I sat down with Lydia Godfrey, Associate Legal Counsel at Ardon Health in beautiful Portland, OR, to talk about compliance and training in the specialty pharmacy industry.
Lydia was born and raised in Detroit, MI, but escaped the Midwest cold for California. She eventually made her way to Portland, where she has spent nine years of her career.
Lydia has a ton of experience having worked as a law clerk, in private practice and now in-house. She's a classically-trained music aficionado, having learned to sing and play piano and guitar – and flute, violin and clarinet (the latter somewhat unsuccessfully - her words, not mine!),.
Some of Lydia's hobbies include swimming, bicycling, hiking (ed. note: I think all Portlanders are required by city code to enjoy biking and hiking) and exercise!
Without further ado, here's our interview with Lydia!
1. Do you have a favorite business/career/legal/etc. book?
Well, I have an affinity for the Blue Book – being a serial organizer and detail devotee, there’s something comforting about all those rules. But as far as a book with practical value in the working world, my choices are probably a bit off the wall. I like books like As A Man Thinketh, that advocate personal responsibility. Like choosing to be conscious about the choices we make, knowing those choices create our successes and inform our so-called failures, declining to be a victim of anything – to take to heart those kinds of truths is very empowering, whether personally or in business. People who embrace them make great leaders. And I mean a leader on any level – you don’t have to be president to be a great leader.
I also like The Slight Edge by Jeff Olson – it’s kind of a practical approach for people who haven't been able to succeed and can't figure out why. The second half of the book is just OK as far as my tastes go, but the first half packs a punch, has great tools, and inspires.
2. Why did you choose to practice in-house?
Something about law firm life wasn’t a good fit for me. When I went to law school, I didn’t really picture myself working in a law firm. Like many who enter law school, I just wanted to do some good in the world, especially to help animals. Even though I’d been in the law profession as a court reporter and legal assistant for some years before law school, I didn’t really have a specific picture of how I would fit in. So I launched from law school to being a court clerk, which I loved. I got to work with a lot of different judges, got to know some of the prosecutors and defense attorneys, and juvenile court’s case workers and DOJ lawyers. I gained a wealth of knowledge about court procedures, too.
Even though I wasn't drawn to law firm practice, I knew that experience would be valuable. So I felt fortunate to have that opportunity after my clerkship. I worked with great people, about eight lawyers in the firm at that time, and had cases mostly in construction defect. As a homeowner, that specialty was super interesting – I loved the little details about building and how all the sub-specialties fit together – although I suppose you could look at it like how all the sub-specialties pointed fingers at each other as to who was responsible for the alleged defects in the lawsuits. But I’m a pretty positive person. I just felt my clients deserved my defending them as honest, hard-working people. Some of them had the potential to lose their entire livelihoods if we couldn’t eliminate or mitigate their liability.
Regardless, I moved from the law firm into solo practice because I still wanted to help animals. Wills and trusts is a nice way to do that, because a lot of people don’t consider what would happen to their beloved pets if something happened to them. I wasn’t completely happy as a solo practitioner, though – I spent substantial time networking, but unless you partner up, by definition, you’re just not part of a team. I missed that.
Out of the blue, a former colleague from the courthouse, then employed as in-house counsel, asked me if I’d be interested working in house. The job would start out as analyst but grow into corporate counsel for a startup specialty pharmacy. I had nothing to lose by checking it out and really liked my future bosses and the idea of creating the job from scratch. I was promoted to contract and compliance officer with a nearly 50% raise after a year. Now, three years from my hire date, I’m associate legal counsel. Officially, general counsel is located within the pharmacy’s parent company.
3. Why is it important to train employees on legal issues?
Compliance in particular is a linchpin in specialty pharmacy. We started with a president, general manager, operations supervisor, head pharmacist, and me. Now we have 35 employees and are about to hire three more. Besides pharmacists, we have certified pharmacy technicians, VPs in operations and business development, a marketing department, a benefits investigator – we are growing, and fast.
Everyone's job involves performing within legal boundaries in one form or another, so it's hugely risky to not take employee training seriously. Noncompliance could lead to anything from pharmacy board sanctions and fines to federal debarment. As we speak, the Office for Civil Rights (i.e., Medicare) is in the middle of conducting surprise audits on various healthcare entities throughout the country. The Oregon Board of Pharmacy performs unscheduled site visits, too. We have to be prepared for those kinds of situations.
We have a plethora of policies and procedures in place, along with training and education covering code of conduct, accreditation, conflict of interest, confidentiality and disclosure of private and personal health information, patient rights and responsibilities, diversity, health literacy, counterfeit drug awareness, and more.
In our first year of operation, we went for and achieved accreditation from the most stringent authority in pharmacy (URAC). The accreditation – including reporting and reaccreditation obligations and the accreditation we’re in the process of obtaining from another authority – has added further compliance obligations to our list, but that’s one of the reasons we went for it … those hoops make us a better pharmacy. And that’s what we want, to be the best. Training and education of everyone on the team – from packing specialist to president to board of directors – is pivotal to the quality and integrity of our services.
4. What are some unique challenges in the specialty pharmacy industry? How do you use training to overcome them?
I'd say our biggest challenges are with federal laws – specifically CMS/the Centers for Medicare and Medicaid Services and HIPAA, HITECH, etc., regulations arising out of the Department of Health and Human Services/Office for Civil Rights. And the reason I single those out from our barrel of other challenges is because the rules are so dense and the stakes are so high.
Noncompliance with one or more of these laws could get you sanctions, exclusions (from doing business with the Fed), or, god forbid, debarment by the Office of the Inspector General, state Medicaid, or other agencies. That would be very, very bad across the board, potentially shattering a business.
