Pharmacists in the Spotlight: Federal Retail Pharmacy Program for COVID-19 Vaccination

The Federal Retail Pharmacy Program for COVID-19 Vaccination will launch this week with a goal to increase access to the vital vaccination across the United States. Early on in the pandemic, pharmacists were identified as trusted members of the health care team to provide testing and education to the public. As vaccines have become available, some states have already engaged pharmacists to assist with vaccination efforts, however, there have been calls to better utilize pharmacist in these efforts.  This program will expand pharmacies’ access to supplies and pharmacist’s opportunity to make an even greater impact on the pandemic. 

What is the Federal Retail Pharmacy Program for COVID-19 Vaccination?

This collaboration between the federal government, states, and numerous national pharmacy partners and networks of independent pharmacies, is part of the strategic plan to help meet President Biden’s goal of administering 100 million vaccines during his first 100 days in office (18 days into his term, 40.5 million doses have been administered in the US). Initially, select community pharmacies will receive limited supplies of the vaccines, the allocation of which is dependent on the number of people in the jurisdiction, number of pharmacies, and reach. For a complete list of participating pharmacies, and which pharmacies based on location will have supply during the roll-out phase, please visit the CDC website. Pharmacies who are not enrolled in the Federal Retail Pharmacy Program can enroll directly with a state or territory’s immunization program to offer vaccination in their communities. 

In addition to improving access, the program is believed to decrease logistical and operational burdens on state, local, and territorial health departments, as the vaccines will be provided directly to the pharmacies from the federal government. The CDC is also offering the Pharmacy Transfer Program, which allows states and territories to transfer allocated vaccine doses to the federal pharmacy partners. However, the states will remain responsible for determining the eligibility of the patients and phases of rollouts within the communities. 

Although this program may be a step in the right direction to improve access to vaccines, the initial list of participating pharmacies is restricted based on limited supplies, and new programs do not come without anticipated challenges. For patients who have not received services at the limited number of pharmacies with access, the pharmacy team will need to take time to create new patient profiles, including adding and assessing allergies, current conditions, medication regimens, and insurance information. The pharmacy team will also need to document vaccine administrations to ensure appropriate tracking, all while maintaining the high level of chronic and acute care needs required by patients. 

In our opinion, the biggest challenge we continue to face during this pandemic remains equitable access for all populations, especially our most vulnerable communities. Although the CDC states that they will continue to collaborate with states and territories to shift vaccine inventory as needed to ensure fair access, how can we ensure equitable administration of the vaccines?

Goal: Improve equitable access to vaccines

The Biden Administration states that the Federal Retail Pharmacy Program is a key component of the Administrations’ strategy to expand equitable access to vaccines for the American public. But will it?

The CDC worked with states and territories to select initial pharmacy locations that would provide access in the communities. Factors that were considered included the “number of stores, the ability to reach some of the populations most at risk for severe illness from COVID-19 (those over 65 years of age, socially vulnerable communities), and alignment with their existing vaccination plan.” Despite vaccine availability in these communities, there’s no guarantee the vaccines will be administered to the most vulnerable populations and providing vaccines in socially vulnerable communities may not prevent people from wealthier neighborhoods from signing up for doses at these locations. 

Additionally, people in underserved neighborhoods continue to experience barriers, including lack of transportation, ability to take time off from jobs to get to appointments, and skepticism about the vaccine, which this program does not address.  The CDC does note that this program relies on a collaboration with public health departments to encourage individuals to receive the vaccine and community outreach to educate on the importance of vaccination and where vaccines are available, though no specific plans are outlined. Furthermore, access to or difficulty navigating registration websites, or even the access to check online to see if a local pharmacy will be administering the vaccine, remains a barrier. 

Pharmacists are highly trusted and trained professionals to help with vaccine administration and increasing supplies of vaccines in the pharmacies may help, but innovative approaches such as mobile vaccination vans and partnerships with faith-based organizations may be key to overcoming some of the barriers that remain to equitable access to the vaccine

Pharmacist Reimbursement for Test and Treat – Guest Writer Parsa Famili

My interest in discussing how pharmacists should be reimbursed for performing diagnostic tests, including rapid strep, influenza, and H. pylori tests, as well as the pharmacists ability to furnish medications to appropriately treat the patient based on the test results, stems from the passion I developed for advocating for these services with our state pharmacy association in February. As members of the Texas Pharmacy Association, student pharmacists, including myself, pharmacists, and corporate leaders across the state participated in the Virtual Pharmacy Legislative Day at the State Capitol, during which we encouraged passage of a bill that would allow pharmacists to be reimbursed to “test and treat.” Specifically, the legislation would permit pharmacists who have protocols with physicians to write prescriptions for medications based on whether the patients receive a positive result from a CLIA-waived test like the Strep or flu test. As a reminder to our readers, a CLIA-waived test is a simple laboratory test that does not have as much risk of leading to a result that is not correct. Pharmacists in the state of Texas cannot prescribe medications for patients who receive a positive test result from the individual tests that the pharmacists perform on the patients. We believe that the legislation that we advocated for would prevent delays in care and allow the patients to recover faster from their symptoms while decreasing the spread of contagious diseases like strep or the flu. We also believe that the legislation would increase the patients’ access to high-quality care, reduce the amount of money the health care system has to pay for patients’ potential health complications from the diseases, and improve overall health outcomes for the patients. By allowing pharmacists to prescribe medications to patients who receive a positive result from a CLIA-waived test, we believe that the legislation would allow the patients to receive the proper treatment in a timely manner for their diseases.

