Accreditation continues to be both relevant and essential for specialty pharmacies who want to earn a “seat at the table” and gain access to payor networks and specialty medication manufacturers.
This week, host Andrew Maddigan, Vice President, Client Engagement welcomes Vijeev Menon, Director of Specialty Pharmacy Consulting and Accreditation at CSI Specialty Group, to break down the role of accreditation in specialty pharmacy, current trends, and how specialty pharmacies can best prepare for the accreditation process.
Tune in to Discover:
- The purpose of accreditation in specialty pharmacy
- What to expect during on-site accreditation visits
- Differences between accrediting bodies
- Common deficiencies observed by accreditors, and how to avoid them
About Vijeev Menon, RPh
Vijeev Menon, RPh serves as Director, Specialty Pharmacy Consulting/Accreditation at CSI Specialty Group. Vijeev has over 20 years of leadership experience in various settings, including setting up a large specialty pharmacy as well as managing pharmacy operations for retail, mail order, pharmacies, health system pharmacies, and pharmacy call centers.
He has also developed and overseen the quality program, successful workflow enhancements and performance improvement initiatives of several organizations. Vijeev is also experienced as an accreditation reviewer and has successfully guided several organizations to achieve accreditation.
About Andrew Maddigan
During the past 30 years, Andrew Maddigan has directed business strategy and marketing functions in a wide range 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. He currently serves as VP of client engagement at CSI Specialty Group.
Andy Madigan: Hello and welcome to the CSI Specialty Pharmacy Podcast. I’m Andy Maddigan, CSI Vice President of Client Engagement and your host for this episode. Today, I’m pleased to welcome Vijeev Menon, CSI’s Director of Specialty Pharmacy Consulting and Accreditation. Welcome, Vijeev.
Vijeev Menon: Thank you.
Andy Madigan: So before we get into today’s topic, which is accreditation, which I know is a very hot topic for many pharmacies out there, I wonder if you can tell us, tell our listeners a little bit about your background as a pharmacist and a little bit about your current role with CSI.
Vijeev Menon: Thanks again, Andy. Yeah, so I started off as a pharmacist over 20 years ago and have had the opportunity to have different types of experiences within the pharmacy field. So, traditional retail pharmacy, I’ve had the opportunity to work in a call center as a clinical pharmacist for a mail order pharmacy, then I had worked with the quality section of the specialty pharmacy, helped set up a large specialty pharmacy, oversaw quality functions, as well as accreditation related activities. And from where I moved to working for a health system, where I managed the specialty and mail order operations. Since then, I’ve had the opportunity to work with an accreditation agency and I’m presently with CSI where I work with the team of folks here in helping organizations achieve or pursue their accreditation and help with the start of the process all the way through the to the end, which can be a very extensive process, which I look forward to talking about more today in detail.
Andy Madigan: Awesome. Very extensive and broad experience, I can tell there’s a lot of the diversity of experience you have lends itself very well to accreditation, which really looks at the entire organization. So first of all, for those of our listeners who may not be familiar with the concept of accreditation pharmacy, especially specialty pharmacy accreditation, can you briefly walk us through that process?
Vijeev Menon: Sure. There are a few different accreditation bodies in specialty pharmacy and the processes are almost similar. Generally, it’s a six month but usually longer process, which starts off with any typical process that you would have with a vendor. In terms of contract negotiations, really there isn’t much to negotiate into the contract, but it still goes through that process of applying to the accreditation entity. That’s followed by submission of documents for desktop review, which basically involves submission of policies, procedures, meeting materials, and any other evidence that the organization provides to the accreditation entity to evaluate at the desktop review, in other words. And once that’s accepted, once the accreditation quality determines that the organization’s policies, processes, procedures, satisfy the intents of their standards, then they move to the next phase, which is a validation review, which is typically on-site. Some entities schedule them, some of them can be a surprise visit that’s not scheduled and some of them even do part of the validation review virtually through a webinar. And at the end of the review, there is a recommendation that is sent by the reviewers to the decision-making body that ultimately issues the accreditation decision. And that’s kind of the summary of the process. Obviously, we’ll talk more about the multitude of activities that have to take place to satisfy each of those phases.
