Case 2:21-cv-00373 Document 1 Filed 01/27/21 Page 1 of 43
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`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF PENNSYLVANIA
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`Plaintiff,
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`v.
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`GENOMIND, INC.
`2200 Renaissance Boulevard, Suite 100
`King of Prussia, PA 19406
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`UNITEDHEALTH GROUP INC.
`9900 Bren Rd E
`Minnetonka, MN, 55343-4402,
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`UNITED HEALTHCARE SERVICES, INC.
`9900 Bren Rd E, Ste 300W
`Minnetonka, MN, 55343-4402,
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`UNITED HEALTHCARE INSURANCE
`COMPANY
`185 Asylum St
`Hartford, CT, 06103-3408,
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`UNITED HEALTHCARE SERVICE LLC
`9900 Bren Rd E
`Minnetonka, MN 55343,
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`UNITED BEHAVIORAL HEALTH
`425 Market St FL 18
`San Francisco, CA, 94105-2532,
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`UMR, INC.
`115 W Wausau Ave
`Wausau, WI 54401,
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`OXFORD HEALTH PLANS, LLC
`48 Monroe Tpke
`Trumbull, CT, 06611-1341,
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`OPTUM, INC.
`11000 Optum Cir
`Eden Prairie, MN, 55344-2503
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`Defendants.
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`Civil Action No. _____________
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`COMPLAINT
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`Case 2:21-cv-00373 Document 1 Filed 01/27/21 Page 2 of 43
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`Plaintiff Genomind, Inc. (“Genomind”), based upon personal knowledge as to itself and its
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`own acts, and information and belief as to all other matters formed after an inquiry reasonable
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`under the circumstances, asserts the following in support of its claims against Defendants
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`UnitedHealth Group Inc. and certain of its subsidiaries (collectively, “United,” “UHC,” or
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`“Defendant”):
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`INTRODUCTION
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`1.
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`Plaintiff Genomind is a high-quality and well-recognized genetic laboratory that
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`regularly provides medically necessary genetic testing to patients who are beneficiaries under
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`health insurance plans issued or administered by United (“United Insureds”). Many are governed
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`by the Employee Retirement Income Security Act (“ERISA”), 29 U.S.C. § 1001, et seq. (“United
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`ERISA Insureds”).
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`2.
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` Defendant UnitedHealth Group Inc., through its wholly-owned and controlled
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`subsidiaries, including Defendants United HealthCare Services, Inc., United HealthCare Insurance
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`Company, United HealthCare Service LLC, United Behavioral Health, UMR, Inc.,1 Oxford Health
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`Plans, LLC, and Optum, Inc. (collectively “United,” “UHC,” or “Defendant”), is a fully integrated
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`company that is in the business of insuring and administering commercial health insurance plans
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`(“United Plans’). Many of those plans are governed by ERISA.
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`3.
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`United administers all United Plans. In that role, United decides what the written
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`terms of the United Plans mean. One way it does so is by interpreting common written plan terms
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`through medical policies, adjudicating claims pursuant to those policies, and then paying resulting
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`claims.
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`1 In bringing this action against United, Genomind explicitly is not bringing direct claims against UMR, Inc.
`(“UMR”), a UnitedHealthcare subsidiary. Genomind’s only claims against UMR, as part of United, is with respect
`to the ERISA claims relating to the United ERISA Insureds identified herein.
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`2
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`4.
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`As detailed herein, United engaged in a persistent course of conduct in which it
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`misled Genomind concerning coverage that would be, and was, available for services provided by
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`Genomind to patients insured by United Plans.
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`5.
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`Reasonably relying on United’s misrepresentations and other misconduct,
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`Genomind developed an entirely new version of its genetic test and provided genetic testing
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`services with the expectation of being paid by United, only to have United withhold such payment
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`without reasonable basis and then mislead about why claims were not being paid. Through this
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`action, Genomind seeks appropriate legal and equitable remedies.
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`6.
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`Genomind is further suing United under ERISA, pursuant to patient-executed
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`assignments of benefits, to remedy United’s wrongful denial of Genomind’s claims.
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`Plaintiff
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`THE PARTIES
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`7.
