Designing and Implementing a Corporate Compliance Program - Using the OIG Database to Determine Exclusion Tuesday, January 7, 2009 2:00 pm 3:00 PM, ET Moderator: Dianne De La Mare Speakers: Ken Burgess, Partner, Poyner & Spruill, LLP Cheri Battee, Senior Vice President of Corporate Compliance, Fundamental Administrative Services, LLC Joanne Francis, Investigation Analyst, Office of Investigations, Office of Inspector General (OIG) Introduction Hello my name is Dianne De La Mare, and I am Vice President of Regulatory Affairs at the American Healthcare Association (AHCA). I would like to welcome you to our third seminar in a series of webinars to learn more about How to Design and Implement a Corporate Compliance Program. Today we are going to focus on the Office of Inspector General (OIG) exclusionary list and the provider s responsibility to ensure that they are not employing or working with individuals on the list. We are pleased to have our panelists: Ken Burgess, who is a partner at Poyner Spruill and who developed the web based guidance program that you see on the AHCA website; Cheri Battee, Senior Vice President of Corporate Compliance at Fundamental Administrative Services; and Joanne Francis from the OIG. Joanne began her career with the Department of Health and Human Services (HHS), OIG in 1997. She now works as an investigation analyst with the Office of Investigations, and her work entails analyzing exclusion and reinstatement cases for implementation. In addition, she serves as a point of contact for the List of Excluded Individual and Entities (LEIE) on the OIG website. We are very pleased to have her today. Before I turn the time over to Ken Burgess to start the presentation, I just want to give you the date of our next webinar. It will be on Tuesday, February 17 at 2:00 PM, ET, so put that on your calendar so you can continue this journey with us. Also, don t forget to go back to AHCA s website at www.ahcancal.org; click on facility operations; then click on compliance program and it will take you to all of our past materials on compliance programs to date. Now I will turn the time over to Ken Burgess. Ken: Thank you, Dianne. Welcome back to those of you from either of our prior two sessions, and also to those of you who are joining us for the first time. As you can see from the title slide, this is our third session in AHCA s How to Design and Implement a Corporate Compliance 1
Program webinar series. In just a moment, I ll be sharing with you what we have done in sessions one and two. We will be doing these sessions monthly throughout November 2009, and in the process of doing that, we will revise and update the AHCA compliance manual we originally wrote in 2000, and updated a couple of years later. Many people have asked me if this a good time to reexamine and update their already existing compliance program, and my answer is that it is a wonderful time, as we go through this and put this material before you hopefully in an easier more user-friendly fashion and on the web. In our first session back in October 2008, we began with the real basics What is a compliance program?, and What are the elements of an effective program as defined by the OIG and also as defined by your colleagues working out in the field with these programs. We looked at corporate philosophy statements and focused on the role of the Board of Directors or Owners in corporate compliance programs. This has been an area of special emphasis over the past couple of years by the OIG and you ll see that if you look at the 2008 OIG Supplemental Compliance Guidance for Nursing Facilities. So, what we have been doing in the first two sessions is looking at the mechanics or the structure of a compliance program including discussing the elements of a corporate compliance program, as well as developing a corporate philosophy statement; then we will move into the substance of laws that make up the heart of the program. These are also referred in the OIG manual as risk areas and we will be getting into those in the future. In session two of November 2008, we covered compliance officers and compliance committees how they work and what are their responsibilities; who should be on them and in some cases who should not be on them. We looked at their role in the structure of an effective compliance program operation, and we will bring in actual providers like Cheri Battee to find out what works and what doesn t work so well; the challenges they have faced in their role as officers or on committees, and some of the successes they recommend to their colleagues. Today we are going to talk about excluded individuals and entities and explain the impact on you, the provider, of not understanding the OIG s exclusion authority, and what can happen to you if you employ, contract with or do business with excluded individuals and entities. The point I will make now and throughout my presentation is that the laws that define the OIG s exclusion authority are broad, and you have an obligation to operate with knowledge of it. Joanne will explain about the OIG s exclusion program what it addresses and the process by which providers can determine if the individual/entity you are going to hire, contract or otherwise do business with is in fact excluded. Cheri will walk us through 2