Andy Madigan: What would motivate or drive a pharmacy to seek accreditation in the first place? Why would they have to do that?
Vijeev Menon: So, accreditation and the specialty pharmacy space have become standard in terms of, I mean we can talk about it in terms of the benefits, financial benefits being the access to payers, so you have a number of peers who require that a specialty pharmacy be accredited by one and sometimes more agencies so that the pharmacy can be a part of the network of pharmacies for that particular payroll third-party insurance. Additionally, there are several manufacturers that have their products, which are referred to as limited distribution drugs, that they give access to only those pharmacies that satisfy several requirements of the manufacturers. Accreditation is one of those requirements, there are additional requirements that data sets, but for today’s discussion, yes, the accreditation plays a key role and from a payer perspective as well as a manufacturer perspective could access with certain specialty medications.
Andy Madigan: So, given that, how do you view the current state of accreditation for specialty pharmacies?
Vijeev Menon: So, as I’ve mentioned, there are a few different accreditation agencies. You are at ACSP, CPPA, TJC of the joint commission and URAC is really become the, has always been the gold standard. And quite often you do see organizations that have URAC and then perhaps another accreditation to go with it to satisfy some of the pair requirements or the manufacturer requirements that I mentioned earlier. So, the current state is, as I said, accreditation is the norm. And it is really a question sometimes though, having one URAC accreditation with perhaps something else.
Andy Madigan: So is there a value for a pharmacy to seek multiple accreditations or is that something that is driven by the payer or is it kind of a combination of both?
Vijeev Menon: So what we see in the marketplace is mostly, they are driven by requirements from payers or professional manufacturers mostly payers requiring multiple accreditations. From a pharmacy’s perspective, having one accreditation, meeting the stringent requirements of URAC for instance, that is, that encompasses different sections such as IT marketing, company operations, patient management, there are quite a few requirements that the pharmacy abides by to maintain the standards of one particular accrediting body. Having an additional organization accredit brings a lot of challenges, but it is the main driver. There is the requirement from the payers, certain payers, that demands that you do have two accreditations in order to be part of their network.
Andy Madigan: You talked a little bit about the different accrediting bodies, you named a few of them. Can you tell our listeners, what’s the difference? Are they all essentially alike? How should they decide which accreditation to pursue?
Vijeev Menon: Yeah, good question. So I think as I stated earlier, URAC is the gold standard, so I think that’s an easy decision really in terms of yes, get URAC accreditation. Now for the second one, there’s ACHC, CPPA and as far as [inaudible] an organization makes that decision. I think first and foremost the organization has to consider the requirements of the primary payers that it is trying to get access to. I mean is the payer requiring an ACC accreditation along with URAC, or are they okay with any of the three or do they require CPPA? So I think that’s one driving factor. Additionally, I think an organization needs to consider, what are the differences between URAC and the secondary accreditation that the organization would like to seek. So to get into some space [inaudible] and there is a patient management program requirement for all these accreditation agencies.
Vijeev Menon: And now URAC may define a care plan or a coordination of care a certain way, whereby by it might not be needed for every patient in specialty pharmacy, whereas ACHC may define it as it is needed for every patient. So it’s these subtle differences that the organization needs to make sure that one, it is in the best interest of their patients. Two, it is operationally feasible, if there are some changes that need to be made and obviously any changes in or any policies and procedures or changes made to satisfy the needs of one organization does not adversely affect the requirements of another organization. And lastly, I will say that there is a cost aspect as well. The accreditations come with a cost and that might play a role in the decision making as well.
Andy Madigan: Are they all about the same or is there quite a variance?
Vijeev Menon: There is a variance and really it does vary from organization to organization depending on the script, volume and the number of sites, for instance, you may have one pharmacy with an oncology pharmacy that’s separate. Do you want to consider it as two separate applications or perhaps as a single application with supplemental sites. So there isn’t a fixed dollar figure that I could use to compare the cost among the different accreditation, but there is scale and that is definitely something that you would want to look into with the individual bodies.
