What pharmacists can expect for health policy from a united government

On January 20th, President Biden was sworn into office, along with Jon Ossoff and Raphael Warnock who were sworn in as Senators representing Georgia. This marks the transition of majority control for both bodies of the legislative branch and the Presidency to the Democrats. The idea of a united government, or one party having majority control, is not rare with ~56% of Congresses and the Presidency (23 Republican, 22 Democrat) being controlled by one party at the same time since the formation of the modern-day political parties in 1861. However, we will note that one party having majority control is decreasing in frequency, with rates falling to 45% over the last 20 years and occuring only a third of the time over the last 10 years.

For years, prominent opinions have expressed that democratic control of Congress and Presidency would be the only hope for any healthcare reform. Now with control of all three seats, we are seeing many news reports of all that is planned to be accomplished. This week, as we prepare for what could be a productive Congress, we review this idea of a united versus divided government’s impact on healthcare bills, and the process by which new bills may move through the current Congress.

Healthcare reform does not require one party control of the government

There have been many bills introduced and passed through Congress that impact the healthcare system. Anecdotally, we have heard from experts, friends, and colleagues (and have even expressed in conversation ourselves), that passage of a major healthcare bill in the U.S. requires one party to have majority control of the government, and likely that party needs to be the democrats. However, as we look to history, we quickly realize that this may not be true. We have compiled a list of major healthcare bills that have passed and the party that held majority control at the time in table 1, below. In table 2 at the end of this article, we provide a more comprehensive, but not exhaustive, list of healthcare bills.

As one can see, despite ~56% of Congresses being majority controlled by one party, most healthcare bills have been passed in a state of divided government. It is important to note that the most major reforms of healthcare in the U.S. did occur when one party controlled the government in 1965 and 2010 with the establishment of Medicare/Medicaid and the passage of the Affordable Care Act, respectively. Relevant to pharmacists, the Medicare Drug, Improvement, and Modernization Act (MMA), which established the Medicare Part D program, was passed in 2003 when Republicans controlled all seats of federal government.

An example of a bill that did not pass during majority control is The Health Security Act, also known as President Clinton’s health plan. The bill was introduced in November of 1993 into the 103rd Congress which had a democratic majority of 82 members (total 258 democrats in the House in 103rd Congress) in the House and 14 members (total 57 democrats in the Senate in 103rd Congress) in the Senate with Democratic President Clinton in the White House. After much debate and media coverage, the bill, which would have been a step towards universal healthcare, was declared dead by then Democratic Senate Majority Leader George Mitchell. The reason for its downfall is multifaceted, however, a large reason is attributed to a series of ad campaigns that rallied public support to oppose the plan.  This exemplifies the power of constituent’s voices as advocates and that the public can make an impact on the legislative process outside of just voting at the ballot box. Grassroots advocacy at it’s finest!

As you can see, just because one party controls Congress and the Presidency does not guarantee that a healthcare bill will pass. In fact, the majority controlled by democrats now is slimmer than the majorities when the ACA was passed and when Clinton’s health plan was defeated. The introduction of any healthcare bill is likely going to result in significant debate and it is up to us as constituents and healthcare providers to inform our elected leaders of our opinions on a bill. In an effort to understand where advocacy efforts may be focused over the coming two years, let’s examine how a healthcare bill will likely move through Congress.

How a health bill may move through Congress

There are many complicated rules for how a bill can work its way through Congress. For the purposes of this overview we will not be getting into too much detail (however, if you are interested in learning more click here). The typical pathway is for a bill to first be introduced into both the Senate and the House of Representatives. Following introduction, the bill is then assigned to a committee or a subcommittee. Once assigned, it is then up to the leadership of that sub/committee to determine prioritization of bills to receive hearings. A bill will receive several hearings where proponent and opponent testimony can be heard and legislators can ask questions, debate the bill, and amend the bill. If the leadership of a sub/committee decides to, the bill can be brought to a vote. If a majority votes in favor of the bill, it is then sent to the floor of whichever chamber it was introduced in for debate and potentially a vote. The only difference is if the bill is in a subcommittee, to which a successful vote then moves the bill on to the full committee. If the Senate and House end up passing bills with different language, the bills are then sent to a Conference Committee to reconcile differences in the bills and then are sent to the Senate for a final vote before going on to the President to sign or veto the bill. 

Understanding the committee process is incredibly important because this is where most bills “die” or become void due to no action being taken on them before the Congress ends. Knowing the elected leaders on these committees, especially if you are a constituent of theirs, can be vitally important. If a piece of legislation that could improve the healthcare system is referred to a committee, constituents have an opportunity to contact their legislators and advocate on behalf of the profession and their patients. In table 3, we include the most common committees in the Senate and the House that health related bills are referred to and links to the members of each committee.

Table 3: Common committees health related bills are referred to and their members

ChamberCommittee (Click for link to members)
SenateCommittee on Finance – Subcommittee on Healthcare
SenateCommittee on Health, Education, Labor & Pensions (HELP)
SenateCommittee on Appropriations – Subcommittee on Labor, Health and Human Services, Education and Related Agencies
HouseCommittee on Ways and Means – Subcommittee on Health
HouseCommittee on Energy and Commerce – Subcommittee on Health
HouseCommittee on Appropriations – Subcommittee on Labor, Health and Human Services, Education and Related Agencies
HouseCommittee on the Budget

*The membership of some house committees are still being assigned but the links provided will be the location of committee assignments once updated

Generally, a majority is needed to advance a bill out of the House and 60 out of 100 Senators are required to pass a bill out of the Senate. This need for 60 votes in the Senate is to be able to stop a filibuster, which is one of the only tools of the minority to prevent a piece of legislation from passing. However, there is a word that is prominent across healthcare legislation which indicates a different process used to advance the bills, reconciliation.

Reconciliation is a process by which legislation can be passed if it is going to have a fiscal impact on the government and only requires a 51 majority (instead of the normal 60) in order to pass out of the Senate. This is because rules for reconciliation bills limit debate to a certain period of time, thus essentially banning the filibuster. This is how the bills listed in table 1 and 2 with reconciliation in their name and more prominent healthcare reform bills like the ACA were able to pass. There are additional limitations on the reconciliation process, for example the number of times it can be used by each Congress, which is the reason it is not used for all legislation. However, given the slim majority the democrats hold, any healthcare bill is likely dependent on the use of reconciliation.

