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14 August 2024

Legal Battle Over Prescription Drug Costs Gains Momentum

Oklahoma challenges federal law to regulate pharmacy benefit managers and lower drug prices for residents

The U.S. legal and regulatory framework surrounding prescription drugs has come under increasing scrutiny due to the complicated systems employed by pharmacy benefit managers (PBMs) and the significant impact on pharmacies and patients alike. Amidst rising prescription costs, independent pharmacies like Oliver Lackey's are facing huge challenges as they grapple with the reimbursement practices enforced by these PBMs.

Oliver Lackey opened his pharmacy with the intention of providing exceptional patient care, yet he found himself struggling financially as the business grew. “I was getting more patients and was filling more prescriptions,” Lackey shared, “But as I grew in revenues, my reimbursement from the insurance companies and PBMs every year was getting worse.”

This situation highlights the power dynamics at play, as PBMs act as intermediaries between pharmacies and health plans, controlling medication availability and pricing. Critics accuse some of these PBMs of anti-competitive practices, alleging they prioritize their profitability over fair access to medications for consumers.

Most recently, the issue drew national attention when all 50 states attempted to enact laws curtailing the power of PBMs. Unfortunately, these efforts hit roadblocks due to the 50-year-old Employee Retirement Income Security Act (ERISA), which protects self-funded employer-sponsored health plans from state regulations.

This federal law has left many Americans, who make up around 65% of those under employer health plans, without the intended protections from soaring drug prices. Now, as lawmakers and independent pharmacists push back, the state of Oklahoma is at the forefront of efforts to challenge this dynamic.

Five years ago, Oklahoma enacted stringent PBM regulations, aimed at preventing unfair practices such as mandatory pharmacy usage tied to PBM networks and excessive hidden fees. The law was hailed as revolutionary by the state's insurance commissioner, Glen Mulready, but it quickly faced legal challenges.

Later, the Pharmaceutical Care Management Association (PCMA), which represents PBMs, sued to overturn Oklahoma’s enacted law. The case made it to the 10th U.S. Circuit Court of Appeals, which ruled the ERISA law considerably restricted the application of Oklahoma's regulations to self-funded plans.

Yet, Oklahoma didn't back down, appealing to the U.S. Supreme Court to review the case. This legal tug-of-war could have widespread ramifications, potentially allowing states more authority to govern how health plans for millions of Americans operate.

Advocates for the state legislation hope to use this case as a stepping stone to introduce similar regulations across the country, increasing accountability for PBMs. A ruling favoring Oklahoma could represent not just state independence, but also increased access to lower-cost medications for vulnerable populations.

On the other side of the spectrum, PBM representatives argue the Oklahoma law could lead to increased healthcare costs for employers and consumers. Greg Lopes, PCMA's vice president of public affairs, remarked, “Oklahoma’s law would devastate employer, union, and Medicare plan sponsors as well as hundreds of thousands of their beneficiaries.”

This debate underscores the complexity and interconnectedness of health care policy, market forces, and state versus federal jurisdiction. The stakes couldn't be higher for patients who rely on affordable medications and strive for better health outcomes amid rising costs.

Research shows the legal confines of ERISA might be clearer if the Supreme Court weighs this critical case. Legal experts have noted the need for clarity, and many across the country are closely watching how this judicial decision will affect similar state laws and the overall market.

Despite the increasing focus on lowering drug prices through state legislations, Oklahoma's pharmacy crisis is also emblematic of broader issues affecting pharmacies nationwide. Lackey was forced to shut down his pharmacy after struggling to make ends meet due to insufficient reimbursements from PBMs.

“I had lots of patients who, when I announced my closing, came in crying,” Lackey recounted, reflecting the emotional toll this situation has not only on pharmacists but on the communities they serve. “It was really tough to go through, because you’re telling your family or your patients you can’t afford to care for them anymore.”

Looking at the broader picture, ERISA was enacted to protect employees against fraud and underfunding of their retirement and health plans, but its application over the past five decades has led to unintended consequences for the health care marketplace. This law, which ensures consistency among employer-sponsored plans, has inadvertently stifled the ability of states to enact measures aimed at regulating PBMs and controlling prescription drug costs.

While many states have tried to push back against this federal overreach, the pace of these legal battles is slow and fraught with challenges. There remains substantial uncertainty over how effectively states can manage their healthcare systems without federal interference, especially when it concerns self-funded plans.

If the Supreme Court sees merit in Oklahoma’s appeal, it could mark the beginning of significant changes to PBM regulations nationwide. Advocates see this opportunity as pivotal and hope it will usher in changes to lower drug prices and protect independent pharmacies, securing better access to medications for patients.

For now, all eyes are on the Supreme Court to see if they will take this case, potentially setting the stage for future legal frameworks surrounding PBM regulations across other states. The outcome will undoubtedly help shape not only the health care industry but also how ordinary Americans experience prescription drugs every day.

This moment represents not just legal battles but serves as a reminder of how policy and regulation can dramatically impact real lives. To many patients, the fight against high prescription drug prices is not just about legalities; it's about health, wellbeing, and economic survival.