Bhambhani, M.D. v. Innovative Health Solutions, Inc.

CourtDistrict Court, D. Maryland
DecidedFebruary 11, 2020
Docket1:19-cv-00355
StatusUnknown

This text of Bhambhani, M.D. v. Innovative Health Solutions, Inc. (Bhambhani, M.D. v. Innovative Health Solutions, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Maryland primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Bhambhani, M.D. v. Innovative Health Solutions, Inc., (D. Md. 2020).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND

RITU BHAMBHANI, M.D., *

Plaintiff, *

v. * Civ. Action No. RDB-19-0355 INNOVATIVE HEALTH SOLUTIONS, * INC., et al. * Defendants. *

* * * * * * * * * * * * MEMORANDUM OPINION Plaintiff Dr. Ritu Bhambhani (“Plaintiff” or “Dr. Bhambhani”), on behalf of herself and others similarly situated, brings this putative class action lawsuit against Defendants Innovative Health Solutions, Inc. (“IHS”), Innovative Healthcare Solutions, LLC (“IHCS”), and Acclivity Medical, LLC (“Acclivity”), alleging fraudulent misrepresentation (Count I); intentional misrepresentation by concealment or nondisclosure (Count II); negligent misrepresentation (Count III); negligence (Count IV); civil conspiracy (Count V); and a request for a declaratory judgment under 28 U.S.C. § 2201(a) (Count VI). Pending before this Court is Defendant Innovative Health Solutions’ Motion to Dismiss (ECF No. 29). IHS challenges the sufficiency of each count in Plaintiff’s First Amended Complaint (ECF No. 23) and insists that any fraudulent conduct may be attributed solely to IHCS and Acclivity. For the following reasons, Defendant’s Motion to Dismiss (ECF No. 29) is GRANTED IN PART AND DENIED IN PART. Specifically, Counts III, IV, and VI are DISMISSED WITH PREJUDICE as to all Defendants. Counts I, II, and V remain pending. BACKGROUND When evaluating a motion to dismiss, this Court must “accept as true all well-pleaded facts in a complaint and construe them in the light most favorable to the plaintiff.” Wikimedia

Found. v. Nat’l Sec. Agency, 857 F.3d 193, 208 (4th Cir. 2017) (citing SD3, LLC v. Black & Decker (U.S.) Inc., 801 F.3d 412, 422 (4th Cir. 2015)). The facts outlined below reflect the substance of Plaintiff’s First Amended Complaint and will be accepted as true for the purpose of Defendant’s Motion to Dismiss. IHS is an Indiana-based corporation engaged in the distribution of medical devices in Maryland and throughout the continental United States. (ECF No. 23 ¶ 12). Since 2014, IHS

has developed, marketed, and distributed the Neuro-Stim System (“Neuro-Stim”), an acupuncture device designed to alleviate pain through field stimulation of the peripheral and cranial nerves. (Id. ¶ 2, Ex. 4). As alleged by the Plaintiff, IHS sold the Neuro-Stim through a series of “exclusive-rights” agreements with various “Sales Agents”—including IHCS and Acclivity. (Id. ¶ 3). Together, IHS and its Sales Agents conducted an extensive advertising campaign, promoting the Neuro-Stim in various online and printed media, in trade shows, and

in presentations to physicians. (Id. ¶¶ 3, 15). Lead Plaintiff Ritu Bhambhani, M.D., is a board-certified doctor based in Abingdon, Maryland. (Id. ¶ 11). She is a certified anesthesiologist and the managing member of both Complete Care of Maryland, her private practice, and Box Hill Surgery Center, LLC, an ambulatory surgery center. (Id.). On August 17, 2015, Robert A. Smith, the Vice President of Sales and Marketing for IHCS, sent Dr. Bhambhani an email claiming his company had

“exclusive rights” to the Neuro-Stim. (Id. ¶ 18, Ex. 3). Smith described the device as a market- first, FDA-approved “nerve stimulator,” and claimed that “extraordinary reimbursement” was available for the treatment.1 (Id.). He encouraged Dr. Bhambhani to participate in IHCS’s Full-Service Program, a payment pipeline that included support for billing and collections and

a ninety-day return policy. (Id. ¶ 18, 21). Included in this email was an educational video marked “the property of Innovative Health Solutions,” (Id.), and an IHCS Physician PowerPoint Slideshow (“the Slideshow”). (Id. ¶ 18, Ex. 2, Ex. 3). The Slideshow depicted the Neuro-Stim as FDA-approved for chronic and acute pain—and further claimed that the Neuro-Stim is fully reimbursable by health insurers, worker’s compensation, and personal injury insurance. (Id.).

