MCIT COSTS

 SEPTEMBER TRUMP RULE

page 54335-7

Regulatory Alternatives.

     Take no action.  Always combine with CED.   These would be inconsistent with the Trump EO to speed access to innovation.

     We consider MCIT for 1 year (e.g. to allow LCD development).

Impact.

    Difficult since many technologies would be covered anyway, or, under DRG.  Acceleration could be as little as a few months, anyway.

    It is not possible to generate a point estimate.

    Either no cost on CMS spending or temporary cost due to acceleration which may be short.

    MCIT may help mitigate chronic health burdens.

    Calculated SPENDING impact based on lowest and highest examples from NTAP.   The highest NTAP patients were 6,500.

   Table 2 shows variance from 0 to $9M to $2B.

    Most companies with MCIT devices due not meet certain definitions of small businesses.

    Regulatory costs on businesses would be de minimis (e.g. sending email to CMS that you have just awarded a BT device).

FINAL TRUMP RULE

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They now include an estimate of application costs as 15 minutes to several hours of staff time at $69.72 per hour for a handful of products.

There is a table of projected budget impact of the R&N rulemaking itself (only in January final).  Main estimate is $0.

BIDEN RULE REOPENING

Primarily asked for public comment on operational aspects of MCIT, as well as welcoming comments on whether the Trump rulemaking was procedurally flawed or overlooked comments of certain types.

No additional cost section.