Pharm. Care Mgmt. Ass'n v. Tufte
This text of 297 F. Supp. 3d 964 (Pharm. Care Mgmt. Ass'n v. Tufte) is published on Counsel Stack Legal Research, covering United States District Court primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Opinion
Daniel L. Hovland, Chief Judge
Before the Court is the Plaintiff's "Emergency Motion for a Temporary Restraining Order and Preliminary Injunction" filed on July 20, 2017. See Docket No. 10. In its motion, the Plaintiff requested the Court temporarily restrain and preliminarily enjoin Defendants from enforcing North Dakota Senate Bills 2258 and 2301. On July 27, 2017, the parties submitted a joint stipulation in which the Plaintiff withdrew its request for a temporary restraining *970order, in order to give the Court additional time to address the merits of the request for preliminary injunctive relief. See Docket No. 18. On July 28, 2017, the Court found as moot the Plaintiff's motion for a temporary restraining order. See Docket No. 19. On August 22, 2017, a hearing was held regarding the preliminary injunction. See Docket No. 24. For the reasons set forth below, the Court denies the Plaintiff's motion for a preliminary injunction.
I. BACKGROUND
The Plaintiff, Pharmaceutical Care Management Association (PCMA), is a national trade association representing pharmacy benefit managers (PBMs), with its principal place of business in Washington, D.C. See Docket No. 1. PBMs are third-party health plan administrators which manage and administer prescription drug benefits on behalf of health insurance plans. Retail pharmacies purchase prescription drugs from wholesalers or manufacturers to fill health plan participants' prescriptions. When a plan participant (a patient or consumer) fills a prescription, the pharmacy contacts the PBM to obtain the participant's coverage and copayment information. After the prescription is filled, the PBM reimburses the pharmacy at a contractually-agreed upon rate. The PBM then bills the health plan, which provides the participant's insurance, at a rate negotiated between the PBM and the health plan. This role renders the PBM a third-party health plan administrator.
In April 2017, North Dakota State Governor Doug Burgum signed into law S.B. 2258 and S.B. 2301, which were to become effective August 1, 2017.1 See S.B. 2258, 2017 Leg., 65th Sess. (ND 2017); S.B. 2301, 2017 Leg., 65th Sess. (ND 2017). Among other things, these laws will regulate how PBMs categorize prescription drugs and also require PBMs to make certain cost disclosures to network pharmacies and plan participants. PCMA highlights the following provisions2 as concerning:
• S.B. 2258 § 1(2) prohibits PBMs and third-party payers from charging pharmacies certain fees, including fees that are imposed after the point of sale, not reported on the remittance advice for a claim, or are not apparent at the time of claim processing.
• S.B. 2258 § 1(3) limits the fees PBMs and third-party payers may impose based on pharmacy performance standards.
• S.B. 2258 § 1(4) bars PBMs and third-party payers from "redac[ting] the adjudicated cost," or the amount the PBM or third-party payer reimburses a pharmacy for a prescription.
• S.B. 2258 § 1(6) allows pharmacists or pharmacies belonging to a pharmacy service administration organization to receive a copy of contracts the pharmacy service administration organization entered into with a *971pharmacy benefits manager or third-party payer on their behalf.
• S.B. 2258 § 1(7) allows pharmacies to disclose "relevant" information to patients, including reimbursement information, and prohibits contracts between PBMs and pharmacies that prevent such disclosure.
• S.B. 2258 § 1(8) authorizes pharmacies to "mail or deliver drugs to a patient as an ancillary service of a pharmacy."
• S.B. 2258 § 1(9) prohibits contracts which provide that a pharmacy may not charge a shipping and handling fee to a patient.
• S.B. 2258 § 1(10) prohibits PBM or third-party payers from imposing accreditation and recertification standards beyond preexisting federal and state licensing requirements.
• S.B. 2301 § 1(2) obligates PBMs and third-party payers having ownership interest in a pharmacy to disclose the difference between the amount paid to the pharmacy and the amount charged to the plan sponsor on request.
• S.B. 2301 § 1(3) prohibits PBMs from having an ownership interest in patient assistance programs or mail-order specialty pharmacy unless the PBM agrees "not to participate in a transaction that benefits the PBM instead of another person owed a fiduciary duty."
• S.B. 2301 § 1(5) authorizes pharmacies to dispense "any and all drugs allowed" under its license.
• S.B. 2301 § 1(11) prohibits a PBM or third-party payer from imposing accreditation standards beyond preexisting federal and state licensing requirements.
See Docket No. 1, pp. 6-8; see also S.B. 2258 and 2301.
