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This proposed rule modifies the Medicare coverage process to streamline coverage of breakthrough technologies that have the potential to improve patient health outcomes and quality of care.

Statement of Need:

We are using regulatory action to address the increasing need for a swift coverage mechanism to allow beneficiary access to certain new technologies.  This proposed rule squarely addresses that need by establishing a program that will allow beneficiary access to new technology.

Summary of the Legal Basis:

This proposed rule makes Medicare coverage policy updates pursuant to the authority at section 1862(a)(1)(E) of the Act.

Alternatives:

None.

Anticipated Costs and Benefits:

The impact of implementing MCIT is difficult to determine without knowing what technologies would be covered.  However, at this point, the MCIT coverage pathway would probably be a cost to the Medicare program in the short-range period when beneficiaries utilize technologies covered through MCIT. Because of the past trend of new technology costing more than existing technology.  Nevertheless, new technology may also mitigate ongoing chronic health issues thereby reducing some costs for Medicare.

 As we move toward publication, estimates of costs and benefits will be included in the proposed rule. 

Risks:

Given that, under the current coverage infrastructure, new technologies may be covered at the local level, MCIT would not create any new risks for beneficiaries that did not exist previously.