The Basics of 340B and the Current Attacks on the Federal Drug Discount Program – Guest Writer Ariel McDuffie

It’s no secret that everyday many patients go without vital medications due to cost. As pharmacists, many of us have heard about the 340B drug pricing program however, the details of it aren’t always well-known. The current drug manufacturer attacks on 340B are bringing the program into the spotlight: not necessarily for good press, but in their attempt to take advantage of our nation’s safety net providers struggling during these difficult times. This week, the Grassroots Pharmacists will bring to light the importance of 340B and how the attacks from drug manufacturers will harm the very patients you serve. 

What is 340B?

It all began in 1990 when Congress created the Medicaid Drug Rebate Program (MDRP) which required drug manufacturers to pay rebates to state Medicaid programs for covered outpatient drugs. Although drug manufacturers offered the rebates, the costs for other discounted drugs rose dramatically which led to Congress enacting Section 340B of the Public Health Service Act in 1992. Section 340B is administered by the Office of Pharmacy Affairs (OPA), a part of the federal Health Resources and Services Administration (HRSA), which is an agency within the Department of Health and Human Services (HHS). As a condition of participation in MDRP, manufacturers must also participate in the federal 340B program. Under a Pharmaceutical Pricing Agreement (PPA) with the Secretary of HHS, section 340B states that the manufacturers agree to charge a price for covered outpatient drugs (to safety net providers) that does not exceed the 340B price designated by HRSA. Safety net providers and clinics are non-profit entities that provide access to services without charge or using a sliding scale to low income and vulnerable patient populations. 340B is a patient service program that was created to protect safety net providers and allows safety-net clinics and health centers, known as covered entities (CE), to stretch their resources to treat more patients and provide more comprehensive services at no cost to taxpayers.

340B CEs save on prescription drug costs by purchasing 340B drugs at a discounted price for eligible patients. These savings occur one of two ways: 1) Passing 340B discounts directly to patients through a Prescription Cash Discount in which the CE provides medications at a greatly reduced price to those patients who are uninsured or underinsured, or 2) Insured claims where the CE bills the insurance like normal for those patients who have insurance and is reimbursed from insurance as a usual claim, but then the CE is able to take advantage of the discounted ingredient cost when replenishing the drug. The savings are then directly returned and invested into patient care.

Eligible CEs of 340B include community health centers, Ryan White HIV/AIDS program grantees, certain hospitals, and specialized clinics. Eligible patients must meet HRSA’s 340B Patient Definition, which include criteria such as patients must receive health care services from a health care professional who is either employed by the CE or provides health care under contractual or other arrangements such that responsibility for the care provided remains with the CE.

HRSA allows CEs to contract with outside pharmacies to act as a dispensing agent. These pharmacies are often located in accessible areas where patients live, work, pray, and play. Under HRSA’s guidelines, the CE is responsible for purchasing the prescription drugs which are then shipped directly to the contract pharmacy. The CE and contract pharmacy must establish and maintain tracking systems to prevent diversion of drugs to individuals who are not patients of the CE and to prevent Medicaid duplicate discounts from occurring.

Overall, the 340B prescription drug program has bipartisan support, reduces outpatient drug costs, provides more comprehensive services for CEs serving large numbers of low-income individuals, and leads to healthier patient outcomes.

Impact of 340B

The impact of 340B on patients is significant, as it helps in assisting the uninsured and underinsured get access to medications that they would otherwise have to go without. Health centers typically use 340B savings to subsidize the cost even further beyond the pass-through 340B discount for patients that meet certain income requirements. Community Health Centers are required by law and mission to reinvest every penny of 340B savings back into patient care and services. This is why 340B savings are so essential, as they help safety-net providers stretch scarce resources so they can serve the people and communities who need them the most.

To illustrate the impact of 340B the National Association of Community Health Centers (NACHC) hosted a press briefing on September 16, 2020. During the briefing, a patient who relies on the 340B program shared her story.

Gina Moore, a patient with diabetes at PrimaryOne Health in Columbus, OH, is among the millions of patients who will be affected by drug manufacturers no longer shipping certain 340B prescriptions to Contract Pharmacies.  She described how the highly concentrated insulin she relies on to stay alive will no longer be available on October 1st unless the health center complies with a specific drug manufacturer’s onerous and impossible data reporting requirements. Given her income circumstances, Moore is eligible for PrimaryOne Health’s prescription assistance program, which uses 340B savings to discount the costs of her prescriptions.  With the help from PrimaryOne Health, Moore’s cost is substantially less than the drug manufacturer’s 340B discount. Moore is able to pick up a 90-day supply of her insulin for less than $15 at a 340B Contract Pharmacy for a drug that would cost more than $1,000 elsewhere—a price beyond what Moore, or any average consumer, can afford.  “I am a Type 1 insulin-dependent diabetic and my pancreas does not work,” said Moore. “I need insulin every day and without it my kidneys will shut down.  I will die.”

You can view the full press conference here.

340B is under attack!

If 340B helps so many patients then why is the program under attack by drug manufacturers, especially during a pandemic? I think that is a question that we would all like the answer to!

The recent attacks began in early July with a drug manufacturer stating that they did not have to provide 340B priced drugs to contract pharmacies. This statement then prompted other drug manufacturers to get on board with attacking the 340B program and push against the use of 340B contract pharmacies. To stir the pot up even more, President Trump signed an executive order indicating that health centers are profiting from the 340B program at the expense of their low-income patients who lack insurance or have high deductibles and co-pays. This statement, although false, definitely added fuel to the fire.

Drug Manufacturers do not want to provide 340B drugs to contract pharmacies:

Recently, many big drug manufacturers have refused to provide the 340B discount prices to safety net providers that use contract pharmacies. This is a huge issue because many CEs rely on these pharmacies because they do not have an in-house (“entity-owned”) pharmacy. As previously mentioned, the contract pharmacies are often located in accessible areas that allow CEs to reach more patients and therefore, provide more services. If CEs are forced to get rid of contract pharmacies, how will vulnerable patients access vital healthcare services and affordable medications?

