Preventing Pharmacy Template Objections (feat. Bryan Connole)

On this episode of Regulatory Joe, Joe Boyle is joined by Penstock’s Director of Plan Management, Bryan Connole, to dive into one of the biggest pain points in ACA regulatory filing: the pharmacy benefit template.

As Plan Year 2026 approaches, CMS and state agencies are tightening expectations—especially around prior authorization and template accuracy. Bryan shares what tripped up issuers last year, what tools are critical for success, and how internal misalignment (especially with PBMs and pharmacy teams) can derail your entire submission.

In this episode:

• The top objection trends from Plan Year 2025

• How to use CMS validation tools to avoid rework

• Why cross-validation errors can still cost you—even if your template looks “clean”

• What to expect from CMS as MPMS continues to evolve

• Practical tips for internal coordination and compliance

Whether you're a seasoned filer or new to regulatory operations, this episode offers actionable insight to help you stay compliant, avoid objections, and file with confidence.

🎧 Listen now and future-proof your pharmacy benefit template strategy.

Episode Transcript

(00:02):
I'm Joe Boyle, the president of Regulatory Solutions here at Penstock, and today I'm very excited to introduce our special guest and also very own director of plan management, Bryan Connole.
Bryan, tell us a little bit about yourself.
Thanks, Joe.
Happy to be here. 7 00:00:14,855.154195011 --> 00:00:27,515.154195011 I've been in that insurance field for about seven to eight years now, initially starting off as a territory manager and where I was working on product implementation for many states in the smaller group, ACA as well as large group space. 8 00:00:27,585.154195011 --> 00:00:33,130.154195011 I was doing that for a few years and then an opportunity actually opened up in the regulatory space within my company. 9 00:00:33,190.154195011 --> 00:00:40,620.154195011 And I jumped on that opportunity to learn more beyond the product implementation piece and grow my career, take another step in my career. 10 00:00:40,630.154195011 --> 00:00:43,180.154195011 It's something I definitely I wasn't sure I would enjoy, but I do. 11 00:00:43,230.154195011 --> 00:00:45,270.154195011 It's something that I definitely have grown into. 12 00:00:45,320.154195011 --> 00:00:59,670.154195011 Definitely enjoyed learning all about the ACA regulatory filing, working with state departments of insurance, working with CMS around, you know, the rules and regulations and trying to improve the processes around the QHP certification and, and filing piece in general. 13 00:00:59,770.154195011 --> 00:01:14,130.154195011 And that kind of led me here over to Penstock where we have partnered up and, you know, hoping to, again, continue to improve the process around QHP certification and regulatory filing and helping clients in states, you know, in that space who need, who need assistance. 14 00:01:14,426.099014155 --> 00:01:20,396.099014155 You know, so, Brian, it's, it's easy for me to forget all the, the years we worked together and, glad to have you here on the team. 15 00:01:20,424.048934677 --> 00:01:31,734.048934677 You know, It's really interesting because with all the complexities in the ACA landscape and the strengthening of both federal and state policy, specifically for plan year 2026, we're up against a lot for this year. 16 00:01:31,764.048934677 --> 00:01:41,812.3722826 What are some of the hot topics, if not the biggest hot topic that you're looking forward to tackling for this year? One of the big topics we've noticed is prior authorization for drugs in the formularies going forward. 17 00:01:41,812.3722826 --> 00:01:52,642.3722826 And so we did notice multiple objections for Plan Year 2025, where states and CMS came back and asked issuers to remove prior authorization from multiple drugs. 18 00:01:52,672.3722826 --> 00:01:59,702.3722826 One being your PrEP formularies because, you know, again, that's not in compliance with several of the rules and regulations going forward. 19 00:01:59,702.3722826 --> 00:02:16,212.3722826 So I think that is a key topic to keep an eye on going forward this year and actually making sure that, you know, issuers are reviewing the state guidelines around prior authorization as well as any rules and regulations being released from CMS, from the federal government to make sure they're in compliance with those statutes. 20 00:02:16,267.2876029 --> 00:02:17,57.2876029 That's great, Bryan. 21 00:02:17,77.2876029 --> 00:02:22,897.2876029 I understand, you know, working with issuers both small and large through the last plan year, prior authorization was a big issue. 22 00:02:23,87.2876029 --> 00:02:28,197.2876029 I think that's a good lesson learned, especially as it relates to working with state divisions of insurance. 23 00:02:28,482.2876029 --> 00:02:36,972.2876029 We're seeing increasing strength with needs for justification forms to be attached to the templates to justify non-compliance for certain issuers. 