DENISE COTE, District Judge.
Fox Rx, Inc. ("Fox"), a serial
In broad strokes, the SAC alleges that the defendants have engaged in two illegal practices. Fox asserts that (1) a drug rebate Dr. Reddy's provided to Omnicare was an illegal kickback, and (2) Omnicare improperly billed the federal government ("Government") for dispensing fees in certain circumstances. By engaging in such practices, Fox asserts that the defendants caused false claims to be submitted to the Government and overcharged Medicare. The following allegations are drawn from the SAC and documents integral to it, as well as certain Government documents concerning Medicare of which the Court takes judicial notice.
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 Government's Part D prescription drug benefit program.
Defendant Omnicare provides pharmacy services to LTC facilities ("LTCFs"). Through contracts with LTCFs, Omnicare serves as a consulting pharmacist and dispenses drugs to approximately 1.4 million LTCF residents in 47 states and the District of Columbia. The SAC alleges that Omnicare operated under a Corporate Integrity Agreement with the Centers for Medicare & Medicaid Services ("CMS") that "specifically covered `Arrangements' with vendors such as Dr. Reddy's and specifically addressed measures to protect against kickback schemes as alleged in this complaint." No further details concerning this Agreement are alleged, and the Agreement is not attached to the SAC.
Defendant Dr. Reddy's is an India-based pharmaceutical company that manufactures generic drugs including simvastatin. Simvastatin is used for the treatment of high cholesterol and the prevention of cardiovascular disease.
Before describing the allegations regarding the defendants' purportedly illegal practices, the Government programs at issue and other information critical to understanding those allegations will be described. The Government programs are Medicare Part D and Part A and Medicaid.
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. CMS, a component of the United States 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,
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. 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, which are calculated according to a complex regulatory formula.
Part D sponsors may also enter into contracts with pharmacy benefit managers ("PBMs") to create a pharmacy network and to administer the sponsors' prescription drug programs. 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. It is the plan sponsor that is responsible for submission of data to CMS.
According to the SAC, Medicare Part A is a program that covers, among other things, the cost of prescription drugs for residents of LTCFs for the first 100 days of a resident's stay. During those 100 days, LTCFs receive per diem payments for that resident from the Part A program, which are used to reimburse pharmacies like Omnicare for drugs prescribed to the resident. Pharmacies bill the LTCF for these prescriptions, not the Government. The Part A per diem payments from the Government for a given resident do not change as a result of the drugs prescribed the resident. Following those 100 days, prescription drug benefits under other Medicare Programs, including Part D, may be provided.
The cost of a given prescription may be split among an LTCF (covered by Part A) and Medicare Part D where a resident's Part A coverage ends in the middle of a prescription supply period and the resident is then eligible for Part D benefits (a "Part A-Part D Transition"). In the case of a Part A-Part D Transition, the pharmacy may request reimbursement from both the LTCF, for the drugs to be consumed during the remainder of the resident's Part A coverage period, as well as from a Part D plan sponsor, for the remainder of the drugs.
The SAC also claims that the defendants defrauded the Government's Medicaid program. Medicaid is a cooperative program between the Government and the states that provides health care benefits principally to the indigent and to disabled individuals. To qualify for federal Medicaid funds, a state must comply with minimum federal standards.
The Medicaid statute requires participating states to pay for prescription drugs. Pharmaceutical manufacturers that want their drugs to be eligible for payment by Medicaid are required to enter into a Rebate Agreement with CMS under which they agree to give state Medicaid programs discounts through a quarterly rebate payment that is calculated based on the utilization of the drug by the state's Medicaid program beneficiaries.
Under Plan D, pharmacies like Omnicare are generally reimbursed for dispensing drugs based on the average wholesale price ("AWP") or maximum allowable cost ("MAC") for a given drug.
A "dispensing fee" is defined, for purposes of Part D reimbursement, as "costs that [a]re incurred at the point of sale and pay for costs in excess of the ingredient cost of a covered Part D drug each time a covered Part D drug is dispensed" and "[i]nclude only pharmacy costs associated with ensuring that possession of the appropriate covered Part D drug is transferred to a Part D enrollee." 42 C.F.R. § 432.100. These costs include "any reasonable costs associated with" activities ranging from "measurement or mixing of the covered Part D drug [and] filling the container" to "a pharmacist's time in checking the computer for information about an individual's coverage" and "performing [certain] quality assurance activities" to "salaries of pharmacists and other pharmacy workers as well as the costs associated with maintaining the pharmacy facility and acquiring and maintaining technology and equipment necessary to operate the pharmacy."
