AHLA's Speaking of Health Law

What Facilities Need to Know About COVID-19 Waivers

March 25, 2020 AHLA Podcasts
AHLA's Speaking of Health Law
What Facilities Need to Know About COVID-19 Waivers
Show Notes Transcript

Delphine O’Rourke, partner, Duane Morris, talks about how hospitals can benefit from recently-issued section 1335 waivers and other applicable waivers. Delphine takes a deep dive into each type of waiver and what facilities need to do now to take advantage of the flexibilities. From the Public Health System Affinity Group of AHLA's Hospitals and Health Systems Practice Group

To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.

Speaker 1:

This is Delph O'Rourke. I'm a partner in the health practice of Dwayne Morris. Welcome to the third in Rapid Covid 19 podcast series posted by the American Health Law Association, firmly known as the American Health Lawyers Association. This is the third podcast. We're gonna be focusing on waivers of section 1335 waivers and covid, um, as well as a blanket waivers, um, that came out of the proclamation on declaring national emergency declared by President Trump a week and a half ago. The first podcast was on supply chain issues, and Michelle to Johnny, the Henry Ford Health System. And I discussed critical issues in supply chain continuity. So the focus of these rapid podcasts is to address the most pressing issues relating to preparedness response and recovery to covid for a healthcare audience. So we can have, um, we have a podcast coming out, onala podcast following this one that will focus on telehealth and a telemedicine blanket waiver. So we're just gonna touch on those briefly today, and there'll be an opportunity to really dive deeper into those. So thank you for joining us, and also, if you have suggestions on topics that you would like to hear about, please let us know. So we're gonna start talking about the blanket waivers, and we're gonna touch on the 1335 waivers. And then certain states, including Pennsylvania, are also providing, uh, state specific waivers and, you know, appreciate that reviewing the waivers while, especially if you're in-house or the midst of really the frontline blocking and tackling. Every day we hear of more confirmed cases of more deaths, of shortages, of ppe, of ventilators, uh, the impact, the economic impact of, uh, elective surgeries being, um, stopped or delayed. You have so much whirling around you that we really wanted to try to take a pause and say, okay, but these waivers are critically important. And we're already hearing from clients a lot of, you know, confusion around what falls within the waivers, what doesn't fall within the waivers, what proactive steps need to be taken, um, and how they need to be documented. And also already starting to see, you know, suggestions that you have one central team or se one central person who is looking at the possibility of submitting a waiver or also, you know, looking at your operations to determine where waivers would apply rather than having, you know, folks who are involved with patient care also making those calls. So already we're hearing a lot of disinformation regarding what falls within the waivers and what doesn't. So just from a practical level of feedback from clients, really suggest that you have a core team that's looking at these waivers and what you wanna do in the coming days or weeks. And on the operational side, we're also getting feedback from regulatory agencies that the waiver requests are coming in quickly, and therefore, like everything else, everyone is backed up. So the sooner you can submit a request, the better, and cause the waivers, even though they're attempted to be as straightforward as possible, um, obviously always a good idea to contact counsel to work through those and the interplay. So let's talk about the blanket waivers. So we knew that, um, uh, secretary, um, Alex Asar at the end of, uh, January declared a national state of emergency, but that's not enough to benefit from waivers, so that we needed to wait until March 13th. And there was a lot of pressure on, uh, the administration to issue national emergency, so that among other things you could benefit from under the National Emergencies Act. So President Donald Trump issued the proclamation on Friday, March 13th, and by doing so, the National Emergency Proclamation opens the door for health and human services to offer regulatory relief to healthcare providers under Section 1135 of a Social Security Act. Now, section 1135 is not new. It's been on the books and it's been used in other, uh, prior national emergencies, hurricanes, tornadoes, et cetera in the past. Um, in indeed there's been wide acceptance, including, uh, statement by Secretary Verna that this was going to be critical for frontline, uh, treatment of patients and, uh, hospital and health systems abilities, as well as other facilities to care for covid patients in the most appropriate setting, as well as transfer those patients that don't need to be in close proximity to covid patients or don't need to be in certain acute care settings into other settings. Really a focus on, uh, making sure that treatment is directed in the most appropriate place and that we have capacity. And you'll see that we're gonna touch on bed capacity, um, now in timely manner, uh, president, excuse me, not president, uh, governor Cuomo of New York that might have been a slip, uh, just announced that he would like hospitals in New York to increase their ICU capacity by 50%. And initiatives to do that. Um, and we're seeing around the country creative ways to try to create new space, um, so that we can treat the patients that need to be treated in the hospital, uh, have testing in parking lots intensive if necessary, and really limit exposure to other