In March 2023, the Department of Health and Human Services – Office of Inspector General (“OIG”) issued its first series of FAQs on general fraud and abuse compliance topics. These FAQs are included on the OIG website. This represents a new development, in terms of OIG communications. Heretofore, OIG has issued only formal guidance (i.e., Advisory Opinions, Special Fraud Alerts). OIG has indicated it will respond to “appropriate and beneficial” general questions regarding the Anti-Kickback Statute, the Beneficiary Inducement Civil Monetary Penalty laws, the OIG Health Care Fraud Self-Disclosure Protocol, as well as general healthcare compliance matters. Please use the following link to this information: https://oig.hhs.gov/faqs/.
The FAQs are non-binding and informal, and thus far have been fairly general in nature. Some questions clarify general principles of fraud and abuse (“When an arrangement does not satisfy a safe harbor under the Federal anti-kickback statute, does that mean it’s automatically illegal?”), whileothers address specific proposed arrangements (“Can a hospital give naloxone rescue kits to patients at risk of opioid overdose after leaving the hospital?”).
In conjunction with the FAQs, the OIG created a new pathway for requesting advice. Questions can be submitted directly to OIGComplianceSuggestions@oig.hhs.gov. Questions should include sufficient background information and facts for OIG to
evaluate the arrangement or comment on the policy issue. All answered questions will be generalized and will not identify the requestor. Unlike an OIG Advisory Opinion, an answered FAQ does not confer prospective immunity from OIG sanctions on the requestor. OIG recommends that parties seeking specific feedback or immunity on complex or novel arrangements continue to make use of the Advisory Opinion process.
The OIG FAQ page also includes previously published FAQs regarding corporate integrity agreements, exclusions, student volunteer service programs, contractor self-disclosures and whistleblower protection coordinators.
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