Sheva J. Sanders

Sheva J. Sanders

Stinson Leonard Street

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FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

3/4/2015 - Distributors FDA Healthcare Manufacturers Medical Device Accessories Medical Devices New Guidance Technology Wellness Programs

CMS Changes Sunshine Rules for CME, Revises List of Data Elements to be Reported

The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more

11/24/2014 - CMS Continuing Medical Education Final Rules Medical Devices Pharmaceutical Pharmaceutical Manufacturers Reporting Requirements Sunshine Act

Rules for CME, Revises List of Data Elements to be Reported

Last Friday, the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable...more

11/7/2014 - CME CMS Data Protection EHR Healthcare Healthcare Reform PHI Sunshine Act

Health & Human Services, Office of Inspector General, Proposes New Fraud and Abuse Rules

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) published 79 Fed. Reg. 59717 on October 3, 2014. This proposed rule has the potential to have an impact on a broad array of financial...more

10/15/2014 - CMS Compliance Fraud and Abuse Healthcare HHS Medicare Part D OIG

Health Law Alert: OIG Issues Updated Special Advisory Bulletin On The Effect Of Exclusion From Participation In Federal Health...

On May 8, 2013, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued an updated Special Advisory Bulletin on the effect of exclusion from participating in federal health care programs....more

5/17/2013 - Civil Monetary Penalty Healthcare OIG Self-Disclosure Requirements

Health Law Alert: Final Sunshine Act Regulations Released

On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Sunshine Act regulations. The Sunshine Act requires disclosure of payments and value transfers (Payments) from drug and...more

2/5/2013 - CMS Covered Products Disclosure Requirements Manufacturers Medicaid Medical Devices Medical Supplies Medicare Reporting Requirements Sunshine Act

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