Pharm. Care Mgmt. Ass'n v. Tufte

297 F. Supp. 3d 964
CourtUnited States District Court
DecidedNovember 7, 2017
DocketCase No.: 1:17–cv–141
StatusPublished
Cited by1 cases

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.

Bluebook
Pharm. Care Mgmt. Ass'n v. Tufte, 297 F. Supp. 3d 964 (usdistct 2017).

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"), 29 U.S.C. § 1001 et seq. , and Medicare Prescription Drug Improvement and Modernization Act of 2003 ("Medicare Part D"), 42 U.S.C. § 1395w-101 et seq. As a result, PCMA seeks this Court's declaration that the North Dakota state laws are expressly preempted by federal legislation. The parties stipulated not to effectuate S.B. 2258 and S.B. 2301 as to ERISA and Medicare Part D plans, pending the resolution of this matter. See Docket No. 19.

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., 640 F.2d 109, 114 (8th Cir. 1981), in determining whether a preliminary injunction should be granted. The Dataphase

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Bluebook (online)
297 F. Supp. 3d 964, Counsel Stack Legal Research, https://law.counselstack.com/opinion/pharm-care-mgmt-assn-v-tufte-usdistct-2017.