Tag: Health and Human Services

OIG Releases October Work Plan Items; Includes Opioid REMS and Specialty Drug Coverage and Medicare Reimbursement

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The October updates include 5 new Work Plan items: Secretary Price’s Use of Chartered Aircraft for Federal Travel. OIG is reviewing Secretary Price’s use of chartered aircraft for Federal travel […]

OIG Releases September Work Plan Items; Includes Part D Sponsor Reporting of Rebates and Price Concessions to Medicare

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The September updates include 9 new Work Plan items: Federal Marketplace Enrollment Systems. OIG will assess operational readiness, internal controls, and IT security in preparation for the fifth open enrollment period. […]

OIG Work Plan Will Now Be Updated Monthly; 14 New Items Added for July

The Office of Inspector General (OIG) for Health and Human Services (HHS) recently announced that it will begin updating its Work Plan initiatives monthly rather than its previous twice-yearly publications, which was most recently released in November 2016. The OIG Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken […]

Advocate Data Breaches Result in Largest HIPAA Settlement To Date

On August 8th, 2016, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date with Advocate Health Care System (Advocate).  Advocate agreed to pay $5.55 million to settle a variety of HIPAA violations.  Advocate […]

HHS Releases Crosswalk Between HIPAA Security Rule and NIST Framework

The U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR)  recently released a “crosswalk” developed with the National Institute of Standards and Technology (NIST) mapping  the Health Insurance Portability and Accountability Act (HIPAA) Security Rule and the NIST Framework for Improving Critical infrastructure Cybersecurity (the Framework). […]

“Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”.  The Common Rule is a uniform federal policy for the Protection of Human Subjects, originally issued in 1991. The U.S. agencies […]

HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 27, 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the Federal Register (the “Proposed Rule”).  The 340B Drug Discount Program is the program by which drug and biologic […]