Let's see if I can get her for you. If Judy Flynn is in the room, there is a gentleman up here to my left that would like to see you. It's rather important. So Judy Flynn, if you're here, there is a gentleman up here to my left. If you can touch base with him, that would be great. Thank you. The presentation number of people came up and said, well, one guy who's an actuary said, oh, he's great. OK, ladies and gentlemen, if you would take your seats, please. Our next topic is the appeals. And our presenter is Patricia Pergall. She is with the Retiree Drug Subsidy Chief Legal Counsel for Government Services Group, VIPS. Patricia is an accomplished health law attorney with over 10 years of experience specializing in regulatory compliance and government affairs. Patricia joined the VIPS team to provide legal counsel for CMS's Retiree Drug Subsidy Contract. She is responsible for the general oversight and coordination of all legal matters concerning program development, operations, and compliance. Patricia has significant experience working with health care organizations, insurers, providers, and government officials on issues involving Medicare, Medicaid, and HIPAA. Patricia earned a JD with specialization in health care law from the University of Maryland School of Law Baltimore, Maryland, and an MS in public health from Case Western Reserve University Cleveland, Ohio. Now, she is our presenter. However, all good presenters sometimes have assistance. And she has a panel of assistants that will be up here with her. Brian Maloney, Pat Ambrose, Kenneth Cole, and Joanne Sosnick. The lady in front of me, Kathy, also known as Vanna, is going to be up here with her throughout the presentation. And having said that, I welcome Patricia. I want to talk to you about the RDS appeals process today. But I want to tell you about something that happened yesterday that made a few cogs in my mind go around. And I thought that I would share that with you today. I also thought I would incorporate it into my presentation. About two days ago, I was looking through my slides. And I noticed there seemed to be a series of three. In every slide, there was always three bullets or three things in common. And I thought about it. I thought it was really interesting.  But I will admit that I have recently read the DaVinci code and the rule of four. So maybe I was seeing something that wasn't there. But I still thought it was interesting. And I also found it to be a very helpful way to remember different things about appeals. The second thing that happened yesterday was that at the end of the day, I went back to the CMS room. And I said, OK, where's my pile of questions for appeals? There was piles all over the place. There had to be over 1,000 questions. I thought, let me see what the questions are. And I'll incorporate them into my presentation. There were no appeals questions. I felt bad. And I said, oh, my. I wonder if that means people aren't interested in appeals. And I'm going to bore them with my presentation. Somebody slipped up at me and very kindly said, yeah, they expect you to be boring.  So I don't know if that was a lawyer joke or not. But anyway, so last night I thought about, what can I do to spice this up a little bit? Well, with the help of Kathy Winfield-Jones and thinking about the rule of four and the DaVinci code, just think of the appeals process as being the rule of three. I'm going to go through the appeals process and where I found those aggregate rules of three. Kathy is going to notify you to keep heads up and see if you can find them also by playing our little school. So with that, let's get started. What I'd like to talk about today is just the appeals process in general, what can be appealed, the steps to an appeal, and then something that was mentioned earlier, actually, in our previous payment session. And that is re-openings. The RDS appeals process is at 42 CFR for 23.890. Now, I don't have a statutory site there. And the reason for that is that there is no appeals process in the Medicare Modernization Act. As Mark Hamelberg mentioned yesterday and as Jim Mayhew has been mentioning, CMS has had the opportunity to be very flexible with this regulation. CMS decided that they felt that you folks, people applying for the subsidy, should have some type of a due process. So in the regulation, they did include an informal appeals process. And again, it's at this regulatory site. All appeals activity, as has been mentioned, will be conducted through the secure RDS website with the sponsor's home page or application page. And the filing will be required to be in writing. And it can, the appeals, sorry, I got a little, I kind of just tuned out when I heard that. Appeals may be, appeals may be filed by the account representative, there you go, a designee, account manager, or a designee. Now, one thing I want to say about my designee here is that I had already started this presentation before I appointed my designee, so I appointed her midway. You can do that too. If you find out that you need to appoint a designee, let's say even during the reconciliation process, if you need to do an appeal, you can appoint a designee anytime during the process, during the calendar, during your plan year, during the reconciliation process. If you do find that you do need to file an appeal, you can appoint a designee in the appropriate manner that Pat discussed yesterday. So that flexibility is built into the system. Also, with the appeals process, there is the ability to submit attachments. And I'll talk a little bit about that later. Decisions, the decision of an appeal will be, the response will be sent by email to the requester, letting them know that a determination has been made on their appeal. The full decision of the RDS Center, as far as the appeal goes, will be found on the sponsor's appeal page. And then also, if there is a determination that's in favor of the sponsor, the RDS Center will implement that within 15 days of the notice of the determination. Now, as far as submitting an appeal, if you think back to yesterday and to the website that Pat and Dave went over, the account representative, account manager, or designee would go to the RDS website and log in. They would go to the plan sponsor application summary page. And then they would go to the section where they want to appeal. There'll be a drop-down box, and then they will select the appeal function from that drop-down box. That will take them to a form that they can complete. You can submit attachments to that and submit that. If you have other attachments or other things that you want to submit to have considered for your appeal, and you don't have an electronic version, you can submit a hard copy. We have a PO box that will be set up for appeals for hard copies. And you could also fax. We have a secure fax at our appeals vendor. But we would do and encourage you to submit everything electronically. What may be appealed? Subsidy payment amount, the determination of actuarial equivalents, and also the eligibility of a covered retiree. Now, if somebody saw this slide and they said, those aren't three, there's four, can't you count? Well, the last line on this is similar determinations to those three areas of appeal that CMS determines, it might be in a gray area and CMS determines that it does fall into one of those other areas of eligibility or amount of payment. Am I wrong? There's three levels of appeal. An informal written consideration, informal hearing that will be conducted by a CMS hearing officer, and also a request for review by the CMS administrator. Now, the last level of appeal, the review by the CMS administrator is discretionary. As far as the informal written reconsideration, that is the reconsideration, the request must be filed within 15 calendar days of the initial determination, adverse determination. Again, you would go to the website and file your appeal there. The content of the appeal should be the issue and dispute, the reasons for the disagreement, and then anything that you want to attach or submit to support your case. I do want to emphasize that the record is established at this reconsideration level. So get everything in there that you have available that you think is in support of your appeal. This, it needs to be submitted at this point. Also the initial reconsideration is the determination is final and binding unless you do apply for a CMS hearing officer hearing. The informal hearing, it's conducted by a CMS hearing officer and it