Most historical healthcare bills were passed under a divided government, though often using the reconciliation process. Healthcare continues to be one of the most important policy issues, exacerbated by the pandemic, and there will likely be the introduction of a major healthcare bill during the current Congress that could increase patient access to quality affordable healthcare provided by pharmacists and other members of the healthcare team. Regardless of democrats having control of the Presidency and Congress and the reconciliation process, we cannot assume a bill will pass, as exemplified by the Clinton health plan. Grassroots advocacy is needed, especially at the committee level, to educate our elected leaders on our viewpoints of legislation as constituents and healthcare providers. Over the next two years, there will be the opportunity to improve the healthcare system, but a key piece of the advancement of any bill will be dependent on constituents speaking up and advocating for the change we wish to see in the world.

Final CMS rule changes that matter to pharmacists

In the final days of the Trump administration, the Centers for Medicare and Medicaid Services (CMS) have finalized a flurry of rules and made announcements that can impact both the profession of pharmacy and the patients of pharmacists. This week, we review these rules and what to look out for as the leadership of CMS switches hands.

Prescription Drug Card for Seniors

Earlier this fall, President Trump signed an executive order (EO) in which he promised to send $200 debit cards ($6.6 billion in total) to seniors to assist them in paying for prescription medications. He claimed under this plan that 33 million Medicare beneficiaries would qualify to receive the assistance, which means over 70% of total Medicare Part D enrollees were set to receive this benefit. In the midst of a pandemic that has had a dramatic economic impact, especially on seniors, the possibility of extra assistance was well received. However, questions quickly arose as to the true impact such a policy would make. For example, if a Medicare beneficiary was in the coverage gap (or donut hole), they have to spend around $2,500 to reach the point of catastrophic coverage. 

Although an 8% discount provided by the $200 debit card would likely not be turned away, the burden our seniors face is hardly minimized. This EO brought to the conversation that policy instituting meager debit cards is not the way to help our seniors with the rising cost of medications. Widespread changes are needed in federal policy to lower the cost of medications and ensure unrealistic financial expectations are not passed on to the patient (read about plans from the incoming administration to address this here). In recent days, news sites have reported that the promised debit cards would not be sent out. Although challenging news for seniors that were anticipating the help, we can only hope that with the plan scrapped, the billions that would have gone to these seniors instead goes towards policy changes that may actually address the underlying issue of rising drug costs.

Prior Authorization – but not the one we hoped for

The Patients Over Paperwork Initiative is a Trump-era program launched by CMS Administrator Seema Verma to decrease regulatory burdens in order to increase the efficiency and quality of healthcare delivery. An example of these efforts may be the removal of certain documentation requirements from providers to allow them more time to deliver patient care rather than filling out electronic health records. One of the targets of the initiative has been prior authorization and attempting to find ways to decrease burden on both providers and patients. 

On January 15, 2021, CMS announced a major rule that will impact patients, providers, and many health insurers, including Medicaid managed care organizations. This rule requires health insurers to include additional information in application programming interfaces (APIs) that will be used to increase efficiency of prior authorizations. This additional information includes, claims data, lab results, and information about prior authorizations and their statuses. There is hope that this information will facilitate more efficient prior authorizations and decrease repeat unnecessary submissions. Although not specifically mentioned in the press release, upon further examination of the rule, one learns that surprisingly “prescription drugs and/or covered outpatient drugs” are excluded. 

Where there may have been hope from pharmacist providers of additional resources to increase efficiency of medication prior authorizations, this rule unfortunately does not move the needle on these efforts, despite creating a façade as if it does so. It was evident from many of the comments included in the rule that health care provider associations were frustrated with this exclusion. Although this rule will not address it, there is hope that change of the prior authorization process for services may result in reevaluation of the medication authorization process in the future. Additionally, many of the comments submitted on this rule were in regard to medication prior authorization, making it challenging for CMS to ignore calls from many of its providers to address issues with the process. The importance here is continuing to voice issues with the process both at the provider level and patient level. There can be hope that continued expressions of the burdens and gaps created in patient care will result in the changes needed to improve the system.

Changes to Medicare Advantage and Part D

One of the final actions taken by CMS leadership in their last days is the expansion of coverage for Medicare Advantage and Part D beneficiaries that hope to lower beneficiary costs, compare costs between different medications, and could save the federal government over $75 million over ten years. Additionally, included in this rule are CMS regulatory changes regarding The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. 

Regulations specific to the SUPPORT Act are focused on addressing the misuse of opioids. Relevant to pharmacists is that part of the provisions of implementing these rules will allow for the suspension of payments to pharmacies if there are credible allegations of fraud. Additionally, CMS, Medicare Advantage Programs, and Part D plans will be increasing data sharing to decrease risk of misuse and abuse of opioids. More information on these rules can be found here.

New Leadership for CMS

The work of CMS has changed over the past four years, with one of the primary focuses being on decreasing regulatory burdens. In the final days of this administration, large packages of rules are being finalized that have the potential to greatly impact both patients and providers, however, it is unclear at this time the true impact they will have. President-elect Joe Biden has chosen Xavier Becerra to be the incoming Secretary of Health and Human Services. It is unknown at the time of writing who will take the place of CMS Administrator. Given the campaign focus of President-elect Biden, and Mr. Becerra’s history as California’s Attorney General, it can be expected that a strong focus of HHS and CMS will be on strengthening and protecting the Affordable Care Act

We will have to wait and see how they will work to accomplish this, and what else will be on the table. But if CMS continues the momentum seen in the past several years, we can expect to see continued rapid changes in the rules and regulations that oversee how millions of patients and providers deliver care across the country.

