iRhythm Technologies, Inc.
Q4 2020 Earnings Call Transcript

Published: 28 Feb 2021

[Operator:]

Ladies and gentlemen, thank you for standing by and welcome to the iRhythm Technologies Inc. Q4 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. Please be advised that today's conference may be recorded. I would now like to hand the conference over to your speaker today Leigh Salvo. Please go ahead.

[Leigh Salvo:]

Thank you. And thank you all for participating in today's call. Joining me are Mike Coyle, CEO; Doug Devine, CFO; and Dan Wilson, EVP, Strategy, Corporate Development, and Investor Relations.

[Mike Coyle:]

Thanks Leigh. Good afternoon and thank you all for joining us. I would like to start by reiterating how excited I am to join the iRhythm team. I've watched the company over many years as much of my career has been in the cardiovascular market and particularly in cardiac arrhythmias management. I have long been aware of the widespread under diagnosis and detection of life-threatening arrhythmias and the significant impact that disruptive technology can have given the well-known limitations of Holter monitors and cardiac event recorders.

[Doug Devine:]

Thanks, Mike. Our fourth quarter results demonstrated steady growth and stability. Sales metrics improved incrementally and home enrollment was once again a stable part of our mix. EBITDA remained positive. First, let's take a look at financial highlights for the fourth quarter of 2020. Revenue increased 33.3% year-on-year and was up sequentially 9.5% quarter-on-quarter. Gross margins were 74% down 2.5% year-on-year and 0.7% quarter-on-quarter. Adjusted EBITDA defined as EBITDA less stock-based compensation was $6.5 million, up $15.7 million year-on-year and down $8.3 million quarter-on-quarter. Finally, cash and short-term investments were $335 million at quarter end, up $8 million from Q3 2020. Taking a more detailed look at the fourth quarter financial results, revenue grew incrementally in the fourth quarter with quarter-on-quarter growth of 9.5%, slightly exceeding the 2019 Q3 to Q4 growth of 8.1%. We saw less seasonal slowdown in December versus historical patterns. Revenue is now solidly above pre COVID levels with the fourth quarter 2020 revenue 24% above revenue in the first quarter of 2020. ZIO XT volume drove the majority of our growth in the fourth quarter while ZIO AT growth continued to outpace total company revenue growth. New account onboarding improved at historical levels in Q4 compared to Q3 new account onboarding of approximately 90% of pre COVID levels. Looking at new store same-store mix. New store accounted 39% of year-on-year growth, down slightly from 45% in Q3, primarily due to lower new account onboarding in the second quarter of 2020. Home enrollment was steady at approximately 25% in the fourth quarter. Turning our attention to the rest of the P&L. Gross margin in the fourth quarter of 2020 was 74% a 0.7% decrease compared to gross margin of 74.7% in Q3 of 2020. The decrease was due to higher shipping costs to mitigate US postal service delays and testing and overtime costs related to COVID. Comparing Q4 2020 gross margin to pre COVID Q1 2020 gross margin of 74.7%, gross margin is down due to higher cost of home enrollment, the ZIO AT ramp, expedited shipping costs and COVID related labor and testing costs offset by cost reductions and volume benefits. Higher costs due to home enrollment decreased gross margin in Q4 2020 by 2% versus pre COVID levels. Operating expenses in the fourth quarter of 2020 were $67.9 million, up 16.1% from Q3 of 2020 and up 7.9% year-over-year. The sequential increase in operating expense was the result of Verily milestone costs of $4 million, restoration of the remaining COVID compensation reductions of $1.5 million, restoration of bad debt expense to normal levels resulting in an increase of $2 million and hiring and restoration of programs resulting in an increase of approximately $3 million offset by reductions in stock-based compensation expenses. Comparing year-on-year OpEx, Q4 2020 OpEx was up 3.2% compared to Q4 2019 excluding Verily milestone expenses. Verily costs included in OpEx were $4.6 million in Q4 2020, compared to $1 million in Q4 2019 and $0.5 million