The 2020 Presidential Election: Focusing on Health Care

8 days. That is all that’s left until the Presidential election. 8 days until millions of voters go to the polls and decide the future of this country on a variety of issues. But at the center of all of it will be health care. 

Note: We recognize that millions of voters have already voted early in this year’s election, breaking all previous records. Due to the record-breaking turnout in this year’s election, amidst a pandemic requiring additional precautions, if you can vote early please do so. Click here to find out additional information about how you can vote early. 

Each election cycle, health care is always one of the top three issues that voters most care about. This year is no different. According to the Pew Research Center, almost 70 percent of voters say that health care is important in determining how they will vote. And for good reason. The United States continues to grapple with a surge of coronavirus cases, reporting 80,000 new cases in one day last week, the highest one-day total of new coronavirus cases since the start of the pandemic. Furthermore, hospitalizations have increased in 38 states, undermining the argument that the increase in cases is simply due to an increase in testing. 

However, health policy in this election is more than just management of the COVID-19 pandemic. We’ve talked previously on the blog about how various COVID-19 centered policies will affect pharmacy and our patients, but in this post we wanted to focus more on the other significant health policy differences between President Trump and Former Vice President Joe Biden. Throughout this campaign, there are two key issues that both candidates have engaged each other on – The Affordable Care Act (ACA) and prescription drug prices. And while the two candidates have stark differences in their views on the future of healthcare in this country, there are surprisingly, some areas where the candidates agree. Like all things though, the devil is in the details. 

The Affordable Care Act and Health Insurance Coverage

President Trump

Let’s start with each candidate’s record on the ACA and their proposals for the future. President Trump campaigned in 2016 on the promise to “repeal and replace” the ACA. Although the ACA is still law four years later, the Administration has supported various efforts to repeal the law. On January 24, 2017, the President signed an executive order stating, “It is the policy of my Administration to seek the prompt repeal of the Patient Protection and Affordable Care Act.” It is important to note that Executive Orders cannot repeal existing laws. However, this order sent a clear message on what the President was going to focus on. Over the coming years, the Trump Administration supported various efforts by House and Senate Republicans to overturn the law such as: 

Each of these efforts inevitably failed due to public outcry and lack of unity amongst Republicans. The ACA still remains popular with 55% finding it favorable to 39% unfavorable. After failing to repeal the law outright, the Trump Administration then focused on eliminating some parts of the law through regulatory and budgetary changes. 

In 2017, President Trump signed the Tax Cut and Jobs Act, which reduced the individual mandate penalties to zero. This action has opened up a Supreme Court Challenge by the Texas State Attorney General in California v Texas. The case challenges the Supreme Court decision in the 2012 Supreme Court Case, National Federation of Independent Business v Sebelius, where the court upheld the individual mandate in the ACA as a part of Congress’s ability to tax. The plaintiffs here argue that since the individual mandate penalties are now zero, then the law is now unconstitutional and the law must be invalidated. The Supreme Court is set to start hearing oral arguments on November 10, 2020, one week after the election. The Supreme Court will also have 9 justices, pending the inevitable confirmation of Judge Amy Coney Barret, after Senate Republicans confirmed her, over Democratic opposition to the rushed process. 

In the absence of repealing the law, President Trump has sought to make it harder for people to get coverage through the ACA. His administration has eliminated cost-sharing reduction payments to individuals who purchase health insurance through the insurance marketplaces and make below 250% of the Federal Poverty Level (FPL). He has also shortened open enrollment and special enrollments for individuals who lose coverage and want to sign up for insurance through the exchanges outside of the normal enrollment window. He has also cut funding for assistance and outreach resources to help guide consumers through enrollment. And finally, the President has utilized a part of the ACA called Section 1332, which granted Innovation Waivers for States “to pursue innovative strategies for providing their residents with access to high quality, affordable health insurance while retaining the basic protections of the ACA.” Unfortunately, the Trump administration has provided waivers to states that provide coverage that deviate from ACA requirements. These changes have essentially weakened ACA protections for residents in states, and have caused 1.2 million Americans to become uninsured since 2016. 