President-Elect Joe Biden & Prescription Drug Pricing Reform – Guest Writer Grace Singson

As the number of cases and lives claimed by the COVID-19 pandemic continue to surge, access to affordable prescription medication remains a leading healthcare priority for Americans. According to the Kaiser Family Foundation,  29% of the estimated 195 million patients taking prescription drugs do not take their medications as directed due to costs. This can lead to negative health outcomes as treatment success is highly dependent on optimal medication adherence. Given the results of the 2020 Presidential Election, it is worth noting how President-elect Joe Biden hopes to ensure affordability of pharmaceutical and biotechnology medications. Pharmaceuticals, also known as traditional or retail medication, account for about 97% of the volume of medications dispensed in 2018. The biotech or specialty drugs, which make up the remaining volume of 3%, drove 43% of the total US drug expenditures in 2019

This post will review the various proposals that President-elect Biden plans to implement over the coming years to reduce prescription drug costs.

Medicare Part D drug price negotiations

One of the hallmarks of President-elect Biden’s plan is to allow Medicare to negotiate directly with drug manufacturers as a way to lower prescription drug costs. The Medicare Prescription Drug, Improvement, and Modernizations Act of 2003 (MMA) introduced the Medicare Part D Program, which is the voluntary prescription drug benefit for Medicare beneficiaries. To receive drug benefit, beneficiaries have to enroll in one of the two options: as a stand-alone drug plan (PDP) or as an add-on to Medicare Advantage plan (MA-PD). Medicare provides Part D benefits by contracting with private health plan sponsors that offer standard Part D plans and reimbursing sponsors on a per-member-per-month amount. Plan sponsors are able to compete for enrollees based on their benefit designs, formulary inclusions, and drug cost-sharing. This market competition is protected by the noninterference provision of the MMA  which states that the Secretary of the US Department of Health and Human Services (HHS) “may not interfere with negotiations between drug manufacturers and pharmacies and PDP sponsors”. By repealing this clause and allowing the Secretary to negotiate with manufacturers for lower drug prices, President-Elect Joe Biden hopes to decrease federal spending on drugs and render medications more affordable for Medicare beneficiaries. 

While the incoming administration has not stated any implementation strategy, evidence supporting the success of federal interventions to control patients’ drug costs are well-documented in European countries. Additionally, propositions allowing price negotiations between the federal government and manufacturers have received wide bipartisan public support. Supporters have stated that employing price negotiations and formulary management strategies comparable to those used by the US Veterans Affairs could lead to Medicare cost-savings of about $14.4 billion. On the contrary, opponents have argued that authorizing federal price negotiations can disrupt the market competition among private payers and undermine research and development; potentially diluting treatment pipelines and patient access to life-saving medications.

External Reference Pricing and Independent Review Board for Specialty Medications

IQVIA, a multinational health information and biotechnology consulting company, reports that 27% of patients who were prescribed a specialty drug did not receive treatment due to unaffordable costs. The recent upsurge in biologics delivered novel therapeutics for diseases with significant unmet needs. Unfortunately, their extremely high costs render specialty medications inaccessible to patients who need them the most. Payers often place specialty medications in higher formulary tiers which require greater patient cost-sharing percentage. Specialty medications administered via infusion or by a physician are covered under Medicare Part B, while self-administered drugs are part of the Part D benefit. Because the patient co-share is not based on a set amount (copay), but rather as a percentage of the drug price, the patients’ out-of-pocket (OOP) costs can generate substantial financial burden. 

To control for the skyrocketing launch prices of specialty medications, President-Elect Biden proposed the use of External Reference Pricing (ERP) and an Independent Review Board. ERP, a widely used practice in international markets, utilizes drug prices in foreign countries to calculate for the value which will be set as the benchmark drug price in their own country.  President-elect Biden anticipates a potential cost-saving of $72.9 billion for Medicare Part D if ERP is employed to determine the reference price for specialty medications covered by Medicare. Unfortunately, despite the cost savings, the use of ERP has been unpopular in the United States. One reason is that newly approved medications often enter the US market first, automatically rendering ERP as inapplicable. 

To confront this issue, the Biden administration recommends the formation of an independent review board. The board, led and created by the Secretary of HHS, will be held responsible to conduct health technology assessments (HTA) to calculate and set the most appropriate price for the drug. Similar to ERP, HTAs are commonly used by European governments in order to regulate prices by identifying the cost-effectiveness indices of patented pharmaceuticals, biotechnology drugs, and medical devices. 

While there is no mention of who the independent review board will be composed of, it may be modeled after the Institute of Clinical and Economic Review (ICER). ICER is an independent, non-profit organization that reviews the cost-effectiveness of new treatments and/or health technology products by comparing the products in the same medication class or product category. In a similar fashion, the Independent Review Board will evaluate the drug, align its value with cost, then recommend a launch price for Medicare-covered drugs. As an incentive, private health payers can access the same low launch price if those payers offer health plans in the CMS individual marketplace. Successful implementation of such strategies can decrease both the patient’s out-of-pocket costs and the rate of uninsured patients in America.

Tax penalties for medications priced above the general inflation rate

The President-Elect plans to impose tax penalties on manufacturers who increase prices of pharmaceuticals (both brand and generic) and biologics above the general inflation rate. Though it was not explicitly stated, this proposal resembles a section of the House passed bill: H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act. Under H.R.3, drug manufacturers are required to pay the inflation-based rebates to the federal government if their set medication price demonstrates a trend increase that is faster than the inflation rate. The objective of enforcing tax penalties is to discourage manufacturers from setting immensely high drug prices to maximize product profitability. 

Drug Importation

A report conducted by the United States House Committee on Ways and Means confirmed that US patients have been paying for medication at a significantly higher rate compared to other consumers from other countries, including American-made drugs. Manufacturers’ narrow revenues in international governments, due to cost-containing strategies, drive the price hikes in the US market. Manufacturers are able to compensate for marginal profits by subjecting US consumers with high-cost medications. Therefore, it is no surprise that such unfair pricing strategies instigated drug importation considerations. 

Similar to President Trump, President Elect-Biden intends to permit consumers to import drugs as a means to reduce drug costs. Importation is limited to products that were considered safe by the Secretary of HHS. However, this proposal is widely unsupported and criticized by national pharmacy associations and government leaders of foreign countries, as it compromises patient safety and drug supply without substantial cost-savings. 

