Expert Discusses Engaging Federal and State Policymakers on Issues that Impact Health-System Pharmacy


Tom Kraus, JD discusses current federal regulatory and legislative issues that impact the practice of health-system pharmacy.

Pharmacy Times interviewed Tom Kraus, JD, Vice President, Government Relations ASHP on the critical issues that are occurring among congress and state legislatures that cause an impact on health system pharmacy. Kraus discussed issues that included drug shortages, provider status, and payer mandated white bagging. Kraus emphasized that there is now a default assumption that a pharmacist will provide some level of clinical care, in a retail and health system setting. Additionally, Kraus discussed the importance of the continued shift in policy makers perception of pharmacists— viewing pharmacists as clinical care providers.

Pharmacy Times

Can you introduce yourself?

Tom Kraus

I'm Tom Kraus, Vice President of Government Relations from the American Society of Health System Pharmacists.

Pharmacy Times

Can you give a brief overview on the critical issues that impact health-system pharmacy?

Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store- Image credit: C Daniels/ |

Image credit: C Daniels/ |


There's a lot going on in Congress and in state legislatures that impacts health system pharmacy. So, we've got active consideration of issues like protecting the 340B Program. That is a drug discount program that is important to supporting a lot of the services provided by health system pharmacies. Congress has been actively considering making some payments for drug administration within hospitals — including hospital outpatient settings, site neutral, and that would be very harmful to patient care delivered in hospitals. So, we are concerned about that —that's another area that we are working to educate policymakers about.

Then of course, there are some of these persistent issues like drug shortages. Obviously, that's an area that has impacted health system pharmacy for a long time and that's really reaching a peak this year. Finally, we're getting more attention from policymakers on that issue. I'm also very interested in what's going on around pharmacist’s provider status. That is another issue that we've been working on for several years, and we're seeing a lot more direct interaction on that issue with members of Congress. We've got two different bills that have been introduced, we've seen the Senate Finance Committee discuss some of those bills in their in their committee. There's a lot more going on in that space. We're excited to see some of those different policy issues being considered.

Pharmacy Times

What are the current federal regulatory and legislative issues that contribute to the practice of health-system pharmacy?


One of the policy issues that is being considered in many state legislatures right now is provider status. We've seen over the past couple of years a number of states —I think we're at 19 now where there's some version of pharmacist’s provider status. That's either a requirement in the commercial market, or in the Medicaid market, or both at the state level. That's really advancing pharmacist practice and recognition of pharmacists, as clinical care providers. That goes along with some of the recent decisions that have been made either by state governors on emergency basis, or by state legislatures and Boards of Pharmacy, to expand scope of practice for pharmacists to provide some of those more clinical services. That's great. I keep wanting ASHP members to know that when I'm having conversations with legislators, the interaction that I have, and their perception of pharmacist has really shifted. From primarily of dispensing to an assumption that pharmacists are going to be providing some level of clinical services to patients. That's an exciting shift and I think that is continuing. It's incremental — it's slower than we would like, but it is it is advancing consistently over time. You see that in the number of state legislatures that have expanded pharmacist provider status and scope of practice, and we continue to have those conversations at the federal level.During COVID-19, we saw the federal government pick some rules related to scope of practice that took the Federal Emergency authority to expand. Now we're pushing for okay, well, you recognize the role of pharmacists as clinical care providers with regard to scope of practice, now it's time to do that with regard to payments. So, there's actually an ability for patients to access those services.

Other things that I think are really top of mind for policymakers right now is payer mandated white bagging. This is an area where ASHP has been working pretty consistently over the past four years. We have model legislation that states can use to limit the ability of payers to restrict the ability of health system pharmacies to dispense clinician administered medications. That's an area again, where we've seen a lot of activity. I think we've seen a dozen states actually passed some version of that legislation. We've seen more than a majority of states introduce and consider that legislation and that continues to be a very active issue.I think other areas where we are seeing regulators and policymakers look to pharmacists is opioid use disorder. That is an area where you may recall if you've been an attendee at Midyear in prior years — you might remember that we were pushing hard for elimination of something called the X waiver. That was a requirement from the federal government that limited who could dispense a buprenorphine for treatment of opioid use disorder. That limitation has been removed. So as a result, there's an opportunity for states to say, okay, that federal limitation on who we can turn to help patients that are struggling with opioid use disorder, that's gone. Now it's the opportunity for the states to step in. We want to leverage pharmacists to provide some of those services for our patients in our state. That's another area where ASHP has provided model legislation and model protocols that states can rely on to turn to pharmacist to help treat patients.The last area that I'll flag is pharmacy residency programs— PGY1 programs are funded by the Centers for Medicare and Medicaid services. There's a mechanism by which they can provide pass through funding to cover the costs of those PGY1 residencies. But what we've seen in the past couple of years, is those programs having some of their resources clawed back for reasons that we think are really uncertain, unclear, and inconsistent. That's an area where we think it's really important that regulators at CMS step in and say, 'look, these are the very clear expectations that we have for residency programs so that they can continue to operate with some certainty around what the expectations are for how they comply so that they can be training the next generation of pharmacists.'

Pharmacy Times

How do these issues impact health pharmacy teams?