An issue bigger than one state

The legislation that is being advocated for in Texas can and should be a priority for pharmacists across the United States. Right now, pharmacists in at least 16 states across the nation can perform diagnostic tests for conditions such as strep and influenza. In the states of Idaho, Illinois, Michigan, Minnesota, Montana, Nebraska, New Mexico, North Dakota, South Dakota, Tennessee, Utah, Vermont, Washington, and Wisconsin, pharmacists are permitted to prescribe medications to patients who test positive on a CLIA-waived diagnostic test pursuant to their collaborative practice agreement laws. Additionally, three states, Idaho, Kentucky, and Florida, have passed specific legislation that allows pharmacists to prescribe medications to treat strep, flu, and other non-chronic minor conditions upon receiving positive results from the diagnostic tests. Each of these states have different requirements, such as whether or not they use state-wide protocols or if it is through an agreement with a physician that these services can be provided. However, all result in the same increased access to pharmacists services and optimal care for patients. 

While it is wonderful that several states already allow pharmacists to have such authority, it is imperative that we push for legislation in the other 34 states and the District of Columbia to allow pharmacists to prescribe medications based on a positive diagnostic test result for acute and minor health conditions that a patient may have! That way, pharmacists can have even more power and direction to improve the health outcomes of patients and provide timely, accessible care to patients. In turn, pharmacists can play a vital role in minimizing the costs associated with the patients’ health conditions in the form of treatment for complications associated with untimely care and additional office or emergency room visits.

The impact of expanding access to test and treat

In the long-run, allowing pharmacists to prescribe medications to treat acute and minor conditions like the flu and strep would deepen the trust that pharmacists have with patients and other health care professionals. Pharmacists could also provide more information to patients about their medications and address any questions or concerns the patients may have. Because patients see pharmacists as approachable and non-judgmental in general, it would also be a boon in terms of providing more of a blame-free zone for the patients to discuss their health problems with regards to the minor and acute health conditions with the pharmacists. Having pharmacists integrated into this model would also provide an easy and accessible provider to follow-up with the patients to ensure appropriate treatment outcomes. Above all, pharmacists can improve the health outcomes of patients by alleviating the patients’ diseases effectively and efficiently.

Limitations to keep in mind

Some problems to keep in mind as we start to consider the idea of pharmacists providing “test and treat” services: the fact that patients generally still consider the physician as the one who primarily diagnoses their diseases, the fact that patients may not know that pharmacists can prescribe medications, and the fact that patients generally are unaware of the expanded role of a pharmacist. The end result is that the patients would feel less confident and comfortable about pharmacists prescribing medications to them. It is particularly important to consider these barriers as we continue to develop and implement these services. Going forward, it is crucial that pharmacists educate their patients about their roles in providing care and improving overall health outcomes while emphasizing that pharmacists have the expertise and training to prescribe the appropriate medications for the patients to treat their conditions. That way, patients can feel more confident and trust that the pharmacists can best manage their acute conditions in collaboration with other health care professionals.

Advocate for a positive future

The future for pharmacists in terms of prescribing medications for acute conditions like the flu or strep after obtaining results from diagnostic tests is bright. Pharmacists have the ability to shape health care for years to come if they gain the ability to conduct diagnostic tests and prescribe medications to patients based on the results of the tests. As we have seen during the pandemic, it is essential for pharmacists to be at the forefront of managing patients’ acute conditions. By doing so, the patients could avoid a trip to either their physician’s office or to the emergency department for a preventable situation. Pharmacists can already administer vaccines and conduct health screenings for other conditions like blood pressure or blood glucose checks. Pharmacists have the appropriate knowledge about medications and health conditions to make decisions that best manage the patients’ conditions. The legislation that we advocated for in Texas is just the beginning of a long road to prove to both health care professionals and patients that pharmacists can play a pivotal role in managing patients’ health instead of being health care professionals who just dispense medications.

Guest Writers Profile

Parsa Famili is currently a third-year pharmacy school student at Texas Tech. He is passionate about expanding the services that pharmacists provide to patients! Parsa was the Policy Vice-President of his APhA-ASP chapter last year. In addition to APhA-ASP, he also serves as a Pharmacy Legislative Week Representative, is a member of the Public Policy Council as a part of the Texas Pharmacy Association, and is a member of Phi Lambda Sigma. In addition to health policy, Parsa is also interested in possibly pursuing any of the following after graduation: retail pharmacy, ambulatory care, or critical care.

Provider Status Explained: What Pharmacists can do to advocate for Provider Status

Last week we got some incredibly exciting news  with the introduction of H.R. 2759 – The Pharmacy and Medically Underserved Areas Enhancement Act — into the United States (U.S.) House of Representatives. This bipartisan piece of legislation was introduced by Representatives G.K. Butterfield (D-NC) and David McKinley (R-WV). As a quick reminder, this bill would increase access to pharmacists provided care in medically underserved areas by allowing for the reimbursement of services under the Medicare Part B benefit. We have already covered on the blog why pharmacists need provider status along with how pharmacists can be recognized as healthcare providers on the federal and state level. With this legislation officially introduced, now is the time to cover what we can do to advocate for this monumental advancement in patient care.

