In this timely and informative episode of ASCA’s Advancing Surgical Care Podcast, ASCA Chief Executive Officer Bill Prentice and ASCA Regulatory Counsel and Director of Government Affairs Kara Newbury discuss the updates to the Interpretive Guidelines for ASCs the Centers for Medicare & Medicaid Services (CMS) released in June. In less than 20 minutes, Bill and Kara provide an overview of the updates and explain several key components, including revisions to the periodic written notice requirements for ASCs, informed consent requirements for ASC patients and the Infection Control Surveyor Worksheet.
In this timely and informative episode of ASCA’s Advancing Surgical Care Podcast, ASCA Chief Executive Officer Bill Prentice and ASCA Regulatory Counsel and Director of Government Affairs Kara Newbury discuss the updates to the Interpretive Guidelines for ASCs the Centers for Medicare & Medicaid Services (CMS) released in June. In less than 20 minutes, Bill and Kara provide an overview of the updates and explain several key components, including revisions to the periodic written notice requirements for ASCs, informed consent requirements for ASC patients and the Infection Control Surveyor Worksheet.
Narrator: 0:06
Welcome to the Advancing Surgical Care Podcast brought to you by ASCA, the Ambulatory Surgery Center Association. ASCA represents the interests of outpatient surgery centers of every specialty and provides advocacy and resources to assist them in delivering safe, high-quality, cost-effective patient care. As with all of ASCA’s communications, please check to make sure you are listening to or viewing our most up-to-date podcasts and announcements.
Bill Prentice: 0:37
Hello, and welcome to the Advancing Surgical Care Podcast brought to you by ASCA. My name is Bill Prentice, I’m ASCA’s CEO and the host of this episode. In just a moment, I’ll be joined by my ASCA colleague Kara Newbury, ASCA’s regulatory counsel and director of government affairs. And I’ve asked Kara to join me on this podcast to discuss the release of recent updates to the State Operations Manual for ASCs by the Centers for Medicare & Medicaid Services, or CMS. Since there is typically more than a year between when CMS announces changes to the State Operations Manual and its actual publication, it’s not uncommon for there to be a lot of confusion about what may be a new regulation or requirement, or simply a technical correction. And this year has proven no exception with quite a few ASCA members reaching out to us over the past few weeks for clarification and guidance. So, in addition to postings on the ASCA website and the online version of the ASC Focus magazine, Kara and I thought a short podcast on the subject might lend some further guidance. So, with that introduction, let me welcome Kara back to the ASC podcast.
Kara Newbury: 1:41
Good morning, Bill. Good to be with you.
Bill Prentice: 1:43
Great, thanks. Well, as I just explained, a lot of the confusion often results from the updating of publications like the State Operations Manual because it’s not always clear what’s new and what is simply a clarification or a technical correction. Before we dive into some of the more important changes in the new manual, it might be helpful for you to provide our listeners with an explanation of the editorial process and prior rule changes that went into this new publication.
Kara Newbury: 2:08
Absolutely. So, I think that to your point, the primary confusion is that people see new language in here, which often is signified by being in red instead of the rest of the language in the document, and they think that it’s a new regulation. Where the regulations have to change through a formal process with an open comment period, then there is typically a delay before the effective date, the State Operations Manual and the guidance that’s within is just that, it’s guidance. So, it includes the Code of Federal Regulations sections that are the regulations, but then it also includes this additional guidance, which we refer to as Interpretive Guidelines. And the Interpretive Guidelines were what were changed here, more so than any rule or regulation, which I said would have to go through a formal process. And the last time that that happened was 2019. So, I can understand why a lot of people are confused because some of this hasn’t really been revisited in three years, and now all of a sudden, they’re seeing it in the Interpretive Guidelines and wondering where it came from.
Bill Prentice: 3:19
That makes sense. And just to restate, because the Interpretive Guidelines is CMS trying to explain the rules that it has already promulgated, and perhaps sometimes in a different way, with a different slant. Is that a fair way of trying to characterize that?
Kara Newbury: 3:35
It is, and after some of the rules came out that we’ll discuss here in a minute, ASCA staff had a meeting with CMS survey and certification staff asking for more clarification because at the time those rules were released, there was a lot of confusion in terms of how facilities would implement the new requirements, and so this is CMS’ attempt to address our concerns.
Bill Prentice: 4:00
Right. So, great point, because we actually try and impact or change these interpretations in a way to make it clearer or better for our members. You mentioned doing that, and one example of that is catching an error in the preliminary draft regarding the medical history and physical (H&P) examination requirements for ASC patients. Can you speak to that correction and how we helped to try and adjust that?