Andy Madigan: Would it be fair to say that the number of pharmacies seeking accreditation is on the rise?
Vijeev Menon: Oh, absolutely. So there is been a significant increase in the pharmacies seeking accreditation. I, just to throw some numbers behind that, I think currently there are over 450 pharmacies that have a specialty pharmacy accreditation through URAC. I do want to point out that there are some organizations that have multiple sites that have, that are individually accredited, that have separate applications by URAC. So it does skew that number a little bit, but it gives you a very good idea that, you know, there has been, there has been an increase. I also want to point out a trend that’s been in place. A few years ago, we saw a lot of pharmacies seeking specialty pharmacy accreditation, which were independent pharmacies. In the recent past there has been a huge increase in the number of health system-owned pharmacy that have been seeking accreditation. So, that is really the one specific trend I’d like to point out.
Andy Madigan: What kind of challenges does this expose? Are there differences in the preparation or the impact of the accreditation experience if you are a health system versus an independent pharmacy or a traditional specialty pharmacy?
Vijeev Menon: Oh, absolutely. So I’d like to summarize the types of organizations, as you have the PBM on specialty pharmacies, you have retail setting, independent pharmacies, or chain retail pharmacies that operate specialty pharmacies. And thirdly, there are the health systems that have specialty pharmacies. And the one unique nature of health system that I like to point out is the fact that they have access to the medical record of the patient, the EMR, the electronic medical record. That gives the health system a unique opportunity that really sets them apart from the other pharmacies that do not have that comprehensive view of the patient. And so while it’s an opportunity, the challenge for the health system is to, how to best utilize the patient information and the electronic medical record, how to best utilize or taking care of the patient from the specialty pharmacy, satisfying the requirements of patient management without having to do double documentation, for instance, within the EMR, the patient management system.
Andy Madigan: So how do most pharmacies prepare for accreditation?
Vijeev Menon: So most pharmacies had to evaluate where they are currently. And usually the first step is to gather the policies and procedures after reviewing the requirements of the accreditation agency. So once you sign up with one of these bodies, you will get a comprehensive guide that explains what each of the standards or elements require as evidence. And from there it’s a matter of developing policies, procedures, developing the required committees, such as the quality committee, the clinical committee, the operational requirements in terms of, for example, cold chain management, satisfying the needs of that. So the preparation process is multifaceted. So you have items that are pharmacy operations, there are a lot of clinical items, there are a lot of items and marketing IT, etc. Gathering all this information together, which does take extensive time, identifying what the gaps are in additional documents that need to be created, a process change that needs to be made and submitting the application and taking it from there.
Andy Madigan: Are there common areas that most pharmacies struggle with?
Vijeev Menon: The most common area that pharmacies struggle with is really having policies and procedures that are found, that meet the requirement of the accreditation agencies. One of the common findings that the accreditation agencies have is when the documents are submitted, they did not want to see a mere repetition of the standard in the form of policy and procedure. The accreditation bodies really need to see how the organization satisfies a particular standard. What is the detailed process in satisfying that particular element? So they need to see a lot of how it is done rather than the fact that the organization simply does some things. So it’s that intricate detail that many organizations struggle with, doing the desktop review and have to make multiple submissions to satisfy the needs of the accreditation agency.
Andy Madigan: All right, so what are the blind spots? Are there areas that pharmacies are threatened by that they don’t realize pose a threat?
Vijeev Menon: So I will stress again on the policy and procedure of these in terms of, I strongly recommend organizations do either create their own policies and procedures or if they are using custom or template policies and procedures to customize them very thoroughly. That is one of the biggest findings of the accreditation agencies is that the organization does not hold its policies and procedures. The review is thoroughly focused on what the policies and procedures are and the fact that the organization is in fact following the policies and procedures. Additionally, documentation is key so whenever the organization has meeting minutes or training sessions, make sure that is thoroughly documented. Personnel files, boards needs to be thoroughly documented as well whether it’s electronic or paper and same thing with patient management. So in the eyes of the accreditation body, similar to many other things and in healthcare or any other space, if there is no documentation, there is no evidence that something actually happened and that is what many organizations struggle with as well, is proving to the accreditation quality that they did in fact do something and there’s the documentation for that patient being assessed or that meeting being conducted.