The necessity of grassroots advocacy

For many seasoned members of the profession, the introduction of a provider status bill in Congress may cause them to roll their eyes and say, “Here we go again. Another campaign that won’t work.” We can understand that reaction, as there have been nine provider status bills introduced in Congress over the past 20 years (107th, 108th, 109th, 110th, 111th, 113th, 114th, 115th, and now the 117th Congress). Although it can be disheartening not to see the passage of a bill, it is important to recognize that this is just a part of the legislative process as the advocacy and education that happens during each campaign builds momentum.

The long-term goal is to recognize pharmacists as providers under the Medicare Part B benefit. However, we cannot lose sight of the short-term goal: to provide education on the value of pharmacist-provided care. As we have described in previous posts, educating the public is an incredibly important piece of advocacy. If we can educate more members of the public on this issue through this advocacy campaign, it would be a major success.  Ideally, this education would result in their support of our perspective on the issue and could further translate to additional advocacy efforts to elected leaders. Grassroots advocacy is in itself a form of influence. You hope that your perspective will influence your elected leaders in a way that will move them to active support. Influence takes a long time and often requires the formation of a relationship.

Addressing opposition through action

It may be surprising to think there would be an active opposition to pharmacists being recognized as healthcare providers, but unfortunately there is. The American Medical Association (AMA) passed official policy in 2012 within their House of Delegates (HOD) opposing expanded pharmacist scope of practice and pharmacist provider status. Just to be clear, there has been no indication yet that the AMA opposes H.R. 2759. However, as the AMA is a membership organization and the membership passed policy in their HOD, there should be no expectation that they would change their lobbying efforts without similar action in the HOD or action from their Board of Trustees. 

The AMA is definitely unrivaled when it comes to lobbying power. As you can see from the data pulled below from OpenSecrets.org, the pharmacy profession’s political action committees (PAC) and lobbying expenditures are significantly lower than many medical associations. Before you panic and think there is no possible way to overcome all that political leverage, know that your voice as a constituent is more powerful than that of a lobbyist. In fact, research from the Congressional Management Foundation has proven exactly that. But it is important to note that you have to use your voice in order to tap into that power. If you want examples of bills the AMA lobbied against but were eventually passed, look no further than Medicare, Medicaid, and the Affordable Care Act. This number goes even higher when you consider the numerous types of regulations that executive agencies have issued over objection letters from the AMA. Although it took a long time for these bills to pass, it is important to recognize that opposition is no reason to remain quiet. It may actually be more of a reason to speak up!

In addition to the importance of grassroots advocacy and connecting with your elected leaders is the importance of joining and regularly contributing to professional associations. Of course, before making a contribution to any PAC, it is important to research the PAC. We recommend reading their most recent annual report and ensuring that their donations align with your expectations prior to becoming a contributor.

Communicating with your elected leader

We have covered in previous blog posts different ways to connect with your elected leader depending on the amount of time you have to invest, from 60 seconds to an hour. A great resource to utilize is the Action Center provided by the American Pharmacists Association. By entering in your contact information, you can quickly find your Congressional representatives and will be provided with a template letter. Now, the next step is incredibly important. Instead of just pressing send, take a few moments to personalize the letter. Research has shown that standardized form letters are a less effective method to influence legislators, but taking a few moments to share a personal story and why this bill is important to you and your patients will go an incredibly long way.

Connect to elected leaders’ constituency

As elected leaders in a representative democracy, our members of Congress have an inherent self-interest to support legislation that can directly improve the lives of those constituents who live in their district. Therefore, when advocating for an issue, it is vital to connect the impact of whatever you are advocating for to the constituency of the elected leader. Don’t make promises that constituents will vote for them if they support a piece of legislation (AKA quid pro quo), but help elected leaders make the connection that a piece of legislation will benefit their constituents.

The Pharmacy and Medically Underserved Areas Enhancement Act would directly increase access to care for Medicare beneficiaries in medically underserved areas. For the purpose of this blog post, we don’t need to get into too much detail around underserved areas. But you should know they are designated by the Federal government, there are different types, and they are areas that don’t have enough medical professionals to support the population. Therefore, an easy connection you could make for an elected leader is that the Pharmacy and Medically Underserved Areas Enhancement Act would increase access to care for their constituents specifically in these needed areas.  

If you look across the continental U.S., you can see that a significant majority of the country is designated as underserved. We created the map below which shows these underserved areas in purple.

Let’s take a closer look at a case example of Ohio. In the below map, underserved areas are designated as a shade of blue, with darker shades of blue depicting that an area has been designated as several different types of a medically underserved area. We overlaid this over a map of Ohio’s 16 Congressional Districts which have been labeled with their respective number. As you can see, there are underserved areas in every member’s district, but some members have more underserved areas than others. For example, Representative Steve Chabot from District 1 has nearly no medically underserved areas in his district as compared to Representative Steve Stivers from District 15, whose almost entire district is an underserved area.

Helping your elected leaders to see how this legislation directly connects back to their district is vital. Follow these links to search for medically underserved areas and health professional shortage areas in your home state.

