Provider Status Explained: Understanding the how behind the federal legislative strategy

Provider status is essential to the future of the profession of pharmacy. We explained last week the reason why pharmacists need provider status now more than ever (if you missed it, check out the post here) and began to discuss some of the background around why this shift in the business model is so substantial. For all the Simon Sinek Golden Circle fans out there, now that we have dissected the why, the natural next step is to understand how we shift this business model in pharmacy. This week we will take a look at how this could happen at the federal level and will follow up with a look at states next.

Public Payors Influence the Private Sector

You may be thinking, “Okay, we need to shift our revenue stream. Why are legislative or regulatory changes even necessary? The role of the pharmacist has shifted, let’s charge for the patient care services we provide.” Although this “build it and they will come mentality may be applicable to other sectors of the economy, the business of healthcare is pretty unique. Because healthcare is so expensive, it is not realistic to expect to build a sustainable business model outside of the health insurance system.

The next challenge is to understand how to integrate the pharmacist into the health insurance system to be paid as providers. So, if we were to simplify the health insurance system to the extreme, we could say there are two paths you could choose to go down: public payors or private payors. Looking at other sectors of the economy, you can make an observation similar to Ellen Glasgow: “The government’s like a mule, it’s slow and it’s sure; it’s slow to turn, and it’s sure to turn the way you don’t want it.” So, you may think the private sector is the way we must go, and may set your sights on behemoths like UnitedHealth Group, Anthem, or Humana.

But, healthcare doesn’t work like other businesses. Despite the normal mantra that the private sector innovates, and the public sector adopts, healthcare tends to be the opposite. This may be because, as was discussed in the first installment of our series, business follows the money. Despite there being behemoths in the private health insurance industry, the single largest insurer of the most people in the United States is the public healthcare system (Medicare and Medicaid). With this significant share of the marketplace, the public payors have created a culture in which they shape change in the healthcare system.

So, a strategy is starting to take shape. An effective way to be recognized as healthcare providers is to create legislative or regulatory changes at the federal level specific to the public health insurance system.

The Social Security Act

What we are seeking is reimbursement for pharmacist-provided patient care services under Medicare Part B. This would align us with other comparable healthcare professionals that are reimbursed for their services under the medical insurance system. So, you may be asking yourself, how do you change who can be reimbursed for healthcare services under Medicare Part B? Well, it all comes back to the Social Security Act, and the influence this giant piece of legislation has had on our healthcare system.

The Social Security Act was signed into law in 1935 and established many of the social programs much of our country has come to depend on (e.g. Social Security Program, unemployment insurance, maternal & child welfare programs). Thirty years after originally signed into law, the 1965 Amendments were passed establishing the Medicare and Medicaid Systems. Included in Section 1861(s)(2) of the Social Security Act is a list of all healthcare providers other than physicians that can be reimbursed under Medicare. The healthcare professionals stretch across the gambit, from physical therapists and physician assistants to social workers and psychologists. Notably missing from this list, though, is the pharmacist.

Our mission is clear: to add pharmacists to this list. But is this even possible? How can we be sure this strategy can even be accomplished? If only we could test this strategy with a recent example from another healthcare (since 1997) provider.

The Nurse Practitioner Strategy

After more than 20 years of grassroots advocacy campaigns and systematic legislative victories in Congress, the 1997 Balanced Budget Act was signed recognizing nurse practitioners (NPs) as healthcare providers under Medicare Part B. Prior to this legislative victory, NP salaries were paid out of the health systems that they worked for, and the justification for their salaries was largely dependent on expected cost savings and an increase in health outcomes of patients that was associated with the care that they provided. Sound familiar?

Recognizing the unsustainability in an indirect ability to bill for patient care services and how this could negatively result in a lack of access to patient care services, nurse leaders began organizing and forming advocacy campaigns in the 1970s. They began with the introduction of a bill in 1974 that would recognize NPs as providers and it died. Recognizing the limited ability to make such a substantial change in one swoop, they reevaluated their strategy and instead began passing smaller, more realistic bills that began to create a culture shift within the healthcare team in our country. Over the course of these decades, NPs came together as a profession, completing numerous grassroots advocacy campaigns that resulted eventually in the signing of the bill in 1997 that finally got them to their goal.

