Marti Arvin joins us to discuss compliance considerations around the Center for Medicare and Medicaid Services Waivers (CMS) that were issued for hospitals under the Public Health Emergency. In part one of this series, Marti covers a number of the section 1135 waivers issued by CMS to support teaching hospitals, teaching physicians, acute care, and other hospitals. Marti also discusses specific waivers and compliance considerations associated with the waiver.
Links to content:
- Read the latest blog on the topic CMS Waivers Under COVID-19: An Overview of Compliance Considerations – Part 1
- Download our 30/60/90 day checklist, “Planning for Incident Response During the COVID-19 Crisis: Tales on Tackling the Security Debit.”
- For a full repository of COVID-19 crisis resources, visit our CTEK COVID-19 Communications page for news, articles, podcasts, and more.
- Contact us with any questions regarding the regulatory changes during the COVID-19 crisis.
Hello and welcome to CTEK Voices the Risk Perspective. I’m your host Lauren Frickle. Before we begin our host, Marti Arvin would like to note a quick disclaimer on the content she will discuss in this episode.
A Message from Marti Arvin:
Everyone the waivers I’m going to talk about in the podcast today are waivers that are applicable to Medicare. They’ve been issued by CMS. So, when you want to look to see how applicable these waivers are two other payers, you’re going to need to look to your State Medicaid Agency for Medicaid and to the commercial payers’ websites for any commercial payer questions you might have.
So just keep in mind as we go through this these are only applicable to Medicare services not to Medicaid or commercial payers those entities might have implemented the same or similar waivers, but you really need to look to their websites and confirm that and don’t just assume that these that at it don’t just assume the ones that I’m talking about in this podcast are applicable to those payers.
Thanks, Marti! Now, back to the show.
Today I’m joined by Marti Arvin, Executive Advisor at CTEK. Today Marti will be discussing compliance consideration around CMS waivers.
Hi Marty! How are you?
I’m well Lauren, Thank you, and hello everyone.
This is a topic that is quite a bit of interest because there have been a plethora of waivers that have come out from CMS regarding particular regulatory provisions, and it’s really across all essentially all of healthcare. If you look at the waivers, they’ve issued, I’m just going to quickly run down the list here and you’ll see that it’s quite extensive.
They’ve issued waivers for teaching hospitals, teaching physicians, and medical residents. A waiver for hospitals, a waiver for physicians, and other clinicians. A waiver for inpatient rehabilitation facilities, for rural health clinics, and federally qualified health centers, for long-term care hospitals and extended neoplastic disease care hospitals, ambulances, laboratories, end-stage renal disease facilities, durable medical equipment prosthetics orthotics and supplies, for home health agencies, for hospice, for the Medicare Advantage and Part D plans. So, you can see they’ve touched on virtually every piece of the industry over which they have some sort of authority.
Again, the podcast I’m going to do today is going to focus on the waivers they’ve issued for teaching hospitals, teaching physicians, and medical residents and hospitals. If I tried to do all of them the podcast would go on for hours. So when you focus on this start looking at it and they’ve listed these out in the guidance documents that they’ve created and what I want to do is go through the waiver criteria that they’ve issued and then give you some thoughts and considerations on some of the compliance things you might want to think about around the specific waiver.
So, one of the first ones is the teaching physician rules. Anyone who’s been dealing in academia and Medicare remembers that the whole premise for compliance programs in academic medical centers triggered with the Physicians at Teaching Hospitals Initiative and this was really around the documentation criteria and the actual service that the teaching physician was provided when a resident was involved in the care. And those rules have been pretty stable from the mid-1990s, to say that the teaching physician has to be present, has to be physically present for the key or critical portions of the service. Well, the waiver that CMS has issued here said that the teaching physician would be permitted to be present virtually through audio-video real-time communication technology.
Now this waiver does not apply to surgical services, high-risk services, interventional or other complex procedures, or services performed through an endoscope, and to anesthesia services. So essentially this is going to apply to evaluation and management services and two minor procedures. So, it’s important to really understand what it does and doesn’t apply to and that the provider couldn’t be virtually participating in the key portions of a surgical procedure. And again, that makes sense because you think about what the physicians getting paid for their getting paid for the actual service to the patient and so the virtual service ties back to the telemedicine type services that CMS has expanded and permitted more waivers around. I’m not going to talk about telemedicine today because we actually have a separate podcast on that if you’d like to listen to that by going to the CynergisTek website.
