In this podcast, Monica Noether, Vice President, Charles River Associates, talks to Robert Canterman, senior attorney, Health Care Division, FTC Bureau of Competition, and Peggy Ward, Partner, Jones Day, about the types of health care provider collaborations likely to happen in response to the COVID-19 pandemic. The podcast discusses limits to the appropriate scope of coordination, available agency guidance for providers seeking to form collaborations, and examines what key issues FTC staff will consider when evaluating proposals. From AHLA's Antitrust Practice Group. Sponsored by Charles River Associates.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
In this podcast, Monica Noether, Vice President, Charles River Associates, talks to Robert Canterman, senior attorney, Health Care Division, FTC Bureau of Competition, and Peggy Ward, Partner, Jones Day, about the types of health care provider collaborations likely to happen in response to the COVID-19 pandemic. The podcast discusses limits to the appropriate scope of coordination, available agency guidance for providers seeking to form collaborations, and examines what key issues FTC staff will consider when evaluating proposals. From AHLA's Antitrust Practice Group. Sponsored by Charles River Associates.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Support for A H L A comes from Charles River Associates, a leading global consulting firm that offers economic, financial, and strategic expertise to major law firms, corporations, accounting firms, and governments around the world. With proven skills and complex cases and exceptional strength in analytics, CRA consultants have provided astute guidance to clients and thousands of successful engagements. For more information, visit c a i.com.
Speaker 2:Hello, this is Monica Noer. I'm an economist and a vice president at Charles River Associate in its competition practice. I've worked in healthcare antitrust for my entire career, beginning with a ST at the Federal Trade Commission. Um, and in the course of those many years, have evaluated dozens of provider and supplier mergers, as well as allegations of anti-competitive behavior in the healthcare industry. I've also recently had a bit of an insider's perspective on the Covid 19 crisis as a board member of Boston Medical Center. Uh, BMC is Boston's Safety net Hospital and also an academic medical center. So on the front lines, caring for a vulnerable population that unfortunately doesn't have resources to socially distance. Today's podcast is certainly most timely. Healthcare providers are scrambling to obtain supplies such as p p e respirators and ventilators, and to develop additional capacity so that they never need to implement the crisis rationing guidelines that they've all had to develop in the event of unmanageable shortages. Meanwhile, new, when existing suppliers are ramping up production to ameliorate existing shortages and r and d efforts are turbocharged to the, to develop the improved tests, vaccines, and therapies that will enable all of us to move beyond the current crisis. The pressure on speed and efficiency is unprecedented and requires extensive collaboration among entities that normally might be considered to be competitors. Certain activities that I've witnessed in my hometown of Boston fortunately seem uncontroversially acceptable on today's environment, such as collaboration among hospitals to transfer patients requiring ventilators to avoid access demand at one location, or better yet, coordinating to transfer the ventilators from hospital to hospital before the unmet peak occurs. But other activities may raise more questions concerning their legality from an antitrust perspective. One example that's come to mind. Uh, we're seeing a massive increase in telehealth services as both public and private payers have expanded their willingness to pay for such services in the wake of our current needs to isolate. But I think substantial confusion remains because of different requirements for documentation, coding, and justification across payers. So, given the importance of facilitating progress while minimizing any distractions placed on providers, I think there's an important question about whether it should be possible for normally competing providers collectively to discuss these issues with payers or for normally competing payers jointly to develop common protocols. Finally, I know it's not the focus of today's discussion, but given the financial beating that all providers are taking now, it seems likely that a new wave of consolidation will begin once we get through the current crisis. So stay tuned. I'm sure we'll be back again to talk more. I'll turn it over now to our well-qualified panelists with just a brief introduction of each. Peggy Ward is a partner in Jones Day's antitrust practice. She's represented healthcare providers and other healthcare organizations in antitrust merger and conduct investigations before federal and state antitrust enforcers, and has been provided counseling and compliance advice on healthcare antitrust issues. Rob Canman is a senior attorney and healthcare division of the Federal Trade Commissions Bureau of Competition. He leads and participates in antitrust conduct and merger investigations and litigation involving healthcare providers, pharmaceutical companies, and other healthcare organizations. He also provides guidance to healthcare industry participants, including through the FTCs advisory opinion process. Rob is also a vice chair in the HLAs Antitrust Practice Group. So with that, Rob, take it away.