ProCare was a PBM that worked both with Fox, as sponsor, and with Omnicare. ProCare entered into a contract with Omnicare that addressed Omnicare's claims for drugs prescribed over a Part A-Part D Transition, providing that Omnicare could file a Part D claim with ProCare for a fraction of the "Ingredient Charge" equal to the fraction of days in the prescription supply period that would fall under Part D coverage, and that "any such Claim shall not include a Dispensing Fee." That contract is not further described in, or attached to, the SAC.
Beginning in January 2007, CMS collected LTC pharmacy rebate data from Part D sponsors, based on concerns that "LTC network pharmacies receive access/performance rebates that may create financial incentives that conflict with Part D sponsors' formularies or drug utilization management (DUM) programs" ("CMS Rebate Data"). Omnicare reported, in connection with the collection of CMS Rebate Data, that in 2007 it received a rebate from Dr. Reddy's on simvastatin of between 2 and 4 cents per tablet. Three other pharmacies that filed claims under Fox's Part D plan — AccessHealth, MHA Long Term Care Network ("MHA"), and American Pharmacy Network Solutions ("APNS") — also reported receiving rebates from Dr. Reddy's on simvastatin in 2007. AccessHealth received rebates ranging from 43 cents to $37.16 per unit; MHA's rebates ranged from 5 cents per tablet, or $19.68 per unit, to $59.03 per unit; APNS's rebate was 58 cents per unit. The SAC alleges that Omnicare was "by far the largest recipient of Dr. Reddy's simvastatin rebates" in 2007.
On November 24, 2008, CMS suspended the collection of that data for the years 2008 and 2009, noting concerns about the efficacy of such data. The SAC alleges that Omnicare has not reported receiving rebates from Dr. Reddy's for simvastatin for the years 2008, 2009, and 2010.
On June 3, 2013, Fox brought this action against Omnicare and Dr. Reddy's, alleging two different sorts of misconduct. Of the Government, the twenty-two states, the District of Columbia, and the two cities on whose behalf Fox brought suit, none has elected to intervene.
First, Fox alleges that, between 2007 and 2010, Dr. Reddy's provided a per-unit rebate to Omnicare on the drug simvastatin in violation of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b ("Rebates Claim"). Fox alleges that, according to its own records, between 2007 and 2010 more than 90% (and in some years, nearly 100%) of the simvastatin dispensed by Omnicare to Fox's plan members was manufactured and sold by Dr. Reddy's. Fox cites no further evidence of rebates paid by Dr. Reddy's to Omnicare for the years 2008, 2009, and 2010. Fox alleges "the existence of multiple manufacturers who sold the same generic equivalent at lower prices during the relevant period."
Fox further alleges, in support of its Rebates Claim, that other pharmacies purchased a lower percentage of their simvastatin from Dr. Reddy's than Omnicare did between 2007 and 2010. For example, Good Neighbor Pharmacy Provider Network purchased 37% of its simvastatin from Dr. Reddy's in 2009; AccessHealth purchased 6% between 2007 and 2010; and MHA purchased 18% during the same period. Fox also alleges that Omnicare "charged more" for Dr. Reddy's simvastatin in the same dosages than other pharmacies did. In support, Fox attaches charts indicating that the "ingredient cost" reported by pharmacies for Dr. Reddy's simvastatin varied, and that in some instances Omnicare's reported ingredient cost was higher for a given dosage than one or more other pharmacies'. Fox has conceded, in its opposition papers, that Omnicare was reimbursed for dispensing simvastatin to Plan D beneficiaries according to the relevant AWP or MAC, not the ingredient cost.
