CSI Specialty Pharmacy Podcast

This week, host Andrew Maddigan, Vice President of Client Engagement, welcomes CSI Senior Consultant, Vijeev Menon, to break down the accreditation process in specialty pharmacy and illustrate how organizations, especially first-time applicants, can best prepare for success. 

Tune in to Discover:

  • An overview of the accreditation process and when organizations should start preparing
  • Why it is critical to have a single point person lead an organization’s accreditation endeavor
  • Best practices for how organizations can optimally prepare for the process
  • The three biggest accreditation areas most pharmacies are ill-equipped for
  • The value in obtaining multiple accreditations and which ones most pharmacies should consider

About Vijeev Menon, RPh

A registered pharmacist, Vijeev Menon has over 20 years of leadership experience across a broad range of pharmacy venues. His experiences have included setting up a large specialty pharmacy as well as managing pharmacy operations for retail, mail order, health system pharmacies and pharmacy call centers.  He has also developed and overseen the quality program, designed and implemented successful workflow enhancements and performance improvement initiatives for several organizations. As a former surveyor for one of the industry’s leading accrediting bodies, Vijeev brings a wealth of experience as an accreditation reviewer, which he regularly draws upon in successfully guiding pharmacy organizations of all kinds to achieve accreditation.

About Andrew Maddigan

During the past 30 years, Andrew Maddigan has directed business strategy and marketing functions in a variety of venues, including health care, education, aerospace, and energy. His previous roles have included VP of marketing for the nation’s largest not-for-profit hospice agency, VP of sales and marketing for a national specialty and long-term care pharmacy, and communications director at a large urban school district.

Andrew also led marketing and strategic communications efforts for an international health care accreditation agency, serving as the organization’s liaison to the United Nations Development Program. Andrew earned his BS in Broadcast Journalism from the S.I. Newhouse School of Public Communications at Syracuse University. He earned an MS in Educational Administration from Canisius College and an MBA from St. Bonaventure University. Andrew currently serves as VP of client engagement at CSI Specialty Group.

Transcript Notes:

Speaker 1: Welcome to the Specialty Pharmacy Podcast, your prescription for specialty pharmacy success.

Andy Maddigan: Hello, and welcome to the CSI Specialty Pharmacy Podcast. I’m Andy [Maddigan 00:00:11], and today’s topic is pharmacy accreditation, and I’m pleased that we’re going to hear from one of the industry’s true experts in that realm. That’s CSI’s senior consultant, Vijeev Menon.

Andy Maddigan: Vijeev is a registered pharmacist with over 20 years of leadership experience across a broad range of pharmacy venues, everything from setting up large specialty pharmacies as well as managing pharmacy operations for retail, mail order, health system pharmacies and pharmacy call centers.

Andy Maddigan: He has also developed and overseen the quality program, designed and implemented successful workflow enhancements and performance improvement initiatives for several organizations. As a former surveyor for one of the industry’s leading accrediting bodies, Vijeev brings a wealth of experience as an accreditation reviewer, which he regularly draws upon in successfully guiding pharmacy organizations of all kinds to achieve accreditation. Welcome, Vijeev.

Vijeev Menon: Thanks, Andy. Thank you for that kind introduction. Really excited to be a part of this podcast conversation today.

Andy Maddigan: Sure. And accreditation is one that always draws a lot of interest. For those who may not be familiar with the concept of accreditation in pharmacy, specifically specialty pharmacy, can you briefly walk us through that process?

Vijeev Menon: Yeah, sure. So there’s a few different accrediting bodies, but most of them have a very similar process, which is it is multi-step, obviously begins with the initial phase of contracting with the accrediting body to establish what kind of program the organization is going to be seeking accreditation for.

Vijeev Menon: That’s mostly contract legal kind of work, which is then followed by a submission of documents which serve as evidence for meeting the different standards of the accreditation program. All the accreditation programs have a whole bunch of standards specific to specialty pharmacy and the organization provides documents such as policies, procedures, meeting minutes, et cetera, to show evidence that they do meet the requirements.

Vijeev Menon: Once that desktop review process is completed, which involves going back and forth between the accrediting body and the organization to tweak those documents as needed, then it goes on to the next phase, which is the validation review, which can be comprised of a visit to the applicant’s pharmacy, the site, and our virtual review as well to be conducted along. So that in a nutshell is the process. And so it goes from the bidding, contracting, desktop review, all by an actual onsite visit.

