ORDER
Plaintiff Pharmaceutical Care Management Associations’s (PCMA) motion for summary judgment [Doc. No.'75] is granted in part and denied in part, and defendant Leslie Rutledge’s (State of Arkansas) motion for summary judgment [Doc. No. 77] is granted in part and denied in part. The joint motions to extend time [Doc. Nos. 103,104] are denied as moot, and this case is dismissed with prejudice.
I. BACKGROUND
Independent community pharmacies have had to eliminate employees during the last five to ten years due to the financial hardships they have faced. PL’s Resp. Def.’s Statement Material Fact ¶¶ 18, 22-24, 28, 44, Doc. No. 85-1. The Arkansas legislature passed and amended Arkansas Code Annotated section 17-92-507 et seq. in an attempt to address this issue. Act 1194 was passed in 2013 to “Provide for the Transparency of Maximum Allowable Cost Lists for Prescription Drugs,” S.B.
A. Act 900 of 2015
Act 900 amended Act 1194 in a number of ways. First, it defines “[pjharmacy acquisition cost” as “the amount that a pharmaceutical wholesaler charges for a pharmaceutical product as listed on the pharmacy’s billing invoice.” Ark. Code Ann. § 17-92-507(a)(6). Second, it provides that a pharmacy benefits manager (“PBM”) must:
[u]pdate its Maximum Allowable Cost List on a timely basis, but in no event longer than seven (7) calendar days from an increase of ten percent (10%) or more in the pharmacy acquisition cost from sixty percent (60%) or more of the pharmaceutical wholesaler doing business in the state or a change in the methodology on which the Maximum Allowable Cost List is based or in the value of a variable involved in the methodology.
Id. § 507(c)(2). Third, it requires a PBM to:
Provide a reasonable administrative appeal procedure to allow pharmacies to challenge maximum allowable costs and reimbursements made under a maximum allowable cost for a specific drug or drugs as: (a) not meeting the requirement of this section or (b) being below the pharmacy acquisition cost.
Id. § 507(c)(4)(A)(i). Fourth, it requires PBMs to permit the challenging pharmacy to reverse and rebill each claim affected by the inability to procure the drug at a cost that is equal to or less than the cost on the relevant maximum allowable cost (“MAC”) list where the drug is not available “below the pharmacy acquisition cost from the pharmaceutical wholesaler from whom the pharmacy or pharmacist purchases the majority of prescription drugs for resale.” Id. § 507(c)(4)(C)(iii). Fifth, it provides that a
pharmacy or pharmacist may decline to provide the pharmacy services to a patient or pharmacy benefits manager if, as a result of a Maximum Allowable Cost List, a pharmacy or pharmacist is to be paid less than the pharmacy acquisition cost of the pharmacy providing pharmacist services.
Id. § 17-92-507(e) (commonly known as the “decline-to-dispense” provision).
B. PCMA, MAC Lists, and Pharmaceutical Reimbursement Scheme
PCMA is a national trade association representing the eleven largest PBMs in the country. Def.’s Resp. Pl.’s Statement Material Fact ¶ 1, Doc. No. 89. None of PCMA’s member PBMs are incorporated in Arkansas, but they have contracts covering beneficiaries in Arkansas. Id. ¶ 19.
PBMs act as intermediaries between health plans and pharmacies. Generally, when a patient is prescribed a drug by a physician, the patient presents the prescription to a pharmacist. The pharmacist, who buys drugs from wholesalers, dispenses the drug to the patient. Often, the patient does not pay the full price that the pharmacist receives for the drug but instead pays a portion, or copay, if the patient is a member of a health plan that covers part of the drug’s cost.
