Episode #6: One Way Digital Health Companies Can Influence National Healthcare
Because we work with hundreds of digital health companies, we’re deep into this topic every day and know what an impact even minor changes can make to a company’s bottom line. So make sure you do your homework!
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In this episode you’ll discover:
What the MPFS is, and why this annual Proposed Rule is so important for digital health companies (plus a little history on CPT code 99091 and how it launched RPM reimbursement);
Why the agency in charge of these reimbursement rules (CMS) doesn’t always get it right;
How ‘Notice and Comment Rulemaking’ helps stakeholders influence regulations;
What to do when Congress doesn’t get it right;
Why you should pencil this time period into your calendar every year to examine the Proposed Rule to advocate on behalf of your company and industry.
Keep scrolling for a transcript of this episode.
Read the transcript:
Rebecca Gwilt (00:00):
It's a big deal, and I don't think that it's leveraged enough by healthcare innovators. This totally accessible and high impact process for influencing public policy is a black box for lots of innovators. And if you know me, I love shining lights into black boxes. So Kaitlyn, are you ready to get into it?
Announcer (00:20):
You're listening to Decoding Healthcare Innovation with Carrie Nixon and Rebecca Gwilt, A podcast for novel and destructive healthcare business leaders seeking to transform how we receive and experience healthcare.
Rebecca Gwilt (00:32):
Hello everyone, and welcome to the latest episode of Decoding Healthcare Innovation. Before we jump in, I just want to say that I was just informed this podcast is now ranked number two in the Apple Healthcare Business News podcast rankings, and I am completely blown away on behalf of Carrie. And I just want to say thank you to you guys who are listening and gals, and please do help letting us do, keep letting us know what topics or people or conversations that you'd like us to cover. We are flying this plane while we're building it, so there is definitely room for input.
Kaitlyn O'Connor (01:10):
Yes, very exciting. And now I'm very excited to be here and help us while we fly it.
Rebecca Gwilt (01:17):
Right. Help me. So today I'm joined by Kaitlyn O'Connor. Kaitlyn is senior counsel at Nixon Gwilt Law. She leads NGL'S remote patient monitoring team, which is kind of a misnomer because she does a lot more than that and I think she's one of the best healthcare innovation lawyers in the country. I'm so excited to have her here today. I invited her to the podcast to speak a bit about the work she does with her clients to influence healthcare policy on behalf of her clients. And no, she is not a lobbyist. In this episode today we'll be talking about how healthcare innovators can influence federal healthcare policy without a budget for lobbyists and public relations professionals. Though those don't hurt, if you can afford them, I would hire them. So Kaitlyn, welcome to the podcast.
Kaitlyn O'Connor (02:05):
Thank you. Thank you. I'm super excited to be here. I do just want to also give an extra kudos to you and Carrie for building this thing. I have been on podcasts before and I used to have one, and it's not super easy to climb up the charts as quickly as you all have, so it's really, really impressive and I'm super excited to be here and talk about this. This is one of my favorite topics.
Rebecca Gwilt (02:28):
Awesome, awesome. So Kaitlyn and I, this is our third time on camera today, we just finished recording a presentation for healthcare industry innovators on remote patient monitoring RPM Remote Therapeutic monitoring, RTM, chronic care management, CCM transitional care management, TCM, principal care management, PCM Virtual Care, and Plain Old Telehealth. We do similar presentations every year after CMS, which is another acronym that's the Centers for Medicare Medicaid Innovation Releases. Its proposed physician fee schedule. This fee schedule is a list of codes that healthcare providers bill to Medicare each code's corresponding to a different service or product. And CMS is required by law to listen to what you think about it. This is quite relevant to healthcare innovation companies, digital health companies, companies who are in the spaces with all the word soup. The letter soup I just went over. It has a tremendous impact.