Speaker 3:Thank you, Monica. I'm pleased to have the opportunity to join, uh, this podcast to talk about antitrust issues, uh, relating to forming provider collaborations, uh, to respond to this pandemic. One point before we get started, the views I share with you today are my own personal views and not necessarily those of the Federal Trade Commission or any commissioner. I'll talk a little later about the recently issued FTC DOJ joint Covid 19 statement, uh, FTC advisory opinions and some antitrust guidance that the agencies have issued. I'm gonna start first though, uh, with some questions, uh, for Peggy. So, uh, to get started, um, Peggy, could you tell us what kinds of healthcare provider collaborations might we see in order to respond to the COVID 19 pandemic?
Speaker 4:Well, thanks, Rob. It's good to be virtually with you today. Um, as, as Monica's helpful introductory comments, uh, illustrated, I think we're seeing a fair amount of collaboration on many fronts to combat covid 19. Um, my comments will be focused, uh, primarily on healthcare providers, but we, we know, for example, that medical supply companies currently are coordinating with each other at the behest of the federal government. Uh, and I'm certain other coordination efforts are ongoing among other healthcare related organizations, whether they be, uh, pharma companies or insurers. But, but, but today I'm gonna focus primarily on the frontline, uh, healthcare providers, hospitals, and doctors. And I think we're seeing a fair amount of, uh, efforts to come together and, uh, combat covid and treat, uh, patients and their communities. Um, at, at one end of the spectrum, I think we're seeing, uh, increased information sharing among hospitals. We're seeing that at the behest of the, the government in Michigan, where on a daily basis, hospitals are being asked to provide, uh, daily updates on capacity and, and, and, uh, uh, patient and, and uh, uh, and availability of space. Um, and then at the other end of the spectrum, I think we're seeing much more, uh, active coordination among healthcare providers, uh, on several fronts. Uh, one being, uh, bed capacity, uh, second being, uh, patient transfers In some areas we're seeing some hospitals being designated as, uh, you know, covid 19 hospitals. Uh, we're certainly seeing some coordination on staffing, uh, whether it be, uh, uh, doctors or nurses or other clinical providers. And of course, uh, we're seeing, as Monica alluded to, we're seeing increased coordination on supplies, whether that be ventilators or P P E or any other, uh, materials that, that hospital providers need to treat the patients they're serving. Uh, but I think it's fair to say we're seeing a, uh, broadly speaking, a fair amount of coordination all along the, the clinical front in an effort to try to get patients the best care possible.
Speaker 3:So it sounds like quite a bit of activities going on. Uh, uh, are there any local or state governments directing these efforts?
