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2019 AdvaMedDx

Improving Patient Care Through Diagnostics

Operating as a division of AdvaMed, AdvaMedDx advocates on behalf of the world’s leading diagnostics manufacturers and promotes the value of diagnostic tests for improved patient care.

In 2019, AdvaMedDx advocacy was critical to the advancement of pro-innovation policy reforms to support diagnostics manufacturers, including:

  • Co-leading with the American Clinical Laboratory Association a broad diagnostics stakeholder coalition in the successful launch of formal deliberations on Capitol Hill for pro-innovation diagnostics regulatory reform legislation – the draft Verifying Accurate Leading-edge IVCT Development (VALID) Act.
  • Working with FDA, member companies, patient groups and others to improve and strengthen the VALID Act in preparation for its formal introduction to modernize the regulatory framework for all diagnostics, foster innovation, and speed patient access. 
  • Securing congressional passage in December of the bipartisan Laboratory Access for Beneficiaries (LAB) Act, in conjunction with key laboratory partners, to facilitate improvement of Medicare reimbursement rates for diagnostics.
  • Achieving inclusion of policies in CMS’s Inpatient Prospective Payment System (IPPS) Final Rule that address antimicrobial resistance (AMR), and finalization of a Medicare requirement that all hospitals have in place an antimicrobial stewardship program.

During the year, AdvaMedDx also continued its broader advocacy and public affairs activities in the U.S. and globally to promote the value of diagnostic tests for patients and public health, including:

  • Development and promotion of AdvaMedDx diagnostics stewardship recommendations with government agencies and key stakeholders to improve antimicrobial stewardship in hospitals. 
  • Leading a delegation of member companies to CDC to discuss the importance of up-to-date diagnostics testing policies and guidelines while also serving as a leading voice in a CDC-led session with CMS and FDA on diagnostics stewardship.
  • Expanding AdvaMedDx’s “Test to Treatment” value campaign with fact sheets and social media activity focused on priorities that include cancer diagnostics, personalized medicine, and women’s health.
  • Co-sponsoring several congressional briefings to highlight the value of diagnostics in oncology, outbreak response, and AMR.
  • Leveraging AdvaMedDx’s leadership of the Global Diagnostics Alliance to engage the World Health Organization on issues surrounding the Essential Diagnostics List, the prequalification program for diagnostics, and the Pandemic Influenza Preparedness Framework.