[Webinar On-Demand] Blurred Lines: Conflict or Not? Establishing an Effective Healthcare COI Program

Speaker  00:08

Welcome, everyone. Today’s live thought leader webinar is titled “Blurred Lines: Conflict or Not a Discussion on Establishing an Effective Healthcare COI Program.” Today’s live thought leader webinar is brought to you by Ntracts. The live webinar will last 60 minutes, and there will be an opportunity for q&a. To submit your questions, please use the q&a feature at the bottom of your zoom window. Now, I will turn our presentation over to our moderator Stephanie Haywood.

Stephanie Haywood  00:43

Good afternoon, everyone. I’m Stephanie Haywood, Senior Vice President of Sales and client engagement with Ntracts. With nearly 20 years of healthcare experience in Contract Lifecycle Management, I’ve held leadership roles throughout my career, including: overseeing all aspects of sales and marketing, client engagement, client satisfaction, success, pre and post implementation. All aimed at providing guidance on Contract Lifecycle Management processes to mitigate compliance and regulatory risks, financial risks within the organization aimed at increasing revenues and enhancing efficiencies. I’m pleased to welcome my speakers today, and I’d like to spend the next couple of minutes introducing them. Sara Low is a certified healthcare compliance professional with Ntracts, who brings over 20 years of leadership and operational experience in technology solutions development and in the health care compliance space. Throughout her career, Sara has served as an in-house compliance expert for health systems and has largely served as a compliance healthcare expert for SaaS companies. Currently, she is the Senior Vice President of strategy and operations at Ntracts, the leading Contract Lifecycle Management solution for the healthcare organizations and industries across the country. Ntracts is uniquely driven by the expertise of dedicated compliance professionals like Sara and is proud to be strategic partners with Hall Render. Ritu Kaur Cooper is a shareholder and Co-managing Office partner of the Washington DC Office of Hall Render Killian Heath and Lyman. Hall render is the nation’s largest health care law firm across the country, reaching a specific area of practice in fraud and abuse and compliance. She represents providers such as hospitals, health care systems, large medical practice groups, as well as pharma and device companies, all in the space of fraud and abuse. She also co-chairs the compliance service line at Hall Render. Day to day she provides counseling to clients on how to be compliant with fraud and abuse laws. Shee also helps providers establish compliance programs, conduct internal investigations, respond to government investigations, sometimes resulting in voluntary disclosures. And last but not least Ritu helps a number of clients manage the requirements under their corporate integrity agreements.

Stephanie Haywood 03:14

I’m also excited to welcome today, Carl Pate. Carl is the chief compliance and privacy officer at physicians’ partners of America. Physician partners of America is at the forefront of the battle against opioid addiction, offering interventional solution to chronic pain at its clinics and ambulatory surgery centers in Florida, Texas, and California. As chief compliance and privacy officer curl is primarily responsible for overseeing PPOA’s compliance program, ensuring compliance with laws, regulatory requirements, policies and procedures and maintaining an effective compliance program. PPOA is currently in year three of its five year Corporate Integrity Agreement.

Stephanie Haywood  04:00

Again, thank you to our speakers. We’re excited to have you here to share your expertise with us today on this very important topic. And just to give our audience a little background on the relationship between Ntracts and Hall render, some of you may be aware of and tracks in Hall render had been very close partners for a number of years, in fact, Ntracts was initially founded by Hall render in the 1980s when floppy disks were still a thing. Today, thankfully, technology has evolved, but partnership between Ntracts and Hall render has continued and remains unique given that we’re both healthcare focused. Before we jump into the presentation, our speakers have prepared a few polling questions so that they can offer some information and understand a bit of information about who’s in the audience so that we can tailor our conversation appropriately. So we’re going to take a few minutes to go through those now.

Stephanie Haywood  04:53

The first polling question if you could just share: What is your role within your organization? Are you in-house counsel, a compliance officer with a private law firm, a consultant, a vendor, or do you have some other role? It looks like our audience is answering right now quite a few compliance officers and legal in-house counsels joining. So welcome everyone. Okay, let’s go ahead and close that poll. About 40% of the attendees today are healthcare compliance officers, followed by in-house counsel, again, thank you for joining us today, this is going to be a really great conversation.

Stephanie Haywood  05:40

Polling question number two: Does your organization have a defined conflict of interest process? And our responses? What is a COI? I love that one I didn’t know that was something I was supposed to manage. Hopefully that’s not the situation today, but excited to talk through. We’ve discussed managing potential COIs, but my organization has no formal COI process in place. I only have a process for the board. My organization’s currently working to formalize the COI process, but still gathering best practices. Or you have a well defined COI process and have for quite some time. Looks like fortunately, most have a well defined COI process. I’m hopeful that today’s discussion will help enhance that process. Or if you’re working to formalize that now, I know that you’ll receive some tips along the way to help.

Stephanie Haywood  06:43

And the third polling question today: I’m most interested to learn about understanding what types of COI we should be managing, how to gain insights into law, such as the Sunshine Act, stark law and the anti Kickback Statute to impact our COI policies and procedures. I’d like to understand best practices for identifying and working through COI, understanding how to leverage my Contract Lifecycle Management solution and pursue IT management, we’ll definitely talk about that, and practical steps for promoting a culture of accountability. And as our poll wraps up looks like most individuals on the call would like to understand best practices for identifying and working through COIs. And we have a lot of those discussions to happen today to come.