Andy Maddigan: So tell me, Vijeev, from your experience, which of the following statements would you say is closer to the truth? Do you think that most pharmacies view accreditation as a mandate that they grudgingly comply with? Or do you think that most of them view accreditation as an opportunity?

Vijeev Menon: So that’s a very good question. And there’s different types of organizations that seek accreditation, just to process this a little bit. I would say that a few years ago when we had a lot of independent pharmacies that were seeking accreditation, there was more of a requirement to comply in order to get paying contracts with payers, et cetera. So quite often we saw that, I don’t know if I want to use the word “grudgingly,” but there was certainly a reluctance on behalf of the pharmacy, the applicant, the independent pharmacy type, especially in seeking accreditation.

Vijeev Menon: However, we have seen a shift in the type of organizations that are opening and seeking accreditation to mostly health systems, specialty pharmacies now, and in their case they actually see it as an opportunity to firm up their processes and see how they can improve their existing functionalities.

Vijeev Menon: So it’s a combination of both. They do see it as an opportunity to improve, but also it is a requirement for getting the payer contracts as well. So I think I would remove the word “grudgingly” for now, because they do see the advantages of going through the process.

Andy Maddigan: All right. I know that the topic of accreditation does cause anxiety. Do you think that that’s well placed? From your experience, do most organizations have good reason to be concerned? Or would you say that most are better off than they give themselves credit for?

Vijeev Menon: We see several instances when as an organization goes through the accreditation process that they realize that they have to make significant changes, improvements, introduction of new programs. So in many cases the anxiety is well placed, but often they are very select areas that the anxiety really needs to be in place, if you will.

Vijeev Menon: Quite often there are many things that the organization does, but they just need to improve things a little bit in terms of documentation or having some structure around some of their processes. While there are certain areas that yet need a lot of work, there are others that the processes just need to be tweaked a little bit. So fair to be anxious, but in many circumstances or many organizations, they have a lot of things already in place, so no need to be too anxious.

Andy Maddigan: When working with pharmacies and helping them prepare, do you find that most of them have one person, like a, I don’t know, head of Quality or Compliance who leads that project, the accreditation project? Or do most of them assign tasks to a lead pharmacist or a team of other professionals who have broader responsibilities like a day job? They’ve got something else that really occupies their time?

Vijeev Menon: Yeah. Most often, yes, there is one person who serves as a point of contact and heads the quality program or oversees the accreditation processes. Several instance, this can be a pharmacist in charge or a clinical pharmacist, but bigger the organization, the chances are they have a dedicated person for quality and accreditation who oversees this process. But of course, they have to work in very close coordination with the clinical team, the pharmacy operations team, other sections within the organization, be it Marketing, IT, Human Resources, et cetera.

Andy Maddigan: Do you think one model tends to work better for the organization [inaudible] having a single point of focus versus a team?

Vijeev Menon: Yeah, absolutely, having one person who takes the lead on the accreditation process definitely works. It’s a smoother process because there is a lot of coordination among different departments, and certainly that is our recommendation.

Andy Maddigan: Can you tell our listeners what are maybe three or four things that they can do as an organization to be better prepared for accreditation?

Vijeev Menon: Sure. I think first and foremost is to familiarize with the requirements of the accrediting body as to understanding what is needed in order to achieve accreditation. So quite often attending a training session from the accreditor, whether it be a webinar or a live training session, pays dividends for sure.

Vijeev Menon: Once that’s done, it is a matter of developing the areas of need. Quite often we see areas such as patient management, a formal quality management program, any functions such as those that need to be developed, quite often from scratch. I would say those need to be developed in the beginning because it involves a lot of work.

Vijeev Menon: And thirdly, I would say having policies and procedures around every aspect of what the specialty pharmacy does. These need to be developed in the beginning. They need to be revised on an ongoing basis in order to make sure that you have the most current and accurately reflecting document upon submission to the accrediting body.

Andy Maddigan: From your experience, what are the three biggest areas that most pharmacies are not prepared for?

Vijeev Menon: I’ll kind of tie this back to the previous question. Some of the biggest areas that they’re ill-prepared for is the quality management program, the patient management program, that these are completely absent in several cases.

