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Under President Trump’s leadership, CMS has delivered unparalleled medical innovation

Thought Leader: Seema Verma
September 24, 2020
Source: Link

The Medicare program represents a solemn promise to seniors that their nation will be there for them in their golden years. Fulfilling that promise involves dismantling the unwieldy bureaucratic morass that too often stands between them and the cutting-edge innovation that can lower their costs or even save their lives.

Thankfully, the Trump Administration has consistently made innovation a top priority. Few if any modern presidents have done more to clear the cobwebs from the great innovative machine that is the American healthcare system.

In recent years, at President Trump’s direction, the Centers for Medicare & Medicaid Services (CMS) has approved coverage and payment for a flurry of groundbreaking drugs, biologics, and medical devices such as therapeutic continuous glucose monitors for diabetic seniors who need them.

But his reforms go far beyond simply extending Medicare coverage and payment for particular treatments for particular diseases, important as that work is; rather, he is tackling the institutional, bureaucratic obstacles standing in the way of access to innovation for American seniors.

The most recent example of such structural reform is a proposed rule, called Medicare Coverage of Innovative Technology (MCIT), which CMS unveiled recently. If finalized, it would more rapidly connect seniors with cutting-edge medical technology that may save their lives.

Our Nation is innovative, but entrenched bureaucracy and red tape have prevented Medicare beneficiaries from accessing new medical devices, even after the Food and Drug Administration authorizes them for marketing. The FDA’s rigorous review process determines whether a device meets the relevant safety and effectiveness standards required by law. Once FDA approves or clears a device, CMS often begins its own review to determine whether the device is “reasonable and necessary” for Medicare beneficiaries – another, separate legal standard.

The lag time between FDA approval and Medicare coverage has been called the “valley of death” for innovators. Years-long investments in achieving FDA marketing authorization for innovative devices are often met with even more delay while CMS performs its review. In the meantime, devices must be approved for coverage on a case-by-case basis, leading to a patchwork of inconsistent coverage across the country. The work and legal mandates of CMS and FDA do differ, but bureaucratic wrangling must not come between a patient and a potentially lifesaving device.

Our MCIT proposal seeks to eliminate the valley of death, potentially giving seniors just the opposite – another chance at life.

MCIT would provide immediate Medicare coverage for all devices designated as “breakthrough” by the FDA once they receive FDA marketing authorization, and that initial coverage would last four years. This time limit will incentivize manufacturers to develop a robust set of real-world evidence and data to bring to CMS, which will evaluate whether to continue full coverage.

With a regulatory regime newly conducive to innovative devices thanks to MCIT, seniors – and, indeed, all beneficiaries – will also benefit from President Trump’s longstanding push for telehealth, which we accelerated dramatically during the pandemic.

The Administration temporarily waived statutory restrictions and allowed for telehealth across the country – not just in rural areas – to be provided in more sites of care, and dramatically expanded the providers authorized to provide it. President Trump then released an executive order directing us to extend many of the new services beyond the end of the public health emergency.

Perhaps the most consequential change of all, however, is the imminent arrival of a healthcare system in which healthcare records travel seamlessly with patients to the providers of their choice – also known as interoperability. Recent Administration rules will put patients in charge of their medical information in a digital format and deliver the convenience Americans should have always had in the 21st century. But it also goes far beyond convenience

Easy access to medical records builds a more robust understanding of a patient’s health history. With a more complete clinical picture, clinicians can deliver more personalized care and treatment based on accurate medical histories.

The seamless flow of data will also do a world of good for medical research, as clinicians and researchers benefit from a wealth of data – contributed with patient consent – that has previously been locked in digital silos. Countless new life-saving, transformative drugs and technologies beyond our conception today will come about thanks to this paradigm-shifting change.

Some may even be delivered to Medicare beneficiaries under MCIT.

In short, President Trump has deconstructed a sputtering regulatory paradigm and reinvigorated America’s innovation engine. For all the good these reforms are doing now, their implications will reverberate for years to come. Each bureaucratic barrier surmounted today facilitates access to a new, innovative product tomorrow – and scores of seniors living better, longer lives for years to come.

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