Supreme Court Case 18540: Rutledge v Pharmaceutical Care Management Association – Guest Writer John Little

For many years, the business practices of Pharmacy Benefit Managers (PBMs) have been scrutinized, since they often limit patient access to medications and have significant impacts on community pharmacies. Research shows that PBMs cause prescription drug prices to increase, which is exactly the opposite of the role they were designed to have. They do this primarily through (1) spread pricing, which is when PBMs bill the insurance plan for a higher amount than the PBM actually paid the pharmacy, and (2) DIR fees, which are assessed when a PBM evaluates a pharmacy’s performance on certain, ambiguous quality measures and subsequently takes money back from a pharmacy claim previously processed. When these PBMs fees cause pharmacies to close, patients in those communities lose a valuable healthcare provider who knows them and cares about their needs. 

In 2015, Arkansas’ state legislature passed a law, Act 900, which attempted to reign in many PBM practices, namely:

  1. Requiring that PBMs reimburse pharmacies at or above the wholesale costs of drugs
  2. Requiring PBMs to update their Maximum Allowable Cost (MAC) lists more frequently
    • MAC is the maximum amount that a payer (PBM) will pay a pharmacy for a specific medication. These lists vary state-to-state and can change often.
  3. Prohibiting PBMs from reimbursing PBM-affiliated pharmacies more than they paid other pharmacies
  4. Creating a reasonable administrative appeal procedure including telephone number, email address or website for the purpose of submitting administrative appeals
  5. Allowing pharmacists/pharmacies to decline to provide the pharmacist services (decline to dispense) to a patient if the pharmacy is to be paid less than the pharmacy acquisition costs based on the MAC list

The critical question of Rutledge v PCMA is whether or not the Employee Retirement and Income Security Act of 1974, commonly referred to as ERISA, preempts Arkansas’ Act 900. Let’s start by breaking down ERISA.

ERISA

ERISA was enacted to set minimum standards for private employee benefit plans, specifically pension and health plans, and to protect the beneficiaries in these plans. ERISA requires the plan to inform beneficiaries about the plan features, follow certain procedures such as establishing an appeals process for patients to use if the medication they need is not covered, and act in the best interest of the beneficiaries. Furthermore, ERISA helps guarantee benefits to the beneficiary if the plan is terminated, such as if the company goes bankrupt or if the employee loses their job. To avoid multiple regulations concerning employee benefit plans, Congress included ERISA preemption of any state laws. By doing so, ERISA regulates employee benefit plans as a federal concern and establishes a nationally uniform administration of employee benefit plans. ERISA applies whether the plan is fully funded or self-funded, meaning whether the employer pays the insurance company a fixed premium or only for submitted claims, respectively. ERISA does not apply, however, to non-private plans, such as those set up by government agencies or churches.

For many years, PBMs have maintained that any state laws attempting to regulate PBMs are preempted by ERISA due to a phrase in ERISA section 514a that states that ERISA preempts state laws insofar as they relate to any employee benefit plans. Interpretation of this phrase, in particular the words relate to, is the main reason why lower courts have had trouble with PBM regulation laws and interpretation of this statute is central to this case. 

Oral arguments are heard

On October 6th, oral arguments for this case were heard by telephone in the Supreme Court. Arkansas’ Solicitor General, Nicholas Bronni, began the oral arguments (on behalf of Arkansas Attorney General Leslie Rutledge) by providing 3 reasons why Act 900 is not preempted by ERISA:

  1. Act 900 doesn’t regulate benefits. Act 900 regulates what the PBM pays the pharmacy for drugs that a plan has already agreed to cover.
  2. Act 900 doesn’t regulate plan administration. Act 900 regulates PBM reimbursement practices which plans neither control nor are even aware of, as PBM-Pharmacy contracts aren’t even shared with the plan.
  3. Act 900 doesn’t discriminate against ERISA entities. Act 900 applies to both ERISA plans as well as non-ERISA plans. 
Diagram, timeline

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General Bronni focused his argument around the fact that Act 900 regulates the PBM itself, not the health plan. General Bronni argued that ERISA was designed to regulate the health plan-beneficiary relationship, and Act 900 in no way regulates that plan-beneficiary relationship. This is an important distinction because attempting to regulate the health plan would certainly be preempted by ERISA because that would impact the plan-beneficiary relationship. General Bronni made clear that Act 900 is simply “rate regulation,” the rate here being the amount paid by the PBM to the pharmacy. He acknowledged many times that regulation of PBM’s payment to pharmacies could indirectly raise the cost of medications to patients if the PBM decides to pass along the associated costs to the plan, and the plan then changes what percent of copay their beneficiary would have to pay. 

