https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf
Monday, September 27, 2021
Sunday, September 26, 2021
CMS New BETOS, new data website
Today, CMS released the Restructured BETOS Classification System (RBCS) – a taxonomy that allows researchers to group healthcare service codes for Medicare Part B services into clinically meaningful categories and subcategories. The RCBS is an update to the Berenson-Eggers Type of Service (BETOS) classification system developed in the 1980s.
Researchers may use the RBCS to analyze trends and perform other types of health services analytic work. The first release of RBCS includes healthcare services between 2014 and 2018. The RBCS will undergo annual updates by a technical expert panel of researchers and clinicians.
To access the RBCS, please visit the following website: https://data.cms.gov/provider-summary-by-type-of-service/provider-service-classifications/restructured-betos-classification-system
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The Centers for Medicare & Medicaid Services (CMS) recently launched a redesigned data.cms.gov website that makes it easier to discover, access, and understand CMS data. Data.cms.gov gives you direct access to public data released by CMS. Our goal is to ensure that CMS data is readily available in open, accessible, and machine-readable formats. For most available data, you can:
- Download data in a variety of formats.
- View and analyze data using interactive tools.
- Access data through an Application Programming Interface, or API. An API lets developers connect other applications to data in real time.
We would love to hear from you! Send feedback on the new site to OEDAUserResearch@cms.hhs.gov.
Zebra Medical Gets AI (Non Human) Screening Code for Vertebral Fractures; CMS Classes as Non Payable
Zebra Medical got a code for FDA-cleared vertebral fracture screening without human intervention on CT scans. (Films and patients are flagged for human review). The code was passed at the February 2021 meeting, meaning it was published around July 1 in final form and with final code number, for use January 1, 2022.
In July 2021 proposals, CMS proposed to class with "New Proposed" pricing (NP) with status E1 (not payable for Medicare.) It would be not payable on the theory that there is a bone density screening benefit for osteoporosis, but there is not a specific screening benefit just for non human AI VFX screening.
BACKGROUND
Code made a splash in the radiology trade journals.
Just Links:
FROM AUNT MINNIE LINK
July 19, 2021
Officially added on July 1 and set to take effect on January 1, 2022, the new category III code -- 0691T -- would apply to the use of AI for automated analysis of existing CT studies for vertebral fracture(s), including assessment of bone density when performed, data preparation, interpretation, and reporting.
Dr. Melissa Chen.
The code was approved by the AMA after representatives from the RSNA, American College of Radiology (ACR), the American Roentgen Ray Society (ARRS), and the Association of University Radiologists initially proposed the code in a presentation at the AMA CPT Editorial Panel meeting in February.
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Similarly
https://www.theimagingwire.com/2021/07/12/imaging-in-h1-ai-code-going-corporate/
he American Medical Association issued the first imaging AI CPT codes on July 1st, including Category III codes for incidental vertebral fracture detection and quantitative ultrasound characterization, allowing clinics to start billing for these applications in January 2022 and potentially leading to the first AI reimbursements (the new AI codes are on page 3).
- The VCF AI Code – Highlighted among the AMA’s CPT update is a new code (0691T) for using AI to automatically analyze existing chest CTs to detect vertebral fractures, potentially paving the way for AI-based population health osteoporosis programs. This CPT code represents quite a milestone for AI (it’s the first radiology-specific AI code) and for Zebra Medical Vision, which is the only company with an FDA/CE-cleared product for population-scale incidental VCF detection.
- Ultrasound AI Codes – The AMA also issued a pair of CPT codes for quantitative ultrasound tissue characterization, which can be used in conjunction or separately from existing ultrasound exam codes (0690T w/ other US exam codes, 0689T separately). These codes could also represent a major step for key ultrasound exams (e.g. breast, thyroid) and ultrasound AI decision support players (e.g. Koios Medical).
FDA Documentation here as K192901
Category is 21 CFR 892.2080, Radiological computer assisted prioritization software
The category descriptor is pretty detailed:
Radiological computer aided triage and notification software.
Trade on FDA
Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.
Saturday, September 18, 2021
Paul Gerrard MD Online Bio
https://www.mwe.com/people/paul-gerrard/
September 2021
Dr Paul Gerrard is a highly regarded physician and healthcare executive with deep experience in both the academic and patient care spaces. He offers clients critical insights across a wide range of clinical areas and healthcare technologies, and provides guidance on Medicare policy and regulatory requirements. Paul also has significant experience in health outcomes research and scientific computing.
Before joining McDermottPlus, Paul served as chief medical officer and MolDX director of clinical science at a commercial provider and Medicare Administrative Contracting company. MolDX has a contract with the Centers for Medicare & Medicaid Services to review and make coverage and payment determinations for new molecular medicine technologies. In this role, he was instrumental in forging consensus among Medicare contractors on emerging and sometimes controversial areas of medicine in a highly visible program, and served as a primary point of contact between MolDX and the Centers for Medicare & Medicaid Services. He also played a critical role in the development of strategic directions for molecular diagnostics, post-acute care, and data analytics.
Prior to that role, Paul worked in private practice in New England, where he advised acute care and post-acute care institutions as well as academic departments on Medicare coverage, billing, and quality measures. In addition to being centrally involved in administrative legal hearings regarding denied payment cases, he also worked closely with various stakeholders to develop a data-driven strategy that was used to enhance care quality and safety, including improving patient satisfaction and hospital readmissions.
Paul served on served on the National Quality Forum Scientific methods panel while in private practice and currently serves on the American Medical Association (AMA) Proprietary Laboratory Analyses (PLA) – Technical Advisory Group (TAG).
Thursday, September 16, 2021
Healthcare Fraud Links
Here is a link to a law firm article that private payer recoupments may occur, as well as government payer recoupments (such as OIG/DOJ).
https://www.hollandhart.com/fraud-and-abuse-in-private-payor-situations
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There are two anti fraud coalitions or organizations:
The first is the National Health Care Anti-fraud Association
Founded in 1985 by several private health insurers and federal and state government officials, the National Health Care Anti-Fraud Association is the leading national organization focused exclusively on the fight against health care fraud. We are a private-public partnership – our members comprise nearly 90 private health insurers and those public-sector law enforcement and regulatory agencies having jurisdiction over health care fraud committed against both private payers and public programs. Established in 2000, The NHCAA Institute for Health Care Fraud Prevention is a separately incorporated, tax-exempt educational foundation that provides education and training to private- and public-sector health care anti-fraud personnel.