We are scrupulous about holding timely and proper employee trainings on fraud, waste, and abuse/FWA, Medicare Parts C&D compliance, privacy and security, confidentiality of PHI, and other trainings related to those two entities alone. CMS actually makes it pretty easy because as of this year, it requires that all FWA and Medicare compliance trainings be conducted using the training materials CMS provides. So we don't have to worry if we missed covering something important in the slides.
CMS even includes quizzes, which people have to pass with a certain score. CMS's is definitely not colorful, fun, or flashy training, but everyone knows how critical it is – I guess that's what keeps them awake.
5. How can corporate counsel get buy-in from management to take up employees' valuable time with training?
Offhand, I'd say make sure you ask questions like that in the job interview and, if you don't like the answers, move on. I'm extremely fortunate to be working with higher ups who know the pharmacy business well, know the risks, know the importance of compliance. It's just a given that adherence trainings are part of work life. Many of the trainings are out-and-out required by laws or regulations, so management would be shooting our business in the foot to ignore them.
I've never had an issue or problem with getting my president and VPs to support trainings that help us comply with the law or be a better specialty pharmacy. I was talking to a paralegal from a large healthcare system the other day, and she told me sometimes she has to wait four months to get signatures from board members for, say, state pharmacy license renewal. That would never happen where I work. My position was one of the original five in the startup, in part, because they knew very well how important licensing, registrations, contracts, training, and compliance are to the heart and soul of the pharmacy. They value training, so employee time spent training is valuable in itself.
6. If you had to list the top three most important topics for corporate counsel at a healthcare organization to focus on for employee training, what would they be and why?
Medicare and the privacy/security/confidentiality arena. Speaking from specialty pharmacy, but including healthcare organizations that have any kind of sales and service departments, the third would probably be anti-trust. It's another federal regulatory minefield, and some of the "don'ts" are not all that straightforward.
We have people in marketing and business development, for instance, who spend a fair amount of time going to industry conventions and other forums, serving on various committees, etc., and they really have to be cognizant about the conversations they're having. If you're not careful about that, you might find yourself talking about things that could be construed as, say, collusion, even though you didn't intend it that way.
We like to do things right. So we intend to make sure our business people are going out there knowing how to communicate without breaking the law. That's especially important now, when we're just starting to more closely involve ourselves with industry groups.
7. There's so much information on compliance, contracts, etc. How do you know what information to present and what to ignore?
Yes, it's a tall order, I agree. In our case, we've posted a position to hire a compliance analyst. We've reached the stage of growth where we have a definite need to have one person focusing on compliance and one focusing on contracting (that's me). Of course, there's lots of crossover, but basically, make sure you don't give one person the responsibility of keeping up with requirements and changes in the laws/rules/regs when you really should have two.
Beyond that, we do share the load. In the beginning, I was trying to keep up with rule changes in all the states we have licenses. But the fact is, our head pharmacist, by any state law, is ultimately responsible for that knowledge. And it makes sense because, even though reading through rules and laws is something I'm good at and do routinely, after combing through some of the pharmacy laws, I can honestly say I am not comfortable being the person to determine which of those is important and which is not. I'm not a pharmacist, so I'm glad our head pharmacist is making those decisions.
In other compliance, contracts, etc., information, I feel like most of the time the important information finds me – so say I'm looking at a contract that will allow us membership in a pharmacy network. I'll review the contract with an eye to what we will have to do to maintain that membership. Those kinds of contracts usually require annual licensure, DEA registration updates, and FWA/compliance training documentation. Sometimes they require more than that.
8. What's the 1 tool you can't live without for legal training?
We'd be in a real bind if we didn't have PowerPoint or a similar easy-to-use slide deck software. But just this month we've implemented Saba software and are already thrilled with it. It's an interactive, online learning management system that accommodates whatever format your training happens to be in.
Most of our trainings are PowerPoints, but we also have PDFs of various documents employees are responsible for knowing and acknowledging. Most of our trainings and such are not live presentations, but with Saba's interactive capability, I believe all our trainings will now be through Saba. When I was wearing so many hats in the startup, one of them was figuring out what trainings we needed, later working with the quality manager to come up with training content and format, tracking who and when employees completed trainings, and other not-fun logistical necessities.
Plus, we're required to maintain a history of some of our trainings for 10 years. So Saba does all that and way more – sends emails reminding employees they have X days left to complete a training, email alerts to supervisors keeping them apprised of who has and hasn't completed training, interactive testing, and a lot more. The VP and supervisor of operations have pretty much taken the reins with Saba, and the system is going to really kick our training efficiencies into high gear and, most importantly, ensure all trainings are timely done – that's really important for legal and accreditation requirements. So with Saba, my involvement will be focused on the content of our legal trainings like anti-trust and supporting operations in content for quality-oriented trainings, and Saba will handle the logistical tasks.
9. Walk me through the step-by-step process you use to prepare for a legal training presentation
I can only dream of having a step-by-step process for a training. Unfortunately, my plate is so full, I don't have that luxury. I have managed to avoid having to put together a bona fide training, even a PowerPoint, non-live presentation. I've been able to edit presentations I borrow from our parent company or delegate creating trainings to others. But as I mentioned, educating our staff on anti-trust issues has become a priority. You and I have talked about a pretty great program InHouseOwl could put together for us, and I've been trying to squeeze onto my president's calendar to talk with her about it. She's pretty savvy, so I expect she may appreciate the value a professionally done training would bring to the team. I know it would hugely benefit me!
Thanks for the great interview, Lydia!