End Taxpayer Subsidies for Drug Ads Act 

In 2016, pharmaceutical and biotechnology companies expended $6.4 billion on Direct-to-Consumer Pharmaceutical Advertising (DTCPA). While there are regulatory requirements employed by the United States Food and Drug Administration (FDA), DTCPA spending continues to increase each year with minimal incentive for manufacturers to control costs. This is because of the Internal Revenue Code of 1986 which grants tax deductions for ordinary and necessary products, including DTCPA. Critics of DTCPA emphasize that advertisements have only consistently benefitted manufacturers by inducing the growth of the pharmaceutical industry, while patient outcomes have been erratic. Initiatives recommending the prohibition of DTC drug advertisements were quickly dismantled as it was deemed a threat to free speech. 

New Hampshire (D) Senator Jeanne Shaheen introduced a bipartisan-supported legislation that would eliminate tax breaks for DTCPA expenditures. Supporters of the bill End Taxpayer Subsidies for Drug Ads Act, including President-Elect Biden, argue that DTCPA are not necessary and do not qualify for subsidy as it is impossible to learn all of the necessary information of prescription medications in the time duration allotted for DTC advertisements. If passed, the bill will drive down the DTCPA expenditures of manufacturers and (hopefully) discourage its use. However, whether its passage will directly impact prescription drug pricing is uncertain.

Endorse proposals that will increase the supply of generic medications

Lastly, President-elect Biden supports and hopes to advance policies and arrangements that prioritizes patient health and ensures access to affordable medication prices. For example, President-elect Biden has supported for The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, introduced by Vermont Senator Leahy and signed into law on December 20, 2019.

 The law expands access to affordable generic medications by preventing manufacturers from conducting tactics that delay the market entry of generic equivalents. For example, manufacturers may apply for, and are subsequently granted, secondary patent exclusivity for minor formulation modifications, an application that is often completed prior to patent expiration. These damaging tactics can deprive patients of critical life-saving medications since they keep drug prices high. By endorsing proposals spearheaded by other lawmakers, President-elect Biden acknowledges that prescription drug pricing reform requires collaboration and agreement with legislators. 

As patient advocates, pharmacy professionals are in a prime position to assist patients and facilitate access to essential medication. Although we can do our best to help patients navigate their prescription benefits, utilize coupons for savings, and apply for patient assistance grants when able, ultimately, the health care system needs drastic reform to reduce drug pricing and ensure adequate access to medications. Knowledge of drug pricing reform and health policy proposals enhances our ability to successfully connect our patients to affordable medication and advocate on their behalf.

Guest Writers Profile

Grace Singson (they/them) is a 3rd year student pharmacist at the University of Southern California, where they are pursuing a dual-degree Doctor of Pharmacy and Master of Science in Healthcare Decision Analysis (HCDA) program. Grace is currently serving as the Vice-President of Professional Conferences, an Affinity Group Liaison, and for the USC School of Pharmacy Student Government Board and the Rx Pride LGBTQ+ Affinity Group, respectively. They are also involved with California Society of Health-System Pharmacists (CSHP), AMCP, ISPOR, CPNP, and Student Committee for Diversity, Equity, and Inclusion (SC-DEI). In addition to health policy, Grace has professional interests in managed care and health economics and outcomes research. They are passionate about optimizing pharmacy practice and medication access to reduce health disparities in marginalized communities.

A reflection on pharmacists’ advocacy in 2020

We hope that each of you are making the most of the season and are finding some comfort in what might be a very different holiday celebration. We here at The Grassroots Pharmacist didn’t anticipate writing an end of the year post, partly because so much of this had been played out and said elsewhere. And while we are all ready to turn the page on this year, we wanted to try and take some time to find things to be hopeful about. There are so many stories of pharmacists advancing health policy this year that gave us pause, gave us a reason to feel happy in 2020, and a reason to be hopeful in 2021. 

Make no mistake though, as we reflect on this past year, there’s a lot that comes to mind. There are shared moments of grief, frustration, and sadness. Long anxious nights that turned into lonely mornings. And as we look forward to January 2021, there’s a lot that we are ready to say goodbye to: Zoom meetings and virtual happy hours, social distancing, convincing our patients (and also probably our loved ones) why they need to wear a mask and follow public health guidelines, and if you’re anything like us, Friday evening press releases from CMS. But it says a lot about us as a people (and for our pharmacists readers, as a profession), that despite the hardships of the last year, so many of us remain optimistic and hopeful about the new year. That we remain willing to challenge ourselves and to incorporate the tough lessons we learned this year.

For all of us at The Grassroots Pharmacist, 2020 brought its own challenges both professionally and personally. We experienced the loss of loved ones, weathered the anxiety and stress of trying to care for patients at the expense of ourselves, and fought the daily struggles against anxiety, burnout, and possibly depression. And through it all, we are still trying to find our place in the changing health care landscape and in the profession at large. 

However, in the midst of the changes of the past year, each of us on this team found a calling in helping to educate members of our profession on the legislative and regulatory changes taking place during the public health emergency, and empowering individuals to better advocate for their patients. None of us are strangers to advocacy and we recognize the opportunities that exist when everything is changing. None of us expected to be authoring a blog at the start of the year, but looking back, we are incredibly thrilled not only to have this platform, but to have readers that have come along with us as we discussed health policy issues that could have consequential impacts on our profession. Here were some of our favorite posts of this past year: 

Posts that Focused on the Expanded Role for Pharmacists

  1. Pharmacists’ Ability to Provide Tests for SARS-COV-2
  2. Are Pharmacists Essential? Congress thinks so! 
  3. Pharmacist state scope of practice overruled by HHS
  4. Deja vu… Pharmacist State Scope of Practice Overruled by HHS: Take 2
  5. Changes to Pharmacist’s Incident to Billing and the Physician Fee Schedule 

Posts that Focused on Health Disparities and the Pharmacist’s Role in Addressing Them

  1. Reflections on Systemic Racism in America 
  2. The Assault on LGBTQ+ Healthcare Access
  3. Why Pharmacists Need to Count on the Census 
  4. Racial Differences in COVID-19 and the Potential for Pharmacists
  5. We Hold These Truths to be Self-Evident: Addressing Gender Inequality in the Profession of Pharmacy
  6. The Pharmacist’s Duty to Address Human Rights Abuses in Immigration Detention Centers

