Each month, we are pleased to share the most recent additions to the Office of Inspector General (OIG) Work Plan items. As of June 2017, OIG updates their Work Plan monthly with any new changes to the active list. Let’s take a look at the new points of emphasis for compliance professionals moving forward.
A few topics that stood out to us for October’s OIG Work Plan are the following:
- Office of the Secretary
- Speciality Drug Coverage and Reimbursement in Medicaid
- FDA Oversight of Risk Evaluation and Mitigation Strategies To Address Prescription Opioid Abuse
This month’s agenda is relatively small from OIG with only 5 new items. Let’s walk through some of these updates so you can address each item within your compliance program.
Office of the Secretary
Unless you have been living under a rock for awhile, you’re probably well aware of the former Secretary of Health and Human Services Tom Price’s resignation. Price got himself in hot water with the current administration and the public for racking up $400,000 in travel bills for chartered flights.
These controversial travel arrangements, as well as other hurdles, lead Price to resign his position on September, 29. OIG is currently looking into Price’s use of chartered flights for Federal travel. Upon an evaluation, OIG will determine compliance with Federal regulations as well as policies and procedures of the Department of Health and Human Services.
Read the full update here.
Specialty Drug Coverage and Reimbursement in Medicaid
There is currently no standard definition for specialty drugs that are covered by Medicaid. Unfortunately, vague interpretations or misuse has lead to dramatic increases in Medicaid spending for drugs that could possibly be understood in such a way.
Although these drugs are covered in different ways depending on each state, OIG will determine how much states paid for specialty drugs based on definition and payment methodologies.
Take a look at the story here.
FDA Oversight of Risk Evaluation and Mitigation Strategies To Address Prescription Opioid Abuse
As complex problems and possible solutions continue to evolve regarding the opioid epidemic in the United States, more agencies are getting involved along with increases in evaluation techniques. Pharmaceutical companies are required to prepare Risk Evaluation and Mitigation Strategies (REMS) when risks of using a drug are more harmful than helpful according to the FDA.
OIG will determine the effort at which FDA has held pharmaceutical companies accountable for these REMS assessments. OIG will consider the extent that REMS sponsors are held accountable for goals put in place to address the following issues:
- Risks of misuse
- Medication errors
To get more information on how these measures are being taken, read on further here.
Do you have any recent experience or background information concerning OIG’s Work Plan updates for October? Let us know in the comments below!
Written by Michael Rosen, ESQ
Michael brings over 20 years of experience founding and leading risk mitigation businesses, receiving numerous accolades such as: Inc Magazine’s Inc 500 Award and Nashville Chamber of Commerce Small Business of the Year.