The market for purchasing prescription drugs is national, id. ¶ 21, and PBMs perform such services as' processing claims, generating reports and data, and managing clinical and financial information as well as retail and mail-order drug sales. Pl.’s Resp. Def.’s Statement Material Fact ¶ 5. PBMs also calculate benefit levels and make disbursements. Def.’s Resp. Pl.’s
Contracts between PBMs and pharmacies create pharmacy networks. Def.’s Resp. Pl.’s Statement Material Fact ¶ 12. These contracts generally require pharmacies to fill prescriptions and dispense prescription medications regardless of the amount that the pharmacy will be reimbursed. Pl.’s Resp. Def.’s Statement Material Fact ¶81. These contracts also allow pharmacies to appeal unfavorable reimbursement decisions. Id. ¶ 75. PBMs often select pharmacies willing to take lower reimbursements in exchange for being placed in a preferred network and receiving patronage from beneficiaries of the plans serviced by the PBMs. Id. ¶ 80; Defi’s Resp. PL’s Statement Material Fact ¶ 13.
C. PCMA’s Challenge to Act 900
PCMA challenges Act 900 claiming that it (1) is preempted by ERISA; (2) is preempted by Medicare Part D; (3) violates the Commerce Clause of the United States Constitution; (4) violates the Contract Clauses of the United States Constitution and the Arkansas Constitution; and (5) is so vague as to violate the Due Process Clauses of the United States Constitution and the Arkansas Constitution. Both parties move for summary judgment on all claims.
II. LEGAL STANDARD
Summary judgment is appropriate when there is no genuine dispute as to any material fact and the moving party is entitled to judgment as a matter of law. See Fed. R. Civ. P. 56(a); Anderson v. Liberty Lobby Inc.,
III. DISCUSSION
A. ERISA Preemption
PCMA’s motion for summary judgment is granted on its claim that Act 900 is ERISA preempted, and the State of Arkansas’s motion is denied because Act 900 is invalid as applied to PBMs in their administration and management of ERISA plans.
Initially, a decision consistent with that reached by the Southern District of Iowa in Pharmaceutical Care Management Association v. Gerhart, No. 4:14-CV-000345,
In Gerhart, the Eighth Circuit held that Iowa Code section 510B.8, which is similar to Act 900 in many of the ways that it regulates PBMs and MAC pricing, is preempted by ERISA because it interferes with nationally uniform plan’ administration. Gerhart held that the Iowa statute interferes with uniform plan' administration by requiring PBMs, as third-party administrators, to provide a procedure by which pharmacies can contest and appeal MAC reimbursements because doing so restricts an administrator’s control in the calculation of drug benefits and removes the ability to conclusively determine final drug benefit payments and monitor funds. See id.,
Gerhart also held that the Iowa law interferes with uniform plan administration by restricting the class of drugs PBMs may place on MAC lists and by restricting the sources from which PBMs may obtain pricing information because both restrictions interfere with the calculation of benefit levels and with making disbursements.
Finally, Gerhart held that the Iowa statute interferes with uniform plan administration by requiring PBMs to report or disclose to pharmacies the economic bases of its MAC lists.
Because Act 900 regulates PBMs in ways fundamentally similar to the Iowa statute in Gerhart, Act 900 is preempted by ERISA. See
B. Medicare Part D Preemption
The State of Arkansas’s motion for summary judgment is granted on PCMA’s Medicare Part D preemption argument, and PCMA’s motion is denied because Act 900 does not act with respect to a standard established under Medicare Part D.
The Medicare statute provides that “[t]he standards established under this part shall supersede any State law or
PCMA asserts that Act 900 acts with respect to Part D’s “negotiated prices” standard, which requires beneficiaries to have access to “negotiated prices.” 42 U.S.C. § 1395w-102(d). The regulations accompanying this provision define “negotiated prices” as “prices for covered Part D drugs that ... the Part D sponsor (or other intermediary contracting organization) and the network dispensing pharmacy ... have negotiated as the amount such network entity will receive, in total, for a particular drug.” 42 C.F.R. § 423.100.
Act 900’s regulation of MAC pricing does not act with respect to Part D’s negotiated prices standard because the standard . excludes “additional . contingent amounts” that “increase prices and cannot reasonably be determined at the point of sale.” See id. If Act 900 has any effect on the price of a drug, it would be to increase the price, and because the increase would be contingent on the outcome of a MAC appeal, it is a contingent amount not able to be determined at the point of sale. Thus, Act 900 does not act with respect to Part D’s negotiated prices standard because the Part D standard excludes it from its scope.