an actual sample check list using a tool her company developed. We will close out with some questions and answers if time permits Rules on Exclusion Here is how it works. Under Federal law, the OIG can or must exclude individuals or entities convicted of a healthcare program-related crime, including clinical issues, and in particular patient abuse crimes under State or Federal law, which is the basis for these exclusions. It covers any individual or entity convicted of such a crime who submits false or fraudulent, or otherwise improper claims during an on-going period of exclusion. The slides reference any Federal healthcare program, and it has two meanings: the first is the offences that can give rise to an exclusion; and the second is the exclusion that can relate to any Federal healthcare program. Once excluded, you cannot participate or be paid by any Federal healthcare program including Medicaid, Medicare, Tricare and the Veterans Administration (VA). Those are the primary Federal healthcare programs for long term care (LTC) providers, but some of you also may encounter other programs in your businesses, such as maternal/child health grants, social services block grants to states and State Children s Health Insurance program. The OIG excludes individuals in any profession related to healthcare, and not just nurses and doctors; as wells as entities that are broadly defined as corporation, partnership or LLC. Basic Rules of Exclusion The basic rule of exclusion is no payment will be made by any Federal healthcare program for any items or services furnished, ordered or prescribed by an excluded individual or entity. It also includes services or items directed by excluded individual/entities. This captures payments whether billed separately, bundled, per cost reports, fee schedules or a Prospective Payment System (PPS) (even where the Federal payment is made to another provider or supplier who is not excluded) if the item is provided, directed or ordered by the excluded individual or entity. It also covers administrative and management services not directly related to patient care, but that are a necessary component of providing items or services to program beneficiaries. Cheri: Ken: If in your facility an admitting/attending physician is excluded then the entire admission of a patient is non-allowable for purposes of Medicare/Medicaid reimbursement which can be a period of months or years. Once the exclusion occurs you may not employ, contract with or allow that individual or entity to direct the ordering or delivery of services or supplies; undertake certain administrative duties; or perform utilization or 3
MDS reviews.. If any of those tasks are reimbursable by a Federal healthcare program then those claims cannot be paid, and that is true even if you don t submit the claim yourself. For example, if your contractor has an excluded employee who performs some task that is reimbursable this is covered by the exclusion rules. There are some limited exceptions. These rules are very broad and complex. The Exclusion Status of Others The next slide highlights the exclusion status of others and you, the provider, and the fact that you are charged by law with knowing the current exclusion status of employees and contractors that work for you, as well as those individuals/entities that you will be contracting or employing. You are not required by law to check the OIG database; however, there are sanctions if you don t check it and a person/entity turns out to be excluded, and you knew or should have known of the exclusion but submitted the claim anyway. The OIG has circulated materials for years making it an affirmative duty the provider to find out who you are doing business with. So, knowing is key Check the database! Check for new hires and contractors as well as subcontractors. I recommend you check the OIG database at least quarterly or monthly. Consequences of Doing Business With Excluded Individuals and Entities The next slide discusses the consequences of doing business with excluded individuals or entities. For the individual or entity that is excluded there is a $10,000 fine for each item/service claimed or caused to be claimed by that individual or entity. Every day of care is a separate offense and it adds up quickly. In addition, there are treble damages, which are three times the amount claimed for each item or service, and if the individual/entity is already under an existing exclusion period it can be extended. Also, re-instatement is not automatic after an exclusion period. There also is a theory out there, with some support, that submitting a claim by somebody excluded directly/indirectly can amount to a false claim under the Federal False Claims Act (FCA), which is separate basis for administrative sanctions and exclusions in the worst case scenario. Consequences of the Provider What about the consequences of a provider doing business with the excluded individual or entities? For the provider who employs/contracts with an excluded individual or entity where you knew or should have known, there are civil money penalties of up to $10,000 for each item or service furnished by the excluded individual or entity, plus Civil Money Penalties (CMPs) of three times the amount claimed for each item/service. 4
In extreme cases, the provider also could be excluded from Federal healthcare programs and put out of business. Many states, in increasing numbers, have parallel State laws that would cover payments made via the State health programs portion of the Medicaid payment.. Rules to follow The following are some simple rules that will serve you. Remember the real goal of these exclusions is that you will have no meaningful role in any Federal Healthcare program. As my grandfather used to say, be aware of the 10 foot pole rule, which means don t touch it with a ten foot pole. My advice is just don t go there and when in doubt do an investigation. We also have talked to clients that say that the individual/entity excluded is so good We always ask them if they are prepared for the possible consequences.. There are some exceptions that will allow them to play a role in healthcare, but as I said earlier these exceptions are very, very limited. On the website, OIG has issued a number of Advisory Opinions which you can read that will give you some sense of an excluded individual/entity and their role in healthcare. If you are going down that road, you must seek guidance from the OIG to see if it is permitted. But, you need to think about what message you are sending the public and the government with this request. Those are my simple rules to keep you out of trouble. I am going to stop and turn it over to Joanne of the OIG who will walk us through some additional materials. Joanne: Hello, my name is Joanne Francis, and I am an investigation analyst with the OIG. I am going to give you some background on what it is we do; give you an idea of what an exclusion is, and what type of authorities we have; and at the end of this webinar, we will do a walk through an online searchable database. Exclusions The OIG has been implementing exclusions for over 30 years. Last year, there were over 3,100 individuals and entities excluded from various Federal Healthcare programs. In the course of OIG s work, we have excluded over 44,000 individuals/entities. We receive our referrals from a variety of sources; including the state licensing boards, United States Attorney s offices, Medicaid Fraud Control Units (MFCUs) and Medicaid State Agencies. Referrals are made to our regional offices, who then determine if there is a basis for exclusion, and if there is they process the case. The following web address gives more information on the exclusion program: http://oig.hhs.gov/fraud/exclusions.asp. 5
