MAIN ISSUES

Innovation Agenda

  • Innovation Agenda

    The medical technology industry is central to the development of medical technologies that will provide the life-saving and life-enhancing treatments of the future. But the innovation ecosystem that supports medical technology is severely stressed.

    READ MORE

Regulatory Affairs

  • 510(k)

    FDA’s 510(k) pre-market review process for medical devices provides strong protections to American patients and promotes medical innovation. It provides FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices. The 510(k) review process provides for the thorough FDA review of a wide range of products – from syringes to imaging systems – in a timely fashion that facilitates patient access to needed medical advancements

    READ MORE
  • Medical Device User Fee Agreement (MDUFA)

    Under the “Medical Device User Fee and Modernization Act of 2002” (MDUFMA), FDA was given the authority to collect user fees from medical device sponsors for review activities. Under the legislation, FDA committed to meeting specific performance goals negotiated between industry and the agency related to medical device reviews.

    READ MORE
  • Unique Device Identifier (UDI)

    UDI consists of a unique code identifier that includes information specific for each device model as well as production data (lot or batch number, the serial number and/or expiration date), and an FDA-created database that will include a standard set of identifying elements for each UDI.

    READ MORE
more

Payment & Health Policy

  • Medicare Reimbursement Policy

    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.

    READ MORE
  • Payment & Delivery Systems Reform

    The Affordable Care Act included several new Medicare payment and health care delivery system reforms designed to improve coordination and collaboration among physicians and other healthcare providers.  These reforms – including the development of Accountable Care Organizations (ACOs) and bundled payments – may provide incentives for providers to use innovative products that improve quality and create efficiencies in the delivery of care. 

    READ MORE
  • Coverage & Coding

    Medicare covers health care items and services, including medical devices and diagnostic tests, for almost 50 million Medicare beneficiaries.  In most cases, local contractors, called Medicare Administrative Contractors (or MACs) – the entities that process and pay Medicare claims –make coverage decisions, as long as those decisions do not conflict with a national policy.  In some cases, Medicare develops a National Coverage Determination (NCD) for an item or service that applies to all Medicare beneficiaries that meet certain criteria for coverage. 

    READ MORE
more

Tax Policies

  • Medical Device Tax

    There is a broad bipartisan support to repeal the device tax which is crushing company growth, job creation and chilling medical progress.

    READ MORE
  • Tax Reform

    There is broad bipartisan agreement that comprehensive corporate tax reform is essential to improve America’s competitiveness and rebuild our nation’s economic future.

    READ MORE

Global & Trade

  • Global Affairs: China

    China presents the most significant growth market for the medical device industry today and for the foreseeable future.  AdvaMed's China initiatives increase opportunities for the industry in China while, at the same time, supporting China's long-term development goals.  Specifically, AdvaMed works with China's government and private sector to promote the value of medical technologies while advocating a fair and level playing field for all manufacturers.

    READ MORE
  • Global Affairs: Japan

    Japan is in the midst of a two-year reimbursement cycle which will culminate in the determination of the rules it will use to adjust reimbursement prices in 2014. A key concern is Japan’s plan to adopt some form of health technology assessment (HTA) as a cost containment mechanism.

    READ MORE
  • Global Strategy and Analysis Department Directory

    AdvaMed's Global Strategy and Analysis Department is seperated by country and issue. This contact list serves a directory.

    READ MORE
more

Legal & Compliance

  • 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.

    READ MORE
  • Foreign Corrupt Practices Act

    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.

    READ MORE
  • Physician Payments Sunshine Law

    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.

    READ MORE
more

Code of Ethics

  • Code of Ethics

    The AdvaMed Code of Ethics on Interactions with Health Care Professionals ("The AdvaMed Code" ) facilitates ethical interactions between MedTech companies and health care professionals to ensure that medical decisions are based on the best interests of the patient.

    READ MORE
  • Certification Program

    The Certification Program is open to AdvaMed member and non-member companies, including manufacturers and distributors of medical devices. The certification requires the signatures of both the CEO and Chief Compliance Officer (CCO), attesting that their company has adopted the AdvaMed Code and implemented an appropriately tailored effective compliance program.

    READ MORE
  • Compliance Positions

    The AdvaMed Board Ethics and Health Care Compliance Committee leads AdvaMed's ethics and health care compliance initiatives, including advocacy for federal physician payment sunshine legislation and stewardship of the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

    READ MORE
more

Corporate Social Responsibility

  • China Code

    The AdvaMed Code of Ethics on Interactions with Health Care Professionals in China ("China Code") facilitates ethical interactions between MedTech companies and health care professionals in the People's Republic of China to help ensure that medical decisions are based on the best interests of the patient.

    READ MORE