Drug Pricing Lab 04/09/2021

CMS Announces Delay of MCIT Final Rule

CMS delays the effective date of MCIT rule on "breakthrough" designation after concerns raised by physicians, including Peter Bach.

The "Medicare Coverage of Innovative Technology" or MCIT final rule, announced in January 2021, established a Medicare coverage pathway to provide beneficiaries with faster access to "new, innovative medical devices" designated as "breakthrough" by the FDA.

The expedited pathway would result in four years of national Medicare coverage starting on the same day as FDA market authorization. However, concerns were raised after the announcement of the original rule, including concerns in benefit category determinations, coding, and payment.

CMS references Dr. Peter Bach's New York Times op-ed with regards to concerns on how breakthrough technology may work for older patients, and the evidence by which coverage is based on. Dr. Bach raised that the designation does not have to do with how the device works in older patients, and may not even be studied in that population at all. Companies already rarely provide sufficient evidence for CMS to base payment and coverage on, and the proposed rule would only perpetuate the practice.

Read the full document here.

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