Massachusetts v. Mylan Laboratories

608 F. Supp. 2d 127, 2008 U.S. Dist. LEXIS 107137, 2008 WL 5650859
CourtDistrict Court, D. Massachusetts
DecidedDecember 23, 2008
DocketCivil Action 03-11865-PBS
StatusPublished
Cited by15 cases

This text of 608 F. Supp. 2d 127 (Massachusetts v. Mylan Laboratories) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Massachusetts v. Mylan Laboratories, 608 F. Supp. 2d 127, 2008 U.S. Dist. LEXIS 107137, 2008 WL 5650859 (D. Mass. 2008).

Opinion

*130 MEMORANDUM AND ORDER

SARIS, District Judge.

I. INTRODUCTION

The Commonwealth of Massachusetts brings this case against nine pharmaceuti *131 cal manufacturers 1 for allegedly causing Massachusetts to overpay for generic prescription drugs under the Massachusetts Medicaid Program (“MassHealth”). Massachusetts contends that the defendants caused such overpayment by fraudulently inflating the “Wholesale Acquisition Cost” (“WAC”) and the “Average Wholesale Price” (“AWP”) of twenty-seven covered drugs.

Massachusetts moves for partial summary judgment as to liability with respect to Count IV of the First Amended Complaint, its claim that the defendants violated the Massachusetts False Claims Act, Mass. Gen. Laws. ch. 12, § 5A et seq. The defendants jointly move for summary judgment as to Count IV, as well as to Massachusetts’ claims based on common law fraud (Count I), the Massachusetts Medicaid False Claims Act, Mass. Gen. Laws ch. 118E, §§ 40-41 (Count III), and breach of the covenant of good faith and fair dealing implicit in the defendants’ rebate agreements (Count VI).

After several hearings, a tutorial, and a review of the briefs and the extensive record, Massachusetts’ cross-cutting motion for partial summary judgment as to Count IV [Docket No. 434] is DENIED on the ground that there is a disputed issue of fact concerning defendants’ scienter. The defendants’ joint motion for summary judgment [Docket No. 450] is DENIED except with respect to AWP-based claims. For the most part, the defendants’ individual motions for summary judgment will be addressed separately.

II. BACKGROUND

The following facts are drawn from the extensive record. The Court also assumes knowledge and incorporates by reference its prior order on the defendants’ motion to dismiss, Massachusetts v. Mylan Labs., 357 F.Supp.2d 314 (D.Mass.2005), and its numerous opinions in the related multidistrict litigation, In re Pharm. Indus. Average Wholesale Price Litig, 263 F.Supp.2d 172 (D.Mass.2003), In re Pharm. Indus. Average Wholesale Price Litig, 307 F.Supp.2d 196 (D.Mass.2004), In re Pharm. Indus. Average Wholesale Price Litig, 230 F.R.D. 61 (D.Mass.2005), In re Pharm. Indus. Average Wholesale Price Litig, 233 F.R.D. 229 (D.Mass.2006), In re Pharm. Indus. Average Wholesale Price Litig, 460 F.Supp.2d 277 (D.Mass.2006), In re Pharm. Indus. Average Wholesale Price Litig, 478 F.Supp.2d 164 (D.Mass.2007). Unless noted, the facts are undisputed.

A. Medicaid Reimbursement

The Medicaid program is a federal-state program that provides medical assistance to low income individuals. MassHealth is the Commonwealth’s component of the Medicaid program. MassHealth, like all state Medicaid agencies, must act in accordance with a State Plan, which the federal Centers for Medicare and Medicaid Services (“CMS”) must review and approve annually. (Defs.’ Joint Statement of Undisputed Material Facts [Docket No. 452] (“Defs.’ SOF”) ¶2.) Among other things, MassHealth reimburses “providers,” such as doctors or pharmacies, for prescription drugs dispensed to insureds. The reimbursements are based on formulae set out in the Commonwealth’s regulations, which *132 were developed in accordance with federal requirements.

1. Federal Regulations

Under federal Medicaid regulations, a state Medicaid program’s payments for a drug may not exceed the “estimated acquisition cost” of the drug plus a reasonable dispensing fee, where the “estimated acquisition cost” (“EAC”) is defined as “the agency’s best estimate of the price generally and currently paid by providers for a drug marketed or sold by a particular manufacturer or labeler in the package size of drug most frequently purchased by providers.” 42 C.F.R. § 447.301 (2006). Federal regulations require that the reimbursements be sufficient to enlist enough providers to provide MassHealth insureds with access equal to that of the rest of the population. See 42 C.F.R. § 447.204 (2006).

Federal regulations also required that payment for drugs not exceed the Federal Upper Limit (“FUL”). 42 C.F.R. § 447.331 (2007).

The Medicaid Act further requires that a Medicaid Plan’s payment rates and any changes to those rates be set by a “public process,” in which the proposed rates and justification for the proposed rates are published, providers and other interested parties are given reasonable opportunity for review and comment, and the final rates, methodologies underlying the establishment of rates, and justification for the final rates are also published. The Commonwealth established its Medicaid payment rates through a public regulatory process and its rates are published in the Code of Massachusetts Regulations.

To set a FUL, CMS groups together a drug’s therapeutically equivalent versions and sets an upper limit on payment for that group. (Donohue Tutorial [Docket No. 514-2] ¶26.) Each version of the drug has several associated published prices, such as an AWP, a WAC, and a Direct Price (“DP”). (Id.) To set a FUL for a class of drugs, CMS finds the lowest of these prices for any member of the class and multiplies it by 150%. (Id.)

2. The State Standard

The drugs at issue here are generic non-innovator “multiple-source drugs.” These are drugs with at least three manufacturers or suppliers. (Donohue Tutorial ¶ 26.) MassHealth based reimbursement for these drugs on the lowest of the following:

(a) the Federal Upper Limit (“FUL”) for the drug, if one is available, plus a dispensing fee;
(b) the Massachusetts Upper Limit (“MUL”) for the drug, if any, plus a dispensing fee;
(c) the Estimated Acquisition Cost (“EAC”) of the drug, plus a dispensing fee; or
(d) the pharmacy’s usual and customary charge (“U & C”) for the drug.

114.3 Mass.Code Regs. 31.04 (2007).

Prior to 2003, the MUL was calculated identically to FUL. 2 (Donohue Tutorial at ¶ 29.) In 2003, Massachusetts regulations were changed to reduce the multiplier from 150% to 130%. See 114.3 Mass.Code Regs. 31.02 (2007). This change was driven not only “to generate additional savings,” but also to keep compensation “sufficient to assure participation by pharmacies in the program.” (Klemeyer Decl.

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Bluebook (online)
608 F. Supp. 2d 127, 2008 U.S. Dist. LEXIS 107137, 2008 WL 5650859, Counsel Stack Legal Research, https://law.counselstack.com/opinion/massachusetts-v-mylan-laboratories-mad-2008.