Posts that Focused on Why and How to be a Better Advocate

  1. Provider Status Explained: A Series Introduction 
  2. Provider Status Explained: Why do Pharmacists Need Provider Status 
  3. Provider Status Explained: Understanding the How Behind the Federal Legislative Strategy
  4. Advocacy Advice: How to Advocate Through Print Media 

Guest Writers: Content Submitted by YOU 

  1. Ariel McDuffie: The Basics of 340B and the Current Attacks on the Federal Drug Discount Program 
  2. Olivia C. Welter: Pharmacy Practice Without the Affordable Care Act
  3. John Little: Supreme Court Case 18540: Rutlege v Pharmaceutical Care Management Association 
  4. Larry Selkow: Racial Disparities During the COVID-19 Pandemic Continue 
  5. Matthew Westling: The Gap with Implementing Pharmacist Policy

Looking back at 2020, there is no doubt that we will remember the hardships and the struggle. But it’s important that we don’t lose sight of all the great strides that our profession has made. Even beyond these blog posts, it’s important we don’t lose sight of the biggest stories that pharmacy made this year. The stories of pharmacists serving each and every day on the front lines throughout the pandemic. Pharmacists who worked in emergency departments and medical ICUs taking care of patients diagnosed with COVID and saving countless lives. Pharmacists who set up COVID-19 testing sites in underserved communities, often without adequate personal protective equipment. Pharmacists who continue to play a major role in the largest vaccination effort in our nation’s history. Those are the stories that defined 2020 for our profession. And so while we look forward to the new year with a renewed sense of optimism for the profession, this year has reaffirmed that you have great power in your voice to advocate for the improvements in the healthcare system our patients deserve.

A sincere thank you to each of you for being a part of this journey with us. Wishing you the best in the New Year. 

-The Grassroots Pharmacist Team

The Gap with Implementing Pharmacist Policy – Guest Writer Matthew Westling

Recently, the Journal of the American Pharmacists Association published a secret shopper study describing counseling provided during the dispensing of naloxone at chain pharmacies in Texas. Although it may seem crazy that the average counseling time was only 89 seconds, what was more striking was that any formulation of naloxone was unavailable at almost one-third of the randomly selected chain pharmacies. Keep in mind, this is naloxone, a drug with no major side effects, is responsible for reducing opioid related overdoses by almost 14%, and does not require a prescription in numerous states. Unfortunately, problems with accessing or utilizing pharmacist services are not unique to naloxone dispensing. So why aren’t pharmacies and pharmacists adopting policies designed for accessibility? The long answer involves a lengthy discussion of stigma, discrimination, and logistical constraints. A reasonable discussion requires  highlighting the importance of ensuring the decisions made during the policy process allow for efficient and effective policy implementation. 

Why is Policy Implementation so Important?

Nurse Practitioners (NPs) interested in expanding their scope of practice use a major talking point that they need independent practice ability so NPs can practice in medically underserved and rural areas and thus increase access to care. However, the American Medical Association recently made a statement arguing that ineffective policy implementation in underserved areas, the main argument many professional groups have utilized to advance scopes of practice, is why these scopes should remain limited and dependent on physicians. You may think this argument is invalid but persistent and equitable implementation issues already exist in states with advanced pharmacy practice, such as those seen with pharmacist-prescribed and OTC hormonal contraception in Los Angeles County. 

Successful policy implementation not only has a significant effect on policy outcomes but also agenda setting and issue framing for subsequent issues that follow. Given pharmacists are the most accessible healthcare provider (with most people living within 5 miles of a pharmacy), it is essential pharmacists effectively and efficiently implement expanded scope policies such that these arguments are discredited.  If pharmacists fail to do this, policy agendas concerning expanded practice will be much harder to push in the future. Of course, more important than expanding pharmacist scope of practice is the responsibility of pharmacists as healthcare providers to ensure all patients (regardless of their geographic location) are receiving affordable and accessible healthcare. Likewise, if pharmacists truly wish to continue to expand the scope of practice to help provide accessible healthcare to patients in need and serve as better members of interprofessional collaborative healthcare teams, then pharmacists must focus on successful implementation of the initial policies at hand. 

What Impacts Policy Implementation?  

There are numerous factors which contribute to a policy’s implementation and success. However, when discussing pharmacy practice policy there are three main areas pharmacists are missing in their implementation: comprehensive implementation style, policy feasibility, and policy salience

There are two main forms of policy implementation styles, top-down and bottom-up. Top down policy implementation follows a more traditional path of governance. Healthcare organizations see this with CMS performance measures. CMS incentives encourage management to require healthcare providers to change their practice behaviors or implement a desired policy/action. Bottom-up policy implementation emphasizes policy decisions that are influenced by the target groups or service deliverers. This is usually seen in patient safety where systems allow individuals to make mistakes and in turn force management to implement new policies. If the failures that result in mistakes go unaddressed and occur frequently, larger policy change may occur through actions by accreditation organizations (e.g. the Joint Commission) or the regulatory system (e.g. CMS or FDA).  

Pharmacy organizations utilizing the narrative of patient need for medical access intuitively emphasize a bottom-up policy implementation style. However, pharmacists are utilizing a top-down implementation style at the federal level by focusing on large centralized statutory changes to be further diluted as it gets implemented downstream. This approach often leads to disconnected, uneven, and sometimes ineffective policy implementation, especially regarding issues regulated at the state-wide level like pharmacy practice. Likewise, if a bottom-up argument is going to be made, suggested policies will have to be significantly more responsive to lower level needs.  Currently, surveys repeatedly show that needs of pharmacists to implement these services not only revolve around reimbursement but also time constraints, lack of healthcare communication, and much more. 

Unless other issues barring the implementation of expanded pharmacy services at community pharmacies are addressed, it is unlikely these services will be implemented in areas with the most need. This brings us to the second missing factor in pharmacy policy implementation: ensuring feasibility. Without appropriate resources, pharmacists will be unable to implement these services across the board. Although provider status will address the issues of payment, if other underlying barriers are not addressed it is unlikely that underserved areas will implement these services due to a constraint in resources. Instead, implementation will mostly be seen in areas with the means to do so. Likewise, pharmacists need to advocate for innovative solutions which allow pharmacies to shift current resources to better fit the policy agenda at hand such as increasing technician responsibilities to focus on administrative functions so the pharmacist can focus on providing care. 