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`Plaintiff Genomind was founded in 2009 with the vision of bringing personalized
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`medicine to neuropsychiatry. Its business provides a proprietary, saliva-based genetic test that
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`predicts patient response to psychiatric medications. The results allow behavioral health providers
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`to prescribe medications that are properly tailored for their patients’ genetic makeup, and are
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`therefore more likely to be efficacious and/or well-tolerated. Genomind is a Pennsylvania
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`corporation, with its executive headquarters and testing facility located in King of Prussia,
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`Pennsylvania.
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`Defendant
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`8.
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`Defendant UnitedHealth Group Inc. is a Minnesota corporation with its principal
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`place of business in Minnetonka, Minnesota. It is a fully integrated company that is in the business
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`of insuring and administering commercial health insurance plans. Defendant UnitedHealth Group
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`Inc. operates as, and owns the trademark to, “UnitedHealthcare.”
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`9.
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`Defendants United HealthCare Services, Inc., United HealthCare Insurance
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`Company, United HealthCare Service LLC, United Behavioral Health, UMR, Inc., Oxford Health
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`Plans, LLC, and Optum, Inc. are wholly-owned and controlled subsidiaries of Defendant
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`UnitedHealth Group Inc. UnitedHealthcare’s subsidiaries do not operate independently and in their
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`own interests, but serve solely to fulfill the purpose, goals, and policies of UnitedHealth Group
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`Inc.
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`JURISDICTION AND VENUE
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`10.
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`Genomind asserts subject matter jurisdiction under 28 U.S.C. § 1331 (federal
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`question jurisdiction), 29 U.S.C. § 1132(e) (ERISA), and 28 U.S.C. § 1367 (supplemental
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`jurisdiction, for the state-law claims asserted herein).
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`11.
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`Venue is appropriate under 28 U.S.C. § 1391(b)(2) because Plaintiff Genomind is
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`headquartered in this District, and Defendant United’s misconduct was directed to Genomind in
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`this District. Venue is also appropriate under 28 U.S.C. § 1391(b)(1) and (c)(2) because
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`Genomind’s claims arise from United transacting business in this District, with Genomind and
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`certain United Insureds.
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`FACTUAL ALLEGATIONS
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`Behavioral Health Background
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`12.
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` The burden of mental health treatment in this country is massive and growing.
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`According to the National Institute of Mental Health, from 2009 to 2013, mental health
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`expenditures in this country group grew from $147 billion to more than $201 billion, as efforts
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`were made to treat the nearly 45 million Americans experiencing mental illness (representing one
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`in six people). It is estimated that depression will represent the number one global health burden
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`by 2030, highlighting the need to provide effective and efficient treatment.
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`13.
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`The problem that faces the behavioral health community, as well as the health
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`insurance industry, is that treatment is empirical and resource intensive. Finding safe and effective
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`treatment for mental health patients can take months of trial and error, with many patients not
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`responding to the first prescribed medication, and many going through multiple failures lasting 8-
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`12 weeks per trial. At the same time, the side effects can become intolerable, while the patients
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`suffer a diminished quality of life and may become so disillusioned that non-compliance becomes
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`a significant problem.
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`14.
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`It is generally understood, that genetic variations among patients can render various
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`psychiatric medications ineffective or increase the risk of serious side effects. Being able to
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`identify those variations, therefore, maximizes the possibility that the most appropriate medication
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`will be selected for each patient early in the treatment process. This both reduces adverse
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`consequences if the wrong medication is selected and reduces reliance on the blind trial and error
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`method. Genomind’s services address that problem.
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`Genomind’s Services
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`15.
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`Genomind provides pharmacogenetics testing through its proprietary product, the
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`Genomind® Professional PGx Express™. Prior to August 5, 2019, Genomind’s product was
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`known as the Genecept Assay®.2 A variation of this product, Genomind® Professional PGx
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`Express™ Core Anxiety and Depression, was created in direct response to discussions with
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`United, as described herein.
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`16.
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`Genomind tests are performed on the patient’s saliva, which is obtained either
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`through a spit sample or from a cheek swab. The saliva samples are taken in the office of the
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`2 The terms the Genomind® Professional PGx Express™ and the Genecept Assay® are used interchangeably in this
`document.
