This next segment is going to deal with many practical aspects of functioning as an MRO. Over the years, so many of our students have asked us questions like, how do I actually get to work as an MRO? How do I set up a practice? What are the liabilities of functioning as an MRO? And do I need to have MRO insurance? And how do I arrange to work with employers and build my business? So we will cover many of these areas in the next few minutes. The first question is, what are the different types of MRO practice? And employers, of course, can have an in-house MRO, or they can sometimes joke about having an outhouse MRO. The outhouse MROs may be in small occupational health clinics, or even people who set up their own little lemonade stand as MROs. MRO services can also be provided by larger, comprehensive occupational health service providers. And over the past decade, a number of specialty MRO organizations developed, and there was a great deal of amalgamation and buying and selling. So, for example, you see that SAMI, the Substance Abuse Management Organization, was acquired by HireCheck, which later became part of First Advantage. If you're going to set up your own MRO practice, you need to deal with a large number of specific questions, like what services are you going to offer? Are you going to have a software system? How are you going to price and deal with financial matters? And do you need to have special liability insurance? So you can function merely as an MRO, or you can offer a much wider range of services. Do you want to do specimen collection, for example? Are you going to have a clinical service that does clinical evaluations of shy, bladder, et cetera? Are you going to choose to become trained and certified as a substance abuse professional? Some MROs are part of a third-party administrator. And, of course, as an occupational physician, you will probably want to offer broader services, such as DOT driver medical examinations or OSHA or EPA medical surveillance exams. If you have staff, they're going to need to be properly trained and credentialed. So, for example, if you're doing urine collection, you will have what we can jokingly call a micturition technician. And there are manuals, for example, from DOT that will train urine collectors. There are classroom and online courses. And, of course, after training, a collector has to demonstrate their initial proficiency demonstration of five different collections. They have to have refresher training every five years. And if there's an error that leads to a canceled test, they have to go through error correction training. Similarly, if you're going to be doing breath alcohol testing, your BAT will have training and retraining similar to that of a urine collection technician. You also will be doing saliva tests, which uses oral fluids, and that'll be done by a screening test technician. And as we move into alternative specimens, we may be doing hair testing. Maybe that would be a hair acquisition technician. And if we're going to do oral fluids, somebody will think up a clever acronym for a SPIT. As an MRO, you must hold an active and unrestricted license in at least one state or province. This program qualifies for the qualification training requirement. And then you'll need to have an active certification exam and license through the MRCC or AAMRO. You'll need to do requalification training on an every-five-year basis and retake the examination. And finally, you'll have to be recertified under federal requirements. The process for being a substance abuse professional is almost exactly parallel to that of an MRO. There's no formal federal requirement for training or certification of MRO assistance, but training is offered by a number of organizations. And MROC actually offers a written voluntary MRO assistance certification exam. Your administrative staff are also operating directly under your authority. So if one of them calls a donor, for example, and makes a mistake and gets the wrong person on the phone, you're really responsible for their actions. MROs often ask, if I start a particular drug test investigation, do I need to be there to complete it? And the answer is no. You can have cross-coverage with other MROs. So even though your name is on the custody and control form, another certified MRO can complete that evaluation. But it's helpful to have cross-coverage so that you can have a vacation or take some time off. You'll be interacting with SAPs, although unfortunately, I don't think we do enough of that. In order to verify prescriptions, you're going to be interacting with the prescribing physicians and pharmacists. And as you evaluate clinical evaluations, you'll be receiving and reviewing reports from clinicians on shy bladder and other types of examinations. I've already given you an entire section on record-keeping requirements, but there's a lot of paperwork and logistical details that need to be taken care of. For example, you'll need to keep a place for your client policies and protocols, which are accessible when questions come up. You'll be receiving and needing to organize the CCFs that come from the collection site, from the lab, and occasional other sources. You'll also have your MRO records and hopefully a standard checklist or tracking form. When you've completed cases, they're going to need to be retrievable. And of course, you'll keep the non-negatives for five years. There'll also be the problem cases, such as the places where you needed a statement of correction, and those need to be kept. You're required, as you know, to personally audit or review 5% of the negatives, including any problem cases. And finally, you'll need to store and be able to supply records of training and certification and continuing education. Dealing with HIPAA can create quite some consternation. Even though both HHS and DOT have clearly stated that HIPAA does not apply to workplace drug testing and that a written employee authorization is not required to disclose drug test information, and even though you don't need it in order to verify prescriptions with a treating physician or pharmacist, that doesn't mean that the person at the front desk of the doctor's office is not going to stop you and insist that a HIPAA authorization be signed. So when I am dealing with a donor who has a positive test result, rather than trying to fight my way through the system, I will usually say, go to your doctor, sign whatever authorization forms they require you to sign, and have them send a verification of your prescription to me at this fax number. There are quite a few data management needs of the different actors in workplace drug testing. The collection site needs to track all of those people who provided a specimen and keep track of their custody and control forms. The MRO, as we've