The second is the Healthcare Fraud Prevention Partnership which I believe is focused on coordinating information and warnings between Federal and State governments and private insurance, regarding healthcare fraud and waste. HFPP.
The HFPP has issued some white papers on laboratory fraud in particular. Coverage of these, here:
For example, see a 16 page 2018 white paper by HFPP about lab fraud.
See a September 2019 DOJ report on genetics fraud:
CPT Code 81408
Quinn later identified that a lot of the mentioned labs, were billing large amounts of code 81408, a $2000 code for sequencing rare genes. This code rose from almost 0 billing in 2017, to being the largest-billed Medicare code in 2019. (National 2020 data will be released in about 10/2021).
Here's a block of data from a September 2020 blog of mine about the explosion of 81408 billing. (Here).
Here's the basics, based on national Part B spending files:
2016 - 361 cases, $490,000 dollars
2017 - 5,817 cases, $9,550,000 dollars
2018 - 62,000 cases, $123,000,000 dollars
2019 - 146,000 cases, $290,000,000 dollars
What code are we talking about? 81408! This is AMA CPT Tier 2, Level 9, CMS price $2000.
That's 13X dollars allowed growth 2017-2018, and 30X growth 2017-2019 and 590X growth 2016-2019.
See a series of linked blog by me, about 2019 lab spending, published by me in December 2020. Here for #1.
Wednesday, September 15, 2021
Auto Transcript January 2021 (YouTube) Agendia v Azar (Appellate Argument)
Auto Transcript - Agendia v Azar (Becerra) Jan 2021 YouTube; Case decided July 2021
http://www.discoveriesinhealthpolicy.com/2021/09/nerd-note-lab-wins-claim-that-lcds.html
https://www.youtube.com/watch?v=piBBRjGG-Fk
AUTO TRANSCRIPT
Unknown Speaker 0:00
And I represent Alex ASR Secretary of HHS who is appellant cross, actually in this case. With the court's permission, I would like to try to reserve five minutes of time for rebuttal. In this case, the district court erred by holding that and a local coverage determination or LCD is covered under the Medicare act rulemaking requirements under Section 1395. h. h. A to under that section, the Secretary is required to engage in notice and comment rulemaking when he promulgate a rule requirement or statement of policy that establishes or changes a substantive legal standard governing payment for items or services. Here, an LCD does not qualify under the plain text of Section 1395. h h. a two for several reasons. First, the Secretary doesn't issue LCDs a local coverage determination is issued by a private contractor and is a determination with respect to a particular item or service that applies solely contract for why it is not a an agency requirement or policy that applies nationwide, such as the one at the Supreme Court.
Unknown Speaker 1:34
Are you saying nationwide coverage? They come under the umbrella of coverage? Is that your position?
Unknown Speaker 1:41
That is one? We think that that when we do think section 1395 ha ha does really does only apply to the nationwide? because by definition, when when the agency is promulgating a war requirement or policy for Medicare, it's it will do so for the program as a whole. But this is but there's other reasons as well, why this stuff move
Unknown Speaker 2:10
out to zero. The reason I'm sure, but just for your initial reason is the opposition that it was not an nit nationwide policy, but it never can be covered because of your position.
Unknown Speaker 2:22
I don't think that I don't think that it could be covered. However, the court does not need to decide that because there are other aspects of this, which distinguish it from the what is covered under 1395. Ah,
Unknown Speaker 2:41
counsel, would it make any difference if you had a service where there was only one provider in the whole country, and it was covered by only one fiscal intermediary decision, even though the services were rendered throughout the country? I mean, the plaintiff in this case contends that basically, for them, where they serve lots of different places, this is sort of like the death penalty for their business. But I could imagine a circumstance where it's like the only provider, would it make any difference to the government in that situation?
Unknown Speaker 3:25
No, Your Honor, because that that would just be a unique factual circumstance of that local coverage determination. As we pointed out in our brief, if you have a test, that a supplier or provider develops somewhere else in the country, even if they there was the situation you described, there could be a provider or supplier that developed a different test that would be covered by a different or you could have another another pipe provider located in a different contractors jurisdiction. But it's the other key point is that even what your honor is referring to would not be binding at higher levels of Administrative Review. The contractor determination is not binding even on qualified independent contractors, which is the next level above reconsideration by the same contractor. It only binds the contractor itself. And it's definite the statutory definition of local coverage determination makes this clear it it actually states that it's covered on an intermediary or carrier wide basis, which is on factor wide basis,
Unknown Speaker 4:42
but it's entitled everywhere to substantial deference, right.
Unknown Speaker 4:47
Under agency regulations, it is, Your Honor. However, the regulations also make clear that at all of those levels of review, that the adjudicators may disagree regard the LCD so long as they give reasons and explanation for doing so.
Unknown Speaker 5:06
Is there anything in the record about how often with particular kinds of LCDs different adjudicators reach on the same issue, different results? That like number one says yes. And number two, when it comes back at another time, it's like the exact same circumstance says, No. Is there anything in the record as to how often that happens?
Unknown Speaker 5:37
I think is the the record in this case shows that that does indeed happen as the Hlj actually rule. Right.
Unknown Speaker 5:45
But that but that's in the same chain, I'm talking like, for a different a different claim. Is there anything in the record about how often there are different results on the same issue?