Timeline

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A pivotal factor that came up in the questioning is whether or not the PBM’s payment to pharmacies is “central to plan administration.” This is relevant because if it were central to plan administration, then that would interfere with the plan-beneficiary relationship. General Bronni repeatedly emphasized that the payment is not a central function of plan administration, as was established by the Supreme Court in New York State Blue Cross Plans v. Travelers Insurance Co, commonly referred to as Travelers, in which the Supreme Court Ruled that payment to a service provider is not central to plan administration. Later, Assistant Solicitor General of the United States Fred Liu also addressed this point, saying “From the plan perspective, pharmacy reimbursement is simply a matter of costs. As this court’s decision in Travelers make clear, cost isn’t a central matter of plan administration.” 

The Justices also brought up a Supreme Court case from 1996, Gobeille v. Liberty Mutual Insurance Co. in which Vermont tried to regulate a third-party administrator by implementing some reporting and recordkeeping requirements. In this case, the Supreme Court ruled ERISA indeed preempted this Vermont law attempting to regulate a third-party administrator. Justice Gorsuch asked General Bronni why, if reporting and recordkeeping of plan administration are preempted, Act 900 shouldn’t be preempted. General Bronni explained that ERISA contains provisions that explicitly detail reporting and recordkeeping, so clearly ERISA was designed to regulate this. 

Another important factor is the question of whether or not Act 900 creates potential for lack of uniformity across states. Assistant Solicitor General Liu responded that all state laws create some potential for lack of uniformity, so the question becomes, is the lack of uniformity in an area that ERISA cares about? If the law is a central matter of plan administration, then ERISA applies. If it is not a central matter of plan administration, then ERISA doesn’t apply. General Liu pointed directly to the wording in ERISA, saying that the infamous line “the provisions of this subchapter and subchapter 3 shall supersede any and all state laws insofar as they may now or hereafter relate to any employee benefit plan” specifically refers to what is outlined in those subchapters. Liu’s point is that if it isn’t specifically outlined in the ERISA chapter, then it is not a central matter of plan administration.

PCMA responds

Lawyer Seth Waxman, representing Pharmaceutical Care Management Association (PCMA), focused his arguments on how Act 900 would allegedly bind plan administrators to certain choices and make uniform national administration impossible, which ERISA sought to prohibit. 

Timeline

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On the lack of uniformity issue, Mr. Waxman stated that the requirement for regular updates to the MAC lists across all states with different requirements for updates would be too complex to keep up with. This uniformity theme is also what Mr. Waxman based his argument for what the relates to term, as mentioned above in the ERISA section, should be interpreted to mean. He said that if a law interferes with nationally uniform plan administration then it must relate to ERISA preemption.

Many justices caught on to the paradoxical situation that basically anything could relate to an ERISA plan. Upon rebuttal, General Bronni addressed this by showing that if the court prevented any costs that relate to plan administration, then even minimum wage laws (as one example) would be preempted. 

The impact on pharmacy and patients

The impact that Rutledge v PCMA could have on pharmacy, and on patients, is enormous. First, it should be noted that although there might appear to be a clear “winner” in terms of whether or not Act 900 is legal, there is much more to it than that. Depending on how the opinion is written, this case could set precedent for many similar PBM regulations to occur in other states. For example, the justices could create new rules that apply to anyone paying a pharmacy, whether a PBM or true health insurer. They could also declare the ERISA statute unconstitutional, which would create a need for Congress to amend the language. They could make rules that effectively make the MAC list obsolete and thus require PBMs to totally reimagine how they price and reimburse medications. Conversely, they could create rules that severely hinder states from any PBM regulation whatsoever, meaning the very small amount of PBM regulation already in place (such as typical reimbursement appellate process, etc.) could be busted wide open to legal challenges across the country. 