24 00:02:37,192.2876029 --> 00:02:45,602.2876029 What else are you seeing in working with your clients that you could share with us that other folks may find beneficial? Exactly, I do agree with you on the, on the justification forms. 25 00:02:45,882.2876029 --> 00:02:56,682.2876029 One other area we are seeing is with, you know, the adverse tiering tool and so we definitely wanna make sure issuers are running that tool on their prescription drug template prior to submitting the template in their binders and to CMS. 26 00:02:56,832.2876029 --> 00:03:00,162.2876029 You want it to be as accurate as possible and avoid any objections that may come up. 27 00:03:00,402.2876029 --> 00:03:14,862.2876029 So once you run that tool and after anything comes back where you need an adverse tiering justification form, you want to make sure that you fill that out and submit that along with your prescription drug template when you are submitting into the binder into CMS to avoid any objections coming back from the state or the federal government. 28 00:03:14,921.17645788 --> 00:03:15,621.17645788 That's great, Bryan. 29 00:03:15,641.17645788 --> 00:03:25,482.30479447 And from a best practice perspective, I acknowledge and recognize and just wanna call out how labor intensive it could be for certain issuers to run these tools and functions and to produce the outputs. 30 00:03:25,482.30479447 --> 00:03:26,562.30479447 There's multiple iterations. 31 00:03:26,562.30479447 --> 00:03:41,257.30479447 It's almost impossible to run the tool and get a clean result output on the first try, would encourage issuers to also create change governance or a change control process to track the versioning of their template outputs to make sure that they're having the most clean submission possible. 32 00:03:41,617.30479447 --> 00:03:59,897.30479447 I also wanted to call out and I think in working with CMS we've noticed that there are other certain tools and instructions issuers can leverage, such as the REGTAP QHP webinars that are just starting now by CMS, where folks can log in and listen to certain sessions, put on by panelists about the best way to run tools, FAQs, and others. 33 00:03:59,999.58675732 --> 00:04:00,689.58675732 Exactly, Joe. 34 00:04:00,689.58675732 --> 00:04:09,579.58675732 So definitely wanna take advantage of those REGTAP webinars, especially when you're creating the prescription drug template, you wanna make sure you're attending that webinar that focuses specifically on that one template. 35 00:04:09,799.58675732 --> 00:04:14,29.58675732 A lot of times they'll do the demo on there so you can see live, you know, to make sure you're filling it out correctly. 36 00:04:14,229.58675732 --> 00:04:15,979.58675732 And there's always a chance for Q&A. 37 00:04:16,159.58675732 --> 00:04:21,39.58675732 In addition to the advanced, you know, tiering tool, there's also the drug count tool in the formulary review suite. 38 00:04:21,39.58675732 --> 00:04:23,439.58675732 So again, those are two other options you can use. 39 00:04:23,489.58675732 --> 00:04:33,319.58675732 My advice is to run as many tools as possible, make sure that it's accurate as possible, just to avoid, you know, again, any objections, any concerns as you submit the templates in the binders going forward. 40 00:04:33,319.58675732 --> 00:04:43,889.58675732 Run as many tools as you can and then if needed, always submit those justification forms for any instances where you have an outlier or you have a result from that, from either any of those tools. 41 00:04:44,459.58675732 --> 00:04:53,454.58675732 You know, that's a really good point, and I almost forgot that too, because with the formulary output suite and the drug count tool, those are three codified tools that issuers should be running. 42 00:04:53,454.58675732 --> 00:05:06,104.58675732 It's interesting because working with different health plans, I know based on how the org design of a department is, you could have the pharmacy team running the tools on the plans and products, or you could be having the product team running the tools on the plans on the products. 43 00:05:06,154.58675732 --> 00:05:14,674.58675732 If you don't have any, develop strong relationships with your stakeholders internally with your pharmacy team, or even in fact the PBM behind the pharmacy or formulary benefits. 44 00:05:14,674.58675732 --> 00:05:30,604.58675732 Because health plans who are reliant on their PBM to give them their RX QEs to give them their retail or mail order supply for tab one or tab two on the template could create a bottleneck between creating justification forms, asking for new data and running the tools. 45 00:05:30,824.58675732 --> 00:05:31,634.58675732 That's true, Joe. 46 00:05:31,634.58675732 --> 00:05:32,54.58675732 Very true. 47 00:05:32,54.58675732 --> 00:05:32,444.58675732 Definitely. 48 00:05:32,444.58675732 --> 00:05:42,524.58675732 You want to communicate, 'cause again, a lot of issuers, you know, you do have separate departments who are working on separate templates, and so sometimes you have that pharmacy area that is working specifically on the, on the pharmacy benefit template. 