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Sector Spotlight — 2018

Overview

Diabetes

AdvaMed’s Diabetes Sector brings together the world’s leading diabetes technology companies to address and help shape critical policies that influence patient access to innovation and the business environment for such technologies around the world. The Sector’s executive leadership group met twice in-person in 2018 to provide high-level strategic thinking and direction on a number of priority areas.

On the policy front, the Sector focused in 2018 on working to alleviate coverage barriers at CMS and to modernize Medicare coverage policies to help make them more hospitable to technologies for diabetes care. The Sector also developed a framework for appropriately assessing the value of diabetes technologies in new payment models, patterned after AdvaMed’s broader Medical Technology Value Framework.

In November, the Sector hosted a Capitol Hill showcase event featuring diabetes-related medical technologies made by AdvaMed member companies. The event was designed to help spotlight the value of such technologies to patients, health care systems and the economy, and the importance of adopting pro-innovation policies. The showcase was attended by over 100 people, including congressional and FDA staff, patient advocacy groups and more.

AdvaMed Digital Health

AdvaMed’s Digital Health Sector works to address the unique policy challenges that influence the business environment for digital health technologies and applications, including critical issues like cybersecurity and software regulation. In March, the Sector hosted its second annual Digital MedTech Conference in San Francisco. The program featured distinguished presenters and actionable insights into the many opportunities, challenges and trends in digital health – a field defined by the accelerating convergence of evolving and emerging medical and digital technologies from advanced diagnostics, cognitive computing and smart devices, to robotics, wearables and telehealth.

On the policy front, the Sector focused on providing significant input to FDA on the agency’s development of its software precertification pilot program, which has the potential to reduce pre- and post-market burdens for both software developers and FDA, and enable streamlined changes and modifications to software products. The Sector also worked closely with Xavier University to develop a white paper on machine learning and artificial intelligence technologies used in health care. On cybersecurity matters, the Sector provided significant input for related FDA and legislative activity, and began development of a MedTech Information Sharing and Analysis Organization.

Wound Healing & Tissue Regeneration

AdvaMed’s Wound Healing and Tissue Regeneration Sector is focused on ensuring patient access to innovative therapies for the treatment of chronic and complex wounds. In 2018, the Sector continued to advocate for effective use of wound technologies, as well as appropriate regulation, coding, coverage and reimbursement policies. This was achieved in part through outreach and engagement with wound specialty groups on key topics, such as through participation in the Society for Advanced Wound Care’s Industry Relations Council and continued work with the Association for the Advancement of Wound Care on their efforts to promote the development and use of appropriate clinical endpoints in the evaluation of wound technologies. In comments to CMS, the Sector also continued to advocate for appropriate reimbursement for skin substitute products via development of an episodic payment approach, and reduced barriers to appropriate coding for all wound products.

During the year, the Sector also met with the Board of the American College of Wound Healing and Tissue Repair – a non-profit organization committed to advancing the field of wound care through education, research and advocacy – to discuss ongoing support for the organization and assistance with their accreditation process.

Ophthalmic

AdvaMed’s Ophthalmic Sector focuses on technologies that preserve, restore and improve healthy eyesight, and meets regularly to discuss current and emerging regulatory, policy and strategic issues. Activities in 2018 focused primarily on developing the Sector’s Vision for Life (VFL) strategic initiative to demonstrate the benefits of life-long vision care, including disease detection and prevention.

The VFL initiative is designed to increase stakeholder understanding of the value of ophthalmic medical products to patients and practitioners, health care systems and the economy. Through strategies such as outreach to the media, Congress and other stakeholders, the initiative seeks to ensure greater confidence in, and use of, ophthalmic devices by health care providers and patients; fair, stable and transparent reimbursement and coverage policies; appropriate, efficient and flexible regulatory review pathways and postmarket surveillance requirements; and support for future medtech innovation.

Ongoing focus areas of the VFL initiative include development of a whitepaper on the economic value of ophthalmic products used for prevention, diagnosis and treatment. The whitepaper – which will underpin VFL strategies in 2019 and beyond – will leverage available literature and data, as well as outreach to professional societies and other stakeholders.

Radiation Therapy

In 2018, AdvaMed’s Radiation Therapy (RT) Sector worked to promote and protect timely patient access to innovative, safe and effective radiation therapies, in part by advancing fair, stable and transparent reimbursement policies. This included successfully advocating for extension of the current RT payment freeze as part of a congressional budget deal. AdvaMed advocacy – in concert with member companies and allies on Capitol Hill – also led CMS to scale back significant payment cuts to RT initially included in a July proposed rule.

During the year, the Sector also supported an industry-wide initiative to standardize reporting and storage of certain RT treatment characteristics, and helped arrange FDA staff visits to several RT member company facilities to bolster the agency’s understanding of the technology and the device development life cycle.

The Sector also hosted a United Kingdom RT stakeholder roundtable at Westminster Palace – including patient groups, providers, charities, government officials and parliamentarians – and subsequently published a report with key recommendations to improve and increase access to radiotherapy in the UK.

Orthopedic

Orthopedic devices help patients by restoring mobility, relieving pain and improving quality of life. In 2018, AdvaMed’s Orthopedic Sector advocacy contributed to FDA’s decision not to enforce unique device identifier (UDI) direct mark requirements for all non-sterile orthopedic devices in inventory prior to the compliance date if the products use a cross reference UDI alternative, potentially saving companies millions of dollars.

The Sector also worked with the American Joint Replacement Registry (AJRR) on a proposal to demonstrate linkage of AJRR registry data with private payer data to increase the utility and value of the registry. The group also worked with AJRR to revise its registry funding mechanism, eliminating annual contributions over time in favor of a value-based fee schedule. Separately, the Sector reached an agreement with the International Society of Arthroplasty Registries to develop an international prosthesis library that would make updating international registries with component data more efficient and less costly.

Meanwhile, the Sector’s Orthopedic Reimbursement Work Group met with the American Academy of Orthopedic Surgeons to discuss ways to collaborate on encouraging changes to CMS’s Comprehensive Care for Joint Replacement bundled payment program and Bundled Payment for Care Improvement initiative, which are expected in 2020. 

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