Hello, everyone, and welcome to this American Society of Nuclear Cardiology webinar entitled Rules of the Road, Navigating the Regulations of Cardiac Imaging. I am Azen Mallah, I'm the president of ASNIC from Houston, and co-moderating this webinar with me is Dr. Larry Phillips from NYU in New York. And we're honored today to have two experts in this field who will educate us about the added value of and the importance of this topic in our everyday practice. And we're honored to have Angela Humphries and Jennifer Michaels with us today from Bass, Berry, and Sims. So what are we going to discuss this afternoon or this evening? We're going to be discussing anti-kickback statute, Stark law, and we're going to go over real-world scenarios for avoiding potential pitfalls and implementing risk mitigation measures. And this is going to be a very informative and educational session. We also would like to have your feedback, so at the end of the webinar, please go to this website, education.asnic.org URL, and you should have received this when you registered, and then give us your feedback on how well we covered these topics or if you think there are any important other aspects that we need to cover in the future. All attendees are muted by default, so this is very important for everyone, so we can have a quiet background. We want you to be interactive and send questions to our expert speakers, so please put your questions throughout the webinar on the Q&A at the bottom of your screen. And this webinar is recorded, and this is by popular demand and will be available on ASNIC website by October 27. And at this point, I would love to pass it over to Angela and Jennifer, who will educate us on this very important topic. Angela? And I just need to share my screen. Okay. Good. Good evening, everyone. As Dr. Almala said, I'm Angela Humphreys. I am chair of the Health Care Practice Group and co-chair of the Health Care Private Equity Team at Bass, Berry, and Sims. For those of you who may not be as familiar with our firm, we're the fourth largest health care firm in the country. And I am joined by my partner, Jennifer Michael, and I'm going to turn it over to her. Angela, I am Jennifer Michael. I'm also a member at Bass, Berry, and Sims, based in the Washington, D.C. office. I've been a health care attorney for over 20 years, and prior to reentering private practice, I served as the chief of the industry guidance branch in the Department of Health and Human Services Office of Inspector General. The next slide. So, here's just a quick agenda. I'm going to walk us through the anti-kickback statute and the False Claims Act and go through an anti-kickback statute hypothetical. Then we'll pause for some questions, and then I'll turn it over to Angela to talk about the physician self-referral law, also known as the Stark Law. And she'll walk through a hypothetical, and then we'll do some more questions. So, we're just going to jump right in. Okay. The anti-kickback statute is a criminal statute that prohibits anyone from knowingly and willfully offering, paying, soliciting, or receiving remuneration in return for or to induce referrals or the purchasing or ordering or arranging for or recommending the purchasing or ordering of federally reimbursable items or services. So, as you can see or hear, this statute is incredibly broad. And unlike the Stark Law, which Angela will touch on in a few minutes, the anti-kickback statute applies to anyone. So, not just physicians, but also practice administrators, pharmaceutical and device manufacturers, private equity firms, sales representatives, literally anyone. On this slide, we'll talk a little bit more about what remuneration means. And the government defines remuneration as anything of value, both in cash and in kind. There are many, many different ways of transferring value, including free or discounted goods or services, payments at other than fair market value, the relief of a financial obligation, and the opportunity to earn a fee, just to name a few. Some examples of potentially problematic remuneration in the PET-CT space could include receiving equipment lease rates that are less than fair market value or having your build-out costs subsidized without having to repay those costs. So, it's important to be cognizant of the difference between a hard-fought, negotiated, arm's-length deal, which can include discounts or favorable terms, and getting something for free or for less than fair market value. Next slide. The anti-kickback statute applies to both sides of a kickback transaction. So, both the payer or offerer and the recipient or person soliciting a kickback can be liable under the statute. It might surprise you to hear that the government does not need to prove patient harm or financial loss to prove an anti-kickback statute violation. While these could be aggravating factors that might make it more likely that the government will pursue enforcement, the government does not actually have to prove these things. As a physician, you are an attractive target for kickback schemes because you decide what drugs your patients use, which specialists they see, and what health care services and supplies they receive. A physician can violate the anti-kickback statute even if the physician actually renders the services and the service was medically necessary. So, the Office of Inspector