New Medicare Regulations Could Curb Prescription Steering Practices

Pharmacy benefit managers (PBMs) play a crucial role in the healthcare landscape of the United States, negotiating access to medicines for a significant portion of the population. However, their activities have come under scrutiny, particularly their practice of directing patients to use their own pharmacies. Research conducted by Weill Cornell Medicine sheds light on this issue, revealing that while these PBMs steer patients towards their owned pharmacies, their market share within Medicare is notably lower than in other segments of the healthcare market.

The study, published in JAMA Health Forum, examined pharmacy spending trends in Medicare Part D. Notably, it was found that about one-third of all Medicare Part D pharmacy expenditures and nearly 40% of specialty drug spending occurred through pharmacies owned by the four leading PBMs: CVS, UnitedHealth Group, Cigna, and Humana. This figure starkly contrasts with the nearly two-thirds national market share indicated in a recent report from the Federal Trade Commission.

The study’s lead author, Dr. Pragya Kakani, emphasized the significance of these findings, stating that the lower market share of PBM-owned pharmacies within Medicare could be attributed to the "any willing pharmacy" rules instituted by the Centers for Medicare and Medicaid Services. These regulations aim to ensure patients have broad access to their medications by allowing any pharmacy meeting Medicare’s conditions to dispense pharmaceuticals. As a result, these rules might limit the ability of PBMs to gain substantial market power within Medicare, creating a more competitive environment for independent pharmacies.

The implications of these findings are profound. While the regulations provide essential protections for Medicare patients, they also highlight potential conflicts of interest inherent in the PBM structure. Insurers with integrated PBM operations generally hold more discretion in excluding certain pharmacies from their networks. This means that patients outside of Medicare Part D often face restrictions that limit their choices, leading to increased steering towards PBM-owned pharmacies. This not only raises concerns about patient autonomy but also may influence pharmacy competition and pricing.

Dr. Kakani’s research also focused on specialty drugs, which tend to be high-cost and complex treatments. Within Medicare, PBM-owned pharmacies accounted for a significant market share for various high-cost specialty medications. For conditions such as pulmonary arterial hypertension, idiopathic pulmonary fibrosis, and multiple sclerosis, more than 60% of the market share had been captured by pharmacies affiliated with PBMs. This raises critical concerns about access to medications and the potential for PBMs to exert undue influence over prescribing practices.

The findings suggest a need for policymakers to closely observe the operations of PBM-owned pharmacies, especially in disease areas where these entities hold substantial market sway. The steering behaviors of these integrated pharmacy systems can have significant ramifications on the overall healthcare market, impacting both patient experience and costs associated with medication. It is essential for legislative measures to expand protections beyond Medicare to ensure that fair competition exists across the entire pharmaceutical landscape.

While the current regulations seem to provide some level of patient protection, the vast market influence of PBMs in the pharmacy sector cannot be overlooked. The study’s insights suggest that even within the constraints of Medicare’s regulations, PBMs still manage to guide a considerable segment of patients to their affiliated pharmacies. This is evident as Medicare beneficiaries utilized these pharmacies at a rate nearly 20% higher than would be expected without steering practices, indicating a troubling trend in aligning patient choices with corporate interests.

The research team, led by Dr. Kakani and senior author Dr. Amelia Bond, is committed to continuing their investigation into the impacts of PBM-owned pharmacies. Future research will explore vital aspects of care quality provided by these pharmacies, such as the accessibility of medications, the timeliness of prescription fulfillment, and adherence to treatment protocols. The findings from these ongoing studies could further inform discussions around how PBMs are regulated and their overarching role in patient care.

Furthermore, the market power held by these PBMs can lead to broader consequences for independent pharmacies, which may struggle to compete against these large conglomerates. The steering behaviors, while potentially offering benefits to some patients in terms of convenience, can be harmful in the context of the overall competitive landscape. This raises ethical considerations regarding patient choice and the importance of maintaining a diverse pharmacy ecosystem that includes independent community pharmacies.

In essence, as the healthcare landscape continues to evolve, the interplay between PBMs, pharmacies, and patients will require careful examination. Regulatory measures must adapt to ensure that patient welfare remains at the forefront, navigating the complex dynamics of pricing, access, and quality in medication delivery. The need for transparency in how PBMs operate and the potential conflicts of interest they represent is paramount to foster a healthcare environment that prioritizes the needs of patients over corporate profit.

The release of this study adds critical insights to an ongoing conversation regarding the future of pharmacy benefit management and how best to balance the roles of PBMs, pharmacies, and patients within the healthcare system. As this discourse continues, the effectiveness of existing regulations and the potential need for reforms to safeguard patient access to medications will undoubtedly remain salient topics within the broader healthcare policy discussions.

In conclusion, the considerations brought forth by the Weill Cornell Medicine research highlight the intricate web of relationships between PBMs, pharmacies, and patients. Understanding these dynamics is essential for crafting policies that ensure equitable access to pharmacy services and protect the interests of consumers within the rapidly changing healthcare market.

Subject of Research: The role of Pharmacy Benefit Managers (PBMs) in Medicare and their impact on pharmacy access and market share.
Article Title: The Steering of Patients by Pharmacy Benefit Managers: Implications for Medicare and Beyond
News Publication Date: 10-Jan-2025
Web References: Federal Trade Commission Report
References: JAMA Health Forum
Image Credits: N/A

Keywords: Pharmacy Benefit Managers, Medicare, pharmaceutical access, healthcare policy, pharmacy steering, specialty medications, independent pharmacies, healthcare regulations.