Compliance, Contingencies and Covid

Becky Templeton

Hey, welcome welcome to compliance contingencies and COVID. I think the regulatory gods are smiling upon us and looking out for our best interests, knowing that 2020 was going to be a little bit of an odd year. If you think about it, there's no regulatory changes, huge implementation dates or items that we have to address, but there are a few things that you all should know about. Here's my top five things to keep you all in the know for compliance. Number one, did you know that PECOS and Medicare are waiving their application fees? So, if you're planning on submitting an 855B to maybe start an immunization program, or an 855S because you want to start billing for DMEPOS products, maybe like shoes or diabetic testing supplies, now's a great time to do it because you can save $595. Both areas are a wonderful way to support your community, get additional patients through your front doors, and get some extra revenue going through your registers. That leads us to item number two. Did you know there was actually a DME paperwork reduction? I think it was the first time I can ever remember one. It could be the first time ever. This is great for all of you who maybe stepped away from DME because there was too much paperwork, or maybe you were afraid to even get started in it because you heard horror stories from other people. Essentially, now you're going to need three things. You'll still need the prescription from the practitioner, and it can be anyone, nurse practitioner, physician's assistant, all the way up to an MD DO, now you're going to need a detailed written description. This takes the place of a written order prior to delivery or a detailed written order. This item actually allows for the pharmacy to fill up the paperwork as opposed to having the signing dock or practitioner sign for it. It'll make it a lot easier. There's a lot less signatures that you have to acquire now. Of course, you still need to have something along the lines of a receipt of goods and services, helping to prove that the patient has picked it up, you've given them all of the information that they needed as well. So, it's going to make it a lot easier for you. A couple of things you need to consider. Do you already have a Medicare number to bill these items? If you don't, do you need to get accredited, or are you already accredited that maybe you just need to add some additional line items to it? Are you in the exemption? Is your number still active? Are you in a competitive bid area? So, consider all those things, but it might not be a bad idea to take another look at offering DME in your area. Next step. Did you know that USP 800 went into full effect on March 12th? No. If you missed it, two days later, President Trump declared a national emergency because of COVID-19. So, a lot of people missed that part. Now, what ended up happening, there was an appeal on USP 795 and 797. It was around beyond use dating. While that dispute and appeal was going on, they reverted to a previous version of 795 and 797, and thus 800 went into full effect. A lot of people still think, "Well, my state board isn't enforcing it, then I have nothing to worry about." But don't forget, USP 800 actually goes beyond your state board of pharmacy. So, please keep that in mind. Now, I've got my fourth tip, which is a great thing for us. Did you know that there's actually a draft NIOSH list pending? Okay, so it's open for public comment between now and the first part of December, but there's some really neat things that are going on in this. Of course, there's a catch too, because it's going to have some extra work for all of you folks that last year and even into this year were really great about creating your assessment of risks. You're probably going to have to redo a majority of them. What we're going to see is a dosey doe, table twos are jumping to table three, table three to table twos. A couple of table ones are rolling off. Last I checked, there was over 80 drugs that were going to be moving between the tables. Those assessment of risks are going to need to get re evaluated and possibly have some additional items added to them. But here's the highlight behind it, the silver lining. There is now clear guidance between who is the higher authority here. Was it NIOSH or USP? Well, NIOSH has conceded and said, "USP, you're the higher authority," and because of that, we now have a very clear answer to, "Can I put these hazardous drugs in my automation? Is it allowed to be in my robot? What about my pill packing systems?" The answer is now yes. Table ones are still excluded, but table twos and table threes can start going back into our automation systems as long as this draft gets adopted. So, stay tuned. I'm still not quite sure what it's going to look like. I can just see the draft right now, but I have a good feeling that things are going to look much better for us on hazardous drugs. Our final did you know, did you know you can get a temporary enrollment CLIA waiver for COVID-19 testing as an independent clinical diagnostic laboratory? Some people already have clear waivers for other things. If you have not gotten a temporary CLIA waiver, I would strongly recommend you check out the support document that I have to this presentation, and you can see some extra ways on how you can enroll. It's a good idea to complete your Medicare application, so you can fully enroll. They're giving you some grace right now on the time to start doing that, but things are temporary. So, if you want to make them more permanent, start now with the temporary, keep your eye moving forward on updates that are coming out. CMS has actually been really great about providing up-to-date information for all types of healthcare practitioners on how they can support their communities when it comes to COVID-19. That's a wonderful segue to bring us to the meat and potatoes of today's section on COVID and contingency planning. Now, we deal with regulatory compliance all the time. We also help pharmacies buy and sell their facilities. When we're talking to our pharmacy owners, we do a lot of succession planning. What do you want your future to look like? Let's get something on paper and try to figure out what you're going to be doing with your pharmacy in the next three years, five years, 10 years, et cetera. When we work with our regulatory compliance, we spend quite a bit of time working through HIPAA and their disaster recovery plans, where we're looking at if something happens to the building, the pharmacy itself, how can we get it back up and running again? We'll look at things like natural threats, maybe it was a hurricane, tornado, a wildfire. Could be a manmade threat, vandalism, arson, different scenarios that we look at to try to figure out how we're going to get the pharmacy back up and running. That's what your disaster recovery plan is. I share this