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`patient’s treating health care provider or by the patient at home, after which the sample is sent to
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`Genomind’s testing facility in King of Prussia, Pennsylvania.
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`17.
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` Genomind runs its tests in its state-of-the-art lab, which is accredited by the
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`College of American Pathologists (CAP), certified by the Centers for Medicare and Medicaid
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`Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA), and licensed
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`by the New York and Pennsylvania Departments of Health. In its facilities, Genomind is approved
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`and authorized to conduct all tests for which it has submitted benefit claims to United, including
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`the Genecept Assay®.
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`18.
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`The Genecept Assay® helps increase the likelihood of treatment response by
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`identifying patient-specific genetic markers that indicate which treatments will likely (i) work as
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`intended to address the patient’s mental health condition, (ii) not be effective in treating that
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`condition, or (iii) cause adverse reactions or side effects. Genomind’s tests, for example, can help
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`detect those at risk for up to 50% increased side effects with particular antidepressants. Once a
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`patient’s unique propensities are identified, an appropriate medication can be prescribed, for which
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`the likelihood of a successful treatment is maximized. Importantly, the Food and Drug
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`Administration (FDA) has approved specific labeling that recommends dose adjustments, or
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`contains precautions, warnings or drug-drug interaction statements using certain genetic
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`biomarkers for dozens of different psychiatric medications that are commonly prescribed, as well
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`as hundreds of other drugs, many of which are incorporated into Genomind’s gene-drug interaction
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`guide, G-DIG®, which accompanies its genetic assay.
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`19.
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`Genomind does not decide which patients to test. Rather, it only tests patients for
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`whom the treating behavioral health provider has prescribed its services based on the determination
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`by that provider that Genomind’s test is medically necessary and appropriate so as to assist with
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`identifying the most appropriate psychiatric medications. Genomind has no financial connection
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`with the treating providers, and offers no financial incentives to them.
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`20.
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`To date, over 15,000 clinicians have ordered Genomind’s tests for more than
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`265,000 patients, with approximately 70% of the clinicians reordering them. Genomind’s tests
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`have substantially benefitted those patients, as the tests have allowed treating behavioral health
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`providers to better identify the proper medications to treat the patients’ underlying conditions.
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`United’s Role in Administering Behavioral Health Plans and Its
`Recent History of Improperly Denying Behavioral Health Coverage
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`21.
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`United is the largest administrator of behavioral health claims in the country,
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`operating through UnitedHealth Group’s subsidiary United Behavioral Health (“UBH”) and
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`serving more than 43 million people.
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`22.
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`For “fully insured” Plans—which are offered, underwritten, and administered by
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`United—United makes benefit payments for covered treatments from its own assets in exchange
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`for premiums paid by the employer and/or employees. For “self-insured” Plans—under which
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`United receives an administrative fee in exchange for administering the plan—United makes the
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`benefit payment and then is reimbursed from the Plan itself, which is funded by the self-insuring
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`Plan sponsor.
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`23.
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`In a recent decision from the United States District Court for the Northern District
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`of California, where UBH is headquartered, UBH was found to have engaged in “pervasive and
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`long-standing violations of ERISA,” by “den[ying] mental health and substance use disorder
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`treatment coverage to tens of thousands of class members using internal guidelines that were
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`inconsistent with the terms of the class members’ health insurance plans.” Wit v. United Behavioral
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`Health, 2020 WL 6479273, *1 (N.D. Cal. Nov. 3, 2020) (describing ERISA trial verdict reached
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`in Wit v. United Behavioral Health, 2019 WL 1033730 (N.D. Cal. Mar. 5, 2019)). Moreover, the
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`court found that UBH’s conduct was intentional, as it “engaged in this course of conduct
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`deliberately, to protect its bottom line,” and, “[t]o conceal its misconduct,” had “lied to state
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`regulators,” with “UBH executives with responsibility for drafting and implementing the
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`guidelines [having] deliberately attempted to mislead the Court at trial in this matter.” Id.
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`24.