Stephanie Haywood  07:34

So I want to thank everyone for spending some time answering our polling questions. Let’s move into the discussion. Carl, I’d love to start with you. Again. Thank you for joining us. I know you’ve got a lot of experience within your role and PPOA. If you don’t mind just starting out talking with us really high-level and maybe giving us an overview of our conflict of interest or COI as we’re going to refer to them throughout this discussion today. What are they? And why is a process around it needed?

Carl Pate  08:09

Thank you, Stephanie. Happy to join you today, and thanks everyone for for joining the webinar. A conflict of interest is a situation where a person has multiple interests, those can be financial or non financial. They can also be internal or external. And basically serving one of those interests would involve working against the other interest. Conflicts may also…well we’ll see some examples. I mentioned a moment ago that you can have internal and external financial/non financial, we’re going to have some examples later on in the presentation. But a true conflict of interest is where an individual has two loyalties. And in my world, what we’re constantly trying to determine is if a conflict of interest exists. My organization has to have a conflict of interest process in place. We’re currently operating under a Corporate Integrity Agreement. As you mentioned earlier, Stephanie, we’re in year three of of a five year agreement. One of the requirements of our CIA is to ensure that all of the arrangements that we enter into with referral sources or potential referral sources are compliant with both Stark Law and the Anti Kickback Statute. This is really no different than any other organization that receives health care funding, and is a provider of Medicare and Medicaid Services. It’s just that when you’re operating under a CIA, the OIGs microscope is focused on you and you require to proactively demonstrate and ensure compliance on an annual basis. If you don’t, you could be subject to stipulated penalties.

Stephanie Haywood  09:44

Thank you, Carl, very, very helpful overview. Ritu, thinking about what Carl just walked through. Perhaps you can share with us why it’s important to identify and disclose conflicts of interest and some of the regulations and laws that require this disclosure.

Ritu Cooper  10:05

And like Carl said, thanks so much, Stephanie, and Sarah, for inviting us to join you today. I think the main reason and we hear this all the time, right is the main focus for the government is that they are focused in ensuring that there isn’t fraud, waste and abuse within the healthcare system. So what that means is they want to make sure that we do not have individuals or organizations who are primarily focused on their own interest, as opposed to what is in the best interest of the patient, right. So quality of care really, really matters. So there’s a couple of laws that we’re thinking about when we’re trying to identify conflicts of interest. One is the Stark law, and I think the reason there is not necessarily just for conflict of interest, but kind of what Carl was talking about. With that organization, being under a CIA and proactively having to be aware of any time they have an arrangement with a potential referral source, or a physician who can be a potential referral source, it’s important to understand the make-up of the parties that organizations are contracting with. So with the Stark law, you need to make sure that if there is a physician on the other end of the arrangement, that that arrangement is compliant with any one of the Stark law exceptions. The only way to really know that is then to either ask your physicians, if they have financial interests in entities or when you are contracting with a party to understand from that party, what the make-up is of the party is. The other is, also the Stark law applies to immediately immediate family members. So in your COIs, as others will talk about your survey is to find out any of the immediate family members of those physicians and any of those individuals who might have entities that conflict with the organization, those contracts also have to then be compliant with a Stark Law exemption.

Ritu Cooper  12:13

The other is something that came out after the Affordable Care Act, which is crazy to think that that was 14 years ago, but it has been over a decade. And that was this push for transparency, and we call that the Sunshine Act. And CMS is requiring that all pharmaceutical and device companies disclose all of their financial relationships with physicians or in that space, it’s healthcare professionals. As many of you may know, the Sunshine Act was recently expanded to go beyond just physicians that includes a number of physician extenders. So with that, it’s important with that transparency, also for hospitals or large position practice groups to also understand what their physicians, where their physicians kind of have their arrangements and what types of relationships they might have with pharma and device. And that has a whole host of reporting requirements. And only recently, I think in the last couple of years, we’ve now started to see the government utilize this information that is on the CMS portal, the open payments portal, in some of their investigations and enforcement trends as well. So those would probably be I would say, the two main laws that we’re thinking about when we’re looking at Friday’s and obviously with Stark anti-kickback as well, right, because you also want to make sure that you also are compliant with your state harbors under the anti Kickback Statute.

Stephanie Haywood  13:40

Thank you Ritu, all important laws and regulations to remember and Carl, do you mind talking about some potential conflicts of interest and maybe hearing some examples?

Ritu Cooper  13:55

Oh, you’re on mute.