follows an adverse reconsideration decision or a reconsideration decision that upheld the initial determination that was adverse. It must be filed again within 15 calendar days of the reconsideration determination. Again, specify the issue and dispute, reasons for your disagreement, but no additional evidence is allowed, okay? So again, you establish that record at the reconsideration level. It is conducted by a CMS hearing officer and the decision is final unless you request a review by the CMS administrator and the CMS administrator grants that review. Hearing options. If you do request a hearing by a CMS hearing officer, there's three types of hearings that are available on the record via telephone or in person. Now in person or by telephone, oral argument is allowed but no testimony. So again, you can go and you can plead your case as long as you stick within and use all the evidence that you've already submitted. You can try to get up there and start including some new facts and some new evidence that would be considered testimony. If you do opt for either in-person hearing or telephonic hearing, the CMS administrator will notify you 10 days prior to the hearing of the date and time of the hearing. The third type of hearing, as I mentioned, is on the record and the CMS administrator would look at the record from below from the reconsideration decision and consider all of that information and is including the documentation that you submitted as far as the reason for your request in making a final decision. And as far as selecting an option, you do select that option at the time of filing for a hearing officer hearing. The last level of appeal is reviewed by the CMS administrator. And I'll just let you know, as it looks now, that will be conducted by Leslie Norwalk, the deputy director of CMS. It is available, reviewed by the CMS administrator, is available following a hearing officer decision. It is, however, discretionary. So even though you submit a request within 15 calendar days of notice of the reconsideration, I mean, of the hearing officer determination, it may not, your request may not be granted. But again, when you do file a request for review by the CMS administrator, you want to specify the issues in dispute, the reasons for your disagreement and no additional evidence, again, is allowed. Now, the review by the CMS administrator, if you get that far, is final and binding. Thank you, you're doing a great job. Okay, re-openings, there are three bullets on this. Re-openings, and this is something that we were just talking about previously with payments. Re-openings apply to initial determinations as well as reconsideration determinations. They are discretionary. You can request a re-opening, but it will be the RDS center's final determination whether to grant that re-opening or whether to conduct a re-opening itself. The decision not to re-open is final and binding. Basis for re-opening, so when can a re-opening happen? Within one year of the determination, again, the initial determination or the reconsideration determination, for any reason at all. Within four years of that determination, if there is good cause, and then at any time, if the determination was obtained through fraud, what are the bases for good cause or what is good cause? If new and material evidence is unavailable at the time of the initial determination, if there was a clerical error in computation of the payments, and then finally, good cause is if, on its face, the evidence that was considered in making either the initial determination or reconsideration determination was clearly erroneous. So these are the three areas or reasons for that are considered good cause. Oh, sorry. Okay, there's no good cause. Although I could probably turn this into three bullets if I wanted. No good cause exists if the only reason for a re-opening is a change in legal interpretation or an administrative ruling upon which the initial determination was made. So in other words, there's no retroactive openings for good cause because the law changed or because there has been an administrative ruling that varied from the initial reason for conducting, making the determination. And with that, Kathy, I wanna thank you very much. Let's hear it for Kathy. Account representative, account manager, thank you, and we will be ready to take questions. Don't go away, Kathy, I may need you. Good, good job. I like that a lot. Thank you. Where did you get that? The guy outside? You took it off the guy outside. Only attorneys can do things like that, right? Okay, for my facilitators that are facilitating the microphones, if you will find your microphone, we are going to another live Q&A. If you have questions, please line up behind one of the microphones. We will start again with my immediate right and work our way over. One question per person name organization is optional. Anybody have any questions about on the division vote or roll of four? Now be patient, they have to get up and it's okay. Attorneys are not boring, I don't think so. Not at all. Well, we're gonna change things a little. The gentleman in the green shirt to my right or to my left. Thank you. Jim McDonough from Bridgestone Firestone. Somewhat related to the appeal process, but if we don't necessarily want to appeal something, but we want to audit the amount of payment so we can verify that it is correct, will there be opportunity for sponsors to be able to do that? That is a CMS policy question and Jim Mayhew, if you're, are you within? Can we hold that until Jim? Is Jim here? If Jim does not come back by the time we finish, please write that question down and hand it to me, would you please? We'll do, thank you. Thank you. The lady to my right, please. Robin Haggerty from Mercer. I'm not sure I'm clear on what a reopening is. Is that CMS opening the case, not the employer? Right, that CMS opening the case, an employer, a sponsor, a planned sponsor can request a reopening, but it is CMS or the RDS Center making a determination whether to reopen a case. And again, there's the three opportunities for reopening that I listed and that are in the handouts. So the reopening is the appeals, I guess I'm not sure I'm mentioning it. It's kind of an addendum, I guess, to the appeals process. In the reg, it's included under the appeals section 890, but it's almost another opportunity to reopen again a case or to take a look at the case after the planned sponsor has gone through the appeals process. The one thing about the reopening again that I want to emphasize is a planned sponsor can request it, but it really is a determination that will be made by CMS or, and the RDS Center working together to decide whether or not to reopen a case. Thank you. Thank you. The lady to my far right, please. Hi, Julie May with Coventry Health Care. Had a quick question that if we submit- Could you speak closer to the microphone, please? Sure. Thank you. Is this better? That's much better, thank you. If we submit via the monthly retiree list, a retiree that we subsequently receive a response that they're not eligible, do we go through the appeals process to get that corrected or simply in the next month put that retiree back on with a retroactive date? Joanne and Pat? I think it depends on the reason for the rejection and your feeling about that. If you believe that the RDS Center has made an incorrect determination about a retiree's eligibility for the subsidy, then that would be an appeal of that retiree's status. If on the other hand, we're telling you that this particular person is not eligible for the subsidy because they're not entitled for Medicare, then, and you agree with that or you don't know any differently, then that would be, and then you obtain information, let's say, from the retiree that they now are entitled, then you would just resubmit that record on an ad as an ad in a later submission of your retiree file. Does that answer your question? I think what you're saying is, if it's, let's say, an eligibility question, we have documentation that they are in fact eligible, but the response came back that said they weren't, we would just simply resubmit them. Actually, if you do, in that case, if you feel that the RDS Center was incorrect in its determination, I would recommend that you appeal it so that someone look at it. We have a process for our RDS Center staff to take that inquiry and go out and do an online lookup of the Medicare beneficiary database and work with you to find out why your information differs from