For this election, the President has not laid out a clear health care vision for the future. Despite unveiling the “America First Healthcare Plan” he has done little to share actual goals. Instead the President has relied on broad statements without any specifics. For this post it was challenging to lay out what the President would seek to change going forward, but here is what we could discern as it relates to health insurance coverage. After repealing the ACA, the President says he wants to allow health insurance companies to compete across state lines as a way of reducing health care costs. However, without the essential health benefits and consumer protections required under the ACA, there is a chance that many of these new plans could end up like the Short-Term Limited Duration Health Insurance plans, otherwise known as “Junk Plans” that have flooded the market. 

Former Vice President Biden

Former Vice President Joe Biden has taken a very different position, arguing that the country needs to build off of the progress made under the Affordable Care Act. The biggest addition would be the development of a Public Option. 

Bidencare, as unveiled during the last Presidential Debate, would create a public option that would be available to all, including those individuals who currently reside in states that did not expand Medicaid. Remember, states were given the option to expand Medicaid eligibility and benefits to those individuals who were between 100 and 137 percent of the FPL, with greater federal financial assistance. For individuals who get coverage through the public option in non-expansion states, individuals would not be required to pay any premium and would be able to receive the full scope of Medicaid benefits. For states that have already expanded Medicaid, they would have the choice of moving the expansion population to the public option. These individuals would also not be required to pay any premiums, however states would have to agree to continue paying their portion of coverage for these patients. 

Biden’s plan also addresses how individuals get enrolled into coverage. Under his proposal, any individual making under 138% of the federal poverty level would automatically be enrolled in the public option whenever they interact with certain institutions like public schools or programs for low income populations like SNAP or TANF. In this way, individuals who would benefit from coverage won’t have to wait for enrollment periods to get health insurance coverage. 

Biden’s proposal also makes certain changes to existing ACA provisions. Specifically, his plan calls for expanding premium subsidies for individuals who make below a certain income level. Currently, the ACA calls for Advanced Premium Tax Credit (APTC) subsidies to be made available to individuals making below 400% of the PFL. Biden’s proposal would eliminate this cap and would focus on limiting the cost of coverage based on an individual’s income level. The plan calls for lowering the limit on insurance costs to 8.5% of income, over the 9.86% that is currently the policy under the ACA. Essentially this would mean that no family who buys coverage through the federal or state exchange, would pay more than 8.5% of their income on health insurance, regardless of income.

It’s important to note that while Biden’s plan does not call for a cap on income for APTCs, several bills proposed by Democrats that are currently in Congress call for a cap at around 600% of the FPL. 

Biden’s proposal also would reinstate funding for consumer enrollment assistance that had been cut under the Trump Administration. 

Prescription Drug Prices

When it comes to prescription drug prices, there are more similarities between the two candidates than there are with the ACA and health insurance coverage.

President Trump

President Trump has spent a lot of the last few years focused on lowering prescription drug prices. As a candidate in 2016, Trump blasted the pharmaceutical industry for setting prices so high, and promised that Americans would pay prices similar to what other countries pay overseas (Ironically, many of these countries have prices that are negotiated by the federal government, something the Trump administration and Republicans have refused to do). 

While the Trump administration has been incredibly vocal on this issue, most of what has been proposed has not been enacted, either due to a delay in issuing federal regulations, challenge in the courts, or waiting to be implemented. 

Early on, his administration signed S. 2553, the Know the Lowest Price Act of 2018, which was a huge win for pharmacists. The law prohibited “gag clauses” that prevented pharmacists from telling patients that they could pay less for prescription medications if they opted to pay for them out of pocket instead of going through their prescription insurance. This was certainly a victory for the profession, as this was something we had been advocating for as a way to promote transparency for patients.

President Trump also signed the Bipartisan Budget Act of 2018, which helped close the Medicare Part D coverage gap, or “donut hole” faster than what had been laid out in the ACA. The President has also focused on reducing costs for Part D beneficiaries by capping insulin copays for some beneficiaries, though this is expected to take effect in 2021. And finally, this summer, President Trump signed executive orders allowing for the importation of prescription drugs. The FDA issued guidance last month on what this proposal would look like. The rule has caused a bit of controversy regarding safety standards and whether the importation of the smaller Canadian drug market, would be enough to significantly impact prices in the American market. 