in Q3 2020. Verily expenses were higher in Q4 2020 due to milestone expenses of $4 million. The company expects the next Verily milestone to occur in Q2 2021. Quarterly adjusted EBITDA was again positive in Q4 2020 at $6.5 million. Expenses reductions due to COVID were approximately $5.8 million in Q4 2020 thus EBITDA would still have been positive at $0.7 million without COVID impacts. Finally, the net loss for the fourth quarter of 2020 was $9.7 million, or a loss of $0.33 per share compared with a net loss of $17.3 million or a loss of $0.65 per share in the same period of the prior year. Moving to internal controls. We are pleased to announce that two of the three material weaknesses from 2019 have been remediated related to the financial statement close process and accounting for revenue and related accounts receivables and reserves. We have made significant progress on the third material weakness related to the effective control environment commensurate with our financial reporting requirements, and expect to close that item in the coming quarters. The company remains committed and focused on continuing to improve our control environment and investing in our infrastructure, hiring and training to support the future growth of the company. Turning our expectations to 2021. As Mike mentioned, due to the continuing uncertainties and reimbursement and the continued COVID related uncertainties, we will not be issuing revenue margin or operating expense guidance at this time. However, we can provide commentary on expected volume growth in the first quarter, gross margin puts and takes and changes in operating expenses that we have visibility to today. We intend to provide more complete guidance when reimbursement uncertainties are resolved, and we are fully able to assess the impact on our business. For the first quarter of 2021, we expect volume growth of 5% over the fourth quarter of 2020. Gross margin is expected to continue to be impacted by the approximately 2% headwind from home enrollment costs and by COVID related testing and overtime costs, assuming stable pricing. Additionally, we expect to launch a new manufacturing facility in 2021 to support capacity growth and future automation of our manufacturing processes. The new facility and planned automation will result in medium to long-term improvements in gross margin, but will decrease gross margin in the near-term due to transition costs and initially lower facility utilization. OpEx is expected to increase by $9 million to $11 million versus Q4 of 2020 due to higher stock-based compensation expense related to the CEO transition, seasonal increases in bad debt and payroll taxes of $3 million and the ramp of hiring in investment programs offset by the $4 million reduction in Verily milestone payments. For the full year, we expect stock-based compensation to increase by $20 million evenly throughout the year due to the CEO transition and the retention of key executives during the transition. And finally, as an update on our claims processing, at the start of the year as we transition to building the new category one CPT codes iRhythm is currently holding approximately 90% of 2021 year-to-date ZIO XT claims. About half of these claims are being held due to ongoing negotiation with payers with the remainder being held, due to timing requirements for implementation of the new category one billing codes with payers. We expect the level of held claims to remain high through the end of Q1 2021. The high level of health claims will delay most Q1 2021 cash flows into Q2 2021, or potentially to Q3 2021. We have adequate balance sheet liquidity to manage through these delays and cash flow timing. The delay in commercial claims submission will most likely push some Q2 2021 revenue recognition into second half 2021. Additionally, as noted previously, we are in discussions with Novitas on Medicare reimbursement levels. If these discussions do not result in updated pricing or if updated pricing is not made retroactive to January 1, 2021, we expect to recognize Medicare's ZIO XT revenue at the Novitas pricing published on January 29, 2021 for the applicable time periods. Mike, Dan, and I would now like to open the call for questions. Operator?

