Go to Wolters Kluwer VitalLaw.comGo to Wolters Kluwer VitalLaw.com
VitalLaw®
  • Find answers to your questions
  • Log in to access your subscriptions
In depth. On point.
In depth. On point.
  • Home
  • Legal Directory
  • Home
  • Legal Directory
In depth. On point.
  • Articles
  • Articles
  • Law Firms
  • Law Firms
  • Organizations
  • Organizations
    • HIPAA—N.D. Tex.: Hospital seeks stay of subpoena enforcement pending appeal
    • ANTI-KICKBACK PROHIBITION—OIG ADVISORY OPINIONS: Orthodontist’s offer of free services to undeserved patients would not violate AKS
    • ANTITRUST—E.D. Pa.: Generic drug pricing MDL claims advance as court sustains overarching conspiracy allegations
    • BLOG TRACKER—Noteworthy blog posts and other commentary
    • DRUGS AND BIOLOGICS—NOTICES: Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments
    • EXPERT INSIGHTS—Peptides At The Crossroads: FDA Tightens The Line As Category 2 Pushes Toward Category 1
    • MEDICAL DEVICES—FINAL RULES: Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples
    • MEDICARE PART C / MEDICARE ADVANTAGE—D.P.R.: Contract dispute over Medicare fee schedule remanded to state court
    • PRESCRIPTION DRUGS—CMS LETTERS: HHS agencies press for expanded use of non-drug mental health care and ongoing medication review
    • PRESCRIPTION DRUGS—Wash. App.: Discrimination action dismissed as a matter of law for denying obesity treatment reversed.
  • Articles
  • Articles
  • Law Firms
  • Law Firms
  • Organizations
  • Organizations

    Health Law Daily Wrap Up, ANTI-KICKBACK PROHIBITION—OIG ADVISORY OPINIONS: Orthodontist’s offer of free services to undeserved patients would not violate AKS, (May 7, 2026)

    By Jeffrey H. Brochin, J.D.

    Although Proposed Arrangement would generate prohibited remuneration under the anti-kickback statute (AKS) if the requisite intent were present, the Proposed Arrangement had features to reduce the risk that it would steer patients to Requestor, or le ...

    By Jeffrey H. Brochin, J.D.

    Although Proposed Arrangement would generate prohibited remuneration under the anti-kickback statute (AKS) if the requisite intent were present, the Proposed Arrangement had features to reduce the risk that it would steer patients to Requestor, or lead to fraud or abuse.

    The Office of Inspector General (OIG) of HHS has issued a favorable advisory opinion in response to the request of an Orthodontist (Requestor) to review his Proposed Arrangement to provide free orthodontia services on a limited basis to a few select existing patients. The Proposed Arrangement’s guidelines contained features that reduced the risk that it would steer patients to Requestor, and which made it unlikely that it would lead to inappropriate utilization or increased costs to federal health care programs. Although the Proposed Arrangement could influence beneficiaries to select Requestor for the receipt of dental or orthodontic services (possibly reimbursable by a federal health care program), thereby implicating the Beneficiary Inducements CMP, the OIG determined--in the exercise of their enforcement discretion--that they would not impose sanctions under the Beneficiary Inducements CMP, (OIG Advisory Opinion, No. 26-09 (Apr. 28, 2026)).

    Pediatric dental and orthodontic services. Requestor is an exclusively pediatric dental and orthodontic services provider that operates practices in three cities. Under the Proposed Arrangement, Requestor would provide free, comprehensive orthodontic treatment (Free Service) to up to one of Requestor’s existing patients per year at each of Requestor’s three locations for a potential total of three new recipients of the Free Service each year. Requestor certified that orthodontic treatment typically spans 12 to 24 months and is valued at approximately $4,725 per patient. Requestor also certified that it would not bill any federal health care programs for the Free Service, and that the Proposed Arrangement was intended solely to provide charitable care to underserved pediatric patients and to highlight the impact of orthodontic treatment on oral and mental health.

    Limiting guidelines. Under the Proposed Arrangement, Requestor’s treating dentists or orthodontists could nominate Requestor’s existing patients to receive the Free Service pursuant to the following guidelines: (1) Patients eligible for nomination must be between the ages of 10 and 14; (2) have clinical necessity for orthodontics; and (3) have financial need and the potential for community impact. Patients with any type of health insurance, including Medicaid, or no insurance at all would be eligible; however, if a nominated patient was insured, then Requestor would require documentation that orthodontic treatment had been denied by their insurer. Furthermore, prospective recipients of the Free Service would be required to meet basic oral health requirements prior to starting orthodontic care; specifically, a licensed dental provider would need to determine that the patient was cavity-free and demonstrating good oral hygiene.