Kara Newbury: 4:23
Sure. There have been a couple of errors in the document. CMS did release a slightly revised version of the Interpretive Guidelines back in 2020, which mentioned the fact that an H&P at the federal level is now at the discretion of the facility. Of course, states can have different requirements, but there was a sentence left in earlier on in the document when they’re speaking directly to the surveyor. So that’s the other thing that should be important to note—this is guidance primarily directed at the surveyors. ASCs use it and it’s beneficial to us because we can see what the surveyors are being told the survey on, but it is really supposed to be directed toward the surveyors. And so, there was language that was unintentionally left in about the 30-day H&P requirement, which, as I said, is no longer a federal requirement. And then there was even, I don’t know if you want to talk about this now, but there was an error in the advanced copy that CMS released of the State Operations Manual section for ASCs compared to what we were able to get in the actual document that was just released a couple of weeks ago. So, there are several opportunities and bites at the apple for engaged community members and associations such as ours to impact what comes out, we just have to be on the ball and constantly looking at this. And we do thank those members in our community who point out some of these errors to us because that is obviously one way that we find them. ASCA isn’t always looking at this document closely on a regular basis. So, if you do see things that you would like to have changed upcoming in a document such as this, of course, now at this point, it might take a few years, but please do feel free to always reach out to me with any suggestions.
Bill Prentice: 6:09
I think that’s all great information and I appreciate the hard work that you and your team put into trying to help our members understand this and make corrections and clarifications where it matters. There’s also the situation where sometimes the surveyors themselves don’t interpret these things right and that’s another place where we can kind of step in and hopefully try and get some clarification on behalf of our members, right?
Kara Newbury: 6:31
Absolutely. And that was the issue I was referring to with the advanced copy. We never thought that facilities should be cited for this, but there was one sentence in the Interpretive Guidelines that indicated that administrative and medical records had to be physically separate from any other entity, it’s part of the distinct entity language and requirements. And obviously, it makes sense and it’s valuable for the patients and facilities to share, for instance, electronic medical records with a physician office. And some of our facilities, actually our board president mentioned that she had recently been cited for this, which we think was a misinterpretation of the requirement. But we said why don’t you just take out that sentence, it would make it clearer. The sentence was left in in the advanced copy, so I reached out to the staff we work with at CMS, they said that that was an error. And then in the final version that was just released a couple of weeks ago, that sentence was removed. So, we’re hopeful that that will no longer be something that our facilities are cited for, in our estimation, inaccurately.
Bill Prentice: 7:38
Oh, great work there. Well, Kara, I’m going to ask you and our listeners to stand by for just a moment while we hear a brief message from our podcast sponsor. We’ll be right back after this short message.
Narrator: 7:49
This episode of the Advancing Surgical Care Podcast is being brought to you by National Medical Billing Services, an ASCA affiliate and leading ASC revenue cycle company that helps ASCs properly capture their revenue and maximize their cash flow in a highly compliant fashion. To learn more about National Medical Billing Services’ wide range of revenue cycle services and analytics, visit nationalascbilling.com.
Bill Prentice: 8:21
Okay, now let’s talk about some of the changes that have prompted a number of administrators to call or write for further clarification recently. Can you tell us about the changes in the periodic written notice requirement for ASCs?
Kara Newbury: 8:33
Absolutely, and this was one that when the rule behind this, which was the Burden Reduction Rule that was finalized in 2019, first came out, raised a lot of confusion. And what happened here was that CMS added, back in 2019, a periodic written notice requirement. It was supposed to appease all parties, hospitals primarily, because CMS had removed the hospital transfer agreement requirements. And hospitals pushed back and said that they wanted to know what was going on at the local ASCs in case there was an emergency that arose. So, this was kind of the compromise that CMS came up with was this “periodic written notice,” and what it requires is for the ASC to periodically send information to the local hospital on the facility’s operations and patient population served. But then there was not a lot of additional information on this, so it was like, how often does it have to be updated? What exactly needs to be included? Can it be emailed over or what format? So, CMS did provide a lot of additional information in the recently updated State Operations Manual. CMS says that when a new ASC opens, then the written notice should be provided then and they believe that every 24 months is a good standard. So, every two years you should be updating the information to the local hospital. In terms of what should be included, it should include the ASC’s name, address, hours of operation, the administrator of the facility and any contact information in case the hospital has follow-up questions. And then regarding the patient population served, you would have to include the surgical specialties and whether or not the ASC is seeing only adult patients, whether they have a pediatric population. So that’s the information that they’re looking for for patient population. CMS went on to add that the notice can be provided either electronically or through the mail, and that the ASC should maintain copies of their notice to demonstrate that they are providing it periodically, per the regulation. So when you get surveyed, you can show the surveyor your notice, maybe show the email receipts or what have you, to make sure that you are complying with this regulation. I also do want to point out because I got a question about this, well, what if we’ve maintained our transfer agreement? Either the state requires it, or a lot of facilities and CMS agrees that it’s just good practice to have that ongoing communication with the local hospital. In the case that you have a transfer agreement in place with the hospital, as long as it includes all of the information I just mentioned, that will count as this periodic written notice.