[Operator:]

Thank you. Our first question comes from David Lewis with Morgan Stanley. You may proceed with your question.

[David Lewis:]

Great, thanks for taking the question. Just maybe one for Doug and then Mike maybe one for you, but maybe you can pass these off a little bit here. So, just on Novitas, I appreciate the commentary on the update there. When did the meeting occur? And can we roughly assume that six to eight weeks is a reasonable timeframe for a decision or update one way or the other from Novitas? And maybe for Doug for you, it sounds like, this Novitas decision will begin to impact kind of rev rec and bad debt around the time that you have to file the first quarter? And then I had a quick follow-up.

[Mike Coyle:]

So, thanks David. On the question about the Novitas timing, the meetings have been relatively recent over the last two weeks. And in fact, there have been two meetings of the consortium members, industry members with Novitas, very constructive in both meetings. We're basically not in a position to describe timing other than to say that we clearly are getting a lot of focus and attention from the Novitas team in terms of evaluating this question of the appropriate rates for these new codes. And so, we expect them to be diligently working on it. So I don't have better visibility to the timing, but they seem to have a lot of effort going behind it right now.

[David Lewis:]

Okay. And then, Doug that question on billing, and then, I have one quick follow-up after that.

[Doug Devine:]

Yes. So, in general our contractual allowances accounting, which impacts revenue and our bad debt expense accounting, they’re 12-month averages, but they're offset by a quarter. So my comment on rev rec in Q2 is more based on that. That's -- when we close Q1, our period for averaging for doing accounting purposes is pretty much calendar year 2020. And then that rolls forward one quarter.

[David Lewis:]

Okay, very helpful. And then for first quarter, team, you're actually guiding above the street for the first quarter. Just help us understand what assumptions are embedded in that number? Obviously you have sort of a bit of a delayed billing cycle, which kind of changes how COVID impacts your business. I'm just kind of curious what assumptions you made here in the first quarter? And then, has there been any change, either channel friction tied to the reimbursement dynamics that are impacting volumes, or any change in the competitive environment Mike, in light of the reimbursement dynamics that are worth considering, so just broad assumptions on Q1 and then channel friction and reimbursement dynamics on the competitive environment? Thanks so much.

[Mike Coyle:]

Sure. Let me start with the second question, and I'll just ask Doug to comment on the assumptions in Q1. But obviously, the customers who are writing scripts for our product, generally are not directly connected to the economics of it that as we do direct bill right to the payers. And so, it's been relatively invisible to them that this whole discussion is going on. Other than the fact that they have become aware, so a number of our customers have become aware that the cross-reference pricing to Holter is a concern to them given that clearly they understand that that would be below the cost of providing the service. So other than that concern obviously, it's not hitting our volumes in any meaningful way as you can see from the strong revenue performance during Q4 and the guidance that we're providing for Q1. Doug, you want to add anything?

[Doug Devine:]

Yes, going to the other part. So the 5% volume up quarter-on-quarter that is in reports posted, which is our standard trigger for revenue recognition. And under our usual accounting flow, we recognize revenue when we post the report. And so even if you took the corner case of a normal flow of something that say the report posted on March 31 and we submitted to the payer two days into April, that would still be under our normal flow Q1 revenue. And so even though that time line is going to be greater we would still be recognizing any report we post in Q1 and 2Q on revenue.

[David Lewis:]

Great. Thanks so much.

[Operator:]

Thank you. Our next question comes from Robbie Marcus with JPMorgan. You may proceed with your question.

[Robbie Marcus:]

Great. Thanks for taking the question. Maybe just to follow-up on reimbursement. Mike, I was hoping when you had your discussions with Novitas, did you at least get an answer of why they decided to crosswalk to Holter monitor rates the $310 CPT 3 code wasn't there anymore for them to crosswalk to. Is that the reason that they cross-walked it, or anything you can give us on the rationale for choosing that rate?

[Mike Coyle:]

It really wasn't a big focus of discussion in the meetings around why that mapping of the Holter rates went in. There’s -- clearly there are administrative reasons why it was beneficial to them to have a number in there. And it's clear that the lack of the ability just map to the existing codes because the temporary codes went away was a challenge. But, obviously, the level of attention that they are paying to understanding the differentiation of long-term ECG relative to Holter, the increased cost components that go into being able to provide that significant clinical and economic advantage relative to Holter monitoring and their interest in understanding fully the RUC recommendations and how they were based tell us that they are very clearly looking at what the right answer is for being able to put in sustainable rates into those codes.

[Robbie Marcus:]

Got it, okay. And you give us a little more detail on Verily and the rollout plans. When should we expect to be able to see a mockup of the product to get more information on the details and sensitivity of the product and a little more color into the new business model? Thanks.

[Mike Coyle:]

Well, as we said in the body of the prepared text, we expect to be seeing a regulatory submission here midyear and likely regulatory approval of both the form factor itself so the sensor, as well as the supporting AI-enabled diagnostic software by either late this calendar year or early next calendar year. And that would be the time for us to talk about the form factor and the design. But clearly as we mentioned in the body of the text, the work that we will be doing clinically with that will be really to evaluate its applicability its performance. This is a whole new way of doing detection of atrial fibrillation. We're going to want to assess the business model. And so the work that we will do clinically after the approval is really in support of just understanding the technology and understanding the economics and the business model so that we can support a reimbursement strategy.

[Robbie Marcus:]

Okay. So we won't see it or get any insight into data versus ZIO until around submission later this year?

[Mike Coyle:]

Right. And then mostly we're really just going to be focusing on doing the clinical evaluation. So we're not talking about a commercial rollout even after those approvals.

