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.

As Unemployment Rises, Access to Healthcare is in Question

Last week, the Department of Labor released its latest number showing nearly three million Americans filed for unemployment, bringing the total number of unemployed to 36.5 million. With the economic situation getting worse each week, Congress needs to consider what additional measures to take to address this growing problem. Last week, the House of Representatives took the first step by narrowly passing the HEROES Act, a $3 trillion relief package designed to provide aid to the struggling economy. While Senate Republicans and the White House have already said the bill is dead on arrival, House Democrats have argued that this bill is a starting point for future negotiations. Therefore it makes sense to look at the points of the bill, and how they would impact patient access to healthcare. 

The bill at its core does a few important things. It includes provisions that would provide sorely needed relief to state and local governments, hazard pay for frontline health care workers, student debt forgiveness, and most important, financial support for Medicaid and Medicare. We’ve talked on the blog before about hazard pay for frontline health care workers. Now we are going to focus on two other provisions of the bill. 

Providing Necessary Relief to Local and State Governments 

The single largest allocation of funding in the bill is $1 trillion in aid for state, local and tribal governments, as well as another $1,200 stimulus payment for households. Senate Majority Leader Mitch McConnell made headlines last month when he said that states facing budget deficits should “instead consider bankruptcy.” Now while he has walked back from those comments, he did raise awareness about how fragile state budgets can be, especially during this pandemic. For example, earlier this year, Ohio had a $200 million surplus. However, in just 2 months, the state registered $777 million in deficits, a nearly $1 billion shift. As a result, Ohio, and many other states who are facing similar circumstances, are being forced to make serious budget cuts. For many of these states, the new fiscal year starts on July 1st, and without federal assistance, they will have to make cuts in education, social assistance programs, emergency response workers, and most notably, Medicaid, all which are vital in a pandemic response. As pharmacists, we should be particularly concerned about cuts to Medicaid, as any cuts will often affect the most vulnerable of our patients who rely on the program for access to primary care services and medications to control chronic health conditions. 

While states have other options, many of these may not be viable. States have the option to borrow money from the U.S. Treasury, but due to underlying issues regarding payment of state pensions, some states have poor credit ratings, making borrowing difficult. States can also seek help from a new Federal Reserve Lending program, but the program usually charges higher interest rates to borrowers, in order to avoid competition with regular investors. Some states, like New Jersey, have alternatively pushed back the start of the fiscal year. 

This is all to say that states desperately need money during this pandemic. States cannot go bankrupt (with some legal scholars arguing that it would take a Constitutional Amendment to make that happen), and for states that try to balance their budget, they will do so at the risk of eliminating an important public health safety net for millions of Americans and exacerbating a public health crisis that is already having more serious impacts on the most vulnerable in our society. 

Impacts on Patient Access to Quality Healthcare 

The HEROES Act has a significant impact on patient access to healthcare that cannot be overstated. As mentioned above, states that are facing budget issues are looking at making cuts to Medicaid. Here is why that is problematic:

As more people lose their jobs and their income, more people will become eligible for Medicaid. For example, the United States saw a surge of Medicare enrollment in 2009, during the Great Recession when unemployment reached 10%. The goal here from a public health perspective is to ensure patients continue to have access to health insurance even if they lose their jobs. This way we can ensure they will continue to have access to COVID-19 tests, medical treatments, a possible vaccine, and continued access to prescription medication and pharmacist-provided clinical services. We know that this virus is particularly devastating to patients with chronic disease conditions, and as pharmacists we must be focused on ensuring continuity of care for our patients. This is why pharmacists should be fighting on behalf of our patients for continued access to Medicaid. 

Evaluating the impact on Medicaid though is particularly difficult since the United States has two “tiers” after passage of the Affordable Care Act (ACA): States that chose to expand Medicaid coverage and states that chose not to expand Medicaid coverage. 

In the states that chose to expand Medicaid coverage, it is unlikely to see large numbers of uninsured populations like we saw during the Great Recession, despite having a larger number of beneficiaries. First of all, by expanding Medicaid, the 37 states (including D.C.) have ensured that more patients qualify for healthcare coverage. The ACA Medicaid expansion allowed for adults with income up to 138% of the federal poverty level (FPL), or $1,467/month for an individual or $3,013/month for a family of four, to qualify for Medicaid. What’s important to note though is that state unemployment benefits do not count as income. Therefore, even though some individuals might be receiving income higher than the Medicaid cut-off, they still qualify for Medicaid eligibility. Despite the increase in the number of beneficiaries, the ACA has already said that the federal government will pay 90% of the costs for the expansion group, on top of the regular match the federal government provides for all states. 