General and various courts take the position that the anti-kickback statute prohibits any arrangement where even one purpose of the remuneration is to induce referrals. This is referred to, not surprisingly, as the one-purpose test. And under this one-purpose test, you cannot justify taking money or gifts from, for example, a manufacturer or a DME supplier by claiming you would have prescribed that drug or you would have ordered that wheelchair even without the kickback. And because our health care system is a for-profit system, it is very difficult to disprove that at least one purpose of the remuneration was in return for or to induce referrals. Next slide. So, why do we have this incredibly broad statute? In short, it exists to protect the health and welfare of federal health care program beneficiaries and the federal feds. As physicians, it's important to provide your patients the benefit of your best clinical judgment. And kickbacks can corrupt that medical judgment. They can also lead to overutilization or inappropriate utilization, increased program costs, patient steering, and unfair competition, which the government sometimes refers to as a race to the bottom. It's also important to know that the anti-kickback statute may be implicated not only when a physician receives remuneration in return for his or her referrals or purchasing or ordering items, but also when physicians give remuneration to federal health care program beneficiaries to use their services, such as by waiving copayments. Next slide. Because the anti-kickback statute is so broad, the Office of Inspector General has issued a number of safe harbors. And safe harbors specify certain practices that pose a very low risk of fraud and abuse, and so are not treated as anti-kickback statute violations. However, an arrangement is protected by a safe harbor only if it satisfies each and every one of the safe harbor's requirements. Compliance with a safe harbor is voluntary. Arrangements that do not comply with a safe harbor are not automatic violations of the anti-kickback statute. They are instead evaluated on a case-by-case basis. And the vast majority of arrangements in the health care space are not black or white, meaning they are not safe harbored, and they don't constitute obvious violations of the anti-kickback statute, but are instead in this gray area where the government would analyze the individual facts and circumstances of the arrangement. As your physicians, we don't expect you also to be lawyers, nor does the government. But it is important for you to be aware of and to understand these laws and to follow your practice's policies and procedures, and in particular policies and procedures governing the acceptance of gifts and conflicts of interest. Those policies are designed to protect you and your practice and help navigate that gray area. And this slide lists many of the safe harbors that are available. Some are used much more frequently than others, such as the safe harbor for employees and ASCs. Others are relatively new, such as the safe harbors for value-based arrangements. And we've just included these for your reference. We're not going to go through all of those or any of the safe harbors. The next statute I want to talk about is the False Claims Act, which is the government's primary and most effective tool for fighting fraud. The False Claims Act imposes liability for seven different types of conduct. However, most False Claims Act cases involve allegations that the defendant knowingly submitted or caused another to submit a false or fraudulent claim to the government. And that causing to be presented language is important because it means that the False Claims Act captures not only persons or entities who submit claims, but also individuals who cause another to submit a claim. There is another basis for liability for knowingly concealing or improperly avoiding or decreasing an obligation to pay money to the government. And this is sometimes referred to as reverse False Claims Act liability. And it comes into play when entities withhold money that they owe to the government. To establish a False Claims Act violation, the plaintiff must prove falsity, scienter, and materiality. Claims can be factually false or legally false. Factually false claims involve billing for goods or services that are incorrectly described or not provided. And a claim is legally false if it is predicated upon a false representation of compliance with a material statutory, regulatory, or contractual term. Exact liability does not attach unless the plaintiff establishes that the defendant acted with the required state of mind, which is known as scienter. The False Claims Act punishes only knowing submissions of false claims. And the False Claims Act defines knowledge broadly to include actual knowledge, deliberate ignorance of the truth or falsity of the information, or reckless disregard of the truth or falsity of the information. So, in other words, you cannot hide your head in the sand and avoid liability. Finally, the false or fraudulent claim must be material to the government's payment decision, meaning that the false or fraudulent conduct was important enough that the government probably would not have paid it had it known. And so, on this slide, we talk about how the two work together. So, as we've discussed, the anti-kickback