On July 11, 2017, PCMA filed a complaint against State Health Officer Mylynn Tufte; Executive Director of the North Dakota Board of Pharmacy, Mark J. Hardy; President of the North Dakota Board of Pharmacy, Fran Gronberg; and Attorney General Wayne Stenehjem. See Docket No. 1. PCMA argues the new laws, which were scheduled to go into effect on August 1, 2017, place restrictions and requirements on PBMs that impermissibly reference or are connected with health plans under the Employee Retirement Income Security Act of 1974 ("ERISA"),
II. STANDARD OF REVIEW
PCMA seeks to obtain a preliminary injunction pursuant to Rule 65(b) of the Federal Rules of Civil Procedure. Rule 65(b) directs the court to look to the specific facts shown by an affidavit to determine whether immediate and irreparable injury, loss, or damage will result to the applicant. It is well-established in the Eighth Circuit Court of Appeals that a court is required to consider the factors set forth in Dataphase Systems, Inc. v. C L Systems, Inc.,
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Daniel L. Hovland, Chief Judge
Before the Court is the Plaintiff's "Emergency Motion for a Temporary Restraining Order and Preliminary Injunction" filed on July 20, 2017. See Docket No. 10. In its motion, the Plaintiff requested the Court temporarily restrain and preliminarily enjoin Defendants from enforcing North Dakota Senate Bills 2258 and 2301. On July 27, 2017, the parties submitted a joint stipulation in which the Plaintiff withdrew its request for a temporary restraining *970order, in order to give the Court additional time to address the merits of the request for preliminary injunctive relief. See Docket No. 18. On July 28, 2017, the Court found as moot the Plaintiff's motion for a temporary restraining order. See Docket No. 19. On August 22, 2017, a hearing was held regarding the preliminary injunction. See Docket No. 24. For the reasons set forth below, the Court denies the Plaintiff's motion for a preliminary injunction.
I. BACKGROUND
The Plaintiff, Pharmaceutical Care Management Association (PCMA), is a national trade association representing pharmacy benefit managers (PBMs), with its principal place of business in Washington, D.C. See Docket No. 1. PBMs are third-party health plan administrators which manage and administer prescription drug benefits on behalf of health insurance plans. Retail pharmacies purchase prescription drugs from wholesalers or manufacturers to fill health plan participants' prescriptions. When a plan participant (a patient or consumer) fills a prescription, the pharmacy contacts the PBM to obtain the participant's coverage and copayment information. After the prescription is filled, the PBM reimburses the pharmacy at a contractually-agreed upon rate. The PBM then bills the health plan, which provides the participant's insurance, at a rate negotiated between the PBM and the health plan. This role renders the PBM a third-party health plan administrator.
In April 2017, North Dakota State Governor Doug Burgum signed into law S.B. 2258 and S.B. 2301, which were to become effective August 1, 2017.1 See S.B. 2258, 2017 Leg., 65th Sess. (ND 2017); S.B. 2301, 2017 Leg., 65th Sess. (ND 2017). Among other things, these laws will regulate how PBMs categorize prescription drugs and also require PBMs to make certain cost disclosures to network pharmacies and plan participants. PCMA highlights the following provisions2 as concerning:
• S.B. 2258 § 1(2) prohibits PBMs and third-party payers from charging pharmacies certain fees, including fees that are imposed after the point of sale, not reported on the remittance advice for a claim, or are not apparent at the time of claim processing.
• S.B. 2258 § 1(3) limits the fees PBMs and third-party payers may impose based on pharmacy performance standards.
• S.B. 2258 § 1(4) bars PBMs and third-party payers from "redac[ting] the adjudicated cost," or the amount the PBM or third-party payer reimburses a pharmacy for a prescription.
• S.B. 2258 § 1(6) allows pharmacists or pharmacies belonging to a pharmacy service administration organization to receive a copy of contracts the pharmacy service administration organization entered into with a *971pharmacy benefits manager or third-party payer on their behalf.
• S.B. 2258 § 1(7) allows pharmacies to disclose "relevant" information to patients, including reimbursement information, and prohibits contracts between PBMs and pharmacies that prevent such disclosure.
• S.B. 2258 § 1(8) authorizes pharmacies to "mail or deliver drugs to a patient as an ancillary service of a pharmacy."
• S.B. 2258 § 1(9) prohibits contracts which provide that a pharmacy may not charge a shipping and handling fee to a patient.
• S.B. 2258 § 1(10) prohibits PBM or third-party payers from imposing accreditation and recertification standards beyond preexisting federal and state licensing requirements.
• S.B. 2301 § 1(2) obligates PBMs and third-party payers having ownership interest in a pharmacy to disclose the difference between the amount paid to the pharmacy and the amount charged to the plan sponsor on request.
• S.B. 2301 § 1(3) prohibits PBMs from having an ownership interest in patient assistance programs or mail-order specialty pharmacy unless the PBM agrees "not to participate in a transaction that benefits the PBM instead of another person owed a fiduciary duty."
• S.B. 2301 § 1(5) authorizes pharmacies to dispense "any and all drugs allowed" under its license.
• S.B. 2301 § 1(11) prohibits a PBM or third-party payer from imposing accreditation standards beyond preexisting federal and state licensing requirements.
See Docket No. 1, pp. 6-8; see also S.B. 2258 and 2301.
