Commonwealth v. TAP Pharmaceutical Products, Inc.

94 A.3d 350, 626 Pa. 1, 2014 WL 2723008, 2014 Pa. LEXIS 1498
Supreme Court of Pennsylvania·Decided June 16, 2014·Published·Cited by 11 cases

Opinions

OPINION ANNOUNCING THE JUDGMENT OF THE COURT

Justice SAYLOR.

This case is among a number of civil actions brought by state attorneys general against pharmaceutical companies nationwide challenging the propriety of prescription drug pricing, in particular, as it impacts third-party reimbursement for brand-name drug purchases subsidized by government social welfare programs. The Commonwealth has centered its claims upon alleged overpayments tied to the use of an industry benchmark figure known as “AWP” in government reimbursement for-muías. While many issues of concern have been raised about the Commonwealth’s approach to this litigation and the judgment it has obtained, our present decision to overturn the monetary component of that judgment is grounded on the Commonwealth’s failure, by any measure, to offer a rational accounting for the billion dollars in rebate monies which Commonwealth agencies received from the drug manufacturers it has haled into court.

I. Background

A. General Overview

The Commonwealth’s Department of Public Welfare (“DPW”) and its Department of Aging (“DOA”) each administer programs using public funds to subsidize purchases of prescription drugs by qualified persons with low incomes and/or disabilities. DPW maintains a cost-sharing relationship with the federal government under Title XIX of the federal Social Security Act, 42 U.S.C. §§ 1396 to 1396w-5, also known as the Medicaid Act, to provide necessary medical care to indigent persons. See 62 P.S. §§ 441.1 to 449 (containing the enabling provisions for the Commonwealth’s Medical Assistance Program).1 DOA operates the Pharmaceutical Assistance Contract for the Elderly (“PACE”), offering financial assistance in prescription drug purchases to low-income, elderly citizens.2

[353]*353Per the relevant aspects of these programs, private entities, including physicians and pharmacies (herein termed “providers”), purchase branded drugs from wholesalers and administer and dispense them to program beneficiaries. The providers then submit claims to DOA and DPW, which tender reimbursement per statutory and regulatory formulas, respectively. See generally 72 P.S. § 3761-509(6); 55 Pa.Code § 1150.51.

In the salient time period (1991 through 2004), state statutes and regulations relied upon industry-reported figures — average wholesale prices or “AWPs” — as a key benchmark in these reimbursement formulas. See 72 P.S. § 3761-502; 55 Pa.Code § 1121.2. AWPs were based upon price reports made by prescription drug manufacturers, including defendant Bristol Myers Squibb Company (“BMS”), to industry publishing services. See TAP, 36 A.3d at 1211 (explaining that “[s]ince the late 1960s, nearly every branded prescription drug sold in the United States has an AWP, which is published in commercial pricing compendia like Red Book, First DataBank, and Medispan” (citing In re Pharm. Indus. AWP Litig., 491 F.Supp.2d 20, 32 (D.Mass.2007), affd, 582 F.3d 156 (1st Cir.2009))). Generally, drug manufacturers reported AWPs at 20 or 25 percent above wholesale acquisition costs (‘WACs”),3 or they simply transmitted their WACs to the publishers, which calculated the AWPs according to the same markup conventions. Despite the self-reporting dynamic, however, neither Congress, nor the Pennsylvania General Assembly, nor the Commonwealth executive branch provided a concrete definition for the AWP conception or otherwise sought to impose meaningful restrictions on their content.4

By 1991, there was a wealth of information available to state officials and to the public at large confirming that AWPs served as a “list” or “book” price, so that the term “average wholesale price” was (or had become) a misnomer. See, e.g., State of Louisiana v. DHHS, 905 F.2d 877, 880 (5th Cir.1990) (reflecting a federal government agency’s observation in the 1970s that “AWP data are frequently inflated” and “should not be equated with the estimated acquisition costs for a drug.” (quoting 40 Fed.Reg. 34518 (Aug. 15, 1975))).5 The disconnect may have initially related to price incentive mechanisms utilized by drug manufacturers to enhance market share, such as discounts and rebates, and narrowing profit margins for wholesalers on account of increased efficiencies and intense competition. See Pharm. Indus. AWP Litig., 491 F.Supp.2d at 33; TAP, 36 A.3d at 1213 (quoting a pharmaceutical company as recognizing that AWPs were “the legacy of a distribution system which ceased to exist in the early 1980s”); id. (asserting that “although the market changed, the mechanism by which AWPs were set did not change, so there became [354]*354an increasing disconnect between reality and price setting”).

Great controversy ensued concerning the degree to which state agencies apprehended the evolving AWP convention and whether providers were being overpaid because of its use in program reimbursement formulas. In response, the federal and state governments implemented various pricing reforms and cost-containment measures within reimbursement systems. For example, DPW and DOA eventually routinized a practice of discounting AWPs in the Medical Assistance and PACE reimbursement formulas, so that instead of paying the listed AWP price to providers, they paid a rate, for example, of AWP minus 10 percent (“AWP-10”).6

In addition, since 1990, federal law has required that, for each brand-name drug, manufacturers must pay rebates to state Medicaid programs. See 42 U.S.C. § 1396r-8. To enable the government to calculate those rebates, manufacturers must submit Average Manufacturer Prices (“AMPs”) and “best prices” to the federal Center for Medicare and Medicaid Services (“CMS”) on a regular basis. See id. § 1396r-8(b)(3). AMPs are defined as “the average price paid to the manufacturer for the drug in the United States by wholesalers for drugs distributed to the retail pharmacy class of trade [after deducting] customary prompt pay discounts.” Id. § 1396r-8(k)(l). “Best price” generally means the lowest price available from the manufacturer during the rebate period, inclusive of discounts and other rebates. Id. § 1396r-8(c)(l)(C)(ii). The main rebate is calculated by multiplying the total units of a drug purchased under a state program in the rebate period by the greater of: 1) the difference between AMP and best price for the drug, or 2) a minimum rebate percentage of the AMP, currently 23.1 percent. See id. § 1396r-8(c)(1). Additional rebates are provided, see, e.g., id. 1396r-8(c)(2), and states have the ability to impose others. The General Assembly also adopted a rebate system for PACE, very similar to the Medical Assistance regime, in 1991. See 72 P.S. §§ 3761-702 to 3671-707.7

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Commonwealth v. TAP Pharmaceutical Products, Inc., 94 A.3d 350, 626 Pa. 1, 2014 WL 2723008, 2014 Pa. LEXIS 1498 (Pa. 2014).

94 A.3d 350 (Commonwealth v. TAP Pharmaceutical Products, Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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