Carl Pate  13:59

Thank you, Stephanie. Sorry about that. Yeah, as mentioned earlier, what we’re trying to attain here is transparency in all of our transactions, and ensure that potential conflicts are identified and they don’t become actual conflicts. So here are a few common scenarios that I think will be familiar to people in this workspace. One of your physicians is an avid speaker, let’s say for pharma or for device manufacturer, and is paid to speak at a conference where they are speaking about how the device is superior to similar products on the market, right. Is this permissible? It is. Is it a potential conflict? It is. Should something like this be disclosed? Absolutely. And can this be managed? Yes. And we’ll talk more about how that’s done later. But that’s, that’s a common example. I’ve got a few more I want to share. The board member, one of your board member’s mother is the chair of a board of a local bank, and your seeking to get a loan from that bank to expand your practice. The board member wants to include that bank in the RFP for the loan. And so obviously, that’s something that would, you would want to have disclosed. And a lot of these as we go through them, and you’ll see they’re fairly common sensical. You’ve got a spouse of a physician provider who is a pharmaceutical rep, whose territory includes the practice of that physician. The pharma rep’s compensation is influenced by the number of prescriptions that are written in that territory. Another other common example, physician has invented a device and receives royalties from the manufacturer of that device. And the practice utilizes that device on a routine basis. And then finally, a member of your leadership team sits on the board of a company who has been excluded from doing business with your organization, because the company is on the government’s federal exclusion list.

Stephanie Haywood  16:04

Thank you, Carl, all important examples. And hopefully, those are resonating with our audience, so thank you for sharing them. Sara, it’s important, obviously, to identify and disclose conflicts of interest. Can you walk through the process and spend some time here in developing an effective COI process and procedure?

Sara Low  16:25

Absolutely, Stephanie, thank you, and thank you, everybody, for joining. I’ll walk through, I’ll be long winded, so in advance, forgive me for the long windedness talking about policy and procedure, but there’s a lot to say here. But I’ll walk through the components of what should be considered to be included in a best practice policy and procedure relating to your conflict of interest. And then following that, perhaps Carl can provide some real life examples of how he’s applied some of these in his experience. But with any effective compliance process, there first needs to be a very clear and well documented understood policy. I think that that’s probably self explanatory. But a well documented and well understood, policy can’t be overstated. I’ll say this many times, and I’ll beat the drum every chance I get. But the best policy is only as good as it is understood and as it as follows. So we’ll talk about some ways that you can really support those initiatives in just a little bit. For COI policy and procedure first, first of all, we want to make sure that we’re clearly defining the intent. So Ritu and Carl have talked a little bit about how the overall intent with conflict of interest, his integrity, and the quality of care for community and also for patients. Ultimately, that’s all that’s why we’re all here, right. It might seem obvious, but it should be restated at the beginning of the policy. It’s a reminder, if nothing else. Your policies should be outlining the “what,” so what is the conflict of interest, the “why” the “who” and “how” very, very clearly, like I talked about before, your policy needs to be very easily understood or well understood.

Sara Low  18:15

So that means you need to define a COI. We’ve heard Ritu and Carl talk about examples and what a conflict of interest is, your policy needs to document that in black and white. And as we talked about before, that means it should explain that it’s not just an actual conflict that needs to be explained that a conflict could be potential or even a perceived conflict that would actually that would also need to be disclosed. So your policy needs to err on the side of caution when you’re laying out this definition.

Sara Low  18:46

Also, your policy needs to outline who it’s applicable to. So that means, who’s responsible for disclosing, so who are the individuals in your organization that need to complete a conflict of interest disclosure? Minimally, and we just talked about our intent, right? So, we need to have integrity and quality of care. So at the very minimum, your care providers, your physicians, advanced practice providers, etc., need to be required at a minimum to complete your conflict of interest. However, that also expands into the more administrative sides side of your organization. They too are making decisions that are going to impact the care of patients and community. So board, they should be an applicable category, as well as executives and perhaps in your organization, you might consider employees with a leadership role and up. Maybe that would be something you’d consider or maybe all employees. It depends on your size and your culture. And even some organizations we see also include their vendors and contracted parties. Again, all of that is going to depend on how you operate organizationally.

Sara Low  19:59

The timing of your conflict of interest disclosure process needs to be well explained in thought. If there is a contract associated with an individual, so your physicians likely will have an employment or a contract documenting their relationship with your organization. But so too might your other employees, like your executives and maybe even the board members, if there’s a contract affiliated with that relationship, then at the onset of contracting or at the onset of employment in general, that’s when a conflict of interest should occur at the very beginning, and then ongoing on a regular basis. And I know Carl will talk about his opinion on timing, but very, at the at the minimum annually, some organizations we or I’ve worked with do that more so more semi annually, depending on the category, but the very minimum as a best practice annually.

Sara Low  20:54

Also, though, the policy needs to outline how does a conflict get disclosed if it’s outside of that formal process? So if something comes throughout the year, which is very likely, there should be a well understood process for disclosing those out of formal launch process? How to do that?

Sara Low  21:15

And then how is it that you’re gathering this information? And that may seem obvious to, and again, I keep talking about what Ritu and Carl have already mentioned. But a survey is most commonly what we all see, what I see out there with clients that we’ve worked with on how to gather the information about potential conflicts.

Sara Low  21:36

It needs to be very well laid out and clear. And with limited variability, but there can be variability amongst your categories, for example, your board members are likely not going to answer clinically driven questions, whereas your clinician might. However, the questioning should be largely consistent, that’s going to help with your management, administration of it, and not most importantly, but importantly, the reportability of different surveys.

Sara Low  22:07

And then Carl we’ll ask him in just a little bit to provide some examples of questions that he’s considered and we might consider including in surveys going forward.

