In what may prove to be the most substantial fraud and abuse rulemaking in over a decade, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) published on
OIG
COVID-19 Update: HHS Issues Notice of Designation to Prevent Hoarding and OIG launches COVID-19 Portal
On March 25, in response to President Trump’s Executive Order, HHS issued a Notice of Designation a list of health and medical resources necessary to respond to COVID-19 that are necessary to combat the spread of the disease. The…
OIG publishes Medicaid Fraud Control Units Fiscal Year 2018 Annual Report
On March 25, 2019, the Office of Inspector General (OIG) published its Medicaid Fraud Control Units Fiscal Year 2018 Annual Report. Forty-nine states and the District of Columbia have a Medicaid Fraud Control Unit (MFCU) which is responsible for…
OIG proposes to eliminate safe harbor protection for drug manufacturer rebates to PBMs; proposes two new safe harbors
On January 31, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed new rule that, if finalized, would eliminate existing protection under the Anti-Kickback Statute (AKS) “discount” safe harbor (42 C.F.R. 1001.952(h)) for…
OIG considers new safe harbors and other incentives to promote coordinated care
As part of the Health and Human Services Department’s (“HHS”) “Regulatory Sprint to Coordinated Care” efforts aimed at alleviating unnecessary regulatory barriers to coordinated care while protecting against fraud and abuse, the Office of Inspector General (“OIG”) issued a Request…
OIG launches new compliance resource portal
The OIG recently launched a new compliance resource portal, compiling some of its resources into one user-friendly webpage.
The Compliance Resource Portal provides a list of links to categories of “handy resources for the public that can help ensure that…
Rumors of sea change in DOJ policy potentially confirmed by two recent memos
Rumors of a significant shift in U.S. Department of Justice (DOJ) policy were confirmed last week when a privileged and confidential internal DOJ memo was leaked to the press. The memo outlines seven factors government attorneys should use for evaluating…
OIG rescinds advisory opinion to charity
For the first time, the OIG has rescinded an advisory opinion issued to a charity.
According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 – was revoked because the charity “failed to comply with…
Republican Senators continue work on health care reform legislation while another insurer withdraws from a state ACA marketplace; U.S. Senate and House of Representatives committees hold hearings this week on the cost of prescription drugs and funding for safety net health programs
Last Tuesday, Senior Republican leadership in the Senate held a closed-door briefing for Republican Senate members regarding Senate health care reform legislation. Senior Republican leadership reportedly indicated that they favor the retention of guaranteed protections for individuals with preexisting conditions,…
No monetary penalties for manufacturer providing physicians with free vaccine refrigeration storage system
In an Advisory Opinion issued on September 23, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) announced that it would not impose administrative sanctions against the manufacturer of a vaccine refrigeration system (the “Requestor”) for providing the devices to physicians without charge. This development comes at a critical time when many are focused on creatively addressing the risks posed by infectious diseases and viruses like Zika.