The situation will be very different in states that have decided not to expand Medicaid. Already, more than 2 million adults have incomes that fall below the FPL and don’t qualify for Medicaid or the subsidized plans available on the ACA marketplaces. Because unemployment benefits don’t count as regular income, only those individuals/families with incomes, not including unemployment insurance, above the poverty line will qualify for subsidized health coverage through the ACA marketplace. This coverage gap will further increase inequities in health care, leaving poor Americans who don’t qualify for Medicaid or subsidized insurance, without any access to public health resources that will be vital in fighting this pandemic. And this disparity only seems to be getting worse. 

Last weekend we learned that of the nearly 36.5 million Americans who have lost their jobs since the start of this pandemic, almost 40 percent are in lower-income households making less than $40,000. That means, almost 15 million Americans who have been laid off since March, were making less than $40,000 a year. 

To put that into context of Medicaid eligibility, here are the 2020 FPL numbers that were used to calculate eligibility for Medicaid and the Children’s Health Insurance Program. 

What this illustrates is that of the 15 million Americans who have been laid off, only some would be eligible for total Medicaid eligibility. Some may be covered by subsidies on the ACA marketplaces. But for many, they have no option for health coverage whatsoever. Given the nature of this pandemic, there has never been a clearer example of how the health of other people in our society affects our own. By having a system, where people are not able to have access to health care services, we are essentially fighting this pandemic with a handicap. 

This is all to say: Federal funding for states and local governments is a must have in the next congressional relief package. Not doing so would have dire consequences on our ability to fight this pandemic, and the consequences for not doing so, would be predominantly faced by the poorest and most vulnerable in our society.

What’s next for the HEROES Act? 

The HEROES Act only narrowly passed the House, a sign of how challenging the road ahead is. President Trump and Senate Republicans have both said that the bill is dead on arrival, and despite a recent willingness to discuss a possible change package, any final package does not seem likely to contain all of these provisions. However, as we look forward as to what a potential bipartisan relief package does look like, one thing is clear… 

We need federal assistance to fund states to ensure that the poorest and most vulnerable aren’t left without access to health care services. 

Keep Engaged!

The fate of this bill is uncertain as it heads to the Senate, but regardless of what happens the debate over Medicaid and Medicare funding will continue as states and the federal government try to balance a growing economic crisis with a public health disaster. As healthcare professionals, it’s important for us to be engaged in this process, and provide our perspectives as essential healthcare providers to elected members of Congress. Advocacy does not have to be limited to legislative activism, consider informing the public about this important issue and pharmacists role through letters to the editor of your local newspaper or Op-Eds. Check out an example here.

Track the current progress of the bill here and find resources on how to engage your legislator here.

Until next time, stay curious and passionate. 

Are pharmacists essential? Congress thinks so!

As states evaluate plans to reopen, despite cases of coronavirus continuing to rise, Congress has been at work on another COVID-19 emergency supplemental bill. House Democrats released a whopping 1,800-word initial draft of the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act this past week. Included in this bill are additional provisions for workers, Medicare & Medicaid beneficiaries, and assistance for agricultural producers. A hefty section of the bill is devoted to healthcare workers and community support provisions.

You might be asking, why does this matter to me? Well, let me direct your attention to two primary points where this bill will impact the practice of pharmacy, 1) essential worker designation, and 2) the drug distribution system.

Essential worker designation

Within the language of this draft, “[p]harmacy work, physically performed in pharmacies, drug stores, or other retail facilities” is recognized as essential work. This may not be jaw-dropping, and to be honest it shouldn’t be, but the importance of this comes into what the government hopes to be able to do to support essential workers. As essential workers that are performing “pharmacy work”, following the stipulations within this legislation, workers would be entitled to premium pay if their employer is receiving certain COVID-19 grants from the government. This is a good thing, as our essential workers deserve appropriate compensation based on the dedication they are making to care for patients during the state of emergency.

The drug distribution system

A second area of interest that could impact pharmacists across care settings is the recommended changes to the drug distribution system as a result of this draft legislation. According to the ASHP Drug Shortage Statistics, the U.S. experienced 186 new drug shortages in 2018 and 166 in 2019. Primary literature and systematic reviews, such as that published by Phuong et al in 2019, have found that drug shortages “have adverse economic, clinical and humanistic outcomes to patients.” Currently, a majority of pharmaceutical manufacturing has been outsourced to other countries. While there are some economic benefits to this strategy, some are worried that the outsourcing of pharmaceutical manufacturing could result in subsequent shortages of medications in the case of emergencies or pandemics.