Advocate smarter, not harder

Given the bill’s focus on pharmacy, it is no surprise that the majority of our profession supports this legislation. However, it is important for our members of Congress to hear our support from us. But, if you only have minimal capacity to advocate for this important bill, consider the impact individuals outside the profession of pharmacy could have. Physician or nursing colleagues,  and even patients, can provide an incredibly effective voice in supporting this bill. Support of physicians can especially help to showcase that the potential opposition of the AMA is not truly representative of the physician community. So many pharmacists have incredible partnerships with other members of the healthcare team and with their patients. It is important to help members of Congress see that the passage of this legislation is not only important to members of the profession of pharmacy, but also to other members of the healthcare team and to our patients.

The focus is the patient

One of the reasons we started this blog is because we have seen a lot of misinformation shared on social media regarding health policy issues that impact pharmacists. We have seen a lot of posts similar to the one below that implies that provider status will dramatically increase pharmacists’ salaries.

The impact of provider status on the pharmacist salary likely deserves its own blog post, but regardless, this should not be the motivation for passing this legislation. The Pharmacy and Medically Underserved Areas Enhancement Act would increase access and efficiency of healthcare. We advocate for this bill because it could help patients. End of reason to care about an issue. Period.

How to track advancements of provider status

If you are interested in staying up to date on this legislation, there are several options for you. Of course, we encourage you to follow the blog as we will keep providing updates as they happen. Joining professional associations will also allow you the opportunity to stay informed on this bill. Another way is to track the legislation yourself and sign up for alerts on Congress.gov.

Now is our time to act as advocates for increased access to pharmacist-provided care. There have been decades of efforts providing education to members of Congress on the role and value of the pharmacist. We can build upon that education to reach for the ultimate success of the pharmacist recognized as a provider under the Medicare Part B benefit. Grassroots advocacy never stops, and the future for patient care holds so much opportunity.

We The People: Voter Suppression and Its Effect on Pharmacy & Health

Civic participation, including voting in local, state, and federal elections, ensures that all people can advocate for issues that concern them, including education, transportation, and of course, health. The impact of an individual’s right to vote is enormous. Voting specifically allows all American citizens the right to choose who will serve them as local and national leaders and in numerous ballot measures. Ballot measures and the subsequent decisions of those elected leaders can have short-term and long-term implications to the practice of pharmacy and access to health care for individuals living in the United States. 

Fifty-six years ago the Voting Rights Act was signed into law by President Lyndon B. Johnson, which was enacted to remove barriers to political participation by racial and ethnic minorities and prohibit any practice that denies the right to vote on account of race. However, in 2013, the Supreme Court case Shelby v. Holder invalidates Section 5 of the Voting Rights Act, which required that counties with a history of discriminatory voting practices obtain congressional approval before making any changes to election policies. Since then, numerous laws have been passed that prohibit many individuals from being able to participate in this fundamental right. 

In addition to not reflecting the voices of all of the people, voter suppression can have a significant effect on the health and well-being of those who are silenced. Not only does this impact the over 114,000 pharmacists who are racial minorities, but more importantly it can impact millions of our patients. As healthcare providers, it is important we understand the different elements that influence health and advocate on behalf of our colleagues and patients to ensure overall health and well-being – including opposing the silencing of our community members through voter suppression. 

Voter Suppression Efforts

Democracy is described as having four basic elements: a political system for choosing and replacing the government through free and fair elections; the active participation of all people in politics and civic life; protection of the human rights of all citizens; and a rule of law, in which the laws and procedures apply equally to all citizens. Therefore, voter suppression of one or more specific groups of people compromises our democracy. 

There are several efforts being made to suppress voting, primarily for minority groups. Voter registration restrictions, including requiring specific identification to register or limiting the times during which individuals can register, may influence voter participation. Voter ID laws create significant barriers, especially in the states that have strict photo ID laws, with over 21 million United States citizens not owning a government-issued photo identification and as many as 13 million citizens not having ready access to the documents required to obtain an ID. Additionally, the cost to obtain an ID or the documents required to obtain an ID leads to additional burden on low-income communities. You can learn more about your state’s voter ID laws here

More significantly, states have been found to wrongfully purge eligible voters from the voting rolls. Voter purges are often conducted to remove voters who have changed addresses or died. However, if not done appropriately, these purges can prevent eligible voters from being able to cast their ballot. A NYU Brennan Center for Justice report describes error rates in voter purges as high as 17%. Other forms of voter suppression include the various rules for convicted felons in each state, as well as gerrymandering, AKA redistricting states to manipulate the results of an election. This often favors one political party and therefore dilutes the power of the voice and confidence in the vote of the minority group.

Voter Suppression and the Relationship to Health

In “The Right to Vote, the Right to Health: Voter Suppression as a Determinant of Racial Health Disparities”, Anna Hing outlines the various ways in which voter suppression harms health and well-being. Several of these pathways are listed below:

1.     Voter suppression creates group-level exclusion. This exclusion primarily reduces voter turnout for racial minorities. Silencing of various groups may result in passing of policies that influence known determinants of health, such as who receives public assistance, how schools are funded, public transportation, and zoning of neighborhoods. 

2.     Disenfranchisement influences an individual’s social position in society. Disenfranchisement can lead to individuals experiencing loss of control and disempowerment, which not only has a direct impact on well-being, but also can lead to less resources to defend against increased discrimination and subsequent stress.

3.     Voter suppression may take place through psychosocial processes which influence health. These psychosocial processes, such as more commonly checking identification for voters of color than for White voters, may lead to consequential effects of discrimination and psychosocial distress. Additionally, negative coping behaviors to overcome this distress, such as substance use, may adversely affect health. 