The attacks do not stop there. Another includes drug manufacturers wanting access to sensitive patient claims data from health centers beyond what is required to comply with statutory requirements. This places unreasonable administrative burden on the CEs and contract pharmacies and frankly, is impossible due to many existing pharmacy contracts that do not allow this.

What do these attacks mean to the safety-net providers?

Without 340B contract pharmacies, many CEs would not be able to serve low-income patients as they currently do. These aggressive actions are harmful to the CEs, but more importantly, to the millions of patients it impacts. Many healthcare professionals are scrambling to figure out appropriate alternative medication options and inform patients of the issues. However, it is near to impossible to keep up with every drug manufacturer’s changes as the attacks keep rolling in. Contract pharmacies are a vital and essential part of the 340B program. Health centers are going to be forced to close their doors at some of the clinics and scale back or completely eliminate some of their comprehensive services if 340B savings are not protected at contract pharmacies.

Why should you be concerned?

Millions of patients are being affected by these attacks nationally. At a time when many have lost their jobs and health insurance, or even been ill themselves, drug manufacturers have chosen their own way of doing things that is detrimental to so many. Unless actions are taken by Congress and HRSA to enforce the statute and protect the intent of the program by penalizing the drug manufacturers for failing to provide 340B pricing to CEs, millions of patients will see their prescription prices increase and may not be able to afford their life-saving medications as well as health centers closing doors. Community Health Centers have bipartisan support and are the primary care backbone of America.

We are the best advocates for our patients and regardless of the outcome, it is our responsibility to create the change we want to see. My hope is that the parties involved decide to put patients over profit and realize the severity in what they are doing and how it will negatively impact millions of individuals.

Guest Writers Profile

Ariel McDuffie is a current PGY2 Ambulatory Care Resident Pharmacist at The Ohio State University College of Pharmacy and PrimaryOne Health (P1H). She received her PharmD from Chicago State University College of Pharmacy and completed a PGY1 Community Care residency at The Ohio State University College of Pharmacy and the Charitable Pharmacy of Central Ohio. Her practice interests are underserved care and managing chronic health conditions. She has a passion for advocating for the field of pharmacy, reducing health disparities in the community, and providing accessible patient-centered care for all. 

Because of her passion for working with vulnerable patient populations, she has had the opportunity to work with and learn from the 340B Oversight Committee team at P1H to better understand how the program operates and its impact on the patients who need it most.

The pharmacist’s duty to address human rights abuses in immigration detention centers

Today, as you read this article, human rights abuses are occurring in the United States of America. Lack of access to vital acute, chronic, and preventative healthcare has resulted in suffering and death of children and adults under the eye of the U.S. government. Many of us do not see these horrors happening in our day-to-day life, as they are taking place out of public sight in the shadows of a complex and controversial immigration system. However, they are happening every day, and healthcare professionals, including pharmacists, must speak up against these atrocities.

What are immigration detention centers?

Immigration detention centers are places of confinement, similar to jails or prisons, where immigrants are held if they submit a claim for asylum, are being deported, or have unlawfully entered into the U.S. These centers are overseen by the Immigration and Customs Enforcement (ICE) agency, and are often outsourced to public and private prisons.

It would be incorrect to assume that this is a geographically limited issue that only impacts states like Texas or Arizona. There are over 200 immigration detention centers in the U.S., with at least two in every state. In 2016, it was reported that nearly 360,000 individuals were detained in these centers across the U.S. 

People may be detained for different periods of time in these centers. Seventy percent of individuals are held for one month or less, with many being released the same day they were detained (often meaning they were immediately deported). Since 1997, children have different rules due to the Flores Settlement, a court agreement that set a nationwide policy of a 20-day limit for holding children. However, some adults are held for months, or even years. 

Why does this matter to the profession of pharmacy?

Unfortunately, for years, there have been consistent reports of human rights and medical abuses that are occurring in immigrant detention centers. These abuses have a direct tie to the values and ethics that members of the profession of pharmacy pledge themselves to uphold. In particular, the Oath of a Pharmacist states, “I will consider the welfare of humanity and relief of suffering my primary concerns.” In October 2019, the American Pharmacists Association (APhA) came out with a statement of concern regarding care provided within migrant detention centers. In addition to the disturbing reports of medical abuses, recent analysis has shown that there are economic consequences as a result of trauma to children and adolescents in detention centers.

As the professional whose duty it is to oversee the appropriate utilization and administration of medications, several categories of these abuses directly relate to the profession of pharmacy. These include: forced administration of unnecessary medications, lack of access to medications and vaccines, lack of access to tools and environment to prevent disease, and forced unnecessary surgeries.

Forced administration of unnecessary medications

Over the years, there have been many reports of inappropriate medical care being provided in detention centers. Legislation has been introduced in the past to address these issues, but has yet to be signed into law. In the past several years, reports have begun to resurface from prominent news organizations and have seemed to increase in frequency. During the summer of 2018, there were many reports of the forced administration of antipsychotics to children without parental or guardian consent in order to sedate them. A jarring quote on the abuses came from an outside physician, who said, “These children tend to be overmedicated with combinations of meds that are really not indicated for children with PTSD [post-traumatic stress disorder], particularly small children. The purpose of that medication is not really to treat an illness, but to tranquilize them. It’s not a tool of therapy, it’s a tool of control.” Federal judges have since ruled against the use of antipsychotic medications in children without appropriate consent, however, additional abuses have continued.

Lack of access to medications and vaccines

There have been repeated reports of detained individuals not having access to acute and chronic medications. Examples of types of medications that have been withheld from detainees include anticoagulants, antihypertensives, antiepileptics, antipsychotics, and more. In one instance of clear patient harm from this practice, a detained man was not allowed to access his anticoagulant, which resulted in a blood clot in his leg. 