But some compliance considerations around this particular waiver. How will the teaching physician’s presence through the audio-video real-time communication technology be documented? So, what do you got to put in the record that demonstrates that he or she was actually participating in this manner and I haven’t seen anything from CMS that talks about what the documentation criteria are?
As you may know, under the regular Medicare rules, the teaching physician has to do some minimal documentation to demonstrate that they again actually provided that service to the patient, and whether that will be sufficient or not, I have not seen anything from CMS that talks about that.
My recommendation would be to encourage the teaching physician to document that they were present through that real-time audio-video communication technology in addition to what they would normally document. And then you have to always consider that once the public health emergency has been lifted that you educate and get your teaching physicians to return to the pre-COVID presence requirements and documentation requirements. They might get used to this process and wonder why they can’t continue it, and it’s just making sure that they’re aware when that switch gets flipped and I have to now go back to the pre-COVID processes.
And when you think about any of these waivers think about when patients have been scheduled, and how patients have been scheduled and understanding that sometimes the patient is getting scheduled weeks out and if they were scheduled thinking they were going to use the audio-video technology for that real-time communication. Then they’re going to have to change that process if the public health emergency has been lifted in the interim. And then once the public health emergency has been lifted this may be an area you want to consider auditing and looking at what’s documented and what the processes are to ensure that anything that got billed under this waiver was billed appropriately and you’ve got appropriate documentation to support it.
Another area that CMS addressed was indirect and direct graduate medical education payments for hospitals. Again, under the pre-code COVID rules, a residence time spent performing services within the scope of his or her GME Program at home or at a patient’s home was not usually counted towards the time the hospital could put in for their direct graduate medical education and their indirect medical education payments. The waiver permits counting this time for those two purposes is and those two payments as long as there’s appropriate physician supervision requirements.
So again, you’re going to have to ensure that that supervision is appropriately documented. So, when you think through this and think about the compliance considerations things to think about might include what could a resident actually be doing from home? Is that resident going to be able to do telemedicine services and if they are doing the resident is doing something from home that’s a telemedicine service, then how are you going to ensure the appropriate teaching physician supervision is accomplished? You might be able to allow residents to do something from the patient’s home and have that real-time audio-video telecommunication technology. But I’m not certain what a resident would be doing from their own home?
You also should consider that there’s a methodology to return to the preceded processes once the national emergencies lifted, and you’re going to hear me say that several times during this podcast because I think it’s really important for folks to be planning and considering what they’re going to do once the public health emergency is lifted and how they’re going to transition their physicians and staff back to those prior policies, and procedures, and processes.
Another area that CMS has issued waivers around for hospitals and teaching hospitals is on sterile compounding. The waiver that they issue permits the reuse of face masks for sterile compounding but there are some criteria around that. The face mask has to remain in the compounding area and it’s only permitted to be read and reused in the same shift. So, I couldn’t be working in the compounding area, put my mask down, leave be gone, come back for my next shift the next day, and reuse that mask. It’s intended only for that same day reuse and as long as the mask has stayed in the compounding area. So Again, this is going to be a matter of just making sure everyone’s educated on what that process is and knowing what they can and can’t do.
Some compliance considerations are how do you ensure the mask stays in the compounding area? What if someone walks out to go grab lunch or something and forgets about it? And is there a process you can have in place to help ensure that your meeting appropriate infection criteria with this waiver? And again, how are you going to ensure the mask is only reused during the same shift? And then finally, how do you ensure that returned to pre-crisis processes once that national emergency is lifted?
Now there have also been some waivers issued around medical staff privileging the waiver, in this case, permits a hospital to allow physicians whose credentials have expired to continue working even if the full board has not approved the renewal yet. Normally if the renewal has not been approved and it’s actually expired that physician would not be able to continue performing services in your hospital. The waiver also permits letting new medical staff begin working even if the full board has not approved their application yet. And again, as you might imagine the pre-COVID activity would say that they have to be privileged and approved before they can actually perform services in your facility. And this is obviously to try to get providers on board and working and supporting your organization as you look at some of the surges and influx of patients and some of the increased work activities that are occurring with the COVID crisis.
