MCIT Comment (Personal)

 

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Agency: CENTERS FOR MEDICARE&MEDICAID SERVICES (CMS)

Document Type: Proposed Rule
Title: Medicare Program: Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary
Document ID: CMS-2020-0098-0560

Comment:
CMS should not finalize 405.201 regarding a legal definition of reasonable and necessary. 

While it may be possible to craft an appropriate legal regulation, this approach of "cutting and pasting" confusing legacy language is not the right idea. Implementing the present manualized guidance as a regulation invokes legal principles that will have unexpected effects. 

For example, neither "safe" nor "effective" are defined, which accomplishes little, nor is there any guidance that "safe" can only be considered in context of an illness or treatment. 

"Furnished in accordance with accepted standard of practice" is also ill-advised, as a MAC could view anything new or recent as by definition "not a standard of practice." 

Similarly, an "appropriate" setting and "qualified" personnel are undefined. A product must be "as beneficial as" an existing alternative, but "beneficial" is a complex concept here and may have many parameters including pain, effectiveness, duration of hospitalization, cost, etc, all of which are left to the imagination of the reader to weigh and balance. 

It would be sad to see ALJs expected to work through these vague and confusing rules step by step, applying each in sequence, in every medical necessity decision. 

I wrote a paper on this topic in 2014 and concluded the structure and form of a coverage decision was very different that the legacy text used by CMS for several decades. CMS could have townhalls, calls for information, etc, on how to craft such a regulation for the 2020's, rather than relying on dusty and vague text from early in the history of Medicare. (Frueh & Quinn, 2014, Expert Rev in Molec Dx, 14:777. Clinical utility strategy: A six part framework.)

Uploaded File(s):
2014 ERMD 14_777 Frueh Quinn Six Part Clin Util Framework July.pdf