There has been discussion and attempts to eliminate the Flores Settlement, which would lift the 20-day limit for holding migrant children in immigration detention centers. In addition to resulting in longer periods of time where children may have limited access to their medications, they may also have limited access to vital preventative healthcare, such as vaccines. The Department of Homeland Security (DHS) has a policy against administering the influenza vaccines to detainees, despite multiple migrant children having died from the flu in the past several years.

Lack of access to tools and environment to prevent disease

During the coronavirus pandemic, medical and healthcare abuses have continued. In addition to there being limited access to medications and preventative care, such as vaccines, there have been reports that there is a higher risk of infection as a result of how individuals are detained. As of September 17th, there have been nearly 5,900 confirmed cases of COVID-19 in immigrant detention centers. On June 4th it was reported that tests of immigrants in detention centers were resulting in a 50% positive rate, indicating that ICE was dramatically under-testing the detained population. When only symptomatic individuals are tested, isolation and treatment to prevent further spread of the virus, in already suboptimal conditions, becomes nearly impossible. 

In addition to being confined in close quarters with inadequate testing, individuals that are detained have limited access to commonplace antiseptics like soap. Washing hands and surfaces with soap is one of the top recommendations by the Centers for Disease Control and Prevention (CDC) for preventing further spread of the virus. As a result of this lack of access to soap, individuals that were detained were forced to go on a hunger strike in order to receive appropriate preventative measures to decrease the spread of COVID-19.

Forced unnecessary surgeries

The most recent reports of abuses have come to light after a nurse’s whistleblower complaint alleging multiple forced unnecessary hysterectomies. Multiple women have come forward with these complaints, unable to explain why they had the surgery, and some are comparing it to the medical experimentation that occurred in the concentration camps of Nazi Germany. ICE has responded that they are investigating the claims, and over 170 members of Congress are requesting immediate investigation. Further inquiry will be necessary to determine the veracity of the whistleblower complaint and if additional details surface regarding inadequate care being provided both pre- and post-op.

How can you take action?

Regardless of the results of the most recent investigation into healthcare abuses, one can feel confident that this trend of inappropriate access to and administration of healthcare will continue unless further legislative and regulatory action is taken. A Grassroots Pharmacist team member published an article in the Journal of the American Pharmacists Association regarding this issue which includes information on current legislation to advocate for and a letter template to send to members of Congress. In addition to sending letters and scheduling visits with our elected leaders, an important role of the healthcare professional is in educating our community members. Discussing this and other social issues with our friends and family is vital to helping others to understand the importance of this issue. Discuss this on social media, with your patients, coworkers, and students. This is not a partisan issue. This is a healthcare issue, and as pharmacists held to our oath and ethics, it is our duty to advocate for the appropriate administration of healthcare.

Along with the action that we can take as individuals, the organizations/businesses that we are associated with can take action as well. As we continue to discuss social issues that impact pharmacists, students, and our patients, we have recognized that a statement or press release is insufficient. These injustices are happening and will continue to happen unless legislative and regulatory action is taken. The profession of pharmacy, including state and national professional associations, employers, and academic institutions must allocate resources to advocate and support legislative and regulatory change to promote healthcare equity and eliminate human rights abuses. 

If we want to be healthcare providers, this comes with the territory. We cannot simply focus on issues that impact pharmacy. We cannot remain blissfully ignorant of the horrible injustices resulting in the pain and suffering of human beings within our country. We must prioritize issues that impact the people we care for. We must take action.

We Hold These Truths To Be Self-Evident: Addressing Gender Inequality in the Profession of Pharmacy

It has been over 170 years since the signing of the Declaration of Rights and Sentiments at the Seneca Falls Convention, a key moment in the gender equality movement. Although significant strides have been made since 1848 to encourage equal rights for women, gender inequality remains an issue in many facets of our society, including in healthcare and the profession of pharmacy. Policy changes and grassroots movements to change societal beliefs are needed for change to occur at every level, including within our profession. 

Gender Inequality in Pharmacy

According to the 2013 “Women in Healthcare” report, women make up the majority of the healthcare workforce, but they only hold 19% of hospital CEO positions and lead only 4% of healthcare companies. Unlike many other health care professions, there are nearly equal numbers of males and females practicing as pharmacists. When we take a look at the leaders of the 13 organizations that comprise the Joint Commission of Pharmacy Practitioners (JCPP), we find seven women at the helm of these organizations. Indeed, some of these organizations, such as American Pharmacists Association Foundation and American Society of Health-System Pharmacists, have developed resources and events to promote women in pharmacy and leadership. 

Although there is an equal representation of females within the profession of pharmacy, gender inequality does still exist. Within academic pharmacy, men are more likely to be tenured or in tenure-track positions, and serve in school and college leadership positions. Additionally, aligned with the national average, in 2019 women pharmacists earned $0.84 for every $1 earned by men. 

Recognizing the detrimental effects of gender inequality in pharmacy, the International Pharmaceutical Federation (FIP) included addressing these inequities as a primary objective in their Workforce Development Goals for the profession of pharmacy. However, more action must be taken by national pharmacy organizations, employers, and academic institutions to close the gaps caused by these gender inequalities.

Past, Present, and Future: The Equal Rights Amendment

The Equal Rights Amendment (ERA), passed by Congress with bipartisan support in 1972, was proposed to guarantee equal legal rights for all American citizens, regardless of sex. In order for the amendment to become part of the United States constitution, it must be ratified by three-fourths (or 38 out of 50) of the states. It wasn’t until January 2020 that Virginia became the 38th state to ratify the ERA. In order for the ERA to be enacted, Congress must vote to eliminate the deadline originally included when this legislation was passed.

The ERA is essential to address sex discrimination in the United States. In addition to improving women’s rights in the workplace, including equal earnings and access to all careers and levels of leadership, it could also prohibit discrimination on the basis of sexual orientation and gender identity. This not only matters for our professional careers, but also for the well-being of our patients. Learn more about how to be an effective advocate for the ERA and ways to share your advocacy stories here

What else can I do to help eliminate these gaps?

