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The history behind the Drug Supply Chain Security Act (DSCSA)

The latest DSCSA exemptions and what that means for trading partners

How this piece of legislation and AI are able to intertwine

Nicholas Saraceno offers an overview of the legislation and how it impacts the pharma supply chain.

Nov. 27 is Here: What Does That Mean for DSCSA?

 interview, Dave DeJean, Systech’s VP of global strategic accounts, dives into:

The valuable lessons he’s learned along the way, given his three and half decades of experience at Systech

An overview of the Drug Supply Chain Security Act (DSCSA), including its three main pillars

How he would interpret this “Stabilization Period” that the FDA provided this past summer, and what he pharma industry do now during this period in order to avoid penalties later

Whether or not he anticipates the FDA implementing any other sort of delays in the near future in order to help remedy these issues/challenges surrounding the enactment of DSCSA

Podcast is available directly on SoundCloud.

Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA). 

Complying With the DSCSA

A cross-sectional study investigates the impact of Dobbs v Jackson’s Women’s Health Organization on national support and personal interest.  

How Advance Provision, OTC Access to Abortion Medication Changed Pre- and Post-Dobbs Ruling

The latest AARP report concludes that plan members who hit this amount are expected to see savings, even when premiums are considered. 

Analysis: Medicare Part D Enrollees Who Reach the $2,000 OOP Spending Cap to Save an Average of $2,474 Nationally 

These medications are used to treat a multitude of conditions including type 2 diabetes, cancer and asthma.

Headlined by Ozempic, Medicare Reveals Second Round of Drugs Selected for Price Negotiations

The program intends to address supply chain challenges surrounding product safety, traceability, and counterfeiting. 

Merck KGaA Unveils Cyber-Physical Trust Platform

A forum intended for HCPs, policy experts, and industry leaders addresses pressing obstacles facing this sector of the industry today. 

Navigating Access and Reimbursement Through Uncertainty 

Addressing Legal Battles in the Pharma Space

, Donald Prentiss, founder and CEO of Qualthera, describes how compounding pharmacies play a critical role in addressing unique and unmet medication needs that cannot be met by commercially available drugs. Their role in the pharmaceutical supply chain varies depending on the type of compounding facility: 503A or 503B.

A 503B facility, also known as an outsourcing facility, primarily supplies office-use medications to healthcare providers, who then administer them to patients. These facilities must adhere to current Good Manufacturing Practice (cGMP) standards, as they are FDA-registered and subject to inspections. In contrast, a 503A facility focuses on compounding medications based on individual prescriptions, typically in smaller, patient-specific batches. This allows for customization, such as removing allergens or adjusting dosage forms to better suit a patient's needs.

Both types of compounding pharmacies are particularly useful in cases of drug shortages or when commercially available drugs are insufficient. For example, if a patient requires a medication that is in short supply, a compounding pharmacy can step in to provide a tailored solution. This flexibility makes compounding pharmacies essential for meeting the unique needs of patients, whether by modifying an existing medication or creating entirely new formulations to address specific medical conditions.

Ultimately, the primary function of compounding pharmacies is to bridge gaps in the pharmaceutical market by providing personalized, alternative treatments that meet the diverse needs of patients.

Prentiss also comments on the tirzepatide shortage, the notion that commercialized and compounded drugs are competing with one another, what needs to be done amid the various legal battles pertaining to GLP-1s that are currently taking place, and much more.

What do you believe needs to be done amid the various legal battles pertaining to GLP-1s that are currently taking place?

I totally sympathize with drug manufacturing. You spend all this money to get the patent, get your drug to market, and it's successful. Then, you run out and try to gear back up; you look around, and there's thousands of these facilities now making your drug and getting that revenue. They go through the process. They respect the FDA process to get these things approved, and so they want to protect their interests. They have stakeholders too, so I totally get that side. On the compounding side, as I alluded to before, there is a statutory framework that allows compounders to make these drugs in shortage, and if there's a medical need to alter that drug in some form or fashion. Both sides have the right to engage in these battles based on what's allowed from a regulatory perspective.

To answer your question, what brings it together goes back to collaboration. When the shortage happened with all these weight loss drugs, compounding arguably helped further the success of the drugs. They made it more widely available. More people started to use it, and saw the benefits of it, and so they kept that demand alive, arguably in the best interest of the Lillies of the world. How do you work together to say, thank you for helping us out, but now we want to transition back to our supply chain. We want to keep you in mind, so maybe we can come up with a preferred list of compounding pharmacies or outsourcing facilities that we can refer out to (contract outsourcing), but more collaboration there, so that we're not having to settle this in the courts and with the FDA.