[Robbie Marcus:]

Got it. Okay. Thanks a lot.

[Operator:]

Thank you. Our next question comes from Margaret Kaczor with William Blair. You may proceed with your question.

[Brandon Vazquez:]

Hi, everyone. Thanks for taking the question. This is Brandon on for Margaret. First, I just wanted to ask a question around guidance and reimbursement. Just to be specific is the lack of guidance or the inability to provide guidance at this point due to uncertainty in rates with Medicare, or is it also uncertainty in some rates with the private commercial side as well?

[Mike Coyle:]

Well, the guidance that we have is a volume expectation right in terms of what we expect to see in terms of registration growth and so we are providing a view of what we see the primary demand for the product is. The question will be, of course, what rate to apply for the Medicare business given where the current Novitas rates are. And, obviously, when that is clarified then we will be able to make an assessment of any potential fleet over effect onto the commercial side of the business. But the open item here is the rates that will be applied to the Novitas business. The other piece I would just point to is, having some level of uncertainty to it is how quickly we emerge from the holding of the claims as we bring on these TPD1 codes on the -- into customer contracts across our commercial direct fill customer base. This is a timing aspect from the standpoint that the whole process involves obviously having to take every one of those contracts and map them from the old codes into the new CPT1 codes. That process involves obviously agreeing on a price for those new contracts it involves, setting up the IT systems for the commercial payers to be able to accept our claims and then to do testing, to make sure that before we send large numbers of claims into the system. That everything is working the way it needs to work. And that is a multi-week process even after we get a signed agreement to actually bring up to speed, each of these payers onto the new systems. And so the timing of that is going to be what determines when we essentially are able to completely have our claims submitted. And that will then normalize our revenue flow.

[Brandon Vazquez:]

Okay. And just to clarify, part of, I guess, what I was trying to ask was, are you seeing any of the commercial payers follow the decision that Novitas had put out there a month or two ago?

[Mike Coyle:]

So as we watch in our discussions of converting over to the CPT1 code with the commercial payers. Generally, what we're seeing is those conversions being done at essentially the same prices that we have today. So, we do obviously see customers who are aware of the ongoing discussions with -- with Novitas. Some of them have indicated that they're going to go ahead with these contracts, but they will be looking to see where those new rates come in to decide if they want to sort of reopen discussions. But the majority of the accounts that we have today are essentially very long-term relationships that we've had at existing pricing. And most of those conversions are taking place at essentially the same price levels.

[Brandon Vazquez:]

Okay. Thanks. And then, the last one for me, maybe for Doug, on the manufacturing facility, are there any kind of qualitative benefits you can give us maybe what will the output of the new facility be? What would the CapEx be on building this facility out? And maybe is there a meaningful headcount reduction and anything like that to kind of get us a little bit of details on, how meaningful the new facility could be? Thank you.

[Doug Devine:]

Sorry, I un-muted the wrong phone. Okay. So going back to the comments that I made in the prepared remarks, this is going to be a bit of a cost drag decrease to margin structure in the short-term. I mean partially because we're going to be operating two facilities for a period of time. And partially it will take time to ramp it up. We'll give you more details on the CapEx and the cost although this is not a CapEx-intensive business. So the number is not going to be huge in terms of the CapEx. In the longer term this is going to -- the medium to long-term this is going to enable us, and we do plan to substantially introduce substantially greater automation into our workflow. As I emphasized before, that's medium to long-term that's not in the short-term, where that's going to happen. In terms of capacity sizing, you're talking the new facility we're not going to build out the purchase all the capital to build out the new facility to its ultimate capacity immediately. Of course, we're going to bring on capacity and capital investments with our volume growth. But this facility will be able to go to ballpark five times more volume than the current facility.

[Operator:]

Thank you. Our next question comes from Kaila Krum with Truist. You may proceed with your question.

[Kaila Krum:]

Great. Hi guys. Thanks for taking my questions. So I just want to be clear on the revenue recognition commentary. I mean, if Novitas doesn't update its rates by the end of March, it sounds like the plan is still to submit these claims, do Novitas recognized revenue at the $43 rate? First is that right, or could you and when would you hold those claims into the second quarter?

[Mike Coyle:]

Let me ask Doug just to comment on the timing of the revenue recognition.