Vijeev Menon: Every pharmacy does patient-counseling, education. There’s a lot of good clinical work that’s done, but quite often there is no structured program around that. Same with the quality management program. There is no formal way of tracking errors, analyzing those errors. So these are areas that need to be developed, documented, have regular follow-ups, et cetera.

Vijeev Menon: Beyond that, one of the other areas that the pharmacies are ill prepared is lack of policies and procedures. Quite often we find pharmacies are doing a lot of work, but nothing is documented, so there is a lot of variability in how different processes are done within the organization.

Vijeev Menon: And thirdly, going back to documentation, is even beyond the pharmacy when it comes to other departments such as Human Resources or personnel files, their IT functions, there is sometimes a lack of documentation there as to making sure the requirements of the personnel, their required qualifications are met or required risk tests are conducted by the IT department, et cetera.

Andy Maddigan: So what are the top areas of deficiency that you most often encounter with companies’ policies and procedures?

Vijeev Menon: Quite often we come across policies and procedures that do not truly reflect what the organization is doing. Quite often the documents are outdated, the procedures have changed, new systems have been introduced, but the actual policy and procedure does not reflect these changes.

Vijeev Menon: We also note in several cases that a lot of operational efficiencies are in place and hence again, the policy and procedure has not been changed to reflect those improvements. So it’s a matter of making sure those documents or policies and procedures are current with what is actually being done, and of course that they are a sound process that is completely vetted.

Andy Maddigan: All right, so when should an organization start planning for accreditation?

Vijeev Menon: That’s a good question too. I would say that the organizations start the planning at least a year before the target date for accreditation. Keep in mind the multi-step process we talked about in the beginning, given the different areas. Then establishing any needs, especially if there is a complete lack of the big programs I talked about, like patient management and quality management, establishing those, getting them in place, getting the right personnel takes quite a bit of time in many instances. So as a general guide, I would say give it a year before your target date for achieving accreditation.

Andy Maddigan: Yeah, good advice. What’s the best way that a pharmacy can educate its staff, its employees, about the accreditation process and how they’re going to need to be prepared?

Vijeev Menon: The best way to do it is through staff meetings and in their relevant areas of practice. So as I mentioned earlier, it’s always good to have one person who is overseeing the accreditation process. The expectation would be that this person has good familiarity with standards across the program. So whether it be the clinical standards, patient management, quality standards, IT, marketing, even if it’s not an in-depth understanding, at least have a cursory understanding.

Vijeev Menon: But when it comes to individual staff members, the general recommendation is that the staff be trained on standards relevant to their job function. In other words, the pharmacy staff are trained on the operational standards. The clinicians, the pharmacists are trained on pharmacy operations as well as patient management. So it’s a matter of dividing and training the staff on what their respective job functions are.

Andy Maddigan: Switching gears a little bit, specialty industry analyst Adam Fein looks each year at the growth of accreditation as a measure of growth in the specialty market. Each year he produces a market report that focuses on, among other things, the market share of the accreditation agencies, so URAC and ACHC and CPPA. I guess the big takeaway the last few years has been that cumulatively the segment of accreditation is still growing at a pretty healthy clip, so a good indication for the specialty market as a whole.

Andy Maddigan: But one noteworthy trend is the site of care. I mean, I think you mentioned that a little bit earlier with hospitals’ and health systems’ specialty pharmacies nearly tripling over the last three-year period while independent specialty pharmacies saw the biggest decline in accreditation. Now with the growth that we’ve seen in health system specialty pharmacies getting into the game, what different advice would you give them about the accreditation process as you might give to an independent or a freestanding specialty pharmacy?

Vijeev Menon: Oh yeah. I mean, it’s a great report out there. And the biggest thing that I would say is health system pharmacies have a lot of advantages in terms of having access to the patient’s medical record, quite often the electronic medical record, which has a lot of clinical data progress, which the specialty pharmacy can take advantage of and making sure that there is patient care taken, patient care that’s done as a whole.

Vijeev Menon: As an example, quite often the lab data for a certain condition, the progress notes are in the electronic medical record and the specialty pharmacy has access to it. So it certainly helps the clinician in taking care of the patients. It’s quite often taking advantage of the patient’s medical record in making their specialty clinical program even more effective, certainly something that an independent pharmacy does not have access to. And this certainly is great for the patient’s continuum of care.

Andy Maddigan: Is there value in obtaining multiple accreditations? And if so, which ones should most pharmacies be considering?