statute is a criminal intent-based statute. The False Claims Act is civil. The two work together. Anti-kickback statutes can give rise to False Claims Act liability because claims tainted by a kickback are deemed false for purposes of the False Claims Act. So, even though the claim itself might properly represent the items or services provided, it is legally false for purposes of the False Claims Act because it is tainted by the kickback. So, for example, if a physician practice violates the anti-kickback statute by accepting remuneration for a laboratory in return for ordering laboratory services for Medicare patients from that laboratory, the physicians can be held criminally liable for violating the anti-kickback statute and civilly liable for under the False Claims Act. False Claims Act. Let's see. Okay. Although the criminal nature of the anti-kickback statute is potentially very scary, the anti-kickback statute is much more likely to be enforced through a False Claims Act action. False Claims Act claims can be brought either directly by the government or by a private person known as a relator or sometimes referred to as a whistleblower in a key TAM action. The False Claims Act provides a very strong financial incentive to relators to report fraud. If a relator files a complaint and the government intervenes, the relator receives between 15 and 25 percent of the total recovery. If the government declines to intervene, the relator typically can move forward on behalf of the government if he or she chooses. And in that case, the relator will receive between 25 and 30 percent of total recovery plus attorney's fees and expenses. Often, relators turn out to be ex-employees or business partners, office staff, competitors, or sometimes even patients. Relators file their complaint under seal, which means that the complaint does not appear on the public docket. And then the government has 60 days to investigate and make an intervention decision, although that timeline is frequently extended. Penalties. False Claims Act penalties can quickly become astronomical. The statute calls for penalties of up to over $27,000 per claim plus three times the amount of damages that the government sustains because of the false claim. As I mentioned earlier, every claim that is tainted by a kickback is considered to be a false claim. So, for example, if you received a kickback from a laboratory, every laboratory service you order for a patient from that lab that the lab submits to the federal health care program for payment would be considered a false claim. So, just to go through a little simple math, if you ordered lab tests for six patients each day, five days per week, for 40 weeks a year, the amount of just the penalties under the False Claims Act for that one single year would exceed $32 million. So, that gives you a sense of the types of financial incentives we're talking about here. There's also potential civil monetary penalties and there is an increasing focus on individual accountability because corporations commit crimes through people. So, the government focuses on the deterrent effect. With that, we're going to walk through a hypothetical. So, in this hypothetical, an independent diagnostic testing facility or IDTF has several locations throughout the state. The IDTF engages a physician to provide reads at one of its locations. The physician is paid $250 per read. It is widely known among local physicians that the going rate is $90 per read. The IDTF also engages the physician to provide supervision services at one of its locations. The physician has an agreement for and is paid for those supervision services, but the physician is available as needed and is not on site at the IDTF. So, any concerns about this arrangement? Hopefully, you all are nodding your heads in agreement, not because you're falling asleep. I have two concerns about this arrangement and the first is the amount that the physician is paid per read. Fair market value is a range, not a specific single number, but here the delta between that going rate of $90 and the $250 payment that the physician is receiving is pretty significant and likely would be difficult to explain if the government started asking questions. So, the government or a relator could take the position that that payment is a kickback because it's too high and it's designed to induce the physician's referrals to the IDTF. The second concern is that the physician is not on site and the physician must be physically present on the premises and in the suite of offices where tests are being performed at an IDTF and those tests require direct supervision, such as CT or an MRI with contrast. And this could be a case where the IDTF is paying the physician for services not provided or for services that are not provided as required. And because the physician is being paid for these services, the government or a relator, again, could take the position that the payment for supervision is a kickback designed to induce the physician's referrals to the IDTF. So that was a super, super fast run through of the anti-kickback statute and the False Claims Act. And so now I will open it for a couple of questions before we transition to Angela. Great, thank you, Jennifer. For those in the audience, if you want to put a question in the Q&A box or the chat box, and it sends it towards us so we can read