United States of America v. Pharmerica Corporation

District Court, S.D. New York·Decided September 15, 2022·No. 1:20-cv-05089·Unknown

Opinion

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK - |e ee ke ee er eee ee eB eR ee ee ee ee ee eH eh ee xX UNITED STATES OF AMERICA; the States of: CALIFORNIA, DELAWARE, FLORIDA, GEORGIA, HAWAII, IOWA, LOUISIANA, MASSACHUSETTS, MICHIGAN, NEVADA, NEW JERSEY, NORTH CAROLINA, MEMORANDUM DECISION RHODE ISLAND, TENNESSEE, TEXAS, AND ORDER VIRGINIA, and the DISTRICT OF COLUMBIA, ex rel. KAVEH ASKARI, 20 Civ. 5089 (GBD) Plaintiffs, -against- : PHARMERICA CORPORATION, PHARMACY CORPORATION OF AMERICA, ONCOMED SPECIALTY PHARMACY, LTD., d/b/a ONCO360, and GREG WEISHAR, PAUL JARDINA, and ROBERT THOMSON, in their individual capacities, Defendants. ree ee ee ee □□□ ee eee ee ee ere ee ee ee eX GEORGE B. DANIELS, United States District Judge: Relator Plaintiff Kaveh Askari brings this gui tam action against Defendants PharMerica Corporation (“PharMerica”), Pharmacy Corporation of America (“PCA”), OncoMed Specialty Pharmacy, Ltd., d/b/a Onco360 (“Onco360”), Gregory Weishar (“Weishar”’), Paul Jardina (“Jardina”) and Robert Thomson (“Thomson”) alleging violations of the federal False Claims Act (“FCA”), as well as analogous statutes in sixteen states and the District of Columbia. (First Amended Complaint (“FAC”), ECF No. 14, § 109-223.) Defendants allegedly engaged in schemes to submit false claims for prescription drugs, including claims to participating Medicare and Medicaid providers. (See Jd.) Neither the Government nor any State exercised its authority to intervene in this action. Defendants now move to dismiss the FAC for failure to state a claim pursuant to Federal Civil Rule 12(b)(6) and 9(b). The motion to dismiss is GRANTED.

I. FACTUAL BACKGROUND A. Relevant Healthcare Laws and Regulations Before detailing the facts, it is important to describe the relevant healthcare and pharmacy regulatory landscape. The federal government helps provide for two healthcare programs — Medicare and Medicaid. The programs try to alleviate the burden of healthcare costs, including prescription drugs, for the elderly, indigent, and disabled. See 42 U.S.C. §1395 et seq.; 42 U.S.C. §§1396 ef seg. Both programs allow for approved insurance or private companies (known as Part D sponsors) to reimburse pharmacies for drug costs. These Part D sponsors (or a third party known as PBMs) enter contracts with pharmacies for the price of drugs. The dispensing pharmacy submits a claim for payment to the Part D Sponsor or PBM using the pharmacy’s unique National Provider Identifier (‘NPI’). See 42 C.F.R. §§ 423.120(c)(5)(i). A valid claim requires a valid prescription. In turn, a valid prescription requires the dispensing pharmacy to comply with applicable federal and state laws. See, e.g., 42 C.F.R. §423.100 and 42 C.F.R. §423.104(h). While Medicaid is a joint federal-state program, it provides similar support for qualified individuals and imposes similar requirements on participating pharmacies. See generally, 42 U.S.C. §1396 et seq. State requirements vary on when out-of-state pharmacies can dispense prescriptions under Medicare or Medicaid. For Medicare, an out-of-state pharmacy only needs a valid license and registration in another state. (FAC at § 53.) Medicaid is more convoluted. Some states only require an out-of-state pharmacy to register with the state’s Medicaid agency, while other states require the pharmacist in charge (“PIC”) of the out-of-state pharmacy to obtain a license from the state. Ud. at § 54-55.) In addition, some states require an out-of-state pharmacy have a physical location in the state and a PIC that is licensed in the state, while other states only require a physical location in the state. (/d. at {/§] 56-57.)

The federal government also enacted a drug pricing program known as 340B. See 42 U.S.C. § 256b. The program is tied to Medicaid and requires pharmaceutical “manufacturers participating in Medicaid [to] offer discounted drugs to covered entities,’ known as Disproportionate Share Hospitals (“DSH Hospitals”). Astra USA, Inc. v. Santa Clara Cnty., Cal., 563 U.S. 110 (2011). “DSH hospitals contract with certain pharmacies to provide drugs covered by the 340B program.” (FAC at § 39.) Drugs purchased under the 340B program are reimbursed under Medicare programs. See, e.g., 82 Fed. Reg. 52361 (Nov. 13, 2017) (“We are changing our current Medicare Part B drug payment methodology for 340B hospitals...”). B. Factual Background Relator Askari is a pharmacist who specializes in oncology drugs. (FAC at 4 11.). In 2002, he founded Defendant Onco360—a retail oncology pharmacy that manages all aspects of a patient’s oncology pharmaceuticals. (/d. at 12, 18, 58.) While he was employed at Onco360, Askari was the PIC. (/d. at §§ 59.) Askari has an out-of-state license in Kentucky, Louisiana, Maryland, Mississippi, Nebraska, and Tennessee. (/d. at 67.) Another supervising pharmacist at the pharmacy was Scott Feigles. (FAC at § 60.) Feigles has an out-of-state license in Alabama, Arkansas, Michigan, Oregon, North Carolina, Virginia, and West Virginia. (/d. at 67.) Across the country, Onco360 provides pharmaceutical services to Medicare and Medicaid beneficiaries, contracts with pharmaceutical manufacturers, and contracts with seven 340B hospitals. (/d. at §§ 61-63, 72-73.) Onco360 has physical locations in New York (Great Neck and Buffalo), Pennsylvania, Massachusetts, and New Jersey. (FAC at 65.) In December 2013, Defendant PCA purchased a minority interest in and secured managerial and operational control of Onco360. (id. at Ff 12, 18, 76.) PCA is a wholly owned subsidiary of Defendant PharMerica. (/d. at § 17.) PharMerica is a long-term and post-acute care

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