Opinion for the Court filed by Circuit Judge GINSBURG.
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,
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_
§ 48-832.01 Fiduciary duty A PBM “owes a fiduciary (a) duty to a covered entity. In performance of that duty [it] shall adhere to the practices in this _section.”_
§ 48-832.01 Fiduciary A PBM “shall ... (b) (1)(A) standard Perform its duties ... in accordance with the standards of conduct applica_ble to a fiduciary.”_
§ 48-832.01 NA Repealed, 53 D.C.Reg. (b)(1)(B)_6899, 6966 (2006).
§ 48-832.01 Disclosure of A PBM shall “notify the (b)(1)(C) conflicts covered entity in writing of ... any conflict of interest with the duties _imposed by” Title II.
§ 48-832.01 Usage pass A PBM “that receives (b)(2) back from any drug manufacturer or labeler any payment or benefit of any land in connection with the utilization of prescription drugs” by the beneficiaries of a covered entity “shall pass that 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].”_
§ 48-832.01 Disclosure of “Upon 2-equest by a eov(c)(1)(A) pur-chases ei-ed entity” a PBM shall disclose “the quantity of di-ugs pui-ehased by the covered entity and the net cost to the eovei-ed _entity for the drugs.”
§ 48-832.01 Disclosure of “Upon request by a cov(c)(1)(B) tei-ms ered entity” a PBM shall disclose the “tei-ms and arrangements for l-emunei-ation” between the PBM and a drug manu_factui-er or labeler._
§ 48-832.01 Confidentiality “Information designated (c) (2) [by a PBM] may not be disclosed by the cover'ed _entity ,, ”_
§ 48-832.01 NA Repealed, 53 D.C.Reg. (d) (1)_6899, 6966 (2006).
§ 48-832.01 Disclosm-e of A PBM that dispenses a (d)(2) substitution substitute drag that “costs moi-e than the p2-esc2-ibed drug shall disclose to the covered entity the cost of both drugs and any benefit or payment ... to the PBM as a result of the substi_tution.”_
§ 48-832.01 Substitution A PBM “shall transfer in (d)(3) pass back full to the cover-ed entity any benefit or payment i-eceived ... as the r-esult of [such] pi-escr-iption _drug substitution.”_
§ 48-832.02 Compliance “Compliance with the requii-ements of [Title II] is r-equii-ed in all contracts between a[PBM] and a covei-ed entity entered into in the District of Columbia .. executed _after May 18, 2004,”
§ 48-832.03 Enfor-cement “A violation of [§ 48-832] is a violation of [the Disti-ict of Columbia Consumer Pr-otection Procedur-es Act], for which a fine of not mor-e 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 Com
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 & Blue Shield Plans v. Travelers Ins.,
A state law “relates to” an EBP “if it [1] has a connection with or [2] reference to such a plan.”
Egelhoff v. Egelhoff,
A. “Connection with” an EBP
In addressing whether a state law has a “connection with” an EBP, the Supreme Court noted that term “is scarcely more restrictive than [the statutory term] ‘relate to,’ ” and “cautioned against an ‘uncritical literalism’ that would make preemption turn on ‘infinite connections.’ ”
Egelhoff,
1. Objectives of ERISA
The PCMA argues Title II “intrudes into areas of express ERISA concern” because it regulates a PBM’s administration of benefits on behalf of an EBP. The administration of employee benefits clearly is an “area of core ERISA concern,”
Egelhoff,
We also agree with the PCMA, and with the district court,
The District does not deny the administration of employee benefits is an area of core ERISA concern or that PBMs administer benefits on behalf of EBPs; indeed at oral argument it conceded as much. Oral arg. at 4:00, 16:55. Rather, the District argues the various provisions of Title II nonetheless fall within the scope of state law the Congress did not intend to preempt with ERISA because they do not regulate “relationships among ERISA entities,” such as a plan and an ERISA fiduciary or a plan and its beneficiaries. The District points to no support for this limitation upon pre-emption either in ERISA itself or in any Supreme Court case interpreting it. Instead, the District relies upon decisions of other circuits holding ERISA did not pre-empt breach of contract or professional malpractice claims against third-parties who provided services to an EBP.
As the PCMA points out, in none of the cases cited by the District did the state law regulate a third party who administered employee benefits on behalf of a plan. Those cases therefore suggest only that the relationship among ERISA entities is an area of ERISA concern, not that the objective of uniformity in plan administration is for some reason inapplicable simply because a plan has contracted with a third party to provide administrative services. Indeed, dicta in two cases central to the District’s argument suggest a state law regulating a third party’s performance of administrative functions on behalf of a plan could be pre-empted.
See Gerosa v. Savasta & Co.,
In sum, § 48-832.01(a), (b)(1)(A), (b)(1)(C), (b)(2), (c)(1)(A), (c)(1)(B), (d)(2), and (d)(3) touch upon “a central matter of plan administration,”
Egelhoff,
2. Effect upon EBPs
The precise point at which a state law so constrains an ERISA plan’s choices as to undermine the goal of uniformity in plan administration is uncertain.
Shaw,
The District argues Title II does not have an impermissible constraining effect upon EBPs because the statute offers “clear benefit[s]” that an EBP may “simply decline.” In this regard the District relies upon
Rowe,
in which the First Circuit held a substantively identical Maine statute was not pre-empted because, “[a]l-though the ERISA plans can re-evaluate their working relationships with the PBMs if they wish in light of the [state law], nothing in [that law] compels them to do so.... The plan administrators here have a free hand to structure the plans as they wish in Maine.”