it. The first question that's coming over is a question about what we used to think about dinners and golf outings. We don't see it as much with pharma anymore because of regulations there, but some equipment or non-pharma related industry in healthcare still continues to do it. How does that link up with AKS? Yeah, so, as I mentioned earlier, the vast majority of arrangements in healthcare operate in that gray space. And this would be one of those that this is in the gray. The anti-kickback statute does not have any kind of de minimis exception. So technically anything of value, including a dinner, a golf game, whatever, would implicate, potentially implicate the anti-kickback statute. And so then you're in that facts and circumstances analysis. And that's why it's so important to have those policies and procedures and to make sure everyone understands and acknowledges those policies and procedures and adheres to those policies and procedures. Many policies allow physicians to accept or the office to accept small gifts or meals, particularly if the meal is in conjunction with some sort of educational program and it's modest in nature. The government does tend to be more concerned if it's seen really fancy meals at like, you know, Michelin starred restaurants or the alcohol is flowing freely. That's when the government may begin to question, is this really an educational event or is this a way to, you know, transfer remuneration to people who I want to refer items or services to me? And then similarly on the other side, you know, for an imaging lab, and often it's commonplace that around the holiday times, gifts might be sent back to refers. Does that fall under AKS or is there a certain dollar amount people should be worried about? How does that work? Yeah, and that's from an anti-kickback statute perspective that the Stark Law is a little different. It's just the converse of, you know, of what we just said. So the entity offering the gift will want to make sure that it is the dollar threshold is consistent with its policies. And then also it's up to the physician's office if they want to accept the gifts. I know that, you know, some entities will take a much more conservative approach than others. So some entities may elect not to receive any gifts and may say, you know, no, thank you. I don't think that's necessary. As I said, the anti-kickback statute does not have any kind of de minimis exception, but it does, there is a statute called the Civil Monetary Penalty Statute prohibiting inducements to beneficiaries that allows for gifts of nominal value. And so that is, it allows for a one-time gift of up to $15 to a federal healthcare program beneficiary. And, you know, we can look to that exception to say, well, if $15 isn't going to influence a beneficiary, it's likely also not going to influence a physician to make a referral either. So, you know, just adhering, you know, having those policies in effect and adhering to those policies is really the best defense. Great. There was a question in the Q&A about patients and their involvement in potential kickback violations. The question is, is there a concern of kickback with regards to patients rather than to referring physicians? For example, can a lab pay for patients' Uber car service to and from a testing facility? So, yeah, patients, you have to be concerned about the anti-kickback statute and also about that statute I just mentioned, you know, the Civil Monetary Penalty Statute that prohibits inducements to beneficiaries to select a particular provider, practitioner, or supplier. There are safe harbors. You mentioned that the Uber ride, which is interesting because there is a specific safe harbor that protects local transportation. You know, like I said earlier, you do have to make sure you carefully read that safe harbor and make sure you satisfy every one of the elements if you're looking to it for protection. But there can be circumstances where, you know, you can provide things more, that are more than nominal value to a beneficiary and it might still be protected. There's also that nominal value exception where an in-kind item or service that is below $15 and no more than $75 annually, so you can do this a few times, but not more than $75 in total, it does have to be an item in-kind, so an item or service and not cash. Got it. There's another question related to the hypothetical scenario that you showed in that second part. And just to clarify, the concern about the AKS violation has to do with the fact that it's a requirement for the supervisor to be on site and that the billing is for that supervisor being on site or that the physician is being paid to supervise and isn't necessarily on site or the company in the middle. Yeah, so, yeah, happy to clarify that. So the hypothetical did not say how much the physician was being paid for the supervision, and so let's assume it's fair market value. But if the physician is being paid for supervision services and the tests that are being performed require that supervision, require direct supervision, meaning the physician needs to be on site and that physician is not on site, then the physician is not doing what's necessary to earn that supervision payment. So the government could take the position that that is a kickback because the physician, according to the regulations, that issue, depending on