PCMA also asserts that Act 900’s decline-to-dispense provision acts with respect to Part D’s “standards' for convenient access to network pharmacies.” 42 C.F.R, § 423.120(a)(1). These standards require Part D sponsors to structure their networks so that certain percentages of beneficiaries live within certain distances of a network pharmacy. See id. Act 900’s decline-to-dispense provision does not act with respect to Part D’s pharmacy-access standards because a pharmacy that declines to dispense a drug in anticipation of a negative reimbursement is not thereby transformed into an out-of-network pharmacy.
C, The Dormant Commerce Clause
The State of Arkansas’s motion for summary judgment is granted on PCMA’s Commerce Clause, claim, and PCMA’s motion is denied because Act 900 does not discriminate against out-of-state economic interests in favor of in-state economic interests and because any burden it imposes on interstate commerce is not “clearly excessive in relation to the putative local benefits.” U & I Sanitation v. City of Columbus,
The Commerce Clause, intended to create an area of free trade among the states, gives Congress the power to regulate interstate commerce. U.S. Const, art. I, § 8, cl. 3; McLeod v. J. E. Dilworth Co.,
Act 900 does not overtly discriminate against interstate commerce. A law discriminates against interstate commerce when it “favors in-state economic interests over their out-of-state counterparts.” Oregon Waste Sys., Inc. v. Dep’t of Envtl. Quality of State of Oregon,
PCMA asserts Act 900 creates impermissible economic protectionism in favor of pharmacies, but “[t]he fact that the burden of a state regulation falls on some interstate companies does not, by itself, establish a claim of discrimination against interstate commerce.” Exxon Corp. v. Governor of Maryland,
Notwithstanding its facially nondiscriminatory status, Act 900 still may incidentally burden interstate commerce. See Ben Oehrleins & Sons & Daughter, Inc. v. Hennepin Cty.,
Act 900’s putative local benefit is legitimate. Independent community pharmacies in Arkansas are in economic distress, PL’s Resp. Def.’s Statement Material Fact ¶¶ 18, 22-24, 28, 44, and the parties agree that Act 900’s purpose is to protect pharmacies. See PL’s Mem. Supp. Summ. J., Doc. No. 75-1 at 26; Def.’s Reply Pl.’s Resp. Defi’s Mot. Summ. J. ¶ 14, Doc. No. 92. The parties agree that the Arkansas legislature considered whether unfair MAC methodologies are resulting in pharmacies closing down, especially in rural areas. The parties agree that approximately 44% of Arkansans live in rural areas. PL’s Resp. Def.’s Statement Material Fact
As for burdens, PCMA asserts that Act 900 forces PBMs to choose between applying a new, uniform business model nationwide; suffering administrative costs by adopting state-specific practices when doing business in Arkansas; or abstaining entirely from conducting business in Arkansas. The possible effects of Act 900 on the administrative costs or on the profits of PBMs is not a cognizable burden under the Commerce Clause, and even if it was, the burden to interstate commerce would not be clearly excessive relative to Act 900’s presumed local benefit. See Rowe,
PCMA asserts that Act 900’s decline-to-dispense provision burdens interstate commerce because it will prevent people who are employed by companies outside the state from buying prescriptions at pharmacies inside the state. Even if this assertion is accepted as true, PCMA acknowledges that “pharmacies receive less than their acquisition cost in a very small number of prescriptions dispensed.” Pl.’s Statement Material Fact ¶ 10; Pl.’s Resp. Defi’s Statement Material Fact ¶ 40 (undisputed that pharmacists experience approximately 10% of reimbursements below cost). Act 900 also requires PBMs to timely update their MAC lists and to provide an appeals procedure, both of which further reduce the likelihood of negative reimbursements. For these reasons, Act 900’s burden on interstate commerce does not clearly outweigh its presumed local benefit.