4.     Voter suppression may manifest as physical violence, hate crimes, or secondary direct effects on health. If a voter has to wait in line in extreme heat for many hours because other poll sites have been closed, they may be at higher risk for adverse events, such as asthma and COPD exacerbations, or hyperthermia. 

5.     Health disparities reinforce voting disparities. Those who are ill are less likely to vote. For example, premature death of African Americans translated into one million Black votes lost in the 2004 Presidential Election.  

6.     Simply put, voter suppression determines who can and cannot vote. This can create stigma for those who cannot vote, which has been associated with internalized racism and subsequently increased metabolic risk, cortisol secretion, and mental health illnesses, including depression. 

Many, including The Grassroots Pharmacist team, argue that health is influenced by many policies, outside of those that have a traditional direct tie to health (for example, access to housing and environmental policies). Although the relationship between voter suppression and health is not proven, evidence shows strong associations and as noted above, it is clear how voter suppression can exacerbate racial health disparities and vice versa. One of the overarching goals of Healthy People 2030 is to eliminate health disparities and achieve health equity. The report states “Achieving health equity requires valuing everyone equally with focused and ongoing societal efforts to address avoidable inequalities, historical and contemporary injustices, and the elimination of health and health care disparities.” As such, eliminating barriers to vote and allowing all people to become involved in civic engagement is essential to ensuring health of our communities in the coming years. 

A Call to Action: Ensuring All Voices are Heard

This is a critical time for us to advocate for the removal of barriers to voter accessibility and encourage our legislators to pass laws that protect all individual’s rights to vote. The For The People Act of 2021, which passed in the House of Representatives and was introduced in the Senate in March 2021, expands voter registration, including online, automatic, and same-day registration, and voting access, by allowing for vote-by-mail and early voting. Additionally, it limits removing voters from voter rolls and requires states to establish independent redistricting commissions to carry out congressional redistricting. This bill also addresses election security, campaign finance, and ethics in all three branches of government. The John R. Lewis Voting Rights Act, which was originally passed in the 116th House of Representatives but made no progress in the Senate, is also expected to be reintroduced during this Congress. This Act would restore the components of the Voting Rights Act which were invalidated in the Supreme Court Shelby vs. Holder case, thereby requiring pre-approval from the Department of Justice or the US District Court before making legal changes that would affect voting rights. 

As healthcare providers, it is our duty to advocate in the best interest of the health and well-being of all of our patients. We the people means all the people, and voting should remain a fundamental right, not a privilege, for all of the people.

What Pharmacist Advocates Need to Know – March 2021

Another month has gone by, which means it’s time for an edition of the Monthly Roundup. This has been an incredibly busy month in health policy, and we have done our best to compile the highlights for you. From a new COVID-19 relief bill to the approval of a new vaccine, there is a lot changing that’s important for pharmacists to understand.

And with that, here is what you need to know from March 2021


The American Rescue Plan Act

On March 12, 2021, President Biden signed the American Rescue Plan (ARP), the first signature piece of legislation of his presidency. The $1.9 trillion package provides significant relief to individuals and businesses to help combat the COVID-19 pandemic and subsequent economic crisis. While most people may be more familiar with provision providing $1,400 stimulus checks, the ARP will have enormous effects on the U.S. healthcare system and is set to be the single largest expansion of health care coverage since the passage of the Affordable Care Act (ACA). A summary of health care provisions are included below: 

  • Funding to set up a national vaccination program in order to reach communities across the country as quickly as possible, including communities of color and rural areas 
  • Funding for disease surveillance, including testing, contact tracing, PPE, and genomic sequencing
  • Investments in the health care workforce, including funding for public health workers, community health centers, and mental health providers 
  • Providing 100 percent subsidies for COBRA coverage for people who have lost their jobs or who have seen their hours reduced 
  • Increased funding for Medicaid expansion incentives and for ACA Marketplaces
  • Expanded subsidies for ACA Marketplace insurance plans and elimination of the 400 percent subsidy cliff, which will drastically expand affordable coverage for millions of people

Read More: Impact of Key Provisions of the American Rescue Plan Act of 2021 COVID-19 Relief on Marketplace Premiums

Approval of the Johnson & Johnson Vaccine

At the end of February, the Food and Drug Administration (FDA) voted to issue an Emergency Use Authorization (EUA) to the Johnson & Johnson vaccine. This vaccine is a single-shot vaccine and is largely seen as a cost-effective alternative to the Pfizer and Moderna vaccines. It does not have some of the same storage challenges that the Pfizer and Moderna vaccines have, and therefore can easily be used in more rural communities. In preventing serious disease, the Johnson & Johnson vaccine is just as effective as the Pfizer and Moderna vaccines. 

Read More: Got Questions About Johnson & Johnson’s COVID-19 Vaccine? We Have Answers

New Guidelines for Vaccinated Individuals 

On March 8, the Centers for Disease Control and Prevention (CDC) issued the first set of public health recommendations for fully vaccinated people. According to the guidance, fully vaccinated people can now visit each other without wearing masks or social distancing. They can also visit with unvaccinated people from a single household, if they are at low risk of getting severe disease. The CDC has also said that fully vaccinated individuals no longer need to quarantine if they come in contact with someone who has tested positive for COVID-19 and are not symptomatic.

