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

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

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

Oral arguments are heard

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

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

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

Timeline

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

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

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

PCMA responds

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

Timeline

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

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

The impact on pharmacy and patients

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

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

Guest Writers Profile

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

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

The 2020 Election: Statewide Ballot Measures

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

Abortion:  

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

Prohibits abortions after a fetus reaches 22 weeks gestational age. 

Louisiana: No Right to Abortion (Amendment 1) 

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

Civil and Constitutional Law 

Montana: Concealed Carry Laws (LR-130)

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

Criminal Justice

California: Voting Rights Restoration for Persons on Parole Amendment 

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

Drug, Alcohol, Tobacco Policy 

Arizona: Marijuana Legalization Initiative (Proposition 207) 

Legalizes the recreational possession and use of marijuana.

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

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

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

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

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

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

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

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

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

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

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

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

New Jersey: Marijuana Legalization (Public Question 1) 

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

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

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

Oregon: Drug Addiction Treatment Initiative (Measure 110)

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

Oregon: Psilocybin Program Initiative (Measure 109)

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

South Dakota: Marijuana Legalization Initiative (Constitutional Amendment A) 

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

South Dakota: Medical Marijuana Initiative (Initiated Measure 26)

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

Education

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

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

Health 

Arkansas: Practice of Optometry Referendum (Issue 6)

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

California: Regulation of Kidney Dialysis (Proposition 23)

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

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

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

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

Establishes a program for paid medical and family leave 

Oregon: Cigarette Tax Increase (Measure 108) 

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

What’s at Stake

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

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

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

Impact to immunizations

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

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

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

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

Impact to MTM

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

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

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

Impact to 340B

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

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

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

Impact to the pharmaceutical industry

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

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

Conclusion

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

Guest Writers Profile

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

The 2020 Presidential Election: Focusing on Health Care

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

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

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

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

The Affordable Care Act and Health Insurance Coverage

President Trump

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

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

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

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

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

Former Vice President Biden

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

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

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

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

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

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

Prescription Drug Prices

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

President Trump

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

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

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

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

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

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

Former Vice President Biden

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

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

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

What’s At Stake

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

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

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

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

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For more information on how to vote click here

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

Pharmacists tapped to provide COVID-19 vaccine in nursing homes

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

Summary of the announcements and what they mean

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

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

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

Potential implications

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

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

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

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

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

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

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

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

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

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

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

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

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

Medicaid

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

A close up of a map

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

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

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

The typical state story

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

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

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

The question of OLP and SPA

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

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

Tipping of the scale

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

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

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

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

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

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

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

Brief Rundown of the Current Supreme Court of the United States

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

The Future of Our Patients’ Rights and Healthcare

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

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

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

The Future of the Affordable Care Act

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

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

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

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

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

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

Presidential Debate Recap for Pharmacists

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

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

Healthcare

Biden

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

Trump

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

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

COVID

Biden

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

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

Trump

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

Racism

Biden

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

Trump

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

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

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