Sara Low  22:17

So we’ve talked about the “whos”, we’ve talked about the “what” and we’ve talked about the “why”. WE also very clearly need to lay out the “how” the conflict of interest disclosure process is going to work. So there should be responsibility for the administration of your conflict of interest disclosure process. Typically, I’ll see that one department or one area within an organization. Again, this is going to vary depending on how your structured, but legal/compliance make-up the majority of our audience, of course, and then also audit and risk. So it depends really on how your organization is structured. But generally, it’s in one of those areas. And it’s either broadly across the entire organization, the disclosure process, or it’s a large organization also see that delegated within individual departments. So maybe one individual is responsible for clinician administration and another individual responsible for board and executives. Another thing to consider when we’re talking about the house is, again, depending on your size, you might want to consider staggering, the launch of your conflict of interest disclosures, for example, if they’re all annually, maybe not all at the same time that can become quite burdensome, and an administration and management process. So consider, I think Ritu and Carl might have some suggestions about timing with that, but maybe one part of the year you’re clinician another part of the year your board and executives.

Sara Low  23:54

Also, not just the administration needs to be laid out, or who’s responsible for administering the COI  process but who’s responsible for reviewing completed conflict of interest? And also, how do they determine if a conflict or potential conflicts exists? So that may or may not be the same people that are responsible for administering the process in whole, and your survey questions should be designed in a way that can support the identification of a potential conflict that can trigger the person that’s reviewing ears to perk up and pay attention and then determine if mitigation or renovation is required. So speaking of that, also as an important component, and the policy and procedure is how to act on those necessity and unnecessary mitigation and remediation processes. So what steps need to occur, how is their acknowledgment of it and how is there how is it made sure that those are actually following through and completed. And, you know, we’re talking about the best policies and best practices with our policies and procedures, we like to assume that they’re followed well, and that everybody is very timely and will complete these as we have requested them to complete them. But I think we can all be honest that another administrative task on someone’s plate is not always very popular. So outlining expectations for there to be followed through on on the timeliness of completion of a conflict of interest disclosures, as well as consequences. So adding some urgency into your policies or procedures are really important.  Lastly, circling back on that, like I said, I was gonna beat the drum, and I am going to beat it in that the best policies are only as good as they are followed. So that’s where education comes in, you have the responsibility of not only documenting your policies and procedures, the expectations and process, but also educating everybody who is a participant in the process, it needs to be a mandatory education at least annually, and design based off of your audience. So those that are responsible for reviewing, they’re gonna have different talking points or education components versus somebody that’s completing a conflict of interest. Also, make sure that you’re gathering feedback from individuals, you want it to be successful, and buy-in is absolutely key to a successful policy and procedure and COI exposures are no exception. So ask them, ask your participants on how the process works for them is it really burdensome, etc. And take that feedback and revise throughout throughout the year, if necessary, and then also educate your team members as  revisions occur. So that was a mouthful, a lot of components to consider in your policies and procedures.

Stephanie Haywood  26:54

Really helpful, Sara, thank you. Yeah, a lot of a lot of information, a lot of really good information that I hope our audience takes away. Carl, you have done this. If you don’t mind. Can you talk to us about how you’ve applied these components within your organization, and then in real life?

Carl Pate  27:14

Sure, sure. Thank you. So I’ll just spend a couple minutes sort of telling you what we do and how we do it. First of all, we didn’t start out as Sara mentioned, with a policy in place, we developed a very well thought out policy, we had a lot of feedback with a wide variety of of individuals throughout the organization, which helps with buying in as well. But we started with the policy, then we developed our questionnaire and here you have an opportunity to not not all questionnaires are the same. You can go out online and find questionnaires of organizations that have put theirs out on on the on the internet, we developed our questionnaire and took the opportunity to make it unique to our business, because we know what potential conflicts our employees or our vendors are likely to encounter. And so we had an opportunity to sort of personalize the questionnaire to the business. One of the things that we do when developing the questions is ensure that those questions are broad, open ended and comprehensive. That way they capture as many possible conflicts as as can be. Then we set about defining the group that would receive the questionnaire and, and we define those in our policy as impacted members. And as Sara mentioned earlier, our impacted members include our board of directors, they include all of the executive staff, they include all of the medical staff, and then any of the administrative staff that is listed by human resources as director and above. And then I’ll just mention one other thing, we did leave a caveat in there in the definition of impacted members and our policy that says that we have the ability to identify someone as an impacted member, you know, other applicable individuals as necessary, as well as family members. Then we set about training the staff and this is a very important and vital role when rolling out a conflict of interest, process or program, especially if you’ve never done one before or if you’re making substantive changes to an existing program. It’s vital to the success of the program. And it’s necessary to obtain buy in both from leaders and from their respective staffs. We trained different groups separately. So we had training for the physician group or the the medical staff group. We had training for the administrative staff, and we’ll do training for our board and so we parsed out the training somewhat to make it a little bit more personalized for each of them as well. The benefit of having a comprehensive training program is that it gives you the opportunity to answer as many questions as you can, before the questionnaire is in the hands of those impacted individuals. And that can save your team a tremendous amount of work after the fact when they’re asked to respond to those questions after the questionnaire is sent out. And you also want to make sure that the questions you’re posing are understood by the individuals that are expected to fill them out. It also provides you with an opportunity to reinforce the purpose, right, the purpose of the program is not only to protect the organization, but it’s to protect the individuals that are filling out the questionnaire, right? If it’s a physician, or if it’s a board member, you want to take the opportunity to remind them that this just isn’t an effort to inquire into their business into their personal business. It’s an effort to protect the organization and themselves. As Sarah mentioned, we then send out the questionnaires on an annual basis. And then we also require updates when a particular individual or impacted members circumstances change during the year. We also compare the results to the CMS Open Payment database and Ritu had mentioned earlier about the Sunshine Act. I think we’re going to talk more about that in a minute. And then finally, I think just as important as the training, we limit access to the data that’s disclosed. In my organization, we’re relatively small, and that data is limited to just the compliance team. And even more so with the board of directors. Those surveys are reviewed only by the Chief Compliance Officer.