Speaker 4:I think yes, uh, and I think the degree of state and regional involvement, at least from from my perspective, uh, regarding efforts to coordinate provider care efforts really varies from state to state. I'll, I'll talk about maybe one notable example. I think many of us may have been tuning in to see Governor Cuomo's daily updates, uh, uh, for the people of the state of New York. And, and in late March, I think around the 30th of the 31st, we saw the state of New York in, in perhaps an unprecedented fashion, uh, announced a new hospital network central coordinating team to facilitate a coordinated approach among the state's healthcare system, including public and private hospitals in combating the COVID 19 pandemic. And, uh, and, and that team is trying to combat covid on a number of fronts. Uh, it's helping, uh, implement, uh, a statewide public-private hospital plan to share information, but not just information, but also supplies staff and patients among hospitals across the state. It's responsible for organizing upstate to downstate staffing, assisting stress hospital, hospital, excuse me, assisting stress hospitals like, uh, the one in Elmhurst, Queens, uh, setting patient thresholds for hospitals, organizing patient transfers, and even coordinating inventory and creating state and city stockpiles and individual stockpiles. And finally, uh, the scope of, of, of that team includes facilitating staffing and recruitment. And, and I mentioned this example because I, I don't think it's, uh, certainly the only one of, uh, state or regional or local, uh, uh, agencies stepping in and trying to work with providers to ensure that patients get the best care possible. Um, uh, and that might prompt some of us antitrust lawyers on the call to wonder whether the fact that the, a state or regional or local health agency is directing this kind of activity, uh, does that make any such coordination efforts immune from federal and state antitrust liability? Let me just offer maybe a couple words on that. I think state action immunity as, as, as the doctrine is referred to private parties from antitrust liability, when the challenge conduct is undertaken pursuant to a statute that reflects a clearly expressed intent to displace competition with some form of state or local regulation, and that conduct has to be actively supervised by the state or other, uh, agency that's directing the conduct. Um, i, I, I would caution folks not to assume that state action immunity applies, uh, because both prongs, uh, of, of the test must be satisfied. And in recent years, we've seen, uh, uh, among courts, uh, uh, finding that there's a, uh, inability to satisfy the increasingly rigorous, uh, scrutiny given to the active supervision requirement. Uh, and so there are some limits to the state action, uh, DOC doctrine. But that being said, I think of the practical matter, any private party's good faith belief that any particular actions that they're taking were compelled or minimized because they were undertaken at the direction of the government official also, I would think would be a mitigating factor in the exercise of any prosecutorial discretion.
Speaker 3:So I expect there are instances when, um, the government's not directing these efforts, may providers collaborate absent any government directive.
Speaker 4:I think the short answer is yes. You know, one example that's been publicly reported on, we're seeing in South Florida in the Miami area, a consortium of hospital systems. I think round five, not only sharing information, but coordinating on issues such as bed capacity and supplies. Um, and so let me talk a little bit more specifically about, at least my own perspective on the ways in which providers may appropriately collaborate to combat covid. Um, you know, certainly, uh, kind of one type of coordination is information sharing. And I think it's fair to say that the US antitrust agencies have recognized that there are legitimate pro-competitive reasons for competitors to share information in response to a crisis like covid 19. Just for one example, as precedent, we saw in 2014 that DOJ and the FTC recognized that there's legitimate need for competitors to share information about cybersecurity threats to improve the safety of our nation's networks. And in that case, they concluded that a properly designed sharing of cybersecurity threat information was, was not likely to raise antitrust concerns. Um, I would also say, as a general matter, if competitors come together for the purpose of influ influencing government decision making, such as to jointly petition the government for relief from certain regulations, uh, I think that action is protected from antitrust challenge as constitutionally protected petitioning activity. And we, antitrust lawyers refer to that as the Nora Pennington doctrine. Um, and I think that that, that that protection would also likely extend to having any joint discussions with competitors about the meaning and interpretation of covid 19 related administrative orders, such as, uh, the scope of shelter in place orders, and what constitutes an essential business. Um, but then that prompts the question of, well, information sharing, is that gonna really be enough? Can can't providers do more regardless of whether a local or state health agency is, or, or government is, is directing to do that? And I think the answer is yes. I think there's certainly an opportunity, if not a compelling need for our hospitals and providers in some instances to coordinate on issues such as beds, capacity, staffing, and supplies. Um, I'll, I'll start though and say that as a general matter, uh, agreements with competitors regarding pricing output customers or the geo areas they'll focus on are, are among the most sensitive in antitrust. And under certain circumstances, which I, which I don't think generally apply here, may create per se or even criminal liability. Um, yet in many instances in this instance, I think cooperation with competitors on, on these issues may be necessary to ensure adequate patient care. And I think that during this time of national emergency, in, in many cases, I would expect that, again, assuming we're talking about coordination on clinical needs, bed staffing capacity supplies, I would expect that many of these activities would be assessed under the rule of reason, uh, with any restrictions on competition being weighed against the pro-competitive benefits or other justification for the con conduct. That being said, I think any goal of any, any coordination effort would be to have any restrictions on competition be limited, both in scope, uh, and, and time duration. Um, so what does that mean as, as, as a practical matter? Just to get a little more specific? I think my own view, I think it's appropriate for providers, uh, uh, to discuss, uh, a number of topics and perhaps even coordinate on them, uh, including, uh, bed capacity and utilization and opportunities to expand capacity to respond to a possible covid 19 surge. I think secondly, I think folks ought to be able to talk about care capabilities to address a, a possible COVID 19 surge. Uh, similarly, you know, third, I, I think providers may appropriately, uh, discuss and propose protocols for triage and transfer of patients. Uh, uh, that would be part of any Covid 19 response plan. Um, and, and then, and then certainly to work with one another to, uh, uh, ideally prepare those plans to be presented to a local, regional, or other agency, um, but failing that, uh, to take the additional step of actually acting on those, on those, uh, covid 19 surge plans.