Read More: Interim Public Health Recommendations for Fully Vaccinated People

Increased Medicare Payment for COVID-19 Vaccine

On March 15, Andy Slavitt, a senior advisor for the federal COVID-19 response, said that the Medicare reimbursement rate for vaccines would be nearly doubled. Prior to the announcement, the Medicare reimbursement rate was about $23. Now the reimbursement rate is $40 per shot, giving providers $80 for a two dose regimen. This change was done as a result of a provision in the American Rescue Plan, requiring no out-of-pocket costs for beneficiaries. The move is likely to make it easier for providers to go into communities to provide vaccinations, and will improve access for the elderly and low-income communities. 

Read More: Biden-Harris Administration Increases Medicare Payment for Life-Saving COVID-19 Vaccine

The White House 

Senate Confirmation of Key individuals to Lead the Department of Health and Human Services 

This past month, the Senate also confirmed three individuals who will lead massive health care initiatives at the Department of Health and Human Services (HHS). The Senate voted  to confirm Xavier Becerra as the Secretary of HHS. The Senate also voted afterwards to confirm Dr. Vivek Murthy to his previous role as Surgeon General under the Obama Administration, and Rachel Levine as Assistant Secretary of Health, making her the first trangender individual approved by the U.S. Senate. These individuals have an incredible challenge ahead as they try to navigate the country out of the pandemic and tackle the rest of President Biden’s health care agenda. 

Read More: 2 More HHS picks hit the Hill

Access to Health Care for Newly Arriving Immigrants

As there often is around presidential administration changes, there has been a recent dramatic increase in the number of migrants seeking to enter the U.S. During times of processing, migrants may be held in immigration detention centers. We have previously written about how there has been limited access to healthcare in these detention centers and even reports of inappropriate care being provided. Due to the large number of migrants currently at the U.S.-Mexico Border there has been reports of children being held in detention centers longer than legally allowed. There have not been recent reports of limits to health care access or inappropriate administration of care in detention centers, however, there is risk that without widespread structural changes to the immigration detention center system that issues have remained. 

Read More: On Mexico’s Border With U.S., Desperation as Migrant Traffic Piles Up

Here’s what else you need to know: 

Legislation We Are Tracking: 

Articles/Papers We Are Reading:

Advocating for the mental health of pharmacists and their patients – Guest Writer Amy Reese

Mental health concerns are a lurking crisis in America that have only been increased by the COVID-19 pandemic. According to the Centers for Disease Control and Prevention (CDC), 19% of adults in the United States struggled with a mental illness as of 2018. As of 2019, of the 19.2% of adults who received treatment for a mental illness 15.8% of them received a prescription. Compliance for psychiatric medications are known to be dismally low ranging around 50% of adherence for depression, 50-60% for schizophrenia, and 35% for bipolar affective disorder. The COVID pandemic has brought difficult times on many people: mental health concerns have escalated since the beginning of this unprecedented time.  Since the COVID-19 pandemic, 40% of adults reported increased conditions associated with mental health issues. We are living in extraordinary times which have greatly impacted people’s mental well-being and this elevated mental health crisis since the COVID-19 pandemic has increased the number of prescriptions for mental illness. 

A community pharmacists experience

As a community pharmacist, I see how pervasive mental health concerns are. Mental health does not only involve the patients who pick up prescriptions for SSRIs or antipsychotics, but it also has to do with the patients who have diabetes and the patients with osteoarthritis. Mental health issues do not only affect the psychiatric patient who picks up her risperidone and divalproex every month. It can also mean the patient with diabetes who gets too depressed from her life situation and doesn’t take her insulin or the patient with hypertension who struggles with anxiety, leading to difficulties taking his lisinopril regularly.

During this pandemic, many people have struggled with isolation and loneliness; some of these people turn to the pharmacist for an ear to hear their worries and sorrows. Community pharmacists are the most accessible healthcare provider available to serve the community. Many patients have opened up to me about their anxiety, their hopelessness, and their sadness. I have seen an uptick in prescriptions for anxiety since the pandemic. I know many other pharmacists have seen this burgeoning of prescriptions for anxiety medications. Personally, I have noticed more younger females receiving medications due to their struggle with anxiety than other groups but that may just be because of the population I serve. When counseling on a new prescription for anxiety, I talk to my patients about breathing exercises, walking outside to ease anxiety, and the importance of therapy in conjunction to medication such as Cognitive Behavioral Therapy (CBT). When I counsel on a new antidepressant, I ingrain the importance of taking the medication every day to ensure the medication is effective; I discuss self-care and the importance of therapy also. My goal is to convey a message that there is no stigma of mental illness when they talk to me. 

I want to address the deeper issues of mental health during a counseling session and be able to have resources to refer patients. As a pharmacist, I am not able to do everything the patient needs but I want to be the first line of defense for hope and resources as the most accessible healthcare provider. People need connection, especially during this unprecedented time. Pharmacists have truly showed up fully to this national crisis, but we can do more to serve our patients. 