Sara Low  31:59

Thank you, Carl, it sounds like you’ve been really thoughtful about putting together your procedures, and also your policies on conflict of interest. However, it also sounds like it’s been a relatively manual process for you. Is that Is that accurate?

Carl Pate  32:16

Yeah, our process is very manual. We we currently use a self built database that that we use to track responses. It’s it’s very manual and cumbersome. And, you know, we have to have different locations to post the disclosures that are made by various questions, right. And so some of the questions that we have include, you know, having individuals identify specific relationships or activities they may have with organizations that PPOA may also have a relationship with. We asked them to describe or disclose outside interests they have with organizations that may compete with PPOA. We ask them to disclose investments they have with organizations that are doing business with PPOA. And then we also have other questions on our questionnaire that address referrals, gifts and gratuities and various compensation arrangements or relationships.

Sara Low  33:20

Yeah. So you mentioned a self self made way to manage your COI disclosure process. And in hindsight, perhaps we should have asked how people are managing that in one of our polling questions. This is a great segway to talk about how CLM can support the automation of process, I don’t think that it is, is foreign to anybody that there that if you have a manual process current state, I think I would assume that there that’s probably pretty widespread. But with CLM, given that COI disclosure is a necessary part of the contracting process, your CLM is also a logical place to manage conflicts of interest and a good CLM should have the functionality necessary to also support that initiative. And we spoke quite a bit about policy and procedure and I promised I would beat the drum, I’m gonna beat it one more time. Again, your best policy is only as good as it is understood and followed. We’ve talked about how to make it understood with education and well written policies. But to make sure that it’s followed it helps to have technology provide some guardrails to support the compliance with your policies. So that’s why it’s important to consider wrapping your CLM around the policy and process. That’s probably one of the most effective ways to support compliance with your policy. And that’s because you’re CLM likely or should house most of your contracts at minimum. Hopefully your clinical contracts and employment contracts are documented, and documentation relating to those contractual relationships are in your CLM. And that’s just the logical place to launch your COI disclosures, beginning with your contract approvals for both new and existing contracts. So for non related non contract related COI the launching place within your CLM  may vary a bit, but the process is largely going to be the same and similar. For new contracts, though just the initiation of brand new contracts, it should be a required step in the initial diligence process, it can save quite a bit of anxiety. And I think Ritu spoke about this being a something to be completed proactively. If this is done proactively it can, it can really be a quite a bit of time and expense and anxiety rather than having to address potential conflict mid contracting, or even at the very end of the contracting process. I worked with an organization, previously a health system where there was quite a bit of urgency to onboard a position quickly. And in that urgency, the disclosure of conflict of interest was skipped until at the very end of the process that was realized that that particular position was also contracted to work at another health system, and ended up being fine. And then we determined that there wasn’t a conflict with that position providing services for our organization. But there was a lot of hours and time spent on making sure that that was that gentle conflict was cleared. And we could have avoided a lot of that time and effort. If we had done that on the front end, I’m sure many of you have experiences that might be similar to that as well. Also in the process and your CLM, we’re talking about new contract or existing contract change approvals, that the person responsible for Conflict of Interest administration should be included as part of your workflow, your contract workflow, at some level, at least, it should be documented that that process has begun at the onset of the contract. And it might sound harsh, but also contracts really shouldn’t be allowed to be considered fully active until that conflict of interest has been completed. And that individual applicable to that contract is clear. For existing contracts, in your CLM, you should have functionality that will support your ability to audit where a COI party exists or disclosure already exists, or where you’ve gotten gaps. And from there, you can make the decision to either one off send out a disclosure to have that contractual relationship compliant with your process. Or you can based on the term off of the term of that agreement, decide if you want to include it in your annual formal launch for that particular category. We talked before that should be at least annually. We’ve mentioned this before, but again, your CLM should support and be flexible enough to determine whether or not your decision to determine whether or not you want to launch all at once across your organization broadly, or if you want to break it out categorically by the clinicians or your board or executives. That’s just for ease of management again.

Carl Pate  38:26

Sarah, could I interrupt for one second, I just want to add to that last point you made, you know, having worked at a large organization previously with with 1000s of impacted members who are receiving those questionnaires, I can’t express the importance of considering a staggered rollout to help ease the burden of the folks that are that are going to be reviewing those questionnaires when they come back.