We don’t need to tell you how toxic it is to our entire system when any person known for sexism and sexual misconduct is in a position of power (if you haven’t already, be sure to register to vote!). In addition to electing qualified officials and advocating for policy changes, there are other ways we can all make an impact on gender inequality. 

In 2010, the U.K. passed an Equality Act, requiring equal pay for men in women in the same job. Despite this significant stride, a gap in earnings remained as more men served in senior leadership roles. Continued grassroots efforts to change societal beliefs are necessary. According to a 2019 Forbes article, four key aspects should be focused on to overcome gender bias in order to address this systemic issue: awareness, attitude, analysis, and systemic change.  

  • Awareness: recognize our own biases and how these biases affect our daily decisions and actions. Try taking the Implicit Association Test
  • Attitude: break gender stereotypes and allow everyone the freedom to pursue roles best suited for them.
  • Analysis: continuously collect data on our organizations to determine where efforts should be focused. 
  • Systemic change: create systems designed to eliminate bias. From policy changes, such as assessing candidates for new positions in a gender-blind fashion, to ensuring equal participation from men and women in meetings, changing the systems is key to creating real change. 

Inequality between men and women affects each one of us, and thus can impact our patients. We must all work together to close this gap, not only to ensure equality between male and female pharmacists, but also to eliminate discrimination and burden for those that we care for. Although policy change is essential, changes in our behaviors and attitudes will serve as a catalyst to overcoming this barrier and ensuring equality for all humans. 

Pharmacy Benefit Managers, Political Action Committees, and Lobbying… Oh My!

The twofold focus of this blog is on recognizing the strength of your individual voice and broadly increasing pharmacist engagement with grassroots advocacy. We firmly believe that the most significant change occurs when more individuals are involved and politically active. Through grassroots advocacy, we ensure our elected leaders know our perspectives on important healthcare issues and that these constituent opinions can influence their votes. However, we recognize that the average pharmacist may not be involved with grassroots advocacy efforts. This leaves us to question: If the views of constituent pharmacists are not being shared with elected leaders, how are elected leaders making informed decisions on pharmacy and healthcare issues? This comes back to the people and organizations whose job it is to advocate on your behalf or against it. In an effort to help explain the importance of grassroots advocacy, pharmacists need to understand the role and power of political action committees (PACs) and lobbyists.

Political Action Committees & Lobbying Expenditures

PACs have gotten a lot of press over the past several years as more of the public have become aware of their influence over the policies of elected leaders. However, this narrow understanding does not encompass the true purpose of PACs. PACs are simply organizations that are formed in order to make donations for the purpose of supporting or defeating political candidates. They are frequently made by businesses or organizations to support candidates that align with their interests. Many state and national pharmacy associations have PACs, as do many of the businesses that we work for. Information on PAC donations is often available through annual reports of associations or through the Center for Responsive Politics. We have summarized PAC donations data and lobbying expenditures for the associations that are members of the Joint Commission of Pharmacy Practitioners (JCPP) below.

The amount of money spent on lobbyists is another important marker for the political engagement of an organization or business. Lobbying expenditures are frequently spent on the salaries of lobbyists. Within our national pharmacy associations, some may only make minimal contributions to candidates through PACs but may spend hundreds of thousands to millions on lobbying expenditures. 

Pharmacy Benefit Managers

We frequently see on social media the posts of frustrated pharmacists who are disappointed that more legislative and regulatory action is not being taken to further oversee the business practices of PBMs. The sentiment of many of these posts is, the evidence is out there, so why is action not being taken? This reminds us similarly to the tobacco industry, which, despite evidence being available for years showcasing the harms of tobacco products, Congress was slow to regulate. This may have been because of the lobbying efforts of the tobacco industry, which successfully persuaded elected leaders not to install drastic regulations over the industry. Similarly, despite there being evidence showcasing patient harm due to PBM business practices, Congress has been slow to react.

You may be thinking, Well, pharmacy associations fund hundreds of thousands in PAC donations and spend millions on lobbyists so we can fight against the PBM efforts. Unfortunately, by looking at the numbers, you will see that the pharmacy associations are not even in the same ballpark as PBMs. We pulled data from the top three PBMs (Caremark/CVS Health, Express Scripts, OptumRx/UnitedHealth Group) and the Pharmaceutical Care Management Association, which are represented in the PBM column of the below graph, and compared it to the sum of all national pharmacy associations in JCPP. 

The Defense for Grassroots Advocacy

As you can see from this graph, the national pharmacy associations advocating on behalf of the profession do not have comparable resources as the PBM industry when it comes to PAC donations and lobbyists. You naturally could come to two conclusions from this fact: either 1) resign to the fact that we cannot impact these issues and stop complaining on social media; or 2) realize that we can make a difference, but we must take action rather than assume action will be taken on our behalf.

If the latter resonates with you, as it does with us, then there are a few ways we can help to overcome the influence gap created by the larger wallets of the PBM industry. An easy way to overcome this is by joining pharmacy associations that are politically active and donating to their PACs. Of course, prior to donating, we recommend reviewing the most recent annual report of the organization to ensure you are aware of how PAC donations are utilized. Other than trying to close the gap with money, the best way to fill the influence gap is through grassroots advocacy. 

The Congressional Management Foundation has found through research that the most effective form of political influence comes from personal constituent meetings and/or correspondence. Through their research they found that this is more effective than visits from lobbyists. If we cannot compete on the same playing field with cash, we need to use what has been proven to be more effective: our individual voices. Through grassroots advocacy, we can overcome this influence gap, and overcome the confusing and often shady fundraising of PAC donations and lobbying expenditures. 