Andy Madigan: If it isn’t documented, it didn’t happen. Yeah, I hear that a lot.
Vijeev Menon: Exactly.
Andy Madigan: You say that most pharmacies view accreditation as a mandate that they have to comply with versus an opportunity, or are there some that you would the other way around?
Vijeev Menon: So quite often the process starts off as, hey, accreditation is mandated by the pair, so the organization better seek accreditation. From there, organizations usually experience that, hey, it makes sense to have these thoroughly documented policies and procedures, to have a very structured program around quality, to have a very structured program for patient management. So the accreditation process, even though starts off as a mandate, as, hey, we got to do this, it quite often evolves into, I’m glad we did that because now the organization knows exactly what is needed and what some of the gaps are.
Vijeev Menon: I will point out one common example that comes from my experience, is an organization going through accreditation. One of the requirements is the strict requirements around cold chain management. Quite often the organization has never thought about it. Several organizations simply put an ice pack with the product and ship it, assuming that it stays cold. And it perhaps does. The accreditation agencies now requires testing of the cold chain process. When the organization does this testing to satisfy the requirement to have the accreditation and quality, that is when they realize, hey, the temperature has been out of range for that refrigerated product, which was supposed to be between 36 and 46.8. It is out, it’s been out of range or it’s not kept in range long enough. Or worse, they realize that the product has been exposed to a much lower temperature below 32 degree Fahrenheit for a period of time immediately upon packing, which could possibly freeze the product and render it inert. So that becomes a critical issue that’s been identified during the accreditation process and obviously corrected thanks to the testing that was done, and identified that problem.
Andy Madigan: So what advice would you give to organizations that are seeking accreditation for the first time?
Vijeev Menon: For the first time I think it is critical for organizations to understand the requirements of the accreditation. In other words, initially many folks read the standards and take it for what it’s worth, but it serves a lot of purpose to read the details behind the standards. So the accreditation guide, for instance, will tell you what the accrediting body is exactly looking for, how to satisfy the intent of the standard, examples as to how to be compliant with it. And the biggest tip was, you know, hey, understand the standards, understand what your needs are, create policies and procedures, make sure you’re adhering to the policies and procedures and have somebody that oversees this entire process. The accreditation process that serves as your quality oversight person. So it is a full time process, at least during the accreditation process, which I said could take six months or longer typically. And then there is that aspect of maintaining the accreditation. So even for organizations that have had a successful initial accreditation, there is time and effort that needs to be put into making sure that the requirements are maintained during the time of accreditation.
Andy Madigan: Why certainly. So, that’s about all the time we have today, and with that, I will say thank you to Vijeev, very much for sharing your thoughts and insights with us. We look forward to having you join us again. There’s a lot more that meets the eye when it comes to accreditation and certainly with the release of the new URAC standards, I’m sure our listeners would love to hear more of some of the specific ways that the new standards will affect them. If someone has a question or wants to get in touch with you, how would they do that?
Vijeev Menon: Oh, absolutely. Thank you again. Thanks for the opportunity and yeah, I’m available by email. My email address is firstname.lastname@example.org. That’s CSI G R O U P dot net. They’ll be available by email, would love to answer any questions that may come up, and support to organizations that are going through the accreditation process. Thanks again.
Andy Madigan: Good. Thanks Vijeev. And thank you for listening to the CSI Specialty Pharmacy podcast. If you’ve enjoyed listening today, I encourage you to subscribe to the podcast on your favorite podcast delivery platform. I also encourage you to visit our website, CSIgroup.net and download your free copy of the 2019 State of Specialty Pharmacy Report. You can also keep up with us on social media by following CSI Specialty Group on LinkedIn, Twitter, and Facebook. CSI Specialty Group is a subsidiary of group purchasing organization Intalere. CSI expands Intalere’s suite of solutions to health care providers, health systems, pharmacies, and pharmaceutical manufacturing partners. Intalere is owned by Intermountain Healthcare, a leading healthcare system based in Salt Lake City, Utah. 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.