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CMS Final Rule Demonstrates What Healthcare Should Be

By Derek Hosford, American Consumer Institute


The coronavirus pandemic has highlighted a major flaw in the delivery of healthcare in the United States. Extensive federal rules and regulations are preventing providers from offering high quality care to their patients in a timely manner.


The latest example of this issue was recently alleviated in the process of the development of new medical innovations. Despite being approved by an intensive Food and Drug Administration (FDA) process, a lag time still existed in between the approval and implementation periods for new innovative medical devices for Medicare participants. The Medicare Coverage of Innovative Technology (MCIT) rule, which is the final rule issued by the Trump Administration’s Centers for Medicare and Medicaid Services (CMS), eliminated the lag time so that patients could have access to more advanced treatments right away.


This new rule is a step in the right direction for healthcare in the U.S. It eliminates bureaucratic barriers and lag periods, while encouraging competition in the healthcare market. This will ultimately benefit patients on Medicare through cheaper prices and new innovative treatments being delivered faster. The new administration’s CMS should build on these efforts of eliminating unnecessary government roadblocks to providing the best available care to Medicare participants.


Even with FDA approval, innovators were still required to receive approval for Medicare coverage first before their innovations could be used prior to the MCIT rule. According to the CMS press release, this created a “valley of death” for some of the country’s most promising treatments. Implementing this new rule will save valuable time and money for both providers and patients and result in the creation of more cures.


The rule gives breakthrough devices immediate national coverage under Medicare after FDA approval for a period of four years. This four-year timeline is designed to incentivize manufacturers to use it to gather evidence on the applicability of their products to Medicare patients, so that they may continue coverage beyond the four-year mark.


Another important benefit of the rule is that because these devices receive national coverage under the MCIT rule, they do not require the approval of local administrative contractors, who decide which non-national items are covered locally. By providing national coverage to these “breakthrough” treatments, CMS can ensure that a product will receive coverage in every region of the country, effectively guaranteeing equal access for seniors and preventing a zip code lottery.


The agency has also taken steps with the introduction of this ruling to reduce a backlog of requests from various innovators for coverage on their treatments, some of which go all the way back to 2014. This effort follows an additional pilot program designed to guide innovators through the government coverage and payment process, all of which will help deliver critical technologies to seniors much faster.


The MCIT rule demonstrates what healthcare in this country should be. It removes red tape and lag periods, and it promotes much needed competition that will bring costs down and deliver new cures faster. More importantly, it focuses on improving patient outcomes.


The future of Medicare and Medicaid Services should be based on delivering the best outcomes for patients, and this rule is a great step forward.



Derek Hosford is a policy analyst at the American Consumer Institute, a nonprofit educational and research organization. For more information about the institute visit or follow us on Twitter @ConsumerPal.