Unknown Speaker 5:58
Your Honor, I think the fact that there's not It's not that I don't know that there's anything in the record on that. I do know that agenda is cited a report that discussed in consistencies among LCDs. And the need for the Secretary to do more with respect to the statutory process outlined by Congress, which we also think supports our position that a local coverage determination is simply a great hit. They're supposed to be precursors of national coverage determinations. And Congress has directed the Secretary to develop a plan to evaluate new local coverage determinations to determine which should be adopted nationally, it also stated that the contractors themselves should consult. And so there, there is an understanding with the 1000s of appeals nationwide by not just providers, suppliers, but beneficiaries, that just to effectively and efficiently administer the Medicare program, there is going to be some inconsistency at the outset. And that may not be with respect to every service or every medical device, or it can't be with respect to everything. But there's so
Unknown Speaker 7:27
let me see I get some clarity. Maybe you can help me because you're much more experienced in this matter than I am, obviously. But today, this case would not be before us. The statutory scheme has been changed as of 2016. From what I understand. So if this was a case that was being litigated under the current statute, would you agree that this would be an LCD that would be applicable?
Unknown Speaker 7:55
Oh, yeah. Well, yes. In that the the LCD. Are you saying, Your Honor, that if it is true that this particular LCD was not subject to the 2016 separate notice and comment procedure?
Unknown Speaker 8:11
If it were? Yes. Would it not be today is what my question is, it seems like with the with the situations that can repeat again, sort of an outlier case, right, dealing with the prior statutory scheme, such as it is or was missing something?
Unknown Speaker 8:30
Your Honor, I think that under the district court's holding the court appeared to think that this in the future, this type of LCD would have to go through both the 2016 separate process under Section 1395. Why and notice and comment. So I mean, we submit that the answer should be the same, both in this case, and currently with LCDs promulgated now, it is true that since 2016, the LCDs are we're required to go through this process. But we think that process shows confirms that Congress never intended LCDs even prior to 2016. But I don't know.
Unknown Speaker 9:21
It seems to me that what the statute has done now is put in place what in practice has existed before the MA C is involved with the creating DLC beads. Right. And it just seems that that has always been the case. But now it's put into a statutory context. Let me back up a little bit. You know, I I'm sure you've read judge Cavanaugh his decision in the district court case when he was a lowly district court judge right in the lead up, and we're talking about what constitutes a substantive legal standard. It seems to me that that's the bottom line of what we have to determine. And he says that at a minimum includes a standard that creates the fines and regulates the rights duties, it empowers the parties. Do you think that the AMA sees the termination in embracing its LCD or rejecting it meets that standard that it does indeed regulate the rights duties and powers of bodies?
Unknown Speaker 10:20
No, Your Honor, we do not because it doesn't bind any agency adjudicator above the contractor itself. And it doesn't announce the agency's policy with respect to the Medicare program. It's just that contractors. Well, I
Unknown Speaker 10:37
get the position, but let me see whether you can answer these questions. Do you agree that ma C's are required to follow the own LCDs? I think we agree on that. Yes. And here it made indetermination. Right. And if a determination based on an LCD is not appealed, isn't that determination find that there's no appeal? We agree with that. Yes, but we think that they are getting creative, right. Okay. So if don't LCDs create the final regulated claimants right at the initial stage of review the initial stage
Unknown Speaker 11:13
at the very initial stage, but that claimant has the right to appeal to the aggrieved beneficiary and can challenge the LCD directly.
Unknown Speaker 11:23
Here's my next question. Do you agree that LCDs are entitled to substantial deference to male js and the Medicare Appeals Council laid out a substantial deference? I think that's what is required by the agency regulations. Yes. You agree whether we know nlg can be reversed for for you to show substantial deference to an LCD like in this case?
Unknown Speaker 11:48
Yes, if the if the Medicare Appeals Council does not think the reasons they Hlj gave for doing that are sort of we don't build see these continue to regulate the rights of parties at higher levels of review? No, they don't, but they don't establish or change a substantive legal standard because that would have to be adopted by the agency and any,
Unknown Speaker 12:15
any a new sample where it would change a subsequent legal determination. We start off now with an LCD the MA C's have required to follow it right? It can't be changed, because substantial deference has to be given isn't that a change?
Unknown Speaker 12:33
No. Change means like over the change what they're getting at there, I think is if a regulation that the agency has already promulgated is changed by a subsequent regulation or the policy? It's it's not within one case of a standard we get what Assad do you have for that?
Unknown Speaker 12:54
Strange interpretation today. Do you have any so what's your best case that supports that?
Unknown Speaker 12:59
I think, Your Honor, again, I would go back to the statutory text. And if you look at 1395 h h A to it's talking about the secretary shall prescribe regulations as may be necessary to carry out the insurance programs. And then it says no rule requirement or other statement of policy other than a national coverage determination. That it would be we think that completely supports our position as well, because an LCD
Unknown Speaker 13:29
for your sickness has to be a national coverage determination. You're getting back to what you originally said when you began your comments today.
Unknown Speaker 13:37
Well, I think that the the text of 1395 ha ha two is discussing things that are promulgated by the secretary or the agency for the Medicare program as a whole. But you can the statute itself defines as an LCD is something entirely different, and also has a completely separate notice and comment. process that the contractor not the Secretary is required to to follow. And if this court were to affirm the district court, it would require the Secretary to engage in notice and comment rulemaking on something the contractor is already separately engaging in its own notice and comment procedure
Unknown Speaker 14:28
today, and then the new statutory scheme, this is exactly what we acquired today. Why is that such an odd proposition?
Unknown Speaker 14:35
Because it's not required? Your Honor, because it did this is the first court that has ever held that an LCD is covered by 1395 h eight,
Unknown Speaker 14:46
because my ra that under the current statutory scheme that in there was enacted in 2016. Notice and comment would be required of LCDs.
Unknown Speaker 14:56
up but it's an entirely separate process. It's by The contract or it's less formal. It's not the Federal Register is for agency obligations by the secretary. And this is the process in 1395. Why is 45 days not 60? It's on the Medicare and contractor website, not the Federal Register.
