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CMS delays rule outlining new technology pathway 

CMS delays rule outlining new technology pathway  ​​​​​​​Rule also implements standards to be used in making reasonable and necessary determinations

WASHINGTON – CMS has delayed the January effective date of a final rule that established a Medicare coverage pathway to provide beneficiaries access to new, innovative medical devices designated as breakthrough technology by the U.S. Food and Drug Administration. 

The agency says it is delaying the final rule’s effective date for 60 days to ensure that the rulemaking process was procedurally adequate; that it properly considered all relevant facts; that it considered statutory or other legal obligations; and that it had adequately considered public comments objecting to certain elements of the rule. 

The move follows a Jan. 20 memo from the assistant to the president and chief of staff titled “Regulatory Freeze Pending Review” that directs agencies to consider delaying the effective date of rules published in the Federal Register that have not yet become effective, consistent with applicable law, for the purpose of reviewing any questions of fact, law and policy the rules that may arise. 

The final rule, published in the Federal Register on Jan. 14, also implemented regulatory standards to be used in making reasonable and necessary determinations under the Social Security Act for items and services that are furnished under Medicare Part A and B. 

The Medicare Coverage of Innovative Technology (MCIT) pathway will result in four years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within two years thereafter. 

HHS is accepting public comments on this interim final rule for 30 days.  


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