Assuming pharmacists address the underlying barriers within pharmacies, it comes down to policy salience to ensure successful usage of these services. Saliency refers to the visibility of a policy to those it impacts. For instance, if prescription prices change for a pharmacy or insurance company due to regulation changes but the co-pay for the patient stays the same, then it is not a salient policy for the patient. In this scenario, the patient is largely unaware this change has occurred since there is minimal interruption to their life. However, if the patient’s prescription co-pay drops then it would become a more salient policy to the patient. A good example of this is how co-pays for birth control dropped after the passage of the Affordable Care Act and subsequently resulted in an increase of birth control usage. In a similar fashion, pharmacists need to ensure expanded services are salient and widely known to the patient to ensure reasonable usage. 

What now? 

Let’s go back to the secret shopper study discussed earlier and apply these concepts of policy implementation. To start, pharmacists dispensing naloxone is already a bottom up policy change stemming from the opioid epidemic. So what could encourage a more equitable implementation? Well the average counseling time was 89 seconds, indicating a possible underlying issue of time constraint. This means future policy should focus on feasibility, which may be addressed by encouraging legislation allowing technicians to practice in more advanced roles so pharmacists have more time to discuss naloxone with patients. The second issue of naloxone being unavailable at one-third of stores could be addressed by increasing policy salience. Pharmacy organizations and pharmacists utilizing ads targeted directly to consumers in locations where pharmacies are not dispensing naloxone, advising them to obtain naloxone from a pharmacy near them, would likely increase the saliency of this policy. This could result in increased demand and force implementation of services at more locations, much like what happened with immunization policies. 

Although regulatory and legislative changes can help pharmacists increase the accessibility of care through expanded practice,  if pharmacy organizations fail to successfully implement policy, then future agenda setting could be at risk. To avoid this, pharmacists need to advocate for changes at the state level that will make practice expansion more feasible and responsive to the needs of the individual pharmacists and organizations responsible for implementing expanded practice services. Additionally, pharmacy organizations need to make these policy changes more widely known when they occur. If pharmacists truly want to expand patient access to medical services, then they must focus on ensuring successful policy implementation. 

Guest Writers Profile

Matthew Westling is a PGY1 Pharmacy Resident at the Ralph H Johnson VA Medical Center. Matthew received his Doctor of Pharmacy and Master of Public Administration from the University of Kentucky. During his time at the University of Kentucky, Matthew was involved with SNPhA, the Kentucky Pharmacist Association, SCCP, Kappa Psi Fraternity inc., Phi Lambda Sigma, and the Student Philanthropy Board. He has a strong interest in policy implementation and research. Specifically, Matthew is interested in how pharmacy practice policy can be best utilized to help correct health inequity/disparities.  He believes pharmacists are uniquely positioned to help directly break down barriers to health equity and wants to ensure policy implementation does not leave under-served patients behind.

Changes to pharmacist’s incident to billing and the Physician Fee Schedule

Wow! We thought things may slow down for a bit after the election, but instead health policy changes seem to be happening more frequently than ever. As rates of COVID surge across the country, it is vitally important pharmacists understand these changes and how they apply to practice. By better understanding these rapid health policy changes, pharmacists will be better informed on how they can currently practice and understand where advocacy initiatives need to be focused to advance patient care in the future.

An important advocacy initiative that we have discussed on the blog is the necessity to establish a sustainable business model for the provision of pharmacist provided patient care services. Although the ability to directly bill for services is a vital goal for the profession (for more see: Why do pharmacists need provider status?), other methods have been employed to allow pharmacists to indirectly bill for their services. One of these methods is for pharmacists to bill incident to a physician for the services that they are providing. For years, there has been a lot of confusion and questions around this indirect billing method. Just last week, the Centers for Medicare & Medicaid Services (CMS) released their annual Physician Fee Schedule (PFS). Within this behemoth of a two thousand page document, it includes key information regarding pharmacist’s ability to bill incident to. This week we review incident to billing and what updates are included in the PFS.

A brief history of incident to billing for pharmacists

Pharmacists billing incident to the physician or nonphysician practitioners (NPPs) is a step in the direction toward provider status. It allows pharmacists to bill insurance companies for services that they would not normally be able to be reimbursed for because they are not recognized as healthcare providers. When this first began, it was a big breakthrough for the profession of pharmacy because it allowed pharmacists to bring in revenue to the businesses that they work for as a result of the cognitive services and medical decision making that they were providing.

Pharmacists billing incident to likely began when the American Academy of Family Physicians (AAFP) sent a letter to CMS asking for clarification if pharmacists could bill incident to physicians. In March 2014, CMS responded by confirming that pharmacists could in fact bill incident to the physician. The ability for pharmacists to bill incident to is consistent with other mid-level practitioners such as nurse practitioners and physician assistants. Although this was trumpeted as a major victory for the profession, there were major roadblocks to pharmacists in all practice settings to be able to utilize this new reimbursement methodology. One of the biggest barriers was the fact that a physician needed to be directly available to the pharmacist when providing incident to services. This was largely interpreted that the physician and pharmacist were in the same physical location and patients were being seen in person. This limited pharmacists billing incident to the physician for telehealth services and created barriers for many community pharmacists that were not practicing in the same physical location as a physician.

Another major barrier to rolling out sustainable programs where pharmacists provided services and billed incident to was regarding a belief that pharmacists could only bill the lowest level of Evaluation & Management (also known as E&M) codes. Normally, in the outpatient setting there are two sets of billing codes that physicians use as the foundation of their patient visits. These are known as E&M codes and the two sets are for new patients (99201-99205) or for established patients (99211-99215). The lower numbers of both of these codes, for example 99201 or 99211, are used for less complex patients, that require less time, and less medical decision making. These lower E/M codes are reimbursed at a lower amount than other E&M codes. As patient visits increase in complexity and time, physicians bill higher E&M codes which are reimbursed at a higher level. This helps to associate the value of services being provided by the physician with a comparable reimbursement amount. Below is a table exemplifying this from the current physician fee schedule of national payment amounts:

After pharmacists learned that they could bill incident to, it quickly began to spread that pharmacists were only allowed to bill the lowest level of return patient code (99211) regardless of the amount of time that a pharmacist spends with the patient or the number of interventions that are made. This information likely came from a regional Medicare Office that provided clarification that pharmacists could only bill these lowest level codes. Obviously, this is not ideal because the level of service being provided by a pharmacist would not align with the amount of reimbursement. This misalignment would create further barriers to pharmacists providing services and growing their practices.