In the coming months, Dr. Bhambhani and IHCS exchanged several emails discussing the Neuro-Stim. (Id. ¶¶ 26–30). On September 8, 2015, the Director of Operations at IHCS sent Dr. Bhambhani an email with forms for billing, certification, and reporting for the Neuro- Stim. (Id. ¶ 26, Ex. 4). On September 9, the Vice President of Sales and Marketing for IHCS sent two more emails: one providing two short training videos produced by IHS, and another disclosing ongoing studies on the Neuro-Stim. (Id. ¶ 27, Ex. 5). The latter was copied to Brian

Carrico, “one of the owners and pioneers of this technology” and the Vice President for Sales for IHS. (Id.). Allegedly impressed with this technology and with IHCS’s promise of

1 The Neuro-Stim was promoted using Current Procedural Terminology (“CPT”), a set of billing codes maintained by the American Medical Associations in accordance with the Health Insurance Portability and Accountability Act of 1996. (Id. ¶ 4). These codes are relied on by medical professionals to track services provided and determine reimbursement. (Id.). IHS promoted the Neuro-Stim as billable under CPT code 64555, Percutaneous Implantation of Neurostimulator Electrodes at a Peripheral Nerve. (Id. ¶ 5). According to Dr. Bhambhani, this code provided for an amount between $4,800 and $11,400 per patient in reimbursements, with few associated costs. (Id.). This “reimbursement-driven marketing,” subsequently reaffirmed by IHCS in various emails throughout late 2015, was a significant factor in the Defendants’ marketing campaigns. (Id.). reimbursement, Dr. Bhambhani decided to enroll in the Full-Service Program. Between September 2015 and June 2016, she purchased 420 Neuro-Stim devices through Acclivity for a total of $264,000.00. (Id. ¶¶ 28–33).

Issues began to emerge in August 2016, when Notivas—Dr. Bhambhani’s Medicare Administrative Contractor—released an opinion identifying Neuro-Stim as an acupuncture device and declaring that it would not be covered by Medicare. (Id. ¶ 37). On October 8, 2016, Novitas initiated audits of Dr. Bhambhani’s practices based on her attempts to obtain reimbursements for the device. (Id. ¶¶ 34, 38). As alleged by Dr. Bhambhani, she responded to these developments by attempting to return her remaining supply directly to IHS. (Id. ¶¶

35–36). In an email on September 1, 2016, Brian Carrico rejected her return attempts, asserting that “IHS has not and does not get involved in billing and coding in any way,” and recommending assorted alternatives. (Id. ¶ 36, Ex. 8). Subsequently, Medicare filed over $1,000,000 in refund demands against Dr. Bhambhani’s practices for prior reimbursements. (Id. ¶ 38). She has appealed to the Office of Administrative Law.2 (Id.). Representing a class of similarly situated healthcare providers, Dr. Bhambhani asserts

that the Defendants knew or should have known that the Neuro-Stim could not be reimbursed with the code sequence they provided. Before marketing the Neuro-Stim, IHS was the FDA- registered primary distributor of the “P-STIM,” an electro-acupuncture device produced by Austrian company Biegler GmbH and marketed throughout the United States. (Id. ¶¶ 15–16). The P-STIM, substantially equivalent in design to the Neuro-Stim, was deemed ineligible for

2 Neither party clarifies what the “Office of Administrative Law” is. Appeals of decisions issued by the Centers for Medicare and Medicaid Services are heard by the Office of Medicare Hearings and Appeals. The identity of the specific administrative body to which Plaintiff has appealed is not dispositive in this case. Medicare reimbursement in 2011. (Id. ¶¶ 16, 23, 31). Based on the substantial similarities in these devices, Dr. Bhambhani asserts that IHS knew or should have known that the Neuro- Stim would be ineligible for reimbursement under the same codes. (Id. ¶¶ 5–7).

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