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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

On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast [Video]

This Diagnosing Health Care episode dives into the prospects of coverage expansion following the 2020 elections and also examines three major health care policy reform issues that have bipartisan support and could see...more

Mental Health Parity Requirements and Medicaid Plans: CMS Seeks Comment on Proposed Rule

On April 10, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a proposed rule (“Proposed Rule”) implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction...more

CMS Releases Updates to Its Medicare Advantage and Part D Plan Audit Protocols and Processes

On February 12, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released an updated version of its Medicare Advantage (“MA”) and prescription drug benefit (“Part D”) plan audit protocols and also announced the...more

Supreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims

On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more

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