AdvaMed strongly supports creation of an alternative, expedited pathway to coverage and payment for emerging devices and diagnostics. Transitional coverage for these technologies would bolster the innovation ecosystem and provide Medicare patients’ swift access to new technologies that existing therapies may be unable to address. A recent study by the Stanford Byers Center for Biodesign found it takes an average of five years for medical technologies to achieve nationwide coding, coverage, and payment. This delay not only impacts patients, but also increases costs, which flow through the entire healthcare system.
The Centers for Medicare & Medicaid Services (CMS) is working with industry stakeholders, including medical device companies, as well as physician societies and patient groups to develop an alternate pathway called Transitional Coverage for Emerging Technologies (TCET).
- AdvaMed has long supported policy and process improvements that would create a predictable pathway to Medicare coverage for new and innovative medical devices and diagnostics, and believes CMS has a critical role in advancing access to innovations that would benefit the Medicare beneficiaries it serves. We are therefore advocating for CMS to move swiftly to develop a proposed TCET rule that will create a new and distinct coverage pathway for emerging technologies that should include: A clearly articulated, voluntary, opt-in process;
- A review of the evidence developed to date;
- An opportunity for the developer to respond; and
- Open engagement between CMS and the developer to identify any evidence gaps and to develop an evidence plan to resolve those gaps.
Medicare beneficiaries deserve access to new and innovative medical technologies as soon as possible.
Benefits of Improved Access to New Technologies
- Improves Access
Seniors are the most vulnerable group of patients in the country. TCET would help ensure these vulnerable patients have access to the new and innovative technologies they need.
- Provides Hope
When an innovative device or diagnostic test is approved by the FDA as safe and effective, Medicare patients can be the first in line to get it. Medicare beneficiaries deserve access to emerging technologies that can improve their health outcomes. A TCET program would provide clinicians with the option to offer new technologies, or order new diagnostic tests, when necessary, for patients who can benefit from them.
- Empowers Patients
By ensuring timely coverage of new technologies, TCET would provide Medicare beneficiaries with a broader range of treatment options. This would enable Medicare beneficiaries, in consultation with their doctor, to make informed, personalized decisions about their care.
- Ensures Safety
All new medical technologies must undergo the rigorous FDA review process – the global gold standard for medical device safety and effectiveness – to achieve approval or clearance. Under TCET, Medicare coverage of an innovative, FDA-approved device under TCET would be expeditious, and would allow for ongoing collection of real-world data and evidence to understand better the true impact of lifechanging medical technologies on Medicare patients.
The impact on Medicare spending would be minimal relative to CMS’s budget. The new technology may mitigate ongoing chronic health issues and reduce some costs for Medicare while increasing quality of life and health outcomes.
What the Experts Say
- Duke-Margolis Center for Health Policy
“For patients on Medicare, the majority of whom are over the age of 65, time matters. However, newly published research from the Stanford Byers Center for Biodesign shows that patients can wait up to 5 years after FDA authorization to access new medical technologies. Indeed, a well-designed transitional coverage program could greatly accelerate patients’ access to care, while reducing the overall cost burden on our healthcare system. This program would also encourage innovation in areas of critically important unmet clinical needs.” Read more