[Doug Devine:]

Yes. So first on the claims piece with Novitas and with most but not all of our payers we have up to 12 months to submit the claim. So there is no -- particularly with Novitas there's no looming deadline to submit the claims. And then really and if we were to get a new price after March 31, but before we had closed the books on Q1 and that price was to be retroactive to some ideally to January 1 then we would be able to use the new price in those circumstances.

[Kaila Krum:]

Got it. Okay. That makes sense. And then I just -- you guys mentioned your hospital customers are concerned about the lower reimbursement rate. So I guess are you seeing hospitals step up as advocate here too? I'm just curious how they're responding to this news.

[Mike Coyle:]

So both the American College of Cardiology and the Heart Rhythm Society submitted letters to Novitas restating their support for the RUC recommendations on pricing. And obviously in the process all that -- also validating the important of long-term ECG technology to their clinical practice. And that was a response from -- driven by multiple members in each of those societies reaching out to ACC and HRS to ask them to do that. So there is strong advocacy as there was in the RUC process from ACC and HRS and we're very appreciative of our customers and those societies in particular for helping advocate for this important technology.

[Kaila Krum:]

Great. No that's super helpful color. And then just a -- last one for me. I mean it's quite a few of your competitors at this point have either been acquired or they're expected to be acquired with deals closing by mid-year. So can you just speak to some of the opportunities and risk around the recent consolidation in this space? And just how you're thinking about the competitive environment evolving over the next 12 to 18 months? Thank you guys.

[Mike Coyle:]

Sure. Thanks Kaila. Well obviously it was a bit of a surprise to see our three biggest competitors or three most important competitors all being acquired in a fairly short period of time. And what was particularly interesting is the commentary by the acquirers all focusing on different reasons as to why they found the opportunity to be compelling. I think the one thing we take away from it is number one, it's a validation of the importance of the long-term ECG technologies as being a real sort of new standard relative to the very large Holter and event monitor shares that exist in the U.S. Also several of those acquirers indicated an interest in really helping to drive the adoption internationally. And that, I think can only be helpful to a company like iRhythm with limited presences if we have much larger players advocating for why the Holter and event monitor market should be replaced with these much more diagnostically effective approaches to identifying arrhythimas it can only be helpful to us. And then obviously the -- I mean that's true in the U.S. as well. And then I think the other thing it does for us is by having more larger voices speaking to the fact that this conversion should take place more rapidly. The fact that we have a very clear lead and I would almost call it a multiyear lead, in terms of all the aspects of our innovation stack, I think it's going to be very helpful to us. Now I don't underestimate the fact that some of these acquirers have large footprint presence in things like the primary care market or with physicians – probably the physicians in the electrophysiology area. But I think the differentiation of our offering is such that I think we're going to really benefit from just having much more let's say time and attention being paid from a promotional standpoint to the space.

[Kaila Krum:]

Great. Thank you.

[Operator:]

Thank you. Our next question comes from Marie Thibault with BTIG. You may proceed with your question.

[Marie Thibault:]

Hi, thank you for taking the question this evening. I wanted to ask just one on the claims side a little bit in the nitty-gritty in the weeds here, but I wanted to see if I could get a sense of how likely it is that Novitas would be willing to make this retroactive if you have any insight into their past experience there? And then one for Doug, what is the latest that iRhythm is able to close their books for Q1? I know that's very detailed.

[Mike Coyle:]

Doug, you want to take the second one and then I'll…

[Doug Devine:]

It's -- I mean, you'd have to back up about two weeks from the Q filing.

[Marie Thibault:]

Okay. Okay.

[Mike Coyle:]

And then on the question relative to Novitas in terms of -- I'm sorry, could you just repeat the?

[Marie Thibault:]

Yes. The possibility of new pricing being retroactive. Do they do that typically, or would that be unconventional? Any insight into that?

[Mike Coyle:]

Sure. It's our understanding that they have full flexibility to implement pricing changes into their schedules at any point and make it retroactive if they choose to do so. And it's been clear in our interactions with Novitas. What they're interested in is making sure that Medicare patients get served with the right technology at a fair price to the Medicare system. So to the extent they think that they've arrived at a fair price, it would not be outside of what they have indicated to us to make it sort of appropriate for the time period. But I have to stress that that's completely at their discretion. And while they have the capacity to do that, we have no way of knowing now whether they would choose to do that when they arrive at final pricing.