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`As a result of UBH’s egregious misconduct, the court in Wit not only found UBH
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`to be liable under ERISA, but it issued a ground-breaking remedies order. Among other things, the
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`court has ordered UBH to adopt and apply the proper coverage guidelines which are consistent
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`with generally accepted standards of care; to reprocess more than 67,000 behavioral health claims
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`that it had improperly denied based on its reliance on its flawed and overly restrictive internal
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`guidelines; to provide training to all UBH employees engaged in making coverage determinations,
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`whether during the mandatory reprocessing or going forward with new claims; and to provide
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`training to all UBH employees, including senior executives, concerning ERISA and what it means
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`to be an ERISA fiduciary. Significantly, all of these steps will be implemented under the oversight
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`of a Special Master that the court will appoint to ensure that UBH is following the court’s orders.
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`25.
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`In adopting these remedies, the court highlighted the fact that UBH, operating as
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`the behavioral health arm of UnitedHealth Group, simply could not be trusted to fulfill its
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`obligations, and that there was a “significant danger of recurrent violation.” Id. at *42.
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`United’s Purported Recognition of the Medical Necessity of Genomind’s Services
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`26.
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`As the use of genetic and molecular lab testing became more common with regard
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`to numerous health care conditions, United announced in August 2017 that, as of November 1,
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`2017, it would require prior authorization relating to such services for certain of its plans. For those
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`plans, United required that such services had to be approved in advance. The process was overseen
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`by Beacon Laboratory Benefit Solutions, Inc. (“Beacon”), a lab services management company
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`that operated as United’s agent in registering participating labs for the program and managing the
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`online notification/prior authorization request system.
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`27.
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`At this time, United did not interpret the United Plans to cover genetic testing for
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`mental health issues, such as the Genecept Assay®. According to United, such testing was
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`experimental and investigational as defined by a written exclusion found in each of those plans.
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`The only exception to this categorical bar to coverage was United’s drug metabolism policy,
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`pursuant to which United deemed testing of three particular genes to not be experimental. During
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`this period, Genomind tested for these three genes and was reimbursed by United.
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`28.
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`From August through November 2017, Genomind engaged with Beacon, as
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`United’s agent, to register for and ensure that Genomind was able to comply with United’s new
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`prior authorization protocol.
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`29.
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`After United’s prior authorization process for genetic testing was initiated on
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`November 1, 2017, Genomind extensively engaged with United for two years additional years in
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`an effort to ensure that it, and the providers who prescribe its tests, were able to comply with
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`United’s prior authorization requirements.
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`30.
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`On August 1, 2019, United announced that, as of October 1, 2019, it would cover
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`genetic testing for mental health issues such as that provided by Genomind. In a new Commercial
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`Medical Policy, United stated that the use of pharmacogenetic Multi-Gene Panels to guide therapy
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`decisions was “proven and medically necessary for antidepressants and antipsychotics medication”
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`when all of three criteria are met:
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`• The individual has a diagnosis of major depressive disorder or anxiety;
`• The individual has failed at least one prior medication to treat their
`condition; and
`• The Multi-Gene Panel has no more than 15 relevant genes.
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`31.
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`In issuing this new policy, United explicitly confirmed that Genomind’s proprietary
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`product, the Genecept Assay®, was one of the products that was removed from United’s list of
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`unproven and not medically necessary panels. This demonstrated that United now recognized that
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`the Genecept Assay® was a proven and medically necessary genetic test that was a covered service
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`under the United Plans when the three conditions identified above were satisfied.
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`32.
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`As soon as Genomind learned of the policy change, it contacted United to begin
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`working to ensure that its product would be covered under the policy. In an August 9, 2019 email,
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`Genomind employee Ariy Krishnaraj wrote to Dr. Jennifer Malin, Senior Medical Director of
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`Oncology and Genetics of United Healthcare:
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`We were extremely pleased to read the recent UHC Commercial Medical Policy on
`Pharmacogenetic Testing that endorses the use of pharmacogenetic multi-gene
`panel to guide therapy decisions as proven and medically necessary for
`antidepressants and antipsychotics when the patient has a diagnosis of major
`depressive disorder or anxiety and provided it meets the other criteria laid out in
`the policy. We were also pleased that our product, Genecept Assay, was one of the
`products that was removed from the list of unproven and not medically necessary
`panels.
