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 to determine compliance with applicable Federal regulations and Department of Health and Human Services (DHHS) policies and procedures.
- Specialty Drug Coverage and Reimbursement in Medicaid. OIG will describe States’ definitions of, and payment methodologies for, Medicaid specialty drugs; determine how much States paid for specialty drugs; and review strategies used by States to manage specialty drug costs, such as formularies, cost sharing, step therapy, and prior authorization.
- FDA Oversight of Risk Evaluation and Mitigation Strategies To Address Prescription Opioid Abuse. OIG will describe how the U.S. Food and Drug Administration (FDA) determined the need for opioid risk evaluation and mitigation strategies (REMS); determine the extent to which FDA has held pharmaceutical companies with required opioid REMS accountable for REMS assessments; and determine the extent to which FDA has held opioid REMS sponsors accountable for REMS goals to mitigate risks of misuse, abuse, addiction, overdose, and serious complications because of medication errors.
- Drug Traceability Test. OIG will determine the extent to which selected drugs can be traced from the dispenser back to the manufacturer in compliance with The Drug Supply Chain Security Act (DSCSA) requirements.
- Review of Medicare Payments for Bariatric Surgeries. OIG will review supporting documentation for bariatric surgery claims to determine whether the services performed met the conditions for coverage and were supported in accordance with Federal requirements.