Unknown Speaker 15:21
You talk about contractors, but it's the MHC that's doing this, the MLC decides whether to embrace an LCD or not,
Unknown Speaker 15:30
Your Honor, that they these decisions are done in the context of a particular claim or appeal. They are not that the MSE is just deciding whether the DOJ properly did or did not defer to the LCD and whether there are reasons to depart from it. With respect to the particular like, in this case, the particular diagnostic test use the MSA with the the Appeals Council. I don't want to say MVC, because MVC is a Medicare administrative contractor. Council. So I don't want to confuse that. But now, who wants to determining whether an LCD should or should not be embraced? That's what is that
Unknown Speaker 16:12
that's what they're there for. They listen to advice, they get information from professionals people comment about it. It's a substantive determination. And you agree that that is absolutely a final determination. If there were no appeal, you agreed to that.
Unknown Speaker 16:27
But that doesn't, that's only if there's, but it's not binding on anyone but that contractor, and it's up to the individual whether or not they want to challenge it. And in the absence of an LCD, it would be just as binding on the provider or beneficiary, if the contractor would still be required to determine and this Court said this in eringer, B. Thompson, that what the contractor is doing is just interpreting the statutory, reasonable and necessary standard, which is the substantive standard here. It's a statutory standard, which the contractor is interpreting. And the LCD just allows the contractor to be more transparent about.
Unknown Speaker 17:15
And counsel, the argument that you just made was an argument that the government chose not to make in the aleena case, as the Supreme Court's opinion points out, saying that the result might have been different had the government made that that argument, is that correct?
Unknown Speaker 17:34
i? Yeah. I mean, there there are different there are different statutory standards that were at issue there. It wasn't a reasonable and necessary case. But yeah, so in here, there is a we are making the argument, this Court has a party held with respect to LCDs. And that is what you're doing in that situation.
Unknown Speaker 17:57
And but I just asked one, one last question, and then we'll give you a little bit of time for rebuttal. But do you think that we should use the DC circuit's definition of substantive legal standard from the DC Circuit opinion? And Alina?
Unknown Speaker 18:11
Um, whether or not you do we would win either way? I mean, because for all the reasons I've given. So you know, I'm not taking a position on that in this case. But I think we think even if you apply the DC Circuit standard, this clearly for the reasons given that it's promulgated by a contractor applies only contractor wide, and it's simply the contractor interpreting for a particular item and service, whether it's reasonable and necessary,
Unknown Speaker 18:44
what would be the practical result today. And in the opposition, with the practical results today, this was happening today.
Unknown Speaker 18:55
Practice practical result would be that the that the new LCD would go through the contract or notice and comment procedure, and that's outlined in the statute. Okay.
Unknown Speaker 19:10
So I'll still give you a couple minutes for rebuttal, because we took you off to a good time. But let's hear from you, Your Honor. Mr. Hooper, in the meantime,
Unknown Speaker 19:18
Thank you, Your Honor. may it please the Court Patrick Cooper for agenda EC council began her argument by saying and stressing that the Secretary didn't issue this policy. And it's not of national. It doesn't cover the entire nation. In my mind, that is a fairly major admission about why we contend This is too much power being given to a Medicare contractor. This is a very significant policy. And the fact that the Secretary does an issue, it triggers the delegation issue that we've identified now recognize that's always an uphill battle. But as you know, in our cross appeal, we thought, if ever, there's a case where a private party has too much authority, it's this situation. And if counsel, if the Secretary had actually actually issued this case, and then national in scope, then that would have been what constitutes a national coverage determination. And we wouldn't be here looking at the impact of a local coverage determination. This is a classic local coverage determination that impacts the United States. If you are a all beneficiaries in the United States, if your doctor, your breast, Pat, a cancer patient, and your doctor orders these very important test to be done, the only provider in the country that can provide these particular tests his agenda, and wherever you are in the country, it will perform the test. And it will be unfortunately denied coverage because of this local coverage determination. So I don't know how you could be. And I don't know how there could be any more of a national impact than this kind of situation.
Unknown Speaker 21:25
So looking at the statute, as it was at the time of this decision. So before the 2016 amendments, why would it make sense for LCDs to have a higher level of notice and comment requirement than the national standards?
Unknown Speaker 21:43
Yes, that's a get I get that, Your Honor. I think when your honor looks at the coverage, it looks at the promulgation process for national coverage determination. I think it is virtually the same, there may be a 30 day as opposed to a 60 day notice period. But the national coverage determination is coming out of the government, with government folks doing it. And there is this independent process it has to go through. I don't think making the LCDs go through the H H, the 1395 h h process is more onerous than going through the national coverage
Unknown Speaker 22:30
Council, as I understand the district court's ruling, that if we affirmed, then the LCDs would now have to go through both. Is that right? They would have to go through the process in the statute, and they would have to go through the normal Federal Register, the agency would have to do the normal Federal Register agency and comment is that right?
Unknown Speaker 22:54
That's what the court said. The court said, That's not they're not mutually exclusive. And I think if you look very hard at the 1395 process, that is a separate process, in my mind, that is intended to get a certain audience to input involved, but then they get the public input. I would think the you'd have to go through the traditional rulemaking, the answer is yes. Your
Unknown Speaker 23:27
position that currently, the LCDs should have to go through both processes.
Unknown Speaker 23:34
Well, that's the district courts position. I think it is sound And who am I do second guessed this, the district court and this, but I think
Unknown Speaker 23:45
we would be looking at that de novo. So what do you think we should say?
Unknown Speaker 23:49
Well, I think that it should go through the H H, excuse me, the 1395 h h process. And before that process, I believe it should go through the 1395. Why process? So yes, but they don't they aren't. They aren't the same when you're really new. And
Unknown Speaker 24:09
you think it's you think it's false plausible, that that's what the Congress intended?
Unknown Speaker 24:20
Well, it seems to me they don't like to go through if it's identical. There's no need to go through both that I don't think they're identical. Your Honor, as I said before, and I think as Judge block pointed out, I think 1395 kind of memorialized what was going on already with the Medicare administrative contractors. They had this kind of de facto process where they would try to get people, doctors involved and others involved, but it wasn't the same process as required on the 1390 Five h h, which is going to involve everyone, including members of the public, including doctors, others who may not even know. So I think they're separate processes. That's that's counsel.
