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CMS Launches First Federal Regulatory Action to Implement Medicare Drug Price Negotiation Program

On January 23, 2023, CMS published in the Federal Register its first proposed rulemaking to implement the Medicare Drug Price Negotiation Program (the “Negotiation Program”), which is included in the Inflation Reduction Act...more

District Court Upholds Medicare Beneficiary’s Challenge to Local Coverage Determination

A recent decision by the U.S. District Court for the District of Columbia has clarified that a Medicare beneficiary may challenge a Medicare Local Coverage Determination (LCD) without first having to exhaust the lengthy...more

CMS Framework for Health Equity: An Opportunity for Client Advocacy

The Centers for Medicare & Medicaid Services (CMS) Office of Minority Health has published its comprehensive CMS Framework for Health Equity 2022–2032 (Framework). CMS’s Framework arose in response to the Biden...more

The No Surprises Act: New and Surprising Challenges for Clinical Laboratories

On July 13, 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury, and the Office of Personnel Management (collectively, “Departments”) published their highly anticipated interim final rule (“First...more

HHS Releases Far-Reaching Proposed Rule to Prohibit Discrimination by “Covered Entities” Pursuant to Section 1557 of the...

On September 8, 2015, the U.S. Department of Health and Human Services (“HHS”) published a proposed rule titled “Nondiscrimination in Health Programs and Activities” (“Proposed Rule”)[1] to implement the nondiscrimination...more

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