Pharm. Care Mgmt. Ass'n v. Dist. Of D.C.

Decision Date09 July 2010
Docket NumberNo. 09-7042.,09-7042.
Citation613 F.3d 179
PartiesPHARMACEUTICAL CARE MANAGEMENT ASSOCIATION, Appellee v. DISTRICT OF COLUMBIA and Adrian Fenty, In his Official Capacity as Mayor of the District of Columbia, Appellants.
CourtU.S. Court of Appeals — District of Columbia Circuit

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Appeal from the United States District Court for the District of Columbia (No. 1:04-cv-01082-RMU).

James C. McKay, Jr., Senior Assistant Attorney General, argued the cause for appellants. With him on the briefs were Peter J. Nickles, Attorney General, Todd S. Kim, Solicitor General, and Donna M. Murasky, Deputy Solicitor General.

Melissa Bowman, Attorney, U.S. Department of Labor, argued the cause for amicus curiae Secretary of Labor in support of appellants. With her on the briefs were Carol A. De Deo, Deputy Solicitor, Deborah Greenfield, Deputy Solicitor, and Nathaniel I. Spiller, Counsel.

Jan May, Stacy J. Canan, and Michael Schuster were on the brief for amici curiae AARP et al. in support of appellants.

Paul J. Ondrasik, Jr. argued the cause for appellee Pharmaceutical Care Management Association. With him on the briefs were Martin D. Schneiderman, Linda S. Stein, and Eric G. Serron. Alice E. Loughran entered an appearance.

Robin S. Conrad and William G. Schiffbauer were on the brief for amici curiae America's Health Insurance Plans, Inc. and Chamber of Commerce of the United States of America in support of appellee.

Before: GINSBURG, BROWN, and KAVANAUGH, Circuit Judges.

Opinion for the Court filed by Circuit Judge GINSBURG.

GINSBURG, Circuit Judge.

The District of Columbia appeals the judgment of the district court holding Title II of the Access Rx Act of 2004, D.C.Code § 48-832.01 et seq. , is pre-empted by the Employee Retirement Income Security Act, 29 U.S.C. § 1001 et seq. (ERISA). Pharm. Care Mgmt. Ass'n v. District of Columbia, 605 F.Supp.2d 77, 84-88 (2009). We agree with the district court that § 48-832.01(a), (b)(1), and (d) of Title II are pre-empted by ERISA insofar as they apply to a pharmaceutical benefits manager (PBM) under contract with an employee benefit plan (EBP) because they “relate to” an EBP. Section 48-832.01(b)(2) and (c) are not pre-empted by ERISA, however, because each may be waived by an EBP in its contract with a PBM. Accordingly, we affirm in part and reverse in part the judgment of the district court, and remand this matter for the district court to consider the Pharmaceutical Care Management Association's (PCMA) constitutional challenges to the provisions not pre-empted by ERISA.

I. Background

Access to prescription drugs is an increasingly important-and expensive-benefit for a health care plan to offer its beneficiaries. Instead of themselves developing a list of covered prescription drugs, purchasing those drugs from pharmaceutical manufacturers, establishing a network of pharmacies to fill prescriptions, and otherwise administering the prescription drug benefit, many health care plans, including many EBPs, contract with a PBM to perform these functions. A PBM offers not just administrative convenience, however; by aggregating the purchasing power of numerous health care plans, a PBM can get greater volume discounts from drug manufacturers and provide access to a larger network of pharmacies than an EBP could do on its own. That the vast majority of insured Americans receive their pharmaceutical benefits through a PBM is, therefore, not surprising.

Title II imposes a number of requirements upon PBMs and, in one respect, upon any health care plan that contracts with a PBM and thus becomes a “covered entity,” § 48-831.02(4)(A). These requirements are summarized in the following table.