what Medicare has. I mean, of course, maybe the information was not completely up to date on the Medicare beneficiary database at the time that we made the determination. Right, that's often the case, it is timing. And our RDS Center staff could, you know, basically troubleshoot that situation. So that's a telephone call to the RDS staff? In this case, you would submit your appeal online in the, on the Secure website and that then request would be transferred to an internal staff person who's working, you know, would work that out. If they make a determination, then you would be notified via email, et cetera. You may get a phone call to talk about the situation and if additional supporting information is needed. So I think just to kind of confirm what you're saying is if that situation occurs, we can take one or two tracks. We can either resubmit in a subsequent month if it goes through, great. If we don't feel that that's going to be a good option, we can go ahead and put an appeal in. Yes, ma'am. Okay, thank you. Also, I just want to say, remind you that there are reason codes for rejecting any of the retirees. So if the reason code is something that's not based on updated, having updated data, then that's probably something that you would want to appeal. The lady to my far left, please. Jane Gilbert with Kentucky Teacher's Retirement System. My question is in regards to the 15-day limitation with the first retiree list submission being submitted with the application and my understanding is CMS will have a response file back around November 1st or somewhere in November. The 15 days to me on that first submission does not seem realistic. I mean, you're looking at thousands of responses and reason codes and I'm just asking, does the 15-day limit apply to that first submission? Again, I think that CMS has to make that determination. The regulation does say 15 days from the date of the adverse determination. So as soon as you get notice, in the case that you're talking about, that a retiree is not qualified, that would start the 15-day clock. Now, we can take that back to CMS and ask them if there's any flexibility or Brian. Yeah, no, I would agree with what Patricia is saying that it would apply. That's that initial retiree list submission, regardless, unfortunately, the volume that potentially could be returned. Thank you. The gentleman to my left, please. Well, from Becker Corporation. We, our company has a rather unique plan design and our actuaries right now, I guess we've stomped them because they don't know if our plan is gonna be credible or not. So my question is, if our actuaries think that the plan is credible and it's submitted to our DS and then you think it's not, what are the procedures then? Would then we then appeal or is it just no at that point or how would we go about it? Well, again, that's an interesting question because I guess you're, I'm just thinking through the process here. Your actuary probably wouldn't want to attest to the gross into the net of the option. So that would hold you back on being able to submit an application. No, no, my question is if, let's say the actuary and us feel that it is credible. Oh, and you want a confirmation? You then review it and then you say, no, it's not. Right. So that's my question. Yeah. What the RDS center, the RDS center won't be going back and looking at the actual actuary calculations of plans that will be done during audit. And I know that we're going to be talking about the audit process this afternoon. Now, Brian has CMS determine or made a decision whether or not if somebody wants to come forward to. Right. I mean, I think if we're, if you submit your application and we're denying it based on and not being credible and that's something that you would want to appeal through us. I think the question is, is that in good faith the plan sponsor and the actuary believe that the plan meets the grossed and net tests but they're not a hundred percent sure because it is a strange configuration. Right. So you would have, you would suggest that they appeal that? We can, we'll look into that and we'll get back to you on it. Okay. Thanks. Thank you. The gentleman to my far right, please. John Bryson, Anthem. My question is similar on the appeals it talks about determination of actuary equivalents and just a further explanation of what is being appealed because I was assuming that once the actuary signs off on that, it's, it just goes forward and I'm not sure what would be appealed. Well again with the appeals process that is something that we are still trying to think about all of the issues that may come up in all the scenarios and you're correct that with the application that the actuary will be signing the application and attesting to the fact of the gross and the net value where I could see there being a question about the actuarial equivalency may be as a result of an audit where it's questioned or some other process where CMS or OIG or whoever will be conducting the audits does have a question about the actuarial equivalents but during the application process you're correct the actuary will be filling out the application, attesting and then getting into the paperwork and determination of actuarial equivalents would be something that would probably come later during an audit. The gentleman to my right please. I'm George Cooper from Ingersoll Rand. My question concerns its follow up to the question about the 15 day rule. We're gonna submit a file in September that's based on the 1106 population and then in October, November we're gonna go through an open enrollment period with our retirees that typically changes our population by 10 to 15%. So if that file is then ready to send to RDS in December, how are we gonna address the 15 day rule? Pat, do you have suggestions for updating files? Well, I have actually kind of, I need to ask you and Brian a clarifying question. Is it, does the 15 days would it apply? He's going to send us an updated retiree file, an update file in December. Then let's say that we receive and process that file by December 30th or something. Does he have 15 days to appeal anything that's on that updated file from December 30th? I think that is that pretty much, or does it go back to the initial submission of September 30th for his initial retiree file? I would think that we're talking about the update file that he would have. Yeah, that's correct. That's correct, the update file. If there were any rejections on the update file, then you could appeal that. So you've got 15 days on for each file. Yeah, correct, correct. We're going to go to the lady to my far right and then the lady to my left. So the lady to my far right, please. This is another question about the eligibility. Can multiple beneficiaries be included in one appeal for the same reject reason? Well, actually the way that we are currently designing the appeal process on the secure website is that it's one retiree at a time. And we will certainly take your feedback if that requirement needs to change in a future release but at this point in time it's retiree by retiree. I also would like to quickly clarify something that was said previously in Trisha's presentation. If you have attachments or other documentation that you need to submit with your appeal, again the first implementation of the appeal process on the secure website, you will not be able to attach it and send it to us on the appeal form that you're filling out. We hope to add that functionality later. So if you need to send additional documentation it has to come to the PO box that will be published on the website for appeals or possibly fax it in. I'm not sure if a fax number would be available as well. But that functionality will be added to be able to attach. I am hoping to add that functionality, yes. The lady to my left please. Ronnie McDonough, Ken Ameddle. My question is the 15 days is that business days or calendar days? They are calendar days. And the lady to my far left please. Cara Jarab, actuary with Watson Wyatt. I have a question about the situation that the gentleman raised where a client has a very close to call plan design and they might even be within our thresholds that we're not sure if they're actuarially equivalent or not. What is the process that CMS has set up to, or is there a process that CMS has set up? Is it working with say Paul Spitalnik in the Office of the Actuaries? How do we get some more clarification in those kinds of instances? Well I think just as a point of clarification