President Trump has also proposed other policy changes that we think would be the basis of a plan in a second term. Specifically, he has called for limiting prices for certain medications to those charged in other countries.He has also called for capping out-of-pocket drug costs for Part D beneficiaries, and has ordered $200 copay cards to be sent to seniors to help them limit out-of-pocket costs. This move is currently being challenged, with many government officials saying that doing so this close to an election would not be legal. 

President Trump has also sought to promote transparency when it comes to letting consumers know how much medications will cost. He has proposed requiring drug companies to disclose list prices in TV advertisements, though this proposal is currently being blocked in a federal court. He has also taken up an issue that the pharmacy profession has rallied behind, which is banning rebates paid to PBMs, starting with Medicare. 

Former Vice President Biden

Former Vice President Joe Biden has also focused much of his platform on reducing prescription drug costs, though his proposals would empower the government to be actively involved in these steps. His plan would create new government rules in order to set the price of prescription medications. 

Specifically, Biden has called for letting the federal government directly negotiate drug prices for Medicare and other federal purchasers. This would put the US on par with many other countries that also negotiate prices with pharmaceutical companies. Biden would create an independent review board to help set the price of new drugs, based on the price of the medication in other countries. This is incredibly similar to President Trump’s proposal, although it would allow the Independent Review Board to take in additional factors to set the negotiated price. Biden and Trump also agree on other ways to reduce drug costs such as capping out-of-pocket costs in Medicare Part D and allowing the importation of prescription medications, provided certain safety guardrails are in place. 

Biden also wants to focus on reining in how fast drug prices can be increased each year, limiting price increases for all brand, biotech, and high cost generic drugs to the rate of inflation as a condition for these medications to be included in Medicare and the Public Option. Since the federal government is a significant payor for prescription medications, this could mitigate some of the egregious causes of price hikes that we had seen in years past like with Epipen and Daraprim. Finally, Biden’s proposal calls for removing tax breaks that pharmaceutical companies currently receive for money spent in advertising. 

What’s At Stake

We hear it every four years, but this election will be one of the most consequential elections of our lifetimes. In the middle of a raging pandemic that has killed over 225,000 people in this country alone, both candidates have drastically different views on how they would manage the next phase. 

This year’s ballot is more than just two candidates or two political parties. It’s more than just policy differences. This year’s ballot is about what the future of health care will look like in this country. It’s about whether or not we believe that health care is a fundamental right for all people. It’s about whether we want to ensure that when you get sick, you will be taken care of, without having to worry about how you will pay for it. It’s about ensuring that our patients don’t go bankrupt trying to afford a treatment or medication that will save their lives. It’s ensuring that women continue to have access to the reproductive care that they need without being discriminated against and being forced to pay higher costs. It’s ensuring that regardless of your age, race, gender, sexual orientation, or previous health status that you have the ability to get the kind of care you need, when you need it. 

What’s at stake is what health care means to all of us as a nation. 

The election is right around the corner. Make sure you vote. 

Photo by cottonbro on Pexels.com

For more information on how to vote click here

For more information on the differences between the candidates see the links below: 

Pharmacists tapped to provide COVID-19 vaccine in nursing homes

Late last week, the Centers for Medicare and Medicaid Services (CMS) made two surprising announcements. First, a press release was sent out that CMS would not be enforcing provider restrictions for the administration of the anticipated COVID-19 vaccine in skilled nursing facilities (SNF), specifically referencing pharmacists. Following this press release, a second announcement shared the collaboration of CVS and Walgreens in the administration of the COVID-19 vaccine in long-term care facilities (LTCF). This week, we break down these announcements, what they mean, and the potential implications they may have.

Summary of the announcements and what they mean

The first announcement is relatively brief in length. The main purpose of this announcement is to share that CMS recognizes pharmacists as key providers of vaccinations and that patients living in LTCF are particularly vulnerable to COVID-19. Surprisingly, CMS highlights a key talking point of pharmacist provider status efforts for the past decade, that reimbursement for services is necessary to expand access to certain care. With this realization, CMS states that they will “exercise enforcement discretion” in order to “facilitate the efficient administration of COVID-19 vaccines to SNF residents”. With pharmacists already granted the authority to administer all CDC recommended vaccines to people above the age of 3 during the public health emergency, this opens the door for pharmacists to be reimbursed by CMS for the administration of the COVID-19 vaccine for LTCF patients once it is approved. The press release states that “CMS will allow Medicare-enrolled immunizers, including but not limited to pharmacies working with the United States, to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare SNF residents.” 

