OIG Publishes Advisory Opinions
The Department of Health and Human Services Office of Inspector General (“OIG”) issued three Advisory Opinions:
Advisory Opinion 24-10 responds to a request regarding a proposal for a requestor to expand its customer loyalty program, which allows customers to earn points on dental-related purchases that are redeemable for other dental-related items or services. The expansion would allow the requestor’s subsidiaries to participate in the loyalty program. The OIG advised that, although the proposed arrangement, if undertaken, would generate prohibited remuneration under the Federal Anti-Kickback statute, if the requisite intent was present, the OIG would not impose administrative sanctions on the requestor.
Advisory Opinion 24-11 addresses whether the requestor, a pharmaceutical manufacturer, can provide free meningococcal vaccinations to eligible patients who are prescribed certain drugs by requestor. The arrangement would require patients to meet certain non-financial requirements and the requestor to cover the full cost of the vaccine and vaccine administration. The OIG concluded that, although the arrangement does not constitute grounds for the imposition of sanctions under the Beneficiary Inducements CMP, it could generate prohibited remuneration under the Federal Anti-Kickback statute, if the requisite intent was present. However, the OIG stated that it will not impose administrative sanctions on requestor in relation to this arrangement.
Advisory Opinion 24-12 responds to a proposed arrangement wherein requestor, a drug manufacturer, would pay for genetic testing and associated genetic counseling, as well a provide disease-state awareness education, to certain eligible patients who are diagnosed with or at risk of a certain rare genetic condition that leads to chronic kidney stones and kidney disease. The OIG found that, while the arrangement would generate prohibited remuneration under both the Anti-Kickback statute and the Beneficiary Inducement CMP, the OIG will not impose administrative sanctions on the requestor.
OIG Issues Special Fraud Alert for Medicare Advantage and Providers
The OIG published a Special Fraud Alert for Medicare Advantage Organizations (“MAO”) and health care professionals. The Alert addresses the risks associated with marketing arrangements between MAOs and health care professionals, as well as arrangements between health care professionals and brokers for Medicare Advantage plans. OIG states that it has warned against certain types of remuneration between these parties that can result in abusive arrangements in violation of Federal law, including the Federal Anti-Kickback statute, Civil Monetary Penalties Law, and False Claims Act.
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