when the applications first submitted we are going on the attestation of the actuary. We are not initially going to be looking to your work papers or anything like that. That's going to happen subsequently during the audit process. And so that's when a potential appeal would come up if we determined at that time that the coverage was incredible. But in terms of getting more information, yes we would be working closely with our Office of the Actuary. And you mentioned Paul Spitalnik, yes he does work there. We would work with him to provide whatever, to get whatever guidance us non-actuaries need to convey that to you all. I mean the problem with the audit process is it's after the fact. And so the subsidies been received by the client and then there's monies that have been transferred, et cetera, et cetera. So I mean what we would like in the circumstance where an organization's plan design is very close to have some kind of process with CMS to get some kind of guidance around the specific issues. So just a thought. No we definitely appreciate that and we'll talk about that. And in a little while we're going to be having the presentation on audits and there will probably be more information provided there on that. But we can certainly take that into consideration. Thank you. Thank you. The gentleman to my right please. Yes my name is James Burris. I'm with the Commonwealth of Pennsylvania. To reiterate the concern about the 15 day period, particularly with the initial submission, I'm going to submit a file to you that's going to have upwards of 40,000 people on it. Some of which you may or may not reject. It's going to be difficult for me to review any rejects within a 15 day period and determine if any supporting documents are going to be required with that kind of numbers. And I'm sure that there are employers out there that have even greater numbers than I have. Is that 15 day, particularly with the initial submission files going to be firm? Or is there any kind of flexibility in that regard? Well I'm hearing a consistent concern in those 15 days and while I'm not in the position to speak right now about what we would do to that matter, I can certainly take that back to individuals like Jim Mayhew and Mark Hamelberg and we'll address that accordingly if at all possible. Just to clarify too, the regulation does say 15 days. Could I make a suggestion when it comes to the retiree files? If a retiree is rejected on your initial submission, there's really nothing stopping you from sending that rejected record again on an update file as an ad record again and attempting it and so that buys you another 15 days I guess we could. It's just a suggestion but it might be a good recommendation to address that concern. The lady to my far left please. Jane again with Kentucky Teacher's Retirement System. Jane could you come closer to the microphone please. Question in regards to the response reason codes of three, four and five. Will we be rejected for receiving a subsidy based upon our system having a different spelling of a first or last name in compared to Medicare's database? There is a matching process on the Medicare beneficiary database that does involve the use of last name. They have a scoring system and unfortunately I don't know it off the top of my head but we're going to take that either the Social Security number or the HIC number that you provide us along with the name and date of birth and those gender, those are the basic elements. So if I don't know if we need to have an exact match on the last name but there is a matching algorithm and I really can't fully answer your question today but there is the possibility that if your information about that retiree is different from what is stored on the Medicare beneficiary database that we would not recognize that person and reject it, reject the record it's possible. So that would be something that we need to turn around and appeal in 15 days? Yes and as I said as you could make a correction to your file try to find out from the retiree what is on their Medicare card, update your file and re-send the record as an ad again and allow it to go through that way. Thank you. The gentleman to my left please. Another question regarding the initial application with the eligibility and understanding when retirees if they try to sign up for Part D they may be informed because CMS already knows that they have employer coverage. I guess my question is when will the initial determination be provided back after the initial application and with the eligibility? Let's see if I understand your question first. You have submitted a retiree to claim the subsidy and we've accepted that record and posted a subsidy period. We put that subsidy period then on the Medicare beneficiary database and for this initial period of time we're trying to do that before open enrollment for Part D starts November 15th. What will happen is if we have posted this period of subsidy for that retiree on the MBD when they go to a Part D plan and attempt to enroll in Part D they will initially receive a rejection and be informed by the Part D plan that you are already claimed by your employer's subsidy program you don't need to, they'll try to do some outreach and educate them. At that same time the RDS system will receive an alert or a notification from that Part D enrollment system and we will turn that around and send it to the plan sponsor on the notification file. So you'll start receiving those on November 15th and subsequent. Then to finish up the process when the retiree or beneficiary can override that rejection and insist upon signing up for Part D it's their right to do so. We will then alert you of that will actually close out or end your subsidy period appropriately according to the dates for the Part D eligibility and inform you of that on a notification file that I discussed yesterday. And again that would start November 15th and going forward that that sort of transaction would take place. Okay. So just a follow up question when we supply that initial eligibility I think on September 15th at our application when will we receive the determination on that initial eligibility file? We should be able to turn those files around in a couple of days but we have a service level agreement of 15 days but it really is a, the process is we send an inquiry essentially to the Medicare beneficiary database and we ask checking on the eligibility and entitlement information for that retiree make our determination create the subsidy record on our own database and then create a response file for you and send it back. So it really should be a couple of days. Okay. Okay, thank you. The lady to my right please. Yeah, I understand that plan sponsors have a 15 day limit in which they're supposed to make their appeal if there's going to be one. What is the timeframe in which RDS has to make its decision with respect to that appeal? The RDS center has a agreement with CMS to make a determination on the reconsideration request within 30 days. Now at the hearing officer level and at the administrator level there are no timeframes associated with the hearing officers or the administrator turning a request around. They are going to try to do it as quickly as possible but of course there's other issues that the hearing officer and the administrator's office are dealing with. So there are no specific timeframes for the hearing officers nor the administrator but that initial reconsideration is 30 days. Okay, thanks. The gentleman immediately behind you please. Is that me? Lay out something of a scenario here. We submit 40,000 some odd names and you reject some percentage of that group and we have the 15 days to appeal that. You had suggested that we could resubmit those names the following month or during the update file at which point you may accept those names that you previously rejected. Now have we lost that month which they were rejected? So for example you had them in for a full 12 month period but they were rejected for the month. Now you've resubmitted then they've been accepted but now you've only got 11 months of subsidy for that individual not 12 because you didn't appeal their initial rejection. Actually once you, you would have them for the full 12 months if we made that determination on the secondary when you send the file the second time we will take information that you're sending us you will request the full 12 months for that retiree as long as according to our records in the Medicare entitlement and