WASHINGTON, D.C. – A growing number of patient groups are expressing their support to the Centers for Medicare & Medicaid Services (CMS) of the Medicare Coverage of Innovative Technology (MCIT) rule that would allow Medicare to cover breakthrough medical technologies that treat chronic and debilitating conditions once the FDA approves or clears those treatments as safe and effective.
“These patient groups recognize the importance of expanding access to life-saving and life-changing medical breakthrough technologies as soon as those treatments are deemed safe and effective by the FDA,” said AdvaMed President and CEO Scott Whitaker. “We agree with CMS’s mission to find ways to expand access for America’s seniors—the MCIT rule is consistent with that mission, allowing FDA-approved breakthrough devices to be covered by Medicare with important requirements for evidence development. MCIT will give seniors on Medicare a lifeline when they need breakthrough medical innovations to manage and treat debilitating illnesses.”
The following patient groups have recently voiced their support for MCIT:
American Diabetes Association: “Under current regulations, individuals with diabetes are often left waiting. FDA approval does not guarantee patients and providers immediate access to breakthrough devices; and obtaining Medicare coverage for new devices that could benefit Medicare-eligible seniors can take several years… However, these technologies and devices are only effective for individuals with diabetes, if they actually make it into their hands.”
Alliance for Aging Research: “We support the proposal to align Medicare coverage for breakthrough medical devices with FDA market approval for a period of up to four years. This change would improve access to innovative devices for which there are no equivalent therapies, or for which outcomes are superior in clinical trials.”
American Association for Homecare: “AAHomecare supports the ability for Medicare beneficiaries to access more innovative devices, particularly those used in the home.”
National Health Council: “We applaud CMS for creating the Medicare Coverage of Innovative Technology (MCIT) pathway to accelerate the coverage of new, innovative breakthrough devices for Medicare beneficiaries. Patients will benefit from these breakthrough devices because the pathway promotes faster coverage and access to devices that can support their health and independence.”
Juvenile Diabetes Research Foundation: “We are supportive of the proposed Medicare Coverage of Innovative Technology (MCIT) pathway because it will lead to a reduced timeline in accessing breakthrough technologies for Medicare beneficiaries. The NCD and LCD processes can be long, and it leaves beneficiaries unable to access the newest and most advanced technology for years after FDA authorization. We have seen this for diabetes technology where Medicare coverage has typically lagged behind the private sector for sometimes years.”
Personalized Medicine Coalition: “The MCIT pathway would mitigate the upfront evidence burden required to meet the current coverage standard and allow breakthrough device manufacturers to gather clinical evidence that can be later submitted to CMS. We applaud CMS’ prioritization of patients’ unmet medical needs and willingness to facilitate patient access to breakthrough devices.”
Heart Valve Voice: “We strongly endorse the concept of providing automatic Medicare coverage for innovative technologies upon their FDA market authorization. Patients deserve the certainty of having access to the most innovative medical technology without concerns over coverage and reimbursement.”
Home Dialyzers United: “We strongly support the Centers for Medicare & Medicaid Services’ (CMS) proposal to include MCIT as a payment pathway for innovative new devices and technology. HDU and patients alike agree that this will advance the goals of the Advancing American Kidney Health (AAKH) Executive Order, provide new and better choices for patients to dialyze safely in their homes, and thus spur greater innovation in home dialysis equipment and technology.”
Sepsis Alliance: “Delays in achieving reimbursement status and difficulties financing new technology developments lead to delays in getting life-saving technology to patients. By ratifying the MCIT rule, you are opening the doors to innovation, early recognition, and life-saving treatment. The acceleration of healthcare innovation will have a deep, meaningful impact on patients, their families, and the healthcare system as a whole.”
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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.