On July 11, 2017, PCMA filed a complaint against State Health Officer Mylynn Tufte; Executive Director of the North Dakota Board of Pharmacy, Mark J. Hardy; President of the North Dakota Board of Pharmacy, Fran Gronberg; and Attorney General Wayne Stenehjem. See Docket No. 1. PCMA argues the new laws, which were scheduled to go into effect on August 1, 2017, place restrictions and requirements on PBMs that impermissibly reference or are connected with health plans under the Employee Retirement Income Security Act of 1974 ("ERISA"),
II. STANDARD OF REVIEW
PCMA seeks to obtain a preliminary injunction pursuant to Rule 65(b) of the Federal Rules of Civil Procedure. Rule 65(b) directs the court to look to the specific facts shown by an affidavit to determine whether immediate and irreparable injury, loss, or damage will result to the applicant. It is well-established in the Eighth Circuit Court of Appeals that a court is required to consider the factors set forth in Dataphase Systems, Inc. v. C L Systems, Inc.,
*972Preliminary injunctive relief is an "extraordinary and drastic remedy." Munaf v. Geren,
III. LEGAL DISCUSSION
PCMA argues S.B. 2258 and S.B. 2301 are preempted by ERISA and Medicare Part D, as those federal laws each contain provisions providing that any state laws relating to them will be superseded by each of them respectively. PCMA argues S.B. 2258 and S.B. 2301 impermissibly regulate ERISA and Medicare Part D health plans by regulating third-party payers and PBMs. According to PCMA, North Dakota's statutory definitions of third-party payers and PBMs are broad enough to encompass ERISA and Medicare Part D health plans. Therefore, PCMA argues, any laws regulating third-party payers and PBMs, as they are statutorily defined, necessarily include ERISA and Medicare Part D health plans, and are therefore preempted by federal law.
A. ERISA PREEMPTION
ERISA comprehensively regulates, among other things, employee welfare benefit plans that "through the purchase of insurance or otherwise," provide medical, surgical, or hospital care, or benefits in the event of sickness, accident, disability, or death.
protect ... participants in employee benefit plans and their beneficiaries, by requiring the disclosure and reporting to participants and beneficiaries of financial and other information with respect thereto, by establishing standards of conduct, responsibility, and obligation for fiduciaries of employee benefit plans, and by providing for appropriate remedies, sanctions, and ready access to the Federal courts.
"To meet the goals of a comprehensive and pervasive Federal interest and the interests of uniformity with respect to interstate [health] plans, Congress included an express preemption clause in ERISA for the displacement of State action in the field of private employee benefit programs." Minn. Chapter of Associated Builders & Contractors, Inc. v. Minn. Dep't of Pub. Safety,
Courts have struggled to reconcile the sweeping language of ERISA's preemption clause with the assumption that Congress does not intend to bar state action in fields of traditional state regulation or historic police powers. See New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co.,
The preemption clause specifically provides that ERISA "shall supersede any and all State laws insofar as they may now or hereafter relate to any employee benefit plan[.]"
1. Likelihood of Success on the Merits
The Eighth Circuit Court of Appeals has held that the likelihood of success on the merits is the "most significant" of the four factors to be considered by the district court in considering preliminary injunctive relief. S & M Constructors, Inc. v. Foley Co.,
PCMA asserts it is likely to prevail on its claim against the Defendants because controlling precedent in the Eighth Circuit requires finding S.B. 2258 and 2301 are expressly preempted by ERISA. See Docket No. 10-1, p. 7. PCMA points specifically to Pharm. Care Mgmt. Ass'n v. Gerhart,
Preemption claims turn on congressional intent.
*974Cipollone v. Liggett Group, Inc.,
[When] Congress has expressly included a broadly worded pre-emption provision in a comprehensive statute such as ERISA, our task of discerning congressional intent is considerably simplified. In § 514(a) of ERISA, as set forth in29 U.S.C. § 1144 (a), Congress provided:
Except as provided in subsection (b) of this section, the provisions of this subchapter and subchapter III of this chapter shall supersede any and all State laws insofar as they may now or hereafter relate to any employee benefit plan described in section 1003(a) of this title and not exempt under section 1003(b) of this title.
Ingersoll-Rand,
a. Whether there is a "reference to" ERISA in S.B. 2258 and S.B. 2301
Under the "reference to" inquiry, the Supreme Court has preempted state laws that (1) imposed requirements by reference to ERISA covered programs4 ; (2) specifically exempted ERISA plans from an otherwise generally applicable statute; and (3) premise a cause of action on the existence of an ERISA plan. Prudential,
The parties seem to agree and the Court finds that neither S.B. 2258 nor S.B. 2301 contain an explicit reference to ERISA. Nowhere in either bill's language is ERISA explicitly mentioned, discussed, defined, or excluded. Therefore, the Court finds no explicit "reference to" ERISA. PCMA argues, however, that both S.B. 2258 and S.B. 2301 contain implicit references to ERISA because, within each bill, PBMs, third party payers, and plan sponsors are defined broadly enough to implicate ERISA health plans.
Both S.B. 2258 and S.B. 2301 explicitly provide that "pharmacy benefit manager," as used within each bill, has the same definition as in N.D.C.C. § 19-03.6-01. See S.B. 2258 § 1 (1)(a) and S.B. 2301 § 1 (1)(a); see also N.D.C.C. §§ 19-02.1-14.2(1)(d) and 19-02.1-16.1(1)(a). "Pharmacy benefits manager" is defined as:
"Pharmacy benefits manger" means a person that performs pharmacy benefits management and includes any other person *975acting for such person under a contractual or employment relationship in the performance of pharmacy benefits management for a managed care company, nonprofit hospital or medical service organization, insurance company, third-party payer, or health program administered by a state agency.
See N.D.C.C. § 19-03.6-01(4) (emphasis added).
