Pharmacist state scope of practice overruled by HHS?

It’s been a few weeks since we launched our blog with our first blog post on pharmacists’s ability to provide SARS-COV-2 testing. But with all the policy changes taking place over the last few days, it was necessary to investigate some of the more recent changes.

Today we’re going to take a look at the Advisory Opinion that was released by the U.S. Department of Health & Human Services (HHS) on May 19th and why we were saying to ourselves when it was released, wait…they can do that?

What you talking ‘bout, HHS?

We know all about the HHS and CMS guidelines that were released in April granting pharmacists the authority to provide COVID-19 tests (if you don’t, check out the post here). After these guidelines were released, several states ended up scratching their heads. They wanted to utilize the access of pharmacists to provide tests, but their sticky statewide scope of practice laws would not allow pharmacists the ability. This Advisory Opinion from HHS is in direct response to this confusion. It states that HHS guidance supersedes state scope of practice that prohibits pharmacists from administering COVID-19 tests.

You might be thinking, how can they do this? And, who is the end-all authority on scope of practice? Well, you’re not the only one.

Let’s talk about Scope of Practice

This is pretty shocking, because without reading in detail it sounds as if it is calling into question a lot of what we have come to expect with scope of practice – that it is determined and overseen by the states. We can’t tell you how often we hear from students first learning about scope of practice who tell us how surprised they are that a pharmacist practicing in New York looks significantly different from a pharmacist practicing in California. We can’t tell you how often we utter the phrase, a PharmD is a PharmD is a PharmD, yet our states don’t seem to agree. From a national perspective, we have observed the general strategy of the expansion of scope of practice in one state leading to similar changes eventually made in others. 

Upon first read, one may think that this advisory opinion could change that precedent. Who actually holds the authority of scope of practice? States? The Feds? Will this mean the change in the authority of scope of practice? If so, it could change advocacy efforts to push for legislation that would expand pharmacists’ scope of practice to enhance patient care across the country, rather than taking the slow drip from state to state. 

Upon closer analysis of the advisory opinion, we can find more answers about scope of practice oversight. 

What even is an Advisory Opinion?

Advisory opinions are frequently released by different government agencies and courts to provide further clarification around laws, rules and regulations. It is important to note that they are truly opinions. This is an important clarification when we start to think about the actual weight that such a document holds. Although advisory opinions do have some legal authority, the opinion is only legally binding between HHS and the requesting parties (in this instance, “pharmacists, pharmacies, and one trade association”). This may lead one to make the argument that HHS has no authority over state scope of practice law and that pharmacists practicing following this advisory opinion, outside their states’ scope of practice, could be subject to consequences.

Well, this is where it is important for us to understand how strange of a world we live in right now, and the fact that the government is actually referring quite frequently to this thing called the Public Readiness and Emergency Preparedness (PREP) Act.

No, it’s not Truvada. It’s the PREP Act…

The PREP Act was created exactly for this type of situation and gives a lot of liberties to government agencies and the Secretary of HHS to do what they believe will be in the best interest of citizens during a public health emergency (PHE). One of the extra super powers that the HHS Secretary gets, and is clarified in this advisory opinion, is the ability to expand scope of practice of professions in order “to use and administer a covered countermeasure even when that person is not authorized to do so under state law.” Although the advisory opinion does not hold any legal or regulatory weight with states, you bet that the PREP Act does. 

This is the legal framework that allows HHS to override state law and allow pharmacists to practice outside their scope of practice. It is important to note that this is just during the PHE, but still, questions are arising about how different the healthcare world will be on the other end of this pandemic.

Seeing that there is federal authority over scope of practice, does it make sense for advocacy efforts to focus on nationwide scope of practice authority for healthcare professionals? Will there be efforts to make permanent expansions in scope of practice that were initiated during the PHE? Will some of the taboo nature around the topic of scope of practice dissolve?

There will definitely be more to discuss about scope of practice soon, but until then, plenty of questions keep popping up about how much this pandemic is going to change things. We will keep asking these questions, and looking for the answers.

Until next time, stay curious and passionate.

Published by The Grassroots Pharmacist

We are pharmacists passionate about engaging pharmacists in advancing health policy

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