the tests being performed, would need to be on site. Great, and I know there are more questions and we're going to get maybe towards the end, we'll loop back and Jennifer some more questions about this. But Angela, I know we want to move on to the second part at this point to talk about the Stark loss. I'll hand it over to Angela. Stuart, thank you. So next we're going to talk about the federal Stark law. Unlike the anti-kickback statute, which is a criminal statute, the Stark law is a civil statute. It's a strict liability statute. And so failure to meet an exception results in a violation. So to boil it down, the Stark law prohibits a physician from referring a patient to an entity in which the physician or an immediate family member has a financial relationship for the furnishing of designated health services. And we're going to talk about each of these elements. So the anti-kickback statute can apply to anyone. It can apply to a lay person. It can apply to any sort of vendor, but the Stark law applies to only a physician and a referral by a physician. So let's start by talking about what is a referral. A referral is the request or ordering or certifying or recertifying the need for any designated health services by a physician. So the mere ordering of a test is a referral. I've had people say to me, well, we get the referrals of these patients from other physicians, or we get these patients who just walk through the door. That really doesn't matter. It's the actual ordering of the test that constitutes the referral. There are certain exceptions to that. So if a physician himself or herself is actually personally performing, the designated health services is actually taking the X-ray, that's excluded. And there are certain exclusions for radiology, radiation oncology, and other services provided pursuant to a consultation. But generally speaking, the mere ordering the test constitutes the referral for purposes of Stark. So the referral has to be to a DHS entity. That includes physician groups, it includes hospitals, it includes independent diagnostic testing facilities. So any entity that is billing Medicare for designated health services. A designated health services entity, however, does not include an entity that is merely leasing or selling space or equipment. So it does not include a vendor who is a mere lessor or who is an equipment leasing company because that entity is not billing for designated health services. The referral, as I said, has to be by a physician or the physician's immediate family member. We have the immediate family member list up there. I always say, look at yourself and your family tree, go up and down and sideways. It includes spouses. It includes in-laws. It includes step relations, adoptive relations. So it includes parents, grandparents, it includes siblings, it includes grandchildren. It does not include nieces and nephews, but that is the list. And so you're looking not only at the physicians themselves, but you're looking at any individuals or immediate family members of those physicians. And there also has to be a financial relationship that can be ownership or it can be compensation. And we're going to talk a little bit about both of those, but it has to be a referral by a physician to an entity where he or she has an ownership interest or some sort of compensation arrangement in order to implicate the STARC law. So what are designated health services? You have the list up here on the screen, but radiology and other imaging services, MRI, CT, ultrasound, x-ray, PET, all of those services constitute designated health services. Anytime you have a physician ordering those services and an entity is going to bill those to Medicare, the STARC law is implicated. There's a decision tree there that you can use and walk through all of the tests. If you answer no to all of those questions, if you don't have a physician, the STARC law doesn't apply. But if you answer yes in that decision tree, then the STARC law does apply and you must meet an exception in order to shield the referrals. So what are the exceptions? There are a number of exceptions. And as I said, failure to meet an exception constitutes a violation. So we have to find an exception to shield these referrals. There are a number of them and we're going to spend time talking about a few of these in detail. The first and one of the most important exceptions is the in-office ancillary services exception. And this applies to physician groups. And it's particularly important for physician owners of medical practices because it's really the only way to shield a physician owner's referrals of designated health services. So we're going to spend quite a bit of time talking about that. The other exception that is important is the personal services exception. If you and a physician practice have independent contractor physicians who you are using, you can use that exception to shield their referrals. It requires a written agreement for a term of at least a year with compensation that doesn't take into account their referrals and the compensation has to be at fair market value. So if you're using independent contractors in your practice and they're ordering DHS, then that exception becomes important. There are a number of others, but for those of you who have employed physicians, the bona fide employment exception applies and