Speaker 3:So it sounds like there's a wide range of, of, of efforts, um, that, that you've mentioned. There are, are there limits to the appropriate scope of coordination?
Speaker 4:Short answer, yes. I, I think any discussions or coordination should be limited to the purpose of, of responding to, uh, covid 19 and treating patients. It should really, I think, in my view, focus on the clinical needs and patients of the community. There may be other legitimate, uh, uh, needs or opportunities, uh, for, uh, coordination, uh, but I think kind of a, uh, but I think it's a practical matter only that business information that is necessary to any discussion in preparation of, of, uh, responding to covid 19 and treating patients should be disclosed or exchanged, uh, among, among competing hospitals. So, so to take one practical example, uh, hospitals that are coordinating with each other on their bed capacity and the placement, the patients probably ought not to be discussing, uh, non-clinical issues like whether and when they will, uh, respectively furlough or reduce the compensation of their non-clinical staff. Um, and I say that because there, there really are no general exemptions or defenses to antitrust liability that can be invoked to immunize actions taken by businesses either individually or collectively in response to the COVID 19, uh, pandemic. Now, I, I think that as a practical matter, federal and state enforcers are likely to recognize the legitimate need for actions taken in response to this pandemic, uh, and to take this into account as a significant factor in their enforcement decisions. But, uh, I don't think, uh, they will turn a blind eye to companies violating the a trust laws, uh, during this time. And, and, you know, one notable example we saw on March 9th, uh, just about a month ago, the DOJ announced its own intention to hold accountable anyone who violates the antitrust laws of the United States in connection with the manufacturing, distribution or sale of public health products such as face masks, respirators, and diagnostics. Um, uh, at the sa at the same time, uh, it's important to keep in mind the companies also face the risk of action by private parties who might seek to pursue antitrust remedies.
Speaker 3:So I think those are all good points, and I'll, I'll, you know, give a little more of the agency's, uh, uh, viewpoint, um, on that a little later. So, so given, you know, the, the limits to the, uh, the appropriate scope here, what antitrust guardrails should coordinating providers put in place to minimize legal risk?