(03:32):
A recent example being the creation of what is now an over 40 billion industry in remote patient monitoring, which is cropped up in the space of the last couple years. We've said a little bit about that on our podcast already. It sprung out of a single CMS billing code that was introduced in this fee schedule which is 99091 proposed in 2018. So just an example of the impact that this fee schedule can have. Each year CMS has expanded reimbursement for RPM and other remote healthcare services, and that is fueling massive success for the biggest players like Livongo and Validic and down to the smaller players. Given this year's proposed rule, the nation's largest telehealth companies, your teladocs and your doctor on demands are almost certainly right now scrambling to support a potential expansion in remote physician supervision. If you want more detail about that, you can check out our blog or our pod podcasts will put some links in the show notes. But I wanted to point out that smaller, newer, early stage players have the same opportunity to be heard through what is called a notice and comment process at CMS. It's a big deal, and I don't think that it's leveraged enough by healthcare innovators. This totally accessible and high impact process for influencing public policy is a black box for lots of innovators. And if you know me, I love shining lights into black boxes. So Kaitlyn, are you ready to get into it?
Kaitlyn O'Connor (05:06):
Yes, I am very ready. Totally agree that it's not leveraged enough, and I'm really excited to share how important this can be because I think we've seen every single year CMS get more and more comments from the public. And I think that as we talk about it more, hopefully they will get even more and everybody will start to use this to their advantage in ways that make sense for both patients and for industry.
Rebecca Gwilt (05:29):
So I want to start with one thing that might be surprising to folks, probably not surprising to the insiders like us and that is that CMS does not always get things right in this fee schedule. And one of the reasons why I wanted Kaitlyn to join today is that she's got a great track record of identifying when that happens and really honing in on how it could negatively impact the ability for healthcare innovation companies to grow. Kaitlyn, I thought that maybe you could give us an example. I have one in mind I think that you'll use, but one example of when CMS put out this fee schedule with the best of intentions believing that these innovations will move the needle on cost and quality and then it sort of falls flat.
Kaitlyn O'Connor (06:18):
Yeah, I think that there are definitely some examples of this. I think that you're absolutely right. I think that when they do get things wrong, which does happen, it's not because they aren't trying to do the right thing. I do think that CMS always has the best intentions behind this. And one really great example of this is 99091, which is the code you just mentioned a few minutes ago. And I want to also point out that I think it's hard for an agency like CMS that doesn't have a ton of opportunity to actually experience how things are happening in real life to draft rules that are practical. The people at CMS that are drafting this rules are not in the doctor's office. They're not in a telemedicine visit or seeing how patients are always benefiting from RPM or something like that. And I think that's why these comments are so important because it gives CMS an A look into how things are happening practically.
(07:11):
So one of the examples where I think they got it wrong initially, like I said, was with 99091, if you're familiar with RPM or you've been in the space for long enough, you will probably remember that when R P M first came about back in 2018 under 99091, one of the biggest limitations or barriers that CMS I think probably accidentally created was the limitation that only providers and qualified healthcare practitioners that were actually billing the codes could count their time that they spend reviewing data as it came in. So just to back up really quickly and talk about rpm, I know you guys have talked about it on the podcast quite a bit, but RPM is literally remote transmission of data from a patient in one location to a doctor in another location. And doctors, as most of us probably know, don't have a ton of time in their day to review all of that data.
(08:08):
99091 required, required 30 minutes of time in a one month period, or it was actually in a 30 day period, but 30 minutes is a lot for one patient. It might not be a huge lift for a doctor to spend 30 minutes with them or reviewing their data in a month, but if you expand that out to 10 patients or 50 patients or a hundred patients or thousands of patients like we are seeing be put on RPM now, there's just no way for doctors to meet that threshold or to put that amount of time into patients. It doesn't mean that time shouldn't be spent, but it does mean that doctors aren't always going to be the ones in the best position to spend that time. So that limitation, I think created a barrier to adoption of RPM back when we only had 99091, and I'm sure we'll talk about in a minute some of the solutions that CMS created, but I do think that's probably the best example in the RPM space of how CMS probably got it wrong initially and ended up fixing it later on.
Rebecca Gwilt (09:09):
Yeah, and I think here also, nobody wants to mention it, but economics play a big role here. The kinds of work, as Kaitlyn said, that go into remote patient monitoring are super important for the quality of the service, but a physician's time is build out at a much higher rate than the services here would've equated to. And so if CMS wants to really incentivize things, if CMS is all in and thinks that if more time is spent on preventative care and monitoring the savings and the long term and the quality of care for the patients will be better, then they've got to create financial incentives for them to do that. And they just didn't in 99091. And I think it was because as Kaitlyn mentioned, they're not on the ground, they're not in the doctor's offices don't, they're not talking with practice managers who are evaluating for their physicians whether a new service is going to be worth it for them.