Recognizing the negative outcomes that can be associated with drug shortages, this draft of the HEROES Act requests the development of strategies to “end United States dependence on foreign manufacturing” for “critical drugs and devices”. Doing so, may end up having positive implications on patient outcomes. By controlling the supply chain, we can better manage drug shortages at all times,  which could have positive implications for patients across the country. However,  doing so would fundamentally change  the entire drug distribution system. What would be the consequences as the U.S. transitions to an independent manufacturing system? What could happen to the countless foreign workers that may be impacted by this change? How might it impact economies and the health of people around the globe?

These are all questions too big for one blog post to answer, but as pharmacists that took an oath to “consider the welfare of humanity and relief of suffering my primary concerns”, we can’t ignore both the positives and negatives that may come from such a disruption. As more information is released, there will be plenty of opportunities to bring the pharmacist perspective to these potential changes.

Your voice matters

This bill will certainly be amended in the coming days and it won’t be the last bill introduced to provide relief from the pandemic. As healthcare professionals, it is important for us to be actively engaged in this process by contacting our members of congress and informing them of our perspectives as essential healthcare providers. 

Track the current progress of the bill here and find resources on how to engage your legislators here. If we all make an effort to get engaged, who knows what progress we could make.

Until next time, stay curious and passionate.

Pharmacists’ ability to provide tests for SARS-COV-2

Testing for severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) to identify coronavirus disease-19 (COVID-19) has been one of the most prominent topics discussed since cases began being reported in early 2020. Increasingly, pharmacists are seen as vital team members in controlling the disease. While a lot of progress has been made, there are still significant opportunities where pharmacists can be leveraged to bridge gaps. In this blog post, we review how far we have come and where progress still needs to be made.

Historical Perspective

In times of great uncertainty, it can be helpful to look to history to guide the decision making of policymakers and public health officials. Although there appear to be many paths out of this immediate pandemic, it is unclear where these paths may lead, and the long-term ramifications to public health and the economy that may be waiting at the ends. Experts and news outlets have frequently compared COVID-19 to the 1918 influenza pandemic and have looked to decisions made by leaders at that time to inform decisions made today. 

Consensus has been found on the singular importance that testing for the disease will lead us down a path out of this first wave of the pandemic and may lessen future waves. Widespread testing during public health emergencies are vital to the public health response. During the 1918 flu, tests were not available to detect or isolate the disease. Without the ability to test, leaders had to rely on quarantine and social distancing instead of the ability to provide more individualized recommendations for those afflicted. 

Despite efforts to increase the availability of testing during the current pandemic, researchers from Harvard University are now projecting that for the U.S. to safely begin reopening, SARS-COV-2 testing needs to triple. As healthcare professionals are pulled in different directions to respond to the pandemic, many have suggested that pharmacists are an underutilized resource. During the pandemic, pharmacists can be better leveraged to increase the provision of SARS-COV-2 testing.

Initial win in increasing access to testing

In March, several policy think tanks began recognizing the pharmacist’s ability to increase testing capacity and made recommendations to legislators and regulators to lift barriers to pharmacists providing SARS-COV-2 tests and to test for other conditions. The Buckeye Institute, a midwestern think tank, recommended that Ohio “should permit pharmacists to test for the virus once tests become available, and encourage them to test and prescribe treatments for common illnesses like the flu and strep throat.” The John Locke Foundation made similar recommendations for flu and strep throat for North Carolina.

In response to recommendations, and thanks to the strong advocacy work of national organizations such as the American Pharmacists Association (APhA), the National Community Pharmacists Association (NCPA), and the American Society of Health-System Pharmacists (ASHP), the U.S. Department of Health and Human Services (HHS) published a guidance on April 8th. This guidance clarified that pharmacists can order and administer COVID-19 tests that the Federal Drug Administration (FDA) has authorized. Unfortunately, the guidance concluded with the following statement: “This guidance does not speak to or change reimbursement policy whether a licensed pharmacist may obtain reimbursement from a government or private payer for ordering or administering an FDA-authorized test.”