Speaker 4:So, with the caveat that I recognize that these are real time life and death fast moving discussions, not all of these guardrails may be, uh, uh, uh, able to may be, um, uh, as a practical matter, uh, uh, be followed. But, uh, in general, I would offer the following thoughts for folks to consider. One, uh, is to, if possible prepare agendas for any discussions, uh, among, uh, competing providers. Um, yeah, two, uh, failing that, or in addition to that, uh, I think it's, it would be helpful and, and, and, and prudent to at least provide some guidance for counsel, provide some guidance to any persons engaged in those discussions. And I think that guidance should, uh, at a minimum highlight that, uh, any participants in these, uh, coordination efforts, uh, should, uh, absence, uh, consulting with counsel. First, really try to avoid discussing competitively sensitive topics that go beyond the scope of covid response. You know, things like avoid discussing the prices charged by individual hospitals, managed care contract rates, or any specific provisions of health plan contracts, profits, or profit levels, uh, current or prospective position, specific, specific wages. Now, as a practical matter, it may be the case that as, for example, hospitals, according on staffing, there may be some legitimate need to share some of this information. Uh, but again, I think, uh, uh, as antitrust analysis is staff specific, uh, it would be probably prudent to, to consult counsel to, to understand the appropriate limits of, of coordination efforts in, in any given situation. Um, I would also say, if possible, involve local and regional state public health agencies in the planning effort. Uh, and then finally, when in doubt, uh, consult legal counsel about the appropriate scope of any information, ex information sharing, uh, or planning efforts. And I'll also just conclude, but just the, also flagging for those counseling in this area. One other potentially useful source of guidance is the FTC DOJ statements of enforcement policy and principles relating to healthcare in any trusts. They were issued, oh, gosh, about 26 years ago, but, but continue to be a relevant and, and helpful source of guidance on, on some of these issues. Uh, and then finally, I think I'll probably turn the questioning, uh, uh, uh, uh, the questions, uh, to you, Rob. Um, it's may be a good pivot that parties also may avail themselves of an expedited biz for you or advisory opinion process that was described in a recent joint statement that the DOJ and the FTC released a few weeks ago regarding COVID 19. So, so maybe to to turn it to you, Rob, can you tell me what is the purpose of the FTC joint statement regarding COVID 19 and, and what does it include?
Speaker 3:Thanks, Peggy. Yes, you're right. A as you mentioned, the FTC and, uh, DOJ recently issued this joint statement, uh, regarding COVID 19. Um, and I'll talk ab a little bit about some of the details of that, um, in, in, in how providers can go about getting some guidance from the agencies. Let me start with just a few comments on the purpose of the statement, um, and how this all came about. Um, as the statement itself discusses the, the agencies understand that, you know, addressing this pandemic will require unprecedented cooperation among, not, among, not just government agencies, but also among private business to protect everyone's health and safeties. And so the agencies wanna provide those are responding to the crisis with, with guidance about how to make sure their efforts comply with the federal antitrust laws. Uh, as many of you know, the agencies already provide ways to ask them to evaluate proposed conduct, uh, involving competitors. And that could be fraught through an advisory opinion letter from the ftc or a business business review letter from the antitrust division of the doj. These ways can take several months after we receive all the necessary information, uh, before we can actually issue, uh, the opinion letter or the business review letter, given how quickly providers and others may need to respond to the pandemic, the agencies are providing a temporary procedure, a for a quicker turnaround time for covid 19 related requests for the advisory opinion or business review letter. And that's what this joint statement is, is all about. So I'm just gonna highlight three main components of the statement without getting into too much of the detail. First, the agencies are aiming to respond to all covid 19 related requests, uh, for a staff advisory opinion or a business review letter within seven calendar days of receiving all information necessary to vet whatever proposal the provider has. Second, the statement also explains the timing and how you go about submitting a request. Uh, for this, this type of guidance, this temporary expedited procedure is use is for use solely for cor coronavirus related public health efforts. And so you can use that in place of, of the current procedures for getting these, these, um, this guidance from the agency. Um, once the agencies, if they do issue a response, it'll be in re in effect for one year in an FTC staff advisory opinion. And, and it's similar, uh, with the business review letter, staff will state their intentions on whether to recommend that the commission bring an enforcement action based on the proposed conduct. The requester can subsequently ask staff to repeat their intention, not to challenge the conduct if more time is necessary after, after it expires. And third, the statement highlights existing guidance that may be useful for providers and others seeking to collaborate. And I'll talk about a little bit of that more later. Some of it, um, Peggy's already talked about or mentioned the agencies wanna make clear that there are many ways providers and others can work together in pro competitive ways that do not violate the antitrust laws. Keep in mind an advisory opinion letter's not required. Um, it, it's there if you, if you are seeking guidance beyond what's already available there, if you have particular issues, in fact, existing guidance may be sufficient to help structure a collaboration to avoid an antitrust problem without seeking an advisory opinion. As I said, I'll talk about some of this guidance a little later, but you know, I, I think it's also worth mentioning what the statement is not. So the statement relates to the procedure for obtaining this guidance, but it does not change enforcement policy. In particular, the statement makes clear that although there are many who are seeking to engage in legitimate pro-competitive activities, there may be some who be, could be trying to hurt competition, uh, or prey on vulnerable consumers. And so I think you're gonna expect the agencies to remain vigilant and enforce the antitrust laws were necessary. If businesses are restraining competition, you know, there may be unlawful agreements on prices or wages or, or decreasing output or reducing quality. Or if we were to see some, some groups using market power to exclude competitors from the market, and is noted in the statement the DOJ will prosecute any criminal violations of the antitrust laws. Uh, in addition, as the statement also points out, it does not relate to or alter efforts that the FTC would take to investigate any fraudulent and deceptive conduct involving COVID-19. So these are some of the key points from the statement, and, and I'll just stop there.
