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2019 Sector Spotlight

Overview

Diabetes

insulin pump

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 2019 to make key policy decisions and provide strategic direction for the Sector’s policy and advocacy agenda.

The Sector focused on advancing a Diabetes Task Force proposal for the Centers for Medicare and Medicaid Services (CMS), developing and advocating for a set of specific Medicare coverage policy reforms to expand patient access to critical diabetes technologies, and working with champions on Capitol Hill. The Sector secured introduction of a bill in the U.S. Senate to create its proposed CMS Diabetes Task Force, and held a series of meetings with the CMS administrator and senior agency officials to encourage the agency to adopt the Sector’s proposed coverage reforms.

AdvaMed Digital Health

doctor typing on a tablet

AdvaMed’s Center for Digital Health was established in 2019 to replace the previous Digital Health Sector and better represent the cross-cutting nature of digital medical technology issues in health care and across AdvaMed’s member companies. The Center promotes the critical role of data and digital medical technologies in improving patient care and advocates for public policies that advance digital health and data-driven health care.

In May, the Center hosted its third annual Digital MedTech Conference in San Francisco, underscoring its role as thought leader and convener, and bringing together industry leaders and key stakeholders. On the policy front, the Center works on a wide range of relevant areas, including FDA regulation, coverage and payment, and data stewardship and privacy. Under the Center’s leadership, AdvaMed adopted U.S. Health Data Privacy Principles and provided extensive input to federal and state legislative bodies on the development of new privacy laws. The Center also worked closely with FDA on digital health regulatory issues, including the agency’s development of its software precertification pilot program. The Center also is focused on the failure of legacy payment systems to incorporate innovative digital health technologies and platforms, and is developing a report on policy reforms to address those barriers.

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 2019, 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 continued outreach and engagement with wound specialty groups on key topics, such as the Society for Advanced Wound Care’s Industry Relations Council and 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. The Sector also continued to advocate for appropriate reimbursement for skin substitute products via comments and the funding of research regarding the development of alternative payment approaches.  We continued to advocate for reduced barriers to appropriate coding for all wound products – including collaborative efforts to ensure appropriate coverage and payment for dressings.

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, areas of collaboration on policy issues, and strategic engagement of physician societies to assist with their accreditation process.

Ophthalmic

ophthalmic device

AdvaMed’s Ophthalmic Sector focuses on technologies that preserve, restore, and improve healthy eyesight. The sector meets regularly to discuss current and emerging regulatory, policy, and strategic issues. Activities in 2019 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. 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.

In 2019, AdvaMed used its Value Assessment framework to promote the objectives of the VFL initiative through development of a use-case focused on the role of ophthalmic devices in correcting and treating myopia. Specifically, AdvaMed highlighted the value of myopia correction and treatment for various framework populations including providers, patients, payers, and the public. In 2020 and beyond, AdvaMed will develop additional ophthalmic use cases and engage external stakeholders regarding its work.

Radiation Therapy

woman enters radiotherapy scan

In 2019, 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 outlining concerns with CMS’s proposed radiation oncology alternative payment model, supported by data developed by the Sector and in collaboration with stakeholders.

During the year, the Sector worked to continue improving education on the benefits of RT by hosting a congressional tour of a radiation therapy site. The group also 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. In recognition of the Sector’s efforts to provide educational opportunities for FDA, the agency’s Nuclear Medicine and Radiation Therapy Branch nominated AdvaMed for an award highlighting current and emerging technologies, and appropriate device standards.

The Sector also supported a United Kingdom parliamentary event at Westminster Palace – including patient groups, providers, charities, government officials and parliamentarians – focused on improving and increasing access to radiotherapy in the UK.

Orthopedic

orthopedic joint

Orthopedic devices help patients by restoring mobility, relieving pain and improving quality of life. In 2019, AdvaMed’s Orthopedic Sector worked to advance joint replacement registries that support innovation for the benefit of patients, including: Working to transition American Joint Replacement Registry voluntary funding contributions to a value-based fee schedule; providing recommendations to the American Academy of Orthopedic Surgeons on issues surrounding new product registries, including funding processes, core datasets and governance representation; and collaborating with select European arthroplasty registries and the International Society of Arthroplasty Registries to harmonize product attribute data libraries used by all registries. 

On the regulatory front, comments were provided on draft FDA guidance documents on metallic bone screws and washers, and spinal plating systems. The Sector also challenged FDA’s authority to reclassify hyaluronic acid to a drug, supported by related legal analysis. 

Meanwhile, the Sector’s Reimbursement Work Group proposed improvements to the CMS Comprehensive Care for Joint Replacement bundled payment program, and Bundled Payment for Care Improvement Advanced initiative. The Sector also supported preparation of subsequently published manuscripts on the importance of joint replacement procedures to general health and well-being, including exploration of issues not commonly addressed by researchers.

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