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A clarion call for regulating PBMs: Health care groups, states push back on legal challenges


 

Mark Nelson, PharmD, recalls the anguish when a major pharmacy benefit manager (PBM) moved all veteran patients with prostate cancer at his facility from an effective medication to a pricier alternative therapy. “All of these patients were stable on their therapy and were extremely distraught about their medications being changed,” said Dr. Nelson, CEO of Northwest Medical Specialties in Washington State. While there was no clinical reason to change the medication, “our oncologists had no choice other than to comply,” he said.

A gavel and a stethoscope Niyazz/ThinkStock

It’s unclear why a PBM would switch to a more expensive medication that has no additional clinical benefit, he continued. “Why upset so many veterans? For what reason? We were not given a reason despite our very vocal protest.”

Angus B. Worthing, MD, sees these scenarios unfold every day in his rheumatology practice in the Washington, D.C., area. “In my clinic with 25 doctors, we have three full-time people that only handle PBMs,” he said in an interview. He and others in the medical community, as well as many states, have been pushing back on what they see as efforts by PBMs to raise drug prices and collect the profits at the expense of patients.

Dr. Angus B. Worthing is chair of the ACR’s Government Affairs Committee and a practicing rheumatologist in the Washington area.

Dr. Angus B. Worthing


PCMA’s challenges against PBM law

The Pharmaceutical Care Management Association (PCMA), a trade group that represents PBMs, has sued at least a half dozen states on their ability to regulate PBMs. However, a landmark case in late 2020 (Pharmaceutical Care Management Association v. Rutledge) set a new precedent. Reversing a lower appeals court decision, the Supreme Court unanimously ruled in favor of allowing states to put in place fair regulation of these entities.

Dr. Worthing and others hope that the medical community and states can leverage this ruling in another lawsuit PCMA brought against North Dakota (PCMA v. Wehbi). PCMA filed this lawsuit in 2017, which challenges two statutes on PBM regulation. The group has issued similar legal challenges in Maine, the District of Columbia, Iowa, Oklahoma, and Arkansas with the Rutledge case.

“PBMs have become massive profit centers while (ironically) increasing patients’ out-of-pocket costs, interfering with doctor-patient relationships, and impairing patient access to appropriate treatment,” according to an amicus brief filed by The Alliance for Transparent & Affordable Prescriptions (ATAP), the Community Oncology Alliance (COA), and American Pharmacies, supporting North Dakota in the Wehbi case.

This is to ensure the case represents the voices of physicians, patients, nurses, and other stakeholders, and underscores PBM abuses, said Dr. Worthing, vice president of ATAP. He also serves as the American College of Rheumatology’s representative on ATAP’s Executive Committee.

PCMA did not respond to requests for comment. Its CEO and president, J.C. Scott, emphasizes that PBMs have a long track record of reducing drug costs for patients and plan sponsors. In 2021, PCMA released 21 policy solutions, a set of industry principles and a three-part policy platform, all with an aim to bring down costs and increase access to pharmaceutical care, according to the organization.

PCMA estimates that the strategies in its platform (updating Medicare Part D, accelerating value-based care, and eliminating anticompetitive ‘pay for delay’ agreements) would save the federal government a maximum of $398.7 billion over 10 years.

According to Wendy Hemmen, senior director with Texas Oncology in Dallas, PBMs do their own unique calculations to arrive at their cost reductions. “Essentially in a PBM, they use things that make their story. Numbers reported to plan sponsors and to the public are not audited and are usually in terms of percentages or a per member per month. Data points are moved around, dropped, or reclassified to make the story that the PBM needs to tell,” Ms. Hemmen said.

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