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`In the process of getting us ready for the policy effective date of Oct 1, we have a
`few clarifying questions regarding the medical policy specifically regarding the
`criteria mentioned in the policy. We want to ensure we have a clear understanding
`of the policy so that we can educate our customers accordingly helping smooth
`implementation of the policy among customers.
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`Towards that end, we would like to request a time on your calendar, preferably over
`the next couple of weeks, for a conference call with you.
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`33.
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`Over the next several months Genomind engaged in extensive communications
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`with senior United representatives to ensure that Genomind would be able to have its Genecept
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`Assay® claims properly submitted to United, consistent with the United coverage policy, so that
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`Genomind would receive proper benefit payments for such services.
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`34.
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`As part of these communications, United told Genomind that because United’s
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`coverage policy required that any Multi-Gene Panel have no more than 15 relevant genes,
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`Genomind’s traditional 24-gene panel would not be deemed a covered service by United, even if
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`the 15 covered genes were included within the 24-gene panel. United further told Genomind that
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`if Genomind developed a new test that only tested the 15 covered genes, the 15-gene test would
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`be covered.
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`35.
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`As a result, Genomind spent months and invested substantial financial resources
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`working with United to develop the Genomind® Professional PGx Express™ Core Anxiety and
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`Depression test (the “Core 15 Test”), a unique 15-gene panel that it could use for United patients
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`to ensure coverage and payment by United. The months-long effort consumed every department
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`at Genomind and constituted a company-wide shift in focus. Genomind’s activities to develop the
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`15-gene test included but were not limited to reviewing medical literature to assess the most
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`relevant genes (which Genomind in turn shared with United); creating new packaging; developing
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`new information technology, customer service, and billing workflows; training the sales force;
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`establishing a separate marketing plan; and training physicians on the new test. In addition,
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`Genomind hired another company to help ordering clinicians obtain prior authorizations;
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`purchased a segmentation model to guide its sales and marketing efforts for the new product;
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`developed an internal compensation plan for the sales force to foster adoption of the new product;
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`and spent over a year working to obtain a Proprietary Laboratory Analyses (PLA) Code for the
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`new test, at United’s direction. In sum, Genomind’s time, labor, and other investments to develop,
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`test, and roll out the 15-gene product well exceeded one million dollars.
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`36.
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`In investing substantial time and financial resources to develop the Core 15 Test,
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`Genomind reasonably relied on United’s representations that testing with Genomind’s new 15-
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`gene panel would be covered. Several examples of those representations follow.
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`37.
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`In a telephone call between Genomind and United representatives on August 23,
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`2019, United confirmed that the Genecept Assay® would now be a covered service, subject to the
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`three requirements. In particular, United explained that Genomind would be able to get coverage
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`for its genetic tests so long as it developed a panel of 15 genes, rather than the 24-gene panel that
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`Genomind was then using, and that Genomind would be able to submit and be paid directly for
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`those claims.
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`38.
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`On that same day, Dr. Jennifer Malin, United’s Senior Medical Director of
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`Oncology and Genetics, emailed Kathryn Stough, United’s National Lab Program Manager,
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`copying Genomind’s Chief Medical Officer, Dr. David Krause. In the email, Dr. Malin stated:
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`“This email is to introduce you to Genomind who have a test that our PGx policy will now cover
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`as of 10/1.”
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`39.
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`Dr. Krause responded to this email later that day, expressing an interest in further
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`discussing the revised gene panel that Genomind would develop to ensure consistency with the
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`United policy.
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`40.
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`Dr. Malin scheduled a follow-up meeting with Genomind in California on October
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`2, 2019. The primary purpose of the meeting was to allow Genomind to demonstrate to Dr. Malin
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`the Core 15 Test that would satisfy United’s coverage policy for the Genecept Assay®. In advance
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`of the October 2 in-person meeting, Genomind had a conference call with Dr. Malin on September
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`4, 2019, to go over various details relating to Genomind’s plans, including how Genomind was
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`going to be developing the Core 15 Test as a subset of its traditional 24-gene panel in order to
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`ensure that Genomind would be able to bill United and be paid for its services, consistent with
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`United’s coverage policy.