It is curious that pharmacies working with the U.S. are specifically called out rather than highlighting the individual practitioner, such as the pharmacist. This specification makes more sense as one reviews the next announcement of CVS and Walgreens collaborating to administer the COVID-19 vaccine to patients at LTCFs. In this second press release, The Pharmacy Partnership for Long-Term Care Program is introduced as a part of Operation Warp Speed (OWS). As a reminder, OWS is the current administration’s plan to operationalize the efficient distribution of the COVID-19 vaccine.

A key point of this announcement is that there will be no out-of-pocket costs to receive a COVID-19 vaccine by a pharmacist at a LTCF. This ties back to CMS’ first announcement that they will be exercising enforcement discretion of provider restrictions at LTCF to allow pharmacists to be reimbursed by CMS. Involvement in this program is not a requirement of LTCFs. Starting on October 19th, LTCFs can opt-in to participate once the COVID-19 vaccine is available. Additionally, it does not appear that pharmacist involvement is limited to those employed by CVS and Walgreens as it is stated in the second press release that LTCFs “can request to use their current pharmacy contracts to support COVID-19 vaccination.”

Potential implications

These announcements are a big deal for primarily two reasons. It is no surprise that pharmacists are being discussed as key providers of care at this time in the pandemic. Pharmacists have continued to come up in important discussions to provide vital healthcare services throughout 2020 due to their expertise and high accessibility by the public. These announcements are a big deal because it continues to highlight the importance of pharmacist provided care, especially in the response of public health emergencies. 

However, with the focus of only two employers of pharmacists (CVS and Walgreens) to provide COVID-19 vaccines in LTCFs, one could question how this contained involvement could limit patient access to this vital vaccine. One of the primary questions that can arise when reflecting on the implementation of this policy is why CVS and Walgreens are only discussed. We could speculate that CVS and Walgreens locations may not be readily accessible to all LTCFs in the U.S., but we would rather let the data talk for itself. We pulled public domain data of LTCFs available from CMS and data on current pharmacy locations available from Homeland Infrastructure Foundation-Level Data (HFILD) to create a series of maps to show where LTCFs are located in the U.S. and where CVS and Walgreens pharmacies are located. 

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 Above shows locations of LTCFs in the U.S according to CMS.

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Above shows locations of CVS (green) and Walgreens (pink) pharmacies in the U.S according to HFILD.

One can observe there is a stark difference in the location of LTCFs as compared to where CVS and Walgreens pharmacies are located. Unsurprisingly, we observe that CVS and Walgreens are primarily located in urban areas, which could leave LTCFs in rural areas with limited access to pharmacist provided COVID-19 vaccines. To exemplify this difference let’s take a look at a specific state example, Colorado:

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Above shows the location of LTCFs in Colorado according to CMS.

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Above shows the location of CVS (green) and Walgreens (pink) pharmacies in Colorado according to HFILD.

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Above shows the locations of all pharmacies in Colorado according to HFILD.

One can see that CVS and Walgreens pharmacies are located primarily in urban areas, whereas other pharmacies are more accessible in the rural communities, where additional LTCFs are located. With the focus of this partnership between pharmacists and LTCFs, it would make more sense to open this opportunity up to all pharmacists rather than limiting it to those employed by CVS and Walgreens in order to ensure all LTCF patients receive this vital vaccine. It is unclear the requirements for pharmacists outside those employed by CVS or Walgreens to partner with a LTCF to provide the COVID-19 vaccine. As details are released regarding this program, if barriers are presented to these pharmacists, consider contacting the U.S. Department of Health & Human Services, CMS, and your elected leaders. As can be observed from these geographical locations, we need all pharmacists on board ready to provide this care, not just a select few. If you are interested in learning more about where LTCFs are located in relation to CVS and Walgreens pharmacies, check out our interactive maps at the end of this article.