Some of the items that I was mentioning are things like white bagging. In the absence of state legislation to restrict payer mandated white bagging, what you see is payers requiring that in order for a patient to access a particular clinician administered medication, that drug has to be what we call brown bag. It's delivered directly to the patient, and they physically transport that drug to the provider for administration. Or white bag where we see that medication shipped from usually a payer affiliated pharmacy to the provider for administration. That has a lot of implications for patient care that results in additional opportunities for errors, and additional opportunities for delayed care. That's one of the biggest impacts we see. Questions for the pharmacy around whether something has been properly maintained, while it's been out of the hands of the pharmacy. It's a practice that really disrupts patient care and we want to make sure that we don't see that happen. We know that policymakers seem to understand that ASHP has put out a document that illustrates this, like what are all the different steps in the medication process. Traditionally, when a drug is provided by a health system pharmacy versus when it is provided via white bagging, you can see all that complexity and how it has the potential to disrupt patient care. And policymakers get that. So, when we have those conversations, really walk step by step through that process. That does seem to have some resonance with policymakers. And they get it because we can show them 'hey, this is how it has a direct impact on patients living in their communities.'Other issues that have impacts on the practice of pharmacy, as I mentioned is pharmacy residency funding. That's just fundamental to how we train pharmacists in this country, and make sure that they have the training that they need. We'd also like to see resources available for PGY2 funding as well as PGY1, so that we can have more pharmacist trained in those clinical specialty areas. I think beyond that, the 340B program that I mentioned earlier — that is an important source of resources for care provided by a Health System Pharmacists. I think what is often missed in the discussion of 34 to B, is it's not just about providing discounted medications to patients — that is often what happens, but also it is about using the resources from those 340B discounts to do other things in the community. To provide other clinical services to subsidize, having additional pharmacists to provide medication management services, or to provide a vaccine clinic, or in some hospitals simply to keep the lights on. So those are the kinds of services and impacts that the 340B program has for health system pharmacy and healthcare generally, that we think policymakers need to be paying attention to.

Pharmacy Times

How do you see the future of health-system pharmacies developing and evolving?


Well, some of what I had mentioned was that we are seeing this shift in policymakers thinking. There is now a default assumption that a pharmacist is going to be providing some level of clinical care and that's actually true in the retail setting. Of course, it's true in the health system setting, and we see that expanding. Just this past year, we saw the 50th state implement collaborative practice agreement legislation. That's great, so now we have that in place. I think there's these continuing conversations of provider status at the federal level. There are ever expanding— I think we're at 19 now states that have some level of state provider status legislation that has passed. There's going to be needs to find ways to provide payments to pharmacists, as part of that clinical care team in a health system. So, we're pushing for provider status and I think that's important in its own. But there's also opportunities to do things like expand incident to payments. That's a mechanism where the federal government can pay another member of the care team, like a physician for care provided by a member of that care team, and so, in this instance, a pharmacist. And so, that is another mechanism, even in the absence of provider status, where we'd like to see some expansion of that payment authority. Because that actually fits very nicely in the way that pharmacists in health systems are providing clinical services as part of a care team.Another area where I think we're going to see a lot more attention is in the role of pharmacy technician. During COVID-19, we saw pharmacy technicians offered to play a greater role in things like vaccine administration. I think we're seeing at the state level, greater flexibility for technicians to take on a greater roll around medication preparation. Things like an increased role for technicians and doing final product verification or playing a greater independent role in compounding. Still under the supervision of a pharmacist but providing some level of autonomy and recognition of that expertise of assistance. I think those are also really exciting opportunities within the roles of the health care workforce.

Pharmacy Times

Is there anything you would like to add?


I think the other theme that I would mention is we've talked quite a bit about how there is this shift in policy makers perception of pharmacists, as clinical care providers. And I think that's absolutely true. What I think is exciting is how we're going to see that continue to shift over the next several years.

I've already mentioned medications for opioid use disorder and support for patients struggling with opioid use disorder. I think that's going to be an area where policymakers are going to be looking for solutions. And they're recognizing that there is an inadequate number of health care professionals that are currently providing those services. If you look for a professional with deep expertise in medications, the pharmacist is an obvious provider to turn to. I think increasingly we're going to see state governments recognizing that clinical role for pharmacists to play in Medicaid managing medications for opioid use disorder.

I think we're also going to see a lot of discussions about the ways that pharmacists can provide some other roles, analogous to what happened during COVID-19. We've already demonstrated that pharmacists were recognized as providers of different services — from vaccination, to testing, to initiation of therapies. And if you're a policymaker saying, 'I don't have an adequate number of primary care providers in my community,' or 'my patients in my community lack access to certain clinical services that I think are important.' Particularly things that are within a pharmacists training to manage, well, let's start unit utilizing those pharmacists to provide those kinds of services.

We're seeing that thinking really start to develop across the states. We see it a lot with regard to infectious disease. You can see that with regard to initiation of therapy for COVID, for influenza, for strep. You can see that as far as initiation for exposure prophylaxis for HIV. Then, as I mentioned, there's an increasing recognition of the role of pharmacists on larger clinical care teams for doing things like, managing medications related to oncology, or transplant, or these other specialized clinical areas.

I think policymakers are increasingly recognizing that there is a need for additional health care providers in those spaces. To the extent that the need is related to having highly trained professionals to manage medication therapy in those areas — the obvious place to turn is to pharmacists. We're going to continue to see that evolving. We're going to see scope of practice is expanding over time. We're going to see increased opportunities for payment for some of those clinical services. And I think all of that adds up to kind of an exciting trajectory for pharmacists providing clinical services.

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