Gregg Wallander: Hello, this is Gregg Wallander with Hall Render and welcome. I’m here today with my colleagues, Joe Wolfe and Alyssa James, and we’re here today to speak about COVID-19.  And we’re also going to talk really about the Stark Anti-Kickback and CMPs, or civil monetary penalties laws and their effect on the physicians and the patients who are experiencing hardships during this time. Joe and Alyssa may also refer to me as Wally, so if you hear that, don’t be alarmed. There’s not a fourth person, it’s just the three of us today. And we’re going to talk about the OIG, CMS response to the issues of Stark and Anti-Kickback and CME in light of COVID-19. We’ve got physicians that are facing hardships due to volume issues in their own practice. We’ve got patients having issues with respect to being quarantined, not being able to get to seek care, and so we want to talk about what the government has done to ease some of the restrictions facing them in this time and this pandemic time right now.

So I’m going to ask Joe to kick it off and talk about some waivers that have been released by CMS, and their impact. Joe?

Joe Wolfe: Thanks, Gregg. To get right into it regarding the waivers, the government is referring to these waivers as the blanket Stark waivers. They were issued last Monday, so March 30th. And they provide us with some flexibility on Stark related to the COVID-19 response. The waivers can be relied on retroactively back to March 1st for Stark, and they can be relied on actually going forward until the termination of the COVID-19 public health emergency when that expires in the future. There is a parallel track for on AKS.  On April 3rd the OIG issued a policy statement saying it would not pursue Anti-Kickback enforcement on arrangements that are covered by these Stark waivers. That kickback waiver is designed only to be forward looking and so like Stark, the waivers will terminate at the end of the health emergency.

So I think practically speaking, if your waivered arrangements started on March 1st you would have Stark cover from day one, but then for kickback you’d have some potential kickback exposure until the OIG statement was issued on April 3rd. So that’s a way to think about how those two waivers concepts sync up for Stark and Anti-Kickback. Probably the most important thing for our listeners to remember is that even though these are called blanket waivers, they’re not just a free pass. I think if you want to rely on them, you need to do some analysis first. Do you have a bona fide COVID-19 purpose to your arrangement? Second, does it fit within one of the Stark waivers we’re going to be talking about today? I think third is whether you have documentation supporting the use of the waivers. And so I think later on in the podcast, Gregg, myself, and Alyssa are going to step through some examples of some of these concepts.

For the first part, the government identified six COVID-19 purposes in the waivers and I’m just going to go through them really quickly, so that they’re there on everyone’s mind. The first is diagnosis for medically necessary treatment of COVID-19 for patients or individuals, whether or not they actually have COVID-19. The second is for securing the services of physicians and healthcare providers in response to the COVID-19 outbreak. Third is ensuring the ability of healthcare providers to address patient and community needs through the COVID-19 outbreak, or expanding the capacity of healthcare providers to address patient and community needs during this outbreak.

Fifth, shifting the diagnosis and care of patients to appropriate alternative settings due to the outbreak and then sixth, a broad category addressing medical practice or business interruption due to the COVID-19 outbreak. And so, those are the six purposes the government has identified, I think as a threshold matter. You should make sure your arrangements fall under one or more of these purposes as part of looking at any arrangement. The second part of the big analysis, I think, is looking to which actual Stark waivers fit your arrangement. The government provided 18 waivers in their waiver document. We’ll be touching on some of those during this podcast.

At a very high level, some areas covered by the waivers includes physician services and that waiver coveres payments to a physician that are above or below fair market value for personally performed professional services. There’s a waiver for space rentals that covers equipment and space leases at rental amounts that are below FMV payments from physicians.  And there’s a more general waiver that covers payments received from a physician for the use of a healthcare organization’s, space, items or services for amounts below fair market value. And if you look at that one, the government gave an example of providing free telehealth equipment to physicians so they could provide care to quarantined patients.

Other examples include some flexibility on the medical staff benefit rules. There’s a waiver allowing hospitals to exceed Stark’s incidental benefits and nonmonetary compensation limits. Other waivers touching on providing credit to physicians and medical groups, physician owned hospitals, hospitals converted from being ASCs, group practices and home health. We’ll hit on some of those in the podcast. The government is also providing some more flexibility on the writing and signature requirements for arrangements that are entered into during the waiver period, and so that otherwise meet an exception.