Although information was published from Regional Medicare offices regarding pharmacists only billing the lowest level codes, there was never an explicit justification as to why this was the case. Additionally, it is not clear if all regional offices have provided this information and because of this, depending on the geographical area that pharmacists practice in, some have been billing the higher E&M codes where others have not been able to. There have even been publications (here is one from the Journal of Managed Care Pharmacy) stating that the belief that pharmacists can only bill 99211 E&M codes is simply “not true” (keep reading because this statement is in fact false). This inconsistency in policies from a national health insurance program (Medicare) is abnormal.

As the pandemic hit 2020, many of the regulations on pharmacist practicing and billing for their services have been changed. One of the key updates that we covered previously was the indication that pharmacists would continue to be able to bill incident to the physician for telehealth services. With the publication of the coming year’s PFS last week we have seen more information come out regarding pharmacists ability to bill for services incident to.

How does the PFS change incident to billing?

The PFS is an annual document that outlines the fees that Medicare will be using to pay physicians and other practitioners for the services that they provide. Additionally, CMS will take time to respond to stakeholder questions in order to provide clarification for how to appropriately utilize the PFS. The 2021 PFS can be accessed here.

Relevant to pharmacists billing incident to the physician or NPPs are pages 352-357, where stakeholders ask for clarification as to whether pharmacists can bill incident to and if they can bill all E&M codes. This question has been asked of CMS previously, however, the information included in the PFS is the most detailed response they have given to date. Included in this response is confirmation from CMS that pharmacists billing Medicare incident to physicians or NPPs can only bill the lowest level of E&M codes (99211). This is a pretty striking confirmation and may result in some pharmacists changing how they are billing for their services if they are billing Medicare incident to for higher level E&M (99202-99205; 99212-99215) codes.

Although it is not ideal that this confirmation may result in a decrease in revenue generation from some pharmacists depending on their billing practices, included in the PFS is an explanation as to why pharmacists cannot bill these higher level codes. With this explanation comes an understanding of what changes need to be advocated for in order to allow pharmacists to bill Medicare for all E&M codes incident to physicians or NPPs.

CMS explains that the reason pharmacists can only bill the lowest level E&M code is because of two definitions used in the Current Procedural Terminology (CPT) codebook. In the CPT codebook the term ‘physician or qualified health professional’ (QHP) and ‘clinical staff’ are used in descriptions as to which individuals can provide different services, such as those included in E&M codes. Specifically, included in the 2021 CPT Codebook is information that higher level E&M codes can only be provided by physicians or QHPs. These definitions are included in the table below:

So, there is no overlap here. A QHP cannot also be ‘clinical staff’. These are mutually exclusive definitions. Included in the CPT codebook is the requirement that higher level E&M codes must be provided by a physician or QHP. Unfortunately, CMS states that they do not consider pharmacists QHPs and because of this, this is the reason pharmacists can not bill Medicare incident to for higher level E&M codes. The justification for why CMS does not consider pharmacists QHPs is that “there is no Medicare statutory benefit allowing them to enroll, bill and receive direct payment for PFS services.” The key term here is ‘direct payment’. So, even though we would be billing incident to the physician, the fact that direct payment is being used is indicative that this is still all coming back to recognizing pharmacists as providers under the Social Security Act (more information about this can be found here).

Additionally CMS states that in some settings pharmacists could be considered QHPs, however under current Medicare Law (the dreaded Social Security Act) even if a pharmacist billed Medicare, CMS says “we do not have ability to pay (or even price) services that are furnished and billed directly by pharmacists.”

What are the next steps?

So this news is not necessarily good or bad, it’s a little of both. It is bad that some pharmacists may not be able to continue to bill Medicare for higher level E&M codes, however, it is good that we now understand what must change in order to allow pharmacists to bill incident to for these higher level E&M codes. So, what needs to change? We believe there are potentially two alternate answers to this question.

The first answer would be for Medicare to recognize pharmacists as QHPs and thus allow them to bill for higher level E&M codes. Although this seems to be a simple advocacy initiative, it gets more complicated as you review the specific language that CMS used as its justification for why pharmacists are not considered QHPs. The justification that CMS uses ties back to pharmacist’s inability to directly bill for services from Medicare, which ties back to pharmacist recognition as providers in the Social Security Act, aka ‘Provider Status’. So the first answer to this question is for pharmacists to get Medicare provider status, which is not something we would recommend anyone holding their breath over…

The second alternative answer is actually outlined in the PFS as something CMS states should be considered. This is indicated when they state, “We note that new coding might be useful to specifically identify these particular models of care.” What they are suggesting here, is that the CPT codebook change the codes for higher level E&M codes to allow clinical staff (which pharmacists are frequently defined as) to bill incident to physicians or NPPs for services they have provided. This would allow CMS the ability to allow pharmacists, designated as clinical staff, to bill Medicare for higher level E&M codes incident to physicians or NPPs. Although this might seem like a simple enough ask, you are not going to like it when we tell you who owns the rights to the CPT codebook…the American Medical Association (AMA).

The AMA has expressed concern over expanded reimbursement models for pharmacists, and has even passed a resolution in their House of Delegates to this effect. Here is where you can make the difference though. Under the current model, pharmacists practicing in incident to reimbursement models are throwing away money and undervaluing their services every time they provide a level of care above a 99211 code. Expressing that revenue is being left on the table to leaders of health systems may be an enticing argument for physicians in leadership positions over health-systems or outpatient clinics. We all want the same thing, which is increasing access to high quality, effective healthcare. We know that with more revenue we can further the missions and visions of the organizations that we work for. Why leave money on the table, when a simple change by the AMA could better patient care and revenue streams for many of their members?

If you work for a health-system or outpatient clinic, we encourage you to ask this question to your administrators and physician leaders. This, along with advocating to the AMA and CMS, may open up incident to billing opportunities for pharmacists across the country, and thus enhance access to patient care.