49 00:05:42,824.58675732 --> 00:05:51,154.58675732 In my previous experience, you know, I had a pharmacy team that ran the pharmacy template and kind of handed it off to us and it was just our job to go ahead and, and submit it. 50 00:05:51,214.58675732 --> 00:06:06,929.58675732 And so you definitely want to have that strong communication, you know, if it's an internal team, definitely have that communication with them to make sure that you're in agreement, you know what is going on with, with the template, both the tabs and if there are any issues, you're having that clear communication as to what the issue might be. 51 00:06:06,939.58675732 --> 00:06:11,379.58675732 And then again, some issuers also have, you know, an outside PBM they're working with as well. 52 00:06:11,379.58675732 --> 00:06:17,359.58675732 So, again, clear communication with them to make sure that you understand everything that they're populating on that template. 53 00:06:17,629.58675732 --> 00:06:21,469.58675732 That PBM or that pharmacy team may be running a template, but you know, maybe you run it again yourself. 54 00:06:21,469.58675732 --> 00:06:22,639.58675732 So maybe you both run it. 55 00:06:22,689.58675732 --> 00:06:32,769.58675732 CMS right now has MPMS, where you run the plan validation, and sometimes issuers might think, you know, I'll run MPMS, the prescription drug template will come back accurate within there, and then they'll kind of move forward. 56 00:06:33,469.58675732 --> 00:06:41,919.58675732 I think it's always a good practice to, beyond just running that plan validation, take a few minutes to run those, you know, separate review tools outside of MPMS. 57 00:06:42,39.58675732 --> 00:06:46,449.58675732 It's only gonna help you, it's always gonna help you to avoid objections or any issues going forward. 58 00:06:46,449.58675732 --> 00:06:51,199.58675732 So again, outside of MPMS, take the time to run those, run those outside tools. 59 00:06:51,199.58675732 --> 00:07:01,524.58675732 And then again, communication with your pharmacy team or outside PBM is definitely critical to making sure that you're both on the same page and everything on that template is as accurate as possible. 60 00:07:02,49.58675732 --> 00:07:02,499.58675732 Awesome. 61 00:07:02,499.58675732 --> 00:07:09,429.58675732 And I couldn't have said it better myself too, because, so in order from A to Z: adverse tiering, drug count tool, formulary review suite. 62 00:07:10,179.58675732 --> 00:07:13,479.58675732 Those are the three that are gonna set you up for success for MPMS validation. 63 00:07:13,479.58675732 --> 00:07:25,167.92009065 Now, I also recall, if I'm not mistaken, that validation in MPMS is one thing, but where issuers also encountered significant issues in rework, almost missing federal deadlines, was during cross validation. 64 00:07:25,497.92009065 --> 00:07:29,817.92009065 So you can validate a template in MPMS all day long, including the pharmacy template. 65 00:07:30,147.92009065 --> 00:07:45,552.92009065 But once that cross validation occurs, and you're comparing the pharmacy template against the PBT, against the rate data template, against all of these other, including business rules, that's where some unknown errors could come back that impact more than just one stakeholder, more than your pharmacy stakeholder. 66 00:07:45,552.92009065 --> 00:08:11,812.92009065 So had you encountered any of that during cross validation or any best practices for issuers? Maybe doing it for the first time? You definitely wanna do cross validation and in the cross validation, that happens within the formulary review suite tool, but then again, when you're running it through MPMS, you run the industry validation, and you're always required to run the cross validation in MPMS as well, where it's going to run, in addition to the prescription drug template, it's going to cross validate all templates within that plan certification. 67 00:08:12,82.92009065 --> 00:08:16,522.92009065 Even if the prescription drug template is accurate, you know, it may be, "oh, I'm good to go." 68 00:08:16,522.92009065 --> 00:08:20,512.92009065 But then you run that cross validation and then you're countering an error within the PBT. 69 00:08:20,512.92009065 --> 00:08:25,492.92009065 The PBT does not agree with, you know, the prescription drug template and there's an area where you need to go ahead and fix. 70 00:08:25,732.92009065 --> 00:08:29,902.92009065 Always, always, always wanna make sure you're running that cross validation to make sure all those templates are agreeing. 71 00:08:29,902.92009065 --> 00:08:31,732.92009065 So yeah, that's definitely a good point, Joe. 72 00:08:31,882.92009065 --> 00:08:32,222.92009065 Awesome. 73 00:08:32,287.92009065 --> 00:08:36,77.92009065 And that's also gonna take care with consideration to the, formulary mapping. 