Unknown Speaker 25:14
counsel, one thing that I want to make sure you address. So my biggest concern with your argument moving away from the delegation argument, is that the, for you to win this has to establish or change a substantive legal standard, governing the scope of benefits. And the government has argued with some force that the substantive legal standard is in 1395, why a one a reasonable and necessary, and that no matter what the LCDs do, or promulgate The only substantive legal standard governing on these issues are reasonable and necessary. So they couldn't possibly these LCDs couldn't possibly change it. And if that's right, you lose on this issue. Why are they wrong?
Unknown Speaker 26:14
Well, Your Honor, I think that was addressed by the court, and Elia. Because a couple reasons. One, as we all know, the statutes contain very general provisions. We're talking about, you know, 1000s and 1000s of services that are provided health care services. No one I think can reasonably read reasonable and necessary as answering the question for each service. Therefore, there's a gap. And I think this is a classic gap
Unknown Speaker 26:52
filling policy. But counsel in a line of the Supreme Court said separately, we can imagine that the government might have sought to argue that the policy at issue here didn't establish or change a substantive legal standard, because the statute required itself to count Part C patients in the Medicare fraction. And here, the government's argument is the statute itself requires reasonable and necessary, and that's the only substantive legal standard here, not whether one test that Mr. Smith or Mr. yoshiwara got was reasonable or necessary.
Unknown Speaker 27:31
Well, this policy that we're looking at impacts much more than agendas, molecular diagnostic testing this in this particular case, and that point might be applicable if we were dealing with a specific kind of procedure. Where you could say the LCD is limited to a particular proceeding, kind of procedure. But Your Honor, I think in this case, this is a very unique national power, excuse me, local coverage determination, because it says, All my neck all my life to have diagnostic tests, not just the molecular diagnostic test here, that all of them that are done by laboratories throughout the country. And this is a very, very important Phil's got some
Unknown Speaker 28:20
counsel as your argument that some LCDs have to go through notice and comment and some don't.
Unknown Speaker 28:28
Yes, I think I think I would agree with that. And in this case, to me, the the simple answer is, as a substantive legal standard is that we had an administrative law judge say that we should agenda should be covered in this particular the testing should be covered. But solely due to this lcsd agenda is not having as testing cover. That's not a procedural or an interpretive rule. That is a change in substance. And and I realize I'm applying it to a case now. But what this policy did was establish didn't change, it established a new policy for all molecular diagnostic tests. You can read reasonable and necessary all you want, Your Honor. And I don't think anybody can say one way or another whether Congress dealt with that issue. This is one of those classic, very, very broad delegation.
Unknown Speaker 29:26
I asked you this I'm a little confused, you know, with one view of this is that the standard is reasonable and necessary. And this has to be changed to what unreasonable and unnecessary. I don't understand what that means. I think that there could be changes in terms of how you go through the process where the differences do or not do. I understand that can change the dynamics, but how do you change from reasonable and unnecessary to something that's not reasonable and
Unknown Speaker 29:55
what else I that if I understand that judge and if that were the case If the administrative law judge had not made a finding that this was reasonable and necessary, I would say that's a problem. Because that the statute is controlling. We always argue in these cases, and we put on evidence to show the statute is controlling, and we had an expert oncologist. And we also had other folks testify at the hearing, and we canceled this
Unknown Speaker 30:25
suit. So does that mean that in your view, what converts this statute into one that requires notice and comment is simply the substantial deference part? And that without that there wouldn't need to be noticed some comment?
Unknown Speaker 30:39
Well, that? I think, to answer that, Your Honor, I think it's not necessary, that that regulation came into power to all of a sudden make that that made it much more difficult. In this case, it made the LCDs, virtually rubber, the agencies had the rubber stamp them. But I think in this particular case, though, that you did not have to add to reach that particular point.
Unknown Speaker 31:13
Okay, I just asked you I wasn't understanding I don't think from your briefs that you were arguing that some LCDs needed notice and comment, but not others. Could you explain which ones needed and which ones don't? Well,
Unknown Speaker 31:28
no, I I honestly cannot explain that I am only dealing with the one here, which was an extremely broad LCD that had national impact. And in that situation, I'm not saying this Court has to make a ruling that affects all local coverage determinations. But does look every
Unknown Speaker 31:47
contractor is announcing an LCD. How does it know whether it needs to do notice and comment first, in your view?
Unknown Speaker 31:55
Well, I think it would be the secretary that should make that determination. And I think when there is a secretary isn't usually involved in the formation of the Right, right, and that's one of the problems and and by the way, I want to come back to judgment there. I lost my thought for a second. But I want to just say, in response to judge Freeland, that, in this particular case, the the LCD was binding on the initial determinations, and that's why we made that's why we cited the Federal Circuit case recently, because it had
Unknown Speaker 32:35
confused with the with the contractor who's issuing the LCD, you know, necessarily whether there was someone else in the country who in a different region who was offering a similar product or service.
Unknown Speaker 32:49
Well, in this case, there's only one, there's only when you have these kind of tests, these molecular diagnostic tests. They are a unique laboratory tests. And only one laboratory provides these particular tests. There are other kinds of breast cancer testing that are provided by other laboratories. But these are unique tasks. And there's only one in the country that does it. And but with the contractor No, that that was my question. Yes, absolutely. They absolutely know what, Your Honor. They don't I'm sorry, please, please go ahead and finish your answer. Did you know that that's, that's exactly what why they have this modex process, because they know all of these molecular diagnostic tests are run by different companies. And they expect each company to come through this process and prove the medical necessity.
Unknown Speaker 33:43
I don't mean this to be a flip question. So it may sound that way. But I don't mean it to be that way. But so are you suggesting that our ruling in this case? Should it be that this particular LCD needed notice and comment? Some do some don't. And we end there and leave it to the next court to decide which do and which don't?