[Marie Thibault:]

Okay. That's very helpful and understood. And then one on the business here. I was pleased to hear that December, you were less impacted than some other businesses. And I know you cited home enrollment is one of the reasons for that. Any other drivers of volume growth at sequential volume growth despite the COVID headwinds?

[Mike Coyle:]

Well, of course, that is a continuation of a trend that we've had in terms of sort of an improving situation around new account openings. I think we mentioned that we were very encouraged by the fact that we now had new account openings back to pre COVID levels. After some pretty significant declines in new -- or a lack of opening of new accounts in Q2 and then Q3. So, obviously that momentum is helping us. And, of course, that this is a pipeline business. So as we're able to open those new accounts it pays dividends to us out two, three and four quarters down the road. But I think the primary opportunity here is that there is just a lot of customer enthusiasm for the benefits the clinical and economic benefits of long-term ECG versus Holter monitoring. And that's just a continuation of the trend that got a little interrupted for COVID for a very short period of time, but just continues to now drive adoption of the technology where we remain less than 20% penetrated into the market.

[Marie Thibault:]

All right. Thank you.

[Operator:]

Thank you. Your next question comes from Bill Plovanic with Canaccord. You may proceed with your question.

[Bill Plovanic:]

Great. Thanks. good evening and thanks for taking my questions. First is just to level set us. I just want to be clear that Novitas pricing CMS is about 25% your business. And then secondly on the level one CPT code that impacts the other contracts because they need to be renegotiated, because you have the new level -- one level CPT code. So all your other commercial contracts and other types of contracts. Is that -- am I -- is that level set? Am I correct in those statements?

[Mike Coyle:]

That is correct. Roughly 25% of our business is in Medicare. And that is what the Novitas discussion is about. On the CPT one code conversion all of our direct bill private customers so private payers have to reset their contracts, because now this new code exists and is what is being built under. So each one of them has to essentially adopt a new contract with us that recognizes those codes or how we're going to be doing the billing.

[Bill Plovanic:]

And then just I want to make sure I understood the statement of -- in terms of the billing and using 12-month averages that's offset by a quarter. So if you haven't gotten the final payment rate from Novitas by the end of the quarter, you would use the 2020 average payment rate for all your contracts including CMS for the first quarter? Is that accurate, or would you use the new lower rate if you didn't get it by the time you need to close the books to close the first quarter? And I understand that you don't -- you wouldn't send the invoices out because you book revenues when you post the reports?

[Mike Coyle:]

So let me ask Doug to take that.

[Doug Devine:]

Sorry, there was a little bit of a mixing of apples and oranges there. There's two different components here. I mean, so the first is we invoice our payers at an agreed-upon rate.

[Mike Coyle:]

Yes.

[Doug Devine:]

For various reasons, which are all grouped together as contractual allowances. Our payers either adjudicate to a lower amount or in some cases they will deny the claim for more information, for medical necessity et cetera. And so as I was talking about the impacts of the delayed claims on revenue recognition, it's on that latter part of what percentage -- what percentage of our revenue basically is taken away from these contractual allowances. And if we don't submit the claims -- if we're very delayed in submitting the claims then obviously there's the initial amount that is adjudicated on the first submission of the claims and then in a substantial number of our cases, we resubmit with more information to address the payers' concern. But the issue with contractual allowances and the delayed claims is that you're not going to -- if you submit the claim a month -- I mean a quarter late because of these various issues you don't have time to work those contractual allowances issues. And so we could be facing temporarily until we get caught up on claims a significantly larger contractual allowance percentage than has been our historical average. So that's -- so separate the two from when we can invoice and the impact to contractual allowances. The percentage of our revenue -- commercial revenue that contractual allowances reduce that revenue by.

[Bill Plovanic:]

I understand. I guess the simple thing I'm trying to ask I'm sorry if I'm not understanding it is, when you for Q1, if you don't have the final Novitas number would you book revenue under the assumption that it's the lower number for Q1 for in terms of just closing the books? Is that how you'd move forward and then you -- when you do finally kind of collect it or it all gets fixed you would just adjust it in the future? I'm just trying to understand -- trying to figure out Q1 is what I'm just trying to figure out?

