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Health Care Enforcement Kept the DOJ Fraud Section Busy in 2020 | Mintz - Health Care Viewpoints

To embed, copy and paste the code into your website or blog: On February 24, 2021, DOJ’s Criminal Division Fraud Section published its annual year-end summary (available here).  The Fraud Section focuses on prosecuting white-collar crime.  The report summarizes enforcement activity in the past year and discusses notable cases from the Fraud Section’s three litigation units:  (1) the Health Care Fraud (HCF) Unit; (2) the Foreign Corrupt Practices Act (FCPA) Unit; and (3) the Market Integrity and Major Frauds (MIMF) Unit.  In summarizing the Fraud Section’s main achievements from 2020, the report also provides valuable insights on what lies ahead for the Fraud Section in 2021.  This post focuses on the health care enforcement portion of the Fraud Section’s report.

HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part VI: Changes to Fundamental Stark Law Terminology | Mintz - Health Care Viewpoints

To embed, copy and paste the code into your website or blog: In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i) key Stark Law terminology, and (ii) the scope and application of the Stark Law exceptions.  The Centers for Medicare & Medicaid Services (CMS) finalized new definitions for various key terms used in the Stark Law regulations as well as revisions to existing terms that are generally intended to provide more certainty and flexibility.  This post discusses a few of the highlights, but the final regulations contain many others.

Telehealth Update: Extension of the Public Health Emergency, OIG Workplan Updates, and the Protecting Access to Post-COVID 19 Telehealth Act | Mintz - Health Care Viewpoints

Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems | Mintz - Health Care Viewpoints

To embed, copy and paste the code into your website or blog: Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings (as reported by our colleagues in this post), several important changes to the laws enforced by the Food and Drug Administration (FDA) were recently enacted by Congress. As legislative actions, those changes are of course unaffected by President Biden’s regulatory freeze and so we thought worth a summary to ensure our readers are up to speed on the large amount of activity that occurred in the final weeks of the 116th Congress and the Trump Administration. 

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