D. State and Federal Contract Clauses
The State of Arkansas’s motion for summary judgment is granted, and PCMA’s motion is denied because Act 900 does not substantially impair preexisting contractual relations.
The United States Constitution and the Arkansas Constitution prohibit the passing of laws that impair the “obligation of contracts.” Consequently, these issues will be analyzed together. U.S. Const, art. I, § 10; Ark. Const, art. II, § 17; see E. Poinsett Cty. Sch. Dist. No. 14 v. Massey,
To violate the Contract Clause, a state law must substantially impair preexisting contractual relationships. Equipment Mfrs. Inst. v. Janklow,
PCMA asserts that Act 900 impairs contractual relations between both PBMs and pharmacies and between PBMs and their client health plans in the context , of MAC pricing, appeals, and guaranteed dispensing.. The record is unclear as to whether any unexpired contracts between PBMs and pharmacies or between PBMs and health plans, which were entered prior to July 22, 2015, still exist. Accordingly, a substantive Contract • Clause analysis follows.
Whether a contractual impairment is substantial depends primarily on the nature of the impairment and the extent to which it disrupts reasonable contractual expectations. Janklow,
PCMA asserts that because pharmacy contracts and health plan contracts tie generic drug reimbursements to a specified MAC list, Act 900 substantially impairs those contracts because it requires PBMs to reimburse pharmacies according to the pharmacy’s acquisition cost instead of according to MAC lists and because health plans will have to pay a cost-based price rather than a MAC price. Act 900, however, does not require PBMs to reimburse pharmacies for the price listed on their wholesaler invoices rather than MAC. Acquisition cost is the standard by which an appeal may be initiated, but Act 900 provides that an appeal of a negative MAC reimbursement may be denied if certain criteria are met. Acquisition price becomes the reimbursement standard only if a PBM cannot satisfy section 507(c)(4)(C)(iii). Further, it is undisputed that “pharmacies receive less than their acquisition cost in a very small number of prescriptions dispensed.” PL’s Statement Material Fact ¶ 10; PL’s Resp. Def.’s Statement Material Fact ¶40. Accordingly, Act 900.does not substantially impair preexisting contracts.
Additionally, the appeals procedure imposed by Act 900 does not disrupt reasonable contractual expectations because contracts. between- PBMs and pharmacies generally provide a procedure for appealing MAC reimbursements, PL’s Resp. Def.’s Statement Material Fact ¶ 75; Def.’s Resp. PL’s Statement Material Fact ¶14. Although PBM contracts generally provide that a pharmacist must accept whatever reimbursement a .PBM deter
Past industry regulation also suggests that PBMs could not have reasonably expected that their reimbursement practices would escape regulation forever. First, the pharmaceuticals industry is already highly regulated. Bober v. Glaxo Wellcome PLC,
Even if Act 900 substantially impairs preexisting contracts, it still does not,violate the Contract Clause because its purpose, as previously established, is legitimate. See id. at 450-51. It is undisputed that Arkansas pharmacies were in economic distress, that MAC lists are confidential and unregulated, and that contracts allow PBMs to reimburse pharmacies for generic drugs in any manner they see fit. See PL’s Resp. Def.’s Statement Material Fact, ¶¶59, 61, 81. As PCMA asserts, leveling the playing field between contracting parties is not a legitimate purpose, but protecting basic societal interests is. Energy Reserves Group, Inc.,
The decline-to-dispense provision does not change the outcome because “pharmacies receive less than their acquisition cost in a very small number of prescriptions dispensed.” Pl.’s Statement Material Fact ¶ 10; Pl.’s Resp. Def.’s Statement Material Fact ¶ 40. Act 900 requires PBMs to timely update their MAC lists and to provide an appeals procedure, both of which reduce the likelihood of negative reimbursements even further. Given these considerations, the decline-to-dispense provision does not substantially impair preexisting contractual relationships, nor is it an unreasonable way of accomplishing its legitimate purpose of protecting local pharmacies access.