If Arkansas wins, the extent of the win could very well depend on the extent of the written opinion. A win for Arkansas would mean that patients all around the state, and subsequently in other states, would retain access to essential healthcare providers they trust. The Court must provide a ruling by the end of June 2021, however it could come much sooner, perhaps March or April of 2021. There is no doubt that the pharmacy world is greatly anticipating the outcome of Rutledge v PCMA, with hopes that pharmacies everywhere will soon be better able to provide higher-quality patient care.

Guest Writers Profile

John Little is the current Executive Fellow at The American Pharmacists Association (APhA). He received his PharmD from The University of Oklahoma College of Pharmacy where he served as class president and student council president. His practice interests include incorporating digital health into patient care and discovering innovative ways for pharmacists to leverage their medication expertise to provide exceptional patient care. He is passionate about serving pharmacists, and advocating for pharmacists’ recognition as essential healthcare providers. 

Through his role at APhA, John has learned the impact that pharmacists can make on a national, regional, and local scale. By advocating for pharmacy practice advancement through associations, John is promoting the patient care that pharmacists provide across the country.

The 2020 Election: Statewide Ballot Measures

Today is the day. It’s finally election day. We’ve spent a lot of time talking on the blog about what is on the ballot during this election as it relates to healthcare, from responding to the COVID-19 public health emergency to the future of the healthcare system and what it means for the tens of millions of Americans whose access to affordable health insurance will depend on the outcome of this election. If that wasn’t a reason enough to get out and vote today, it’s also important to know that voters across the country will also be voting on statewide ballot measures on a variety of policy areas. For our last 2020 election post, we wanted to highlight what other healthcare implications this election will have, on issues such as abortion, marijuana legalization, and access to treatment for substance use disorder. This list was compiled by the National Conference of State Legislature’s database. For the full list, please click here

Abortion:  

Colorado: Prohibition of Late-Term Abortions (Proposition 115) 

Prohibits abortions after a fetus reaches 22 weeks gestational age. 

Louisiana: No Right to Abortion (Amendment 1) 

Adds a section to the Constitution of Louisiana that states nothing in the constitution shall be construed to secure or protect a right to abortion or require the public or private funding of abortion. 

Civil and Constitutional Law 

Montana: Concealed Carry Laws (LR-130)

Revises firearms laws to secure the right to keep and bear arms and to prevent a patchwork of restrictions by local governments across the state and providing that local governments may not regulate the carrying of concealed weapons.

Criminal Justice

California: Voting Rights Restoration for Persons on Parole Amendment 

Restores the right to vote to people convicted of felonies who are on parole.

Drug, Alcohol, Tobacco Policy 

Arizona: Marijuana Legalization Initiative (Proposition 207) 

Legalizes the recreational possession and use of marijuana.

Colorado: Cigarette Tobacco and Nicotine Products Tax (Proposition EE) 

Increases tax on tobacco, creates a new tax on nicotine products such as e-cigarettes; dedicates funds to education and health programs.

District of Columbia: Entheogenic Plants and Fungus Measure (Initiative 81)

Declares that investigations and arrests related to non-commercial prices with entheogenic plants and fungi are among the district’s lowest law enforcement priorities.

Mississippi: Medical Marijuana Amendment (Initiative 65 and Alternative 65a) 

Legalizes medical marijuana for qualified persons with debilitating medical conditions. Voters can signify whether they want either Initiative 65 or Alternative 65A to pass, thereby allowing the use of medical marijuana by qualified patients. The voter must then proceed to the second question to choose their preferred version. Voters can also signify neither measure (against both), and can then proceed to the second question to choose their preferred version in the event the “either” option gets more votes. 

Measure text: Initiative 65: Initiative Measure No. 65 proposes to amend the Mississippi Constitution to allow qualified patients with debilitating medical conditions, as certified by Mississippi licensed physicians, to use medical marijuana. This amendment would allow medical marijuana to be provided only by licensed treatment centers. The Mississippi State Department of Health would regulate and enforce the provisions of this amendment. 

Alternative 65A: This constitutional amendment is proposed as a legislative alternative measure to Initiative Measure No. 65 and would establish a program to allow the medical use of marijuana products by qualified persons with debilitating medical conditions.

