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FDA Issues Guidance for Classification Pathways for New Accessory Types

Accessories to medical devices play an integral role for their parent medical devices, supporting or adding to the parent device’s functionality.  Accessories historically took the classification of the parent device, except in cases where the Food and Drug Administration (“FDA”) classified the accessory in its own right.    The 21st Century Cures Act, passed into law … Continue Reading

New Book Outlines Important Clinical Integration Considerations

Providers and policy makers have struggled  to find solutions to rein in health care costs while improving clinical outcomes.  Clinical integration is one approach to meet these challenges. In short, clinical integration is a legal arrangement for healthcare provider integration that involves a carefully structured collaboration of healthcare professionals to provide coordinated care across multiple … Continue Reading

CMS Finalizes Medicare Part C and Part D Program Changes for Contract Year 2015: Moderate Deviations from Proposed Rule

On January 8, 2014, we noted several proposed changes to the Medicare Part C and D programs as delineated in CMS’ January 8th proposed rule (hereinafter “Proposed Rule”). On Monday, May 19, 2014, CMS issued the final rule, titled Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare … Continue Reading

CMS Issues Medicare and Medicaid Final Rule: Significant Changes to Conditions of Participation

On Wednesday, the Centers for Medicare and Medicaid Services (“CMS”) issued a second round of long-awaited red tape reduction initiatives aimed at ameliorating overly burdensome provider regulations.  The changes, memorialized within a Final Rule scheduled for publication on May 12, 2014 (available for review here: http://federalregister.gov/a/2014-10687) (“Unpublished Final Rule”)  include significant easing of Conditions of … Continue Reading

Preserving the Attorney-Client Privilege for In-House Counsel

In the December 2013 edition of AHLA Connections, Tom Zeno and Emily Root analyzed the application of the attorney-client privilege to in house counsel and provided five practice tips to maximize the protection of the privilege for in house counsel.  In the article, Emily and Tom explore often overlooked principles of the privilege and illustrate … Continue Reading

Medical Transcription: Business Transparency and Professional Accountability

Scott A. Edelstein co-authored Medical Transcription: Business Transparency and Professional Accountability, which was published in the June issue of Compliance Today. Scott discusses how the medical transcription industry is developing greater transparency and professional service accountability in preparation for the transition to digital health records management. The industry’s professional society and trade association collaborated to … Continue Reading
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