We have four mandatory authorities. These are the cases that we must process. We have our 1128A(1) authority which is based on a felony or a misdemeanor conviction. There is the 1128A(2) authority, which is a conviction for patient abuse or neglect, which also can be a felony or misdemeanor conviction. We have our 1128A(3) authority which is healthcare fraud, and 1128A(4) a felony conviction for controlled substances. We also have permissive authorities in 1128B(4), which is a license revocation, suspension or surrender. We have 1128B(1) authority, which is a misdemeanor related to healthcare fraud; and we have 1128B(3) authority which is a misdemeanor for controlled substances. We have 1128(b)(14) authority which is a default on a healthcare education assistance loan. That is just a brief overview of our authorities. I ve put a link here to our authorities page so that you can see what other authorities we have http://oigh/hhs/fraud/exclusions/authorities.asp. Effect of Exclusion The effect of exclusion is this: it is remedial in purpose and its intent is to protect the Federal healthcare programs and beneficiaries from improper payment, improper abusive practices and halt further program remuneration. It does result in a government-wide debarment, and then it is referred to the Office of Personal Management (OPM) for their debarment. It does not affect the beneficiary s ability to receive benefits under either the Medicaid /Medicare programs. Reinstatement The individual/entity that is excluded, is excluded until re-instated by the OIG regardless of the length of exclusion imposed. For example, a doctor who is excluded under section 1128(a)(1), the minimum period of 5 years, is eligible to apply for reinstatement 120 days before the 5-year period expires. Another example is a nurse who is excluded under section 1128(b)(4). He/she would be eligible to apply for reinstatement once the license has been returned to active status by the licensing board. Excluded individuals and entities must complete a reinstatement application and sign an authorization which allows the OIG to request information from employers. An investigation is conducted based on the information provided in the completed application. The average processing time for the application process is 90-120 days. The OIG notifies the individual or entity of its decision on reinstatement via letter, and the reinstated individuals/entities are removed from the LEIE in the next update. So, you may have individuals/entities reinstated by the OIG, but not removed from the LEIE list until the following month. 6
If you have this instance, call the OIG reinstatement office and the agency will confirm the reinstatement for you. If reinstatement is denied, the individual/entity may request a review. If the review is still denied, the individual or entity is eligible to apply again in one year. Withdrawal If the basis for an exclusion is reversed or vacated, then the individual or entity is reinstated back to the date of the original exclusion. For example, if a pharmacist excluded under section 1128(a)(4), with a conviction for controlled substances has conviction overturned on appeal, then once the OIG gets that information, it will withdraw the exclusion. Waiver Individuals or entities may be granted a waiver under the OIG s mandatory authority, except under section 1128(a)(2), which is patient abuse/neglect. If the subject is the sole community physician and the sole source of essential specialized services in a community, the waiver may be granted for permissive exclusions if the OIG determines that the imposition of the current exclusion is not in the public s best interest. The waiver requires a written request from the individual administering the Federal or State healthcare program. The individual cannot request the waiver themselves. The waiver applies to a limited geographical area. The exclusion would remain in place everywhere else. LEIE The List of Excluded Individuals/Entities (LEIE) contains individuals and entities currently excluded by the OIG. Our downloadable database has been available since September 1995, and an online searchable data base site has been available since March 1999. Both sites are updated monthly by the 15 th of the new month. The following link is for our online searchable database http://exclusions.oig.hhs.gov. Again, the LEIE only contains current exclusions that are in effect. The LEIE only contains exclusion actions taken by the OIG and not by any other agencies. I have a slide that is only a snapshot of the exclusions program page on the OIG website and I ve included a link to the list of excluded individuals and entities. I want to point out the Special Advisory Bulletin on the effect of an exclusion I think that this would be a valuable tool to read and review. It does detail what it means for a provider who may be hiring someone that may be on the exclusion list. This last slide is a snapshot of the online searchable database. I will now be turning it over to Cherri, so she can show you how providers use the database. 7
