The US Supreme Court has announced it will hear a case in the coming months that could determine whether states have the right to regulate pharmacy benefit managers (PBMs).

The US Court of Appeals for the Eighth Circuit, covering Arkansas and 6 other states, previously ruled on Rutledge v. Pharmaceutical Care Management Association. The Eighth Circuit decision favored the Pharmaceutical Care Management Association (PCMA), ruling that the Employee Retirement Income Security Act of 1974 (ERISA), a federal law that sets minimum standards for voluntarily established retirement and health plans in private industry, superseded an Arkansas law that sought to regulate PBMs.1

Passed in 2015, Arkansas Act 900 required PBMs to raise reimbursement rates for drugs if they fell below the pharmacy’s wholesale costs and created an appeal process for pharmacies to challenge PBM reimbursement rates. This effectively prohibited PBMs from reimbursing pharmacies below the pharmacies’ cost of acquisition.2

In his brief to the US Supreme Court, Solicitor General Noel Francisco disagreed with the Eighth Circuit decision, stating that the ruling was contrary to higher court’s precedent and should be reviewed and corrected. He urged the court to take up the case, siding with attorney generals from 31 states and the District of Columbia that want the US Supreme Court to reverse the Eighth Circuit’s ruling.3

The National Community Pharmacists Association’s (NCPA) vice president, Mustafa Hersi, told Pharmacy Times that the organization is optimistic about the potential for the US Supreme Court to rule in favor of Arkansas, which is represented in the case by the state’s Attorney General Leslie Rutledge. The NCPA, together with the Arkansas Pharmacists Association, previously filed a brief supporting the state before the Eighth Circuit court, and plans to file a similar brief before the Supreme Court.5

“We feel that this matter has national implications. PBMs have been relying on ERISA preemption to avoid meaningful oversight by states, and states like Arkansas have taken it upon themselves to draft well-tailored legislation—that does not implicate or involve ERISA—to regulate PBMs that operate within their state. The implications are that, if the court were to not only grant the request but rule in the favor of Arkansas, that states would be empowered to make more decisions to regulate PBMs and the role that they have in our health care system so that their citizens can make informed decisions with the respect to the choices that they have in health care,” Hersi said.

PBMs are intermediaries between health plans and pharmacies, and provide services such as claims processing, managing data, mail-order drug sales, calculating benefit levels, and making disbursements. Pharmacies acquire their drug inventories from wholesalers. When a patient buys a drug from a pharmacy, they often do so at a lower price through a health plan that covers part of the price. The PBMs then create a maximum affordable cost list that sets reimbursement rates to pharmacies dispensing generic drugs.2

Contracts between PBMs and pharmacies create pharmacy networks. Based upon these contracts, and in order to participate in a preferred network, some pharmacies choose to accept lower reimbursements for dispensed prescriptions. Thus, a pharmacy may lose money on a given prescription transaction.2

Although the Arkansas law set to change this practice, PCMA, the trade association that represents all major PBMs, has pointed to ERISA, saying that it preempts state laws that may relate to ERISA-governed employee benefit plans.4

“The (ERISA) has long enabled employers to provide consistent, nationwide health care benefits due to its preemption of state laws.  We are committed to federal preemption, which is a vitally important issue to ensuring high quality health care for patients,” said PCMA President and CEO JC Scott in a press release. “Unique state laws governing the administration of pharmacy benefits are proliferating across the country, establishing vastly different standards. These inconsistent and often conflicting state policies eliminate flexibility for plan sponsors and create significant administrative inefficiencies. These inefficiencies divert funds from where they should be spent: providing access to the health care services on which employees of plans across the country rely.”

However, Hersi said that ERISA has been used previously by PBM groups to avoid regulation and litigation.

“Previously in the Eighth Circuit, there was litigation in North Dakota that related to the use of ERISA as a means to potentially shield meaningful oversight by states with respect to PBMs that operate in their state. We feel as though, states that have taken steps, like the state of Arkansas, to draft well-tailored legislation to ensure that ERISA is not implicated should be able to do that for their citizens,” Hersai told Pharmacy Times.

Ron Lanton, III, Esq, principal of Lanton Law, a national health care law and government affairs firm in Washington DC, agrees.

“Like many, I was disappointed in the Eighth Circuit's decision. I have advocated for retail pharmacy issues in state legislatures and ERISA and higher insurance costs were the ‘go to’ arguments from opponents like PBMs, who did not want any transparency on their business practices. Without laws like Arkansas, whose intent was to ensure transparency and patient access, pharmacies will have a harder time operating in an already challenging marketplace. I believe there is precedent that shows that the ERISA statute should not be interpreted as broad as opponents of the Arkansas law are calling for.”

The Solicitor General argued that there is no distinction between regulating PBM administration, which is not preempted by ERISA, and regulating plan administration, which could lead to preemption under ERISA. To the extent it affects health plans, the solicitor general adds, the law is not specifically focused on ERISA plans, and a Supreme Court decision would help address conflicting decisions by a federal appeals court on ERISA state law preemption.3

The Solicitor General’s brief increased the likelihood that the Supreme Court to review Rutledge and to address the scope of the States’ authority to regulate PBMs, even when those PBMS are working for ERISA plans.1

The Supreme Court will now set the case for briefing and oral argument for Rutledge, the latter of which would likely occur in March or April 2020.1

“This is an important moment for community pharmacies. There’s strong bipartisan agreement in the states that PBM behavior is out of control. The US is the only country in the world that has turned over the management of prescription drugs to PBMs and the U.S. has the highest drug costs in the world. We don’t think that is coincidence,” said B. Douglas Hoey, pharmacist, MBA, CEO of the NCPA in a prepared statement.5

In addition to Arkansas, the Eighth Circuit covers Iowa, Minnesota, Missouri, Nebraska, North Dakota, and South Dakota.


REFERENCES
  1. Analysis: SCOTUS Could Open the Door for States to Regulate PBMS. NCPA website. http://www.ncpa.co/pdf/analysis-scotus-states-pbms.pdf. Accessed January 10, 2020.
  2. Pharmaceutical Care Management Association v. Rutledge Case Report. FindLaw.com Published June 8, 2019. https://caselaw.findlaw.com/us-8th-circuit/1898787.html. Accessed January 10, 2020.
  3. Karlin-Smith, Sarah; Owermohle, Sarah. 2020 Drug Price Increases Unlikely to Change Policy. Politco.com. Published January 7, 2020. https://www.politico.com/newsletters/prescription-pulse/2020/01/07/2020-drug-price-increases-unlikely-to-change-policy-488001. Accessed January 10, 2020.
  4. ERISA Broadly Preempts State Regulation of PBM-Pharmacy and PBM-Plan Agreements. McDermott Will & Emery website. Published July 26, 2018. https://www.mwe.com/insights/erisa-preempt-pbm-pharmacy-pricing-agreement-2/. Accessed January 10, 2020.
  5. Community Pharmacy Cheers SCOTUS Decision to Rule on States’ Authority to Regulate PBMs [press release]. NCPA website. Published January 10, 2020. https://www.ncpanet.org/newsroom/news-releases/2020/01/10/community-pharmacy-cheers-scotus-decision-to-rule-on-states-authority-to-regulate-pbms. Accessed January 13, 2020.