Ritu Cooper  38:50

Well I have something to add with that, Carl, so I think you’re right, but I think your staggered rollout should try to make sense. And by that I mean, you know, and Oh, and one point I someone just sent in a question about, you know, we talked about fraud abuse laws and Sunshine act of the reasons of having a COI policy, but not the tax exempt rules for nonprofits. And that’s completely correct. Yes, obviously, from a tax exempt perspective, you’re required to have a policy to ensure that none of your officers or directors or others are sitting in and making decisions where they may have a conflict. But you also so those individuals you may do maybe at the end of the year because the timing of that may not as matter as much as that as long as you’ve ensured that you’ve received that information, but when we’re talking about the Sunshine Act and wanting to make sure that we are aware of the relationships that our physicians might have externally. We may want to have our physicians or healthcare professionals in general right since the Sunshine Act has expanded complete their questionnaire. I would say maybe like that January February space for the previous year, so that they can disclose all of that for to us. Because pharma and device they have to report to CMS at the end of March and March 30. And then there’s a 45 day window for, for when the healthcare professionals can review their information on the CMS website, ensure that it’s accurate, it may trigger their memory of maybe they did not disclose something to us that they should have disclosed to the organization. And then they have some time of correcting that information. And then it gets published, I think it gets published sometime in the summer, or, you know, maybe even up until September. And so I think we would want to know that information early, so that it gives the healthcare professionals time to look into it, update their information with us. And then our processes as a health system should be that in maybe third quarter to actually query the information to ensure that the information we have is accurate for our physician. So I agree with the staggered, but I think it shouldn’t be willy nilly staggered, it should just it should kind of coincide with, with what with what’s out there. But um, you know, I did notice you guys, we have a couple of questions that have popped in, it may make sense to answer those, as we’re talking. So So one of them is for you, Carl, and it says Carl, are you able to share how many individuals complete your COI survey annually, this individuals organization is considering a move to a homegrown self built COI platform and the person is curious of how their numbers compared to your numbers with your organization?

Carl Pate  41:40

Sure. So our organization currently Physician Partners of America has about 400 employees across three states. I think I mentioned that earlier. The impacted members total of that group is about it’s a little less than 100. So less than 25%, probably closer to 20% of the entire employee population group. And hopefully that that helps answer Elizabeth’s questions. And And if she has more questions, I’m happy to discuss them with her later.

Ritu Cooper  42:13

I think Carl, it may also be helpful to talk about in your previous role when you’re at a much bigger organization. I mean, because that’s different, right? A small organization of 400 is very different than when you’re an organization with 35,000 employees. And obviously, the number would be different. So any thoughts on that?

Carl Pate  42:31

Yeah, we so at my previous organization, we had a team of individuals reviewing the questionnaires as they came back in, they were just too many to, to be able to have one person or, you know, one, one compliance person reviewing those we had, we had a whole team of individuals review those. And then once a perceived or potential conflict was identified, we had a smaller subset of that team reach out to those individuals directly to get additional information. And then once it was identified as a as a actual conflict, then we put in a, a management action plan to handle those. But as you work your way through the, you know, the good news is that both organizations, a lot of the disclosures really don’t end up representing conflicts, or they fall into a category of potential conflict, and can be managed effectively. But yeah, so Ritu, to answer your question, a long, long answer to an easy question. We had a team of people reviewing them at my previous organization. And it took a lot of time and effort. But as we went on down the disclosures, and categorize them, it became a little easier to manage. And then once they’re once they’re disclosed, you know, in that first year, right, then we know what those potential disclosures are in year two, and year three. So when you’re starting up a process or making substantive changes, it’s always hardest in that first year.

Ritu Cooper  44:09

Right, I think that goes to Sara’s point about when you have a very manual process, it takes so much time, and maybe leveraging your your contract, lifecycle management solution might be a great way to kind of automate it, or actually have the data help you and have it work for yourself. Right. So I mean, one of the things that you know, we constantly looking at is okay, you get all this information from your questionnaire, and now what do you do with it and how do you actually respond to potential issues and I think if, if we’re able to have this contract, Lifecycle Management Solution work for us, then perhaps, you can have audits that are run for you or you can see whether you know, a physician has a relationship With a vendor who you are contracting with, and you want to then make sure that that particular physician, then is not involved in the process of selecting, let’s say it’s a device that the organization has decided to put, like on your formulary or something, you know, maybe that physician then doesn’t add, isn’t voting on whether to use that or not? Or, or something like that. So I, I think that it’s just important to really think about how can you take that information and ensure that you’re utilizing it and not just saying that you have checked, you know, checking the box, I’ve got a COI policy and a process check we did it, it’s, it’s not there just for any old reason, it’s actually because we’re supposed to be then ensuring that we aren’t putting ourselves in a situation where we might have individuals who have conflicts of interest who are involved with decision making. And then obviously, on the start and kickback side, especially if you’re an organization that’s under a CIA, we need to know that all of the different parties to see if they’re considered to be covered entities, under the CIA, which means that you’ve got training requirements and, and other things that you need to do. That’s very difficult to do if you don’t know, who are the individuals behind the name, right, like ABC Corporation. But does ABC Corporation have, you know, what is it that they’re providing, but also, in addition to that, do that physician ownership, which then also triggers, you know, triggers some additional requirements for us to do so?

