Informal Summary of Some Association Comments on MCIT (October 2021)

This blog includes some informal notes secondary to an October 21, 2021, Discoveries in Health Policy blog about comments on the Fall 2021 MCIT rulemaking.

http://www.discoveriesinhealthpolicy.com/2021/10/mcit-rule-3rd-cycle-of-comments-now.html

The comments below are informal only and I apologize in advance if I have "mis-summarized" any key points.  

As an alternative, see the blog link above and find the Zip file of full association comments in their original form.

Zip file

https://drive.google.com/file/d/16c9lCIxFdacRWQ3KJkR4d8E-Xcq2V437/view?usp=sharing

AAMC

Don't finalize MCIT because FDA studies lack enough Medicare population data.  

Don't finalize R&N rule, due to references to commercial populations.  Make any changes carefully.

ABBOTT

We support broader changes than MCIT.   Create 60 day timelines for NCD requests and 90 day timelimes for implementing NCDs (not a year).  Don't include blanket future non coverage language in NCDs.  Rather, include language that future FDA indications are covered (without reopening NCD).  Update a list of pending NCD requests frequently.  Enact a CED time limit wherever CED is used (CMS actually proposed this itself, in the past).   Use Parallel Review more.  

Don't finalize R&N rule.

ACLA

This interesting comment focuses on the many vague aspects of the proposed R&N rule.   (I made a short personal public comment to CMS on the same topic).

ADVAMED

In this 8 page comment, don't revoke the MCIT rule and AdvaMed will work with CMS to strengthen it.  Make MCIT a voluntary opt-in program.   Use Feedback between CMS and Mfgr to identify any issues CMS may have, collaborate with Mfgr on evidence development.  AdvaMed is confident any operational issues raised by MCIT could be handled.  Mfgrs can engage with CMS prior to the date of FDA approval (which itself is often a year or two or more after BT status is assigned by FDA in the review cycle).

Don't codify R&N.

AMP

Don't codify R&N; numerous issues cited.  Don't refer to commercial insurance.  

[Note, BQ, MOLDX for example frequently covers tests before commercial insurance does, so incorporating commercial insurance in the gateway considerations would slow down CMS coverage.]

BIO

We support not finalizing R&N rule.

We are concerned about the use of "Medicare patient" in rulemaking, as Medicare patients are diverse.  

If there are operational issues in implementing MCIT (re rapid coding and pricing) then that is a signal there are also operational issues for new technologies, regardless of BT status, MCIT rulemaking.

We were disappointed that (in the January Trump rule) diagnostics were included but NOT if they were screening diagnostics.  Screening diagnostics are important.  [Note, BQ, the rule modified 1861(a)(1)(A), the fundamental R&N clause, so it indeed it would  not have applied to screening tests and services.]

Coalition for 21st Century Medicine

If CMS deletes MCIT as it  is, then the rule should propose a new approach to BT device coverage as well.   CMS could do new rulemaking with proposal and finalization by early 2022.

We support MCIT but CMS could add ideas like coverage rescission based on certain benchmarks.

Digital Therapeutics Alliance

Disappointing that CMS does not recognize digital medtech in the rule.  "Digital medical devices do not have a Medicare benefit category and they are not presently covered by Medicare.  We ask CMS...to exercise its leadership to explore how existing benefit categories may work...or work with Congressional leaders..."

Detach R&N rulemaking to a separate process.  

Masimo

Reject the repeal, implement the rule.  Urgent issues face the Medicare population.  Masimo has opioid use disorder technologies  and "using traditional pathways, these new technologies would take years to reach this at risk population."  (E.g. respiratory suppression monitoring.)

MDMA

We submitted detailed comments in favor of, and helping implement, the MCIT.  Disappointed by CMS's revocation position.  There was overwhelming support for MCIT, quickly develop and finalize a new rule.

Don't codify R&N, no good rationale provided.

Medtronic

We are disappointed.  The lengthy FDA review could have been used as a time period for operationalizing implementation for a product.

Use a voluntary opt in process to identify products in BT pipeline that will need MCIT implementation and resolve issues.  Ensure flexibility in any CED under MCIT.   Options include mfgr-directed evidence and CMS-directed evidence.  Implement "beneficiary safeguards" as necessary - don't use bene safeguards as a reason to nix the rule.

MISONIX

We agree that MCIT presented operational issues, and unanticipated scale issues.  Separate the R&N rulemaking.

Consider bringing HCPCS coding and CPT and RUC pricing into the MCIT process.  

CMS posed many questions on the MCIT process and R&N rule, but few frameworks or answers.  

Strongly supports repealing the R&N rule.

PCMA

Pharmaceutical Care Management Association.  

The repeal is not that bad because BT products can be adjucated claim by claim, or policies created by LCD and NCD.

The R&N regulation requires clear definitions and the applicability to drugs and biologicals needs discussion.  This risks "nationalizing" the coverage process for drugs rather than leaving them "regional" with MACs.  Mention of interactions between Part B and Part D policy.  Discussion of need to manage high cost drugs.   

PHRMA

We invested $91B in R&D in 2020.

We support recission of R&N rule.   "Any change must be made with caution."  Don't refer to commercial policies, because there are no CMS rules or processes that govern how those decisions come into being.  

PMC

Personalized Medicine Coalition,  PMC supported the original PMC so it is disappointed by the proposal to nix it.  It's important the agency continue to consider alternatives, as promised.

We have concerns with codifying R&N rule.  Discussion at length of "safety and effectiveness" (which is incorporated as a bullet under R&N), "appropriateness" (not otherwise defined), and commercial coverage as a factor to be weighed in coverage.