patients. So another critical piece of the blanket waivers is even though they were declared on March 13th, they're retro retroactive to March 1st, 2020. So really critical to look at the dates and if you are adjusting your services back on the waiver to make sure that the dates line up. So for the blanket waiver, there's nothing for the health systems to do. Everyone is benefiting from these waivers. There's nothing affirmative that you need to do to benefit from that waiver. Um, of course, take advantage of the waiver and to do so, again, suggest that you work with your, your teams and legal counsel to revise your operations and figure out how you can take advantage of the waivers, interpret them accurately, document the waivers that you're going to be relying on, um, and making sure that you're coordinating the changes with the others. Now, unlike the blanket waiver, we'll go into greater detail. The state, the section 1335 waivers, you are individualized by facility. So I'll pause on that there. Facility specific and a submission must be made and approved to benefit from 1335. And this is relief from federal laws. Okay? And then we also state waivers. And so far, the state waivers are also facility specific and affirmative action needs to occur. So if facilities need to submit a request for re waiver of state requirements, now let's recall that both the blanket waiver and 1335 are only for waiver of federal regulations. So for example, Medicare, it's Medicaid, and it's children's health insurance program. The CHIP requirements, the Medicare, Medicaid chip, it is not state requirements. And again, we're seeing confusion, um, or confluence of some of these concepts. So licensure issues, um, that are state level are not gonna fall within the blanket. Waivers are 1335. If you're in a corporate practice of medicine state, same thing, not covered by the blanket waivers. So what do you do for the 1335 that need to assess your need and identify any additional federal laws that you would like to, that would be reasonable for you to benefit from some relaxation. So examples of those, and we'll get into greater deal de data, greater detail later, will be timing, for example, meeting deadlines that you reasonably are just not gonna be able to meet because you're taking care of covid patients in your community, or fraud and abuse laws. You have, uh, you know, change in resource allocation and physician arrangements are not going to be lining up with the care that you're providing, uh, conditions of participation, et cetera, et cetera. So, um, let's talk about the blanket waivers and, um, of the blanket waivers, their, their categories. I'm gonna put them in the categories starting first of the, the 12 major waivers, those that affect hospitals. Okay, so really there's a critical one for cri for the critical access hospitals. CMS is waiving the requirements to allow critical access hospitals to have in excess of 25 beds and to allow patients to prax access hospitals to stay longer than 92 hours. And this is much needed relief. Critical access hospitals were already requesting weeks before the, the announcement that they would have some relief. I know in Pennsylvania, um, trying to lobby these, they said they could not prepare for a surge of patients without being able to increase their bed capacity and their, their, uh, stays if they didn't have relief. So that's really important for the critical access hospitals. So similarly, for long term care acute hospitals, uh, there will, CMS is waiving the requirement to allow them to, um, you know, to, uh, to meet the demands for, uh, the Covid emergency. And even if they're, um, if the length of stay is gonna be longer than 25 days, uh, usually there's a 25 day length of stay requirement and the ability to waive that requirement. So again, going to increase access for covid patients in long-term care acute hospital setting. Similarly, when we're talking about increasing, um, access, there's gonna be for the step down beds, CMS is waiving requirements to allow step down beds, um, to care for acute care inpatients, and at the same time, to also be reimbursed through Medicare's inpatient for pres perspective payment system. So important are all of these to document that if you are shifting patients to step down beds and you will be submitting reimbursement claims for reimbursement, that you're documenting that that's what your plan is and that you're not retrospectively trying to recreate, uh, a plan and reliance on the waivers. Uh, ideally you have an overall plan that's been documented that you can refer back to. So going same thing on the theme of more inpatient inpatient beds. Um, CMS is waiving the requirements to permit acute care hospitals to relocate, uh, acute care hospitals that have distinct inpatient psychiatric units or inpatient rehab units to relocate inpatients to acute care beds. So if necessary as a result of the covid emergency. So again, an opportunity to move acute care patients, um, into different spaces in your facility to care for them. Um, and as part of that, because it's care and obviously on the backside, it's also reimbursement that CMS is allowing certain exclusions from calculations that impact a facility's classification and as an inpatient rehab facility under the 60% rule. So if that's an exception or exclusion that you're looking to take advantage of, important to look to make sure that you qualify for those exclusions from the 60% rule so that you're not only providing the care but can reimbursed for it on the back end. Um, again, and another one, um, another waiver, which is gonna be critical to hospitals but to all facilities is provider locations. So CMS is waiving requirements that out-of-state providers be licensed in the state where they're