Sara Low  46:29

Yeah, yeah. Thank you, those Carl and Ritu for, for suggesting that we respond back to these questions. And I think there was a good point and Ritu talking about leveraging your CLM. And this process. So one of the questions was that we were seeking to is, you know, we’ve done all the disclosures, now what? Well, you’ve got a well defined workflow around getting your disclosures completed and that process, but we’ve just barely touched on the whole workflow process for reviewing and remediation and mitigation, of those relationships. So your CLM should also provide the support for workflow for that. And then also as Ritu was mentioning reportability is key. So all of those vendor and contract relationships should be housed in your CLM. So you can then associate your relationships, how many contracts are do you have in your organization with a particular vendor? What to Ritu’s point, what are they specifically doing for your organization? Have their is there an associated conflict that’s been disclosed? And how are you going to deal with that? So all of the data, it should be housed with your CLM to help support your conflict of interest disclosure, and mitigation and remediation process. And as Carl mentioned, a lot of the lift is that initial disclosure. So I think a lot of the people that responded to this, one of our polling questions said that they have a well operating conflict, disclosure, a conflict of interest disclosure process, that the ongoing becomes a lighter lift, you’ve got all of that historical information, ideally, in your CLM to reference going forward, and then hopefully, the lift begins to decrease as you’re going forward. And you’re leveraging the data that you’ve already got.

Sara Low  48:18

So that was taking me takes me to my next talking point, which really happened very organically, which I love is the reportability. Your CLM needs to be had a well, power or very powerful reporting machine. So all of the data in your CLM should be reportable, it’s there for you to use and support your policies and processes. So that needs to be very key, not just with compliance with your process, yes, you should be able to easily run reports to see if there’s been broad compliance with your annual launch, but also how you should have with relating back to your policy, that report should support how those potential conflicts are going to be mitigated or need to be. So all of those things within your CLM will be very helpful. And I’ll add to that a lot of what we’re talking about. For those that are looking to improve or establish a conflict of interest disclosure process. It might seem overwhelming, right. There’s a lot of things to consider as far as timing who’s and the what’s and the hows. But when you’re working with a CLM provider, you also need to be considering that they’re able to support you in this process. So they should because they’re Contract Lifecycle Management System or provider, they should also have expertise in how your conflict of interest disclosure process should work, and handled and guide you through the process so it’s a little bit less overwhelming.

Stephanie Haywood  49:49

We’ve talked a lot about the importance of the process before we move on to kind of our last really topic around why this is important in contracting Sara which I’ll ask you Ritu and Carl to speak on briefly. Just if we could answer one more question, really. And that’s going back to, you know, the reviews conducted by the team. Carl, you mentioned that you, you know, in your former organization, there was a large team that can review those COI conflicts of interest disclosure statements to make sure there wasn’t truly a conflict. But how do you? Or do you have any best practices on how those reviews were conducted and make sure that there, there’s consistency in that review across various team members?

Carl Pate  50:39

Sure, in my previous organization, because of the size, we actually had a tool that we utilized and the tool performed a lot of the features that Sara has mentioned already, and were absolutely necessary in that process. It helped us triage for lack of a better word, the disclosures as they came back, and helped us that the tool helped us identify those disclosures that needed a management plan, quicker than we would have been able to had we were had we been reviewing those questionnaires all one at a time, the current process because it’s a smaller organization, we’re, as Sara mentioned, we’re still doing it manually. And it is quite time consuming. And so, you know, hopefully, we’ll be making changes to that process. In the near future.

Ritu Cooper  51:31

I think another thing stephanie if I can add, I think another thing was a good idea, even if it’s a smaller team, is to have training and education internally. If you see this, what are you going to do with it? Right? So having that understanding of if you’re, if you see physicians who maybe are speaking for pharma device, that’s not a problem, they obviously can speak with pharma device, but wanting to make sure that they are then that there’s disclosures that are made, if we’re considering a particular product that they may be, may be speaking on. And so I think having that policy that Sara was mentioning earlier is so important, not only for the individuals who are filling out the surveys, but also for the individuals who are reviewing the data that’s coming in, and making sure that we’re consistently applying that but you guys, I actually got a friend who said she could not put her question in the chat and sent me a question, I thought it’s a really good question for all of us to look at. So it’s for professional corporations that employ physicians and contract them to hospitals and or practices, what is the best way to manage conflict of interest given that there are two organizations involved in the process? I’ll put my two cents in, but obviously, Sara, Carl, add in, I think, for your own organization. So for for the person that sent this in, I think it’s a good idea that when you’re contracting, and or employing physicians, you have them provide you with their list of where their affiliations are. So you’re aware, and then as you are and obviously share with them, that that information will be shared as you’re contracting them out to another entity. And that entity obviously will decide whether your question or your statement or your summary of where they may have relations is enough, or if they will then make them complete another survey with that organization. But I think to protect your own organization, you know, your your professional corporation, it makes sense to have a full fledged conflict of interest, a questionnaire or policy or procedure, that you cover yourself, because if you’re contracting out two hospitals on behalf of those physicians, you want to make sure that they can say that, yes, you know, this, this organization provided me with the information that I needed at the time of contracting. So I don’t think it hurts for there to be a two level process. I do think you may also want to share with the other organization that if your physician the physician that you employ that you then contract out shares, any conflicts over there that that gets shared back with you that there isn’t anything where you moved on the information related to to those positions. So I hope that was helpful. And Carl or Sara, anything to add?