Unknown Speaker 34:10
Well, I think a line of did a little bit of that, Your Honor. And I wish there was a bright line, but all I know is this one, which says all molecular diagnostic testing, none of it is covered until we approve it. That to me, is broad enough and chain and establishes a new legal standard that in this case, the court can say this one should have been promulgated as a regulation. I'm not certain the contractor would even know what the Administrative Procedure Act is wrong. That's one of our problems here. These are not government people. This this is the medical director at a private insurance company who decided the fate of all these molecular diagnostic tests. That's why we're so troubled by the delegation in this case. No, I can't say for sure getting back to you judge Freeman. I can't say for sure they wouldn't know what which ones have to go through which ones. So it was I think Jerry needs to come into this and straighten it out, due respect me criticized by their own Inspector General. But we want coverage determination there. And it goes, I think judge block is trying to ask the question, if it's a little hard to hear,
Unknown Speaker 35:21
heard or not now with this wonderful system we have, but I'd like to ask you this. Tell me whether I'm wrong here. Seems to me we're talking about who is that person, Shakespeare's Much Ado About Nothing? That, you know, all you're asking is that the same process that exists today should have been implemented way back before the new statute came into existence that obviously, they will be doing it today. And they should have been doing it before. And we're really talking about a sort of an outlier situation, which is not likely to repeat. And it seems to me, it's as simple as that. These are rights that are being determined that final by the NAC, and they can be subject to appeal, they can be given deference, they can be changed. Seems to me that that's what you're trying to say. But I'm a little bit muddled in how you're trying to articulate yourself. Well.
Unknown Speaker 36:10
That's why you're the judge. And I'm the lawyer. But no, i i agree. Your Honor. You I think you've identified it. I accept that what got me a little thrown off there was that the district court does seem to say there should be two processes. And that's that's that's not easy to reconcile unless they're two separate processes. But using your reasoning that the process definitely applies once 2016. Yes, you could conclude they should have done that.
Unknown Speaker 36:40
What is the process today are the two processes under the new statute? I'm a little confused.
Unknown Speaker 36:46
That's that's what I would say. One is what I would call a preliminary. Why is a legislative process. Another is the traditional
Unknown Speaker 36:58
rulemaking. It's the same that existed before in practice, which is now being formalized by the new statute, correct.
Unknown Speaker 37:09
Okay, we've taken you over your time. Thank you. I will give Ms. Marcus, two minutes for rebuttal. You're muted?
Unknown Speaker 37:22
I'm sorry. Thank you, Your Honor. I first wanted to respond to and it led was counsels seeming argument that it would be specific LCDs, some would be subject to 1395. And some wouldn't. And that's completely impractical under the Medicare statute, and the whole administrative appeals process. Practical today. But it also be equally impractical. Yes, Your Honor. And today, the LCDs do need to go through the contractor led more informal process that Congress itself requires in 1395. Why? That's undisputed that that that applies, however, to have the secretary engage in rulemaking for you know, hundreds of LCDs and some some of which, as we pointed out, you could have two different LCDs. And then there'd have to be a separate determination about whether this LCD is better or not.
Unknown Speaker 38:30
LCDs did two different MHC determinations, how many ma C's do we have in the country today? 10 1112? Five? I think it's around that, Your Honor. All right. So these are not all sorts of LCDs is ma c determinations. And Congress in its wisdom decided this type of process would be the best process, rather than to have a national process in the first instance. And these ma sees the dynamics lead ultimately to MIT's so why should we not have the same opportunity for people to comment and interact with the pro video these particular determinations?
Unknown Speaker 39:06
Oh, but they do, Your Honor. There's the local coverage determination process under 1395 allows for that. And, and the contractor has to not only put it on its own website, but on the Medicare internet website, at least 45 days before the effective date. And the public has a chance to comment but I would just direct your honor to the provisions about national coverage determinations, which again, are expressly excluded from 1395. h. h. A to those are what the Secretary is supposed to consider, you know, LCDs for possible creation of a national coverage of termination and that beneficiaries can request that the Secretary do so and the Secretary there's also a process in 1395 why for national coverage determinations, the same statutory subsection as governs notice and comment for LCDs. It's separate and different. And exclusive from 1395, h, h, and LCDs. And ncds are expressly mentioned in 1395. Why?
Unknown Speaker 40:22
To get it the wise Q's double x to the double A tos. And that seems to be amazed, because I never had any exposure to this. I apologize for my ignorance. But we're talking about the same thing today, as existed before in the real world now has been formalized in a structured way. I don't see the difference between before and now maybe you can explain to me what we're talking about?
Unknown Speaker 40:46
No, I think to some extent, Congress was in its provisions about LCDs, formalizing what was happening with the contractors, again, just interpreting the substantive legal standard that is there on the statute, the reasonable, unnecessary standard, what would be the huge change? We
Unknown Speaker 41:05
change, but you're suggesting I have to interrupt us? What are you telling me that we'd have to have a change from reasonable unnecessary to unreasonable and unnecessary? What kind of change are you talking about?
Unknown Speaker 41:21
I yes, I think that's what i mean that the substantive legal standard is in in the statute, and there isn't that necessary? How can I be paged? But Your Honor, again, that the contractors are interpreting that standard for only the particular item and service for that claimant? These are very, it's called a determination, not a rule requirement or policy. It's an individual determination. If it is National scope, and it's going to cover everything, then you have a different process set forth in 1395. Why, but it's still not the notice and comment 1395 h. h standard, and that shows that Congress made sure you're not relegating form over substance here, Counselor? Yes, I am sure, because of the fact that it would make no sense to have national coverage determinations, excluded from the more formal Federal Register policy fact your presumption that there has to be
Unknown Speaker 42:27
a national coverage. That's the only thing that applies,
Unknown Speaker 42:31
right. And that even for an N and Congress has recognized for this particular statutory standard, that even with national, the National ones don't
Unknown Speaker 42:42
have a comment or, you know, comments and notices ever needed even now, and this is National determination. Is that your position?
Unknown Speaker 42:49
Oh, no, Your Honor. We are saying that for both national and local coverage determinations that interpret the reasonable and necessary standard, they do have to go through notice and comment, but it's a different type of notice and comment procedure that is set forth in 1395. Why? And Congress recognized that it the agency didn't need to go through the 1395 h h procedure.