                +-----------------------------------------------------------------------------+
                ¦Provision¦Summary   ¦Requirement                                             ¦
                +---------+----------+--------------------------------------------------------¦
                ¦§        ¦Fiduciary ¦A PBM “owes a fiduciary duty to a covered entity. In    ¦
                ¦48-832.01¦duty      ¦performance of that duty [it] shall adhere to the       ¦
                ¦(a)      ¦          ¦practices in this section.”                             ¦
                +---------+----------+--------------------------------------------------------¦
                ¦§        ¦Fiduciary ¦A PBM “shall ... Perform its duties ... in accordance   ¦
                ¦48-832.01¦standard  ¦with the standards of conduct applicable to a           ¦
                ¦(b)(1)(A)¦          ¦fiduciary.”                                             ¦
                +---------+----------+--------------------------------------------------------¦
                ¦§        ¦          ¦                                                        ¦
                ¦48-832.01¦NA        ¦Repealed, 53 D.C.Reg. 6899, 6966 (2006).                ¦
                ¦(b)(1)(B)¦          ¦                                                        ¦
                +---------+----------+--------------------------------------------------------¦
                ¦§        ¦Disclosure¦A PBM shall “notify the covered entity in writing of ...¦
                ¦48-832.01¦of        ¦any conflict of interest with the duties imposed by”    ¦
                ¦(b)(1)(C)¦conflicts ¦Title II.                                               ¦
                +---------+----------+--------------------------------------------------------¦
                ¦         ¦          ¦A PBM “that receives from any drug manufacturer or      ¦
                ¦         ¦          ¦labeler any payment or benefit of any kind in connection¦
                ¦§        ¦          ¦with the utilization of prescription drugs” by the      ¦
                ¦48-832.01¦Usage pass¦beneficiaries of a covered entity “shall pass that      ¦
                ¦(b)(2)   ¦back      ¦payment or benefit on in full to the covered entity.    ¦
                ¦         ¦          ¦This provision does not prohibit the covered entity from¦
                ¦         ¦          ¦agreeing by contract to ... return [ ] a portion of the ¦
                ¦         ¦          ¦benefit or payment to the [PBM].”                       ¦
                +---------+----------+--------------------------------------------------------¦
                ¦§        ¦Disclosure¦“Upon request by a covered entity” a PBM shall disclose ¦
                ¦48-832.01¦of        ¦“the quantity of drugs purchased by the covered entity  ¦
                ¦(c)(1)(A)¦purchases ¦and the net cost to the covered entity for the drugs.”  ¦
                +-----------------------------------------------------------------------------+
                 
                +-----------------------------------------------------------------------------+
                ¦§        ¦               ¦“Upon request by a covered entity” a PBM shall     ¦
                ¦48-832.01¦Disclosure of  ¦disclose the “terms and arrangements for           ¦
                ¦(c)(1)(B)¦terms          ¦remuneration” between the PBM and a drug           ¦
                ¦         ¦               ¦manufacturer or labeler.                           ¦
                +---------+---------------+---------------------------------------------------¦
                ¦§        ¦               ¦“Information designated [by a PBM] may not be      ¦
                ¦48-832.01¦Confidentiality¦disclosed by the covered entity ...”               ¦
                ¦(c)(2)   ¦               ¦                                                   ¦
                +---------+---------------+---------------------------------------------------¦
                ¦§        ¦               ¦                                                   ¦
                ¦48-832.01¦NA             ¦Repealed, 53 D.C.Reg. 6899, 6966 (2006).           ¦
                ¦(d)(1)   ¦               ¦                                                   ¦
                +---------+---------------+---------------------------------------------------¦
                ¦         ¦               ¦A PBM that dispenses a substitute drug that “costs ¦
                ¦§        ¦Disclosure of  ¦more than the prescribed drug shall disclose to the¦
                ¦48-832.01¦substitution   ¦covered entity the cost of both drugs and any      ¦
                ¦(d)(2)   ¦               ¦benefit or payment ... to the PBM as a result of   ¦
                ¦         ¦               ¦the substitution.”                                 ¦
                +---------+---------------+---------------------------------------------------¦
                ¦§        ¦Substitution   ¦A PBM “shall transfer in full to the covered entity¦
                ¦48-832.01¦pass back      ¦any benefit or payment received ... as the result  ¦
                ¦(d)(3)   ¦               ¦of [such] prescription drug substitution.”         ¦
                +---------+---------------+---------------------------------------------------¦
                ¦         ¦               ¦“Compliance with the requirements of [Title II] is ¦
                ¦§        ¦Compliance     ¦required in all contracts between a[PBM] and a     ¦
                ¦48-832.02¦               ¦covered entity entered into in the District of     ¦
                ¦         ¦               ¦Columbia ... executed after May 18, 2004.”         ¦
                +---------+---------------+---------------------------------------------------¦
                ¦         ¦               ¦“A violation of [§ 48-832] is a violation of [the  ¦
                ¦§        ¦Enforcement    ¦District of Columbia Consumer Protection Procedures¦
                ¦48-832.03¦               ¦Act], for which a fine of not more than $10,000 may¦
                ¦         ¦               ¦be adjudged.”                                      ¦
                +-----------------------------------------------------------------------------+
                

The PCMA, a national trade association representing PBMs, filed suit arguing Title II is pre-empted by ERISA. It also argued Title II is pre-empted by the Commerce Clause, and violates the First Amendment and the Takings Clause of the Fifth Amendment, of the Constitution of the United States. We held in PCMA v. District of Columbia, 522 F.3d 443 (2008), the Association is not collaterally estopped from bringing this suit by the decision of the First Circuit in PCMA v. Rowe, 429 F.3d 294 (2005), which rejected its argument that a similar Maine statute was pre-empted by ERISA. On remand the district court held Title II is pre-empted in its entirety by ERISA, and granted summary judgment for the PCMA, which the District now appeals.

II. Analysis

ERISA expressly pre-empts “any and all State laws insofar as they ... relate to any employee benefit plan.” 29 U.S.C. § 1144(a). Although “clearly expansive,” N.Y. State Conf. of Blue Cross &...

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