OIG Work Plan Monthly Review: October 2017
Drugs continue to command the OIG’s attention with three of this month’s five new Work Plan items dedicated to the issue. Although none of the new items specifically address lab services, four of them could have an indirect impact on some labs, particularly the item targeting Medicare payments for bariatric surgeries. 1. Medicare Payments for […]
Drugs continue to command the OIG's attention with three of this month's five new Work Plan items dedicated to the issue. Although none of the new items specifically address lab services, four of them could have an indirect impact on some labs, particularly the item targeting Medicare payments for bariatric surgeries.
1. Medicare Payments for Bariatric Surgeries
Concern: A Comprehensive Error Rate Testing program's special study of certain HCPCS codes for bariatric surgical procedures found that approximately 98% of improper payments lacked sufficient documentation to support the procedures.
What OIG Will Investigate: The OIG will review the supporting documentation to determine whether the bariatric services billed for under Medicare Parts A and B met coverage requirements.
2. Specialty Drug Coverage and Medicaid Reimbursement
Concern: Medicaid spending on specialty drugs, the definition of which varies from state to state, has sharply increased in recent years.
What OIG Will Investigate: The OIG will review how states define and pay for specialty drugs under Medicaid, how much they pay for them and what strategies they use, e.g., formularies, cost sharing, step therapy and prior authorization to manage those costs.
3. FDA Oversight of Prescription Opioid Abuse Risk Evaluation & Mitigation Strategies
Concern: A 2007 law gives the FDA authority to require pharmaceutical companies to develop Risk Evaluation and Mitigation Strategies (REMS) if the agency thinks the risk of using a drug outweighs its benefits.
What OIG Will Investigate: The OIG will review how the FDA uses this authority with regard to opioid drugs, specifically how it determines the need for opioid-related REMS and holds manufacturers and sponsors accountable for mitigating risks of opioid misuse, addiction, overdose and serious complications due to medication errors.
4. Drug Traceability Test
Concern: The Drug Supply Chain Security Act (DSCSA) gives the FDA new powers to keep diverted, counterfeit, imported and other potentially harmful drugs from getting into the supply chain and to spot and remove any that are already there. Those powers include requiring trading partners to exchange drug product tracing information when they take ownership of drugs.
What OIG Will Investigate: The OIG will determine the extent to which DSCA records can be used to trace drugs from the dispenser back to the manufacturer.
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