And so, the compliance considerations for this is just ensuring that there’s a continuing review of applications and approvals so that they can be done as quickly as possible. You can let the providers go to work, but that doesn’t mean you shouldn’t continue your process for actually evaluating those applications and approving credentials and then again returning to that normal process as soon as the public health in urgency has been lifted.
Now, there are several conditions of participation that have waivers associated with them and one of those is the current requirement for Medicare, is that all Medicare impatience have to be under the care of a physician and the waiver eliminates the requirement that they have to be under the care of a physician. There now permitting that care oversight to be by a physician assistant, or nurse practitioner, or a clinical nurse specialist, or some other form of maybe advanced practice nurse, but not necessarily a physician and again that still has to be consistent with the State Emergency Preparedness and Pandemic Plan.
So, it’s trying to free up the time of physicians and trying to allow those non-physician practitioners to operate at their highest and best use as we try to get through this pandemic. It does not waive the requirement that patients be admitted by a licensed practitioner licensed in the state to admit patients and that’s important because while that non-physician practitioners may be able to oversee the care while the inpatient is in the facility when normally that would have to be a physician. They are not permitted, or the waiver doesn’t address whether they can admit patients and to admit a patient that ER has to be privileged to admit the patient and that privilege can’t go beyond this their scope of practice that they’re licensed under in the state.
So again, those are some of the compliance considerations making sure the physician assistants and NP’s are not writing those admission orders if they’re not licensed in the state to do so and privileged at your facility to do so. And then also thinking about how you are going to transition those patients and ensure that a physician is overseeing their care once the public health emergency is lifted.
Another thing that was modified are anesthesia services. Traditionally, you would see anesthesia services being medically directed by a physician and the actual service provider might be a certified registered nurse anesthetist and they can the physician can oversee up to four cases that are occurring concurrently. So, this extends the services of the physician. But with the waiver, there extending that even further and saying that the CRNA can function independently and does not have to be supervised by the physician.
So again, that supervision requirement for the CRNA is being left to the discretion of the hospital or the Ambulatory Surgery Center where that CRNA might practice and it’s intended to allow them to practice to the full extent of their licensure. So, a compliance consideration you would have to look to is what’s the state licensure requirements for a CRNA and that varies by state. So is the CRNA permitted to function without physician supervision under state law this waiver will only apply to services provided to Medicare patients but that doesn’t address what may be a concurrent obligation of ensuring that the CRNA is practicing at an appropriate level under their state licensure. And so that may be a requirement to evaluate state licensure issues and we’ve also seen in the pandemic that there’s discussion of allowing people to operate across state lines, even though they might not technically be licensed in that second state, and that might be a consideration too. And then again making sure you’ve got that plan and process for returning to normal or what was normal pre-COVID emergency.
There is also a waiver for respiratory care procedures, and that waiver waives the requirement that an organization designates in writing the personnel qualified to perform certain respiratory care and that what the required supervision might be for that. And again, they specified that the services that the individual performs cannot be inconsistent with state licensure. So, the waiver really applies to a Medicare requirement that says you had to designate those individuals in writing and designate what the supervision requirements were. But nothing has changed about the fact that they can’t operate outside the scope of their licensure and so that’s one of the compliance considerations. Making sure the personnel that are not designated as qualified specifically in writing only perform procedures that are within their scope of practice and that again you have a process in place to go back to what your normal policies and procedures are that were in place prior to the public health emergency.
There have also been provisions for critical access hospitals. The waiver, one of the waivers for critical access hospitals waive the federal regulations regarding clinical nurse specialist, physicians’ assistants, and nurse practitioners and how they can operate within the critical access hospital. They still again must operate to meet all their state licensure and scope of practice limitations. So again, compliance considerations making sure the non-physician practitioners are practicing within their licensure and scope of practice and this particular waiver is a time discussing is only applicable to critical access hospitals.
Another waiver applicable only to critical access hospitals is staff licensure. It waves the obligation to meet federal regulations for staff licensure certification and registration. So for example, if the federal requirement was that you had to have a registered clinician like a respiratory therapist a physical therapist or someone of that nature or if that same type of staff member had to be licensed but the licensure provision wasn’t there under state law then obviously operating in “normal circumstances”, you’d have to make sure that licensure or certification or registration was in place. Under the waiver, they’re permitting more flexibility where the federal law might have been more stringent than the state law. So, you don’t have to think about meeting that federal law obligation for purposes of staff licensure certification or registration for critical access hospitals you just need to ensure that you’re meeting any state or local law provisions.