providing license, providing services when they're licensed in another state. And we could have an entire podcast on provider locations. And, um, it'll be very interesting to see how this plays out. We're already, um, hearing that it's providing, um, much needed, this waivers providing much needed relief so that we can have the providers, the physicians and mid-level provide, provide services. But beyond this, what will be the impact? Because there's been a lot of push and pull on the possibility of out-of-state providers providing services without that in-state license and possibly having a NA national license. So again, critically important and critically important to document which providers are providing services in your facility with an out-of-state license. Um, and that's gonna impact all facilities, as I said before, um, and relating to suppliers enrollment in Medicare, um, CMS is also allowing new non-certified part B suppliers, physicians and non-physician practitioners to, um, obtain temporary Medicare billing privileges on an expedited basis. So we all know that that privileging, um, can take a while and would be a barrier to care, and therefore it is very important that, um, they're allowed to enroll in Medicare. So to get payment at the back end. CMS is also waiving certain application fees, criminal background checks and site visits with respect to provider enrollment, recognizing the need for care, and that there isn't just the administrative bandwidth right now to comply both on at the national level in the facilities level with some of their requirements. Um, CMS is also on the Medicare administrative appeal side, providing additional flexibilities, uh, pertaining to Medicare appeals and fee for service, Medicare Advantage and part D, and important to know that CMS is also doing providers an extension to file an appeal and, um, processing requests for appeals that do not meet the required elements using the information available. So again, three, three components there. Um, appealing for, for fee for service and providing extensions to file the appeal. And even if some of the appeals don't have all the clinical information, they're still processing, recognizing that when the focus of the facility is on caring for patients that are coming in, the patient surge, the issues with supply chain that facilities need some relief from this influx. So all of those will affect, um, facilities not beyond hospitals, uh, including hipaa. So, um, so HIPAA's gonna be primarily in, in the hospital space, um, but still will be critical for everybody to know. So effective March 15th, HHS is waiving sanctions and penalties against hospitals that didn't comply with the following HIPAA privacy rules. So a requirement to obtain a patient's agreement to speak with family members or friends involved in patient's care. As everybody knows, we usually need that patient's agreement and, um, h is determined that we can obviously try to get it, but if that's not possible, that the penalties will be waived request, you know, usually a patient can opt out of the facility directory again, in emergency times, recognizing that that process will take longer and maybe isn't critical. Same thing as requirement to distribute a notice of privacy practices to the patients, patient's right to request privacy restrictions and patient's right to request confidential communications. There's just, again, isn't the bandwidth to comply with those requirements and care for patients the way they need to be cared for, um, expeditiously and with a shortage of supplies and services. So beyond hospitals, um, for skilled nursing facilities. And this relates to the connection between hospitals and skilled nursing facilities. Um, CMS is waiving the, so the so-called three day rule, um, so that now Medicare beneficiaries can be transferred to a sniff without the three day pro inpatient hospitalization. So this is key, uh, additionally beneficiaries that recently exhausted. There's sniff benefits can also obtain renewed coverage. Okay, again, very important. And CMS is also waiving certain timeframe requirements for data submissions for sns. Now what we're hearing from clients is that, you know, this is, this is obviously helpful and that they're also challenges that nursing facilities are full or nursing facilities, um, are not able to meet the demands or have concerns with covid infections. So, um, the three day rule is helpful, um, but we're also going to need to figure out a way to increase nursing home, um, capacity. So now shifting to home health agencies, um, again, you're seeing themes of relief on timing. So for home health agencies, um, CMS is providing summary relief on timeframes relating to, uh, the assist transmission and is also allowing Medicare administrative contractors to extend the auto cancellation dates of request for anticipated payment during these emergencies. So we're not gonna drill down into that process on this podcast, but representing home agencies, uh, important to look at the details on timing and the scope of the relief. So, um, also important to hospitals and other facilities relating to the cost of, of DMEs. Um, as well as, um, the cost of DMEs and supplies is, if any, so durable medical equipment, prosthetics, um, orthotics or supplies, if they're lost, destroy, irreparably damaged or otherwise rendered unusable or available as a result of the emergency, um, CMS contractors are going to waive some of the requirements so that the facility can still be reimbursed for those high cost items. So, um, probably as I mentioned, we're gonna have a podcast that's gonna dive into the details in the telehealth, and we're seeing this, uh, exploding and really providing relief to health systems to and to patients, right, to patients