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`41.
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`On the September 4, 2019 call, Dr. Malin and others at United confirmed that
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`Genomind’s product, when reduced to a 15-gene panel, would be covered by United; that providers
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`who wished to use the Genomind test could obtain approval through the prior authorization process
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`overseen by Beacon, where applicable; and that these services would be covered with Genomind
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`be proceeding as an out-of-network provider, unless and until Genomind’s application to become
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`in-network was processed and accepted.
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`42. While Genomind was working with Dr. Malin to confirm its ability to create and
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`use the Core 15 Test that would be covered by United, Genomind also communicated with Beacon
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`to ensure that Genomind would be in a position to get prior authorization for its genetic tests
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`through the Beacon portal.
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`43.
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`Around that same time, Genomind also submitted a completed application to
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`become a United in-network provider. The application included Genomind’s CAP certification,
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`CLIA Certificate of Accreditation, and Clinical Laboratory Permits from the New York and
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`Pennsylvania Departments of Health. Genomind’s application was forwarded to United’s National
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`Ancillary Strategy Provider Inquiry Group, and identified as a “Referral from Dr. Malin.”
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`44.
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`On a September 6, 2019 call between Genomind and United representatives, Ms.
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`Stough and others at United again confirmed that Genomind’s Core 15 Test would receive prior
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`authorization and be covered under United’s new coverage policy while Genomind continued as
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`an out-of-network provider. At the same time, Ms. Stough encouraged Genomind to continue
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`pursuing an in-network contract, expressing the view that Genomind was ideally situated to be in-
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`network with United. Following the call, she sent a “credentialing application” to Genomind, to
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`further advance its effort to go in-network.
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`45.
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`On September 10 and 11, 2019, Genomind emailed Ms. Barnes from Beacon and
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`Ms. Stough from United to highlight Genomind’s new Core 15 Test that was created to conform
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`to United’s coverage policy.
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`46.
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`During the scheduled in-person meeting on October, 2, 2019 between Dr. Malin,
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`Dr. Krause, and Genomind’s CEO Shawn O’Brien, United again reassured Genomind that
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`everything was set for Genomind to be able to obtain prior authorization, when necessary, and
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`coverage and payment for its Core 15 Test, consistent with United’s coverage policy.
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`United’s Improper Refusal to Cover Genomind’s Services
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`47.
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`United implemented its coverage policy on October 1, 2019. By that time, United
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`had repeatedly assured Genomind that its services would now be able to receive prior authorization
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`and be covered as an out-of-network service.
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`48.
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`In reasonable reliance on those representations, Genomind conducted its genetic
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`tests for United insureds whose treating behavioral health care providers had prescribed them, after
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`having submitted such claims for prior authorization and being approved by United. Thereafter,
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`Genomind submitted the claims for payment of the Core 15 Test based on the reasonable
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`expectation that it would be paid. Yet, for the vast majority of such tests, United did not pay the
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`benefits, without any appropriate justification and continued its misconduct.
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`49.
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`After the new policy went into effect, Genomind continued to have regular contacts
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`with United and/or Beacon, as United’s agent, to address difficulties that arose either with treating
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`providers obtaining necessary prior authorization or with claims submitted by Genomind.
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`Throughout the process, United and Beacon continued to reassure Genomind that there were no
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`problems with Genomind submitting or being paid for its claims and that it should continue to
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`provide the tests and submit the claims.
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`50.
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`For example, in response to certain difficulties that occurred with regard to prior
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`authorization, Ms. Barnes, for Beacon, explained in an email that the prior authorization program
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`“does not apply to [certain] lines of business,” and then referred Genomind to a United website
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`that
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`identified
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`the
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`“line
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`of
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`business
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`[which]
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`falls within
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`this
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`program:
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`https://www.uhcprovider.com/en/prior-auth-advance-notification/genetic-molecular-lab.html.
