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Legal & Compliance

  • Working with nearly 300 in-house lawyers from member companies, AdvaMed’s Committee provides legal direction and leadership to ensure a legal environment that fosters medical technology innovation.

  • AdvaMed works to facilitate ethical interactions between companies and health care professionals (HCPs) globally. Ethical interactions enhance patient access to the safe and effective use of medical technologies by ensuring appropriate training of HCPs by companies.

  • The Affordable Care Act included several new Medicare payment system reforms designed to improve coordination and collaboration among physicians and other healthcare providers. AdvaMed and its team of policy experts study these changes and determine their impact on patients, future medical innovation and our member companies.

  • AdvaMed and MedTech Europe have developed joint compliance guidance and tools on Distributor Relations as part of an ongoing commitment to provide ethical guidance on appropriate industry interactions. We believe clear, established compliance programs will safeguard the integrity of medical decision making and promote further public confidence in our industry.

  • AdvaMed collaborated with AORN and the AHA to provide clinically based recommendations to support health care organizations and medical device representatives when resuming elective procedures--the Joint Statement: Re-entry Guidance for Health Care Facilities and Medical Device Representatives.  The recommended framework calls for hospitals to be the primary provider of personal protective equipment (PPE) to control for potential contamination, so that PPE is prioritized to providers where it is most needed. The guidance accounts for crisis capacity situations by allowing for company reps to be the back-up providers of their own PPE for emergency procedures. The guidance also recommends against COVID-19 diagnostic testing of asymptomatic reps, so that diagnostic testing resources can be prioritized for patients, symptomatic health care workers, and those with known or suspected exposures, consistent with CDC and other clinical guidelines.

  • We understand the pressing need to ensure access to high-quality, life-saving medical technology for patients in India, in the most affordable and efficient manner possible. To advance toward this goal, we share a commitment to and fundamental belief in operating with the highest standards of ethics and integrity. The companies listed here have Ethics and Compliance teams dedicated to communicating and enforcing clear standards of conduct for their employees and distributors. If there are gaps, concerns or observations, we welcome information via the compliance hotlines, websites, and/or contacts listed here.

  • Physician-own distributorships, or "PODs," include device companies and distributors that offer substantial equity positions to physicians, in some cases, selected because collectively they are in a position to generate a substantial amount of business for the entities through ordering (or influencing orders for) devices sold or manufactured by the company. In a March 26, 2013 Special Fraud Alert, the U.S. Department of Health and Human Services Office of Inspector General (OIG) notes that the POD business structure is inherently suspect, and cites OIG's 2006 correspondence with AdvaMed on the issue.

  • In partnership with the National Association of Manufacturers, AdvaMed members have free access to the Manufacturers’ Compliance Institute (MCI), which provides prompt, complimentary answers to questions regarding compliance issues from experienced attorneys working with top-tier legal counsel.

  • The U.S. health care system is transitioning from a fee-for-service and fee-for-product (volume-based) model to value-based paradigm to deliver more coordinated, high-quality, affordable health care.

    Value-based arrangements – also referred to as results-based, outcomes-based, or performance-based payment arrangements – may condition payment or modify pricing for health care items or services based upon a clinical, economic, and / or patient-experience outcome, to increase shared accountability for both quality and the total cost of care.