Bill Prentice: 11:15
Right. Well, and that’s an important thing that people have to always remember that just because the federal government might set a baseline of something, your state could require something additional and you’ve got to make sure that you’re abiding by both state and federal as well as any local requirements, and just stay updated with all of them. And I think that’s a good reminder for our members. Kara, in other sections of the revised manual, it’s important to point out that ASCs have been given some relief and additional discretion in complying with the Conditions for Coverage. Let’s go through a few of these, and let’s start with the anesthetic risk requirement.
Kara Newbury: 11:52
Sure. So, this is a change that was included in the 2020 Physician Fee Schedule, so kind of a different avenue for a rule. As I was mentioning, the 2019 Burden Reduction Rule was where we found some of the other changes, including the elimination of the H&P and hospital transfer agreement. But in a payment rule, CMS raised this change. And what the change is is that it used to state that the presurgical risk assessment could only be performed by a physician, whereas the postop could be performed by an anesthetist who was not a physician, such as a CRNA. So, I think CMS was trying to make things easier on us and trying to allow an anesthetist to do the anesthesia risk assessment. Unfortunately, the way that the wording was in the previous Code of Federal Regulations section, if they had just simply said an anesthetist can do the risk assessment that would have included a surgical risk assessment as well, which I don’t think that most of us believe that an anesthetist should be doing the surgical risk assessment, that should probably be the surgeon who’s operating on the patient. So, while it is allowing more flexibility to the anesthetist to do the preanesthesia risk assessment, it does look like it adds an additional layer where the physician is doing the presurgical assessment for the risk of the surgery itself. Now it could certainly still be the case where an anesthesiologist could do both assessments, they could assess for the risk of the surgery and assess for the risk of the anesthesia, and a physician could still do both. But if you want to have a CRNA do the preop assessment for anesthesia, you’re going to then have to have a separate physician do the presurgical assessment for the risk of the surgery itself. So, a lot of questions and confusion on that and, like I said, it does look like it could add a layer or add a requirement. I’ve talked to Gina Throneberry, our clinical director, and we both kind of think that facilities will probably just keep doing it how they were doing it, either the surgeon will do both or the anesthesiologist will do both. But if it is a situation where you would like a CRNA to do the anesthesia risk assessment, you could certainly do that now.
Bill Prentice: 14:17
Great. Well, thanks for that explanation. I understand that there have also been a couple of small changes to the informed consent requirements as well as the infection control worksheet that, again, allow for some additional discretion on the part of the ASC. Can you tell us about each of those changes? So, let’s start with the informed consent.
Kara Newbury: 14:37
Yes. So, it says in the standard that the informed consent, the form and content of the record, must be signed by the patient or the patient’s representative. I’m hoping that most facilities were already doing this because it’s the informed consent of the patient or the patient’s representative acting on behalf of the patient. But it wasn’t explicitly stated in the State Operations Manual, so CMS did add that language indicating that any documentation that you have of the properly executed informed consent must be signed by the patient or the patient’s representative. Like I said, I believe that surveyors were already surveying on behalf of that thinking that a properly executed informed consent would include a signature, but it wasn’t explicitly stated until now.
Bill Prentice: 15:28
Got it. And what about the infection control worksheet and the adjustment they made there?
Kara Newbury: 15:34
Sure. So, CMS, as you mentioned, did also make a small change to the Infection Control Surveyor Worksheet, which clarifies that multidose eyedrop bottles are not included when you’re looking at limitations or prohibitions on multiuse medication. So, I think that that was a question that had been raised probably also by the ophthalmic communities, and so it was something that CMS added just to make sure that facilities were not getting cited if they were using multidose eyedrop bottles on multiple patients.
Bill Prentice: 16:09
Great. Well, Kara, I think it’s fair to say on balance that the changes we’ve just discussed, as well as others that can be found in the manual’s appendix, are generally beneficial to ASCs. And so, thank you for your help in trying to get those clarifications and adjustments. And though technical and often time consuming, the work that you and your team do to inform CMS of our members’ challenges and desires is extremely important. And in this instance, I think it paid several dividends. So, thank you for that. And I think that’s all the time we have today, but I want to thank you and the rest of ASCA’s Government Affairs team for your work on this and other regulatory issues. And I know that our members appreciate the insights and guidance that you provide. So, any closing words?
Kara Newbury: 16:51
I just want to say that we’ve enjoyed a great working relationship and collaborative relationship with the CMS staff who handle these issues. And we are also having a meeting with them coming up just next week to discuss what the new guidelines can mean to our members, if there are any additional changes that need to be made, any questions or clarification. So, I appreciate everyone who reaches out to me and provides feedback because that is really what allows us to promote the best interests of our facilities to CMS.
Bill Prentice: 17:28
Well, thank you, Kara. Before signing off, I’d also like to once again thank our podcast sponsor, National Medical Billing Services, an ASCA affiliate and leading ASC revenue cycle company. To learn more, visit nationalascbilling.com. And finally, if anyone listening has additional questions, such as the ones Kara was talking about, please don’t hesitate to contact us or visit the ASCA website where more details on these and other important regulatory issues can be found.