So again, thinking through the compliance considerations you want to make sure that the federal provisions are met, or staff work is changed to meet the federal law once the public health emergency is lifted. And you might also consider some auditing activity in this area once a public health emergency is lifted and that would be looking at the service various staff engaged in to ensure that they didn’t exceed their scope of practice or whether the staff license your registration or certification met state law in place at the time. Now, one of the things to keep in mind is your state law might have been modified on a temporary basis during the public health emergency.
So, something that might not have been appropriate pre-COVID under state law might now be okay and that’s another consideration you have to think about when you look at these types of things where CMS has waived a federal requirement and deferred to the state law what the state law was in place at the time of the public health emergency, which might be different than what it was pre-emergency. They have also allowed for what they’re calling temporary expansion sites, and this is really permitting the hospital to have patience cared for and non-traditional locations. Again, when the law prior to the COVID emergency required that hospitals provide care within the departments of the hospital. The waiver here permits the hospitals to provide certain types of activity in those temporary expansion sites, like room and board, nursing care, and other hospital services. You this might be provided in locations like hotels or community facilities and it also intended to allow for the separation of COVID positive and non-COVID positive patients to help again with that infection control.
This does not negate the obligation for the hospital to oversee and control the services provided in those sites. So there needs to be that methodology to ensure that there are appropriate measures and control in place to oversee the services at these temporary expansion sites if your hospital elects to do that and you also need to think about from a compliance consideration whether the EHR, your electronic health record, will or can be extended to these sites and how secure is that electronic health record in the sights. And then finally if you can’t extend your electronic health record to these sites. How are you going to handle documentation? And how are you going to ensure that if you’re using a temporary documentation methodology that the appropriate information gets into the permanent electronic health record?
The final topic I’m going to talk about in today’s podcast is waivers regarding certain other conditions of participation under the current process Ambulatory Surgery Centers that are enrolled. This waiver permits Ambulatory Surgery Centers that are currently enrolled in Medicare to submit a registration as a hospital. It would be a temporary registration as a hospital and that would then permit them to provide hospital services. This again is intended to extend the amount of beds and space where patients can be seen so that there can be more separation between COVID positive and non-positive patients that need some of that essential urgent care.
Also, there’s a potential that they would permit freestanding emergency room or other types of entities to take advantage of this. The way the waiver is published the freestanding emergency room would first have to enroll as an Ambulatory Surgery Center and then once that enrollment is completed convert that enrollment to a hospital and they could then function as a hospital and provide hospital services as well.
In order to do this, these entities have to contact the contractor for their jurisdiction and complete an attestation. So that conversion from Ambulatory Surgery Center to a hospital would be done through that process of contacting that contractor for their jurisdiction and completing that attestation.
So, what are some of the compliance considerations for this particular waiver? Well, first you might want to sure that their capabilities to provide the appropriate level of care. Ambulatory Surgery centers are not generally set up to provide overnight hospital types of services. So, what needs to be done to ensure that they actually can provide that appropriate level of care? You also might want to consider the billing and coding issues around this. Again, billing for an Ambulatory Surgery Center service is not the same as billing for a hospital inpatient service. So, how are you going to train individuals that are performing those services on the appropriate documentation and if necessary, coding concerns around now providing hospital services in what was an Ambulatory Surgery Center?
And then finally once the public health emergency is lifted, you might consider auditing that billing and documentation and coding to ensure that it does match up to what appropriate for the inpatient prospective payment fee schedule as opposed to an Ambulatory Surgery Center fee schedule.
So those are all the waivers I wanted to cover in this podcast. We will have a second part of the podcast. It’s going to cover most of the additional waivers that CMS has issued for teaching hospitals, teaching physicians, and medical residents and hospitals.
Thank you for listening and I hope you enjoy this and part two as well.
Great, thank you, Marti, for that important compliance information. Stay tuned to our listeners for part two of this CMS waiver series and thank you very much for listening.
Final Message from Marti Arvin:
I just want to remind everybody that the waivers that I’ve been talking about in this podcast were issued by CMS. So, therefore, they’re applicable to Medicare. You need to look to your State Medicaid Agency or to your commercial payer websites to see what if any waivers they might have issued and whether they’ve adopted similar waivers to those adopted by you have masks that were discussed in this podcast. Thank you.