eligibility if we will back date it I guess is what I'm trying to say. Sorry. Sorry. The lady to my far right please. Patricia this is another question for you regarding the verification is there any kind of a verification or audit process that will be implemented for a Part D provider that tries to resubmit a beneficiary a second time prior to the employer even talking with that member. I mean you know what audit or procedures will be in place to prevent that from happening where the Part D provider actually resubmits that member and they're really with the employer. Could I hold that and have our audit presentation address that issue I think that that would probably be the most appropriate place to address that. And we're taking notes of that right now that's the presentation that follows lunch. Our time has lapsed for the two gentlemen that are there with questions. Do you each have a facilitator if you would write those two questions down I will and bring them up to me then I will be sure that we answer those. We are now adjourned until 1 30 p.m. Thank you. Before we begin the program on program oversight Mark Hamelberg has some comments to make and so I will turn the program over to Mark. Can we get the mic in front of Mark open please. Can you hear me now. Yes. Okay. A couple of clarifications based upon some issues and concerns that were raised before the break for lunch. The first is that there was a question or two dealing with the case where liability under the plan may accrue for the payment of a drug cost but actual payment doesn't occur until the next plan year or the plan doesn't know about that obligation until the next plan year. Our intent is to say in that case that your ability to get the subsidy payment relates back to the year that the claim was incurred not to the year of actual payment. Okay. So I had a request to say it again. So it relates back to because you like it so much the first time she's actually doesn't trust me to say at the same time same way again. It will in this situation for example if a cost an obligation under the plan to pay a drug cost arises say in December of a given year and the plans an obligation to pay under the plan doesn't actually get found out and payment isn't actually made until the subsequent year. The event that triggers the subsidy payment relates back to the prior year not to the next year. So the question was raised for example well what if we have this situation where it occurs and in the following year we're not even taking the subsidy do we lose that potential subsidy payment and the answer is no you don't lose it. It's all gonna be relating back to the prior year. Okay. Obviously during the reconciliation process if there are adjustments in what was actually paid whether it's because of actual rebates incurred whether it's because of coordination of benefits activities that adjust what was actually paid those will be fleshed out in the reconciliation process but again you're gonna be focusing on a plan year basis. Is that clear to folks or reasonably clear enough that I can go on to the next issue? Okay. And I'll be hanging around through the rest of the day and we also have, well I'll be hanging around through the rest of the day. The next issue has to do with appeals. There were some concerns raised about the 15 day appeal rule in the regulation. And I believe Patricia did indicate in the presentation prior to the Q and A that the 15 day rule isn't the only type of appeal provision that's available. In fact there is a rule that allows up to one year requests for reconsideration of a decision for no reason at all. Is it even a longer period, I think it's four years for good cause. But there's a one year from the date of the initial determination that you can request a reconsideration. A reopening from the PNIC gallery over there called the reopening. Now a couple of things to mention here. One as Patricia rightly pointed out the regulation is written in a way that says that CMS has a discretion whether to reopen. But I can assure you that particularly in the early years of the program that CMS will be extremely flexible and generous in this area. So if you are unable to submit within a 15 day period an appeal request on a rejected enrollee that doesn't end it for you. The matter will not be over. Obviously we need to create some standards in the process that even on an intermediate or an interim basis we get some finality so that the system and the processing can go forward. But if you're unable, because you have, I think the example was given 40,000 retirees or more. If you're unable within a 15 day period to figure out what's going on and to request a reconsideration of a rejected retiree you have not lost your ability to appeal it and that we will be extremely flexible in making sure that the right information, both we have it and that you have it and that reopening we can relate back to the first day of the period or whatever the proper period is. So I hope that gives people some additional level of comfort. You're not gonna have to forego vacation the entire year. You will be able to get this resolved. Is that okay too? Any, I'll take applause for that as well. Thank you. Can you use validation? And that's it. I'm gonna now turn it over to your regularly scheduled program. Thanks. In a minute you'll see why I'm smiling. It's kind of fun. We are going to have a slight change in the afternoon program, which I think will be very beneficial to all of you. We are not going to go to the program oversight Q&A after the presentation. What we are going to do because of the amount of interest generated both yesterday and today and the volume of questions both formally, informally, offline by all of you, which are really some of the best feedback that we've had throughout these conferences. And it's really important that when you leave here at the close of the conference today that you feel that you have enough information to do what you need to do in a short period of time. And if you don't have that information you know where to get it. So what we are going to do is immediately after this panel is done we have rescheduled the break. The break will be a little bit longer than what is scheduled now. Then we are going to set up an expanded panel so that when the questions come this afternoon in addition to those from today, those from yesterday that we will be able to provide the best responses to those questions as possible. We will be using only written questions and the panel has spent most of their lunch hour going through to try and make sure that we address those that are going to be the most pertinent and relevant. Again, all the questions eventually will show up on the website. And I say eventually it takes some place around six weeks but we're trying to look at a way that given what we need to know about this group that we can find the most expeditious way possible. So that is why the decision was made to expand the Q&A for this afternoon. So having said that, they've just handed me something that I probably need to figure out what to do with in just a second. Oh my goodness. Anybody missing a cell phone? It was found in the ladies room. So I'm going to assume it belongs to one of the ladies. And if the opening, if you can tell me what it says on the opening screen which is really quite unique. I mean it's really unique. But it does say vibrator on. So that's an even better thing. So that's a good thing. Now when this lady comes up here, don't all of you applaud at one time. But actually if the owner of this will see Janine, Janine is this lady right over here. She will have it in the back of the room if this is your cell phone. Don't go there now. Don't go there. You don't want to do that. Okay, our program oversight is being presented by James Crawl, Maryland Harrington and David LaMere. I will introduce each of them individually. Maryland Harrington, retiree, drug subsidy fraud and abuse manager, Arkansas Blue Cross and Blue Shield. She is an accredited healthcare fraud investigator as designated by the National Healthcare Anti Fraud Association.  She is the primary point of contract for law enforcement requests and all CMS communications concerning fraud and abuse related to the retiree drug subsidy program. Maryland is also the primary contact for all law enforcement agencies in the Sixth State Arkansas Blue Cross and Blue Shield consortium.  