Executive Director of Medical Imaging & Technology Alliance (MITA)

Patrick Hope, Executive Director of Medical Imaging & Technology Alliance (MITA)

For decades, the United States has prided itself as the global leader of medical innovation. From record-breaking vaccine production and advanced nuclear imaging modalities to cutting-edge focused ultrasound technologies, America has been at the forefront of the modern world’s most watershed medical breakthroughs.

Recognizing the value of the nation’s most recent medical innovations, stakeholders across the healthcare continuum found cause for celebration in early 2021 when the Centers for Medicare and Medicaid Services (CMS) finalized the Medicare Coverage of Innovative Technology (MCIT) program. As proposed, the program would eliminate the gap between Food & Drug Administration (FDA) approval processes and CMS Medicare coverage decisions for the most innovative medical devices, providing more certainty to manufacturers, more tools in clinicians’ toolboxes to treat disease, and more universal and equitable treatment options for patients.

Above all, the program aligns well with the spirit of President Joe Biden’s policy approach to healthcare: expand access, encourage innovation, and support patients grappling with life-altering diseases.

Unfortunately, despite significant enthusiasm for the program, CMS 

 on March 17, 2021, that delayed implementation of the MCIT program by 60 days. The announcement also provided a 30-day public comment period to solicit additional feedback on the rule.

In the strongest possible terms, we urge CMS to implement the MCIT program following the 60-day delay period. Here is why:

MCIT Provides a Clear – and Necessary – Public Health Benefit

Nearly five years ago, Congress passed the 21st Century Cures Act. The law established a new pathway for the FDA to fast-track the development, review, and approval of cutting-edge medical devices, which the agency designated as “breakthrough.” As the name implies, this designation is only given to medical technologies that address debilitating and largely unmet health needs.

As important as the new FDA “breakthrough” pathway was, most of the devices that received expedited approval would soon collide with a substantial roadblock at CMS. That’s because Congress, while giving the FDA the power to fast-track the approval of advanced medical devices, did not allocate similar authority to CMS to expedite Medicare coverage for these devices following their approval.

The result – referred to by some as the “valley of death” – is that breakthrough medical devices sulk in limbo as CMS determines whether to cover them, a process that takes years. Meanwhile, Medicare beneficiaries battling chronic conditions, such as diabetes, Parkinson’s disease, heart disease, and advanced cancers are unable to access the latest innovations the Medical Technology (MedTech) sector has to offer. Since breakthrough coverage often varies across regions and different public and private payers, this also creates access disparities that forces many beneficiaries to pay high out-of-pocket costs to receive care.

By providing patients with immediate, four-year coverage for “breakthrough” designated medical technologies, MCIT would bridge the gap between FDA approval and subsequent Medicare coverage of innovative diagnostics and treatments. MCIT would also support more equitable treatment access for Medicare beneficiaries and reduce out-of-pocket expenses for vulnerable patients seeking advanced care. Accounting for these advantages, the program provides clear public health benefits by increasing access to new medical innovations that can improve outcomes and reduce costs.

MCIT Would Catalyze Future Innovations Across the MedTech Sector

In years past, limited beneficiary access to breakthrough medical devices undermined the ability of clinicians and product developers to collect the requisite data needed to establish that their devices met Medicare’s “reasonable and necessary” coverage criteria. This created an incentive structure in which innovators were better off focusing on developing cheaper products that utilized existing reimbursement codes rather than truly “breakthrough” technologies that would need to clear antiquated bureaucratic approval hurdles and require new reimbursement codes and policies.

If implemented, the MCIT program would improve the current incentive structure by modernizing the CMS “reasonable and necessary” criteria to ensure innovators can obtain coverage for their devices. At the same time, it would allow these innovators to collect the necessary clinical evidence to demonstrate that their devices offer clear and discernible benefits for patients. In other words, by doing away with previous regulatory snags, the streamlined coverage process outlined by MCIT would create strong incentives for companies and investors to devote additional resources towards the development of future breakthrough products.