Second, Fox alleges that from 2007 to 2010, Omnicare has improperly billed dispensing fees to Medicare Part D where a prescription straddled a Part A-Part D Transition (the "Dispensing Fees Claim"). Fox alleges that either Omnicare double-billed, because it also billed the LTCF for a dispensing fee, or that it must have engaged in an illegal "swapping" kickback scheme by agreeing not to charge the fee "in exchange for those facilities providing Omnicare access to the facilities' patients and the opportunity to submit Part D claims." No other facts evidencing such a scheme are alleged.
On August 8, 2014, Omnicare and Dr. Reddy's each moved to dismiss Fox's Second Amended Complaint. In its opposition papers of September 9, Fox consented to the dismissal of all but its federal claims. The motions were fully submitted on September 23.
When considering a motion to dismiss under Rule 12(b)(6), a court must accept as true all allegations in the complaint and draw all reasonable inferences in the plaintiffs' favor.
Applying the plausibility standard is "a context-specific task that requires the reviewing court to draw on its judicial experience and common sense."
In addition, because Fox's claims allege fraud, they must also meet the heightened pleading standard set out in Rule 9(b).
The FCA creates liability when a person
31 U.S.C. § 3729(a)(1).
A certification may be either factually or legally false. A factually false certification is one that involves "an incorrect description of goods or services provided or a request for reimbursement for goods or services never provided."
Because state and local agencies are best suited to monitor quality of care issues in the health care industry, an impliedly false certification theory of liability is only available "in limited circumstances" in connection with Government health care reimbursement claims.
The Anti-Kickback Statute provides, in relevant part, that
42 U.S.C. § 1320a-7b(b).
Those regulations provide that the Anti-Kickback Statute does not reach discounts provided to the buyer "in whose name a claim or request for payment is submitted for the discounted item or service and payment may be made, in whole or in part, under Medicare, Medicaid or other Federal health care programs" provided that the following two conditions are met:
42 C.F.R. § 1001.952(h)(1)(iii).
Similarly, these regulations offer a safe harbor to those who sell to such buyers where the following two conditions are met:
42 C.F.R. § 1001.952(h)(2)(iii).
Fox's Rebates Claim fails because the rebates allegedly accepted by Omnicare fall within the regulatory safe harbors for discounts, and therefore do not constitute a violation of the Anti-Kickback Statute.
As described above, pursuant to federal regulations, the buyer of a pharmaceutical drug is exempt from the Anti-Kickback Statute if it is an entity "in whose name a claim or request for payment is submitted for the discounted item or service and payment may be made, in whole or in part, under Medicare," provided (1) the per-unit rebates were "fixed" at the time of the sale to the buyer, and (2) the rebates were disclosed to the buyer in writing at the time of sale.
Dr. Reddy's provision of the rebate is protected by the parallel safe harbor for sellers.
Fox's only argument to the contrary is based on a misreading of this regulation. Fox argues that subparagraph (ii), not subparagraph (iii), applies to Omnicare. Yet, subparagraph (ii) applies where "the buyer is an entity which reports its costs on a cost report required by the Department or a State health care program." Fox has not alleged that Omnicare "reports its costs on a cost report," nor could it, since cost reports are required of "Medicare-certified institutional providers" like hospitals, health clinics, home health agencies, and hospices — not pharmacies.
Fox's Dispensing Fees Claim fails because the conduct Fox actually alleges — Omnicare charged a dispensing fee to Medicare Part D for prescriptions that bridged a Part A-Part D Transition — did not render any Part D claims factually or legally false.
Nor does the definition of "dispensing fee" suggest that it would be improper to split this fee between the LTCF (under Part A) and the Part D sponsor. As noted above, a "dispensing fee" may include "pharmacy costs associated with ensuring that possession of the appropriate covered Part D drug is transferred to a Part D enrollee," defined to encompass not just the "measurement or mixing of the covered Part D drug [and] filling the container," but also "any reasonable costs associated with," for example, "maintaining the pharmacy facility and acquiring and maintaining technology and equipment necessary to operate the pharmacy." 42 C.F.R. § 432.100. Fox points to no statutory or regulatory provision that would prohibit such a split.
Fox's only rejoinder is that it believes Omnicare did
Finally, Fox argues that Omnicare
Omnicare's and Dr. Reddy's August 8, 2014 motions to dismiss Fox's Second Amended Complaint are granted. The Clerk of Court is directed to close this case.
SO ORDERED.