I believe I saw it from the Ros, and the Hims, and the Hers of the world—they're largely used compounding pharmacies to supply their medications. What was really neat was that I think it was Ro who had some kind of agreement with Lily to channel their drugs to that platform now too, so that was a nice little kind of collaboration that I saw there. If these telehealth platforms can collaborate with drug manufacturers, and compounders having already collaborated with telehealth platforms, let's bring in the FDA. Let's bring in other stakeholders. Let's give the patients a voice. What do they want? A lot of these patients are paying cash for this stuff. That's how important it is for them to reach their healthcare goals, and and I think that's another kind of underlying thing here.

Even through COVID, we still saw demand for compounds. They're willing to pay cash even through economic downturns, because it was so powerful. Health is a great equalizer, as you know, and so without it, money is worthless, so I think collaboration is the key. The FDA does a good job of creating listening sessions and other conferences on the compounding side. They have a whole website dedicated to compounding excellence. A lot of useful materials on how to educate compounders on how to do things appropriately—getting that information from the industry. I think really pushing that, bringing in the trade groups like the OFA [Outsourcing Facilities Association], just to put our heads together to solve this together, instead of fighting each other across it.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, explains how collaboration between compounding pharmacies, drug manufacturers, and telehealth platforms can drive success, despite the various litigations pertaining to GLP-1s that currently taking place.

Peer Exchange: The Future of RFID and Supply Chain Management (Episode 6)

 roundtable discussion, Nicholas Saraceno, editor of 

 and the peer exchange’s moderator, alongside a panel of experts, discussed the role of radio frequency identification (RFID) technology in the pharmaceutical and healthcare sectors. RFID is a technology that utilizes radio waves to automatically collect and transfer data, providing efficient tracking and tracing of products. This discussion covers the potential and challenges of RFID in the industry.

The panel consisted of Matt Campasano, Managing Director, Criterion Consulting; Sean O’Hearen; Founder & Principal Consultant, 1

 Line Partners; Tim Marsh, Founder & Head of Strategy, MDB; and Bahar Aliakbarian, PhD, Associate Professor, Sr. Director of R&D, Axia Institute (at Michigan State University).

Each expert brought unique perspectives on RFID’s applications, including brand protection, traceability, and supply chain efficiency.

Campasano highlighted RFID’s value in pharmaceutical traceability, particularly in relation to the Drug Supply Chain Security Act (DSCSA). RFID offers significant operational efficiencies in warehousing, as it eliminates the need for line-of-sight scanning and speeds up product verification, saving both time and resources.

The discussion also explored the fluctuating adoption of RFID over the past two decades. Marsh provided historical context, explaining that while RFID technology showed promise for improving supply chain operations and patient safety, it faced challenges, particularly in the early 2000s. High costs and reliability issues led to disillusionment, with many RFID installations being dismantled. Furthermore, the lack of widespread adoption of RFID by wholesalers, who required the majority of products to be tagged for it to be effective, hampered progress.

Today, RFID is making a gradual comeback in the pharmaceutical industry, primarily driven by regulatory compliance needs and the growing need for improved product traceability. However, its widespread adoption remains limited by cost concerns and the lack of clear, immediate value for all stakeholders.

In the final part of this roundtable discussion, a panel of subject matter experts discuss what the future holds for this technology, why end-to-end visibility is necessary in healthcare, and the opportunities for greater RFID adoption that lie ahead.

The Gap in DSCSA Readiness 

, Joe Lipari, direct of product management for Systech, dives into how the Drug Supply Chain Security Act (DSCSA), signed into law by President Obama in 2013, has actually been in development for nearly two decades, with earlier state-level efforts like California’s e-Pedigree push. Initially, the full implementation deadline was set for Nov. 27, 2023, marking the completion of serialization and traceability across the pharmaceutical supply chain. However, due to industry readiness issues, the FDA introduced a “stabilization period” to allow for testing and system adjustments. The stabilization period, meant to iron out bugs, turned into a series of delays, and the implementation date has been pushed back multiple times.

In October 2023, the FDA announced another delay, introducing a phased approach to DSCSA compliance. Manufacturers now have until May 2025 to meet requirements, wholesale distributors until August 2025, and mid-to-large dispensers until November 2025. Small dispensers, defined as those with 25 or fewer employees (including pharmacists and pharmacy technicians), have an extended deadline of November 2026. This phased approach allows different parts of the supply chain to comply gradually, but the full implementation will not be realized until at least 2026.

