepted by the broad medical community as effective treatments." App. III at 298a. That agreement defines "Experimental or Investigative" as follows:

the use of any . . . procedure . . . which[Highmark], relying on the advice of the general medical community which includes but is not limited to medical consultants, medical journals and/or gover nmental regulations, does not accept as standar d medical treatment of the condition being treated, or any such items requiring federal or other governmental agency approval for which approval has not been granted at the time the services were rendered.

App. III at 300a.

3 Highmark's Medical Policy Department ("MPD") r eviews developments in health care practice and pr ocedure and makes determinations as to when a new pr oduct or procedure has advanced beyond the experimental or investigational stage and becomes an accepted part of standard medical practice. Highmark's Benefits Utilization Management Department ("BUMD") conducts post-payment audits of health care providers to assur e that their billings to Highmark have been in accordance with the applicable policies and regulations, that services ar e reported and paid accurately, and that unnecessary services ar e not being prescribed.

In October of 1990, Ralph Cohen, Neurotr on's President, wrote to Highmark requesting that the Neur ometer be reviewed and evaluated for coverage. Highmark r eferred the request to the MPD which, pursuant to Highmark's policy, initiated a "consultant review." Thr ee independent neurologists, Drs. Brennan, Jeffries, and Lossing, evaluated the Neurometer and CPT. Based upon the consultant review, Highmark concluded that CPT was investigational in nature and was, therefore, an uncovered service.

In October of 1991, Dr. Jefferson Katims, Neurotron's Director of Research, wrote to Highmark to request again that the Neurometer be reviewed and evaluated for coverage. Dr. Joseph Ricci, Highmark's V ice President for Medical Affairs, responded in November of 1991 that Highmark's opinion remained unchanged and that, consequently, CPT would remain noncover ed.

In 1994, Dr. Katims again wrote to Dr . Ricci to request reevaluation of CPT. Dr. Ricci r eferred the request to the MPD for review by Douglas Worley. W orley solicited advice from Drs. Lossing, Samuels, and Silverman. Based upon the advice of these independent consultants, Highmark concluded that CPT continued to be investigational. Highmark added CPT to Medical Policy Bulletin Z-24 which listed numerous products and procedur es which were not covered because they had been determined to be investigational.

In 1996, Emelie Sconing, Manager of the BUMD, conducted a claims review of certain chir opractors who

4 appeared to be inappropriately billing noncovered CPT as covered nerve conduction velocity tests. She sent the claims files of the providers under investigation to consultants for review. The consultants, Drs. Tar ola and Samuels, concluded that the providers under investigation had actually performed CPT and not nerve conduction velocity tests. Dr. Tarola opined that"CPT is a nonspecific electrodiagnostic procedure that lacks proof of validity and reliability, and has limited clinical utility." App. III at 223a.

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