From a historical perspective, we can see that legislative victories in this country often come down the path of incremental change. One may make the observation that by leaning into those incremental changes for 20 years, NPs were able to get to their final goal: provider status. If you’re interested in reading more about the nurse practitioner journey and how it relates to pharmacists, check out the great article here.

If we are to adopt a similar strategy, the profession of pharmacy should consider what the incremental changes are that we can adopt to get us to the finish line. There has never been a better time. The COVID-19 pandemic has highlighted the essential nature of pharmacists in our healthcare infrastructure, and has showcased to policy makers how vital pharmacists are in local communities. 

Incremental change, you say?

We’ve torn apart the why and the importance behind this issue. We’ve examined the how when it comes to our federal legislative strategy. But we can’t ignore the states and their (proportionally) greater nimbleness when it comes to implementing change. In the next installment of the Provider Status Explained series, we will be tackling the how behind the state strategy to reach provider status and postulate around the eventual tipping of a scale when a majority of states pass the finish line that may increase the chances of national success.

Until next time, stay curious and passionate.

Provider Status Explained: Why do pharmacists need provider status?

Provider status has been such a focus of the pharmacy profession for decades. However, before we talk about how to advocate for provider status, it’s important to understand why something needs to change. 

It’s all about that product

My grandfather was a community pharmacist in the Cleveland, Ohio area for nearly 50 years. I remember hearing about how when he graduated pharmacy school in 1959, the practice of pharmacy was (shockingly) different. When a patient came into the pharmacy to fill a medication, the pharmacist was not allowed to tell the patient what the medicine was, or provide much counseling information at all. In the eyes of the patient, the value being provided by the pharmacist was in the compounding and dispensing of this tangible product – and that is exactly what the patient paid for. In the 1980s, for example, a majority (70%) of prescriptions were paid out-of-pocket by the patient. Over the years, as the cost of prescription medication increased, insurance companies began covering more of the costs.  

Despite this shift in who is paying for the product, the way the pharmacist brings in revenue to the healthcare businesses they work for has remained largely tied to the dispensing of medications. This is fundamentally different than how other healthcare professionals bring in revenue to their healthcare businesses. In business terminology, there is a spectrum of the types of products that customers will purchase, called the goods-service continuum which can be important for us to understand how important this difference is. 

At one end is goods. Goods are completely tangible products that have no level of service associated with them. They are something that can be put on a shelf that a customer will purchase. Take, for instance: table salt. It is a completely tangible good that requires no additional service to the customer. On the other side of the spectrum is services. These are completely intangible and more aligned with a business providing an action that their customer is paying for. Think of education. Education is an intangible service that is offered by a teacher. You can’t put education on a shelf – it is provided by a skilled teacher to their students. In the center of this continuum are things that have a bit of both goods and services. For example, take a tailored suit. Customers are paying for the clothes, but also paying for a level of service to make the clothes fit just for them. 

When it comes to the way pharmacists bring in revenue to their businesses, through dispensing medications, what the pharmacist is offering falls in the center of this spectrum: a tangible good that has a level of service associated with it. Now, there is a significant level of service happening behind and in front of the counter (i.e. drug utilization review, counseling, consultations, etc.), however, this is largely not the services that are being paid for by the patient or payor. This is different from how other healthcare professionals bring in revenue to the healthcare businesses that they work for. For example, let’s look at the physician. The physician offers many things to their patients, however, what the patient is often purchasing (through the help of insurance) is the expertise of the physician. This is aligned farther toward the service end of the spectrum. 

This is similar to other healthcare professionals (think physician assistants, nurse practitioners, dentists, etc.). They provide expertise, or a service, to their patients, and that is what is paid for and how these professions bring in revenue to the healthcare businesses that they work for. 

Why is pharmacy different?

