CMMI Program Delays and Suspensions—Recommended Next Steps

The week of March 1st, the Center for Medicare and Medicaid Innovation (CMMI) officially delayed and suspended three of its programs, two of which, the Kidney Care Choices model and Seriously Ill Populations (SIP) track of the Primary Care First model, were set to begin on April 1. The Geographic Direct Contracting model has been indefinitely suspended, and CMMI made changes to the terms of the Direct Contracting model. In this Ropes & Gray podcast, health care partner, Christina Bergeron, and health care counsel, Sarah Blumenthal, discuss these actions, their implications and recommended next steps for providers, groups, and others participating, or interested in participating, in these programs.

Transcript:

Sarah Blumenthal: Hi Christina. I'm so glad we're doing this together. Christina and I both work with many clients that participate in the Center for Medicare and Medicaid Innovation, otherwise known as CMMI, value-based programs. As such, we thought it would be helpful to discuss the recent delays in a few of the CMMI programs and the legal implications related thereto. More specifically, as many of you may be aware, the week of March 1st, CMMI announced the delay and suspension of three CMMI programs, two of which were set to start on April 1st. Christina, can you give us some details on these programs? 

Christina Bergeron: Yes, absolutely. So, the first one to talk about is the KCC program, otherwise known as the Kidney Care Choices program. This program has been delayed from a start date of April 1st until January 1, 2022. Importantly, CMS also announced last week that it will not open another round of applications for this program until 2022 for a 2023 start date. Sarah, do you want to walk us through the other one? 

Sarah Blumenthal: Sure. Thanks, Christina. CMMI has suspended the Seriously Ill Population (the SIP) track of the Primary Care First Model. Physician practices began participating in Primary Care First as of January 1st, but SIP practices that were set to begin on April 1st have been suspended. CMMI has not even notified those applicants whether they've been accepted into the program. CMMI has said it is currently reviewing the structure of the SIP program. Christina, can you tell us about the last action of CMMI? 

Christina Bergeron: Yes, this one is unsurprising. CMMI paused or suspended the Geographic Direct Contracting Model, otherwise known as “Geo.” This program had gotten a lot of pushback from provider groups and other industry stakeholders, and so we’re not really surprised to see it suspended. This was a variation of the DCE model that required providers to take 100% of the risk on attributed beneficiaries within a particular geographic region. The pushback focused on the lack of details related to a program of that size, and concern that without more specificity, the program would not be successful. The good news is that there have been no changes for the start date for the professional and global DCE models—those are still set to begin on April 1st, which is exciting. However, importantly, CMS had previously informally indicated that there would be a second round of applications for new entrants into that program this spring and there hasn’t been an update on when those applications will be available yet. So, we’ll keep an eye out to see if they’ll still be available this spring or if they’ll be pushed out, and that would be for applicants applying for performance year 2022. So, with that background, Sarah, why now—do we think the administration wants these programs to continue, or what's with all the suspensions?

Sarah Blumenthal: Yes, that's a good question, Christina. CMMI's announcements come on the heels of the official appointment of Liz Fowler as the Director of CMMI. Fowler is a veteran health policy leader. She helped craft the ACA when she was on the staff of Senator Max Baucus. She's worked in and out of government for years. We do think the Biden administration is supportive of these programs and we think she is supportive in particular. Given her experience and what we know of her, I think she's really going to evaluate the success of prior programs in terms of savings and outcomes to come. She's particularly focused on accountability and transparency, and what tools does the government have to measure and evaluate the success of these programs. So, to be seen what, if any, modifications there will be. At least for many of these programs, we do anticipate they will go forward, although potentially in a slightly modified context. 