Cheri: Ken: Thank you Joanne. I wanted to show you how quick and easy it is to search the list of excluded individuals and entities. Remember that this is something you should do before employing or contracting with an individual or entity. This is the main page of the OIG (www.oig.hhs.gov). If you look at the link on the left hand side, you can click on the exclusions program. Under the exclusions program, click online searchable database. When you get to that page, enter one to five individuals or businesses. At the results screen it shows you the day and time the screening was conducted, and the last time the source data was updated. I would recommend keeping a copy of the results in a confidential file. If there is a match, you will see the detailed results of the individual. If you want to see if the individual was sanctioned, you have to enter the social security number or the EIN number. It is a very simple procedure, but failure to conduct the screening can cost you a lot in penalties. It is best to look at this issue from the front end rather than bring someone on board as a contractor or employee only to discover months later that they have a whole array of services or items that should have never been billed. If you have any questions or concerns regarding a potentially excluded individual or entity, Joanne has kindly given her contact information on the slides. Questions and Answers Joanne: Our first question from the audience is: What is the difference between the downloadable and the searchable database? Is one easier to use then the other? Does it depend on the computer equipment you have in the facility? They are similar in that they both have all the current exclusion information. Due to the privacy act restrictions that we have at the OIG, the downloadable database does not allow input of the social security number. Again, depending on how many employees you have, and how many contractors you have, it might be easier to run a program using the downloadable databases versus the online searchable. We provide, for the downloadable database, an updated LEIE, where we take the reinstated individuals off, and add the new exclusions to it. It is a rolling file. We also provide supplement files to the reinstatements and exclusions for the downloadable database; so if someone wants to download the exclusions and add the reinstatement dates to their own database, they can do that. Again, if anyone has any questions on how to use the downloadable database, feel free to call me, and I will walk you through it. 8
Joanne: Joanne: Cheri: Ken: Cheri: Ken: Our next question from the audience is: Is the downloadable database used more often by a large corporation versus a small independent? Yes, because the large corporations have more people, the downloadable database is usually more efficient for them.. For someone that has five or six employees, they may find the online database easier to use. Our next question from the audience is: Can you provide more detailed information about the reinstatement process, and do you have anything online? If you had a nurse for example, who had their license returned to them in their particular state, and they come to you looking for a position, and you still see them on the OIG website just because they got their license back, doesn t mean the OIG has reinstated them. If this is the situation, my recommendation is that the person contact the OIG as soon as possible, so that OIG can get the reinstatement process rolling and get them reinstated as quickly as possible. Our next question is for Cheri - how often do you, in a bigger company, find that a person is excluded from a Federal program? It doesn t happen very often but it happens more often than we like. We have caught on our pre-hire screening a number of individuals that we stop from being hired. In a large corporation it is a challenge, and some individuals/entities do fall through the cracks. That is why we run the downloadable database against our payroll file; and other files against the LEIE every week. Here in NC, it rarely happens, but what offsets the number of hits is the breadth of these laws. Remember it covers all contractors; and it covers subcontractors in a chain of transactions from something as simple as an admission to ordering a wheelchair. While we don t find hits on the list very frequently, it happens more often than you think. I don t want to leave the impression that this isn t a big deal; but sometimes problems result because of how complex some of our arrangements are in long term care. In terms of contractors, I do screen before expediting the contract; and I continue to screen on an ongoing basis. I also run the OIG file against our accounts payable file so that we can catch anyone excluded subsequent to the original contract date. Cherri that is a really a great point. All of our contracts have language putting the affirmative duty on the contracting party to check their own folks. That is a wonderful thing, but the most security that gives you is a 9
contract remedy against that particular individual or entity if they have failed to comply with that requirement. What you are describing helps the provider from being an unwitting victim in a chain of transactions where the sanction won t only be lost income, but CMPs; and, in the worst case scenario other problems with Joanne: Cheri: Are next question from the audience is: There can be problems with the database Joanne you were talking about a reinstatement document that individuals could bring with them that providers could check at the time of hire? Any individual that is reinstated by the OIG receives a notice from us telling them that they have been reinstated so if they tell you they have been reinstated; but they don t provide the documentation, I would be a little concerned. Providers also can contact the OIG, and we can confirm or deny if they have been reinstated. Reinstatements are posted the next month after the reinstatement has been confirmed, so when in doubt check! Are there any final comments from the panelists? Just that a little time going through this procedure can save you a lot of heartache after the fact. Thank you to the panelists and all of you who participated today. Again all of this will be posted on the website in the next couple of days, and we hope you can join us for the next webinar in this series on February 17 th. 10