Pharmacists’ patients lose access to meds as USPS disrupted

As the medication experts on the healthcare team, pharmacists understand the negative impact when patients do not have access to their necessary and life-saving medications. For many unfortunate reasons, the current disruption with the United States Postal Service (USPS) must be addressed as millions of patients receive their medication by mail and thus are facing unnecessary and unplanned interruptions to their healthcare. Although subsequent disruptions have been delayed until November, the impact of the changes already made, and those made after the election could result in patient harm. While pharmacy organizations have recognized disruptions in medication access must be addressed immediately, they have decided to use this opportunity to focus on a different issue – PBM reform

USPS and The Impact of Disruptions on the Medication Delivery System

With more than 90% of Americans living within five miles of a pharmacy, the pharmacy is an essential community health center for many patients. While many patients do use their local pharmacy to fill prescriptions or obtain over-the-counter products, there are millions of patients who utilize mail order services for their routine medications. For example, the US Department of Veterans Affairs fills 80% of veterans’ prescriptions through the mail. This equates to around 120 million prescriptions per year for the veteran population, though this estimate is thought to be inflated. In the United States, for every 100 people, 50 prescriptions are sent through the mail. Although some of these medications may be delivered via FedEx or UPS, the utilization of the USPS to distribute medications is a vital piece of the healthcare delivery infrastructure in the US. The recent analysis from Drug Channels Institute may lead one to believe that a majority of patients that receive medications from the mail will not be affected by the USPS disruptions, however, as the American Pharmacists Association (APhA) stated in their press release on this issue, “Any patient that goes without one prescription is too many.”

When patients who typically use mail order for their prescriptions face shortages of their medications, they also turn to their local community pharmacy. Because of changes with the USPS, pharmacists are increasingly working with patients going without access to their medications, or who are facing an unnecessary burden to receive their medication. The disruption of the medication delivery infrastructure may result in increased strain at other points in the supply chain. This strain could result in decreased access to medications, decreased efficiency of medication dispensing, and increased burden on pharmacists and pharmacy support staff. 

Patient’s Right to Choose

Use of mail order services have been shown to improve medication adherence, including for stroke survivors and patients with diabetes. Utilizing such services can remove barriers such as transportation to and from pharmacies and allow patients to maintain access to medications during pandemics. However, we do support that patients should be able to choose whether or not they want to take advantage of mail order pharmacy services. 

Increasingly, patients are required to use mail order pharmacies, or another location that is not their local and preferred pharmacy. Although we do agree that elected leaders need to review current policies which may restrict patient choice and provide legislative and regulatory recommendations to limit these activities, taking this opportunity to focus on PBM reform seems like an easy way to circumvent the real issue and avoid taking a stance on an issue that is clearly affecting our patients. Let’s not lose track of what really matters – the patients. Even without PBMs requiring patients to utilize mail order services, some patients would (and perhaps should) continue to want to utilize mail order services. 

There is no doubt that when patients lose access to their medications, either through temporary actions or through requirements that do not allow them to use the pharmacy of their choice, patient health and safety is put at risk. While Americans continue to struggle with healthcare costs and issues with access to care, pharmacists must be focused on maintaining patient access to medications in order to: 1.) Improve patient health outcomes, 2.) Maintain patient safety, and 3.) Reduce overall healthcare cost through effective use of medications.

In other words, we should remain focused on the overall well-being of our patients. Immediate cessation of legislative or regulatory action that disrupts the medication supply chain infrastructure, thus jeopardizing patient access to healthcare, is needed. Through appropriately funding USPS services, patient access to medications through legitimate mail order services can be delivered in a timely and effective manner. As this news story falls out of the headlines, we must remain vigilant to observe consequences of disruptions and further disruptions following November. Many of our patients may not have the ability to advocate for themselves when access to their healthcare is infringed upon, but as a profession, we can be the voice that brings forth concerns when our patients are put at risk.

An Open Letter to Incoming Student Pharmacists: Our Profession Needs you

Dear Incoming Student Pharmacists,

Congratulations, and welcome to the profession of pharmacy! You have taken the first step in the incredible journey of becoming the most accessible and one of the most trusted healthcare professionals, a pharmacist. Take this moment to reflect on the incredible hard work and dedication that resulted in you being where you are right now. Before you is curriculum and experiences that will result in you becoming a valued and essential member of the healthcare team. 

We join the profession of pharmacy because we want to help people. Maybe some of us had an encounter with a pharmacist in our youth and we were inspired. Others were fascinated by chemistry and the effects of drugs on the body. So many more stumbled upon this spectacular profession in other colorful ways. 

We write this letter to share our excitement for the future of pharmacy. Over the past 100 years, the pharmacist’s roles and responsibilities have significantly evolved. We have evolved from a profession focused on the compounding of medicine to one that optimizes therapy and provides direct patient care. However, these changes, and the endless possibilities we now have to make a significant impact on our communities, did not come without effort. They were the result of leaders who came before us recognizing the potential in the profession and advocating for change that would benefit future patients. 

As you begin your time as a student pharmacist, you may hear concerning issues – things like the job market, pharmacy benefit managers’ influence on patient care, pharmacist salaries, and others. If you feel scared or angry when you think about these issues, your emotions are understandable and warranted. However, we challenge you to think about those leaders who came before us who faced similarly large issues, but decided to make a difference and find a solution to improve patient care rather than accept the current reality. One of the most effective tools you can use to make a difference is grassroots advocacy.

Grassroots advocacy is empowering citizens to get involved with solving their community’s problems by engaging their elected leaders and the public. Grassroots advocacy is an important part of our democracy, but many do not participate, especially healthcare professionals. Our mission is to help you identify the power of your voice and use it to improve the lives of our patients. If every day we each took a few minutes to dedicate to grassroots advocacy, we are confident we could dramatically improve our healthcare system and the care our patients receive.

As you take in this special moment at that start of your career, we challenge you to look to the future. The future holds so much opportunity for you, your patients, and your community. You have the power to create positive change to improve patient care today and tomorrow. You do not have to do this alone. We will do this together. Don’t lose that excitement you feel now. There is so much change on the horizon…all we have to do is advocate for it.