Maryland previously worked as a white collar crime and consumer fraud investigator for the Arkansas Attorney General's office. James Crawl is the health insurance specialist for the RDS operations. He is a health insurance specialist for operations with the employer policy and operations group within the Center for Medicare and Medicaid Services. He is responsible for helping establish operations for the RDS program. James has over 15 years of Medicare operations experience including project officer responsibilities in the areas of EDI operations, electronic attachments development, contractor performance evaluations and HEPA transactions. David LaMaire is the CPA manager in the Office of Audit Services for the Office of Inspector General in the Boston Regional Office with over 18 years of experience with auditing. It is my pleasure to welcome this panel. Good afternoon. Can everybody see me now? I have to get on my soapbox for this, so y'all just please bear with me. Did everyone have a good lunch? No. Is everyone sleepy now for a nap? Go ahead, that's all right. I am the manager of the fraud unit for RDS. I have worked in Medicare fraud since 1997. I worked at the Attorney General's Office in Arkansas prior to that in consumer protection, in white collar crime and in Medicaid fraud. And while I was with Medicaid fraud, I did a lot of pharmacy cases and so that just kind of blends over into RDS. Excuse me. To launch right into this program, the goals of the Benefit Integrity Unit. The first one is to confirm the identity of individuals and organizations in the RDS program. We have to know who we are doing business with. We have to know that the people that we are making payments to are really who they say they are. And the process of confirming the identity of the individuals who make application into the program actually begins with the application process. If the individuals in the application department, for some reason have problems confirming the identity of a person who has made application. For some reason, they just can't find information or whatever the case may be. They will send it on up to the fraud unit. We'll take a little bit closer look at it. Nothing to be worried about there unless you're not really who you say you are. Another goal is to make the accurate payments and to protect the Medicare trust fund and detect and prevent fraud and abuse. That is our number one goal, to detect and prevent fraud and abuse on the front end. We don't wanna have to pay in chase. Occasionally we do and we will but we don't wanna have to. To detect and prevent fraud, we will do this by both proactive and reactive means. And I'll go into that in just a little bit. The primary responsibilities of the benefit integrity unit are to respond to complaints of fraud and or abuse. If you see that your employer or someone that you know maybe is not doing things just exactly like you think they should be done and you think maybe something's a little bit strange, you can call our customer service line. They will take the information that you give them and they will pass it on up to us in the fraud unit and we will take a look at it. We will respond to all the complaints. Responding to the complaints is a reactive method. We will also do proactive methods of detecting fraud by doing some data analysis on payments, that kind of thing to see if there's any aberrancy, to see if there's someone who's really an outlier as far as payments go. So we plan to do both of these methods. We develop cases for referral to law enforcement. We will take that complaint or we will take the results of that data analysis. We will work it up to a certain point where we feel that there is a strong indication of fraud and we will then refer it to the Inspector General's office or to other law enforcement to see if they're interested in pursuing it and to support law enforcement is our third responsibility. Whenever we refer a case to law enforcement, we obviously send them all the information, all the data that we have. When they really get into the meat and bones of an investigation, they usually will need other information and so they come back to us for that and we will have to go to the other departments. They may want to see the application file. They may want to see an appeals file, something like that but the law enforcement will come back to the fraud unit and we will handle all of their requests for them. Okay, this is just a definition of fraud but there again, this is what everything is based on. Fraud is the intentional deception or misrepresentation which an individual knows to be false or does not believe to be true and he makes it anyway, knowing that the deception could result in some unauthorized benefit. Fraud is intentional. It's not an accident. It's not an error. It's not a keystroke error. Fraud's intentional. It's planned. Some examples of the potential fraud that could occur in the RDS program and again, this program is very new. We're still feeling our way around when it's all up and running, we will have a much better idea of what we may need to look for. Some examples of potential fraud and I hope you all don't get any ideas from these slides though. So, if you think you might just close your eyes, submitting false information on the RDS program application, false information on the retiree list or creating false or misleading documentation on the actuarial equivalence. Say that three times in a row. Some more examples, false or misleading data on your drug costs. Submitting false or misleading data regarding rebates, other price concessions or false or misleading documentations in appeals. These are all pretty self-explanatory. The actions that can be taken if fraud is identified. Of course, we will refer to the Office of Inspector General if they declined to take the case. We may get CMS approval to take it somewhere else possibly to the FBI or somewhere like that.  An action that can be taken is exclusion from participation in federal programs. If you are convicted of a crime in a federal program, you will be excluded from doing business with the federal government. And this is across all programs. Administrative sanctions, that can mean a suspension of future payments by RDS or we can withhold an overpayment amount from future claims. The civil monetary penalties, those can be levied by the Department of Justice as fines or restitution. Okay, the referral to the OIG, the Office of Inspector General. We've already talked about the first two bullets on this slide. The last one, however, the criminal penalties, incarceration, fines or restitution, asset seizure. I have been to numerous fraud conferences where some of the speakers have been either Inspector General's Office members or FBI members. They did their presentation and the first thing they like to do is to throw up pictures of automobiles, boats, other properties that they have seized. I don't know if they get extra points for that or not, but they really like to seize those assets. We don't do that. We're the good guys, we don't do that. Some situations that may not be fraud, making a drug cost calculation or processing error, unknowingly submitting incorrect data on rebates, unknowingly submitting incorrect information on retirees. Now the key words here are error and unknowingly. Everybody makes mistakes. I don't know anybody that walks on water. We're all subject to mistakes. And so if that's what it is, an honest mistake or an honest error, we might tell you about it, we might help you correct it, but we're not gonna work a fraud case, we're not gonna refer you to law enforcement because fraud is intentional. Abuse is the incident or practice of planned sponsors that is inconsistent with accepted sound, business or fiscal practices. These practices may directly or indirectly result in unnecessary costs to Medicare and or the RDS program. An example of abuse, maybe where the entity submits a list of retirees and none of them are eligible for the subsidy. Okay, we'll tell you if you submit a retiree that is ineligible, we will send that information back to you. If you just keep on submitting that list over and over and over again and you submit payments over and over and over again and try to game the system in the hopes that one of these claims will get through and get paid because the system may be confused from all the information that you're sending to it, this is abuse, this could also be fraud, it just depends, but I know that everyone here is very honest and they may make mistakes but they're never gonna commit fraud, right? Okay, when abuse is