who are eager to have their, um, not only covid related symptoms, um, but also just general health, um, treated through telehealth services. So in addition to 500 million appropriated for telehealth reimbursement, uh, shes has issued waivers to remove a lot of the limitations for virtual care. So, and that is under the blanket waiver. So for example, and those of you who focus on the telehealth space know that the regulations are seen, existing regulations are seen really as the main bearer. There's a demand for telehealth services. More and more patients have the technology, particularly on smartphones and regulations have been seen as really the main obstacle to, um, increasing significant access to services. So under the broad waiver, and that doesn't mean, again, your facility can submit additional specified waivers under 1335 if you need them. Um, but under the broad blanket waiver, under telehealth four areas that I'll touch on briefly is that the telehealth services may be furnished to Medicare beneficiaries in any healthcare facility and in their home. So big change there and welcome change, um, they can use, uh, smartphones. So again, uh, to be able to use a smartphone in your home and get care when hospitals are, uh, preparing or caring for COVID-19 patients. And we're trying to stop the spread of covid-19. This is really critical. Um, and you can also, as I mentioned, provide a range of services now under telehealth, uh, unrelated to Covid 19 and for new patients, which again, was not previously possible. So a lot of, um, exciting possibilities under the telehealth blanket waiver that we can dive into, uh, or that will be dived into another podcast. So those are the blanket waivers. Um, touched on them briefly. They're the administrative order. And if any of these apply to your facility or if you'd like to take advantage of any of those, again, um, much more detail in the documentation and suggest crafting an approach, working with your operational folks that you're all in agreement, um, and all clear on which waivers you're gonna take advantage of so that those can be communicated to staff. Now, I always advise education, education and appreciate that with Covid 19 education focused on that initiative. Education on the waivers might be more challenging and would need to be focused really on those who need to know, but education's gonna be critical so folks know what they can do, and also at some point know when they can't do it anymore, so it doesn't become the normal that's never fixed. Um, so going on to the specific waivers, and as I mentioned, this is section 1135 under the Social security yet, and, um, nothing new. They have been available, they've always been critical in emergency situations and will be hopefully for this Covid-19 emergency. Now, again, these are, uh, they, they permit federal agencies to waive requirements relating to Medicare, medicated and ship. They're done on case by case basis, and they're not waivers of state requirements. I can't stress that enough. Not state requirements. Just federal. So what would be an example? So for example, uh, stark Law, you know, you, your physicians, you might have already, um, been experiencing the resource allocation where your ED docs are working many more hours than you prob maybe have in a professional services agreement with them, or the medical director is blowing through the hours that you in any monthly period. Um, yet at the same time, your orthopedic surgeons, uh, don't have the volumes that you usually have, and your compensation structure is based on those volumes. And you are in practice now changing that allocation of resources and may not have, um, committed those to writing in a way that would be appropriate. And maybe you did four 80% of them, um, ahead of time when you were preparing, but there's some that have fallen through the cracks or you can't anticipate. I mean, we we're hearing, um, you know, I have clients where, um, nobody's been prac, somebody hasn't been practicing, uh, pulmonology, but has been trained in pulmonology, and it's being pulled in to help with ventilators because there just aren't, um, the resources available. So all of those, um, could potentially present stark and anti kickback concerns. So you might say, you know what, this is an area where we're gonna have exposure and, and therefore we are going to seek specific request. Um, submit a specific request under section 1135 for relief. Another area that's really worth, again, considering and appreciate that there's not much bandwidth if you're in house, um, are, are, you know, waivers of conditions of participations, conditions of payments for Medicare and Medicaid claims. Um, you know, in my experience, you have the acute emergency situation and then you spend months, um, if not years, and on the back end trying to get payment, trying to get things fixed, trying to get things reimbursed and insurance. Um, and here, unlike let's say, you know, floods that have been involved with, where then the water recedes and you still have to clean up and, and go back to a certain level of normalcy, we have no indication that this is going to be an acute event that ends, uh, rapidly. So conditions of participation are definitely in payment worth looking at, considering and studying I'm taller would be another great area. Um, there might be patients that are unstabilized, um, per<inaudible> regulations, but that are coming in and they just can't treat. Um, maybe you don't have capacity, maybe you know, their variety of reasons, um, maybe you have capacity, but bringing them in would expose them to covid 19 infection. And you, um, you know, don't want to set yourself up, create enterprise risks for, uh, consistent and violations because you're transferring unstabilized