E. Vagueness Under State and Federal Due Process Clauses
The State of Arkansas’s motion for summary judgment is granted, and PCMA’s motion is denied on PCMA’s facial void-for-vagueness challenge because Act 900 gives fair notice of what is required.
No state can “deprive any person of life, liberty or property, without due process of law.” U.S. Const, amend. XIV, § 1; Ark. Const, art. II, § 8. Statutes violate due process when they fail to sufficiently define prohibited conduct so that a person of ordinary intelligence can understand what conduct is prohibited. Woodis v. Westark Cmty. Coll.,
Generally, “[w]hen a state statute is challenged on its face as unconstitutionally vague, and no First Amendment interests are imperiled, that assertion is far too broad.” Reprod. Health Servs. of Planned Parenthood of St. Louis Region, Inc. v. Nixon,
PCMA takes issue with Act 900’s “MAC Update Provision,” which requires a PBM to
Update its Maximum Allowable Cost List on a timely basis, but in no event longer than seven (7) calendar days from an increase of ten percent (10%) or more in the pharmacy acquisition cost from sixty percent (60%) or more of the pharmaceutical wholesaler [sic] doing business in the state....
According to PCMA, “PBMs have no way to know when their obligations under Act 900’s MAC Update Provision are triggered” because “the statute does not specify whether sixty percent should be calculated by reference to the volume of drug sales or the number of wholesalers.” Pl.’s Mem. Supp. Summ. J., Doc. No. 75-1 at 33. PCMA correctly acknowledges in subsequent briefing, however, that “[t]he plain language of the law requires a PBM to change [its] MAC list when sixty percent of [the] pharmacy wholesalers doing business in Arkansas have an increase in prices” and that the volume of business is “irrelevant” under this language. PL’s Opp. Def.’s Mot. Summ. J., Doc. No. 85 at 37. Thus, PCMA seems to have resolved its vagueness issue, and in any case, the language of the MAC Update Provision is reasonably clear.
To the extent that this language is unclear, no criminal penalties would attach to a PBM in violation of Act 900. This is true because a criminal penalty attaches only if the Arkansas Deceptive Trade Practices Act is violated by a deceptive trade practice that is committed “knowingly and willfully.” Ark. Code Ann. § 4-88-103; see Vill. of Hoffman Estates,
PCMA further argues that even if a PBM could determine what constitutes 60% of wholesalers, it still cannot determine what those wholesalers’ prices are because PBMs do not have access to wholesaler price lists. Pl.’s Mem. Supp. Summ. J., Doc. No. 75-1 at 33-34. In addition to implicitly admitting that PBMs can reasonably understand what Act 900 requires of them, this argument does not present an issue of vagueness. Instead, it addresses whether a PBM can comply with Act 900. The question of “vagueness” asks whether the law itself defines illegal behavior sufficiently, Woodis,
PCMA further asserts that it cannot comply with Act 900 because gathering the data needed would be an “insurmountable act.” Pl. Resp. Def.’s Statement Material Facts ¶ 72 (undisputed that Optum Rx, a PBM, has not explored the possibility of obtaining a direct data feed with wholesalers). But, MAC “methodologies are based upon the market intelligence that the PBMs have devised as their way of accounting for actual acquisition costs....” Id. ¶ 60. PBMs also have access to wholesale pricing information via Medispan and, in some instances, via automated data feed access directly to individual wholesalers. Id. ¶¶ 69-71. Whether PBMs have the ability to comply with the law’s reasonably clear requirements, though disputed, is not an issue of vagueness and remains to be determined.
IV. CONCLUSION
For these reasons, PCMA’s motion for summary judgment [Doc. No. 75] is granted on PCMA’s ERISA claim because act 900 is invalid as applied to PBMs in their administration and management of ERISA plans. The government’s motion for summary judgment [Doc. No. 77] is granted on all other claims. The joint motions to extend time [Doc. Nos. 103, 104] are denied
IT IS SO ORDERED this 1st day of March 2017.