The District’s point is well-taken with regard to the usage pass back provision, § 48-832.01(b)(2), because it expressly provides that it “does not prohibit the covered entity from agreeing by contract to compensate the [PBM] by returning a portion of the benefit or payment,” and
To be sure, the procedure for opting out of a state law may so affect plan administration as not to save the statute from pre-emption.
See Egelhoff,
At oral argument the District took the position for the first time that an EBP can also waive the other provisions of Title II. In the supplemental brief we requested, the District backtracked, conceding § 48-832.01(b)(1)(C) (disclosure of conflicts of interest) and (d)(2) (disclosure of PBM’s gains from substituting drugs) cannot be waived, arguing § 48-832.01(d)(3) (substitution pass back) can be waived, and remaining silent as to whether § 48-832.01(a) (fiduciary duty) and (b)(1)(A) (fiduciary standard of conduct) can be waived.
The District’s belated interpretation of Title II is inconsistent with both the text and the declared purpose of that statute. As for text, none of the provisions the District now argues may be waived says or implies anything about the possibility of waiver. When contrasted with the provisions that expressly allow for waiver, that silence presumably bespeaks the intent of the D.C. Council to make the other provisions non-waivable.
See Russello v. United States,
As to purpose, this interpretation is bolstered by § 48-832.03, which provides a violation of Title II is a violation of the District of Columbia Consumer Protection Procedures Act, D.C.Code §§ 28-3901 to - 3913, enforceable by the Attorney General, § 28-3909, or by any “person, whether acting for the interests of itself, its members, or the general public,” § 28-3905(k)(i). If § 48-832.01(a), (b)(1), and (d) could be waived by an EBP, then they would not protect the interests of third parties, such as plan beneficiaries, and it
Affordability is critical in providing access to prescription drugs for District of Columbia residents. Access Rx enables the District to take steps to make prescription drugs more affordable for qualified District residents....
§ 48 — 831.01(1H2). If Title II could be waived in its entirety by an EBP, then the District would not be able to “take steps” on behalf of plan beneficiaries in precisely those circumstances at which the statute is aimed, i.e., where the contract between the EBP and the PBM is, in its view, insufficiently protective of the beneficiaries.
Although the District argues ambiguity in a state law should be resolved against pre-emption, here the D.C. Council has sounded no “uncertain trumpet,”
Vote Choice, Inc. v. DiStefano,
The District argues § 48-832.01(a), (b)(1), and (d) nonetheless leave plan administrators with “a free hand to structure the plans as they wish,”
Rowe,
The Supreme Court has not prescribed a standard for determining whether a state law sufficiently constrains an EBP’s decision-making in an area of ERISA concern that the law is pre-empted, but it has indicated a law that “bind[s] plan administrators to any particular choice” is preempted.
Travelers,
The District would have us abjure this conclusion on the ground that “the [ ] standards of conduct, requirements of transparency, and restrictions on self-dealing [imposed upon a PBM by Title II] are not qualitatively different from” laws regulating others who provide services to an EBP, such as accountants, lawyers, and securities dealers; its point is that if Title II is pre-empted by ERISA because it has
A dictum in
Egelhoff
suggests there may be an exception to pre-emption under ERISA for long-standing and widely observed state laws.
B. PCMA’s Other Arguments
The PCMA raises two alternative statutory grounds for affirming the judgment of the district court as to the provisions of Title II that an EBP can waive,
viz.,
§ 48-832.01(b)(2) (usage pass back) and (c) (disclosures upon request). Specifically, it argues every part of Title II is pre-empted by ERISA both because Title II has a “reference to” a plan and therefore “relates to” an EBP and because it creates an enforcement mechanism alternative to that provided in ERISA itself. Although the district court did not reach these arguments because it held Title II was preempted in its entirety by reason of a “connection with” an EBP,
As the Supreme Court has explicated the phrase, a law makes “reference to” a plan “[w]here [it] acts immediately and exclusively upon ERISA plans ... or where the existence of ERISA plans is essential to the law’s operation.”
Dillingham,
Nor does either provision create an enforcement mechanism for the rights provided by ERISA. Rather, each creates an enforceable but “independent legal duty” — to pass back or upon request to disclose certain information — separate from any duty created by ERISA.
Aetna Health Inc. v. Davila,
III. Conclusion
Section 48-832.01(a), (b)(1), and (d) of Title II require an EBP that outsources the administration of its pharmaceutical benefits in the District of Columbia do so in a particular way. Those provisions have a “connection with” and therefore “relate to” an EBP and are pre-empted by ERISA. * Because an EBP readily may avoid the default terms of § 48-832.01(b)(2) and (c) by contract, and because those provisions do not make “reference to” ERISA plans or create an enforcement mechanism for the rights provided by ERISA, they are not preempted by ERISA.
The PCMA raised several constitutional arguments for pre-emption not reached by the district court. Because the parties have not briefed them at any length, we leave those issues, as they relate to the provisions we have held are not pre-empted by ERISA and the application of Title II to covered entities that are not EBPs, for the district court to consider in the first instance. Accordingly, the judgment of the district court is affirmed in part and reversed in part, and this matter is remanded to the district court for further proceedings consistent herewith.
So ordered.
Notes
This holding differs from that of the First Circuit in
Rowe,
which held no part of a nearly identical Maine statute was pre-empted by ERISA.
See