(10:11):
Doctors are already overburdened as it is. We know. And so what we saw was there wasn't a lot of uptake on this. Luckily, when CMS doesn't get it right, there's a process, and this is called notice and comment. And if you haven't taken administrative law like Kaitlyn and I will distill it down for you so that you have to spend a semester in it like we did you pick up this notice and comment process right at the tail end of the little jingle. When a bill becomes a law, right? Laws are passed by Congress. Those laws give executive agencies like CMS, the authority to promulgate rules that implement those laws. CMS the agency that we're talking about can't exceed the authority given by Congress. They have an interpreted role. So legislation is often broad and not descriptive enough to tell us sort of exactly how to implement it.
(11:05):
That's the job of these executive agencies. So that's what they do. They write law, they write regulations. I was at CMS in my early career, this is what I did. We put together regulations to implement the big law, which is the Affordable Care Act and then we entered into the notice and comment process before agencies like CMS can finalize these rules, these implementing rules. They've got to give the public a chance to disagree with them. They have to give notice. Then the public gets to give comment, get it notice, comment. Then they have to by law, read those comments, consider them and then finalize the policy. The agency gets to weigh all those comments. They get to get educated by the public about how they might have gotten it wrong. It's really a huge opportunity to be part of the policy making progress process that I think a lot of folks in the industry are not aware of.
Kaitlyn O'Connor (12:02):
Agreed. Also, I actually didn't take admin law. I should have, and I wish that I did. So if any future or current law students out there are interested in healthcare law, highly recommend taking admin law if you still have the opportunity. I've done a lot of learning over the past couple years on how this all works, but it actually is very exciting, and I totally agree that this opportunity to comment what the thing I always say to my clients is you get one time a year to speak directly to CMS about the Medicare physician fee schedule, and it's the one time of year that they're required to read you, read your comments and listen to you. So it's a huge opportunity. It's really, really valuable. We'll talk in a second about some examples of success that we've had in submitting these comments but totally agree. If you don't know about it, if you're not doing it, you should absolutely get into this game.
Rebecca Gwilt (12:51):
So now we know Kaitlyn cannot tell a lie. She could not let me advertise that she took,
Kaitlyn O'Connor (12:56):
I couldn't.
Rebecca Gwilt (12:58):
You can also receive great training at <laugh> Nixon Gwilt Law, student law. Yes. Okay. So I think what holds a lot of folks back, even if they know about the noticing comment process, I think what holds a lot of folks back is they think it's sort of shouting into the ether, right? CMS is huge. They're going to get tens of thousands of comments. They're not going to listen to us. Actually, we have seen some success in CMS modifying policy based on comments that are rooted in how it will be implemented on the ground, right? CMS is putting these laws together because they want them putting these codes out there because they want them to be used. If you come back and say, okay, we understand and appreciate what you're trying to do here. We believe in it too. Here's how this would look to us, and so we recommend you do X, Y, and Z. And I just wanted to Kaitlyn to share maybe one or two stories about some of the successes that she's had on behalf of her clients in really influencing federal policy.
Kaitlyn O'Connor (14:10):
Yeah, absolutely. Happy to share. I think that this is absolutely where the industry becomes really important. So just to give an example, right? Following up on 99091, we saw the barrier that was created when CMS limited reimbursement to time spent by physicians and qualified healthcare practitioners, or in other words, the billing practitioner because that was such a barrier. What everyone realized was these physicians and providers really need to be able to leverage their clinical staff. They've got to be able to leverage those LPNs that know what they're doing are super valuable, but have more time or are a little bit of a lower resource cost than a physician is going to be. So in 2019, yes, 2019, CMS introduced CPT codes, 99457, 99453, and 99454. That 99457 code was really, really important. And these are the codes that if you're in rpm, you've probably heard about them a bunch of times. You may or may not have them memorized like I do, but they were really exciting because 99457 said that clinical staff could now provide the services and they could count their time. So we had 99091 that said, physicians have to spend 30 minutes doing the monitoring. And then we had 99457 that said, clinical staff can spend 20 minutes a month doing monitoring, and that would still be reimbursable.
