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Sector Spotlight

Overview

Diabetes

In 2017, the Association created the Diabetes Sector to bring 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 is led by an executive leadership group that convened a kick off meeting in September to provide strategic direction.

Recognizing that diabetes is the fastest growing chronic disease in the world, the Sector will work to build awareness of the extraordinary value of diagnostic and therapeutic technologies for diabetes care, and to advance pro-innovation policies that benefit patients, including policies impacting Medicare coverage in particular. Building on AdvaMed’s established record of working with companies of all sizes in the diabetes space –  with the active support of relevant working groups across the Association’s regulatory, reimbursement and global departments – the Sector will provide a forum for policy development and a platform for robust advocacy on behalf of its member companies and diabetes patients.

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. During the year, the Sector established an Executive Leadership Group to provide high-level strategic direction and develop a formal strategic plan.

In March, the Sector launched the first-ever 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 development of a precertification software 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 established a task force to develop policy recommendations surrounding emerging machine learning and artificial intelligence technologies. On cybersecurity matters, the Sector provided input for related legislative activity on Capitol Hill.

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 2017, 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 with the Association for the Advancement of Wound Care on their efforts to develop a white paper on appropriate clinical evidence, and efforts exploring development of a payment model that accounts for efficiencies generated by wound products used in the Medicare population. In comments to CMS, the Sector also continued to advocate for appropriate reimbursement for skin substitute products, and reduced barriers to appropriate coding for all wound products.

During the year, the Sector collected additional funding for 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 support the organization’s 2017 projects. The Sector continues to maintain a working relationship with the organization and promote it to other external stakeholders as it moves closer to gaining accreditation.

Ophthalmic

AdvaMed’s Ophthalmic Devices Sector focuses on technologies that preserve, restore and improve healthy eyesight. The Sector meets monthly to discuss current and emerging regulatory, policy and strategic issues that affect members and the patients they serve. 

Ongoing activities in 2017 included leveraging the MDUFA IV commitment letter to improve the regulatory predictability and impact of patient reported outcomes (PROs). Of note, the letter clarifies that a sponsor’s use of PROs is voluntary. Sector members additionally engaged professional society and regulatory leads about tools to enhance product introduction and expanded indications. Examples include outreach to the American Academy of Optometry’s IRIS registry to understand how the registry might support product development, premarket applications and postmarket monitoring. Members also aligned with FDA device center leadership to develop strategies to expedite answers to reviewer questions, which in turn will speed submission review. 

Sector work during the year also focused on payment issues, with AdvaMed driving efforts to improve the update factors used to adjust ambulatory surgery center payments and advocating for the market basket update instead of CPI-U. AdvaMed also promoted payment policies directly impacting ophthalmology, including improved timing for obtaining CPT codes and coverage improvements for Category III CPT codes.

Radiation Therapy

In 2017, AdvaMed’s Radiation Therapy Sector focused on sustaining and building relationships, working with key stakeholders to increase awareness of the value of radiation therapy and the benefits of expanded patient access, and addressing key policy challenges. These efforts included hosting a briefing for the U.K. Parliament with remarks by the newly appointed health minister of cancer services, several clinicians and a cancer patient receiving radiation therapy. The Sector also developed related educational materials and fact sheets on individual radiation therapy technologies, including a use case on stereotactic body radiation therapy for non-small cell lung cancer.

During the year, the Sector hosted two vendor days at FDA to provide members with an important opportunity to continue to educate agency reviewers on their products and strengthen professional relationships. On the policy front, the Sector remained engaged on standards development, resulting in FDA recognition in December of the RT-2 Radiotherapy Readiness Check standard. The Sector also continued to work with ASTRO to address reimbursement-related challenges at CMS, alternative payment model development, and implementation of the Medicare and CHIP Reauthorization Act.

Orthopedic

Orthopedic devices help patients by restoring mobility, relieving pain and improving quality of life. In 2017, AdvaMed’s Orthopedic Sector worked to advance key priorities, in part through continued strong engagement with the American Joint Replacement Registry (AJRR). Such engagement – which includes providing financial support and AdvaMed member representation on AJRR’s board – aims to ensure the registry becomes the essential source for patient care outcomes data demonstrating the true promise of orthopedic technologies. During the year, the Sector successfully negotiated a data access licensing agreement with AJRR, and developed key industry requirements for AJRR's merger with the American Academy of Orthopedic Surgeons (AAOS).

AdvaMed’s Orthopedic Reimbursement Work Group also met with AAOS to discuss policy recommendations for changes to CMS’s Comprehensive Care for Joint Replacement bundled payment program. Discovering that AAOS shared many of AdvaMed's concerns, the work group explored ways to collaborate to encourage changes to the program.