Lauren Groebe

Lauren Groebe

Polsinelli

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Recent 340B Orphan Drug Decision May Have Widespread Implications

In This Issue: - Orphan Drug Rule Background - PhRMA Sues to Block the Orphan Drug Rule - District Court Says HHS Overstepped Its Authority and Invalidates Orphan Drug Rule - Implications on the...more

6/4/2014 - 340B HHS Orphan Drugs Patent Litigation Patents Pharmaceutical Pharmaceutical Patents PHRMA Prescription Drugs

HHS Extends Patient Access To Laboratories

On February 6, 2014, the Department of Health and Human Services (HHS) published a Final Rule amending regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance...more

2/24/2014 - CLIA EHR HHS HIPAA OCR PHI

CMS Creates "Open Payments" Website For Reporting Under The Physician Payment Sunshine Act

On April 12, 2013, the Center for Medicare and Medicaid Services (“CMS”) created the “Open Payments” website where reported information under Section 6002 of the Affordable Care Act (“ACA”), commonly referred to as the...more

4/18/2013 - CMS Physician Payments Sunshine Act Websites

Physician Payment Sunshine Act Final Rule Released

In This Issue: - Interpretation and Clarification of Key Definitions ..Applicable Manufacturers ..Applicable GPOs ..Covered Drug, Device, Biological or Medical Supply ..Covered Recipients ...more

3/7/2013 - Affordable Care Act CMS Healthcare Manufacturers Medical Devices Pharmaceutical Physicians Sunshine Act

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