I think the third part is your documentation. If you have a bona fide COVID-19 purpose and you fit within one of the Stark waivers, then you’re supposed to maintain documentation supporting the use of the waivers that must be made available to the government upon request. And so, and not only do we need to do the analysis, but also create the documentation we’re going to need for later on. That’s a high level overview of how the waivers work, how the purposes are set out and some general parameters, and then how the waivers/exceptions and the documentation fit together. Back to you Wally.

Gregg Wallander: Great. Thank you. Alyssa, you want to touch a little bit on what we’re seeing with health systems and their employment of physicians?

Alyssa James: Sure. Thanks, Wally. And thanks for that overview, Joe. That was great. We’ve received some questions from clients of course, who are still more in the preparation and planning phase that are wanting to evaluate what their options are if existing physicians, volumes and productivity drastically increases as they respond to a potential influx of patients in this pandemic response. More frequently though, I would say right now we’re getting questions from providers who fortunately have not yet had that influx of patients in their facilities and have physicians that are experiencing decreased volumes, which may affect their compensation.

And so many of these providers have been evaluating ways to make these physicians whole or close to it in order to maintain that continuity of care and to retain those physicians if needed for redeployment during the pandemic response, or also just to have for their usual patient care services once this pandemic period ends. One way to do this would be to enter into a written amendment potentially for any arrangement that the facility or provider may have with that physician or physician group, and perhaps look to historical production volumes or wRVU’s as a benchmark instead of utilizing the current metrics, which may not reflect the physician’s availability to provide services if the patients were there.

Gregg Wallander: It’s really interesting with respect to the unprecedented situation that we’re in with respect to hospital physician relationships and health systems really looking forward into the future and saying, we need a stable physician workforce. We need this group of specialties to take care of the community for emergencies, etc. And then overnight practically, some of these volumes dropped, they’re shutting down or needing redeployment. It’s such a unique time and it’s great that CMS and the OIG have recognized the unique situation we are in, and are allowing health systems to enter into arrangements to help out physicians who may be paid on productivity, paid on those kinds of  formulas. It’s just a reasonable thing to do during the situation, for sure.

I’d like to transition a little bit into space and equipment rentals, which is another waiver that Joe, in his good overview mentioned, we’re getting a lot of questions with respect to health systems that lease space to physicians. And in light of the pandemic, the real hardship going on with respect to practices and again, what is a health system to do? Before the waiver, we were advising health system landlords to look at the commercial market, what’s going on with, for example, mall owners, what’s going on in the commercial marketplace. That’s how health systems need to act.

CMS is now allowing that,  during this time you may be able to help out some physicians with below fair market value rent to keep things and stabilize things as much as we can in the healthcare marketplace, which is obviously needed from a public health perspective, as well. So I don’t think that, Alyssa or Joe, do you have any comments or questions that you guys have seen on the lease side?

Joe Wolfe: Yeah, Wally. Joe here. Yeah. I think leases are an area that I know our firm has been getting a lot of questions about, especially as you mentioned in the situations where physicians are working through challenges with back rent, is one that’s come up a lot. The government seems to view this as an area where there is an opportunity for flexibility. If you go into the waiver discussion by the government, they talk about providing free use of space on a campus so physicians can provide the COVID-19 services to patients who come to the hospital but did not need inpatient care.

So they’re viewing this as an opportunity to be creative in your overall COVID-19 response. This can be part of a broader strategy on the patient throughput and how you can ensure the patient population is protected from areas where COVID-19 may be more prevalent, to get safer throughput as well. I think there’s a lot of opportunity to work with rates and to allow flexibility under real estate.

Gregg Wallander: That’s a great point too, Joe. And speaking of throughput, I empathize right now with the healthcare provider marketplace and what they’re going through in terms of the throughput. We’re doing this podcast, each of us from the safety of our own homes. And so some of the transition can be a little awkward because we don’t see each other and we’re doing the best we can, but we’re not facing the hundreds and thousands of patients and redeployment right now. So folks we’re working with are on the front lines. So thank you. Thank you to all of you folks. And the throughput is certainly an issue.

Joe, speaking of physicians, you touched briefly on medical staff and nonmonetary compensation waiver?

Joe Wolfe: Yeah, thanks Wally. I mentioned earlier that one example of a waiver that’s available, allows hospitals to exceed Stark’s incidental benefits and nonmonetary compensation limits. As people, many listening in today, know there’s a cap of $423 for nonmonetary compensation for hospitals and there also is a $36 per instance cap on medical staff incidental benefits. The government here is alowing some more flexibility under these two areas. In the waiver comments, the government talked about the ability to provide meals and comfort items, things like changes of clothing and onsite childcare for physicians that goes above the $36 per instance on the incidental benefits cap for medical staff.