74 00:08:36,77.92009065 --> 00:08:42,47.92009065 So for issuers also who are mapping different formulary IDs to parent IDs, have to be mindful of that. 75 00:08:42,47.92009065 --> 00:09:10,677.92009065 Do you have a two tier formulary? Three tier, four tier? We've worked with carriers that have up to six plus tiers of prescription drugs through generic, brand-preferred or specialty across the board so it can get complex also, wouldn't probably be a bad use of issuers' time to work with your product strategy team to make sure your product strategists are developing their plan designs appropriately because all the decisions made up here or up at the beginning by leadership, are gonna cascade downstream and could cause a rework or abrasion. 76 00:09:10,833.57399917 --> 00:09:11,403.57399917 Definitely yes. 77 00:09:11,403.57399917 --> 00:09:13,233.57399917 No, you definitely want to work with your product strategist. 78 00:09:13,233.57399917 --> 00:09:21,663.57399917 And to your point too, yes, we've had, you know, multiple clients where they've had six or seven tiers, within their formulary, up to 13, 14, 15, you know, formulary IDs. 79 00:09:21,888.57399917 --> 00:09:28,458.57399917 Which when you're translating that over to the plan and benefit template, you wanna make sure you're lining up the correct formulary ID with correct plan on the correct tab. 80 00:09:28,458.57399917 --> 00:09:39,348.57399917 It's obviously very detail-oriented, but you know, those are two pieces where you wanna make sure everything's lining up correctly with the templates and then yeah, you want to have that communication with the strategy team to make sure you know what they are proposing. 81 00:09:39,628.57399917 --> 00:09:47,478.57399917 You definitely wanna make sure that you're up to date, you're following along with the new laws and regulations that are being passed by the states and by the federal government going forward. 82 00:09:47,728.57399917 --> 00:09:52,798.57399917 Sometimes, you know, laws are passed after you have gone ahead and submitted your prescription drug template. 83 00:09:53,48.57399917 --> 00:10:03,488.57399917 I had an example of that just this past year where one state came back after we had submitted, and due to a prior authorization for the PrEP formularies, we actually had to go back after we submitted. 84 00:10:03,577.35346937 --> 00:10:06,757.35346937 So definitely always want to make sure that you're keeping up to date on that. 85 00:10:06,757.35346937 --> 00:10:12,107.35346937 You never know when the state is gonna come back or the government may come back and ask you to go ahead and, and fix that template. 86 00:10:12,107.35346937 --> 00:10:21,67.35346937 And if you can formulate a way to make sure that you are having someone on your team, regularly checking to make sure, you know, uh, check on those federal regulations, state regulations. 87 00:10:21,327.35346937 --> 00:10:22,777.35346937 So This has been a great discussion, Bryan. 88 00:10:22,797.35346937 --> 00:10:31,97.35346937 And you know, when I pick up my proverbial crystal ball and when we look into the future calendar year 2025, plan year 2026 even, let's skip ahead to 2027. 89 00:10:32,117.35346937 --> 00:10:39,582.35346937 What do you see the future of the prescription drug template or even frankly, pharmacy regulations going? That's a great question, Joe. 90 00:10:39,582.35346937 --> 00:10:49,452.35346937 Most issues are aware, you know, CMS has been moving a lot of things into MPMS lately, trying to automate and make things easier as far as submissions and validation. 91 00:10:49,452.35346937 --> 00:10:49,812.35346937 So. 92 00:10:50,67.35346937 --> 00:10:59,347.35346937 You know, crystal ball looking to the future? As they continue to move more into MPMS, like this year I think they're moving in the URT into MPMS. 93 00:10:59,427.35346937 --> 00:11:06,587.35346937 I could see a, a scenario where, you know, they start moving in validation tools, the formulary review suite, you know, the drug count tool, the reverse tiering tool. 94 00:11:06,587.35346937 --> 00:11:10,217.35346937 You wanna make sure that you're keeping up on that to make sure you're in compliance as well. 95 00:11:10,467.35346937 --> 00:11:18,402.35346937 We've noticed lately too, there's a lot centered around, you know, PBM licensure in each states, they're kind of tightening that up and making things a little harder on the PBMs. 96 00:11:18,402.35346937 --> 00:11:20,772.35346937 Something that you want to kind of, kind of keep an eye on. 97 00:11:20,822.35346937 --> 00:11:26,762.35346937 I don't envision, you know, any major changes, any major rework coming to the prescription or drug template, but there could be some tweaks here and there. 98 00:11:27,72.35346937 --> 00:11:33,622.35346937 Hopefully that kind stays the course, but those are the kind of things I'm seeing going forward to kind of keep an eye on and best practices going forward. 99 00:11:33,997.35346937 --> 00:11:37,777.35346937 That's definitely some valuable advice and I think all our listeners will definitely appreciate it. 100 00:11:38,167.35346937 --> 00:11:39,52.35346937 Well, that's a wrap. 101 00:11:39,152.35346937 --> 00:11:40,413.42532312 Bryan, thank you for your time. 102 00:11:40,463.42532312 --> 00:11:42,563.42532312 Give us a like, give us a share and we'll see you next time.