United States ex rel. Fox Rx, Inc. v. Omnicare, Inc.

38 F. Supp. 3d 398, 2014 WL 3928780, 2014 U.S. Dist. LEXIS 111593
CourtDistrict Court, S.D. New York
DecidedAugust 12, 2014
DocketNo. 12cv275 (DLC)
StatusPublished
Cited by5 cases

This text of 38 F. Supp. 3d 398 (United States ex rel. Fox Rx, Inc. v. Omnicare, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States ex rel. Fox Rx, Inc. v. Omnicare, Inc., 38 F. Supp. 3d 398, 2014 WL 3928780, 2014 U.S. Dist. LEXIS 111593 (S.D.N.Y. 2014).

Opinion

OPINION & ORDER

DENISE COTE, District Judge:

A qui torn relator has brought this action under the federal False Claims Act, 31 U.S.C. § 3729 et seq. (“FCA”), and twenty-one states’ and the District of Columbia’s false claims statutes against entities that provide or assist others to provide pharmacy services to long-term care facilities (“LTCFs”). The defendants have moved to dismiss the Second Amended Complaint (“SAC”) in this action. For the reasons given below, these motions are granted.

BACKGROUND

The following allegations are drawn from the SAC and documents integral to it. In broad strokes, the SAC asserts that the defendants have engaged in two illegal practices. The plaintiff asserts that the defendants (1) failed to substitute generic drugs for brand-name drugs in states that have laws mandating such substitution, and (2) dispensed drugs after the termination date of a national drug code in states that have laws prohibiting pharmacies from dispensing drugs beyond their shelf-life expiration dates. By engaging in such practices, the plaintiff asserts that the defendants falsely indicated in “submissions” to a federal agency that the drugs they dispensed were “covered” by Medicare, and overcharged Medicare and Medicaid.

I. The Parties

The relator is Fox Rx, Inc., the corporate parent of Fox Insurance, Inc. (together, “Fox”). From 2006 to 2010, Fox sponsored prescription drug plans pursuant to the federal government’s Part D prescription drug benefit program.1 Fox asserts that it, along with the federal government (“Government”) and the states, was a victim of the defendants’ fraudulent practices.

Fox has sued four defendants: Omnicare, Inc. and NeighborCare, Inc. (together “Omnicare”), PharMerica Corp. (“PharMerica”), and MHA Long Term Care Network ( “MHA”). Omnicare and PharMerica (together, “Pharmacy Defendants”) provide pharmacy services to LTCFs. Through contracts with LTCFs, they dispense drugs to 1.4 million residents of LTCFs.

MHA contracts with independent long-term care pharmacies to, inter alia, negotiate reimbursement rates on their behalf and manage Medicare Part D claims. MHA receives an administrative fee per paid prescription. MHA provides its member pharmacists and pharmacies with its RxPertise software, which assists pharmacies in determining insurance plan coverage and covered therapeutic alternatives quickly.

MHA enters into agreements with Pharmacy Benefits Managers (“PBMs”) on behalf of the pharmacies in its network that [402]*402allow the PBMs to provide claims adjudication services when claims are submitted to Medicare and Medicaid for payment. One such agreement, executed by MHA and ProCare PBM, is attached as an exhibit to the SAC. In that document MHA agreed that the “Pharmacy Provider” also had certain obligations. (A “Pharmacy Provider” was defined in that agreement as the “dispenser of drug products and/or services.”) Those obligations include the Pharmacy Provider’s

obligation to ensure that any pharmacist who is performing on behalf of the Pharmacy Provider shall use his or her professional judgment when filling prescript orders, and will comply with all legal, professional and ethical obligations applicable to pharmacists under the laws of the jurisdiction in which the prescription service is received.

(Emphasis added.) In addition, the “Pharmacy Provider agrees to inform [prescription drug plan] Part D enrollees at the point of sale of any differential between the price of the lowest-priced therapeutically equivalent and bio-equivalent generic drug unless the lowest price drug is being purchased in accordance with 42 CFR § 423.132(a).”2

II. Federal Programs At Issue

A. Medicare Part D

The SAC asserts that the defendants defrauded the Government’s Medicare Part D program. Medicare is a federally funded health insurance program for the elderly and disabled. The federal agency Centers for Medicare & Medicaid Services (“CMS”), which is a component of the Department of Health and Human Services (“HHS”), administers the Government’s Medicare and Medicaid programs. 42 U.S.C. §§ 1395, 1396. In December 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act (“MMA”), which established a voluntary prescription drug benefit program for Medicare enrollees known as Medicare Part D. Pub.L. No. 108-173, 117 Stat. 2066, codified at 42 U.S.C. § 1395w-101 et seq.

To provide Part D benefits to enrollees, Medicare enters into contracts with private companies known as Part D sponsors. The sponsors administer prescription drug plans (“PDPs”). Fox was one such sponsor.

The sponsors may contract with pharmacies and pharmacy networks to provide the prescription drugs to Part D beneficiaries who have enrolled in their plans. When a Medicare Part D beneficiary has a prescription filled, the pharmacy presents a claim to the sponsor. The sponsor then notifies CMS of the transaction, including the cost the sponsor incurred in making a payment to the pharmacy.

CMS provides advance monthly payments to sponsors based on a subsidy per enrollee in the sponsor’s program and on estimates of the subsidies CMS will be required to pay to the sponsors. At the end of a payment year, CMS reconciles the advance payments it made to the sponsor and the actual costs- the sponsor has incurred. To the extent that the sponsor paid out more than it received in advance payments from CMS, CMS may provide the sponsor with additional payments, [403]*403which are calculated according to a complex regulatory formula. 42 C.F.R. § 423.3S6(a)-(b).

Part D sponsors may also enter into contracts with PBMs to create a pharmacy network and to administer their prescription drug programs. PBMs may develop and implement a prescription drug formulary, that is, a list of prescription drugs the purchase of which will be reimbursed by the sponsor’s plan. PBMs may also provide automated processing services to “adjudicate” claims submitted by pharmacies. CMS regulations require that the contracts between sponsors and either PBMs or pharmacies contain language obligating the pharmacy to comply with federal law and CMS instructions.

When pharmacies dispense drugs to a Medicare Part D enrollee, they submit a claim electronically to the enrollee’s sponsor, often through a PBM. The claim contains information about the cost of the drug, the dispensing fee, any taxes paid, any payments made by the enrollee, and any rebates received from the drug’s manufacturer or distributor. According to the SAC, if the drug was a brand-name “multisource drug,” the pharmacy also provides the basis for its decision not to substitute a generic.

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Bluebook (online)
38 F. Supp. 3d 398, 2014 WL 3928780, 2014 U.S. Dist. LEXIS 111593, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-fox-rx-inc-v-omnicare-inc-nysd-2014.