GENOMIND, INC. v. UNITEDHEALTH GROUP INC.

CourtDistrict Court, E.D. Pennsylvania
DecidedSeptember 1, 2021
Docket2:21-cv-00373
StatusUnknown

This text of GENOMIND, INC. v. UNITEDHEALTH GROUP INC. (GENOMIND, INC. v. UNITEDHEALTH GROUP INC.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
GENOMIND, INC. v. UNITEDHEALTH GROUP INC., (E.D. Pa. 2021).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

GENOMIND, INC., CIVIL ACTION Plaintiff,

v. NO. 21-373 UNITEDHEALTH GROUP INC.; UNITED HEALTHCARE SERVICES, INC.; UNITED HEALTHCARE INSURANCE COMPANY; UNITED HEALTHCARE SERVICE LLC; UNITED BEHAVIORAL HEALTH; UMR, INC.; OXFORD HEALTH PLANS, LLC; OPTUM, INC., Defendants.

MEMORANDUM OPINION At the heart of this dispute is Plaintiff Genomind, Inc.’s allegation that Defendant UnitedHealth Group, Inc. (“United”), a health insurance company, and its subsidiaries (together “Defendants”), failed to pay for genetic tests Genomind performed for patients with United insurance plans.1 Genomind claims that it had an implied contract with United to develop a new version of its genetic test to meet United’s specifications for the test to be covered under United insurance plans, but after Genomind developed (incurring expenses in doing so) and patients started using this test Defendants did not pay as it promised. Plaintiff thus asserts claims against all Defendants under the Employee Retirement Income Security Act of 1974 (“ERISA”), 29 U.S.C. § 1001, et seq., and against United under several Pennsylvania common law causes of action. Defendants now move to dismiss the Complaint for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6).

1 Per the Complaint, these “wholly-owned subsidiaries and controlled subsidiaries” include United HealthCare Services, Inc., United HealthCare Insurance Company, United HealthCare Service LLC, United Behavioral Health, UMR, Inc., Oxford Health Plans, LLC, and Optum, Inc. I. BACKGROUND2 Genomind provides a genetic testing service that “predicts patient response to psychiatric medications,” and thus allows health providers “to prescribe medications that are properly tailored for their patients’ genetic makeup.” Genomind only tests patients whose treating health

provider has prescribed Genomind’s services based on that provider’s determination that “Genomind’s test is medically necessary and appropriate . . . to assist with identifying the most appropriate psychiatric medications.” Before August 2019, United interpreted health plans it offered or administered to exclude Genomind’s genetic tests from coverage because “[a]ccording to United, such testing was experimental and investigational as defined by a written exclusion found in each of those plans.” In August 2019, however, United issued a new commercial medical policy (“2019 Policy”) announcing that, beginning on October 1, 2019, it would cover genetic testing for mental health issues, such as those provided by Genomind. Under the 2019 Policy, United deemed such tests “proven and medically necessary for antidepressants and antipsychotics medication,” and thus could be covered under United insurance plans, when three

criteria were satisfied: (1) the patient “has a diagnosis of major depressive disorder or anxiety”; (2) the patient “has failed at least one prior medication to treat their condition; and (3) the test tests “no more than 15 relevant genes.” The Policy also stated, however, that “[b]enefit coverage for health services is determined by the member specific benefit plan document and applicable laws.” After United announced the 2019 Policy, Genomind “engaged in extensive communications with senior United representatives to ensure that Genomind would be able to

2 The following facts are drawn from the allegations of the Complaint and are taken as true, as required on a motion to dismiss under Rule 12(b)(6), as well as from United’s 2019 Policy, which was relied upon by the Complaint and attached to Defendants’ Motion to Dismiss. See Phillips v. Cnty. of Allegheny, 515 F.3d 224, 228 (3d Cir. 2008); Pension Benefit Guar. v. White Consol. Indus., 998 F.2d 1192, 1196 (3d Cir. 1993). have its . . . claims properly submitted to United, consistent with the United coverage policy, so that Genomind would receive proper benefit payments for such services.” There was one wrinkle: Genomind’s test – the “Full 24 Test” – tested 24 genes, not 15. United informed Genomind that its 24-gene test “would not be deemed a covered service by United, even if the 15

covered genes were included within the 24-gene panel.” The Complaint alleges that this “restrictive policy . . . leads to the denial of coverage for medically necessary health care services,” as even “if a provider prescribed a genetic testing panel that included 16 genes, 15 of which United recognized as medically necessary, United would nevertheless deny coverage for the entire test.” However, United also informed Genomind that it “would be able to get coverage for its genetic tests so long as it developed a panel of 15 genes, rather than the 24-gene panel that .Genomind was then using, and that Genomind would be able to submit and be paid directly for those claims.” Accordingly, Genomind “spent months and invested substantial financial resources” to develop the “Core 15 Test,” a new and “unique 15-gene panel that it could use for

United patients to ensure coverage and payment by United.” Its “time, labor, and other investments to develop, test, and roll out the 15-gene product well exceeded one million dollars.” While developing the Core 15 Test, Genomind employees met, spoke, and corresponded with United employees concerning Genomind’s new test. United’s employees confirmed that “Genomind’s product, when reduced to a 15-gene panel, would be covered by United,” that medical care providers “who wished to use the Genomind test could obtain approval through [a] prior authorization process” if specific insurance plans required that genetic testing services to be approved in advance, and that Genomind’s genetic testing services “would be covered with Genomind . . . proceeding as an out-of-network provider.” After the new policy went into effect, Genomind submitted claims to Defendants for payment for its provision of genetic testing services to patients with United insurance plans. Genomind soon recognized, however, that “its claims were frequently not being paid by United, even when prior authorization had been received.” Although Defendants frequently failed to pay claims “without issuing a formal

denial, leaving Genomind in limbo about how to handle the unpaid claim[s],” Defendants also denied claims for “baseless” reasons, including for lack of prior authorization where none was required and because, contrary to United’s stated policy, the test was experimental or not medically necessary. In all, Defendants failed to pay 4,373 claims, including for 1,235 Core 15 Tests and 3,138 Full 24 Tests. Of relevance here is that of these 4,373 claims, 3,698 claims are for United insured patients with plans governed by ERISA. Genomind’s “standard practice is to file internal appeals to challenge United’s wrongful denials” of coverage for insurance claims, and Genomind did so for the unpaid claims at issue here. The Complaint asserts ERISA claims against all Defendants, including to recover benefits due under United’s ERISA-governed insurance plans pursuant to 29 U.S.C. §

1132(a)(1)(B), and, in the alternative, for appropriate equitable relief under 29 U.S.C. § 1132(a)(3)(A) and (B). Genomind also asserts claims under Pennsylvania law against United only for breach of implied in fact contract, promissory estoppel, quantum meruit, unjust enrichment, and negligent misrepresentation.

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