Our profession has significantly changed in its roles and responsibilities in the past century. In the 1950s, a community pharmacist’s responsibility was focused on compounding a medication and dispensing this to the patient. As healthcare continued to grow in complexity, it became obvious that healthcare teams required a medication expert… i.e. they needed a pharmacist. This new demand, coupled with the publication of landmark studies and calls from professional organizations, established the doctoral education as the baseline for new practitioners. With this new baseline, pharmacists were now able to provide fundamentally different services for patients. However despite these monumental shifts, there was no change in the business model. 

The current landscape

Since the pharmacy business model continues to be driven by medications, the pharmacist’s main responsibility continues to be the product.  It is no surprise that businesses follow where the money is. Without the ability for the pharmacist to directly bill for most of the patient care services they provide, they are forced to fit them in between their other responsibilities. In the past this was an issue because the pharmacist was not allowed their full time to do what they are trained to do: provide patient care and serve as the medication expert. This resulted in a lack of access to patient care for many, especially those in rural communities. However, dispensing fees were not in jeopardy at the time and pharmacists were able to continue practicing in this non-ideal environment.

The current business model is no longer viable! Declines in dispensing fees and anticompetitive practices of some businesses have made pharmacy practice significantly more challenging.  As dispensing fees have fallen, the businesses that pharmacists work for are asking pharmacists to do more with less in an attempt to maintain a sustainable business. This has resulted in a system of unrealistic community metrics that is squeezing everything out of the pharmacist to dispense as many products as they can, and we have seen the effects of this system. The New York Times detailed these risks in the excellent article, How Chaos at Chain Pharmacies is Putting Patients at Risk.

Because pharmacy payment models have not evolved, pharmacists’ responsibilities continue to be largely aligned with dispensing products. Although this is not optimal for patient care, the pharmacist is able to continue to function and provide care while also dispensing. Small advances have been made with the ability to bill for Medication Therapy Management codes, but these codes alone are not enough to create a sustainable business around them. In other settings, such as ambulatory care or in health systems, pharmacists are often hired with the expectation that there will be indirect cost savings that can justify their salary. Other methods have been utilized for pharmacists to bill incident-to the physician, however, there remain barriers to creating widespread sustainable pharmacist care clinics through these alternative billing methods.

Why now?

Now that the foundation of the dispensing model is collapsing, we are seeing the results in news stories across the country. Independent pharmacies are closing at an alarming rate, grocery stores are closing their pharmacies as well, and big-box stores are closing and slowing the opening of new stores. Because the business model of pharmacy did not shift with the roles and responsibilities of the pharmacist, the profession of pharmacy is now in crisis. 

As noted above, business practices follow the money. With the ability to directly bill for the patient care services that they provide, the healthcare businesses that pharmacists work for would allow them more time in their responsibilities to focus on the provision of patient care, which aligns with their training and expertise. Provider status moves pharmacists further toward the service end of the goods-service continuum and would be more aligned with how comparable healthcare professionals bring in revenue to the healthcare businesses that they work for. This would increase patient access to care and have numerous positive therapeutic and economic benefits for our communities.

Okay, so we now understand a little about the history and importance of why provider status is so essential – but there is still a lot left to unpack! What is the Pharmacy and Medically Underserved Areas Enhancement Act, why has the advocacy strategy been largely focused on public health insurers, and are we the only healthcare professional that has had to go through such a dramatic shift in our business model? All these answers and more coming soon in the next installments of our Provider Status Explained series!

The Assault on LGBTQ+ Health Access

Estimates predict that 1.4 million adults in the United States identify as transgender. Today we unpack a recent rule proposal that could jeopardize these individuals’ access to healthcare and how the most accessible healthcare professional, the pharmacist, can advocate against this systemic discrimination.

On Monday, June 15, 2020, the Supreme Court of the United States made a monumental ruling that impacted LGBTQ+ rights in our country. In Bostock v. Clayton County, the Court decided that employers could not discriminate against LGBTQ+ workers. Specifically, it said that Title VII of the Civil Rights Act of 1964, which barred employment descrimination on the basis of “race, color, religion, sex, or national origin,” includes a prohibition of discrimination based on sexual orientation and gender identity. This is a major decision coming from the court because it makes clear that so many policies that have been enacted by the majority of states, and have been advocated for by the Trump Administration and Republican Members of Congress, are illegal. In fact, before the ruling, if you lived in one of these 27 states, employers could legally discriminate against you on the basis of sexual orientation or gender identity in employment, housing, and public accommodations. This ruling was the first Supreme Court Decision concerning any sort of protections for transgender Americans, and by establishing legal precedent, we hope that all attempts to deny members of the LGBTQ+ community access to equal opportunities are shut down. 