Speaker 4:Hey, Rob, can you talk a little more about the existing available agency guidance for providers seeking to form a collaboration?
Speaker 3:Sure. And, and there's quite a bit of it. So let me try to, um, give you some of the highlights here as well. Uh, you may wanna start with taking a look at previously issued advisory opinion letters and business review letters. This will give you some understanding of how the agencies have approached a broad variety of issues the FTC makes available on its website, uh, something called the topic and Yearly Indices of healthcare Antitrust Advisory opinions by commission and staff. Um, and all advisory opinion letters are made public when they're issued, and this index will give you a brief summary of each one with links to actually get to those opinion letters. We believe that these advisory opinions provide useful guidance, not just for the requesting party, but our hope is that it can be used by others who are looking into forming a collaboration to seek guidance from those as well. Um, and the business review letters, they're available as well on the Antitrust Divisions website. Beyond the advisory opinion letters themselves, the agencies have issued a lot of guidance for the healthcare industry. And as the statement points out, there is existing relevance guidance that could be very useful for providers responding to the pandemic. Um, and, and I think Peggy mentioned some of these, there, there are the statements of healthcare enforcement policy. Um, in particular, statements two through nine provide guidance for various types of joint ventures and how the a agencies would analyze them. There's also the competitor collaboration guidelines, um, which we'll talk about how the agencies would analyze cooperation, um, collaboration among competitors. The agencies are aware of the enormous challenges here, um, and the time constraints that many are facing. So the agencies recognize that some businesses may need to act immediately, uh, to deal with the pandemic, and they may not have time, uh, to go through this process. The statement points out many types of collaborative activities, um, that are designed to improve health and safety in response to the pandemic, and that those would be consistent with the antitrust laws. So some, some examples include research and development, sharing, technical know-how, maybe developing practice parameters. Peggy, I think you mentioned that as well. Joint purchasing arrangements, um, and lobbying addressed to, to the use of federal emergency authority. We don't have time today discuss these activities and details, but if you take a look at the statement, there's a little more detail there, and there are links and some, and some sites for getting more guidance on these activities. By the way, I guess I should point out where to find all this guidance, um, as well as other guidance that may be useful here. The statement itself has some links, um, but you can also find everything on the FTC website. I'm sure many of you are familiar with the FTC website. Uh, for those of you who are not, um, here is hopefully a quick and helpful way to find it. Um, if you go to www.ftc.gov in the upper right hand corner, there's a search box type in the words competition guidance, and in your results, the first three hits have links to relevant guidance. Uh, the first is for coronavirus information. You'll find the statement in there. Um, the second hit is for competition guidance. This will take you to a page with a lot of guidance, uh, for competitors, um, including a lot of what we're talking about today. And the third is a link to healthcare competition, which has a lot of specific information geared for, um, healthcare providers and others in the healthcare industry. So it's quite a lot of, bit of, of, of stuff here that I've covered. Um, but I did want to give you a flavor for the things that are available out there.