Montana: Allow for a Legal Age for Marijuana Amendment (Ballot Issues #11)

Authorizes the legislature or a citizen initiative to set a legal age for marijuana purchase, use, and possession.

Montana: Marijuana Legalization and Tax Initiative (Ballot Issue #14)

Legalizes marijuana for individuals over the age of 21 and taxes the sale of non-medical marijuana at a rate of 20 percent.

New Jersey: Marijuana Legalization (Public Question 1) 

Adds an amendment to the state constitution that legalizes the recreational use of marijuana, also known as cannabis, for persons over a certain age and legalizes the cultivation, processing, and sale of retail marijuana.

Oklahoma: Decrease Tobacco Settlement Endowment Trust Fund Deposits and Fund Medicaid Program Amendment (Question 814)

Decreases payments made to the Tobacco Settlement Endowment Trust Fund from 75% to 25%, directs the legislature to appropriate money from the fund to secure federal matching funds for the state’s Medicaid program.

Oregon: Drug Addiction Treatment Initiative (Measure 110)

Decriminalizes possession of certain drugs and establishes a drug addiction treatment and recovery program funded by the state’s marijuana tax revenue.

Oregon: Psilocybin Program Initiative (Measure 109)

Legalizes psilocybin mushrooms for Oregon Psilocybin Services Program under the Oregon Health Authority.

South Dakota: Marijuana Legalization Initiative (Constitutional Amendment A) 

Legalizes the recreational use of marijuana for individuals over a certain age; authorizes individuals to possess or distribute up to one ounce of marijuana; requires the State Legislature to pass laws providing for a program for medical marijuana and the sale of hemp by a specified date.

South Dakota: Medical Marijuana Initiative (Initiated Measure 26)

Establishes a medical marijuana program in the state for individuals who have a debilitating medical condition as certified by a physician; provides that patients would be allowed to possess a maximum of three ounces of marijuana; limits the amount of cannabis products a person may possess as set by the Department of Health; allows registered to cultivate marijuana and grow three plants or another amount with a physician’s prescription.

Education

Washington: Sex Education in Public Schools Measure (Referendum 90) 

Repeals Senate Bill 5395 (2020), which requires public schools to provide comprehensive sexual health education for all students and requires students to be excused if requested by their parents.

Health 

Arkansas: Practice of Optometry Referendum (Issue 6)

Note: Although this question will appear on the ballot, the results will be neither counted nor certified. A referendum on Act 579 (House Bill 1251), which amends the definition of practice of optometry to allow optometrists to perform surgical procedures.

California: Regulation of Kidney Dialysis (Proposition 23)

Authorizes state regulation of kidney dialysis clinics. Establishes minimum staffing and other requirements.

California: Stem Cell Research Institute Bond Initiative (Proposition 14)

Issues $5.5 billion in bonds for state stem cell research institute 

Colorado: Paid Family and Medical Leave Insurance Program (Proposition 118) 

Establishes a program for paid medical and family leave 

Oregon: Cigarette Tax Increase (Measure 108) 

Creates an additional tax upon distributions of cigarettes at the rate of 100 mills for each cigarette in the state. Provides that all money received from the cigarette tax be paid to the State Treasurer. It shall first be used to pay administrative and enforcement expenses and refunds, and the remaining balance shall be sued by the Oregon Health Authority Fund

What’s at Stake

We’ve all heard it before: this election is the most consequential in generations. There is so much at stake today, and like many of you, we here at The Grassroots Pharmacist are a anxious about the outcomes of today’s election. We’ve spent the greater part of the last six months trying to inform our readers about the health implications of various federal and state policies, and trying to provide you with the best tools to advocate for your patients, yourselves, and the pharmacy profession at large. Of all the tools that we’ve provided for you though, nothing is more important than voting. Your vote is the single greatest way that you can advocate and regardless of your views, you have a responsibility to shape the future and direction of this country. Grassroots advocacy starts with each one of you, and with your vote you plant the seeds for what the future will look like. To all of our readers, we ask that if you haven’t voted, please vote today. There’s too much on the line to sit this out.