The reimbursement question

The lack of reimbursement for pharmacist-provided patient care services has devalued pharmacy services in the eyes of the public and other healthcare professionals. Continuing to provide these services without a sustainable business model, is more likely to cause pharmacies and critical healthcare access points to close, impacting patients’ ability to seek out care. It is empowering to see this guidance from HHS and the recognition that pharmacists can be better leveraged to provide care during the pandemic, however, without a sustainable business model supporting this policy, it is unlikely that healthcare practices will invest in allowing pharmacists to provide tests, especially when other healthcare providers can bill for administering the same service. 

Testing needs to increase in order to lead the country down a path out of this pandemic. However, at the time of publication, this guidance appeared to be nothing more than an encouraging, but unactionable statement. Analysis of recent legislation passed through Congress may be exactly what is needed to make the HHS guidance actionable. 

The Families First Coronavirus Response (FFCR) Act was signed into law on March 18th. As identified by analysts, including the Kaiser Family Foundation, this legislation requires health insurers to cover COVID-19 testing and prohibits cost-sharing with patients for said tests. Soon after, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law on March 27th. The CARES Act brought further clarification, that may be particularly pertinent to pharmacists. It is stated that if there is no previous relationship between a health plan and a provider, the “plan or issuer shall reimburse the provider in an amount that equals the cash price for such service.”

As a result of the change in law from the CARES Act and the FFCR Act, one may make the argument that there was already an established reimbursement pathway for pharmacists to provide COVID-19 testing, they just needed further guidance from HHS allowing them to begin testing. With the HHS guidance published on April 8, it is made clear that the guidance “does not speak to or change reimbursement policy whether a licensed pharmacist may obtain reimbursement from a government or private payer for ordering or administering an FDA-authorized test.” If a reimbursement pathway was already outlined in legislation signed into law on March 18 and March 27, this guidance issued on April 8 does not change the law and simply allows pharmacists the ability to test for SARS-COV-2. 

Inconsistencies in rules

Despite the HHS guidance and the potential path to reimbursement, questions began to arise about pharmacists ability to provide testing due to inconsistencies in recent rules. Although many expected that the point-of-care serological tests that pharmacists will likely be providing would be allowed without Emergency Use Authorization (EUA), the FDA clarified that these tests can only be performed in high-complexity CLIA laboratories. Without further guidance and changes in rules, this put the breaks on many pharmacists ability to provide these tests.

On April 28th, HHS published an interim rule amending current regulation and allowing Medicare to reimburse pharmacists for providing COVID-19 tests. It is important to note that this rule is only in effect during the COVID-19 public health emergency and pertains to the following tests: COVID-19 tests and  tests for “influenza virus and respiratory syncytial virus”. CMS is currently finalizing a full list of tests that will be covered and will publish in the coming days.

Although encouraging, this interim rule has requirements that makes it more complicated for pharmacists to provide and receive reimbursement for these tests. Medicare will only reimburse these tests if the pharmacist is a part of a Medicare enrolled laboratory. In a guidance published by CMS on April 29th, they state, “A pharmacy that acquires a [Clinical Laboratory Improvement Act] CLIA certificate can enroll with Medicare as a clinical diagnostic laboratory to conduct and bill for clinical diagnostic laboratory tests it is authorized to perform under its CLIA certificate.” In order to provide these tests pharmacists either need to submit an initial CLIA application for certificate or request to amend their current certificate. Information for how to apply for a CLIA certificate can be found here.

Gaps in testing pharmacists can fill

Recent reports have shown that minority populations, that may be at higher risk of COVID-19, have decreased access to current pharmacist testing locations. As of April 24th, less than 13 percent of testing locations “are in predominantly black neighborhoods.” As more pharmacists receive CLIA certificates and ramp up testing, they have the potential of making a significant impact, especially for the patient populations which have been shown to have decreased access to testing.

Throughout history, we have seen that expanding the global testing capability is vital to overcoming pandemic diseases. In 1918, these tests were unavailable, resulting in extended quarantines of numerous citizens. In 2020, much of the focus has been on increasing the availability of diagnostic and serological tests. However, we must consider scaling the number of healthcare professionals that are able to administer these tests to the broader public. Pharmacists now have guidance from HHS to provide testing, and can receive reimbursement from Medicare. Other payors, such as State Medicaid Departments and private insurers should consider following CMS’ example. As pharmacists scale up testing sites, they can maximize their impact by providing care where there are gaps for patient populations that need increased access to testing. Through the ability to test for COVID-19, the pharmacist can be more optimally leveraged during the pandemic and get the country closer to the number of tests being provided needed to take us down a path out of the current state of emergency.