covered, has to keep detailed records of the MRO review. The third-party administrators and consortia are often dealing with hundreds or even thousands of drug tests, so they often have sophisticated software systems. And an employer needs to be able to put people in safety-sensitive position into testing pools so that they can select names for random testing, and also they're required to submit various statistical reports to federal agencies. Large MRO firms and TPAs and consortia have often developed very sophisticated and complex software systems. But for a private MRO practitioner, you'll want to ask the question, can I do this all manually by paper, or do I want to use a software system? There are a number of programs available. One that has stood the test of time and I continue to receive updates from by email is called DrugPak. There are also a number of software programs which will allow employers to keep people in random test pools and to select random drawings for random specimen collection. Quality assurance is an important issue in any aspect of healthcare, and that pertains to MROs as well. And sometimes MRO practices are audited, particularly by federal agencies, such as the Federal Railway Administration. I found that it's helpful for MROs to have a buddy and to look over each other's shoulder and periodically look at their record-keeping practices and make sure that they're doing everything necessary. MROs are often asking about what are appropriate prices, so we'll go into this in some detail. In general, there are two different methods. The first is the individual drug testing services can be priced separately, which we could call a la carte or the European plan, but quite frequently these services are bundled together in what might be called the American plan. So, for example, there might be a single fee for collecting a specimen and laboratory analysis. Sometimes there's a bundled fee for a laboratory analysis and an MRO review, and all three of them can be bundled together. How are you going to charge for your services? Some MROs charge a flat hourly rate. I do that because I'm usually reviewing very complex cases or doing legal reviews. But you'll need to decide what is your cost to process a negative, and that will obviously be much lower than your cost for dealing with a non-negative where the MRO personally has to try to interview the donor. Most employers don't want to be nickled and dimed and charged for negatives and positives. They prefer a flat bundled fee for both negatives and positives. And so if you come up with a fee, you're going to need to take several factors into consideration. What's the percent of federally regulated versus non-federally regulated drug tests? What's the projected rate of your non-negatives that require personal MRO review? That has gone up since the semi-synthetic opioids were added, and you need to take that into consideration. And finally, what kind of a client are you dealing with? Is this a highly demanding client that wants to know the results almost immediately, or do you have a little more leeway? As a practical matter, then, you will be charging lower prices if there's a very high volume of work, if you're dealing with non-federally regulated situations, and if you anticipate that you'll have less than, for example, 3% non-negatives. In addition, you'll need to figure out how to charge for consultation and dealing with problem cases. That's where I charge a flat hourly fee. And finally, how are you going to bill for your time when there are administrative reviews, when a donor challenges a drug test result or appeals a ruling, when there are audits, for example, of federal agencies, and when a case goes to litigation. Legal cases can often be very time-consuming and unpredictable. For example, you may be called to testify and then spend hours or even occasionally days outside of a courtroom waiting to be called in to provide your deposition or your information. So legal matters are usually billed on an hourly or time and material basis. Now some MROs charge a premium fee for testimony. I don't do that because I know I'm very likely to be asked what my fee is and I don't want to indicate that I'm getting a premium for testifying in a particular case. I'm always surprised that lawyers ask me what my retainer fee is. I know that's a common practice in law where you get paid before you start the work. But I always wonder, isn't that interesting? Does that mean if I do my work as an MRO and the attorney does not like the outcome that they're not going to pay me unless I've already been paid a retainer? So let's get down to some specific prices. And I need to point out that these are old data that were published in the MRO manual a couple of editions ago. But you'll notice that the price of collecting a urine specimen or a hair specimen is generally about the same. The price of collecting oral fluids generally is a little higher, and it's about the same as a breath alcohol test. And remember that the screening test is treated separately from the confirmation test, so both of those are billed separately. Now if somebody is providing urine specimen, they need to drink water and wait for three hours and you need to keep your office open late, then there will often be a charge for extended collection times, and particularly if someone has to come in after hours and do a urine collection, then the prices can be considerably higher. Laboratory prices can vary considerably, and the least expensive way for an employer is to have the initial and the confirmation both done on a bundled rate, most of them only needing an initial test and a few of them needing confirmation testing. So if there's a very low volume for a particular client, they might charge more than if there's a high volume. Now when on-site testing is done and a specimen is sent for confirmation only, you can see that that's a custom test and the price is considerably higher. Similarly, the analysis of a split specimen at Laboratory B is going to be considerably higher. DNL isomers, if they're routinely tested for every positive methamphetamine, can be as low as $30, but if they're done on a case-by-case basis, again, they can be $100 or more. And you see that although the collection prices are the same for urine and hair, the test of actually examining the hair is much higher. If MROs are going to charge separately for processing negatives and positives, you can see a considerable difference in what's charged. But usually they're bundled together, so negatives and non-negatives are priced the same. And here you see a range of maybe $10 to $20. The bundling of collection, laboratory analysis, and MRO services can be in the $35 to $50 range. The hourly rates that MRO charges vary considerably. There's often a