there you're actually not even required to have a written agreement with an employed physician. So that exception can be used to shield their referrals, but for physician owners, it's really the in-office ancillary services exception that is key. There are a number of other exceptions that apply to STARC and this is not exhaustive depending on the circumstances. You have space and equipment leases, but again, that doesn't apply to an equipment leasing company or a vendor that doesn't have physician ownership. It would apply if you had a relationship with a hospital or another physician group, but not for example, your imaging equipment leasing company, because it's not implicated because they themselves are not a DHS entity. So let's move now to talk about the in-office ancillary services exception, which as we said is key for shielding referrals by owners of a physician practice. The most important piece of the in-office ancillary services exception is that a physician practice has to qualify as a group practice and meet that definition under the STARC law in order to satisfy the in-office ancillary services exception. And the group practice definition has very detailed requirements. And I'm gonna hit on the key ones and really where we sometimes see people inadvertently trip up. To be a group practice, the practice has to have at least two physicians who are members of the group. And importantly, owners count as members of the group, employees count as members of the group, independent contractors however, do not count as members of the group. And we have seen in diligence in transactions, a number of physician practices who have chosen for various reasons to have their non-owner physicians be independent contractor physicians, just know that that has to be analyzed carefully because it can trip up the group practice definition. In addition, under the group practice definition, at least 75% of the total patient care services of the group must be furnished through the group and billed through the group on average. And so again, an independent contractor physician doesn't count as a member of the group. And so that independent contractor physician will count against that 75% test. And in addition, the members of the group must perform at least 75% of their total patient encounters through the group. And where you can get in trouble there is if you have physicians who are moonlighting, who are providing services through other entities who aren't working exclusively full-time on a 100% basis through the group, that can cause issues under that prong of the test. And then in addition, the group practice must compensate physicians in a manner that is not based directly or indirectly on the volume or value of DHS referrals. And there are some special rules for profit shares and productivity bonuses. There are some special rules for value-based enterprises, but generally speaking, you can't compensate physicians directly or indirectly for the referrals that they're making for designated health services. So in addition to being a great practice and having that requirement, the in-office ancillary services exception also has location requirements. So designated health services can be provided in the same building or part of a building where non-DHS services are provided, or they can be provided in a centralized billing that is used by the group practice for some or all of the group's clinical laboratory services, or finally, they can be provided in a centralized building that is used by the group practice for the provision of some or all of the group practices DHS. And so what does it mean to be in the same building or a centralized building? There are specific requirements in the regulations. The same building requires a single street address. It does not include a mobile vehicle or trailer, but the centralized building does include a mobile vehicle, van, or trailer. So in-office ancillary services can be provided through a mobile unit, provided, and this is an important part, that the mobile unit has to be owned or leased on a full-time basis. And that is defined in the regulations as on a 24-7 basis for a term of not less than six months. So not part-time, not one day a week, 24 hours a day, seven days a week for at least six months in order to meet that centralized building test. With respect to the same building requirement, there are three tests that can be met to meet that requirement. I'm gonna go through these fairly quickly. They're very detailed. The first is what I call the regular practice or 3530 test. And that means that the physician's office is open 35 hours a week and someone in the group, either the referring physician or another member of the group, is furnishing services to patients in that office 30 hours a week. So that's the first test. The second test is what I call the 86 test for satellite offices. And under that test, the office itself has to be open to serve patients eight hours a week. And the referring physician has to furnish services at that office at least six hours a week. Last but not least, under the group presence test, it has the same requirements as the previous test in that the office has to be open eight hours a week, the referring physician or someone in the group. So the previous test was just the referring physician had to be there six hours a week. Under this test, the