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February 20, 2019

By Gary A. Puckrein, PhD

February 15, 2019 | Washington, DC

The National Minority Quality Forum has released the following statement regarding the proposed rule by Department of Health and Human Services that would create incentives to lower list prices and reduce out-of-pocket spending on prescription drugs:


“The Department of Health and Human Services (DHHS) published on February 6, 2019 a proposed rule to reduce the costs of prescription drugs for American patients that appears to be a step in the right direction. The National Minority Quality Forum believes that the business model and regulatory environment that defines the manner in which prescription drug prices and discounts are negotiated has benefitted from a lack of transparency that makes it difficult for patients and their families to engage constructively as informed consumers.

“According to a fact sheet published by DHHS, ‘The proposed regulation would address a perverse incentive identified by the Department by expressly excluding from safe harbor protection under the Anti-Kickback Statute (AKS) rebates on prescription drugs paid by manufacturers to pharmacy benefit managers (PBMs), Part D plans, and Medicaid managed care organizations. The proposal would create a new safe harbor protecting discounts offered to patients at the pharmacy counter. Finally, the proposal would create new safe harbor protection for fixed fee services arrangements between manufacturers and PBMs.’

“During the 60-day public comment window that opened on February 6, 2019, the National Minority Quality Forum will take steps to analyze the impact of this proposed rule in context of other proposed reforms to clarify our understanding of the regulatory realignments that are ahead of us and the impact on consumer spending. We welcome opportunities to discuss these reforms with other patient advocacy groups and stakeholders, including medical and nursing societies, insurers/payers and hospital associations. As we have stated previously, the National Minority Quality Forum believes that the value of policy and regulatory changes must be assessed by examining the impact of those changes on the outcomes of care in patients and communities.”

CMS issued the proposed rule on February 6, 2019. In order to be considered, public comments must be received by 5 p.m. Eastern Standard Time on April 8, 2019. The fact sheet [1] that summarizes the proposed changes is available online; the proposed rule [2] can be downloaded from the Federal Register.


About the National Minority Quality Forum

The National Minority Quality Forum (the Forum) is a 501(c)(3) not-for-profit, non-partisan, independent research and education organization. The Forum’s vision is a health services research, delivery and financing system that provides quality and effective health services to the biodiverse American general population of the 21st century. The Forum helps assure that national and local quality improvement initiatives are informed by scientific evidence, and place a priority on the quality of care and patient outcomes in all populations. For additional information about the National Minority Quality Forum, please contact Gretchen Clark Wartman, Vice President for Policy and Program, at 202-223-7560 or