To improve the quality of healthcare by encouraging research, development, and commercialization of innovative diagnostic technologies that will personalize patient care, improve patient outcomes, and substantially reduce healthcare costs.
Advanced Diagnostics — Key to the Future of Quality, Affordable Healthcare
Development of and access to innovative molecular diagnostics is essential to enabling individualized treatment and has the potential to revolutionize our healthcare system. However, the potential for advanced diagnostics to help patients has yet to be fully realized, due in large part to the widespread perception by many companies/investors that the costs, risks, and barriers associated with diagnostic development outweigh the anticipated returns. Advances in technology and genomic information are rapidly changing the commercial diagnostic landscape and opening up new opportunities for advanced diagnostic tests. Government policies will play a crucial role in diagnostic innovation and have the potential either to slow such innovation or to help lower diagnostic development risks/barriers.
Ensuring Diagnostics Innovation and Availability
The Coalition for 21st Century Medicine represents more than two dozen of the world’s most renowned diagnostic technology companies, clinical laboratories, researchers, physicians, venture capitalists, and patient advocacy groups. We’re working to ensure that high quality, innovative diagnostic tests — necessary to assure that timely and accurate information is available when diagnosis, prognosis, and therapy decisions need to be made — are available to patients and their physicians. To that end, we’re working with policymakers to maintain the balance between regulation and innovation and to ensure that regulatory policy promotes rapid access to new diagnostic information.
Opportunities Have Never Been Greater
Our confidence in the Coalition’s ability to successfully advocate, on Capitol Hill, in the Administration, and at the FDA, stems from our past achievements. Established in the fall of 2006 to address the FDA’s proposed regulation of laboratory developed tests, for the first time, through the In Vitro Diagnostic Multivariate Index Assays (IVDMIA) Draft Guidance, we were successful in working with HHS Office of the Secretary and the White House Office of Management and Budget (OMB) to challenge the rationale of the draft guidance and to work with the FDA to propose a risk based classification system based on the impact of test results on patient care.
Since that time, the Coalition has continued to work with stakeholders across the diagnostics industry, with regulators at FDA and policymakers at HHS, the White House, and on Capitol Hill to:
- Help develop and support a new policy and legislative framework for appropriate regulation of advanced diagnostic tests.
- Advocate the abandonment of the ill-defined technology based risk approach of the IVDMIA draft guidance documents, and work with the agency on more rationale approaches.
- Support continued FDA enforcement discretion over laboratory developed tests until new regulations (rather than draft guidance) could be published and finalized.
In addition, since our formation, we have focused on creating a pathway for successful commercialization of advanced diagnostic tests through coverage, coding, and reimbursement by working with the Centers for Medicare & Medicaid Services (CMS), local Medicare Administrative Contractors such as the Palmetto GBA MolDx program, and the American Medical Association in implementing MAAA CPT codes. In 2014, the Coalition was a prominent advocate for the passages of the Protecting Access to Medicare Act (PAMA) Section 216 that has created a framework for value-based reimbursement of advanced diagnostic tests in Medicare.
The Coalition for 21st Century Medicine advocates for protection of intellectual property rights for innovators of advanced diagnostics tests and the industry in general. In this effort we monitor the federal and Supreme courts for landmark cases where our expertise, expressed through Amicus Briefs, aids in shaping legal outcomes that having bearing on our industry. We also have a good working relationship with the United States Patent and Trademark Office on the issues surrounding patent eligible subject matter.
The Coalition for 21st Century Medicine will continue to engage with stakeholders and lawmakers to craft meaningful legislative, regulatory and policy solutions that propels regulatory approaches that ensure accuracy and reliability of LDTs without overly burdensome regulations.