with you because we're finding that a lot of our owners, our small business owners, those entrepreneurs, they're spending a lot of time planning for the disaster to happen to the building, but not necessarily a lot of time if a disaster happens to their person. As a small business owner, you wear many, many, many hats. Right now, you might be the owner, then you have to be the pharmacist in charge, then your customer service. Later today, you're going to be HR, and you might end up being the janitor at some point in time too. Along the way, we need to realize that some type of event can happen. We have to have a knee replacement. We have to have some type of surgery. Sometimes those things are planned, and we can preplan for a couple of weeks, a couple months going into them, and then something like COVID hits,a and now all of a sudden you find out that you were exposed to somebody and you have to quarantine for two weeks, or you've tested positive and you definitely need to sequester at home for two weeks, or you find out that you are actually very, very sick and you're going to be out of the pharmacy for an unknown amount of time. All right. This next part, we're going to talk about ICE. No, I'm not talking about ice, ice, baby or iced coffee or black ice. I'm talking about in case of emergency. Some people call it an emergency contact person. This is somebody that you should hopefully have in your phone that knows what to do in case of that emergency. Like for me, I have two listed. I have my husband, so it says number one, ICE, Dave Templeton, husband, and then I have number two ICE, Jeff and Mary Hedges, parents. That way, if I'm in an accident with my husband, they can contact my parents and let them know that they need to start going through our emergency contingency plan. So, first off, make sure that you've got that done. Second, make sure that your emergency contact knows that they are your emergency contact so they're not surprised. Third, go over a list of things with them so they know what is actually expected of them. Are they to pick up your kids? Are they to take care of your dog? Are they to contact someone within your pharmacy to let them know what's happening, et cetera. I have three main areas you should really consider. How are we going to notify our staff, potentially patients if needed, who has the keys, and what type of access points and authorizations are we granting to this emergency contact person? First off, do you have an updated contact list for all of your staff and your important vendors or business partners? Is there a phone chain that's going to be executed, or do you have one particular person who's going to contact all your staff, or do you simply want your staff to show up on the next business day and be told in person what's going on? Those are considerations that you need to have for a couple of different scenarios. What happens if I have a heart attack? What happens if I'm in a car accident? What happens if I get hit with a baseball at the baseball game and I can't remember my first name? And unfortunately, what happens if I was exposed to COVID and I'm now on a two week quarantine? The last thing is, what kind of information do you want this person to share with your patients and staff? Right? Let's talk about keys. Who has the keys? You are a smaller pharmacy, you may be the owner and only pharmacist. So, how are you going to get your staff to open the doors, come the next business day? Are there keys for the building? Maybe some locked doors or files. Is there a drug supply cabinet that needs unlocked? If you're the only pharmacist, is there some additional protocol that you need to implement to close the pharmacy temporarily until a relief pharmacist is able to come in? Are there additional keys staff will need an event that you're unable to come to the facility for an extended amount of time? Possibly a lock box, your personal mailbox, if it's at the post office, et cetera. Then there's access points and authorizations that you need to consider. Does your emergency contact person need to get ahold of your attorney or your CPA? Is there something that they should do once they contact them to let them know what's happening? Have you consulted your personal attorney in the past to make additional arrangements, maybe to have a temporary power of attorney in play and an envelope waiting for whatever incident may occur? The main thing we want to address is how can you open your doors to continue to support your community and allow your staff to operate in your absence? So, can your pharmacy operate without you? It kind of goes back to the you wearing a lot of different hats. So, having a lot of information mapped out and discussions with your staff, with your emergency contact people, with your other partners and owners is really going to help to ensure that if an incident, an illness, an accident has happened, you are able to open your doors. Let's talk about staffing. Do you already have enough staff in place that they can operate if you're not there? Do you have a relief pharmacist that's just a phone call away? Maybe there's a retired pharmacist in your community that pinch hits for you when you go on vacation, have a meeting out of town, et cetera, or is there a staffing company that you've done business with in the past that your staff can contact and see about having a relief pharmacist sent in? The next area would be operations. Who has the authority to run your business in your absence? Do you have a partnership with your spouse who normally works in the pharmacy that they can handle things on your own? Do you have a business partner that's going to be able to handle the reigns while you're gone? Or do you have maybe a business manager that's able to take care of a majority of items in your absence? The next question is, have they been trained? Have you spent any time showing them exactly what should be done if you're not able to come into the facility? Maybe there's multiple people, and that's great. If you have a whole team of people to support you, that's amazing, and you can go into your planning with a little extra gold star knowing that you've got enough staff to help carry you through. So, what happens if multiple people end up possibly getting sick? If we have COVID, maybe you and a few members of your staff have now been placed on quarantine. What's your secondary contingency strategy going to be for operations if multiple key people in your pharmacy are now unable to operate? Then the next area is additional responsibilities. Are there functions that you have that you're the only one in your pharmacy that takes care of? I'd probably be willing to bet yes. A lot of folks, especially our small business owners and entrepreneurs, they have so many hats that they have to wear, and there's a lot of areas that sometimes we're just not comfortable handing off to an employee. Even