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New watchdog bureau to tackle prescription drug costs

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Wed, May 11th 2022 03:40 pm

Pharmacy Benefits Bureau to supervise unregulated pharmacy benefit manager industry

√ Directs Department of Financial Services to establish standards to protect consumers & independent small businesses

√ Pharmacy benefit managers required to register with new bureau by June 1 and submit annual report by July 1

√ Guidance on PBM registration and reporting now available on the DFS website

Gov. Kathy Hochul announced the first-in-the-nation approach to bring oversight to pharmacy benefit managers with the creation of the Department of Financial Services' Pharmacy Benefits Bureau. 

Her team said, “Pharmacy benefit managers are key intermediaries in the prescription drug supply chain that have, without regulatory oversight, long controlled the price of drugs for health plans and reimbursement rates for pharmacies. The new bureau will be tasked with licensing and supervising the industry, keeping a watchful eye on pharmacy benefit managers' impact on consumers and the cost of health care.”

Hochul said, "As we continue our comeback from the COVID-19 pandemic, it's crucial that we take every opportunity to improve the health care system and reduce costs for New Yorkers. This landmark regulatory body will provide careful oversight to protect consumers from predatory practices in the largely unregulated pharmacy benefits managers industry. My administration remains committed to doing everything in its power to reduce the burden of health insurance and prescription drug costs on New Yorkers.”

Earlier this year, Hochul signed into law a regulatory regime for pharmacy benefit managers, assigning DFS new authority to license and supervise the industry. DFS now has the power to address the “widely reported problematic practices in the PBM industry, which, in turn will help lower drug and health insurance costs, protect New Yorkers accessing those drugs, and support New York's pharmacies, many of which are independent small businesses.”

Additionally, with the passage of the enacted 2023 state budget, Hochul secured a $5 million appropriation to fund and staff the new bureau. As the program fully develops, costs to administer this initiative will be offset through the application of fees, assessments and penalties directly on the PBM industry, “ensuring the cost of regulating this industry will fall on the PBMs, not on the taxpayers.”

In addition to the regulation of PBMs, DFS' existing authority to investigate drug price spikes now falls under the supervision of the new Pharmacy Benefits Bureau. DFS will continue to review reporting, monitor the market conduct and ensure proper enforcement of consumer protections in New York.

Superintendent of Financial Services Adrienne A. Harris said, "The health and wellness of New Yorkers depends on having access to fairly priced prescription drugs. With regulatory oversight of the Pharmacy Benefits Industry, DFS will increase transparency and accountability across the industry, ultimately putting more money in New Yorkers' pockets."

New York State Health Commissioner Dr. Mary T. Bassett said, "Rising prescription drug prices not only increase the cost of health care for all New Yorkers, but place a particular burden on the elderly and exacerbate the systemic inequities in health care delivery. DOH and DFS will work in concert to promote transparency, preserve access, and curb the rising cost of prescription drug prices for the most vulnerable."

DFS has met with external stakeholders in preparation for the registration deadlines. DFS reminds all PBMs of their requirement to register with the bureau by June 1, and to submit their first annual report by July 1. The bureau has releases guidance on both registration and the annual report on the DFS website.

DFS will soon file regulatory amendments reflecting the creation of this bureau. More information will be available in the State Register.

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