On March 16, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-05 (Advisory Opinion) in which it declined to impose sanctions against a medical device manufacturer (Requestor) that proposes to pay certain cost-sharing obligations of clinical trial participants, including Medicare beneficiaries. The OIG concluded that although the proposed arrangement (described below) would constitute prohibited remuneration under the Federal anti-kickback statute (AKS) and the beneficiary inducement prohibitions of the Civil Monetary Penalties Law (CMP), the low-risk nature of the proposed arrangement did not warrant the imposition of sanctions.
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CMS Announces Merit-Based Incentive Payment for Clinicians Participating in COVID-19 Clinical Trial
On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that clinicians participating in the Quality Payment Program (QPP) can earn credit in the Merit-based Incentive payment system (MIPS) by attesting to a new COVID-19 Clinical Trials improvement activity based on participation in a clinical trial and reporting information. Clinicians who may earn this MIPS credit include physicians, physician assistants, nurse practitioners and others. MIPS is one of two options for clinicians to participate in Medicare’s QPP, and requires clinicians to report certain quality, cost and other data to Medicare. A clinician’s Medicare reimbursement may be reduced if the clinician does not meet certain quality and performance measures. …
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FDA Amends Regulations for Acceptance of Data from Foreign and Domestic Investigation for Medical Devices
By Melissa (Lisa) Thompson on
On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as well as modifying certain regulations applicable to data from US-sited investigations. The Final Rule does not go into effect until February 21, 2019 – a full year after promulgation. The FDA also issued guidance in the form of Frequently Asked Questions (FAQ) addressing the new regulations. In the FAQ document, the FDA explained its rationale that more research and marketing applications and submissions are being submitted that are supported by foreign investigations and that it was seeking to make its requirements more uniform.
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