PCMA argues S.B. 2258 and S.B. 2301 attempt to regulate PBMs, and some of these PBMs provide services for ERISA health plans. Therefore, PCMA argues, the bills both implicitly reference ERISA. However, the legislation defines PBMs as a "person" who has a contractual relationship with a "managed care company, nonprofit hospital or medical service organization, insurance company, third-party payer, or health program administered by a state agency." N.D.C.C. § 19-03.6-01(4). For purposes of S.B. 2258 and S.B. 2301, it appears that a PBM is a distinct "person," entering a contractual relationship with one of the listed entities. The PBM is a separate entity distinguishable from any health benefit plan, let alone an ERISA-covered employee health benefit plan.
It is certainly conceivable that a "pharmacy benefits manager" could enter into a contractual relationship with an employer sponsored health benefit plan, and that such an employer sponsored health benefit plan would be subject to ERISA. However, that is merely one outcome of many and not one that is clearly expressed in the statutory language.5 The standard set by the Supreme Court does not require preempting any laws that could be read to include ERISA health plans. Rather, the standard set by the Supreme Court requires finding an impermissible "reference to" ERISA plans when a state law "acts immediately and exclusively upon ERISA plans ... or where the existence of ERISA plans is essential to the law's operation[.]" Gobeille,
Through S.B. 2258 and S.B. 2301, North Dakota seeks to regulate persons or entities who independently serve as third parties in a relationship between insurance plans and plan participants. The insurance plans that they contract with may or may not be ERISA plans. North Dakota's regulation of these third party entities has little or nothing to do with who is the insurance plan carrier. ERISA regulates employer sponsored health benefit plans. It does not preempt a state from regulating independent entities entering contractual relationships with insurance plans, whether they be employer sponsored or not. An independent entity choosing to do business with an employee health benefit plan is not given a shield from state and local regulations; to find that ERISA's preemption clause did as much would be to "extend to the furthest stretch of its indeterminacy." De Buono,
Similarly, S.B. 2258 and S.B. 2301 explicitly provide that "third party payer," as used within each bill, has the same definition as in N.D.C.C. § 19-03.6-01. See S.B. 2258 § 1 (1)(c) and S.B. 2301 § 1 (1)(d); see also N.D.C.C. § 19-02.1-16.1(1)(c). "Third party payer" is defined as "an organization other than the patient or health *976care provider involved in the financing of personal health services." N.D.C.C. § 19-03.6-01(6). PCMA argues this is another impermissible, implicit reference to ERISA. The Court is unconvinced. While the statutory language could be read to include the employer sponsored health benefit plans subject to ERISA, nowhere in either bill does it say as much. The definition clearly applies to a broad range of entities that have no relation to ERISA or employer sponsored health plans. As described above, to apply the preemption clause under this circumstance would result in "uncritical literalism," for if " 'relate to' were taken to extend to the furthest stretch of its indeterminacy, then for all practical purposes pre-emption would never run its course, for really, universally, relations stop nowhere." Travelers,
S.B. 2258 and S.B. 2301 also explicitly provide that "plan sponsors," as used within each bill, have the same definition as in N.D.C.C. § 19-03.6-01. See S.B. 2258 § 1(1)(b) and S.B. 2301 § 1(1)(b); see also N.D.C.C. § 19-02.1-16.1(1)(b). PCMA points to the definition of a "plan sponsor" as the mirror image of ERISA's definition of "plan sponsor," and argues this constitutes an implicit and impermissible reference to health care benefit plans covered by ERISA. "Plan sponsors" are defined as "the employer in the case of an employee benefit plan established or maintained by a single employer, or the employee organization in the case of a plan established or maintained by an employee organization." See N.D.C.C. § 19-03.6-01(5).
Like the definitions of "pharmacy benefits manager" and "third party payer," the definition of "plan sponsors" is referring to a person or entity separate and removed from the health plan itself. Unlike the definitions of "pharmacy benefits manager" and "third party payer," however, the definition of "plan sponsor," explicitly references an employer who provides an employee benefit plan and makes mention of an employee benefit plan. The Court finds PCMA's argument that the statutory definition of "plan sponsor" makes "reference to" ERISA to be its most convincing argument. In order to fully explore the effect of "plan sponsor," the Court will review the relevant analysis.
"A state law has a prohibited "reference to" ERISA or ERISA plans when that law (1) impos[es] requirements by reference to [ERISA] covered programs, (2) specifically exempt[s] ERISA plans from an otherwise generally applicable [statute], or (3) premises a cause of action on the existence of an ERISA plan." Prudential,
Applying those three factors to this case, the Court finds that S.B. 2258 and S.B. 2301's definition of "plan sponsor," which includes an employer who provides an employee benefit plan, is not an implicit reference to ERISA. First, neither S.B. 2258 and 2301 "impose requirements by reference to ERISA covered programs." See Dillingham,
"Plan sponsors" are referenced in one section of each bill:
S.B. 2258: "A pharmacy benefits manager or third-party payer may not prohibit a pharmacist or pharmacy from participating in a class action lawsuit. A pharmacy or pharmacist may disclose to the plan sponsor or to the patient information regarding the adjudicated reimbursement paid to the pharmacy which is compliant under the federal Health Insurance Portability and Accountability Act of 1996 ...."