Unknown Speaker 43:20
Can I can I just ask. So in this, the 2016 amendment that added the in sort of less formal notice and comment procedure for LCDs. It sounds like you and judge block might know about the history more than I do. So was that happening informally? Already? The posting on the website? Is it?
Unknown Speaker 43:38
Your Honor, I don't know. And I'm sorry. I don't I mean, there, I assume. And before that happened, there was an LCD proc some type of process that contractors were doing. I do not know if they were doing and then maybe the purpose of this was made sure it was consistent among contractors and save the record. I don't know how many days I don't know if you had a doctors who were the MA see doctors were making these judgments if they didn't do this and a clear blue sky, if they have professional representation studies, and they reach out to the public and other medical people to make a reasoned determination. I mean, I'm sure that was happening before. Do you take issue with that? I don't take issue with it. I'm not sure I do know that there was some kind of procedure set up and Congress recognized the whole idea of local coverage determinations when it actually defined the term in the statute, which was well after the 1395 h provision, so there was no need to expressly exclude LCDs then and then it was already implicit because Congress in 2003, included the provisions about the secretary basically examining LCDs and put as potential precursors for a national coverage determination.
Unknown Speaker 45:00
So, because we're way over time, sorry. But thank you both sides for the very helpful arguments. This case is submitted. And we are adjourned for the day. Thank you both so much. Thank you. This court for this session stands adjourned.
Agendia Vs Azar; LCDs Ruled Invalid without notice & comment under APA; but Reversed at Appeals Court
Agendia has disputed denials of claims in 2012 and 2013 under an early MOLDX LCD. They used constitutional arguments against LCDs. They won at the federal court level in 2019 but the decision in their favor was reversed at the appeals level in July 2021.
______
The case was delayed due to ALJ backlog from 2014 to 2018. An ALJ supported payment in 2018, finding the claims were "reasonable and necessary" despite the position of the MAC and QIC.
The Department Appeals Council overruled, saying the ALJ had not clearly explained why he was overriding the LCD (although he has the right to do so with justification.)
Agendia appealed to federal district course. HERE. Agendia v Azar, 10/29/2019. Agendia argued that
- LCDs are an illegal delegation of responsibility from CMS to a private entity.
- LCDs violate the Administrative Procedures Act.
- LCDs were arbitrary and capricious.
- LCDs are not an illegal delegation, as CMS continues to supervise MACs and LCD claim decisions can be overturned (even if "deference" is paid to the LCD) and LCDs can be invalidated under a beneficiary's LCD challenge.
- LCDs do violate the administrative procedures act. They set operational CMS policy. They may set CMS's initial policy. Regardless of whether LCDs have a public comment period of sorts, there is no statutory basis for this to be different than APA notice and comment rulemaking. (There IS, however, a separate statutory comment provided for NCDs.)
- The judge need not address #3 because he has decided the case on #2.
Some Quotes and Links about Colonoscopy Co-Pays
Last March, I had a routine screening colonoscopy at a major medical center, Cedars-Sinai (Los Angeles). After six months of silence, I suddenly got a bill from Cedars for $4000 because my insurer (California Blue Shield) had denied the claim. This is ridiculous - it was a completely routine, legally covered, no-copay (no-deductible) service. I have no idea what happened to my transaction that was different than the thousands of bills that Cedars must submit to a range of insurers (and often California Blue Shield) for screening colonoscopy. But I'm not tied up in a mess of 30 minute calls to the provider, 30 minute calls on hold to the insurer, each asking me to call the other, and so on.
I pulled a range of government links that screening services are covered under the Affordable Care Act with neither deductible nor copay.
###
GOVT LINK:
https://www.healthcare.gov/preventive-care-adults/
All Marketplace health plans and many other plans must cover the following list of preventive services without charging you a copayment or coinsurance. This is true even if you haven’t met your yearly deductible.
ASSOCIATION LINK:
https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/screening-coverage-laws.html
The law stipulates that there should be no out-of-pocket costs for patients, such as co-pays or deductibles, for these screening tests. But the definition of a "screening" test can sometimes be confusing, as discussed below.
Kaiser Article
https://www.kff.org/report-section/coverage-of-colonoscopies-under-the-affordable-care-acts-prevention-benefit-report/
From 2012, early on under the ACA, but describes: Confusion/
Long 2012 report.
Examples of patients harassing their insurer to get the correct adjucation.
Govt Link: Official ACA guidance and regulations
https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12#Coverage_of_Preventive_Services
PHS Act section 2713 and the interim final regulations[5] require non-grandfathered group health plans and health insurance coverage offered in the individual or group market to provide benefits for and prohibit the imposition of cost-sharing requirements with respect to, the following: (...)
Q5: If a colonoscopy is scheduled and performed as a screening procedure pursuant to the USPSTF recommendation, is it permissible for a plan or issuer to impose cost-sharing for the cost of a polyp removal during the colonoscopy?
No. Based on clinical practice and comments received from the American College of Gastroenterology, American Gastroenterological Association, American Society of Gastrointestinal Endoscopy, and the Society for Gastroenterology Nurses and Associates, polyp removal is an integral part of a colonoscopy. Accordingly, the plan or issuer may not impose cost-sharing with respect to a polyp removal during a colonoscopy performed as a screening procedure. On the other hand, a plan or issuer may impose cost-sharing for a treatment that is not a recommended preventive service, even if the treatment results from a recommended preventive service.
###
For Medicare patients, there has been a slower pathway to avoiding copays when the colonoscopy includes a biopsy. However, that is moving to no-copay, no-deductible status based on ongoing updates to law and regulations. (See discussion near the bottom of my 7/13/2021 blog here.)
Tuesday, September 14, 2021
Very Brief BLog: CMS Blogs on "First 100 Days" and "CMMI"
CMS has had several publications about innovation and new directions in the past few weeks.
MCIT #1
There's yesterday's announcement CMS plans to cancel the MCIT, Medicare Coverage for New Technologies, which was developed under the Trump administration last fall. Here.