And that’s really linking up with knowing that physicians are going to be working longer hours and being able to provide them more support in that space. The government also talked about allowing for nonmonetary compensation that exceeded that $423 for things like continuing medical education related to COVID-19, supplies and food and groceries, isolation related needs, needs like hotels and meals, childcare and transportation.

And I think this kind of goes back to what we’re saying about the leases. This really plays into an overall COVID-19 strategy as you’re thinking about your staffing model, and what more you can do to help the staffing burden of your physicians. There’s lots of opportunities here to provide that food and support and hotels and meals as part of an overall strategy, especially as you build up your surge plan and need to stretch provider hours and provider staffing. More and more, this is an area that normally we might not have looked to, but here the government’s saying  you can do this kind of planning and provide this kind of support.

Gregg Wallander: Thanks, Joe. Good overview there. Want to switch gears a little bit from hospital physician relationships to physician owned hospitals. Alyssa, you want to chat on that a bit?

Alyssa James: Sure. Happy to. So CMS has stated in their waiver and other guidance, that physician owned hospitals which typically are barred from expansion as of March 23rd, 2010, can on a temporary basis increase their number of beds, procedure rooms and or operating rooms in order to be better equipped to respond to the pandemic and treat that influx of patients that may be anticipated due to their COVID-19 responses. This would be a limited expansion opportunity and would not be able to continue past the public health emergency period, but does allow physician owned hospitals that opportunity to expand to serve the needs of their communities.

Gregg Wallander: Great. And quickly while we try to touch base on here, a lot of different issues. Joe, a little bit on group practices, physician owned group practices.

Joe Wolfe: Yeah, thanks, Wally. Very briefly on group practices, there is an exception, or a waiver that relates to group practices that provides more flexibility around this, what are called the same building and centralized building requirements of the group practice rules. It’s very technical, but it does allow for these services to be provided to a patient in his or her private home, at an assisted living facility or an independent living facility. So greater flexibility, understanding that patients may not be in the same building or centralized building of the practice when the care is provided.

The government, in the waiver discussion, also talked about potentially furnishing MRIs and CTs, CT services in mobile vehicles and vans or trailers in the parking lot of a group practices office, to Medicare beneficiaries who would normally receive those services at a hospital. So again, the government is being flexible here, understanding where care needs to be performed is evolving as part of the COVID-19 response.

Gregg Wallander: Thank you. So finally, let me wrap up here a little bit with respect to the Stark waivers, and then we’ll get into some patient stuff. If you’re faced with a situation regarding physicians that might need, where it might seem necessary to have some assistance, think about the waiver situation. You’ve got to make sure you do it for a proper purpose, as Joe talked about at the beginning of the podcast. It can’t be for an improper purpose like doing it for referrals or something like that. It really needs to be related to COVID-19 and the waiver document released by CMS outlines the proper purposes. That needs to be documented.

If you still can meet an exception, it’s preferable. But if you can’t, that’s when this waiver piece comes into effect. And ultimately, and Joe referenced this also, maintaining proper documentation of your proper purpose, the arrangement and why it was entered into is something that is absolutely necessary because CMS under the waivers said it can ask for or add at any time. So you want to be prepared for that if you’re going to take advantage of this waiver, and I don’t mean take advantage of it in the pejorative sense, but really use it as needed, then make sure you have proper documentation.

So now I want to switch gears here a little bit and talk about the relationships with patients. We’re done talking about relationships with physicians, and now I want to transition to chat a little bit about patients and the implications that are going on in COVID-19 with respect to these fraud and abuse laws. I’ll ask Alyssa to take this on just to start us off.   Alyssa?

Alyssa James: Thanks, Wally. The CMP laws provide for monetary penalties, as Gregg mentioned, against individuals or entities who give something of value to a Medicare or Medicaid beneficiary or that may be likely to influence the beneficiary’s selection of a particular provider or supplier. When evaluating the provision of items or services to individuals, it’s important to remember that incentives that are of nominal value, meaning less than $15 per item and less than $75 annually, are permitted and do not pose CMP concerns.