    AKS and “remuneration”. The OIG noted that the AKS makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce, or in return for, the referral of an individual to a person for the furnishing of, or arranging for the furnishing of, any item or service reimbursable under a federal health care program. The statute’s prohibition also extends to remuneration to induce, or in return for, the purchasing, leasing, or ordering of, or arranging for or recommending the purchasing, leasing, or ordering of, any good, facility, service, or item reimbursable by a federal health care program. For the purposes of the AKS, “remuneration” includes the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind. Violation of the statute constitutes a felony punishable by a maximum fine of $100,000, imprisonment up to 10 years, or both. Conviction also will lead to exclusion from federal health care programs, including Medicare and Medicaid.

    Beneficiary Inducements CMP. The Beneficiary Inducements CMP provides for the imposition of civil monetary penalties against any person who offers or transfers remuneration to a Medicare or State health care program beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier for the order or receipt of any item or service for which payment may be made, in whole or in part, by Medicare or a State health care program. The OIG also may initiate administrative proceedings to exclude such person from federal health care programs.

    AKS and Beneficiary Inducements CMP implicated. The OIG noted that the AKS was implicated because, under the Proposed Arrangement, Requestor would offer remuneration in the form of free orthodontia to patients, including federal health care program enrollees, who could self-refer to Requestor for services billable to a federal health care program. The OIG has maintained longstanding and continuing concerns regarding the provision of free items or services by individuals and entities, including dentists and orthodontists, to patients that could lead to the ordering and provision of an item or service payable by federal health care programs. However, as noted below, the OIG determined that the risk of fraud and abuse presented by the Proposed Arrangement was sufficiently low under the AKS for the OIG to issue a favorable advisory opinion.

    With respect to the Beneficiary Inducements CMP, the OIG concluded that the Proposed Arrangement could influence beneficiaries to select Requestor for the receipt of dental or orthodontic services that could be reimbursable by a federal health care program, and therefore the Proposed Arrangement would implicate the Beneficiary Inducements CMP; and, the Proposed Arrangement did not satisfy any exceptions to the definition of remuneration in the Beneficiary Inducements CMP. However, the same reduced risk factors pertaining to the AKS also applied to the Beneficiary Inducements CMP.

    Guiderails in place. The Proposed Arrangement contained features that reduced the risk that it would steer patients to Requestor: the Free Service would be available only to existing patients of Requestor and, as such, those individuals had already selected Requestor for their dental or orthodontic care. Importantly, Requestor would publicize neither the fact that it selected from among its patient population nor that it selected recipients each year or otherwise present an ongoing opportunity for selection. Additionally, patients could not nominate themselves for the Free Service. Such safeguards significantly reduced the risk that new patients would be steered toward Requestor in the hopes of being selected to receive the Free Service.

    In addition, the Proposed Arrangement was unlikely to lead to inappropriate utilization or increased costs to federal health care programs because Requestor would offer the Free Service free of charge and would not bill any federal health care program for it. And, the Proposed Arrangement had additional features that reduced its risk under the AKS because it contemplated the Free Service being provided in modest numbers: up to one patient per practice per year. Requestor also certified that it would make limited public reference to the Proposed Arrangement for the sole purpose of highlighting the community service aspect of the Free Service and its positive impact on recipients.

    Fraud and abuse unlikely. The OIG determined that the risk of fraud and abuse presented by the Proposed Arrangement was sufficiently low under the AKS for the OIG to issue a favorable advisory opinion and that the Proposed Arrangement did not constitute grounds for the imposition of sanctions under the Beneficiary Inducements CMP. Although the Arrangement would generate—if the requisite intent were present—prohibited remuneration under the AKS, the OIG concluded that it would not impose administrative sanctions on the Requestor in connection with the Proposed Arrangement under sections 1128A(a)(7) or 1128(b)(7) of the Act.

    AdvisoryOpinions: OIGAdvisoryOpinions AntikickbackNews CMPNews EnforcementNews

    © 2026 CCH Incorporated and its affiliates and licensors. All rights reserved.

    • Manage Cookie Preferences
    • Privacy Statement
    • Terms of Use