On Friday, January 27, the Centers for Medicare & Medicaid Services  (CMS) posted its long-awaited proposed rule implementing the Medicaid  pricing and reimbursement provisions of the Patient Protection and  Affordable Care Act (ACA) and related legislation. The Federal Register published the proposed rule (“ACA Proposed Rule”) on February 2, which  is available here. King & Spalding’s January 30 summary of significant  changes is available here.

CMS provided manufacturers and other stakeholders with only two months  to assess and comment on the implications of the ACA Proposed Rule. The ACA Proposed Rule may affect decisions related to an array of ongoing  business operations, including clinical development, product life-cycle management, mergers and acquisitions, and ongoing pricing recalculations  or reviews. Given the scope and complexity of the issues presented,  manufacturers must act quickly to educate relevant members of their  management and government pricing teams about CMS’s proposals,  analyze the business implications of the ACA Proposed Rule, evaluate their  systems for implementing any potential changes, and formulate strategies  for submitting effective, persuasive comments. Comments are due to CMS  no later than April 2, 2012 at 5 pm.

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