However, if the provision of free or discounted items or services goes beyond that, those nominal value limits, it doesn’t mean that you have automatically violated the CMP, but rather does present some level of risks that then that must be evaluated based on the specific facts and circumstances at issue. The CMP, similar to the Stark Law and Anti-Kickback statute does have exceptions in place that protects certain types of incentives provided to federal healthcare program beneficiaries.

One of these exceptions is geared toward items or services that are provided to individuals with a demonstrated financial need. Compliance with this exception is a bit more difficult to implement quickly. For example, in response to this COVID-19 pandemic, because it does require that the provider has a policy in place for how the financial need assessment will be made. So for providers who don’t already have that in place, it can take a little bit to kind of get the framework up and running there in order to utilize that exception.

However, another exception which may provide more flexibility and a more rapid ability to respond by providers is the exception for remuneration that promotes access to care, imposes a low risk of harm to patients in federal healthcare programs. We often refer to this as the Access to Care Exception. And this is very broad and gives providers, both within the context of the COVID-19 pandemic, as well as just more generally a pretty good range of flexibility as far as the types of incentives that they can provide to patients.

We’ve seen some examples just in recent conversations with clients of types of incentives that they’re considering offering to patients that I think might be a little bit helpful to walk through. And Joe and Wally, I welcome your thoughts and input as well. One example that we’ve seen recently is the desire of clients to waive certain telemedicine visit fees. With respect to telemedicine specifically, the OIG did issue a policy statement, so not a waiver or an exception but just a policy statement on March 17th, stating that physicians and other practitioners would not be subject to administrative sanctions if they choose to reduce or waive federal healthcare program beneficiary cost sharing obligations for telehealth services during the declared public emergency period.

Again, note that this is limited exclusively to the public health emergency period, much like the Stark waivers that we described earlier in the podcast. So those telehealth services, cost-sharing obligations can be waived but it’s on a limited duration of time. So for any policies or other plans to waive those fees, providers just need to make sure that they have a plan in place to dial that back once the pandemic is over. Another kind of similar aspect but is not covered by the OIG policy statement that we’ve seen is the request from pharmacies to waive delivery fees, obviously with the goal to incentivize patients to stay home and decrease the spread of the virus.

This also promotes access of course to pharmaceuticals of pharmacy patients while limiting exposure to other individuals who may be carrying the virus, and hopefully you can keep those that may have comorbidities or other compromised immune system issues, keep them home and able to get their pharmaceuticals without having to drive to a pharmacy and wait in line around a bunch of other people.

Gregg Wallander: Those are good examples, Alyssa. I think in this case, as you said, it’s different from Stark where CMS has issued broad waivers. And so we’re dealing with this a little bit differently. But the OIG has stated that their goal is to minimize burdens on folks acting in good faith. Certainly we see the news, there are frauds being perpetrated out there with respect to COVID-19 and so there are some bad actors out there. The questions we’re being asked generally by our clients are, what can we do in order to stay within public health guidelines? What can we do to help our patients who are truly in need?

And there’s really not, what we’re seeing, an intent to violate any of these laws, but just to really respond in good faith, not infect other people as little as possible. So I think there’s a lot of good faith going on out there. If you’ve got questions with respect to patients, again, know that you don’t have any waivers per se, but you’ve got to act with common sense. Alyssa, anything? It seems to me that this is more of what makes sense for quality patient care acting within public health guidelines, but then not getting too far afield, it’s always getting that porridge the right temperature.

Alyssa James: I think that’s exactly right. I have one other example, kind of speaking more to the public health implications and considerations. We haven’t been asked this question by clients or seen clients implement this yet, but I think this would be a situation that again would be ripe for that promotes Access to Care Exception, would be if a provider or supplier wanted to equip patients with perhaps nonmedical grade fabric or other types of face masks or other personal protection equipment for more civilians, so to speak, to utilize if they need to attend medical appointments or purchase groceries or things like that. Again, to kind of try to thwart any public health or increased public health issues. That would be an example of something that may otherwise be viewed as an incentive but here, seems pretty low risk in the sense of promoting Access to Care and imposing a low risk of harm.

Gregg Wallander: Great. Thanks. Well, with that, we want to be judicious with your time. We appreciate you listening and we’ll be signing off here in a bit. Thanks again for your time. Again, if you’ve got relationships with physicians, there are some waivers out there. Feel free to check us out on our website, www.HallRender.com. We’ve got some information for you and a special COVID-19 page. You’ve got issues with patients, they’re not waivers per se, but as we’ve said, use some common sense. Thanks and be safe, everybody. Take care.