[Doug Devine:]

So we switched from a category three code to a category one code January 1. We cannot under any circumstances continue to build Novitas for the category three code. That one is no longer in service. So as we talked about before, if Novitas -- Novitas has published an official price. So that price is what we would have to recognize revenue at unless they publish a new price as we are certainly hoping they will. And then when they publish the new price, if they make it retroactive to January 1 or some other date then we would be able to use that new price to recognize revenue. And then even if the quarter has ended, we would be able to go back and do the catch-up transaction in the second quarter in that case. But in the absence of a new -- as I said in my prepared comments, in the absence of a new price there is an official Novitas price for the new category one code. And that is the price we would have to use in the absence of a new price -- that price being updated.

[Bill Plovanic:]

Great. And then does -- in terms of the discussions and I don't know if you can answer this or expand on this. But is there a discussion with less than seven days versus greater than seven days of re-separating that out? And then lastly just with the SCREEN AF published, does that have any impact on the payer discussions? And that's all I have. Thank you.

[Mike Coyle:]

Yes. So on the question of SCREEN AF that is new data on the asymptomatic AF opportunity. So it's not particularly relevant to the payer discussions other than the fact that clearly linking to the mSToPS data, we're able to show clinical outcome benefits associated with long-term ECG that simply aren't available from the Holter technologies. And then I'm sorry, could you just repeat the first question you had?

[Bill Plovanic:]

In the discussions with Novitas, they basically gave one rate for less than seven days and greater than seven days. In terms of the discussions, do you think that that -- as you go through this are they looking at under seven days and greater seven days, or is it looked at one bucket? Any color would be helpful. Thanks.

[Mike Coyle:]

So certainly, there are two codes that have to be assigned a rate, right? So, we basically presented data during the discussion. That showed higher resource intensity associated with the longer-term -- the longer-term code, right? So you have essentially more than twice the level of data that you're having to adjudicate. It's much more complex with the longer runs of data. And so the oversight of the certified cardiac technologies is actually greater in those longer codes. And so we highlighted the cost differential associated with just providing that service for the longer code. Now, whether that winds up resulting from -- in two different rates for those two different codes will be entirely up to Novitas, but it clearly was discussed in our meetings as two sort of distinct code requirements.

[Bill Plovanic:]

Thanks for taking my questions.

[Operator:]

Thank you. Your next question comes from Suraj Kalia with Oppenheimer. You may proceed with your question.

[Suraj Kalia:]

Good afternoon Mike, Doug. Can you hear me all right?

[Mike Coyle:]

Yes we can. Thank you, Suraj.

[Suraj Kalia:]

Perfect. So Mike -- Doug forgive me for belaboring this. It's been a -- quite a confusing set of commentaries. So I'm just trying to get my head wrapped around. So Mike, let's do it this way. Just piggybacking on what Bill's question was. If we don't have updated rates from Novitas by April let's say, is it safe to say, we are headed towards the CMS proposal then? It's essentially too late and there is a chance now we are headed into that CMS cycle. Is that even a possibility?

[Mike Coyle:]

Well, I think it's fair to look at these two as two distinct work streams, right? Novitas is basically looking at the pricing of codes that are in their system and they have full autonomy to decide how they want to determine, what methodologies they want to use to determine, what the appropriate rates should be for those two new codes. And obviously, they've engaged with us as an industry consortium to discuss it in detail. So that's a work stream we would expect they are going to pursue and then decide what the answer is whether they leave the code where it is, whether they accept the recommendations of the RUC process or whether they arrive at a different methodology for arriving at their rates. That seems to be a distinct work stream. The second obviously is the CMS work stream around the potential for a national price to these codes. And that's a process that is really now entering into a meaningful comment period in March, where we will avail ourselves of the opportunity to provide additional data and methodologies for being able to revisit the question of whether a national price can be established. And we will do that independent of the Novitas activities. Now whether there's interaction between those two things after Novitas rate has been set, I don't know, but we are certainly pursuing them as two very distinct work streams.

[Suraj Kalia:]

Got it. Mike, you mentioned about a consortium you met with Novitas I believe a couple of weeks ago. Forgive me, if I got that wrong. The fundamental question I think so all of us are trying to figure out, were any invoices provided by any of the participants in this -- in these meetings? That seems to be sort of the hiccup in this whole process that could yield tangible results pretty quickly. I'd love to get your comments on that?