referring physician or someone in the group has to be there and seeing patients six hours a week. But under this test, the referring physician or the member of the group has to be present in the office. So this test is slightly different than the other tests. And I guess the comment there would be, if you have satellite offices, just know that these requirements are very detailed. So before you open a satellite office, if you're going to be providing imaging services, it's important to evaluate these rules. And it's also important to evaluate them on an ongoing and continuing basis. There also are specific billing requirements under the in-office ancillary services exception. I'm not gonna spend time on those, but there are specific billing requirements. And then why does all this matter? Well, the Stark Law, much like the anti-kickback statute, as Jennifer said, can result in heavy penalties and False Claims Act liability. Civil monetary penalties under the Stark Law are $25,820 for each prohibited referral. So if you have a particular issue, every referral that relates to that issue counts towards the penalties. So the penalties can quickly add up and there can be False Claims Act liability. Under the Affordable Care Act, the government clarified that we have to pay that once providers are aware of a Stark Law violation, they have 60 days to make a repayment and failure to make a repayment under the Stark Law can result in False Claims Act liability. As a result of that, and I would say about 40% of the physician practice transactions that we do have some sort of issue that needs to be evaluated that may result in a self-disclosure, but the government encourages physician practices who have discovered these issues to go through the self-referral disclosure protocol, and that's a voluntary protocol. And when you do that, if you do discover an issue, you usually are able to settle that with somewhere between four and six cents on the dollar. So the government does view this as encouraging compliance and encouraging voluntary reporting. And we work with clients to do that when we identify an issue in diligence or otherwise. So I wanna spend just a few minutes on a few hypotheticals here. So the first question is, can a physician practice that has three owners and one independent contractor who works part-time for the practice bill for DHS imaging services under the in-office ancillary services exception? I would say it depends, right? Because at least 75% of the total patient care services have to be provided by members of the group, and they have to be furnished through the group by the members of the group. So if you have an independent contractor who is providing a lot of the patient encounters, that can bring down that 75% test. So you always need to evaluate that based on the work that the members of the group are performing versus the work that independent contractors are performing. Next hypothetical, can a physician practice bill for designated health services under the in-office ancillary service exception if the DHS is provided through equipment that is through a mobile unit that the practice leases one day per week? Well, if you'll remember our discussion, the same building test does not include a mobile vehicle or trailer, and the centralized building test requires that the lease be on a full-time basis, 24 hours a day, seven days a week for a term of not less than six months. So if the practice is only leasing that equipment one day a week, it would not satisfy the centralized building requirement that's necessary to meet the STAARC exception. And then finally, let's assume that we have hometown cardiology. It has a satellite office that is open 10 days a week. We have Dr. Jones who sees patients there about four hours a week, but Dr. Jones' partner, Dr. Smith, sees patients there seven hours a week. If Dr. Jones orders a PET scan for Ms. Payne to be performed at the satellite office next Tuesday, and Dr. Jones is not at the office on Tuesday, but Dr. Smith is, does that comply? And here it would comply because a member of the practice, Dr. Smith, would be present where the DHS is furnished the office is open 10 hours a week. So it meets the eight hour requirement. And then one member of the group must be at the office six hours a week and Dr. Jones is there seven hours a week. So here we would be able to meet the requirements under the STAARC law. And just to boil it down, the takeaway is that the STAARC law is very technical. It has a number of requirements. And so anytime you're considering adding employees or independent contractors to your practice, adding services to your practice, and certainly opening up new locations of your practice, it's very important to evaluate the requirements that you need to be able to bill for these designated health services to ensure that you're in compliance with the STAARC law. And with that, I think we're going to open it up to some STAARC law questions. Thank you, Angela, for a great discussion. And I would say this is Law School 101 and probably a lot of us are just flooded with all the information that we're getting. So we'll start with the first question that just came in from one of our attendee. It says, in the hypothetical case, there may not be a problem with the STAARC law, but wouldn't there be a problem with the established patient clause of