whenever you grow to a larger size, there's probably still some things that you like to do on your own. How can you help to train somebody else in your facility, that if you're not there, they can at least take care of them for you for the short-term or for the long-term? Have you consulted your personal attorney about a power of attorney to grant access to accounting and banking privileges, and do you have a plan for continuing your inventory, maybe helping to hire or acquire more staff? Who's going to take care of the HR functions while you're gone if that's something you normally take care of, like scheduling? These are all areas that I hope you're going to be able to start contemplating and mapping out a couple of different scenarios that might be impacted in the future. I love this quote from Damien Conway. It says, "Documentation is a love letter that you write to your future self." A contingency plan is great if you've been thinking about it, but if you've never written it down and shared it with anyone, there's really no way that it can get deployed. So, I would encourage you as you're coming up with these things, make sure you're documenting and training and informing multiple people so they can execute your contingency plan the way that you want it to. Let's talk about training. Have you ever discussed a contingency plan with your staff and with the other owners? Do you hold regular trainings for maybe things like regulatory compliance, maybe doing your HIPAA training or your fraud, waste and abuse training that you can tuck in a couple extra minutes and talk about that contingency of, "All right, so something happens, I've been in a car accident. I can't come into the pharmacy today. What are you going to do?" Hopefully your staff will be able to answer you well because you've spent time training them. Documentation. Hopefully you have your succession plan and your contingency plan written down somewhere, so you have this process in a written form that others can easily replicate. Now, depending how your facility is set up, are you a sole proprietor? Or are there multiple owners within your facility? This area is something that you need to consider too. Have you ever listed a second contact name on your account, such as your software, your ordering systems, your banks, any of those types of billing companies, et cetera. So, if somebody other than you contacts, they are already authorized to make system changes, make additional purchases, upgrades, get information, and answer to their questions. Do you have someone at your pharmacy that's going to be checking your mail, both your personal and your business mail if you're out for a few weeks, and your mail is just sitting on your desk and they're gathering it, but it's just sitting there. Is someone going to be authorized to open the mail to make sure that there are no bills that are becoming past due? There's no notices that need to be addressed. There's no requests for information that needs to be passed on to the appropriate party. In some cases, look at Medicare. If they send a revalidation request and it goes beyond 30 days and it hasn't been addressed, it's possible they can revoke your numbers. So, we want to make sure that you have a key person of your staff that's responsible, that's trustworthy, that they're going to be able to proctor and monitor your mail, your physical mail, and even your email, too, your business email to make sure that there isn't sensitive information, time-sensitive information that's being overlooked. I really appreciate the quote from Claire Cook on contingency plans. She says, "If plan A doesn't work, remember the alphabet has 25 more letters." In a lot of instances, your contingency plans are probably going to start to look like alphabet soup. You're going to have lots of letters, lots of numbers. It's going to hopefully be fairly well organized. But those contingency plans, you need to look at both short-term and long-term scenarios. What are the short-term incidents that may cause you to be out of the building for a few days, or maybe one or two weeks? Then on the long-term, what are some other incidents that might cause you to be out for a few weeks or a few months? Then we go into the permanent side as well. It's very possible for all of us, we're not going to live forever, that unfortunately something tragic can happen, and now all of a sudden, we're no longer able to come to the pharmacy because we're no longer here. So, now, instead of a contingency plan, we move more into succession plan. Who's going to acquire your pharmacy? Is it to be sold? Is it to be gifted to someone? Is it to be absorbed by another independent owner in your area? Those are a lot of things that you really need to think about. Now, I know we're kind of coming in on the time of the end of my presentation, so I want to let you know, whenever you're writing these things out, you're not going to be able to address every single scenario that happens, but you're going to want to try to think about ways to make your staff, maybe your spouse, your business partners lives just a little bit easier when you're not there. I've got some additional resources that you all might be interested in. I talked in the beginning about the Medicare application fees being waived. I've included my nine steps to starting an immunization program. It goes over really why it's a great idea to start one, and a couple of things you need to do to get it up and running. I've also attached the CLIA waiver supplements. There's a link for that as well. I've got an expanded version on my top five compliance happenings in case you want to share that with somebody else in your pharmacy. And, of course, I've got my contingency plan brainstorming worksheet. We've gone over an awful lot of information in a short amount of time, and I want to wish you all the best of luck while you're brainstorming. I actually had a succession planning workshop last night with a group of entrepreneurs where we were talking about what's the next step? What does it look like for retirement and death? It can be a little bit morbid whenever you're thinking about it, but in the end it brought me great joy knowing that we've got action steps that are now going to be in place to help for smooth transitions in the absence of our owners and absence of our leadership in the event that something happens. I wish you all the best of luck with your contingency planning. I hope that you are able to work through it smoothly, quickly, efficiently, you're able to train your staff and of course share this information so in your absence, everything's able to run smoothly. I wish you the best of luck in the remainder of 2020. I hope that you, your staff and your family stay happy, stay healthy, stay prosperous, and I hope you get a lot of great information out of the rest of this Climb summit that RMS was so gracious to help host.