The second reason that these announcements are important is because CMS has highlighted both the importance of reimbursement for services and pharmacists in a statement together. One could take this as proof that advocacy is working. For years, pharmacists, students, and other advocates for the profession of pharmacy have shared with elected leaders the challenges surrounding the current reimbursement model in pharmacy. The original tying of reimbursement to a product has resulted in challenges as the roles and responsibilities of the profession have evolved to be more focused on the provision of patient care services. As the sustainability of a dispensing foundation business model has begun to shake in current years, members of the profession have advocated even harder for the shift of the pharmacist business model to be more tied to the services being provided rather than the products. 

Although it is a small step to only be reimbursed for the provision of a COVID-19 vaccine in a LTCF during the public health emergency, it is a step, nonetheless. We have discussed throughout this blog, the power of incremental change rather than the expectation that one bill should accomplish everything. What we as a profession must do at this moment is not turn our backs on this opportunity. This is the chance for the pharmacist to show the therapeutic and economic value associated with the care we provide. Elected leaders will be watching and how the profession responds could have a direct impact on future legislative efforts.

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

It’s been a while since we posted in our Provider Status Explained series because of all that has been evolving in the quickly changing world of health policy. We now want to come back to continue our discussion on one of the most important legislative priorities for the patients of pharmacists and the pharmacy profession: provider status. As a reminder, we started this series with a discussion around why pharmacists need provider status. We then began evaluating how we could achieve provider status at the federal level. Now let’s move on to the states, where things are moving much more quickly!

Medicaid

Just as we had described with the federal legislative strategy, efforts on the state level have largely revolved around the public health insurance system, Medicaid. As a refresher, the Medicaid system was established at the same time as Medicare with the signing of the 1965 Amendments to the Social Security Act. While the role of Medicare was to be a federally-funded public health insurance system primarily for the elderly, Medicaid’s role was to be a federal- and state-funded public health insurance system for those with low incomes, children, pregnant women, and people with disabilities. Where the funding comes from is vitally important in understanding how these systems are regulated. Being a completely federally-funded program, decisions on how Medicare is run are made by Congress. Alternatively, the fate of Medicaid and many of the decisions around it are largely in the hands of state lawmakers. You may jump to the conclusion that this is because funding for the programs primarily comes from the states, but this is not true, as you can see from the below map.

A close up of a map

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Despite the fact that only one state pays a majority of Medicaid funding (50.1% in Virginia), state lawmakers and regulators largely control the day-to-day operations of the programs, such as deciding which types of providers can enroll. This is where provider status comes in to play, and why efforts to gain provider status are focused on reaching out to your local legislators. Not as simple as the Social Security Act, where pharmacists only need to be added to the list of eligible providers, state law can be a bit messier. Some states may already recognize pharmacists as providers in some pieces of their law, or states may not recognize them at all. State-level provider status will require a consistent definition of a pharmacist as a provider through rules and laws in order to allow for them to be reimbursed by health insurance companies and Medicaid. 

It is important to note, though, that the federal government is not completely out of the picture when it comes to Medicaid. They don’t just hand over up to 79% of a department’s budget without providing some oversight. Because of the complexities and opaqueness of the Centers for Medicare & Medicaid Services (CMS), as more states pass provider status, we do not know how or if CMS will react and flex their oversight muscles.

Budgetary considerations are important to understand because opponents of provider status may bring up cost implications to adding another provider to the Medicaid system. Although research, such as the Asheville Project, shows that when pharmacists provide patient care services, insurance claims eventually go down, opponents may suggest that the addition of an entire class of new providers will increase costs to the state. We are unsure of the liberty that states have with their federal funding, but if there was a place it may make sense for the feds to flex their oversight, it would be with how states specifically use their funds. And, as we know, the feds have not come around yet to the idea of the pharmacist provider. That leaves the state to deal with these potential additional costs. Due to the fact that nearly all states are required to pass a balanced budget, if a cost is added, that means either something has to go, or taxes must be raised. It is important to be prepared to address these concerns when you are advocating to state lawmakers and explain the positive therapeutic and economic value of pharmacist-provided patient care services.