While this is great news, this win is sandwiched by a concerted effort by the Trump Administration to revoke health care protections for members of the transgender community. On Friday, June 12, the Trump Administration released rules cutting health care protections for members of the transgender community. The new rule essentially enables healthcare providers, medical facilities and health insurance providers to discriminate against transgender patients and removes any ability for patients to fight back. This is particularly concerning because studies have shown these individuals are already at a significantly higher risk of being discriminated against by a healthcare provider during their lifetime (70% will face this discrimination). While disturbing  in and of itself, what is worse about this rule is that it is being released while the nation is in the midst of a national conversation about the impacts of systemic racism in all elements of society, including healthcare, in the aftermath of the numerous murders of members of minority populations by police officers. 

The Fight For Equity in Healthcare

The Trump Administration has called their rule “The Nondiscrimination in Health Programs and Activities”, however, this does not align with the language of this rule, which in fact promotes discrimination in healthcare. HHS refers to Section 1557 of the Affordable Care Act, which protects patients from discrimination on the basis of “color, race, age, national origin, sex or diasbility” in any “health program or activity” that receives financial assistance from the federal government. The Obama Administration used this language to prohibit discrimination based on sexual orienation, pregnancy, and gender identity. Based on the original rule as written by the Obama administration, healthcare providers and insurers were required to provide medically appropriate treatment for members of the transgender community. 

The Trump administration’s argument is that in sex is binary and the sex assigned at birth is necessary for healthcare. They also go on to argue that providing healthcare to members of the transgender community may be confusing for providers. The argument here grossly mischaracterizes the healthcare needs of these individuals and undermines the commitment to lifelong learning that providers embark on when pursuing careers in health care. 

The new HHS rule also goes further and affects regulations pertaining to transgender health access, including cost-sharing, health plan marketing, and benefits. 

What about the Supreme Court Ruling?

Despite the decision from the Supreme Court, the Trump Administration moved ahead on Friday and finalized the rules with HHS publishing the proposed rule in the Federal Register, with a “start date” of August 18. This regressive and almost certainly non-coincidental move is especially boldfaced given the decision from the Supreme Court, which ruled broadly that laws that explicitly prevent discrimination on the basis of sex or gender also prevent discrimination on the basis of sexual orientation and gender identity. The legal argument here is the exact same, even if the context is employment versus healthcare. The distinction is technical at best and on very flimsy ground. If the legal precedent holds, then the word “sex” in Section 1557 of the Affordable Care Act includes sexual orientation and gender identity. While HHS can reject any charge of discrimination by arguing that they “respect the dignity of every human being,” their actions speak louder than their words. We all know exactly what they are trying to do. 

What Can Pharmacists Do In the Meantime? 

As equity takes center stage in the broader discussion of healthcare access, it is encouraging to see all healthcare practitioners focusing on how to eliminate disparities in healthcare. Over the last few months in the aftermath of countless episodes of police violence, we’ve seen more research being highlighted out about racial disparities in healthcare and some language from professional organizations highlighting a commitment to learn more about social injustices and challenges related to health care. We must do the same thing when it comes to healthcare disparities faced by the LGBTQ+ community. Pharmacists and other healthcare professionals need to take time to learn how to use inclusive terminology in order to make LGBTQ+ patients feel comfortable when discussing their healthcare needs, and provide better health access for our LGBTQ+ patients. Resources and webinars from organizations like The Fenway Institute, Southeast AIDS Education and Training Center, the LGBT Training Curricula for Behavior Health and Primary Care Practitioners from SAMHSA and the National LGBT Health Education Center are great places to start. You can also take a look at the Healthcare Equality Index by the Human Rights Campaign

Other steps pharmacists, students, and other healthcare professionals can take: 