[Mike Coyle:]

Sure. I think one of the benefits of having the four largest producers of the -- or suppliers of the service available. And the four companies, who are involved in these discussions, represent about 97% of the billing under the old temporary code, with iRhythm frankly representing about 85% of that. But all of the major players who actually provide the service as called out for the code were there. And all of us were able to identify the key components of being able to successfully deliver that service as inclusive of a patch technology that can reliably provide 14-day data with high patient compliance and is labeled as such by the FDA. That when you start to talk about that length of a period of time for collecting, what is essentially 1.5 million cardiac cycles that then have to be analyzed. Doing that in the manual process or with a base Holter-like software approach simply doesn't work because of the complexity and massive amount of data that's being analyzed. So having an advanced analytic platform and in our case driven by AI and machine learned algorithms is critical to being able to have an efficient identification in a sensitive way of where there could be potentially risk -- high-risk rhythms in that 14 days of code. You may only be looking for five or eight minutes of time over that entire period. And being able to find it with high sensitivity requires these advanced analytics. And then once those areas of potential risk or of concerned parts of the electrogram you need a team of highly trained individuals who could then look at those data. And make conclusions about in our case 13 different potential arrhythmias that could exist versus what you would typically see with a Holter, which is about four. So the idea of a patch being identified at some cost point. That is in part of a fully-integrated system. It isn't going to get you the fundamental report that is what becomes useful for the physician enable -- in determining whether there is actionable rhythms there and what that action should be. And obviously that's where the fully-integrated long-term ECG technology comes in. And all of the players in the space would point to the fact that having these fully integrated systems is what's important to be able to get the outcome that the code is looking for.

[Suraj Kalia:]

Got it. Doug, one final question and hop back in queue. Again please forgive me. Just trying to get my arms around all the commentary. So there are a, sort of, percent of direct commercial contracts that are indexed to Medicare and you all are holding back claims on that also. Did I get that right, or no?

[Leigh Salvo:]

I think you muted that.

[Doug Devine:]

Too much technology. So I mean, first there's two reasons that we're holding back claims. I mean, one is that the contract is in negotiation. And the other one is that at least hasn't been signed. I mean there's cases where we're in verbal agreement, but haven't inked the agreement. But then after that the payer IT has to implement this payer IT's are -- that's not a that's not a matter of days. That's often a matter of weeks even months for payer IT departments to implement the new contract. And then we go through a testing process because we, of course, will send through like a half a dozen claims and make sure they adjudicate properly before -- if we've got thousands of claims rather than risk there being a glitch. So it's roughly evenly split between the two of those of places where we're in agreement, but we're still going through that administrative and IT portion and places where we're holding the claims because we haven't reached an agreement yet although Novitas being the larger fraction of that.

[Suraj Kalia:]

Doug, would this approach be more -- I mean it comes across as a negotiating tool in terms of holding back claims right? The reverse would also be true. Let's say, I agree on your $43 price target right to file a claim today. I get a certain revenue level fine. I fundamentally don't like the dollar amount, but then when I argued on the same premise that what you all are doing today but then let's say whatever time frame it gets reset then you can come back and do it retroactively also. Am I right in thinking the reason -- and rightfully so should be -- if I accept the price right now my negotiating leverage in essence it gets weakened? Thank you for taking my question.

[Doug Devine:]

Let me say, that there's -- that's not an angle here. This is purely administrative that if they change the price, I mean, even if we -- I could go ahead and submit all the claims at the current price. And if they change the price and make it retroactive to Jan 1, I will be able to resubmit the claims at the new higher price and collect the differential. So I'm not losing or gaining anything by holding other than the fact that it's administratively much more time-consuming and resource consuming to submit the claim twice versus once.

[Mike Coyle:]

And the one thing I would just point out is that what's going on here is a good faith negotiation between Novitas and the industry around what the appropriate level these payments should be for these new codes. I mean there's nothing else going on and we're very focused on respecting the process that Novitas has. And providing them all the information they need to be able to make the decision as timely a fashion as we can all have it. So that's really all that's going on.

[Suraj Kalia:]

Thank you.

[Operator:]

Thank you. I would now like to turn the call back over to Mike Coyle for any further remarks.

[Mike Coyle:]

Thank you all very much. Obviously, very exciting for me for my first earnings call to be with you all and we appreciate all the time and attention you focused on the company and we look forward to our future communications that will be coming up in future months. So thank you all very much.

[Operator:]

Thank you. Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.