The typical state story

Alright, so just like with the federal strategy, now we understand more behind how the state laws and rules have to change and basics of the complex Medicaid funding system. Let’s take a look at some states that have passed provider status and how they did it. Two of the most prominent states to pass legislation early were Washington and California. In both states, pharmacists and state associations worked effectively with their state lawmakers to pass initial legislation that recognized pharmacists as providers. However, once it was passed, they seemed to hit a wall. The laws recognized pharmacists as providers, but there was no mandate that insurance companies had to pay for the services pharmacists were providing. Many other states have also passed provider status and hit this same roadblock, ending up locked in negotiations with payors that say they are not required to pay, so why would they start?

California and Washington both went down the path of additional legislation. Going back to their state lawmakers, they were able to make the argument that the legislature’s intent with provider status legislation was not only to recognize them as providers in name, but to actually compensate pharmacists for their cognitive services. Both were able to pass additional legislation requiring payors to begin credentialing and paying pharmacists for their services. Washington’s language in this bill is generalizable, which is strong policy that can apply to new situations as the profession evolves. California’s is more specific, listing types of services that can be reimbursed, which means that every new service that pharmacists want to be paid for will require legislative or regulatory action. 

And this is where most states are, hanging somewhere in between either passing provider status or passing legislation that would require reimbursement. However, one state has recently been different in their efforts to implement provider status. After passing provider status in January 2019, Ohio has had success in starting initial programs with Medicaid Managed Care Organizations (MCOs) to pay pharmacists for their cognitive services and the Medicaid Department is planning to enact rules in January 2021 to begin credentialing pharmacists as Medicaid providers. This has all happened without the passage of an additional law mandating reimbursement because of advocacy and public optics. Around the same time that provider status was passing, it was coming to light in Ohio that $244 million was unaccountable in the state budget as a result of the Pharmacy Benefit Managers (PBMs) working underneath Medicaid. There was ample media coverage of this by local news sources, which eventually led to them discussing more issues around pharmacy and provider status. We’ve explained previously on the blog the incredible importance of public advocacy. Well, all of this bad PR around PBMs and Medicaid made the MCOs in the state look around and raise their hand and say, “Actually, we want to work with the pharmacists.” As these programs continue to roll out, there could be nationwide implications and less of a need for future states to have to pass additional legislation to mandate reimbursement by payors after provider status is passed.

The question of OLP and SPA

As states have continued to pass provider status legislation, some have made the argument that an additional step needs to be taken in order for pharmacists to be enrolled as eligible providers that will be approved under CMS. Other Licensed Practitioners (OLP) are defined in rule 42 CFR 440.60 of Medicaid regulations. These are the rules that define non-physician practitioner services in Medicaid. Some have made the argument that in order for pharmacists to be enrolled as Medicaid providers, states must submit State Plan Amendments (SPA) to CMS in order to add pharmacists to the list of OLPs for the state. So far, five states have submitted SPAs and been approved under OLP rules to add pharmacists. In addition to OLP, other states have also added pharmacists as providers under Medicaid under other regulations using SPAs.

There is not much information out there regarding OLP, and it does not seem to be a requirement, as states such as Washington and Ohio do not have an approved SPA. The full necessity of OLP will need to be evaluated and clarified in the future.

Tipping of the scale

As we can see, the strategy to add pharmacists as providers under Medicaid compared to Medicare has some similarities and stark differences. Both require legislative and regulatory changes; however, states have had far more success even with incremental legislative victories in the past decade as compared to Congress. Although budgets need to be considered in both state and federal advocacy, because nearly all states have a mandate to pass a balanced budget, this adds another level of complexity.

In the past, following the passage of this legislation, there has been a need to pass additional laws to mandate health insurers to pay pharmacists. However, we have seen from recent examples that this may no longer be a requirement. 

When there is not enough political will to move legislation in Congress, and as more states pass similar laws, eventually there can be a tipping of the scales and national action may be taken (as happened with  the women’s suffrage movement). We should recognize how success on the state level could further influence the action of national legislation. State-level lawmakers are often more accessible than your members of Congress, so reach out and keep advocating for change on your state level. This could be the change we need to tip the scales and move forward with the federal legislative strategy for provider status!

So far, we have unpacked the “why” of provider status, and how provider status can be accomplished on the national and state level. Next on the Provider Status Explained series, we will delve into what you can do to advocate to your legislators and the public to be recognized as providers!