identified, if payments are made in error, the RDS program, RDS Center will send a demand letter out to the planned sponsor who got the money we will ask them for the money back. There are some other language that goes in that letter. If the overpayment amount is not sent back within a certain amount of time, we can withhold from future payments and as a last resort, CMS may give us the authority to suspend all future payments until the issue is resolved. And I've been involved in some payment suspensions in a former life and it hurts, it hurts the providers, it hurts the planned sponsors because all your money is cut off, it's 100% payment suspension. Education warnings, you may receive some written correspondence from the RDS program saying that maybe this isn't exactly how you need to be doing things. Once you're educated, if it happens again and again and again, that's abuse, could be fraud. We'll turn it over to law enforcement or CMS and see what they think about that. And then again, the last bullet, refer to the CMS or law enforcement for audit or investigation. And as much as you don't want to see me appear on your doorstep and you don't want to see a YG on your doorstep, you really don't want to see an auditor show up on your doorstep, I'm sorry. Sorry, Jim. Had to throw that in there. In conclusion, we believe that most planned sponsors will be honest, careful and conscientious. We know that you want to do a good job. We know that you don't want to see any of us. We know that mistakes can and do happen. Sometimes they happen over and over again. If that's the case, we may contact you and say, hey, what's going on? Is there something we can do to help you to get over this hurdle, whatever we need to do. The Benefit Integrity Unit will not refer planned sponsors to law enforcement unless there is evidence of fraud. And again, evidence of fraud means that fraud is intentional, that we have a strong suspicion that it was intentional. And remember that when someone commits fraud abuse, they're taking money out of Medicare. We all share the responsibility of protecting our Medicare benefits. And it's everyone's job to be the eyes and ears of the community and to let us know if they see something wrong out there. We'll be glad to take whatever information you want to give us, call the hotline, call the customer service lines. They will connect you with either me or someone in the fraud unit. We'll be glad to take your information and see what we can do with it. But again, it's everyone's job to be ever vigilant and to help us preserve Medicare for future generations. And that's all I have right now. I'm gonna get off my soapbox. It's too hot. Good afternoon and thank you for staying. I'm Jim Caroll from CMS and I want to continue the discussion on program oversight and in particular, speak about the RDS program audits. I'd like to share our vision for RDS program audits and where we believe we are going and what we are thinking currently. Essentially, we're looking at two types of audits, a random audit where the plan sponsors will be selected using statistically valid random samples within strata based on plan sponsor size. And what that means is we would take the plan sponsors and possibly put them into a small, medium, or large size based on the number of qualified retirees and then do our statistically valid random sample within each of those segments or strata. Another type of audit is targeted. And essentially the subjects would be selected based on information derived or received by CMS from RDS center referrals, random audit findings, complaints, and or law enforcement officials. Those are some specific examples of how we would get to the targeted. And right now, we believe our audit categories would be credible coverage disclosures, actuarial equivalency attestation, and subsidy payments. And how this would work with the random sample is again, going back to the plan sponsor sizes, small, medium, and large, we would select our statistically valid random sample within, for example, the large plan sponsor size. And then we would look at these audit categories if a particular plan sponsor was selected. We would look at the credible coverage, the actual equivalency and the subsidy payments. I wanna talk briefly about the credible coverage disclosure. And the purpose is to determine if plan sponsor credible coverage disclosure is in accordance with the law, regulations, and CMS guidance. And that's, the authority is 42 CFR 423.56. I'm sure you're familiar with that citation. For credible coverage disclosure, what will be examined? At this time, we are thinking that we would look at the actual credible coverage disclosure that was made by the plan sponsor, whether it be a letter, a bulletin, or a plan benefit booklet. And then we'd like to know the intended target audience for the disclosure, whether it be the entire qualified retiree population or some segment, depending on the medium you've chosen to reach that select retiree group. And then also, we would like some type of evidence that the disclosure occurred, for example, what retirees did you contact, that type of thing, and what date did you contact them? Regarding the actuarial equivalency attestation, the purpose of this audit is to, to confirm that the plan is at least actuarial equivalent to standard Medicare Part D drug benefit. And currently, when performing this type of audit, we believe at this time that we will be actually looking at the actuarial working papers to determine if the actuarial principles were correct. You would generally accept it. And also the accuracy of the gross value test calculation and the accuracy of the net value test calculation. Another category of audits is the subsidy payment audits. The purpose of this audit is to confirm the accuracy of plan sponsor payment requests and RDS center subsidy payments. At this point, we envision that we will be examining the RDS center electronic funds transfers and remittance advices, the plan sponsor payment requests and the source data such as drug claim rebate, charge back and price concession data. And currently we do have some open issues as we go down the road of audit. And for example, how will we get the source data to the auditor? Will it be electronic or hard copy? And will there be a particular format or record layout or could we build on something that's in existence today to make it easier for you all to provide the information? And then also, what proportion of the audits will be desk reviews versus onsite? And that question may turn on the percentage of electronic, percentage of audits that can be performed electronically. And I'll turn it over to Dave from our office inspector general. Good afternoon. My name is Dave Lomero. I'm with the OIG office of audit services in Boston. I'm here to discuss briefly today the OIG mission and structure, our regulatory authority, and our role in the IDS program area. I promise I'm gonna be brief. I know it's the second day in the conference. It's after lunch. I'm the last speaker. And I believe I use that term loosely. I'm no speaker and you're gonna recognize that in a couple of minutes. I almost like, I think I drew the short straw in Boston. So anyway, regarding our mission and structure, the statutory mission of the OIG is to improve HHS programs and operations and to protect those programs from fraud, waste, and abuse. We have about 1400 staff throughout the country and our four compliance components. Daniel Levinson is our inspector general. Mr. Levinson was appointed by the president. He was recently confirmed by the Senate. Our mission is carried out to a nationwide independent and objective audits, investigations, program evaluations conducted by our four components, the office of audit services, the office of investigations, the office of program evaluation inspections, and the office of counsel to the inspector general. I'm not used to, I usually just use the acronyms, O-A-S-O-I, O-SIG, O-E-I. I'm used to spelling out these names and if you didn't realize before this conference you're probably aware now that it's like acronym SUP. There's a ton of acronyms in the federal government, particularly with Department of Health and Human Services, so get used to it. To distinguish between, again, through these audits, criminal and civil investigations, program inspections, we try to provide independent, timely, and reliable information to the department officials, to the administration, to Congress, to the public. Just a brief, we'll