S.B. 2301: "If requested by a plan sponsor contracted payer, a pharmacy benefits manager or third-party payer that has an ownership interest, either directly or through an affiliate or subsidiary, in a pharmacy shall disclose to the plan sponsor contracted payer any difference between the amount paid to a pharmacy and the amount charged to the plan sponsor contracted payer."
See S.B. 2258(1)(5) and S.B. 2301(1)(2) (emphasis added).
The Court finds that S.B. 2258 does not impose requirements by making reference to ERISA covered programs. Looking to the statutory language, which is clear and unambiguous on its face, S.B. 2258 permits pharmacies and pharmacists to disclose information to a plan sponsor. See S.B. 2258 § 1(5). While, S.B. 2258 allows pharmacies and pharmacists to disclose information, it does not require them to, so it cannot be said that S.B. 2258 imposes requirements by making reference to an ERISA program. Even if the statutory language required , rather than permitted, pharmacies and pharmacists to disclose information to a plan sponsor, it would not change the outcome. In that instance, S.B. 2258 would impose a requirement on pharmacies and pharmacists, but not an ERISA covered program.
In contrast, S.B. 2301 requires , rather than permits, PBMs and third party payers to disclose information to plan sponsors. While S.B. 2301 imposes a requirement, the Court finds it does not do so by reference to an ERISA-covered program. Instead, S.B. 2301 imposes a requirement on PBMs and third party payers by reference to plan sponsors. Plan sponsors, by definition, refer to an employer or an employee organization ,6 both of which are separate and distinct entities and distinguishable from an employee benefit plan. Section 514(a) of
The second consideration for a court deciding whether a state law has a "reference to" ERISA is whether the laws specifically exempt ERISA plans from an otherwise generally applicable statute. See Mackey v. Lanier Collection Agency & Service, Inc.,
*978See Ingersoll-Rand,
Accordingly, the Court finds that neither S.B. 2258 nor S.B. 2301 contain an implicit reference to ERISA. Significantly, neither of the bills act "immediately and exclusively upon ERISA plans." Dillingham,
"In the end, what saves the [state law] from ERISA preemption is that it does not have anything to do with employee benefit plans in particular. It is merely one of many state laws that regulates one of many products that an employee benefit plan might choose to buy. The [state law] regulates health insurance in a broad and neutral way ... The mere fact that many ERISA plans choose to buy health insurance for their plan members does not cause a regulation of health insurance automatically to 'relate to' an employee benefit plan...." Washington Physicians Service Ass'n v. Gregoire,
b. Whether S.B. 2258 and S.B. 2301 have a "connection with" ERISA
Because the Court finds that neither bill makes a "reference to" ERISA, the Court continues its preemption analysis, under the "connection with" prong. A state law has an impermissible "connection with" ERISA plans when it "governs ... a central matter of plan administration" or "interferes with nationally uniform plan administration." Gobeille,
First, neither S.B. 2258 nor S.B. 2301 govern "a central matter of plan administration." Gobeille,
Neither S.B. 2258 nor S.B. 2301 contain any provisions discussing or addressing claimant eligibility determinations, the monitoring of funds for benefit payments, or the keeping of appropriate records for reporting requirements. If either bill is disguising some serious consequence in any of these matters, PCMA has not demonstrated it. PCMA does argue that the bills' provisions relate to calculations of benefit levels and making of disbursements. Some of the provisions in the bills which PCMA points to for support include *979those preventing PBMs from charging pharmacies fees imposed after the point of sale; authorizing pharmacies to mail or deliver drugs to patients; requiring that PBMs allow pharmacies to charge shipping and handling fees; authorizing pharmacies to dispense any drugs allowed by their licensure; and barring PBMs from providing specialty drug benefits through mail-order specialty pharmacies in which the PBM owns an interest. See Docket No. 10-1, pp. 11-12.
The Defendants respond that not all state laws related to health care can constitute laws governing central matters of plan administration. If that were the case, the roles the state plays in which physicians to license or which controlled substances to restrict could be said to affect how a health plan is administered because they ultimately impact the plan participants' benefit levels, prescription drug disbursements, and overall care. The Defendants point to cases in which the Supreme Court held that when a plan (or its agent) enters the marketplace for goods or services, the state may regulate those transactions without running afoul of ERISA. See De Buono,
The Court finds no provisions in either S.B. 2258 or S.B. 2301 governing central matters of plan administration. The bills at issue permit pharmacies to dispense prescription drugs the State has already licensed them to dispense.10 The bills provide for greater disclosure of third party payer's and PBMs' prescription drug pricing. The bills also limit the requirements and fees a third party payer or PBM can place on a pharmacy. The majority of provisions in both S.B. 2258 and S.B. 2301 relate to communication issues between pharmacies and PBMs and, as such, do not govern central matters of any health plan's plan administration.
Because neither S.B. 2258 nor S.B. 2301 "govern ... a central matter of plan administration," the Court finds they do not "interfere[ ] with nationally uniform plan administration." PCMA argues that these bills will impose a variety of burdens and expenses upon its members that will interfere with the "benefit structures" selected by ERISA benefit plans and administered by them. But, in the same breath, PCMA admits S.B. 2258 and S.B. 2301 can go into effect as to non-ERISA and non-Medicare Part D health plans. PCMA, is a national trade association representing multiple *980PBMs, some of whom provide services for health plans covered by ERISA and some of whom provide services for non-ERISA health plans. PCMA cannot claim in good faith that S.B. 2258 or S.B. 2301 interferes with nationally uniform plan administration, while conceding the bills may ultimately take effect as to other health plans.