Vijeev Menon: We have noticed recently that there are some payers that do require multiple accreditation. Usually what we see is a combination of URAC plus one of the other ones, whether it be CPPA or ACHC. A part of what dictates that depends on the individual payer requirements, which may vary depending on the market and who the biggest patient population has as their insurance provider.

Vijeev Menon: But the one other aspect I will point to is for the organization to evaluate the synergies between the different accreditation programs. And sometimes there may be one accreditation that’s easier to pursue when you already have the URAC accreditation, or you may end up having to make several tweaks to the program in order to satisfy both. So it’s a little bit of payer requirements and what the differences between individual accreditations are that need to be evaluated by the pharmacy.

Andy Maddigan: What advice would you give to an organization that’s pursuing accreditation for the first time?

Vijeev Menon: Yes, so when an organization is pursuing accreditation for the first time, like we mentioned earlier, it’s important that they have a dedicated person who is able to coordinate with the different parts of the organization, get staff trained appropriately, operationalize different programs, et cetera. In other words, it is a very involved process. It takes a lot of effort that the entire organization needs to be part of, be aware of what the purpose is and be very involved in developing the requirements from those specific departments. So that in a nutshell is what I would tell an organization seeking accreditation for the first time.

Andy Maddigan: And what about advice that you’d give an organization as it pertains to working with a consultant? I know some of the larger organizations that have more developed quality and compliance functions might undertake an accreditation on their own, but some of them oftentimes will choose to seek advice from various different companies. What sort of counsel would you give them on making that decision wisely?

Vijeev Menon: Yeah, I think it is very critical to have the right type of consultant for the accreditation effort. And ideally the consultants should have experience with the accreditation process, of course, but not just a cursory understanding of the accreditation requirements, the standards or printed material, if you will, that the accreditation agency provides.

Vijeev Menon: Quite often there is a lot more to the accreditation standard than meets the eye, so it may be a matter of having a more involved process. But more importantly, what we see is there are many ways to meet the requirements of an accreditation standard more efficiently. The organization sometimes does not even realize that a certain standard can be met or is already being met, but it just needs to be tweaked a little, or the process needs to be documented, or like we said earlier, taking advantage of the electronic medical record to satisfy many of the requirements for patient management, et cetera. So there’s a lot of efficiencies that can be realized in using the right consultant to make the whole process a lot smoother.

Andy Maddigan: Great. Thanks much for that. That’s about all the time that we have today. So with that, I’ll thank Vijeev for sharing your insights with us, and we look forward to having you join us again.

Vijeev Menon: Thanks, Andy. My pleasure. It was definitely very exciting to share some of my thoughts.

Andy Maddigan: And thank you to our listeners for tuning in to the CSI Specialty Pharmacy Podcast. If you’ve enjoyed today’s episode, I encourage you to subscribe on your favorite podcast delivery platform. I also encourage you to visit our website, csigroup.net, where you can download your free copy of the 2019 State of Specialty Pharmacy Report. And if you’d like your voice to be heard on the 2020 State of Specialty Pharmacy Report, the survey window is currently open, so you can find a link to complete the 2020 survey on our website. That site again is csigroup.net/survey.

Andy Maddigan: You can also keep up with us on social media by following us on LinkedIn, Twitter, and Facebook. CSI Specialty Group is a subsidiary of group purchasing organization Intalere. CSI expands Intalere’s suite of solutions to healthcare providers, health systems, pharmacies, and pharmaceutical partners. Intalere is owned by Intermountain Healthcare, a leading healthcare system based in Salt Lake City, Utah.

Andy Maddigan: CSI supports our parent organization’s vision of providing tailored smart solutions to help deliver superior services at an affordable cost. You’ve been listening to the CSI Specialty Pharmacy Podcast. Until next time, good day.

Speaker 1: Thanks for listening to the Specialty Pharmacy Podcast. If there’s anything we mentioned in today’s show you missed, don’t worry. We take the show notes for you at csigroup.net/podcast.

Speaker 1: If you’re not already a subscriber, please consider pressing the Subscribe button on our podcast player so you never miss one of our future episodes, and if you haven’t given us a rating or a review on iTunes yet, please find a spare minute and help us reach and educate even more of our specialty pharmacy peers. The Specialty Pharmacy Podcast is a production of CSI Specialty Group, your go-to firm for all things specialty pharmacy. Thanks again for listening, and we’ll catch you next on doctor’s orders.

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