The Future of the Supreme Court of the United States and Healthcare

With the passing of Justice Ruth Bader Ginsburg, feminist icon and inspiration to many, the future of many healthcare issues are uncertain. The Supreme Court of the United States serves to protect the rights and liberties of the American people and utilizes the Constitution to ensure “Equal Justice Under Law.” Although the precedent was set in 2016 to delay nomination of a Supreme Court Justice until after the election and inauguration during an election year, the Trump Administration and Republican Senators are working diligently to get their nominee, Amy Coney Barrett, confirmed faster than ever done in the past. The future makeup of the Supreme Court will have lasting effects on our communities, patients, and healthcare. 

The Supreme Court has made countless rulings in the past that impact the profession of pharmacy and the patients of pharmacists’ access to healthcare. Much of the profession has been focused on the Court in recent months as anticipation over Rutledge v. PCMA grows. However, arguably more pressing is the future of the Affordable Care Act (ACA), and if the healthcare of patients that pharmacists care for is put in jeopardy. This week, we breakdown the possible consequences to patient access to healthcare as a result of changes to the court.

Brief Rundown of the Current Supreme Court of the United States

The Chief Justice is John Roberts, who, although conservative, has voted against the Trump administration on multiple issues.

The Future of Our Patients’ Rights and Healthcare

The addition of another conservative justice to the Supreme Court makes the future of various healthcare issues uncertain, including immigrants’ rights and potential repeal of DACA; women’s rights and reproductive rights, including possible overturn of Roe vs. Wade; and LGBTQ+ rights, including elimination of protections for these individuals. And, of course, the future of the ACA is at the forefront of the discussions. 

It is not yet confirmed if Amy Coney Barrett, who President Trump has chosen to fill the void left by RBG on the court, would consider the entire ACA invalid if the individual mandate is determined to be unconstitutional. Indeed, we can’t say for sure how a Justice Barrett would rule on many of the issues that may affect our communities and patients. However, Barrett has been on record numerous times criticizing the ACA. She has also signed a newspaper advertisement that referred to Roe vs. Wade as “barbaric” and has shown hostility towards LGBTQ+ rights. After the announcement of her nomination, Barrett stated of the late Justice Antonin Scalia: “His judicial philosophy is mine, too.” Can we assume she will align with her mentor’s previous stances on these issues? In addition to these known issues affecting public health, the Supreme Court may begin to hear cases in the next term related to the pandemic, which could lead to decisions that change the way we handle response to public health emergencies for years to come. 

As the possibility of the Supreme Court leaning even further right and the threat of overturning the ACA become more real, it’s important for pharmacists to understand what changes could come.

The Future of the Affordable Care Act

The future of the ACA remains uncertain, as arguments for Texas vs. US are scheduled to begin a week after the election. This case challenges the individual mandate, or the minimal essential coverage provision. The result of this decision calls into question whether or not the entire law will survive if the individual mandate is deemed unconstitutional. There are a few possible outcomes, all of which would result in different severity of effect on our patients and communities.

1)    There is no standing for the lawsuit, and the ACA would remain to exist as it does today (low likelihood pending the makeup of the Supreme Court).

2)    Individual mandate is unconstitutional, which invalidates only that provision. This would leave the rest of the ACA intact with the only change being that there is no enforceable mandate requiring all individuals to maintain a minimum level of health insurance coverage.

3)    Invalidate individual mandate and protections for people with pre-existing conditions. This would result in federal funding for premium subsidies and the Medicaid expansion to remain intake, but states would have to determine whether or not to reinstate protections. 

4)    All or most of the ACA is overturned. This would result in overturning the significant changes the ACA made to the individual insurance market, including requiring protections for people with pre-existing conditions and authorizing premium subsidies based on income, as well as expansion of Medicaid eligibility, coverage of preventative services, and establishment of national initiatives to promote public health, care quality, and delivery system reforms. 

You may be asking yourself, what can I do to ensure protection of my patients now and in the future? First, it is important to stay informed on these topics (click here to sign up to receive regular communications from The Grassroots Pharmacist). Second, utilize resources available to contact your elected officials. Examples of advocacy resources are available on our website, and additional resources are available from the American Public Health Association. Additionally, getting involved at the local level to protect individual rights is a good step to helping protect your patient’s rights for years to come. This may be in the form of volunteering or donating to local civil rights organizations. Finally, although the timeline of the confirmation hearings is now questionable with multiple Senators testing positive for COVID-19 and remaining in quarantine, you can still urge your Senator to delay the appointment of a new Supreme Court Justice until after the election and inauguration. Communicate to them that it is in the best interest of our patients and profession to ensure continuity of the ACA and thus protections to our patients access to healthcare, along with following the precedent set in 2016.