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`Case 2:21-cv-00373 Document 1 Filed 01/27/21 Page 15 of 43
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`51.
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`The current version of that website reports that “[t]he notification/prior
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`authorization requirement for certain genetic and molecular
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`tests applies
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`to: Certain
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`UnitedHealthcare commercial benefit plans when UnitedHealthcare is the primary payer; Oxford
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`Health Insurance; [and] UnitedHealthcare Community Plan in select states,” adding:
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`Ordering care providers will complete the notification/prior authorization process
`online or over the phone. Labs must register their tests to participate as part of the
`Genetic and Molecular Lab Testing Notification/Prior Authorization process.
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`On its website, United further discloses that “[n]otification/prior authorization for genetic and
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`molecular tests has been required for certain UnitedHealthcare commercial benefit plans since
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`Nov. 1, 2017,” with various plans being added over time, including Oxford as of April 1, 2020.
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`This meant, of course, that Oxford did not require prior authorization for the Genomind test prior
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`to that date. Genomind communicated this information to its ordering providers, so they would
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`know which United plans required prior authorization, and which ones did not.
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`52.
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`On November 1, 2019, Genomind raised another issue with Ms. Stough—that it
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`had received several denials or very little reimbursement because of a “so-called agreement” that
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`Genomind had with Multiplan. A United Explanation of Benefits (EOB) reflected that Genomind
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`had been paid for services provided to a patient insured under an ERISA plan issued by United. In
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`explaining how the claim was processed, United stated that there were “Payer Initiated
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`Reductions” applied based on a “Claim Specific Negotiated Discount,” such that the patient bore
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`no financial responsibility for the treatment. The EOB then stated: “This out-of-network provider
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`has accepted a discount for this service based on an agreement with Multiplan.” The problem with
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`this communication was that Genomind did not have an agreement with Multiplan and, as an out-
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`of-network provider, had never agreed to accept a negotiated discounted rate from United. That
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`was precisely why Genomind was seeking to go in-network, pursuant to which it would accept a
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`15
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`Case 2:21-cv-00373 Document 1 Filed 01/27/21 Page 16 of 43
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`negotiated discounted rate in exchange for being given greater and more efficient access to United
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`insureds.
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`53. Ms. Stough responded by pointing to United’s “LINK online system,” which was
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`wholly unrelated to the fact that United was improperly imposing a discounted rate on Genomind.
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`54.
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`Throughout November and December 2019, as providers prescribed the Core 15
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`Test based on repeated assurances from United and/or Beacon that Genomind’s services would be
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`covered under the United Plans, Genomind continued to engage with United and/or Beacon
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`whenever issues arose over getting prior authorization.
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`55.
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`Another in-person meeting between Genomind and United representatives was held
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`at United offices in Minnetonka on January 17, 2020. Many representatives from Genomind
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`attended, including its CEO, President, Director of Market Access, and Chief Medical Officer. At
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`the meeting United and Genomind discussed the status of Genomind’s ongoing submission of
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`claims relating to the Genecept Assay® being used for United Insureds, as well as Genomind’s
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`on-going application to go in-network.
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`56.
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`In a January 20, 2020 follow-up email to United after the in-person meeting,
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`Genomind summarized that it had been working closely with United to ensure that its claims were
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`being processed and paid properly, and was “fully utilizing” United’s prior authorization process
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`“to ensure that the test ordered complies completely with United Healthcare’s medical policy” so
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`that Genomind could continue to treat United’s insurers and be reasonably compensated in return.
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`The email also reminded United that Genomind had developed a specific test, the Core 15 Test,
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`specifically to comply with United’s current policy.
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`57.
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`Throughout January and February 2020, Genomind continued to engage directly
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`with United and Beacon to ensure that the process was running smoothly so that Genomind could
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`be assured that it would be covered for the Genecept Assay®. Soon, however, Genomind
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`16
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`Case 2:21-cv-00373 Document 1 Filed 01/27/21 Page 17 of 43
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`recognized that its claims were frequently not being paid by United, even when prior authorization
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`had been received.
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`58.
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`On February 20, 2020, Genomind’s Reimbursement Leader Grace Innamorato
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`email