PCMA's argument is too abstract. "If ERISA were concerned with any state action-such as medical-care quality standards or hospital workplace regulations-that increased costs of providing certain benefits, and thereby potentially affected the choices made by ERISA plans, [the Court] could scarcely see the end of ERISA's preemptive reach, and the words 'relate to' would limit nothing." Dillingham,
c. ERISA's Savings Clause
Neither party in this case argues the applicability of ERISA's so-called "savings" clause. "While § 514(a) of ERISA broadly pre-empts state laws that relate to an employee benefit plan, that pre-emption is substantially qualified by an 'insurance savings clause.' " Metropolitan Life Ins. Co. v. Massachusetts,
In determining the scope of the savings clause, the Court begins by taking a "common-sense" view of the question of whether the state laws in question "regulate insurance." Metropolitan Life,
[F]irst, whether the practice has the effect of transferring or spreading a policyholder's risk; second, whether the practice is an integral part of the policy relationship between the insurer and the insured; and third, whether the practice is limited to entities within the insurance industry."
The Supreme Court noted that the focus of the statutory term under the McCarran-Ferguson Act was "the relationship between the insurance company and the policyholder." Metropolitan Life,
*981Therefore, the North Dakota state laws will be found to "regulate insurance" if (1) they are directed specifically toward the insurance industry, and (2) they apply to the "business of insurance" within the meaning of the McCarran-Ferguson Act. See
The Court concludes that even if S.B. 2258 and S.B. 2301 were found to "relate to" ERISA, they would be saved from preemption by the ERISA savings clause. First, both bills "regulate insurance" under a common-sense approach," because they are laws "specifically directly toward that industry." Pilot Life Ins. Co.,
Further, the North Dakota laws satisfy the McCarran-Ferguson factors. First, they have the effect of transferring or spreading the policyholder's risk. See Gregoire,
Second, the North Dakota bills are an integral part of the policy relationship between the insurer and the insured. Metropolitan Life,
Finally, the North Dakota laws are limited to entities within the insurance industry. S.B. 2258 and S.B. 2301 impose requirements on PBMs and third party payers, which are entities engaged in the business of health insurance, as discussed above. Neither S.B. 2258 nor S.B. 2301 contain regulations on entities outside the business of health insurance. Accordingly, the Court alternatively finds that even if S.B. 2258 and S.B. 2301 "relate to" ERISA, both bills "regulate insurance" within the common-sense meaning and are thus saved by ERISA's preemption clause.
In evaluating PCMA's likelihood of success on the merits, the Court considered its responsibility to "flexibly weigh the case's particular circumstances to determine 'whether the balance of equities so favors the movant that justice requires the court to intervene...." Calvin Klein Cosmetics,
2. Irreparable Harm
PCMA alleges it will experience irreparable harm if injunctive relief is not granted and that such harm will not be compensable by an award of money damages because the United States Constitution grants states immunity from such damage claims. See Docket No. 10-1, p. 19. PCMA alleges the State's bills impose "significant administrative, operational, and financial burdens on PBMs and health plans," and that the enforcement of these laws "may cause a loss of goodwill and injury to that PBM's reputation." See Docket No. 10-1, p. 24-25. The Defendants argue PCMA's alleged harm is overstated because PCMA will still have to comply with S.B. 2258 and S.B. 2301 as to non-ERISA and non-Medicare Part D plans, regardless of the outcome of this case. See Docket No. 22, pp. 7-8. Because PCMA will ultimately be forced to comply with the State's bills in some respects, the State argues, any harm is not as perilous as PCMA would lead the Court to believe. Both parties agree that ERISA and Medicare Part D preemption applies only as to ERISA and Medicare Part D plans, and that PCMA's members will be forced to comply with the laws in some capacity, however the Court must still make an independent finding regarding the potential for irreparable harm.
"Irreparable harm occurs when a party has no adequate remedy at law, typically because its injuries cannot be fully compensated through an award of damages." General Motors Corp. v. Harry Brown's, LLC,
Here, PCMA asserts its members will experience significant financial burdens and may experience a loss of reputation. PCMA does not offer any predictions or figures to demonstrate what its view of what a "significant" financial burden might mean. Neither does PCMA address how complying with the State's bills as they relate to non-ERISA and non-Medicare Part D plans might mitigate any financial burdens. PCMA also fails to explain the theory that enforcement of the State bills may result in a loss of reputation. It is not immediately clear why complying with state law would be viewed so negatively as to result in a loss of reputation. PCMA does not allege S.B. 2258 or S.B. 2301 threaten the existence of its members' business and PCMA admits its members will comply with the State's laws as to non-ERSA and non-Medicare Part D health plans. The Court is not willing to find that this factor weighs in favor of the Plaintiff, where Plaintiff has failed to provide any evidence supporting its bare assertions that its members will experience a financial loss and may experience a loss of reputation. Accordingly, the Court finds this Dataphase factor weighs in favor of the Defendants.