Sara Low  54:23

I don’t think so. Ritu, I think you were pretty thorough. Thank you for that.

Stephanie Haywood  54:28

Great, thank you. Let’s, um, we’ve got just a couple of minutes. So let’s just quickly talk about why COIs process is so important as a part of the contracting process. And, Sara, again, I know you touched on this a bit earlier, but if the three of you all wouldn’t mind weighting in.

Sara Low  54:44

Ritu specifically, I’d love to hear from you. We talked a lot about CLM and how it can support the process. And it may be obvious at this point, but maybe just a little bit reinforcement why it’s such a necessary component in contracting.

Ritu Cooper  54:58

Well, I mean, I think obviously you guys, are the brains behind CLM? I only look at it over it cause it’s really helping from a compliance perspective. But I think given your CLM, you have something that has the question of, you know, is there a physician ownership? Or let’s say it’s a contract with a physician, right you already know that there’s a physician Because it’s an employment agreement that’s going into the, the CLM. Maybe asking them, you know, do you have family members who also contract with the organization or that own businesses that could contract with the organization, something like that, that would be super helpful, because then as those new contracts come in to the CLM process, they can be pinged, and then you’ll know whether you need to make sure that we have to have a fair market valuation for the for the, the arrangement or not, right, usually, you wouldn’t have a fair market valuation for a florist. But if your florist is the spouse of your, you know, highest referring physician who you have a contract with, then you might want to be a little bit careful to make sure that that agreement with a florist is fair market value. And I know that sounds so extreme, but you know, in this day and age, when we have the government that has major eyes and scrutiny on all of these different organizations, and they’re looking at data, and you know, individuals who are might be outliers in terms of the amount of services that they use and utilize, you want to make sure that all arrangements that touch that, because technically Stark applies not only to the physicians, but also their immediate family members. Also, you can show well, we’ve taken that proactive step. And we’ve ensured that if we are contracting with any family members, they also are under the umbrella, and we’ve done a review, and we are making sure that if a signed contract, it’s in writing, you know, the services are defined, and then we’re paying what’s considered to be commercial reasonableness, you know, reasonable and fair market value. So, I think that is really important. And then like I was saying before, I think to be able to utilize a system that, that where you can run reports, and help you from a compliance perspective or compliance side to be able to audit and monitor is super helpful. If you have everything that’s tucked away on your your desktop in a file, or it’s on an Excel spreadsheet, I think it makes it that much harder to figure out, well, what am I auditing? How do I audit, which things should I be auditing, whereas if you have a tool that can spit out reports, and you can teach your, your CLM, the types of things that you want to be aware of? I think it just will help you in the long run. And then especially for those organizations that are under a CIA, where, you know, you have to be proactive, even more. So, if you’re under a focused arrangement CIA, you really want to be able to show that you’re being as proactive as possible and trying to head off conflicts at the front end.

Stephanie Haywood 57:54

Thank you, Ritu, Carl, anything to add?

Carl Pate 57:54

No. Nope.

Stephanie Haywood 57:56

Thank you. Um, so one more question. And then we’ll wrap up and again, want to thank everybody for joining if the circumstances around the conflict, should change during the year? Um, any recommendations on how to manage that process?

Sara Low 58:20

Well, I think in my, in my opinion, Carl, probably would be the best person to answer this question. Just because I think he’s alluded to a little bit about it. We definitely want the process to be well laid out and your CLM should support it, support it but Carl, forgive me for throwing you under the bus, but I feel like I would love to hear from you about this.

Carl Pate 58:43

No, I am happy. You know, it’s interesting, because when you’re when you’re talking about requiring folks to modify a COI questionnaire in the middle of the year, you know, it’s sort of on a, you know, honor basis, right? You have to trust that your your folks understand why it’s necessary. And this goes back to the importance of having an effective training program up front. And then in year two, you know, asking if anything changed, and if it changed, and it changed mid mid year, the previous year, when they disclose it, you know, you have an opportunity to go back and remind them that they have a duty to update it when it happens and not wait till the next next questionnaire period on an annual basis. So, just a couple of things, but you know, you really are left to, you know, folks doing this, you know, in their own best interest, and that’s why the training is so important.

Stephanie Haywood 59:44

Right. Thank you, Carl. I want to thank everyone for joining us today. With that we’re going to wrap up if again Ritu Sara as well. Thank you for joining us. If you’d like to learn more about compliance conversations or hear more compliance conversations from Ntracts, please be sure to check out our webinars that are on demand @www.Ntracts.com. And of course, if you’d like to learn more about establishing an effective conflict of interest disclosure program, we’re happy to answer your questions to follow this presentation. As you can see, we walked through several items on the agenda. But to follow this presentation, we will be sending out as part of our program materials, a sample COI disclosure statement with some sample questions, as well as an information sheet on best practices. So, thank you for joining us today. And everyone. Have a great afternoon.

Ritu Cooper  1:00:38

Thank you, Stephanie. Thanks, everyone. Bye, everybody.

Speaker  1:00:41

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