Christina Bergeron: Yes, that makes a ton of sense. I know that from other CMS announcements that it's been hard to track outcomes and success for all of the programs, so it'll be interesting to see what comes with that renewed focus. So, what are the implications of these delays? That's really the key of what we wanted to talk through today and we're going to do it program by program. So, starting with the KCC program, one of the big things here that's helpful is that CMMI will allow existing or otherwise approved KCE’s to add additional KCE participants in May. So, for those still looking for nephrologists or health systems to partner with their program, you have more time if you have an approved KCE for a certain market, which is huge. And also, for those providers that have already signed participation agreements, we do recommend reviewing those agreements to ensure that they're subject to changes in CMS programming—you want to make sure they account for this date change. And we work on drafting those agreements, Sarah and I, and others at Ropes, and we're happy to help interpret those provisions or answer any questions folks may have about any implications to those programs given the delay. Sarah, anything else we should be thinking about as it relates to the KCC program?

Sarah Blumenthal: Yes, a couple additional points here. One, critically, CMS has officially extended the fraud and abuse waivers that were issued back in October when the implementation period began. Those were set to expire on April 1st, but they've now been extended through the beginning of the new performance period, January 1, 2022. So, this means that any KCE’s and KCE participants that were operating under these waivers can continue to do so in this interim period. I know many of our clients have been waiting to see what the performance period waivers will be—those may be program-specific or they may flow from the CMS model sponsored value-based safe harbor that came out back last fall, so that's still an open question for many of our clients and many KCE's. Another important collateral point is that nephrology groups who had been participating in the Comprehensive ESRD Care Model, also known as ESCO, on a risk-based structure may now be left in this interim period without a risk-based arrangement. These risk-based arrangements qualify as Alternative Payment Models under MIPS and may change their reporting obligations. Some of these groups may be required to do mixed reporting and they may or may not be prepared for it. If groups or other nephrologists have questions about this and the legal implications, it's also an area where we advise our clients. KCE's and KCE participants may also be interested in aligning with other value-based networks in the interim period. Maybe this is an opportunity to get your feet wet—you’ve already come together as a network; you have a structure, an operation that works. Aligning informally, or even formally, as a preferred provider with other value-based networks won't preclude your later participation in the KCE. Christina, there's more information with respect to the DCE program and other considerations that KCE participants may have? 

Christina Bergeron: Yes, that's true, Sarah. So, as of last week, for the DCE programs, CMS came out with a revised participation agreement, and it really had some material changes to some of the terms of that program. And so, with respect to the KCC program, we would expect probably a similar update. So, we are keeping our eyes open for any kind of updated participation agreement probably to come out in the fall, I would guess. And it will be critical to run a red line and understand what the differences are and make sure that you can implement those differences as it relates to things like quality reporting, financial guarantees, etc. by the January 1, 2022 start date. I think the good news overall here for this program is that I don't think it'll be pushed out again given the fact that the date is set, as opposed to suspended like some of the other programs that we've seen. So, I think it's a good chance it'll kick off January 1. And it just gives folks more time to plan and implement structural and operational changes, especially some of the IT changes that organizations have to make to be ready for these programs and, if interested, grow your current KCE participation provider base. Switching gears to other programs, how will this impact those that are planning on participating in the SIP program? 

Sarah Blumenthal: Good question. I think, for the SIP program, it's been suspended and CMS has said it's under review. We do have reason to believe though that we don't think this program is on ice—we do think that some version of this program will come out. So, maybe that means slowing down work on your work plan, but continuing to slowly operationalize given that we are fairly confident that there will be some type of program. Make sure your SIP entity is formed; it's enrolled in Medicare. Understand who your providers are going to be and what kind of IT infrastructure is needed so that when we do get the green light, you can hit the ground running. Given the structure of the SIP program and the fact that the SIP model did anticipate commercial payer and commercial contracting, this is also an opportunity to jumpstart that work with commercial payers. No timeline there, and we know many commercial payers are interested in establishing similar types of programs. Christina, what about the DCE program? You've given us a fair amount of information on the Geo program, as well as the DCE program that set to go forward. What should providers that are or want to participate in that program be doing these days? 

