Real-World Evidence for Medical Device Approval

Embracing Modern Data: FDA’s New Guidance on Real-World Evidence for Medical...

By: Christopher A. Parrella, Esq., CPC, CHC, CPCO Parrella Health Law, Boston, Ma. The U.S. Food and Drug Administration (FDA) recently issued draft guidance clarifying the evaluation of real-world data (RWD) for regulatory decision-making...

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Medical Code G2211

Understanding the New CMS G2211 Code for E/M Visit Complexity

By: Christopher A. Parrella, Esq., CPC, CHC, CPCOParrella Health Law, Boston, Ma. CMS has introduced a significant update regarding the Office and Outpatient Evaluation and Management (E/M) Visit Complexity Add-on Code G2211, effective January 1,...

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Enhancing Primary Care through Medicare’s Behavioral Health Services: A Guide for...

By: Christopher A. Parrella, Esq., CPC, CHC, CPCO The CMS article discusses three key behavioral health services covered by Medicare, which are crucial for improving patient outcomes. The services include Behavioral Health Integration (BHI)...

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Parrella Health Law

Understanding the HHS’s New $115 Fee for Surprise Billing Law Disputes

By: Christopher A. Parrella, Esq., CPC, CPCO, CHC The U.S. Department of Health and Human Services (HHS) recently finalized a significant aspect of the No Surprises Act: a $115 fee for initiating arbitration in disputes between health insurers and...

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Parrella Health Law

Navigating Compliance: A Critical Review of the Stark Law in Light...

By: Christopher A. Parrella, Esq., CPC, CPCO, CHC In a significant development that underscores the importance of stringent compliance with healthcare regulations, the U.S. Attorney’s Office has initiated a legal action that highlights the...

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Parrella Health Law

The DOJ Case of BioTelemetry and LifeWatch’s $14.7 Million Settlement for...

By: Christopher A. Parrella, Esq., CPC, CPCO, CHC BioTelemetry Inc. and its subsidiary, LifeWatch Services Inc., recently faced serious allegations concerning their billing practices in the realm of remote cardiac monitoring services. This case...

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