The FDA’s latest exemption allows eligible trading partners that have either completed or documented efforts to complete data exchange connections to be given some leeway in enforcement. This continues the trend of delays and phased compliance, highlighting ongoing challenges in fully implementing the DSCSA across the industry.

Lipari also explains the penalty for non-compliance, the likelihood that these deadlines put forth by the FDA will be met, and more.A transcript of Lipari’s conversation with

What do you believe the likelihood is that these deadlines put forth by the FDA will be met?

The funny thing is, we were having this conversation back in August and September. The HDA [Healthcare Distribution Allinace] does their Traceability Seminar in DC every year. You have the FDA there and a lot of different legal entities there, and that question continues to be asked of, what are you guys going to do? The answer was, no, there will not be any more delays. And a month later, we have the announcement. History has sort of shown us that any dates within the DSCSA implementation framework are subject to change.

If I was a betting man. I’d have to look at the track record of this implementation and say that I'm not sure if any of the dates will hold. But I mean, from my experience with Systech, we are more on the manufacturing side. A majority of our serialization customers are Big Pharma, mid-, mid-tier pharma. With our traceability platform, we have manufacturers, we have distributors, we have repackagers, CMOs. There is whole breadth of trade partners, but the manufacturers, for the most part, are ready. They've been serializing product for quite some time. They have systems in place to do verification. They have systems in place to handle tracing requests. They have systems in place to electronically share data. You hear from the wholesale distributor—from a KPI perspective—the wholesale distributors ramping up their enablement across their DCs.

In the beginning, you heard numbers and by the end of the stabilization period, definitely those numbers all went in the right direction, as far as how much was enabled, and then furthest downstream, you get to the dispensers. That's really where I think the main problem with readiness lies, and it's a tough space.

In the US, there's something to the tune of 90,000 different dispense locations. That ranges from the CVS and Costcos of the world—which are massive corporations—all the way to your mom and pops, those little pharmacies. I have one in my town, and they're independently owned, a single location, but that doesn't mean they're not exempt from DSCSA. They are the same prescription serialized drugs that are flowing through those facilities, just like CVS. It’s a tough space because of how many different types and the wide range of business types that exist in that space. There was a clear message that the dispense side was not going to be ready. If this thing did get pushed through, [there may have been] calls for patient safety, and what happens with quarantine product if you can't meet the letters of the law? I get that side of it, but there's a piece of me that feels we've been talking about this since 2013, and so how much further can we kick this can down the road?

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, predicts the probability that these DSCSA compliance deadlines put forth by the FDA will be met.

Consequences of Non-Compliance 

Lipari also explains the penalty for non-compliance, the likelihood that these deadlines put forth by the FDA will be met, and more.

A transcript of Lipari’s conversation with

What is the penalty for stakeholders who don’t comply with the DSCSA?

The FDA does take action against supply chain trade partners. There’re implications of non-conformance to disciplinary action. There’re warning letters—they publicly post those warning letters on websites, so there's some negative press that comes along with that for the trade partner. You could have products that could quarantine. You could have seizures. You could have court-ordered injunctions; civil, criminal penalties if it got really far down the line. There’s sort of a full range of disciplinary actions that the FDA can take.

DSCSA doesn't change that. It just adds a few others to this list. The questionaround the industry is, because it's an enforcement discretion saying the law went into law, the law is the law, and the dates in the law are the dates in the law. We're choosing not to enforce some of the requirements on the specific dates. There's always that notion of, will the FDA make an example out of somebody? It hasn't happened.

Is it an option on the table? Sure. But in reality, I think you know the language that you have successfully completed, you have made documented [efforts]. It's really tough to enforce that. I think the general sort of feeling in the industry is that this is just a broad exemption. Here's some new dates, and take it for what it's worth.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, comments on what the repercussions are for failing to comply with the DSCSA.

Navigating DSCSA Delays

Could you describe the latest state of DSCSA implementation guidelines?

