MOLDX State and MAC Count

 

PGX MAC LINKS

Novitas Draft LCD PGX DL39063

Comment June 10 - July 24

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39062&ver=14&stateRegion=all&contractorNumber=all&proposedStatus=F&sortBy=title&bc=11

Novitas Final LCD PGX L39063 (Oct 28)

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39063&ver=11&stateRegion=all&contractorNumber=all&proposedStatus=F&sortBy=title&bc=11

Comment October 28; Effective December 12

Billing and Coding A58801

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=58801&ver=9

Response to Comments 

A58929

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=58929&ver=3

Novitas Anti Fraud Article

http://www.discoveriesinhealthpolicy.com/2021/10/novitas-article-attacks-genetics.html

Operation Double Helix

https://www.justice.gov/opa/pr/federal-law-enforcement-action-involving-fraudulent-genetic-testing-results-charges-against

Oct 27 2021. Auto transcript. Discussion of Prior Adminstration and MCIT Rule

 From webinar at USC on 10/27/2021 with Scott Gottlieb and Joe Grogan.

http://www.discoveriesinhealthpolicy.com/2021/10/very-brief-blog-joe-grogans-blog-on.html

AUTO TRANSCRIPT (Not corrected)

ERIN TRISH

 

Great, thank you. So I think, you know, you both have touched on the the kind of value of getting new therapies or new diagnostics or new treatments to patients quickly. And that's, you know, quite obvious during a pandemic, why we see such value there.

 

But, you know, switching gears a bit, I think there is a lot of value to getting new therapies or diagnostics to patients with unmet need, even beyond the pandemic setting.

 

So, Joe, you recently, you know, you did a nice job at the beginning of laying out the differences between reimbursement for devices and how that differs from the drug reimbursement or coverage pathways. But ultimately, you know, you recently wrote a blog post that described one of the rules that was moved forward under the Trump administration during your time there that was really pushing to accelerate coverage for innovative technologies for Medicare patients, on the exit rule that was moved forward and finalized during the Trump administration, but recently pulled back under the Biden administration out of raising some concerns. So can you describe kind of what were the goals? Or what were you trying to achieve with that policy? And what are some of the reasons why the Biden ministration is concerned with it today?

 

JOE GROGAN

Well, we were talking trying to do is get innovative technologies out to the marketplace as quickly as possible. So it's called the Medicare coverage and innovative, innovative technologies will and basically, it laid out that FDA designated device is breakthrough and then approves it, it would automatically be covered at on the CMS site, not every device, not every diagnostic, a small subset that was determined to be breakthrough would be covered. And that would short circuit, some of the bureaucratic hurdles that CMS erected to getting these out into the marketplace to the Medicare population, you would still have to figure out how much this product would get reimbursed for and go through. But that whole coverage, reasonable and necessary standard, which is different than safe and effective, and FDA would be dispensed with frequently, CMS raises objections about various devices and says they have to run their own trials and look at their own data and saying, Oh, this isn't suitable for the Medicare population, the population that FDA looked at was not representative Medicare. It's something certainly that device companies, diagnostic companies need to look at when they're designing their trials and figuring out hey, is this going to be suitable for CMS? Or am I going to have to do a whole new series of trials after FDA review? And, and so I think the reason why the Biden ministration didn't like this, and it was it was controversial. And Peter Bach wrote a wrote a big long hit piece about this, that this was going to be opening the floodgates to dangerous products, getting into the market and all this stuff, which I categorically disagree with. I mean, FDA, I have faith in the FDA, to approve it on the CMS side, I fail to see why you can't allow the marketplace to decide what is suitable or not once FDA decided to did safe and effective, and frankly, the Biden ministration wanted CMS to have more control over these products. We were more sympathetic to innovation in and of itself and letting the market decide. I'm hopeful that in the end, if the Biden ministration doesn't finalize some version of this that Congress will step in common it's it's a provision a similar provision is included included in the cures 2.0 bill which may go in the spring, and that I think would be great for patients but but we were a deregulatory administration. We were a deregulatory team and cutting out that level of review was important to us. The last thing I'd say about that too is the CMS staff who reviews these products at the various stages of coverage, coding and reimbursement frequently speaks of being understaffed and not having the technical expertise to review them. So this is another and finding people, frankly, who are technically sound to review complicated devices is a is a challenge at FDA to challenge and CMS, people like this don't don't grow on trees, and they're very in demand in private industry. So having unnecessary barriers because the bureaucracy can add qualified civil servants. We didn't think was a was a was was reason to keep the product from patients.

 

SCOTT GOTTLIEB

Yeah, the the genesis of this idea was actually FDA, and it came from the professional staff inside CDRH. And initial discussions were directly with SEEMA VERMA about this. She, she faced opposition initially inside CMS, not because I think they were philosophically opposed to it. But the CMS didn't like the idea that professional staff there didn't like the idea of giving up their discretion by tying their coverage decisions to a decision made by FDA. So that, you know, CMS would effectively be forced to cover something just because FDA gave it a breakthrough designation. And that would take their discretion away. No, no agency likes to lose discretion. So the way we tried to solve that was by giving CMS, you know, more of a seat at the table and in how the breakthrough designations were determined as well. And that that seemed to get us there. Sema was ultimately able to move this through her own agency, the elegance of it was that not only was it sort of a presumption of coverage, but that presumption of coverage was going to be worth a lot of money in terms of foam was no cost, you were going to be able to finance this innovation much more easily. So if you know a new device, new breakthrough device, got a breakthrough designation, and there was a presumption that it was going to be covered on the back end, if it was successful, that was going to make it much easier to raise venture capital and get it financed in the private markets. And so really, for no cost to the federal government, all of a sudden, they were going to create a lot of Fiat investment, just by virtue of conferring a status on something. And that's always kind of advantageous, you know, you don't have to spend any money, but you can help promote a lot more capital formation. That was the elegance of it. My My feeling is that the Biden administration's decision to pull it was just gratuitous politics. There were some Democratic interests against this, particularly among the payers, who thought it would force them to have to cover technologies that they otherwise would have been reluctant to cover, or being will exercise more discretion about covering and, you know, they were pushing on the administration. And I think this was just an example of a new administration coming in and unraveling a policy from the old administration. I don't I don't think that there was sort of, based on what I've not heard, any kind of like philosophical, really hard feelings about this. I think this is was the kind of thing that kind of gratuitous policymaking you sometimes see when administration's change over. So I agree with Joe, I think that this could be done legislatively, I don't think that there is a whole lot of opposition to it, you know, the bureaucracy could be solved for their angst, I think the the payers just really isn't going to be a big hit to the payers, the reality is, most of these, most of these breakthrough products are going to get covered anyway. I mean, a vast majority of them are going to get paid for just a question of how quickly they'll they'll be paid for. So you know, it's not, it's hard to envision, and there are some estimates on how much money this is going to cost. But there's always seemed to be inflated to me, because most of these technologies will, will, in fact, get covered because they are breakthrough, medical technologies that are transformative from a healthcare standpoint.

 

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.

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