Speaker 4:And Rob, as someone who has, uh, regularly consulted, uh, those forms of guidance, whether it's advisory opinions, guidelines, gives review letters over the years, I found it to be often very, uh, helpful and informative. Uh, so all, all good suggestions. Um, so, so Rob, is there anything else that would be helpful for someone wanting to obtain an advisory opinion to know?
Speaker 3:Good? Well, well, firstly, I'm, I'm glad that the, uh, guidance has been been useful for you. Um, in addition to the guidance I just mentioned, let me talk about a few things that I think would be helpful if you are preparing a request for an advisory opinion, or if you're just thinking about, you know, whether or not you wanna even submit one. And today I'm gonna focus on what's in the COVID 19 statement, um, which has some specific procedures for advisory opinions and then some other specifics for the FTCs advisory opinion process. If you want to submit a request for a business review letter to the doj, there's a link in the statement that will take you to the antitrust divisions webpage that has further guidance on submissions to the doj. So first, let me start with, with the, the statement itself, um, and go through the procedures for submitting a request for an advisory opinion. Um, it needs to be in writing, and you'll send it to the email address provided in the statement, uh, which is FTC covid-19 ftc.gov. It's in the statement, I note that this procedure differs from the existing procedure. So we have a, for this temporary procedure, there's a quicker way of, of submitting everything to us in this submission. You should explain how the proposed collaboration relates to covid 19. Um, remember this, this procedure is only available if what you're gonna be proposing to do relates to the pandemic. Uh, give a description of the proposal. Uh, we'd like to see the names of the participants, the products or services covered, um, what, what the time and geographic scope of the proposal is. If there are contractual or other arrangements, you should discuss those in there as well. Names of any customers, and then any available information you may, you may have regarding the competitive significance of other providers of the products or services to be offered. And, and, and don't forget to include contact information, um, for someone, staff may contact for additional information in addition to those procedures in the statement itself, you may want to take a look at something called guidance from staff of the Bureau of Competition's Healthcare Division, or requesting and obtaining advisory opinion. This is on the FTCs website. It's on that healthcare competition page I I mentioned earlier. This is chocks full of, of I think, very useful practical information. Some of the nuts and bolts are in here. It discusses a number of things relevant to seeking advisory opinion, including who may submit a request proper subjects for an advisory opinion. Um, keep in mind a request must relate to proposed or future conduct, not ongoing conduct. There's some questions in there that staff usually ask in this situation, and there's also some practice tips. So I think these materials should answer a lot of questions, um, that you have.
Speaker 4:So, Rob, what does FTC staff need to know in order to evaluate a proposed collaboration and what can someone expect from the advisory opinion process?
Speaker 3:All right, so let me give you some thoughts on that just based on, on prior experience we've had in, in responding to, to requests and, and working. You know, usually, typically we work directly with counsel, um, on, on these requests, as you were dissing a request, remember that antitrust analysis is fact intensive. So the more we can understand about what the parties are doing and why, the better position we are in to give an advisory opinion. The advisory opinion is based on the information provided to us and any any representations made by the parties. Um, we typically don't do an independent investigations, and certainly here, we're not gonna have any time to do that. As the statement indicates, the timing is, is based on getting all the necessary information, um, to analyze the request. So it's really important, um, to, to let us know everything that you know about the request that you think would be helpful for us. We recognize the time constraints everyone is facing. Um, staff will work with you as best as we can. Um, once we have a request, um, we typically, uh, will contact a requesting party with any questions or additional requests for information that we have. And I, you know, I would expect that, you know, certainly will be the case here. So, so these are some of the key, uh, things to keep in mind.
Speaker 4:So Rob, what are the key issues staff will think about when evaluating proposal?
