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New Supreme Court Ruling Affirms State Regulation of PBM Reimbursement Pricing

By Danielle C. Gordet & Amber Roberts on January 28, 2021
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The U.S. Supreme Court ruled against pharmacy benefit managers (“PBMs”) last month, in a decision that marks a major win for state regulators. (See Rutledge v. Pharmaceutical Care Management Association, 2020 WL 7250098 (U.S. 2020)). On December 10, 2020, the U.S. Supreme Court held that Arkansas’s Act 900, which “effectively requires PBMs to reimburse Arkansas pharmacies at a price equal to or higher than the pharmacy’s wholesale cost,” is not preempted by the Employee Retirement Income Security Act of 1974 (ERISA).

The Arkansas legislature enacted Act 900 in response to concerns that PBMs were reimbursing pharmacies in amounts that were too low to cover the costs incurred by the pharmacies. PBMs reimburse pharmacies for the cost of drugs covered by prescription-drug plans. The amount that PBMs reimburse pharmacies is typically set by their contracts with pharmacies, according to a list specifying the maximum allowable cost for each drug. In turn, prescription-drug plans reimburse PBMs according to contracts between the particular plan and PBM. Proponents of PBM regulation laws argue that the amount the PBM is reimbursed by plans differs from and (often) exceeds the amount the PBM reimburses the pharmacy.

The Pharmaceutical Care Management Association (“PCMA”), which represents the 11 largest PBMs in the country, filed suit against Leslie Rutledge, Arkansas’ Attorney General, alleging that ERISA preempted Act 900. As noted in the text of the statute, ERISA will preempt and “supersede any and all state laws insofar as they may…relate to any employee benefit plan.” PCMA contended that Act 900 has “an impermissible connection with an ERISA plan because its enforcement mechanisms both directly affect central matters of plan administration and interfere with nationally uniform plan administration.” The U.S. Supreme Court disagreed, holding, “In short, ERISA does not pre-empt state rate regulations that merely increase costs or alter incentives for ERISA plans without forcing plans to adopt any particular scheme of substantive coverage.” The Court held that Act 900 is merely a form of cost regulation, requiring PBMs to pay pharmacies at rates equal to or higher than the wholesale cost of the prescription drugs.

This case is significant because it could pave the way for other states to enact similar laws regulating PBM business activities, including pricing arrangements. Attorney General Rutledge issued the following statement regarding the Court’s decision: “This is an important unanimous win for not only locally owned pharmacies that have experienced financial hardships at the hands of pharmacy benefit managers, but more importantly, this is a win for all Arkansans and Americans to have access to affordable healthcare. I will always protect Arkansans and small businesses from unfair practices and fight to lower the costs of prescription drugs.” As noted in a prior blog post, given that PBM arrangements have been subject to increased scrutiny, it is possible that this Supreme Court case will embolden states that have been trending towards implementing additional PBM-focused regulatory measures.

Photo of Danielle C. Gordet Danielle C. Gordet

Danielle Gordet focuses her practice on healthcare, including healthcare compliance, conflicts of interest, scope of practice issues, physician contracting, and regulations. Her ability to identify, investigate, and resolve complex issues in collaboration with healthcare administrators allows her to provide them with effective counsel…

Danielle Gordet focuses her practice on healthcare, including healthcare compliance, conflicts of interest, scope of practice issues, physician contracting, and regulations. Her ability to identify, investigate, and resolve complex issues in collaboration with healthcare administrators allows her to provide them with effective counsel in developing policies and procedures which reduce the risk of inappropriate conduct and prevent non-compliance. She provides expertise on federal and state healthcare statutory and regulatory issues, including adherence to the Stark Law, the Anti-Kickback Statute, and licensure compliance. In addition, Danielle assists manufacturers of U.S. Food and Drug Administration (FDA) regulated products in obtaining necessary FDA clearances for their devices. Danielle works with healthcare administrators on resolving a variety of legal matters, including issues surrounding hospital bylaws, licensure and credentialing, telemedicine, codes of conduct, and Emergency Medical Treatment and Labor Act. On behalf of healthcare providers, she negotiates and drafts contractual agreements including medical directorships, physician employment, clinical trials, and consulting arrangements.

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Photo of Amber Roberts Amber Roberts

Amber Roberts focuses her practice on the design and implementation of qualified and non-qualified retirement and deferred compensation plans, welfare plans, cafeteria plans, and other employee benefit programs for both public and private companies. She assists clients on executive compensation and benefits issues

…

Amber Roberts focuses her practice on the design and implementation of qualified and non-qualified retirement and deferred compensation plans, welfare plans, cafeteria plans, and other employee benefit programs for both public and private companies. She assists clients on executive compensation and benefits issues arising in the context of mergers, acquisitions, and other corporate matters. Amber also helps clients maintain compliance with the federal laws and regulations associated with these plans, including ERISA, the Internal Revenue Code, COBRA, HIPAA, nonqualified deferred compensation plans, performance-based compensation, fringe benefits, privacy matters, and state regulatory guidance and withdrawal liability for multiemployer plans.

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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    Health Law Rx
  • Organization:
    Akerman LLP
  • Article: View Original Source

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