3. Balance of Harms
"Failure to show irreparable harm is an independently sufficient ground upon which to deny a preliminary injunction." Watkins, Inc. v. Lewis,
The Court finds that any harm PCMA's members may experience resulting from S.B. 2258 and S.B. 2301 is outweighed by the potential harm and injury a preliminary injunction may inflict on other interested parties. Testimony before the North Dakota Senate Industry, Business and Labor Committee indicated PBMs increasingly engage in anticompetitive or deceptive conduct that harms consumers, health plans, and local pharmacies. Testimony Before the S. Indus. Bus. & Labor Comm. , 65th Leg. Assemb., Reg. Sess. (N.D. 2017) (statement of Mike Schwab, Executive Vice President of the North Dakota Pharmacists Association).
For example, PBMs have the ability to prevent local pharmacies from dispensing any prescription drugs the PBM determines to be a "specialty drug," irrespective of what federal, state, and local authorities have already determined. The PBM then directs consumers to purchase the specialty drug through PBM's own mail-order pharmacies. In addition to being anticompetitive, legislative history indicates this practice can be wasteful as patients have found their "specialty drugs" frozen on their doorstep or baking in their mailbox. In those instances, the PBM can provide an override code permitting the local pharmacists to provide an emergency refill or short-day supply of the medication. Testimony Before the S. Indus. Bus. & Labor Comm. , 65th Leg. Assemb., Reg. Sess. (N.D. 2017) (statement of Mike Schwab, *984Executive Vice President of the North Dakota Pharmacists Association). Such testimony is evidence of the harms faced by other interested parties, including consumers, who are limited by where they may obtain their prescription drugs and how they obtain them, and local pharmacies who are limited by what prescription drugs they may provide and how and when they provide them.
The Court has reviewed the legislative history of both bills, including testimony from Howard Anderson Jr. of the North Dakota Pharmacists Association; Dr. Erik Christenson, Chief Professional Officer at Heart of America Medical Center; representatives from Workforce Safety; representatives from CVS health; local pharmacists; and a public interest antitrust attorney. The overwhelming majority of testimony to the Committees indicated that consumers, pharmacies, and plan sponsors all suffer when PBMs exercise their power to restrict consumers to the PBM's own captive mail order and specialty pharmacy operations by reducing the available choices for accessing prescription drugs.12 Both S.B. 2258 and S.B. 2301 seek to address these and the other issues presented to the North Dakota State Legislature. After completing its review, the Court finds that the potential harm other interested parties would experience by preempting these bills, outweighs any potential harm PCMA may experience due to their implementation. Accordingly, the Court finds that the third Dataphase factor weighs in favor of the Defendants.
4. Public Interest
The final Dataphase factor for the Court to consider is the public's interest in the outcome. For the same reasons enumerated in the Court's analysis of the third Dataphase factor, the public's interest in the outcome of this case requires a finding that this factor weighs in favor of the Defendants. The public interests served by the implementation of S.B. 2258 and S.B. 2301 are those of transparency, accessibility, and free and open markets for prescription drugs. More specifically, the public has an interest in a plan sponsor's ability to obtain information regarding the rate at which a PBM reimburses a pharmacy and the rate at which the PBM then bills the plan sponsor because this type of transparency allows pharmacies and plan sponsors, as well as PBMs, to *985evaluate, compare, and determine fair values of the products and services for which they are contracting.
The public also has an interest in encouraging as many prescription drug providers to enter the marketplace as federal, state, and local governments will allow because the public values increasing competition for products and services as a way to lower costs. Additionally, increasing the number of market participants serves the public interest by allowing consumers the choice to obtain their prescription drugs either over-the-phone, by mail, or in-person at their local pharmacy. The choice of how to obtain prescription drugs serves the public interest of accessibility and safety because consumers have more control of when and how to get their medications, as well as the method by which they will be taught to use them (either over the phone or in person).
There is some evidence in the record that the public interest in keeping health care costs low might be injured by implementation of S.B. 2258 and S.B. 2301. Testimony Before the S. Indus. Bus. & Labor Comm. , 65th Leg. Assemb., Reg. Sess. (N.D. 2017) ("They may tell you this bill is going to raise costs. To be honest, that might be true in some circumstances. However, if costs go up, overall there is a high probability that it is because of the PBM not the pharmacy." Statement of Mike Schwab, Executive Vice President of the North Dakota Pharmacists Association). However, in the aggregate, the Court finds that the potential injury to public interests caused by implementation of S.B. 2258 and S.B. 2301 pales in comparison to the actual injuries the legislation seeks to remedy. Therefore, the Court finds this Dataphase factor weighs in favor of the Defendants.
Because the Court finds that all four Dataphase factors weigh in the Defendants' favor, PCMA's motion to preliminarily enjoin the State's enforcement of S.B. 2258 and S.B. 2301 as to ERISA health care plans is denied.
B. MEDICARE PART D PREEMPTION
PCMA also requests this Court preliminarily enjoin the State from enforcing S.B. 2258 and S.B. 2301 as they relate to Medicare Part D health plans because PCMA believes a provision contained in Medicare Part D preempts the State's bills. The Court will apply the same Dataphase factors to PCMA's Medicare Part D claim to determine whether PCMA is entitled to a preliminary injunction on this basis.