Racial Disparities During the COVID-19 Pandemic Continue – Featuring Larry Selkow

Earlier during the COVID-19 pandemic, we reported on the racial differences affecting our communities and the potential solutions pharmacists can provide. As the pandemic continues on, we see how these disparities remain magnified during public health emergencies. An analysis published last week describes continued higher mortality rates of communities of color as compared to Whites, despite these differences having been identified early during the COVID-19 pandemic. As the rate of infections and deaths continue to rise, and with 12 million Americans at risk for losing unemployment benefits come December 26th, we are likely to see worsening rates of food insecurity, homelessness, and of course, inability to pay for health care over the coming months.  

In our last post, we noted several inequities in social determinants of health that put racial and ethnic minority groups at an increased risk of morbidity and mortality associated with COVID-19. These factors include, but are not limited to, healthcare access and utilization, such as access to COVID-19 testing; occupations, as many people of color are essential workers; and housing. Another factor that has amplified these disparities and must be addressed in order for solutions to be made, is the delay in translating critical health alerts and recommendations into other languages. Pharmacists practicing in different areas are faced with this problem all too frequently. 

We have shared the stats and have seen the widespread impact that without policy solutions these racial differences, amplified by the pandemic, will continue to expand. Recognizing the power of stories and that each of us need to hold ourselves accountable for addressing racism, inequities, and disparities in our society, we bring you a narrative reflection on how language barriers can impact patient care from a pharmacist in the field. 

Where Do We Go From Here? A Reflection by Larry Selkow, A Pharmacist in the Field

I have been a community pharmacist for almost 40 years. Currently, I live in a well-to-do golf course community in the Palm Springs area of Southern California. President Barack Obama played a round of golf on the course where I live a few years ago. My current position also puts me in a very affluent area. However, a few years ago I was employed by a large retail pharmacy chain in a not so well-to-do neighborhood, not too far from my current home. Actually, if I drive around 5-10 minutes from my home, the area is very poor with a large Latino population. When I worked in that neighborhood, there was a huge language barrier that I faced on a daily basis. 

I do not speak Spanish, but my pharmacy technicians did and they would often have to translate for me back and forth. If my technician was not there, which occurred at night and on weekends, I would often have to page another Spanish speaking employee to the pharmacy to translate for me. When I think about my work in the Latino neighborhood, I often wonder… what kind of care was I really providing? In the current state of affairs in this country, what I have experienced happens on a daily basis. Actually, when you think about it, a language barrier is a huge public health issue in this country. If patients are not able to communicate properly with their pharmacist or any other health professional, this creates a public health issue,: like any other public health issue such as smoking, HIV, or obesity. It is perfectly fine to have someone translate back and forth. But, does it provide equitable care to these patients? Do these patients fully understand their current health situation? 

Many pharmacists may not have the ability to speak Spanish fluently when working in a Latino neighborhood. This creates a problem for all. These patients often do not get the proper consultation or health information that they need. During the pandemic, we are facing a time when timely dissemination of accurate information is crucial, there has been a lot of press coverage about the huge disparities between different ethnic groups. The Latino population has been hit especially hard from COVID-19. Imperial County in California, which is about an hour drive from my home, has been devastated by COVID-19. This area has an even larger Latino population than where I worked. I know a few pharmacists that have worked in Imperial County, and from talking to them, the language barrier is even worse than I experienced. Again, what level of health care is actually being provided? Sometimes I myself, get frustrated that I am letting my patients down. I know other pharmacists that get frustrated as well. But, we as health professionals must do the best we can with the current situation, while also advocating for future equitable solutions. 

We became pharmacists to provide care to all patients regardless of the language that they speak. We must realize that a language barrier is a huge public health issue, like any other public health issue. So, the question is: where do we go from here? There is no perfect answer, but if we can look at the current situation in this country, one word comes to mind: Empathy. Yes, we heard that word often during the 2020 Presidential campaign. Now that the campaign is over, we must apply that word to our daily practice. I feel a little more understanding of our patients needs can go a long way towards providing the necessary care that they deserve. In the long run, their health and well-being will be much better off.

Solutions Needed: Empathy and Policy Change

Empathy is crucial not only to understand our patient’s needs, but to build trusting relationships that allow for patients to express their thoughts and concerns. Although there is hope for a COVID-19 vaccine becoming available soon, historically communities of color have been underrepresented in clinical trials and have a deeper mistrust for the healthcare system, which may cause significant barriers to administering vaccines to this vulnerable population. In a recent New England Journal of Medicine perspective the authors note “When Covid-19 vaccines are eventually approved by the FDA, their success in Black and other communities will depend on whether members of these communities not only trust that they are safe and effective, but also believe that the organizations offering them are trustworthy.”  Although there are steps that must be taken, such as ensuring these communities have access to necessary healthcare if they are injured as a result of receiving the vaccine, they also note that efforts must be grounded in grassroots involvement of individuals and organizations with reputations of trustworthiness among these populations. We believe pharmacists are key players in building and maintaining these relationships, and serving as a voice for the underrepresented.  

Additionally, advocating for our patient’s needs, ensuring access to care, and providing educational resources that are easily understood by all patients will also help build these trusting relationships. As we described in August, policy changes including development and implementation of payment models are needed in order to ensure access to pharmacist’s services, such as COVID-19 testing and vaccines, for all people. Furthermore, funding to support agencies to provide public health infrastructure are crucial to combating the inequities of social determinants of health that impact many of our patients. We challenge pharmacists and national pharmacy organizations to also consider these factors when developing resources for your communities and ensuring minority voices are properly represented.

Featured Writers Profile

Larry Selkow lives in La Quinta CA. He graduated in 1982 from The Arnold and Marie Schwartz College of Pharmacy, Brooklyn NY.  He has always worked in community pharmacy and belongs to various pharmacy organizations, including the American Pharmacists Association (APhA) in which he is heavily involved with various committees and special interest groups. He also works with APhA on Policy, being a member of the APhA House of Delegates for many years. He is currently President of  the Palm Springs Chapter of the California Pharmacists Association. Larry has a huge interest in pharmacy policy as it pertains to community pharmacy on a State and Federal level.

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 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. 


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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. 


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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


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.


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.


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.


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.