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Articles by Lisa Damhof
OIG Reaffirms: Fair Market Value Alone Does Not Eliminate Anti-Kickback Statute Ris | JD Supra
On April 23, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) updated its General Questions Regarding Certain Fraud and Abuse Authorities FAQs .
OIG Advisory Opinion 26‑10 Signals Scrutiny of Royalty‑Based HCP Consulting Arrangements
In May 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 26‑10 (Opinion) and concluded that a medical products company’s proposed consulting and royalty arrangement with health care provider (HCP) consultants presented fraud and abuse concerns under the federal Anti‑Kickback Statute (AKS) and therefore received an unfavorable opinion from OIG.
OIG Advisory Opinion 25-11: Key Compliance Insights for Manufacturers
In Advisory Opinion 25-11 issued December 15, 2025, the Department of Health and Human Services Office of Inspector General (OIG) offers important and practical guidance for pharmaceutical and medical device manufacturers on its approach to evaluating discount and rebate arrangements under the Federal Anti-Kickback Statute (AKS).
Sunshine Reporting Season Has Begun: Are You Meeting the Requirements? | JD Supra
Medical products manufacturers should be deep into reporting season planning. The federal Physician Payments Sunshine Act and Open Payments Program deadline is March 31, 2026, and it covers transfers of value made during calendar year 2025. CMS uses Open Payments to promote transparency in financial relationships between industry and U.S. healthcare providers. CMS and state authorities have increasingly emphasized audits, data integrity, and enforcement. Federal reporting is only part of the story.
Clarity in Complexity: The Benefits of a Business Stance Playbook | JD Supra
Medical device and pharmaceutical manufacturers regularly face commercial contracting challenges in a complex healthcare environment. Whether a manufacturer is a small start-up or a large global organization, it operates under increased pricing scrutiny, often complex contracting models, and evolving regulatory and stakeholder expectations. One practical approach to addressing these challenges is the creation and implementation of a commercial contracting business stance playbook.
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