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[co-author: Josue Silva]
On February 17, 2021, it was reported that President Biden would nominate Chiquita Brooks-LaSure as Administrator of the Centers for Medicare & Medicaid Services (CMS), the largest operating division of the U.S. Department of Health and Human Services (HHS).
The CMS Administrator enjoys considerable influence. Administrator-designate Brooks-LaSure, if confirmed, will run the largest HHS operating division with more than $1 trillion in annual expenditures, more than 6,000 employees, 10 offices around the country, regulatory oversight of nearly all health care providers in the nation and control of federal health programs covering 145 million Americans, including Medicare, Medicaid, the Children’s Health Insurance Program (CHIP) and the Affordable Care Act (ACA) marketplaces. Because of this role, the Administrator and her actions often have wide-reaching effects on health care, even beyond the programs CMS administers.
NCPA January 27, 2021
In a letter to the acting administrator of CMS, NCPA urged the agency to rescind the Most Favored Nations rule for Medicare Part B Drugs and Biologicals. A summary of the MFN model can be found here. NCPA asked CMS to work with NCPA and other stakeholders to identify more appropriate models to curb the cost of prescription drugs. NCPA comments highlighted concerns related to patient access, specifically creating a situation where pharmacists are unable to acquire MFN model drugs at prices commensurate with MFN model reimbursement. The letter also raised several legal concerns, which have led federal courts to block implementation of the MFN rule in three separate cases, each order effectively blocking the MFN rule from taking effect. These legal developments, in addition to the Regulatory Freeze Pending Review memo issued by the Biden administration on Jan. 20, mean that the MFN rule will not take effect in the short term.
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In part one, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander break down the background, substance, and procedural issues of the two Final Drug Pricing Rules released on November 30, 2020: the Most-Favored Nations (MFN) Rule and the Rebate Rule.
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