  1. Revise health intake forms to be inclusive of a variety of sexual orientations and gender identities 
  2. Ask technology vendors to include sexual orientations and gender identities as a part of a patient’s EHR
  3. Allow patients to enter their own information into a database to give patients control over how they give this information to providers 
  4. Develop and display non-discrimination policies that include sexual orientations and gender identities
  5. Train all staff to respectfully interact with all patients, and ask all patients what their preferred names and pronouns are. 
  6. Create a welcoming environment within patient consultation rooms
  7. When asking about sexual and social histories, talk to all patients in an open, non-judgemental way 
  8. Ask open-ended questions when talking about appearance or sexual behavior, such as “Are you in a relationship?” instead of “Do you have a boyfriend/girlfriend”
  9. Advocate for Professional Pharmacy Organizations to adopt policy opposing any local, state, or federal attempt to legalize healthcare discriminations based on sexual orientation and gender identity, and actively lobby against proposed rules that do
  10. Advocate for the inclusion content on providing care to members of the LGBTQ+ community in the curriculum of Doctor of Pharmacy programs

If our profession is serious about removing disparities in healthcare, we need to start with educating ourselves where there are gaps. We can do the work today to teach ourselves how to take better care of our patients, and then advocate for structural changes to better promote health access for all of our current and future patients.

Provider Status Explained: Series Introduction

Provider Status….These two words are thrown around everywhere in our profession.  We see them on signs, flyers, and billboards. We have said them to Members of Congress, State Legislators, and even presidents. They have consumed the focus of a large amount of our profession’s advocacy efforts for the last ten years. However, even with the frequency of the use of the term provider status, we have noticed key misunderstandings in what it means. How will it change the practice of pharmacy, and why it is essential to the future of the profession? To better everybody’s understanding and to answer some questions, we are going to be spending the next several weeks answering some of these key questions about provider status. 

We hope that these discussions will inform advocacy efforts you are participating in with legislators and members of the public.

So buckle up as we take a wild ride into the business model of pharmacy and why our best hope to fix it is the all too often used (but not always understood) phrase, provider status.

Coming soon…Provider Status Explained: Why do pharmacists need provider status?

Reflections on Systemic Racism in America

Over the past week, we have been torn about how to respond to the death of George Floyd and the resulting demands for justice taking place across our country. The murder of another human being by police officers is a symptom of underlying disease that has been a part of this country since it’s founding: systemic racism. Systemic racism is a public health crisis that we have allowed to go unaddressed for generations. Today must be the day we change that. We cannot stay silent about the public systems in this country that have abused African Americans and other racial minorities for centuries. 

As pharmacists, we can no longer remain blind and feign ignorance to the fact that the healthcare industry in this country is stacked against black Americans and people of color. It is not a coincidence that maternal death rates are highest among black women. Or that people of color collectively have higher rates of chronic illness, premature death, and often fail to receive the right care for pain, pneumonia, and post-surgery complications. Systemic racism is the reason for poorer health outcomes. It is the basis for social determinants of health, and we must commit ourselves to breaking this system to build a more equitable one. Small fixes just won’t work anymore. 

We have two goals at the Grassroots Pharmacist: to provide high value educational resources to shape perspectives on policy and to inspire others to make change. While we are committed to doing our part to provide education on how policy will impact racial health disparities in this country, we recognize that there is more to be done. We implore all of our readers, regardless of race, to educate yourselves on the issues affecting our friends and neighbors. Learn about the challenges they face in our society, and then ask questions when you need to. Take the time to amplify black voices and do your part to create a more equitable society for all of us. 

Here are some resources to help us get started: 

Tragic Death of George Floyd Reveals Continuing Problem of Police Violence

2 Public Health Crises have Collided in the Protests Over George Floyd’s Death 

Racism is a Public Health Issue and ‘Police Brutality Must Stop.’ Medical Groups Say

Please consider donating to the following groups to support the people risking their lives to speak out against injustice and create a more just world. 

Black Lives Matter

American Civil Liberties Union

National Association for the Advancement of Colored People

Official George Floyd Memorial Fund

Official Breonna Taylor Memorial Fund 

Nationwide Bail Fund

Michael & Nimit

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.