Speaker 3:So let me flag some of the, um, key issues that we generally, generally look at some of the, the questions that we have. And I, and maybe this will be helpful then as you pull together the information, um, that you think will be useful for us. And as I mentioned before, you know, you know, what are the providers planning to do and why are they doing this? Um, it's, it's important that we have a good understanding of, of what the purpose of, of the collaboration is and what are the specific goals, and then how the providers expect to accomplish those goals. Then it's helpful to know, you know, what basis is there to think that they will actually seek to accomplish these goals. You know, are there incentives? What are the commitments? How is the collaboration gonna be structured so that it it's capable to accomplish its goals? Um, you know, what's the EF efficiency enhance enhancing integration, um, that may be necessary to accomplish these goals. Or, or maybe there might be some financial risk sharing. And what results can reasonably expected, um, from this collaboration. How do any restraints on competition, you know, uh, is, is there gonna be joint contracting with health health plans? Is there gonna be any setting up prices? What are the constraints on competition that that may occur as a result of the collaboration? And it, we need to know how are those going to contribute to accomplishing these goals. So in other words, are those restraints reasonably necessary to achieve these goals? Um, as I mentioned before, you can look at the prior opinions and business review letters to get a better understanding, um, of how the agencies analyze these, um, specific proposals. So the, these are some of the key issues. Um, just one more thing. I should also point out that the statement notes that the agencies will take into, um, with the term used in the, um, statement is exigent circumstances in evaluating re a request. So I, I suggest you may wanna take a look at that in the statement, um, because I expect, you know, a lot of providers may be facing, you know, emergency situations. And so I think the guidance and the statement could be very useful there as well.
Speaker 4:Have the agencies issued any advisory opinions or business review letters so far under the COVID 19 statement?
Speaker 3:Yes. Um, a, as of the date, we are recording this podcast, April 13th, 2020, I'm aware of one. And that's from the antitrust division of the DO doj. Um, they issued a business review letter on April 4th, 2020 to McKesson Corporation and several other parties for proposals of expedite and increased manufac sourcing and distribution of personal protective equipment and various medications, um, for patients. Um, if you take a look at the business review letter, you'll see that these collaborative efforts are part of an emergency response developed and led by the Federal Emergency Management Agency and the US Department of Health and Human Services to address supply needs arising from the pandemic. The antitrust division stated in the letter that based on the information and representations the parties provided, the DOJ presently does not intend to challenge the efforts of the parties. And you can find a copy of this letter on the Antitrust Divisions website.
Speaker 4:So, Rob, it's been good talking to you today. Um, do you have any closing thoughts?
Speaker 3:Um, yes. Uh,<inaudible>, I really enjoyed the discussion with you as well today. Um, maybe what I'll do here is, is share some big, big picture thoughts with everyone. Staff at the FTC wanna provide as much guidance as we can. We are here to help. Um, it is worth pointing out that efforts to improve quality of care and develop ways to help patients during this pandemic are consistent with the purpose of the antitrust laws, uh, which, which is to protect competition and consumers, that through competition, um, that benefits consumers through better quality products and services, increased innovation and choice and lower costs. And, you know, these are all goals. Part of legitimate pro-competitive collaboration, um, that providers may once engage in to address the pandemic. The antitrust laws are flexible enough to take into account changing market conditions and new forms of, of healthcare delivery. Uh, but keep in mind, the FTC also remains fully prepared, uh, to enforce the antitrust laws and will continue to do so where there are those trying to take advantage of this crisis to harm competition and, and consumers. Um, as the chairman of the FTC said, when the agencies issued the statement, we understand that businesses collaborating on public health initiatives may need an expedited response from US antitrust authorities. We are committed to doing everything we can to help with these efforts while continuing to aggressively enforce the antitrust laws. Um, and, and lastly, I just wanna wish everyone all the best in your efforts to respond to the pandemic. Um, thanks for listening and I, I hope our discussion was useful. Thanks, Peggy.
Speaker 2:Thank you, Rob. It's a pleasure. And thank you both. This is Monica for your valuable insights.