Pharmacy Practice Without the Affordable Care Act – Guest Writer Olivia C. Welter

The Patient Protection and Affordable Care Act (ACA) provided millions of Americans with access to health insurance. However, in today’s political climate with the recent confirmation of Amy Coney Barrett, there is a possibility that the ACA will get overturned in the near future. We know that this means tens of millions of Americans will lose access to their health insurance and hundreds more will lose access to basic consumer protections, but what does it mean for the profession of pharmacy? Our profession must begin to grapple with the implications if the ACA is overturned: the reduction in coverage for Medicare beneficiaries, increased threats to Medicaid funding and 340B, and significant impacts to the pharmaceutical industry.

Impact to immunizations

As a result of the provisions laid out in the ACA, preventive healthcare has become standard practice in healthcare. Repealing the ACA means that insurers would no longer be required to cover certain services with no cost sharing responsibility for the patient. This includes vaccines. One vaccine in particular that has had a heavy influence on community pharmacy is the influenza vaccine. If influenza vaccinations no longer have a zero-dollar copay at the pharmacy, many patients would likely opt out of getting the annual vaccine. For some independent practices, this loss could prove to be devastating. Flu vaccines bring in significant profits for pharmacies each year, and often this profit makes up for losses related to direct and indirect remuneration (DIR) fees and reduced reimbursement for prescriptions, both of which already contribute to why community pharmacies are struggling.

The numbers signify that the influenza vaccination rate in pharmacies has significantly increased in the years after this provision of the ACA was implemented; the 2012-2013 flu season saw 18.4% of adult patients receiving their vaccine at a pharmacy, and in the 2018-2019 early season pharmacies provided 32.2% of flu vaccines. Overall, the estimate for total number of adults receiving a flu vaccination in the early part of flu season was almost 10% greater in 2018-2019 than it was in 2012-2013. While there is not definitive evidence that the ACA is the only cause of increasing flu vaccine rates, it still demonstrates that 10% of adults in the United States, or nearly 21 million people, put themselves and those around them at lower risk of severe flu disease in the years after the ACA went into effect.

Note from the TGP: Given the nature of the global health pandemic, we wanted to remind all readers how it is especially important that you receive the flu vaccine this year. With many public health experts warning that the coming months will be dangerous, please take the necessary steps that you can take to protect not only your health, but that of the people around you as well.

It would be in insurers’ best interest to continue covering vaccines as they have been, but if the ACA is overturned, they will have the ability to decide whether or not their covered patients will receive necessary vaccines at no cost. If we do end up seeing this shift, community pharmacies may face yet another barrier as a result of patients choosing to forgo the vaccine because of the copay.

Impact to MTM

In addition to immunization programs, community pharmacies provide Medication Therapy Management (MTM) services as a way to ensure proper medication outcomes and improve revenue. In general, MTM is known to contribute to cost savings as well as improved patient outcomes. One study showed that pharmacist-provided MTM services resulted in 12% fewer hospital admissions per 1,000 patients. There are many different aspects of MTM, but Comprehensive Medication Reviews (CMRs) often generate the highest payment for pharmacies relative to other MTM services offered.

As part of the ACA, Part D plans are required to cover an annual CMR for targeted beneficiaries. These CMRs are responsible for a significant amount of interventions among a high-risk patient population and help bring additional revenue to the pharmacy. In 2019, 73% of plans targeted only the patients that met minimum requirements, while only about 27% of plans offered expanded eligibility to include more beneficiaries in MTM efforts. This shows that nearly three-quarters of Part D plans are only willing to cover what is absolutely necessary when it comes to MTM. If requirements put in place by the ACA no longer remain, these plans may revert back to covering only the requirements established in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Unfortunately, this would leave out the annual CMR requirement among other fundamental MTM standardizations.

Furthermore, some pharmacists are employed exclusively to provide MTM services. These changes could potentially lead to fewer jobs for pharmacists. We all know how concerning the existing job market is for the profession, and a loss of positions in MTM practice only exacerbates the issue. While it is possible that insurers recognize the value of MTM services and may continue to provide MTM coverage as usual, there are no guarantees. Therefore, pharmacies and patients must be prepared for these hypotheticals to become reality. 