Like you said, Obama signed it into law in 2013, so we're talking that far back. Even prior to that, we're talking mid 2000s, where, prior to it being federal law, there were individual states that were kind of doing their own thing. There was a big California e-Pedigree push where there was some serialization and aggregation, but very local at the state level. It’s been around coming up on almost 20 years, right of some sort of US serialization push. Originally, the goal line was Nov. 27, 2023. That’s when full implementation—soup, the nuts, everything—would have gone live. Obviously, what happened was, with the state of readiness in the industry, the FDA announced what they called a stabilization period, which was meant to be a time to where all of the trade partners were flexing and testing all the systems they had in place, and that's the key word. Stabilization has a very specific meaning.

You're supposed to be stabilizing the existing systems in place, working out the bugs. Well, you can't stabilize something if you don't have a system in place, so unfortunately, the stabilization period really wound up being a proverbial “kick the can down the road.” There’s been a few up to this point, so DSCSA implementation in general has seen its fair share of delays, whether that be enforcement or non-enforcement, whatever verbiage you want to use. There's been multiple delays in this thing since the beginning.

The stabilization period was really meant for a time when everyone was to work out the kinks in the system so that we could all go live the 27th of November. That didn't happen. We had the announcements back in October—which were the latest round of announcements—where the FDA came out and gave a broader exemption to the industry. This really applied to—this is the language in the exemption—eligible trading partners who have either successfully completed or made documented efforts to complete these connections and data exchange with their trade partners.

Now, we can have a conversation about that language, because how do you enforce something that, but what that really meant was that it was a phased approach. FDA came out and said, hey, listen, we're going to take a step back. We're going to do a phased approach, starting from the front of supply chain to the back of supply chain, where you have your manufacturers that now have until May of 2025, you have your wholesale distributors that now have until August 2025, and now you have your mid-to-large dispensers that have until next November of 2025, so a full year. You have this phased approach for those categories.

The other piece, which was in June, was the announcement about small dispensers, defined as 25 or fewer employees. There's language in there too, which was under some scrutiny within the industry, because it's the corporate entity. The corporate entity that owns the dispenser has a total of 25 or fewer full-time employees, licensed pharmacists, and pharmacy techs. Small dispensers now have until Nov. 27, 2026, so the full breadth of this thing, as it is today, is not going to be realized now for another two years for all the different personas in the supply chain. That's kind of the latest state of implementation timelines.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, describes the latest state of DSCSA implementation guidelines.

Key Challenges Facing the Pharma Industry in 2025

, Gaurav Gupta, managing director and head of R&D 

, discusses the regulatory pressures and rising R&D costs impacting the pharmaceutical industry as it looks toward 2025. Gupta highlighted that many regulatory challenges, such as drug pricing pressures from the Inflation Reduction Act, will persist in the coming years. Additionally, he pointed out the growing integration of real-world evidence into clinical trials and the need for regulators to keep pace with emerging technologies like AI. Gupta believes that these trends will continue to shape the industry without major new disruptions expected in the short term.

He also comments on the steps pharmaceutical leaders should take to better prepare their teams and organizations for supply chain disruptions; specific technical and "soft" skills that will be critical for pharmaceutical leaders and frontline employees to thrive in the evolving industry landscape, and how this can help when it comes to proactivity in handling talent shortages.

A transcript of Gupta’s conversation with

Looking ahead to 2025, what types of regulatory pressures and areas pertaining to rising R&D costs will impact the pharma industry, and how can companies proactively address these obstacles?

On the regulatory pressures, in many ways, it's a continuation of what we've seen over the last couple of years. Of course, there could always be something new that happens, particularly with the new administration, but I think we've already seen some of the pressures on pricing, for example, with the Inflation Reduction Act, and that's going to play out over the next couple of years in various different ways. I think that's going to continue. I think we're already seeing some new sort of thinking from regulators around things like real-world evidence and how that's being integrated into trials. We're going to continue to see that evolve.

We're going to see the evolution of regulation around emerging technologies, whether that's AI obviously being a big component of that, but also other new technologies. I think that's always a constant—as the technology develops, the regulations have to step in and keep up. I think we're going to continue to see that over the next couple of years. I don't know that there's—at least at the moment—anything significant that we can forecast that's all that different from what's already been happening. I think it's going to be a continuation of that.

On the R&D costs, it’s a similar story because the underlying dynamics haven't changed. The underlying dynamics still drive some of the same challenges probably more so around where to invest, and what’s the right sort of allocation of R&D resources, whether that's thinking about white space versus existing areas; thinking about target population, smaller target populations, which has sort of been a trend that's been going on for a little while now; thinking about even things like digital therapeutics, or AI and technology, and how much are we investing in that, versus investing in that versus investing in traditional drug development. I think that the big question will be, where do you allocate your resources? There's no question that there's going to be an increase in R&D spending. I think that's been consistent for the last 20 years at this stage.