the anti-kickback statute since Dr. Smith has never seen Ms. Payne before? So I'm not familiar with, I'm not sure I know what they're referring to by the established patient clause of the anti-kickback statute. There might be, if there's a regulatory requirement related to whether or not you can bill for that patient, that's, and you don't follow that, and it would have been material to the government's decision to pay. There is possibly a false claims act issue, but I'm not sure I'm seeing an anti-kickback statute issue there. Yeah, and under the hypothetical, the ordering physician would have the established patient relationship and he would be sending the patient just to get a test. And so it's just that a member of the group, someone within the group practice is providing services at that location at least six hours a week. So it's a very technical requirement, but we're certainly happy to take that up offline if someone would like to email us and engage in a more fulsome discussion. All right, so continuing on the group criteria, we're gonna have like, there's a little bit of a question regarding a single physician-owned entity with one office, which is used for clinical evaluation, but also for PET imaging as an in-office ancillary. And the physician practices 35 hours per week. Would that meet the group criteria, even though it's a single physician? Yeah, so good question. And the one caveat to all of this is if you have a true solo practitioner operating independently, then you do not need to meet the group practice definition. So if you're truly operating solo, you would not need to meet the group practice definition. Okay, maybe Larry, you wanna take it over for more questions? Sure. So a couple of questions about the mobile or satellite offices. One is, you know, based on the explanation, if a cardiology group does not own a mobile trailer 24 seven for six months, are they then liable under the Stark rules? I think that's what you said. You know, there's sometimes with any type of imaging where there might be a trailer that's not being utilized for that period of time that's shorter. So how does that work with Stark? Yeah, so remember, we're only needing to avail ourselves of the in-office ancillary services exception to shield referrals of owners. So if you have referrals of DHS by employed physicians, their referrals are shielded under their employment agreements. If you have referrals of DHS by independent contractor physicians, their referrals can be shielded through their personal services agreements provided that they meet the Stark law requirements. But with respect to owners, we need to meet the in-office ancillary services exception. And that's where that same building requirement comes in that does not include a mobile unit. And then for a centralized building to meet that test for a mobile unit, it does require 24 seven possession, if you will, on a full-time basis for at least six months. And that would be what would be necessary to shield referrals of DHS of the owners. One last quick question back to Jennifer's presentation earlier. So say a situation comes where someone says, I might have accepted some kind of remuneration that violated the anti-kickback statute, what do you do? Well, I would say the first thing to do is call your legal counsel because you wanna determine whether it actually does potentially, whether it does implicate and potentially violate the anti-kickback statute. If it does, it's not, you know, and it's not in that gray area, it's not consistent with your policies. There's a couple of things you can do. Often people will, like Angela said, with the self-disclosure, the Stark self-disclosure protocol, OIG also has a self-disclosure protocol where you can self-disclose any potential kickback violations. And what the benefit of self-disclosure, there's a few benefits, but one of them is that you pay remuneration-based damages, which means that the way you calculate the amount of the damages that you would repay is how much you received as the alleged kickback. There is one caveat to that, and that is that the self-disclosure protocol does have a minimum amount, and for kickbacks, that is $100,000 right now. So definitely something to consider. Also, if you go through the self-disclosure route, you don't, you won't have to enter into a corporate integrity agreement, which is something that OIG often requires. If it's going through the enforcement route, there's a False Claims Act violation, you're negotiating a settlement with DOJ, OIG, the Department of Justice, the Office of Inspector General will relinquish its exclusion authorities in return for entering into a corporate integrity agreement. And if you go through the self-disclosure route, you likely won't have to enter into one of those. Great. Well, I think we're at time, on behalf of the American Society of Nuclear Cardiology, want to thank Jennifer, Michael, Angela Humphries for presenting this evening. Like Moa mentioned earlier, we're going to have this available to the membership through the website. For those questions we were not able to get to, we copied them down. We'll try and get you answers offline. But again, thank you to our presenters and have a wonderful evening. Thank you.

webinar

anti-kickback statute

Stark law

cardiac imaging

referrals

physicians

exceptions

penalties

compliance