The role of community pharmacists

Community Pharmacists ought to be trained to deal with mental health issues in all types of patients deeper than just counseling a patient on his/her/their medication or making pharmacotherapeutic recommendations. We may not be therapists, but we need to be able to know how to navigate the key issues of mental health conditions. I have the ability to talk to patients about some mental health concerns such as anxiety and depression from seeing friends and family struggle with these burdens, but I lack the training to make a deeper connection with these patients. Making connections with patients in a deep meaningful manner can enhance their lives significantly. David Woods Bartley gave a TEDx Talk about how connection saved his life. He opened up about how clinical depression had taken a hold of him and convinced him to commit suicide. He was on a bridge about to jump to his death when an EMT made a connection with him which gave him hope. Mr. Woods Bartley stresses how connection gives each one of us hope and how hope saves lives. How many times do you think a pharmacist has saved a life of a patient through connecting with that person? We cannot always tell who suffers from clinical depression; it could even be the happy nationally-recognized achiever such as David Woods Bartley. Martin Rubin, MD, a psychiatrist at Kaiser Permanente in Sacramento, California recently gave a talk about the mental health crisis in this country. He stated that pharmacists are in a unique position to connect with patients: pharmacists know what ailments the patients has due to their medication indications and pharmacists may be the only human interaction that a patient has in a day.

In creating deeper connections with patients, pharmacists should also have the knowledge of resources to refer patients. Pharmacists can refer patients to organizations such as National Alliance for Mental Illness (NAMI) which connects people who are working to overcome mental illness to support groups and social workers who can better address each individual’s needs. NAMI has a hotline to talk to a person; the organization developed a hotline specifically for COVID-related mental illness because they realized the pandemic has been difficult for many people. One branch of NAMI is partnering with its local police department to connect all the patients who are held under an involuntary psychiatric hospitalization have resources to cope with their illness when they are released. If NAMI could be a resource for pharmacists as it is to police departments, maybe we can alleviate some of the mental health crisis occurring in this country one person at a time.

Advocating for change

Despite pharmacists’ obvious role in providing mental health services, there are barriers that limit patient access to these services. The most obvious of these barriers include restrictive state scope of practice laws that limit patient access to services provided by the pharmacist and lack of an ability to directly bill for the services provided (provider status). The latter disincentives the businesses pharmacists work for to allow them the time they need to provide these mental health services. Advocating for expanded scope of practice for pharmacists and provider status can be effective ways to increase access to these mental health services.  

In addition to increasing the prevalence of pharmacists in providing mental health services to our patients, it is imperative that mental health considerations for members of the profession be prioritized as well. Studies have shown that pharmacists experience a high degree of burnout, over 50% in health-systems and nearly 75% in community pharmacies! This high rate of burnout could contribute to higher rates of suicide and rates of substance use disorder within the profession. This is an unsustainable issue and needs to be addressed in order to ensure both pharmacist and patient safety. National pharmacy associations have taken up the cause of advocating for the mental health of pharmacists but more help is needed. In addition to advocating for policy changes to address the underlying system that contributes to these mental health effects, advocating within organizations can be effective to raise concerns about both employee and patient safety.

The pharmacist has a definite role in providing mental health services to our patients. By advocating for policy to expand these efforts, our patients can receive greater access to the care we provide while we fight for a system that appropriately cares for the practitioners wellbeing as well.

Guest writer profile

Amy Reese currently works as a community pharmacist at Wal-Mart Pharmacy in Southern California and a mass COVID vaccination clinic at Loma Linda University. She graduated from Loma Linda University School of Pharmacy in 2019. She completed a Masters degree in Bioethics through Loma Linda University School of Religion while she was in pharmacy school and graduated with her MBe in 2018. After pharmacy school, she went on to do a fellowship at Sherwin B. Nuland Summer Institute in Bioethics at Yale Interdisciplinary Center for Bioethics, Yale University. Dr. Reese started working in community pharmacy in 2019 and is passionate about the intersection of bioethics and pharmacy practice.

Monthly Roundup – February 2021

It is hard to believe, but we at The Grassroots Pharmacist have been putting out content and resources for nearly a year. During the first year of the pandemic, we saw such dramatic health policy changes happening so frequently that it warranted continual blog posts on all that was changing. As we look forward, and less frequent health policy changes occur, we wanted to identify a more sustainable way to inform and empower pharmacists to be involved in grassroots advocacy efforts. That is why we will be publishing a monthly roundup of legislative and regulatory updates relevant to pharmacists moving forward. Many of the topics discussed on these monthly roundups should not only be viewed as us sharing information with our readers, but as calls to action to increase civic engagement and discourse on issues that directly and indirectly relate to pharmacists and the communities we serve. There is so much room for improvement in the healthcare system, and active civic engagement is necessary to ensure advancements in the delivery of quality, equitable, and accessible healthcare.

So with that, let’s get started. There is no time like the present to advocate for the change we hope to see in the world.

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There has been a lot of action in the new Congress with the reintroduction of bills that died at the conclusion of the last Congress and discussions on the next COVID package. Here are a few of the top bills we are tracking:

American Rescue Plan 

Of course, much of the focus of Congress and the new administration has been on President Biden’s American Rescue Plan. This $1.9 trillion stimulus package is planned to move forward in the coming weeks utilizing the budget reconciliation process in order for Democrats to pass the law without any Republican support. Key provisions of this bill that are relevant to pharmacists include:

  • The creation of a national vaccination program that would include the creation of community vaccination sites nationwide. Pharmacists have already been tapped by the administration in expanding COVID vaccine efforts, and would likely be a key piece of this national vaccination program
  • Increasing equitable access to the COVID vaccine by ensuring access to those in underserved communities
  • Expand access for employers of frontline workers to Occupational Safety and Health Administration (OSHA) grants to ensure workers are protected from unsafe working conditions
  • Expand the subsidization of COBRA health benefits through September for those that lost employment and thus health coverage during the pandemic