I think that's probably where you're going to see some of the decision making, and I do think, to your question surrounding if those are connected: I think what's connected is that both of those create a level of sort of uncertainty in decision-making because we don't have all of the information that we're going to need to decide what we should be doing on the regulatory front, or what we should be doing on the R&D front. I think that the skillset around how you make decisions in an uncertain world, and how you make decisions with incomplete information is probably the key to success for most leaders and most businesses.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Gaurav Gupta, managing director and head of R&D at Kotter, details the types of regulatory pressures and factors surrounding rising R&D costs that will affect the pharmaceutical industry.

Peer Exchange: An Overview of RFID Within the Pharmaceutical Industry (Episode 1)

The panel consisted of Matt Campasano, Managing Director, Criterion Consulting; Sean O’Hearen; Founder & Principal Consultant, 1st Line Partners; Tim Marsh, Founder & Head of Strategy, MDB; and Bahar Aliakbarian, PhD, Associate Professor, Sr. Director of R&D, Axia Institute (at Michigan State University).

In the first part of this roundtable discussion, a panel of subject matter experts introduce themselves, while discussing why the pharma supply chain sees value in this technology and why its use has fluctuated over the past decade.

Pharmacy Benefit Management Trends

, Albert Thigpen, co-founder, Talentwise Consulting, discussed how the panel on “Playing the Chess Endgame–Healthcare Policies Targeting Drug Commercialization” underscored the complexities of implementing the Inflation Reduction Act (IRA), predicting significant challenges for stakeholders like retail pharmacies, payers, and pharmacy benefit managers. They highlighted concerns about the unintended consequences of negotiated maximum fair prices (MFPs), particularly on the generics industry and oncology drug distribution, which could complicate decisions for companies and affect in-office dispensing practices. Overall, the panelists noted that the IRA's intricate framework might lead to unforeseen difficulties in the healthcare landscape.

Thigpen also emphasized the importance of taking a long-term and measured perspective for manufacturers when it comes to strategic approaches to pricing and commercialization in light of future US. healthcare policies. He noted that, similar to the evolving landscape of Medicare Part D over the past 20 years, the Inflation Reduction Act (IRA) will also undergo significant changes. Manufacturers should prepare for initial challenges and be ready to reassess their strategies annually, adapting to new rules and market dynamics as they emerge. This approach may involve delaying product launches or adjusting commercialization tactics based on negotiated MFPs and market conditions, akin to the strategies seen with AbbVie and Humira. Beyond that, Thigpen dove into key trends impacting the pharmacy benefit management and specialty pharmacy spaces, while providing a crash course on retail consumerism.

A transcript of Thigpen’s conversation with

Could you describe some of the key trends that are impacting the pharmacy benefit management space?

I think there are a couple of things. I think regarding the PBM benefit by itself, you have split it into two buckets. I view the PBM benefit of the vertically integrated companies very differently than the PBM benefit of a non-vertically integrated company. Just to be clear on what those are, the vertically integrated companies are those that are also tied to a rather large insurance carrier: UnitedHealthcare and OptumRx has integrated; Cigna and Express Scripts have integrated; Aetna and CVS are integrated; the true vertically integrated companies that do that, they view that very differently.

The pharmacy benefit continues to be our first line of defense for treating disease states across the board. I'm a pharmacist by training, and I love the pharmacy benefit, but it has become incredibly commoditized over the course of the years, but it's also a very valuable piece of the healthcare benefit architecture. Those vertically integrated companies, specifically in the government space, have figured out a way where they can lose money in the pharmacy benefit, but also be much more profitable in the medical space. A company like United, for example, can say, “hey Nico, I'm going to cover you as your medical carrier and also provide your prescription drug coverage through OptumRx. The premiums I'm charging you, in total, I could actually do quite well onm even though I may not be doing quite well on the pharmacy side.” Those vertically integrated companies have the ability to manage to spend very differently than a standalone PBM that is just out there, only surviving and trying to operate their business on prescription benefit drugs alone.