MCIT #2
On September 13, CMS revisited the MCIT topic in a long blog that parallels the release of the rulemaking. Here. Penned by Dr. Lee Fleischer, Chief Medical Officer.
CMMI in Review
In August, CMS published a long blog at Health Affairs on CMMI, The First Ten Years. Here.
CMS Administrator: Looking Ahead
September 9: Administrator Chiquita Brooks-LaSure pens an essay on her first several months and her outlook. Here.
Research Facilitation Websites
PUBMED, PUBMEDCENTRAL
PubMed is the world's medical literature. Usually with abstracts. With flags if there is a free version. (You can also search PubMed with a check box on left, Free Full Text).
PubMedCentral is a parallel entry point which offers you ONLY free article results.
https://pubmed.ncbi.nlm.nih.gov/
https://www.ncbi.nlm.nih.gov/pmc/ (Pub Med Central, known as PMC)
RESEARCH RABBIT
Elaborate hub for research paper tracking. Free for academics. Can petition for special permission to get an account for example, leveraging a ResearchGate account to ask for a Research Rabbitt account.
https://www.researchrabbit.ai/
Cool video by Danny Hatcher demonstrates how powerful Research Rabbitt is. (Check out his channel too).
https://www.youtube.com/watch?v=wHBql2JncyU
SCI HUB
This is known as a quasi illicit resource or in Wikipedia's term, "shadow library," that may have posted PDFs of articles that are otherwise behind a paywall. Requires search by a tag like the IOL universal link.
RESEARCH GATE
This has a level for free accounts but requires review and authorization if you aren't at a recognized business or university. I've applied for a free account (it found some 20 papers I was a coauthor on), which they gave me after some correspondence and proof I've authored true academic articles.
Research Gate been described both as a library resource AND a sort of Facebook for science (wikipedia, https://en.wikipedia.org/wiki/ResearchGate ) Among other things it appears to search keywords in BioRxiv (which could be searched directly). You can search a concept and get a three-column result listing (papers) and (common authors, locations) and (questions answered by forum). They send perpetual emails once you get signed up, so I have my email filter those to a back folder away from my main inbox.
Somewhat similar to Research Gate is Academia.edu, although I haven't spent much time with it.
BIORXIV
Preprints. Zillions. https://www.biorxiv.org/
GOOGLE SCHOLAR
Handy Google based search of world literature
GOOGLE BIOMED EXPLORER
BioMed Explorer mostly produced PubMed results, BUT, produces somewhat different results with broader/smarter/more-AI-type recognition of keyword ideas than you get with a PubMed direct search. Worth trying.
https://sites.research.google/biomedexplorer/
UNPAYWALL (Plug In)
This is a free background Google Chrome Plug-in that shows a green flag if an article is available for free somewhere. I think much of the time it's just doing what PubMedCentral (the free paper version of PubMed) does but it's still helpful when the green flag pops up.
ENDNOTE CLICK (Plug In)
I use Endnote XX (Endnote 20) software for reference citation management and bibliography formatting. (Other choices include Mendeley, etc). I installed an Endnote Click Chrome plug-in which gives me a purple View PDF banner when a free PDF is available. Again, I'm not sure what UnPaywall and Endnote Click offer beyond PubMed's own notification of when a free PDF is on PubMedCentral, but maybe there are in fact sometimes papers at only one of these. See graphic below. The native PubMed free article tags are in blue, the Endnote Click tag in purple, and the UnPayWall tag in green.
 |
| Here, I'm being told in triplicate (blue, purple, green) there's free PDF. |
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Google NGRAMS vs PubMed Hits by Year
This is the website where you can do word frequency searches over centuries. It's books, so use this when you're looking at word use over decades.
https://books.google.com/ngrams
Note that PUBMED now gives you a hit frequency bar chart for searches (e.g. your topic hit10 papers in 2010, 15 in 2011, 25 in 2012 etc).
For whatever reason, "physician extender" (e.g. nurse practitioner) had a boom, in books, only around 1980 (Ngram left), but remains popular in PubMed today (PubMed bar chart by year, right).
 |
| click to enlarge |
On a different note, BioRender.com is a graphics & illlustration website that has an initial free level, which lets you make very complex cell biology charts as used in journals like Nature.
Reader Aggregators
I get numerous newsletters, blog posts, articles, aggregated into a collected eReader called FEEDLY. (I used the free version; extra tools with the paid one.)
FEEDLY automatically aggregates. In contrast to that, there are also places to "send" articles from anywhere, for reading later, such as Instapaper, Pocket, Raindrop.io. I have tried these briefly and found they often failed with my frequently subscription-based reading (NYT for example). However, I send articles often to a reading folder in EVERNOTE (or ONENOTE) which seem to handle the subscription articles almost always perfectly. Another "send to" reader is Readwise.io, which I understand is designed to hold "highlights" and can aggregate in highlights from Kindle. In a paid version, it can sync Kindle clippings into organizational software called NOTION.
Video
Also on a different note, I sometimes make short videos on "hot topics" to help people understand Medicare policy innovations. I have a fairly elaborate setup with a Sony ZV-1 camera, and Elgato studio light, Key Light Air, $110, and a fast gaming laptop to support video. I film via OBS Studio, which is fairly elaborate freeware. This lets me use e.g. a green screen while filming, while using another channel to put a PowerPoint slide over my shoulder. I initially used a simple $15 green screen cloth from Amazon, and later upgraded to a $140 Elgato green screen system. (And a very simple trick I like: make your PowerPoints for videos on a bright green background, then use OBS to greenscreen or chromakey-out the background.)
Windows 10 has very simple video editor - at the tic-tac-toe level - so you can e.g. film a 30 second intro and a 2 minute PowerPoint talk and then bind them together before uploading to YouTube, or clip off the last 5 seconds when you're reaching to turn off the camera. After some research and dithering, I graduated to a $70 amateur editing program called Filmora X. Another choice would be what I'm told is a slightly friendlier editor, MovAvi, $60. There are also 3 popular free editors, OpenShot, ShotCut, KdenLive, any one of which would probably be a good entry point. YouTube and Google offer tons of reviews and instructions about all fo these.
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