Sincerely,

The Grassroots Pharmacist

Déjà vu…Pharmacist state scope of practice overruled by HHS: Take 2!

If you liked the premiere, you are going to love the sequel. In a huge move on August 19, the Secretary of the U.S. Department of Health & Human Services (HHS) has further amended his declaration of the Public Readiness and Emergency Preparedness (PREP) Act. In doing so, he has allowed pharmacists and pharmacy interns the ability to provide any Advisory Committee on Immunization Practices (ACIP) recommended vaccine to all children ages 3 to 18 during the public health emergency (PHE), regardless of state scope of practice. If you’re sitting there scratching your head thinking, “But…what about state scope of practice?” we will refer you to our previous post where we explained the power the Secretary of HHS gets during PHE to supersede state scope of practice law.

There is plenty to break down here on how this health policy impacts you and your practice. So, let’s get to it!

Let’s break down this amendment

The original declaration of the PREP Act by the Secretary was declared back in March. In May, he filed an amendment to allow pharmacists the ability to provide COVID-19 tests regardless of state scope. And now, with this Amendment, we see the government anticipating what is expected to be a rough flu season. Any pharmacist or pharmacy intern that meets the specific criteria outlined in the amendment (APhA put together a good overview of requirements here) can provide any ACIP recommended vaccine to children age 3-18 years old during the PHE, regardless of state scope of practice. This covers current vaccines and, when approved, the COVID-19 vaccine. 

So why is this necessary? Well, in the first few months of the pandemic, 98% of primary care offices saw a decrease in revenue, meaning that patients weren’t receiving their normal preventative healthcare, including vaccines. According to the background information of the amendment, over 40% of pediatrician offices surveyed reported that either they were not planning to resume immunization services for all patients, or they were unsure of their future plans. This leaves a potential for a huge gap in patient care which could result in long-term negative health outcomes and economic consequences. This will not affect pharmacists in every state, but in those states that have age restrictions on some or all vaccinations, it opens the door for pharmacists to ensure children are receiving the care they need from an accessible and highly trained professional. We have included a map above of the states that are affected based on data from APhA / National Alliance of State Pharmacy Associations (NASPA) Survey of State Laws/Rules which was last updated in June 2020.

Further clarification was also brought to the PREP Act declaration to expand the definition of COVID-19 to cover other diseases that may be caused by the virus, or mutation of the virus, in the future.

Instead of a cherry on top of this sundae, let’s add some future-casting!

So, what does this mean for the future? This continued overruling of state scope of practice by HHS during the PHE is making at least a few pharmacists see state scope of practice laws in a different light. From those opposing scope of practice expansion of non-physician practitioners, it is a frequent talking point that expansion should be limited in order to ensure quality of care is maintained. However, at some time in hopefully the near future, we will face the lifting of the PHE, and on one day pharmacists will have the training in order to provide quality care through vaccinations to any child age 3-18 years old, and on the next day that training is no longer relevant. This calls in to question the purpose of scope of practice laws to be different from state to state. Is this truly a method to ensure quality of care is being provided? If so, why should a patient in Arkansas not be afforded the same quality of healthcare as someone in Florida? And is this quality really only different because of the PHE?

We have seen many of the rules and laws that have gone into effect only during the PHE begin to transition into permanent changes if they increase efficiency of care delivery without jeopardizing quality. There is the potential for a slew of legislative introductions to come following the lifting of the PHE to allow similar ability for pharmacists to provide vaccinations to children age 3-18 years old. However, this may not be the limit of the potential for change. With the overruling of state scope of practice, it calls into question why the service a healthcare professional can provide is dependent on where they practice. Maybe this will be the start of the conversation in the US for campaigns for standardized scope of practice for our healthcare team members? Only time will tell.

Final thought…Kudos to the advocacy work of our national pharmacy organizations for championing this win! If you have not already, give them some praise!

Senate introduces bill to expand pharmacists’ ability to provide telehealth services

On August 4th, U.S. Senators Chris Murphy (D-CT) and Roy Blunt (R-MO) introduced Senate Bill 4421: the Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act. As stated by Murphy’s and Blunt’s press releases, this bill “allows any health care practitioner or professional in good standing with a valid practitioners’ license to render services—including telehealth—anywhere for the duration of the COVID-19 pandemic.” This is the latest example of how the pandemic is going to have lasting permanent changes to the U.S. healthcare system.

Where is the current gap in care?

Prior to the pandemic, the provision of telehealth services across the healthcare continuum was limited. This was likely a result of telehealth services being reimbursed lower than the same service provided face-to-face as well as confusing rules and regulations. Some large medical centers had begun to support expansion of telehealth programs, however, there remained gaps in optimizing the use of telehealth. A big gap was in the rules and regulations that limited access to telehealth services, such as the fact that providers must be licensed in every state a patient is receiving telehealth services in, regardless of where that provider is practicing from.

Then the pandemic hit and we saw our healthcare system upended as we began to prepare for potential surges and spikes in cases. In the first months, primary care offices were unable to practice in the way that they always had. They were canceling appointments and patients did the same out of fear of risking themselves to an exposure. 98% of primary care offices saw a decrease in revenue and there was concern that many would close, further limiting access to care, especially for those that live in rural or medically underserved communities. 

Recognizing the potential long-term negative therapeutic consequences as a result of lapses in care, which could have further economic ramifications, CMS passed emergency rules and waivers to better compensate providers for telehealth services. This resulted in a boom in the utilization of telehealth by patients across the country. Some larger practices reported that their weekly percentage of telehealth visits before and during the pandemic went from 0% to 8.2%. Experts have predicted that telehealth will remain a more substantial piece of the healthcare marketplace in a post-COVID world. We have already begun to see this becoming a reality with the signing of executive orders and proposed rules from CMS to make expansions allowed during the public health emergency (PHE) permanent (read more about these expansions and how they apply to pharmacists here).