Christina Bergeron: Yes, so it's a good call out. So, with respect to the DCE program that is kicking off on 4/1, it's business as usual with the caveat that there are new participating provider agreements that came out last week, as I noted, with changes to things like the financial reserve requirements as well as quality reporting and other material changes. Based on experience with some of our clients, I think folks are really hitting the ground running to make sure they understand those changes, are listening to the office hours that will be coming up this month to make sure that they have what they need on 4/1 to be successful in this program. If any folks have any questions about those changes, Sarah and I are available, as well as others on our team, to help answer those questions or interpret some of the new provisions in those agreements. Otherwise, I would say keep alert for delays potentially in new applications that are supposed to come out this spring. If you're not yet approved, but hoping to apply to participate in future years, continue to have discussions with providers that you would want to be part of your network so you're not scrambling when you do get the green light for your application. But just know that new applications may be delayed—it’s to be determined, really—we hope they come out this spring, but it's something we're keeping our eye on given the change in administration and some of these changes we're already seeing as of last week. So, Sarah, to turn back to you again, what do you think makes sense for those who were going to participate in these programs, but can either no longer apply or have some other options that have been closed out? Is there a silver lining here that we're seeing with some of our clients or that we're thinking could be beneficial to some of those who were preparing to participate? 

Sarah Blumenthal: Well, as I said with the SIP program, I do think a lot of work has happened already—infrastructure has been built, new organizations established, new provider entities created, enrolled in Medicare; care protocols have been developed; data linkages have been established, really big networks of groups have come together to try to operationalize these programs. You've got a network already out there ready and available, and I do think this is very attractive for commercial payer opportunities advancing beyond Medicare. These models are built off of predecessor models, and when I say “these models,” I'm referring to CMMI's models. They're all built off of CMMI models and other Medicare models where there is proof of concept already, so payers may not be squeamish to dive in to providers now. I also think that the value-based care safe harbors to the Anti-Kickback Statute and the exceptions to the Stark Law lay the groundwork for compensation models and organizational structures that promote and enhance performance. I think many of our existing clients are already going down the route of establishing what are called VBE's. This is an opportunity now to shift gears or expand your business opportunities and we're glad to think through what kinds of structures fit within the new rules in the context of these programs and their delays. Christina, I'd say just as we wrap up, there are a few key takeaways to highlight:

• We do think that Fowler, CMMI, the new administration, they're really champions of these programs. We've already seen, in the most recent stimulus bill, the Biden administration looking to enhance and strengthen aspects of the Affordable Care Act. I think we'll keep seeing that.
• I do think that these programs will be evaluated critically going forward, which is frankly why we think that they were suspended. There are more details for CMS and CMMI to think through and work out, and we expect that Fowler and her colleagues will be thoughtful and critical as they review these programs.
• As we discussed today, there are steps that providers can take in the interim so that you can be prepared as these changes roll out and, when new information comes to light, you’re ready, quick on your feet to get up and running, and respond to any of these changes. And we, of course, are keeping our eye on what CMMI is doing and what the new contract terms and program terms will be. Christina, anything else you could add there? 

Christina Bergeron: Yes, I think it's all good points. And I think, importantly, the bottom line is that, Sarah, you and I both know from our current client base that value-based health care is the way of the future. We are seeing a lot of health plans, health systems, hospitals, insurers be very interested in not only the government CMMI programs, but also, to your point, mirroring similar programs on the commercial side. We have a lot of experience with helping folks through that and think through the legal implications, both on the Stark and AKS side, and data privacy side, and other risk-bearing organization implications and things of that nature—definitely a lot of opportunity here. Well, that brings us to the end of the podcast. Thank you so much for tuning in. Sarah and I want to thank you all for joining us. And for information on these topics and others particular to the health care community, please visit our website at www.ropesgray.com. Of course, we can help you navigate any of these areas—please do not hesitate to get in touch. Both my and Sarah's emails are on our profiles on the Ropes & Gray website. You can also subscribe and listen to this series wherever you regularly listen to podcasts, including on Apple and Spotify. Thanks again for your time and listening to our podcast.