higher fee for expert testimony. And notice that the charge for an SAP evaluation, which is a face-to-face evaluation that may take more than an hour and require a written record in detail, is going to be the highest charge that you'll find. Here you see some pricing for alternative ways of collecting specimens. Alternative collection testing generally combines the on-site test and the laboratory confirmation. Hair testing, you see the price for collection for the lab analysis and the bundling, which generally lowers the fee. MROs often ask me, how risky is it to be an MRO? And there definitely are legal liabilities. Remember, we're acting as a service agent to the employer. And so if something goes wrong in a drug testing case, and if there's a legal challenge to a drug test result, often the employer is sued, the name of the laboratory is added, and so is the name of the MRO, although various jurisdictions will often throw out one of these three if they're not directly liable. Remember, MROs have a duty to comply not only with the federal law, which we have emphasized strongly in this course, but also the widely varying state laws. A useful resource on the legal issues and legal liabilities was written by an attorney with the appropriate name, William Judge, and that's available in your syllabus supplement. Dr. Judge talks about the constitutional balance between the right to privacy and the necessity for public safety. And of course, these issues come up all the time when one is going into an airport and being searched by the TSA. They come up in the workplace in terms of the privacy of one's locker or one's desk, and they definitely come up in relationship to drug testing and bodily fluids. And this pertains to each of the different types of drug testing. Almost always, the duty to protect public safety outweighs the right to individual privacy. So in terms of insurance, do you need to get a special type of insurance to function as an MRO? Well, medical malpractice liability generally only covers the clinical role, and this is an issue for occupational and environmental physicians in general, where our duty is to an employer. There are some MRO liability insurance policies that were put together by enterprising insurance agencies, but generally, my colleagues have said, if you're in clinical practice, make a detailed record of all the duties and responsibilities you perform in your clinical role, including drug testing. Submit that to your liability carrier every year, and then if at a later time they want to deny coverage for a drug test case, you can show them that they've been paid and communicated all along for what you've been doing. Because I'm licensed in a number of different states, I was not able to sustain malpractice liability, and I've gotten something called errors and omissions liability, which I was able to obtain through ACOP. In dealing with liability, it's often important that you have indemnification clauses. They can be tricky, and there's some examples of these in the supplement to your syllabus. If you're setting up shop and want to market your services as an MRO, what do you do? Well, the one advantage that you may have over larger firms is that you will know your individual state laws. For example, the workers' compensation provisions that may lower liability insurance for employers. Again, I refer you to Dr. Smith's chart summarizing the different state laws. You also need to figure out who your audience is for your MRO practice. It's good to start with the current relationships that you have, but there are always local companies such as local trucking companies or local cab companies. There's local healthcare facilities and also local government agencies, and these are places where you could approach them and offer your services. In marketing your services, you want to gain visibility, and that can often be done by giving presentations, for example, at a breakfast meeting or a lunch meeting of a rotary club or another community organization. Drug testing is a hot topic. It's a fascinating topic, and therefore, audiences are always interested in presentations on this subject. I'd suggest that you contact the laboratories because most labs have a list of certified MROs. They don't recommend particular MROs, but they do provide lists to employers. You could, for example, offer a free consultation to a local company, offer to review their drug and alcohol policies, and tell them where they are in compliance and where they may not be in compliance with regulations. Every company needs to have training of supervisors, and as somebody who knows a lot about drug use, this is another way to get your foot in the door. Now if you're actually going to be preparing a written proposal for services, it's helpful to have a portfolio which outlines your skills and your services and your past history. You'll also need to occasionally respond to requests for proposals or RFPs, and that's where it's helpful to have boilerplate language that you can quickly put into a proposal. When you're approaching a prospective client, then, these are the issues that I covered earlier that MROs need to clarify with employers. But if you demonstrate that you are knowledgeable about drug testing, if you ask them questions that they may not have thought of before, you can build a relationship and build confidence and have them want you to work with them. When you establish a working relationship with a client, it's useful to have a written contractual agreement, and we've provided some samples in the supplements to this syllabus. The MROCC established a code of ethics for MROs some years ago, and they include an emphasis on highly professional behavior, following the highest standards and honesty and integrity, always keeping up to date with science and not misrepresenting anything, maintaining your competence through continuing education, honoring confidentiality, and personally not using or misusing or being dependent on drugs. A couple of final things to consider. As an MRO, you're going to want to have someone with whom you can do cross-coverage so that you can take trips, have time off, and not constantly be tied to your telephone. You may be invited to do expert testimony on cases, which can be very anxiety-provoking, but also very interesting. And in the day of buying MRO practices, you may consider selling your practice once you've achieved a certain level of volume. Here are the additional resources that I mentioned earlier. Dr. Judge's Limiting Risk, which discusses legal issues facing the MRO, and also several different sample contracts for MROs and employers. And APACOM put together a very detailed and very excellent one a few years ago.

MRO

Medical Review Officer

practice setup

liabilities

insurance

specimen collection