Despite these expansions, there remain issues with the provision of telehealth services. One of the biggest issues identified is that it matters where the patient and professionals are physically located when providing services. 

How will this bill fill this gap?

The TREAT Act does a few things that are notable and need to be discussed. Of course, the biggest is that it will allow for healthcare professionals to provide telehealth services to any patient as long as both of them are physically in the U.S. It specifically clarified that services can be provided regardless of if there is a prior relationship between the patient and the healthcare professional. 

From the perspective that this will be able to increase access to care, there are a lot of positives to this bill. Instead of being limited to your geographical area, healthcare professionals would have the ability to provide care to patients across the country. This would be incredibly important, especially for those that live in rural or medically underserved areas that previously may have had to travel a long distance to receive healthcare and may have been limited to utilizing telehealth services only if there was a previously established relationship. 

Another huge positive to this bill is not in what the bill does but in how the bill is written. Any health policy geek out there knows that when bills are typically written regarding what healthcare professionals can do, the term “healthcare professional” is often defined as referring back to the Social Security Act. We have already discussed that national provider status efforts essentially aim to add the pharmacist to this list of healthcare providers. What is different about the TREAT Act is that healthcare professional is broadly defined as an individual who “has a valid and unrestricted license or certification from, or is otherwise authorized by, a State, the District of Columbia, or a territory or possession of the United States, for any health profession, including mental health”. The all-encompassing language of how “healthcare professional” is defined means that this bill applies to pharmacists as well!

Where does this bill miss the mark?

Although there are positives to this bill, we have some logistical questions and are concerned with what is missing from the language. Despite the positives regarding access issues, what are the long-term hopes for the types of provider-patient relationships that may result from a completely virtual care experience? Will only acute services be offered that do not require an in-person physical examination? What if labs need to be drawn? A provider in Maine caring for a patient in Texas may not be familiar with local labs and the burden of those logistics may fall on the patient. If the patient is unable to solve such questions by themselves, this could result in providers making medical decisions without all the information they need. What if a referral is needed to be placed to a specialist? Providers often utilize their professional networks with local practitioners that they have referred to previously. This may be another logistical concern. Although these are some gaps, there would be plenty of opportunities for the private sector to step in to solve these issues through a lab/specialist referral interface. Although his bill would only be applicable during the current PHE,  we have seen so many rules and laws planned to be expanded beyond the PHE and this could have the potential of doing the same if it ends up being signed into law. Long term solutions to these concerns should be addressed from the beginning of implementation. 

Where else this bill misses the mark is in how it could impact the setting in which healthcare professionals practice. If bills such as the TREAT Act pass and telehealth continues to expand, some healthcare professionals may worry that their practice setting may resemble more of a call center rather than what they are traditionally used to. Although some healthcare professionals may not prefer this setting, healthcare businesses such as SinfoniaRx have embraced this model and use it to provide patient care to thousands across the country. Some healthcare professionals may not like the idea of practicing in a call center, but we should recognize that at the end of the day, we need to do what is in the best interest of the patient. If evidence supports that it means where we practice begins to change, then we should embrace what better helps our patients, not fight it because of personal preferences.

An obvious exclusion from this bill is any discussion on payment. This is likely because payment rules and executive orders for telehealth services are already in place and will likely remain in place following the lifting of the PHE. A gap remains for healthcare professionals that are included in the TREAT Act but are not listed under the Social Security Act (such as pharmacists), and thus still will not be able to directly bill for their services.

How can you advocate for or against this bill?

The TREAT Act has been referred to the Senate Committee on Health, Education, Labor, and Pensions. Currently the bill only has two cosponsors, but given the bipartisanship of those cosponsors, it has the potential to get some attention from other Senate members. At the time of the writing of this post, no pharmacy associations had come out in support or opposition of the bill, however, many other healthcare organizations had spoken out in support of it. Below is a selected list of supporters:

You can track the progress of the bill here. Click here to identify who your elected leaders are and here for communication templates to help let your legislators know your perspective on this bill.

Also, if you feel that the profession of pharmacy should take a stance on this bill, contact the elected leaders of the associations you are members of and ask for them to review the TREAT Act.

Racial Differences in COVID-19 and the Potential for Pharmacists

At the end of July, CMS published updated data on COVID-19 impacts on the Medicare population, including details on the American Indian/Alaskan Native Medicare beneficiaries for the first time. The new data indicated that this population has the second highest rate of hospitalization for COVID-19 among racial and ethnic groups after Blacks. The updated information further confirms the disproportionate effect the pandemic is having on vulnerable populations.  

It is not enough to note the differences, but to address why they occur. According to the CDC, there are several inequities in social determinants of health that put racial and ethnic minority groups at an increased risk of morbidity and mortality associated with COVID-19: discrimination; healthcare access and utilization; occupations; educational, income, and wealth gaps; and housing. With many Americans facing eviction and limited ongoing support for the unemployed, we will continue to see how these disparities are magnified during emergencies. 

While the press release did report that the CMS Office of Minority Health was hosting sessions to receive insight into ways in which CMS can address health disparities, no action has been taken. Regardless, it is crucial that all health care providers, including pharmacists, continue to address inequities in social determinants of health. Afterall, the first vow of the Oath of a Pharmacist is to “consider the welfare of humanity and relief of suffering my primary concern.”

