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Competitiveness Agenda
America’s medical technology industry is the acknowledged world leader and an engine of economic growth and job creation for the American economy. Today that leadership is increasingly challenged. That’s why AdvaMed has created a policy framework that, when enacted, will help preserve our leadership and foster future growth and innovation. Without strategic government policies to support the medical technology industry’s efforts to compete in world markets, American economic leadership will be lost.
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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
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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.
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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.
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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.
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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.
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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.
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Medical Device Tax
AdvaMed has consistently and strongly opposed the $30 billion medical device tax because it will harm job creation, deter medical innovation and increase the cost of health care. Congress should repeal it before it can do more damage to American Innovation.
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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.
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Global Affairs: India
As India strives to promote access to healthcare – and in doing so build up their own domestic healthcare industry - the government has come to recognize that medical technologies and the regulatory infrastructure to support their development are a critical element in the healthcare delivery system and infrastructure. The medical device industry is committed to working with the Indian government to develop an appropriate regulatory framework for medical devices
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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.
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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.
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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.
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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.
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Code of Ethics
The AdvaMed Code of Ethics on Interactions with Health Care Professionals ("The AdvaMed Code" ) facilitates ethical interactions betweek MedTech companies and health care professionals to ensure that medical decisions are based on the best interests of the patient.
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Certification Program
Medtech Companies that have certified to the AdvaMed Code support ethical collaborations between medtech manufacturers and health care providers, which are essential to advancing new, safe and effective technologies that benefit patients. It is by driving ethical collaborations that we help protect patients. Certifying Companies are listed here, along with access to their compliance department contacts.
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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.
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