Rebecca Gwilt (15:39):
And I want to point out that the creation of those additional codes was a direct result of folks commenting in the prior year that they didn't think 99091 was going to be taken up, and in fact, the data bore that out. So just getting those additional codes was attributable to a lot of the comments that happened in 20, I want to say 2018.
Kaitlyn O'Connor (16:03):
Yes. Yeah. Yeah. So we had this new code. Everybody was really, really excited. We were like, great clinical staff can now provide these services. They can help out the physicians. A lot more patients are going to get RPN. Awesome. Unfortunately, in the proposed rule in 2019, CMS said they actually just made a mistake. The code itself said that clinical staff could provide services, but in the commentary, CMS said, no clinical staff can't provide remote monitoring services on behalf of physicians. It's only physicians and qualified healthcare providers. So on behalf of a bunch of our clients as well as the firm and a lot of other stakeholders we know that weren't working directly with us commented, we submitted these public comments to CMS and we said, Hey, you really got this wrong. This is a code that allows for clinical staff to provide the services, and you've got to correct that.
(16:59):
And so they, they came back and they actually issued what was called a technical correction after the final rule. So this is a little bit later but they issued a technical correction and they said, you're right. Clinical staff can provide these services. It's right there in the code and it was fixed. So that was one example where we all came together, stakeholders all came together and gave feedback to CMS, and they went ahead and changed their original position, which was incorrect. The second part that was really, really important, where we had a lot of success was the following year when everybody said to CMS, we really need not only for clinical staff to be able to provide services on behalf of physicians, but we need them to be able to do this on a remote basis. We need physicians in the same way.
(17:44):
If you're familiar with chronic care management CMS, we need physicians to be able to outsource a clinical staff team that can monitor this data that's not necessarily in the office with the physician all the time. They might be at home, they might be at a third party call center, they might be somewhere else, but they're remote from the physician. We need them to be able to spend the time monitoring this data so that there's someone looking at it and then escalate that data back to the physician. But it has to be done on a remote basis. And this is what's called general supervision. I'm not going to get too much into the weeds of the difference, the different types of supervision, but suffice it to say that initially general supervision was not allowed. They said that clinical staff had to be physically located in the office with the physician.
(18:30):
We said, that's not going to work. And so after a bunch of stakeholders came together and submitted those comments to CMS, they made the change and they said, you're right. We understand that clinical staff need to be remote from the physician. Therefore, we're going to change the supervision level for these services, and we're now going to allow for clinical staff to provide services remote from the physician, monitor the data in a separate location and escalate things to the physician when necessary. And that was hugely important because before that, a lot of our clients who are vendors to physicians, were getting a lot of feedback from their customers, those physicians saying, we really want to do this with a lot more of our patients, but we don't have the resources in our office. We don't have enough RNs even to monitor all of this data. We think so many of our patients could benefit, but we can't provide the service. We don't have the resources for it. Can you do this for us? And our clients weren't able to do it initially, but once we got this change, now our clients were able to build a clinical team and provide that as an additional service to their customers. So they were able to add that value. They were able to offer the service, and the physician now was able to offer RPM for a lot more patients that could benefit from it.
Rebecca Gwilt (19:47):
This is a very specific use case, but I think it illustrates how industry, the tech companies, healthcare innovator, tech companies who are working directly with clinicians who understand how these actually get implemented, these programs get implemented in practice, are absolutely necessary. Their input is absolutely necessary to teach CMS how this is actually working. So anyway, so this is why I say it's a huge opportunity. Now, the fee physician fee schedule is one of lots of regulations that get put out by CMS every year. If your industry may not industry may sell only to hospitals, in which case the physician fee schedule is less applicable. You might sell into post-acute or long-term care facilities where the reimbursement structure is very different. Your company may be impacted by different proposed rules, but the takeaway here is you should be paying attention. As Kaitlyn mentioned, this is your chance.