In order to ensure fair access to health, specifically during the current pandemic, the CDC made recommendations for various groups, including the healthcare delivery system:

  • Ensure that chronic disease management and services to prevent illnesses are maintained and accessible
  • Increase availability and accessibility of COVID-19 testing for racial and ethnic minority populations and other populations that are disproportionately affected
  • Work with community health workers/promoters, healthcare providers, and patient navigators to connect community members with health resources
  • Increase engagement with trusted community and faith-based organizations and institutions that have relationships with local communities
  • Provide telehealth options that are tailored to the needs of patients
  • Ensure providers show awareness of and respect for culture when providing COVID-19 testing and care
  • Train employees at all levels of the organization to identify and interrupt all forms of discrimination; provide them with training in implicit bias
  • Increase language access and help adapt public health guidance to local circumstances so that health information and recommendations reach the people who need it the most

Pharmacists role in increasing access to testing

In a previous post, we discussed the gaps in testing for communities of color, namely Black and Latinx, and how pharmacists have the potential to significantly impact the rates of testing. Although pharmacists in every state can provide COVID-19 tests, unfortunately, implementation has stalled for various reasons, including access to testing kits, lack of information on where to send the kits for processing, and guidelines for reimbursement. There is enthusiasm for pharmacists to expand their role, as seen with significantly more pharmacies obtaining CLIA certificates. However, if the proper infrastructure is not in place for processing and payment, these barriers will inhibit pharmacists from being utilized as key players in improving access to testing. 

On the horizon: pharmacists to provide COVID-19 vaccines

Although a vaccine is not yet available, there is already concern that communities of color, who have historically been underrepresented in clinical trials and have deeper distrust for healthcare systems, may face greater barriers to obtaining the COVID-19 vaccination once it is available.  We do not need to tell you how important pharmacists are in increasing access to vaccinations for the general public, but the relationships pharmacists have with their patients will be even more critical to ensure widespread vaccination against COVID-19. Pharmacists may also consider partnering with other organizations in the communities, such as places of worship, to increase access to testing and vaccinations for these populations. 

Many questions still remain as vaccine development continues. Innovative models, such as pharmacy technician administration of vaccines, will need to be considered to ensure access to COVID-19 vaccines, while maintaining vaccination rates for other key illnesses, such as influenza. We suspect there will be more to come on this topic in future blogs (*insert shameless plug about subscribing to our emails here*). 

Pharmacist-led disease state management and addressing social determinants of health

Beyond testing and vaccinations, there is a significant opportunity for all pharmacists to improve chronic disease state management and provide patient-centered, prevention-based care, which incorporates recognition and addresses social determinants of health. 

Population health initiatives that target patients at highest risk for medication non-adherence or poor outcomes may be employed within local pharmacies and health-systems. Additionally, regular screenings for chronic diseases and education on the importance of preventing and appropriately managing these chronic diseases should be available within pharmacies and other easily accessible locations within our communities.

Outreach activities may include phone calls to patients with uncontrolled blood pressure or diabetes, or to patients prescribed multiple medications for a specific indication. At touch points between patients and pharmacy staff, specific questions can be asked to identify barriers to medication adherence, as well as addressing the factors that may impact a patient’s overall health and well-being. Acutely, unemployment and unstable housing may lead to limited medication and healthcare access. Although pharmacists may not be able to solve these problems directly on their own, screening tools may help identify the problems and help triage or refer patients to other resources in the community, such as Community Health Workers or mental health clinicians, for further assistance. Additional considerations, such as abbreviated public transportation schedules, may make it difficult for patients to get to the pharmacy to pick up medications. Medication synchronization programs or coordination of delivery of medications may help improve access. When applicable, pharmacists should continue to find ways to reduce pill burden and cost, and improve overall access to care. These recommendations may include optimization of medications, recommendations to improve disease control, and monitoring and health maintenance follow-up.  Pharmacists have an opportunity, or perhaps rather an obligation, to connect with their patients during this time in order to gain an understanding of their needs and help improve outcomes.

Unfortunately, policy change, including development and implementation of payment models (see our past blog post on the “why” behind provider status), are needed in order to ensure access to these pharmacist’s services for all people, especially our most vulnerable populations. Additionally, funding to support CDC and state and local public health agencies to provide public health infrastructure are crucial to combating the inequities of social determinants of health that impact many of our patients.

Pharmacist Medicare incident-to telehealth services here to stay?

It is no news that pharmacists are able to bill incident to a physician when providing patient care services. This has been widely discussed since the American Academy of Family Physicians (AAFP) requested clarification on this from CMS back in 2014. Despite this clarification, some pharmacists have still faced pushback on billing incident to the physician and there have been additional restrictions placed on the types of codes and level of service that pharmacists can bill incident to. 

An additional gap in pharmacists’ ability to bill incident to has been through the provision of telehealth services. However, with the pandemic we have seen an explosion in demand of telehealth services and quick rule changes allowing for non-physician practitioners (NPP) to bill incident to the physician through telehealth services. We saw Medicare provide further clarification around this during the pandemic detailing out that pharmacists can bill incident to for their telehealth services as well. While encouraging, these rule changes all had the provision that they would continue in effect through the public health emergency (PHE). Many pharmacists have been understandably concerned that once the PHE is lifted, they will no longer be able to bill for telehealth services, and patients will consequently lose access to care they have come to expect.

On August 3rd, President Trump signed an Executive Order (EO) that requests the Secretary of HHS to evaluate within 60 days the additional telehealth services offered for Medicare beneficiaries during the PHE, and propose a regulation to extend these measures beyond the PHE. In response to the EO, CMS specifically mentioned pharmacists being able to bill incident to a physician or other NPP as a service that it would recommend for continuation after the PHE. This is encouraging as we hope this means pharmacists will be able to continue to bill incident to for the telehealth services they are providing. CMS included similar language in its Proposed Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2021 as well, providing further confidence of the center’s prioritization of this in future plans. 

Although encouraging, we have discussed the need by our patients for pharmacists to directly bill for our services through recognition as healthcare providers under Medicare Part B. Billing incident to the physician and NPP with further expansion to the telehealth space is a step in the right direction, but still far off from where we need to be. There remains an opportunity to advocate for provider status language in the next COVID-19 legislative package. Check out our post here where we discuss ways you can take a few minutes to make a positive impact for patient access to care.

More will come soon as the Secretary of HHS releases their plan in the coming two months and we will likely see more health and pharmacy policy changes that will impact the practice of pharmacy.