Impact to 340B

Medicaid expansion was a controversial yet key component of the ACA. A larger Medicaid coverage population meant that more public hospitals were able to meet requirements to enroll as 340B covered entities, specifically as disproportionate share hospitals (DSHs). Patients receiving Medicaid are a crucial factor in the calculation for DSHs to be eligible for 340B drug discounts. These savings are vital in order to maintain financial stability of safety net hospitals providing care to a disproportionately low-income population. DSHs are just one of many covered entities eligible to enroll in 340B, alongside children’s hospitals, community health centers, critical access hospitals, and more; the list of covered entities was expanded as part of the ACA, allowing for even broader access to 340B pricing and subsequent savings.

Thanks to the Medicaid expansion provision implemented by the ACA, the number of DSHs enrolled in 340B nearly doubled between 2005 and 2014. This increase allowed  lower-income patients to better access health care services. Recently, we’ve seen attacks on the 340B program by drug manufacturers, specifically through their refusal to provide the 340B discounted prices to 340B covered entities partnered with contract pharmacies. While financially vulnerable patients are caught in the middle of these 340B attacks, they are also the ones who will be affected should Medicaid funding be cut.

With the repeal of the ACA, federal funding for Medicaid programs would almost certainly be reduced; states may be limited to receiving block grants or per capita caps as their only form of funding from the federal government. Less funding leads to less patients covered under state insurance. Reversing Medicaid expansion foreshadows the reversal of 340B enrollment, and as a result fewer pharmacies will be entered into contracts to provide outpatient medications for patients treated within a 340B facility. The cumulative effects of slashed Medicaid funding and gatekeeping of 340B savings alludes to worsened outcomes for both patients and pharmacy practice.

Impact to the pharmaceutical industry

While direct patient care settings have seen the most positive change in response to the ACA, the pharmaceutical industry experienced a key success as well. With the passage of the ACA came the Biosimilars Price Competition and Innovation Act (BPCIA). Biologics are incredibly complex drugs, and thus, incredibly expensive. Though their pivotal role in the treatment of diseases, including cancer, has proven lifesaving for patients, their use can take a significant financial toll on patients and payers. BPCIA offered an incentive for the development of biosimilars – an abbreviated application process. Because of this process, manufacturers are able to develop biosimilar drugs at reduced costs compared to their respective reference biologic products.

BPCIA will no longer exist if the ACA is overturned, which would unravel an intricate framework that guides the biosimilars industry. Industry leaders expressed concerns after each time Congress tried to invalidate the ACA. If BPCIA is rescinded as part of the ACA decision, biosimilar approval would be halted, and entirely new legislation would have to be enacted in order for it to resume as usual. One industry executive even noted that this decision would ensure patients losing critical access to both biosimilar medications and prescription drug benefits.

Conclusion

The bottom line is that the ACA brought many positive changes to the pharmacy world, and its impact will perpetuate regardless of how the Supreme Court rules. Accountable Care Organizations and Patient-Centered Medical Homes are likely to remain even if the ACA is overturned, and these provisions are hugely beneficial to patient care. As a profession, we must remain active advocates in order to ensure pharmacists continue to provide quality patient care. Contact your legislators and remind them how the integration of pharmacists into care teams has led to health successes for patients over the lifespan of the ACA. Keep up with advocacy efforts stemming from professional organizations so that in the event the ACA does get overturned, we have an opportunity to push for new language in the next healthcare reform package. Though the future of preventive services, MTM, 340B, and biosimilars remain in limbo, we’ve learned important information about the impact that the ACA has had on patients and the profession of pharmacy, and we can carry that knowledge into impending discussions surrounding healthcare reform.

Guest Writers Profile

Olivia C. Welter is a final-year student pharmacist at Drake University College of Pharmacy and Health Sciences. Olivia has a professional interest in health policy and has served as a legislative intern in the Iowa House of Representatives, where she was involved with healthcare-related legislation at its origin. Pharmacy advocacy has been a motivator for Olivia throughout her career as a student pharmacist and remains a cornerstone of her professional identity going forward as she transitions into a new practitioner. She is passionate about transforming patient care through association work and she is excited to continue being part of the charge to improve patient outcomes nationwide. 

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.