(20:56):
Usually big rules like this for whatever, whatever program come out about once a year, sometimes twice a year, and it is your chance to make your voice heard. It is your very individual, inexpensive way to make your voice heard. In Washington, what I will say is they don't work on a tally basis. So the more people that say this, they don't say, well, we got 10 votes for this and five votes for this, so we're going to go with the 10. CMS still gets to say, no, we don't agree with you. We hear what you're saying, but that's not what we're going to do. That's when documentation, evidence, studies and all of that become very important. Commenting and saying what you think based on what's best for your business is okay. Really what you should be talking about is what's best for beneficiaries, what's best for the goals of the agency, and that's when folks who do this on a regular basis like Kaitlyn can be helpful.
(22:01):
Before we close out, I just wanted to say one more thing which maybe even less surprising to folks than the fact that CMS doesn't always get it right. It's that Congress doesn't get it right all the time especially in big legislation, which gets pushed through very quickly and people aren't paying attention to the individual words used. It is very important for us to be advocating for smart legislation. Well, well-crafted legislation. One recent example is the CAA, which was passed in the fall of 2020 and was meant to provide greater access to Telemental health services. So, and then in the same bill restricted reimbursement for virtual mental health services to visits that come after an in-person service. So they handicap themselves just by sloppy drafting, frankly. And the agencies, as I mentioned before, cannot exceed the authority given to them by Congress.
(23:03):
And so in some cases, the agencies can do creative interpretive things, but they can't implement something that's not in line with the legislation. This is a little bit more difficult. It is hard to lobby swaths of the legislature and of course politics is involved, but I would call your local representatives, I would call the representatives that lead the committees that draft out the Senate Help Committee and the House Health Education Committee. I'm saying the wrong words now. I'll follow up with apologies in the show notes, but let them know how important it is to get this right and also join an association. These associations are meant to bring together industry folks. One great one is the Connected Health Initiative certainly ATA. Any others you can think of, Kaitlyn? Alliance for Connected Care.
Kaitlyn O'Connor (23:59):
Yeah. None off the top of my head.
Rebecca Gwilt (24:01):
Yeah, there's a ton of them. Depending on your industry what I would do is if it's not cost prohibitive, I would join one of these associations and then get really active. They're seeking input from members for what's important to those members. If there's something in a summary of a proposed rule that goes out to the members of your association, make sure that you're responding and saying, Hey, don't forget to put this in that letter because they all, in addition to submitting comments to CMS for these rulemakings, they actually will be actively lobbying members of Congress and visiting with folks in the agencies. So that's just another path that you can take to influence federal policy.
Kaitlyn O'Connor (24:45):
Yeah, agreed. And I think this is where we can also talk about telehealth a little bit. I don't want to dig into it too much because we've already been talking for a while, but this is also a really important way to make sure that Congress is not only passing new legislation, but also updating old leg legislation. If you're familiar with telehealth, there are some federal laws that put forth some pretty tight restrictions on telehealth under Medicare, that CMS can't change because it's in the federal laws. And so the way to change that is to get Congress to update these very old laws that have been in place for a long time that don't really make sense anymore based on the technology that we have. So that's just another reason why going to Congress, if you can, is really important to make sure that that old laws are being updated on an ongoing basis as technology is changing so that innovation is not restricted by these older laws that are in place.
Rebecca Gwilt (25:44):
Yeah, one of the big lessons I learned from starting my career in DC is that you should not assume the people who are writing the rules know what they're talking about not by Ill intention in most cases but your voice is quite important. And so even if you're an early stage company make your voice heard. This is an easy way to do it. Okay. So thank you so much, Kaitlyn, for joining me. Thank you all of you for listening. You can find the webinar we recorded earlier. If you're interested on the most physician fee schedule in the comments, reach out and let us know. If there's a topic you'd like us to cover, follow us on all the things, Facebook and Twitter and Instagram. You can see other episodes that we've put together on Apple Podcast, Spotify, YouTube, wherever else you stream, and we will see you for another episode in two weeks.
Kaitlyn O'Connor (26:36):
Thanks everybody.
Rebecca Gwilt (26:37):
Thanks.
Kaitlyn O'Connor (26:38):
Thanks for having me, Rebecca.
Rebecca Gwilt (26:40):
Of course.
Learn more from Carrie and Rebecca:
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Contact representatives and advocacy groups directly:
Connected Health Initiative (The App Association)