Taken together, MCIT represents a much-needed regulatory upgrade that further solidifies the remarkable legacy of the 21st Century Cures Act. While further expansion of the program is welcomed, implementation of the MCIT rule would hasten the equitable delivery of medical innovations to patients while ensuring that important safety and efficacy standards remain intact. It is our sincere belief CMS should expeditiously finalize this program.

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CMS Must Provide Coverage for Breakthrough Medical Technologies  

As the first wave of COVID-19 patients began arriving in emergency rooms and intensive care units across the nation in early March, the medical imaging industry encountered a major problem: a heightened need for point-of-care medical imaging systems and associated replacement parts.

These critical medical products are complex to manufacture, with source components from multiple suppliers coming from all over the world. They are usually manufactured to a healthcare providers’ specifications – i.e., just-in-time manufacturing – which does require a certain amount of time. Also, each step along the way is regulated by the U.S. Food and Drug Administration (FDA) to ensure the safety and efficacy of the final medical device. When the world is not in a public health emergency, products usually move seamlessly through the manufacturing and regulatory processes.

Due to COVID-19, the ability of manufacturers to deliver medical imaging devices to the front lines was suddenly at risk due to the need to follow the federal government's guidelines to socially distance and shelter-in-place, as well as the impact this could have on the availability of FDA inspection teams at the same time hospitals were using their medical imaging equipment at a high capacity, needing additional parts for service. 

For example, early in the pandemic, FUJIFILM Medical Systems USA was alerted that it had a potentially significant problem. Critical medical parts for company products used in the COVID-19 care pathway were not gaining entry to U.S. markets quickly enough to meet escalated demand. For medical device parts, qualifying examinations were typically done by FDA officials, forward deployed to airports and other points of entry. This was a careful, but rapid, process – until federal stay-at-home orders began to sideline many agents of the U.S. inspection teams. 

 for complex parts became more severe in March as shipments needed to be directly examined by knowledgeable FDA agents who might also check for safety and damage issues, before moving the packages on to increasingly anxious U.S. domestic buyers in the nation’s hospitals and clinics where pandemic victims were being treated.

What followed was a great story of industry and government working together quickly to meet new, unexpected challenges.

In mid-March, Fujifilm contacted the nation’s principal 

 for medical imaging manufacturers, the Medical Imaging & Technology Alliance (MITA), of which it is a member, to see what could be done to address current and future delays. After discussing the urgency of the issue, Fujifilm and MITA quickly reached out to the FDA’s Center for Devices and Radiological Health and requested additional flexibility in bringing essential products to healthcare facilities during the public health emergency. 

The request included the following policy suggestions:

Prioritize review and clearance of key medical imaging devices which play a role in COVID-19 care.

Expedite generation and issue of compliance numbers for cleared products.

Generate greater flexibility for manufacturers in repurposing and converting devices to the applications most in demand by COVID-19 responders in hospitals and clinics.

Streamline coordination with the Department of Homeland Security and other intervening government agencies to facilitate the movement of personnel who are servicing and doing equipment conversions on these critical devices.

Rapid communication and collaboration between MITA and key FDA officials had the issue resolved in a matter of 

 as the agency issued guidance documents giving manufacturers the flexibility they needed. 

 on behalf of the FDA, accelerating deployment review of trapped systems and parts and other frontline equipment within days of our request, be a new template for cooperative private/public action during current and future Public Health Emergencies. 

All of those connected to and supportive of healthcare responders are under pressure during this historic public health challenge, as are those medical heroes. 

We hope that the collaboration between industry and regulators earlier this spring will be welcomed and remembered by frontline pandemic warriors now serving and saving a nation that has already suffered such pain and loss during this terrible pandemic.

FDA regulators moved quickly to accelerate the delivery of replacement parts for imaging equipment that has proven to be critical tools in the diagnosis and treatment of COVID-19.


Patrick Hope, Executive Director of Medical Imaging & Technology Alliance (MITA)

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