In regards to Medicare, Congress has proclaimed that "[t]he standards established under this part shall supersede any State law or regulation ... with respect to [Part D] plans which are offered by [Part D] organizations under this part." 42 U.S.C. § 1395w-26(b)(3) (incorporating Part C's preemption provision, 42 U.S.C. § 1395w-112(g) ) (emphasis added). A "standard within the meaning of this preemption provision means a statutory provision or a regulation promulgated under Medicare and published in the Code of Federal Regulations. Do Sung Uhm v. Humana, Inc.,
PCMA first argues it is not obligated to show that S.B. 2258 and S.B. 2301 regulate areas also regulated by Medicare D, but this is plainly untrue. See Docket No. 23, p. 2-4. Medicare Part D preemption "operates only when CMS13 actually creates standards in the area regulated." Medicare Program; Medicare Prescription Drug Benefit ,
PCMA alternatively argues that if it is required to show that there are provisions in S.B. 2258 and S.B. 2301 that act with respect to Medicare Part D standards that the State laws are still preempted. PCMA offered a list of C.F.R. regulations, each paired with a one-sentence legal conclusion supporting its position and nothing more. See Docket No. 23, pp. 4-6. PCMA left for the Court with the task of finding and then analyzing any relevant provisions within each cited C.F.R. regulation. This Court is unwilling to do this, particularly when the remedy sought by PCMA is one as "extraordinary" and "drastic" as a preliminary injunction. Munaf v. Geren,
The Court has reviewed the nine C.F.R. regulations listed by PCMA. Each regulation contains numerous pages of text. Some portions of text refer to additional regulations. Other portions of text are merely definitions. The Court cannot and will not guess at which portions PCMA finds relevant or problematic in this matter. To do so would require the Court to analyze an issue not properly presented and rule on an argument not sufficiently made. Constructing a party's argument for them is not within a court's purview. See Hopper v. Berryhill,
In a preliminary injunction, the party seeking relief bears the burden of establishing its propriety with "clear proof." Frejlach,
As with its argument regarding ERISA preemption, PCMA alleges it will experience irreparable harm if injunctive relief is not granted. PCMA alleges the state legislation ultimately imposes "significant administrative, operational, and financial burdens on PBMs and health plans," and that the enforcement of these laws "may cause a loss of goodwill and injury to that PBM's reputation." See Docket No. 10-1, p. 24-25. As previously discussed, "[i]rreparable harm occurs when a party has no adequate remedy at law, typically because its injuries cannot be fully compensated through an award of damages." General Motors Corp.,
For the reasons enumerated in the Court's previous analysis of irreparable harm in considering the ERISA claim, the Court is not inclined to find that this factor weighs in favor of the Plaintiff when the Plaintiff has failed to provide any evidence supporting its bare assertions that it will experience a financial loss and may experience a loss of reputation. Such vague and unsubstantiated claims will not suffice for an "extraordinary" and "drastic" remedy. Accordingly, the Court finds that this Dataphase factor weighs in favor of the Defendants.
While "the absence of irreparable injury is by itself sufficient to defeat a motion for a preliminary injunction," the Court notes that it finds the third Dataphase factor weighs in favor of the Defendants as well. See DISH Network Service L.L.C.,
For the reasons enumerated in its above analysis, the Court finds that any harm PCMA's members may experience resulting from S.B. 2258 and S.B. 2301 is outweighed by the potential harm and injury a preliminary injunction may inflict on other interested parties. PCMA's bare assertions of harm, without any supporting *988evidence, are outweighed by testimony before the North Dakota State Legislature detailing the harms that North Dakota consumers, health plans, and local pharmacies experience when PBMs engage in anticompetitive or deceptive conduct. Testimony Before the S. Indus. Bus. & Labor Comm. , 65th Leg. Assemb., Reg. Sess. (N.D. 2017) (statement of Mike Schwab, Executive Vice President of the North Dakota Pharmacists Association). Accordingly, the Court finds that this Dataphase factor weighs in favor of the Defendants.
The final Dataphase factor for the Court to consider is the public's interest in the outcome. For the same reasons enumerated in the Court's above analysis of this Dataphase factor, and for the reasons enumerated in the Court's analysis of the third Dataphase factor relating to the balance of harms, the Court finds that the public's interest in the outcome of this case does not support preliminary injunctive relief. The public interests served by the implementation of S.B. 2258 and S.B. 2301 are those of transparency, accessibility, and free and open markets for prescription drugs. These and other public interests listed previously require finding that this Dataphase factor weighs in favor of the Defendants.
Preliminary injunctive relief is an "extraordinary and drastic remedy." Munaf,
IV. CONCLUSION
The Court has carefully reviewed the parties' briefs, the Court's notes from the preliminary injunction hearing, the entire record in this case, and the relevant case law, including the Dataphase factors, and finds that the Plaintiff has not met its burden for establishing the necessity of a preliminary injunction. Accordingly, the Court DENIES the motion for a preliminary injunction (Docket No. 10).
IT IS SO ORDERED .
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Cite This Page — Counsel Stack
297 F. Supp. 3d 964, Counsel Stack Legal Research, https://law.counselstack.com/opinion/pharm-care-mgmt-assn-v-tufte-usdistct-2017.