patients. Um, same thing on medical screening at alternative off-campus locations, over, you know, we we're seeing tents being set up in parking lots. We're seeing Coumadin clinics being set up so that, uh, patients can just drive through. It might be a real benefit based on, you know, again, uh, a desire to distance, uh, covid patients from, um, healthy patients or non covid patients. And also to maximize the space in your facilities. It might be great to have some, uh, medical screening locations, temporary locations in an off-campus location, maybe a physician practice that isn't being used, um, for, um, because they focus on elective surgeries. So, you know, those are just some examples, but you can think of others. Timing is another great area that I mentioned before. Uh, you might have deadlines and, and timetables to perform required activities that are, are coming up and your staff is just, um, hundred 20% focused on covid 19, and you're just not going to have an opportunity to do that. Those would be great to submit under the 1135 waivers. So if you decide that you wanna submit a request for section 1135 and that you can connect that request to your treatment of covid patients in the community, you need to submit the request to both the State Survey agency, um, or the applicable accreditation organization and the CMS regional office. Okay. And, um, you're even some, some pushback on that, but it needs to be both. Can't expect that, uh, the regional office will send the info to State Survey Agency or vice versa. They both need to get it, and it should include key information about the facility. So key information about your facility so they don't have to look it up. What is the information that's gonna be relevant to this application? Um, and not necessarily information that you would include in another type of submission, which would be broader, but really focusing on Covid-19, remembering that they don't have a lot of time or bandwidth to review, uh, excessive information that's not relevant. So in addition to the key information about the facility, brief justification for requesting the waiver modification, um, doesn't need to be, uh, uh, you know, lengthy description, but why does your facility need this waiver or a modification? And, and hopefully that's pretty straightforward. Um, and that you can make it that link with caring for, for covid patients, um, as well as protecting covid patients and as well as protecting your healthcare, uh, providers. So again, um, need to affirmatively make a section 1135 request. Need to submit it to both the state survey agency and regional office info on the facility and justification for requesting. So similarly for, um, state, um, state waivers, uh, while the standards are different, we're finding, uh, states are announcing these daily, um, similar requirements. Why, which makes sense, you know, why do you need these waivers to take care of, of these patients, and why is it important, you know, why is it important that these be obtained in in rapid timeframes? So, you know, in addition to we say they're, um, statewide emergencies are triggering similar flexibilities under state law. Um, so what can, and we're already seeing are causing, okay, what's gonna fall under the blanket? What's gonna fall under 1135? Do I really need to file the 1135 or is the blanket gonna be broad enough? And how will those interact with your, um, with the state requirements? And some state requirements, frankly, haven't been, been completely fleshed out, so it's not clear what's gonna come in and what's not, what's gonna come out. Many states are also providing facilities with the opportunity to comment on what's currently included and what's currently excluded. Um, and, and I would suggest that you take advantage of that opportunity, not just for your facility, but for, you know, for care in your state. Generally, everybody's trying to figure this out on the fly. And, and the more resources can be pulled and insight into what really makes a difference, the better. So from, again, from a practical perspective, because navigating these waivers and, um, not only navigating the waivers that you can read through and say, okay, this is what, that, what's been approved, but also coming up with what would be ideal. I mean, it's, it's rare that we're in a situation where we could say, okay, there are all these federal regs that we would like to have waived or omissions because of our specific situation. Um, that's not usually the, usually we're, we're trying to, um, adapt our facts to the laws. Uh, and this is returning of situations. We're saying, okay, these are our facts and we'd like the laws to adapt to us. So really an opportunity, particularly we've heard everything from this is gonna continue for another month to another 18 months. Um, some of these waivers are gonna be critical to the sustainability of health systems. Um, clients and we're reading in the news, um, are already even only a month and a half in the cancellation of elective procedures has been such a financial hit that, particularly for health systems that have small margins, this could have, um, really challenging impact. So anything we can do as counsel on this end, to not only assist our, our facilities and our clients to provide the care to protect their employees, but also on the back end to get the reimbursement that they're going to need, um, that they're gonna have access to under the waivers that they wouldn't otherwise have. In addition to, um, all of the additional sources of funding that are, are coming out, um, and hopefully the federal government will also come up with a comprehensive bill to, to help our hospitals. So that's section 1335 waivers and the blanket waiver, as I say, we have an upcoming thank you.