I think that on the surface, those two business models had very different mechanics in their trends by themselves. I think overall, cost continues to decline in general. There are still a ton of generics that continue to be very important to the pharmacy benefit. Specialty continues to be a large driver of the spend. More drugs are in the FDA pipeline that are specialty and/or rare orphan, ultra-orphan drugs that are incredibly expensive across the board. How we figure out the best coverage mechanisms for specialty, biosimilars, rare orphan, ultra orphan—these are key issues and trends that everyone is focused on. Then I would say, just as another benefit design trend, is that the cash markets continue to thrive here. Bill Roth alluded to it in his opening comments that companies like GoodRx or Mark Cuban’s Cost Plus Drugs and the like, are there for a reason. The cost or the cash pay marketplace is important because you can get drugs pretty affordable through a cash benefit, much cheaper than sometimes your drug benefit that is covered, which is something that is going to continue to rise. It plays into the knowledge and the power of the consumer, and ultimately what’s best for them.

Albert Thigpen, co-founder, Talentwise Consulting, discusses the valuable buckets pertaining to the PBM space. 

Latest Conference Coverage

Access Insights 2024: Pharmacy Benefit Management Trends

Key Nuggets Surrounding the Chess Endgame

What were the main nuggets that came out of your “Playing the Chess Endgame–Healthcare Policies Targeting Drug Commercialization” panel?

I think probably the biggest takeaway is that the IRA is complicated. The implementation of it is going to be super complex. I think the panel universally agrees that the implementation of the IRA that has implications on the retail pharmacies, the payers, the patients, the PBMs, in general, hasn't quite been architected in the way for success, and we're just planning on some train wrecks, as we had referred to it in the panel. I think that's the first thing.

The second thing is that the MFPs that have been negotiated as a result of the IRA are going to have some unintended consequences across the board to other constituents—for example, the generics industry. How does a generic company decide to launch or not launch because the MFP has already been negotiated to a very low point already, and what are the unintended consequences of that? Negotiating an MFP on an oncology drug: going forward, how much does that impact, or have an unintended consequence of a physician that does in-office dispensing? I think for the vast, high level, I would say the IRA is complex. It's not fully thought out of all the consequences that will occur. We're starting to figure out some of those solutions, but very murky waters as we know it today.

Albert Thigpen, co-founder, Talentwise Consulting, offers highlights of the drug commercialization panel that he participated in.

Access Insights 2024: Key Nuggets Surrounding the Chess Endgame

Expanding Pharmacies’ Scope of Practice 

 Jenni Zilka, SVP, community & specialty pharmacy and president, Good Neighbor Pharmacy, noted that pharmacy deserts are communities without access to pharmacies, hindering residents' ability to fill prescriptions and access healthcare services. These areas are often also healthcare deserts. Definitions vary by location: urban areas lack pharmacies within a mile, suburban areas within two miles, and rural areas within ten miles. Approximately 35 million people live in pharmacy deserts, making this issue pressing. Factors contributing to their rise include reimbursement pressures, decreased foot traffic post-COVID, and the inability of pharmacies to bill for services beyond prescription filling. Independent pharmacies, often serving underserved communities with a majority of government-paid patients, are particularly affected. Zilka also alluded to legislation that is helping to improve patient access.

A transcript of Zilka’s conversation with 

How can pending legislation improve patient access, and how are these helping with recognizing pharmacists as healthcare providers?

Right now, we have some challenges around expanding the scope of practice for our pharmacies, along with the reimbursement pressure. The good news is there's a fair amount of legislation that's currently on the table. We're in an election year, so we probably won't see it go through this year, but it definitely has bipartisan support. We expect it to persist and continue into 2025, and hopefully pass. There is the Equitable Community Access to Pharmacist Services Act that is in Congress, which would ensure that Medicare beneficiaries—so these patients—have prompt access to essential services for vaccinations, testing, and treatment of common infectious diseases.

The way that they would do that is establishing Part B reimbursement for pharmacists to deliver these essential services. That's really important, and we are continuing to advocate, along with the rest of the profession, for that sort of access, so they can not only reach patients, but they can do more to care for them going forward. And candidly, a lot of these services, they're already doing it. They're already vaccinating, they're already testing. This just allows them a pathway to be reimbursed, which will help with some of the reimbursement pressure that they're facing. And there is, of course, legislation currently within both at the state and federal level, around reimbursement reform and ensuring that pharmacies are adequately reimbursed for the services that they provide. I think continuing to advocate and enable our pharmacies to be able to tell their story and continue down that path is really important at a high level.

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenni Zilka, SVP, community & specialty pharmacy and president, Good Neighbor Pharmacy, explains how pending legislation can improve patient access, and how these are helping with recognizing pharmacists as HCPs.

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