HHS OIG Publishes Two Advisory Opinions
The Department of Health and Human Services Office of Inspector General (“OIG”) published two advisory opinions:
- Advisory Opinion 25-04 looks at a proposed arrangement in which the requestor would be requested or required by its customers, as a condition of doing business, to pay an annual fee to a third-party company that would screen and monitor the requestor for exclusion from federal health care programs and compliance with certain other legal requirements. This fee would otherwise be incurred by each of the customers, as they are the ones who would receive the screening and monitoring reports and use those reports to determine if they can continue doing business with the requestor. The OIG noted that this proposed arrangement could inappropriately steer customers to the requestor and away from competitors who can’t or won’t pay these fees. The OIG concluded that this proposed arrangement would generate prohibited remuneration under the federal anti-kickback statute if the requisite intent were present, which would constitute grounds for the imposition of sanctions under that statute.
- Advisory Opinion 25-05 looks at a proposed arrangement in which a requestor would reimburse a purchaser of the requestor’s medical device up to $2,500 for actual costs incurred by that purchaser as a result of a needle stick injury caused by a failure of the device’s safety mechanism. After analyzing the relevant facts and applicable law, the OIG concluded that the requestor’s proposed arrangement would be protected by the safe harbor for warranties and thus would not generate prohibited remuneration under the federal anti-kickback statute.
HHS OIG Participates in Record Setting Nationwide Fraud Enforcement Action
The Department of Justice, in partnership with the HHS OIG and other federal and state law enforcement agencies, announced the results of the joint “2025 National Health Care Fraud Takedown.” The joint action resulted in 324 defendants (including 96 licensed medical professionals) in 50 federal districts being criminally charged for allegedly participating in various health care fraud schemes resulting in more than $14.6 billion in intended losses to Medicare and other healthcare benefit programs. This is the largest Health Care Fraud Takedown in U.S. history, more than doubling the previous $6 billion record.
CMS Grants Continued Recognition of the Joint Commission’s Hospital Accreditation Program
The Centers for Medicare & Medicaid Services (“CMS”) issued a notice announcing its approval of the Joint Commission for continued recognition as a national accrediting organization for hospitals that want to participate in the Medicare or Medicaid program. This approval is effective July 15, 2025 through July 15, 2030.
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