Presidential Debate Recap for Pharmacists

On Tuesday night, the candidates faced off for the first time to discuss healthcare, COVID-19, and other important issues impacting the healthcare system. Vice President Joe Biden and President Donald Trump met at the Cleveland Clinic, in Ohio in a heated exchange in which both candidates were rarely able to provide a complete statement without being interrupted.

Unfortunately, most of the discussion from both sides seemed more focused on getting in quick one-liners without much substantive discussion on the serious policies that will impact the citizens of the country. As we have discussed previously on the blog, nearly all policy issues can be tied back to impacting healthcare or public health. However, we will be focusing on the specific discussion on direct healthcare issues important for pharmacists and do our best to illustrate where the candidates stand on these important policies. Let’s focus on healthcare, the response to COVID, and systemic racism.

Healthcare

Biden

Biden’s message, when he was able to complete a sentence, was that his healthcare plans for the country are to expand public health insurance options for vulnerable communities in the country. When asked if his healthcare plan would result in the dissolving of private health insurance companies, Vice President Biden responded that they would be expanding Medicaid, and that the vast majority of people would remain on their private health insurance. This seems aligned with how Biden has described his plans in the past, in that his goal is to build upon the Affordable Care Act and expand access to healthcare for the uninsured and underinsured.

Trump

During the section of the debate on healthcare, President Trump was requested to explain what his plans are for how he would improve the healthcare system. Responses were largely claims that healthcare would improve under his leadership, but detailed policy recommendations were not provided. On the topic of the price of medications, Trump provided a similar explanation that prices would come down, without providing a clear explanation as to how this would be accomplished. When pressed on this issue he explained that insulin would be a comparable price to water, once again without providing detail on how this would happen.

This section of the debate took a dovetail into the pandemic, with Biden stating Trump’s actions during the pandemic, “ has cost 10 million people their healthcare because of his recession.”

COVID

Biden

During much of this section, Biden transitioned to be more on the attack rather than providing policy recommendations on what would be done differently. Statements such as, “The President has no plan” were the primary themes weaving throughout his statements. When discussing what would be done differently, or would be done if he becomes President, recommendations were vaguely worded, such as, keeping businesses and schools open and funding what needs to be funded in order to save lives.

One of the most clear statements said during this section was Biden’s support of wearing masks and following public health recommendations to minimize the spread of the virus. Biden paraphrased Trumps CDC Director, that if the American public wore masks between now and January, 100,000 lives would be saved. 

Trump

Trump continued in this section to jump from one vague argument to another, while largely being focused on how media coverage of the administration’s response has been unfair. In a surprising turn to detail, Trump did provide some direction on Operation Warp Speed and what the administration has done to overcome manufacturing inefficiencies once a vaccine is discovered. He mentioned the military is prepared to administer 200,000 vaccines per day, supporting plans which have outlined that the military will be a primary access point for this key preventative healthcare measure.

Racism

Biden

Not much fruitful discussion was had on the topic of racism from either candidate. When asked point blank on his perspective on racism as a public health crisis and ties to police brutality, Biden expressed that we currently have a system in which racial insensitivity exists and that we must work towards one where we better hold people accountable.

Trump

Trump’s comments were largely focused in response to why he banned sensitivity training on racism. In response to these questions, Trump explained that he believed these trainings were racist, radical, and teaching people to hate the country.

“So let’s try to be serious about this”

Chris Wallace’s quote during the debate, which served as an attempt to ask both candidates to be respectful of one another, seems to be the overarching theme of the night. America showed up tonight to listen to a serious policy discussion and unfortunately, more focus was on making accusations of one another than seriously evaluating the policy differences of either candidate. As pharmacists, we need to understand the health policy positions of who we vote for because not only will the policies of the next President impact our ability to provide care, but it will impact our patients ability to access that care. More information on the policy positions of either candidate can be found on their campaign websites, along with what is reported on reputable news sources.

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.