try to distinguish between the four components. Again, I'm with the Office of Audit Services. We provide all auditing services to Health and Human Service, either directly with our own resources or as an oversight through contracted audits. Our Office of Investigations conducts criminal, civil, and administrative investigations based on allegations of wrongdoing in the HHS programs. Their results, O-I's investigations, usually lead or quite often lead to criminal convictions, administrative sanctions, and civil monetary penalties. The Office of Evaluation Inspections, they conduct management and program reviews based on issues of immediate concern, concern of the administration, Congress, to the public. And finally, our Office of Counsel to the Inspector General provides general legal services to the O-I-G. They impose program exclusions in civil monetary penalties against healthcare providers, and they litigate those actions within the department. And they also represent O-I-G in the settlement of cases arising under the False Claims Act. They're busy. They develop corporate integrity agreements. They monitor those corporate integrity agreements. They provide compliance guidance and other industry guidance. With respect to our regulatory authority, I'm gonna reinforce what Marilyn was talking about. She touched briefly on False Claims and civil monetary penalties. Sponsors and employers that participate in the Medicare Paddy program should be aware that the knowing submission of false or fraudulent claims is not a good thing. The False Claims Act, civil monetary penalties, they prohibit the knowing submission of false or fraudulent claims for payment to the United States. These laws also prohibit the knowing submission of false records, false statements in order to induce payment for false claims. Violations that either of these laws could result in significant monetary penalties and fines for individuals or for entities that normally submit false claims or cause the submission of false claims. The finding that either one of these laws has been violated will depend on the facts and circumstances of each situation. But it's important that sponsors and employers are aware of the potential penalties that could result from the submission of the false claims. But it's equally important to note, as Marilyn was talking about, that the False Claims Act's liability provisions weren't intended to apply to innocent mistakes or inadvertent reporting errors. Our authority was granted under the Inspector General Act of 1978, authorizes us to access to all records, reports, documents, reviews, prior audits, any other available materials that relate to programs and operations that we have oversight responsibilities for. And reading the federal regulations that were put out for MMA, it refers to OIG's authority to conduct audits and program oversight activities in the IDSA area. So in other words, sponsors must provide OIG any requested documentation for the purpose of audits and related oversight activities. This would include documentation to assure the integrity of actuarial attestations, to assure the accuracy of the subsidy payments, and so forth. If anybody has any specific concerns or questions regarding our regulatory authority, anything about the False Claims Act, civil penalties, civil monetary penalties law, I encourage you to contact our Office of Public Affairs at<PHONE_NUMBER>. You could also get additional guidance or information through our website at www.oig.hhs.gov. A real brief discourse on our area, again, I'm coming from the Office of Audit Services and I'm just gonna give you a quick spiel on what we do, how we approach our reviews. We focus a real disproportionate significant share of our resources in the Medicare program area due to the size and scope of the area, the program in terms of both significance to the beneficiaries and in terms of program expenditures. With the implementation of any new payment system, and there's been several of them recently with respect to the health care providers, skilled nursing facilities, home health agencies, outpatient hospitals, long-term care hospitals, every one of them has a recent new prospective payment system that's been indoctrinated within the last seven or eight years. And similar to, with the IDS for the employers, it's similar. We'll take a look at the new payment systems. We conduct detailed reviews to identify any vulnerabilities so that hopefully we can identify vulnerabilities in a timely manner and make recommendations that will protect the Medicare program's assets. When we initially review a new area, such as the IDS, we would typically conduct what we call a risk assessment. That would include a review of laws, regulations, program guidance, basically to determine the intent of that particular program or the component of that program, and then allow us to determine the criteria for compliance purposes. We'll do analysis of any available data, determine program participation and expenditures, and then we'll go out and do survey work, oftentimes in the field, at a provider level or at the entity level to determine any kinds of weaknesses, how the program actually works, and assess the level of risk. For those areas that when we believe the risk is high, we conduct detailed reviews to determine the extent and the materiality of the weakness. Our reviews often employ statistical sampling techniques, nationwide or regional computer-based data matches, and validation work out at the field level to confirm vulnerabilities, to determine underlying causes of non-compliance, and those are the types of things that allow us to make the best possible recommendations to mitigate the problem and to get the program back on the right foot. With respect to the IDS, this provision of MMA, the whole MMA, including the IDS, represents probably the most significant changes in the Medicare program since the inception. And there was potential risk in the IDS area due to several factors, most notably implementation, rather quick implementation, short timeframe for the implementation, the potential significant amount of sponsors that will participate, and the significant amount of expenditures that will be out there. Consequently, our FY 2006 work plan will incorporate reviews in the IDS program area. Our reviews, again, will focus on some of the key areas, most notably actuarial equivalents and the calculation of the drug subsidy payments. It's very difficult to say exactly what will review the scope right now. I guess the best we can say is the nature, the timing, the extent of those reviews in those areas will depend on several factors. When the data is available, what type of data is available, OIG priorities that come up in other areas, and CMS's planned route approaches, whether we can supplement what they're doing, compliment their activities, if their needs arise, and they want to take advantage of some of our resources. So again, it's kind of up in the air now, but I'm sure at some juncture shortly we will be involved in some form of detailed reviews. That's about all I have, thank you very much. Thank you. Thank you very much. I learned a lot about what not to do. I really learned a lot from that. I didn't realize there was such a problem out there. Maybe I've been naive all these years, huh? Wow, can you imagine Marilyn showing up at our front door? Okay, I have been asked to announce another website that apparently several of you have inquired about, so I'm going to read it off to you. It's http colon backwards slash, backwards slash www.cms.hhs.gov slash partnerships. And I understand this link is from the Medicare site as well. Let me repeat it one more time. It's http colon backwards slash, backwards slash www.cms.hhs.gov slash partnerships. And I guess several of you have asked for this, so that's the only one, and they're going to put some additional ones I understand up on the website as well. Having said that, we will now adjourn until three o'clock. At that time we will come back, there will be an extended panel. I'm sure that during this time, several of you are going to want to direct some specific questions to the members individually during the break. However, they are going to do a pre-panel debriefing or briefing, if you will. So they're going to come up here during that time to get ready for the panel. So if they're not accessible to you, it's because they're getting ready for that panel at three o'clock. Thank you. The reason I just said.