S. 298: Pharmacy Benefit Manager Accountability Study Act

Introduced by Senator Blackburn (R-TN), this bill would require the Government Accountability Office to study the role of pharmacy benefit managers (PBMs) in the drug supply chain and submit a report to Congress. This bill was introduced in the last Congress (S. 1532/H.R. 3223), though it did not make any progress and gained minimal cosponsors. If the language of S. 298 is consistent with the last version of the bill, the report that would be submitted to Congress would include 1) the state of competition in the PBM industry, 2) the use of rebates/fees by PBMs and who the rebates benefit (patients, payors, or PBMs), 3) if PBMs structure formularies to prioritize high-rebate drugs over lower-rebate drugs, 4) average prior authorization time, 5) analysis of step therapy, and 6) the extent of spread pricing.

The bill has been referred to the Senate Health, Education, Labor, and Pensions (HELP) Committee, which is chaired by Senator Patty Murray (D-WA). Although Senator Murray has supported legislation in the past that looked to reign in PBMs, S. 298 is currently only supported by Republicans, giving it a low likelihood of being prioritized for a committee hearing. If the profession of pharmacy would like such a bill to advance, grassroots efforts should be focused on drumming up bipartisan support for the bill, especially for constituents whose members serve on the Senate HELP Committee.

H.R. 153: Protecting Consumer Access to Generic Drugs Act

Introduced by Representative Bobby Rush (D-IL-1), this bill would prohibit brand name drug manufacturers from paying generic drug manufacturers to delay bringing generic drugs to market. This is one of those bills that leaves you scratching your head and thinking, “Wow…we need a bill for this? This isn’t already illegal?” Well, unfortunately it’s not, and the Federal Trade Commission estimates it’s resulting in $3.5 billion in higher drug costs per year. H.R. 153 would prohibit drug manufacturers from agreeing not to compete with each other in what is referred to as “pay-for-delay.” Banning these anticompetitive deals would benefit patients by ensuring that they have greater access to generic medications.

Versions of this bill have been introduced since 2007. The current bill has been referred to the House Energy and Commerce Committee and the Judiciary Committee. It has gained 15 cosponsors so far, and according to GovTrack and Skopos Labs has a 46% chance of being enacted, which is one of highest rated probabilities of any health-related bill in Congress right now. However, a companion bill has not yet been introduced into the Senate, which means there are still many steps ahead for this bill if it has any hopes of passing into law. 

H.R. 280: PDMPs Help Patients Act of 2021

Introduced by Representative David McKinley (R-WV-1), this bill would create a pilot program in five states to integrate a substance use disorder (SUD) and behavioral health treatment locator tool into their prescription drug monitoring programs (PDMP). This tool could then be utilized by health care providers if they suspect misuse or abuse to refer patients for treatment or an assessment. The language of this bill does not specify which health care providers this would apply to. However, with more than half of states requiring pharmacists to register with their PDMP, it would not be surprising if additional expectations may be placed on the pharmacist as a result of H.R. 280. Assuming the implementation of such a policy is done in a way that does not result in significant more burden on the pharmacist, the profession would be in a key and accessible position to provide counseling to patients for SUD assessment and treatment.

This bill does have bipartisan support, but has gained minimal cosponsors and may not make much progress in the current Congress. 

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Things have slowed down a bit on the regulatory side as the new administration works to get its legs under itself. Below are some of the big updates over this past month:

Chiquita Brooks-LaSure to be nominated CMS Administrator

A past Obama Administration official, Ms. Brooks-LaSure brings with her decades of experiences including roles in the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health & Human Services (HHS). She previously played a large role in the crafting and implementation of the Affordable Care Act (ACA). Ms. Brooks-LaSure has not spoken publicly in the past regarding pharmacy/pharmacist policy, so it is too early to say where she will align herself on some of the policy priorities of pharmacists. Given her past work on the ACA and the resulting increase in access to healthcare for millions across the country, one could make the argument that she could be supportive of further leveraging health care professionals, such as pharmacists, to further increase access to care.

Delays in effective dates of regulations

A normal course of action for new presidential administrations is to place a regulatory freeze on the work that agencies were completing under the direction of the past administration. There are two regulations that have been delayed in being implemented that are relevant to pharmacists. The first is a program that would have required the use of an electronic prior authorization program for Medicare Part-D covered medications. This rule was set to go into effect on February 1, 2021, but has been delayed to March 30, 2021 in order for the new administration to further review the rule.

The second rule is related to pharmaceutical rebates, point-of-sale of medications reductions, and PBM fees. This rule makes three changes under safe harbor regulations within the anti-kickback statute in the Social Security Act. First, protections will be removed that allow PBMs to reduce the price of medications in connection with the sale or purchase of the medication from manufacturers or plan sponsors under Medicare Part D. Second, protections are set in place for certain point-of-sale reductions in prices. And finally, new protections were added for fixed fees that manufacturers pay to PBMs for the services they provide. This rule has been delayed until March 22, 2021, but may be delayed further due to pending litigation from the Pharmaceutical Care Management Association.

Now is the time to take action

Civic engagement should not be limited to voting at the ballot box. Engaging in grassroots advocacy can happen throughout the year and as legislation and regulation advance. As healthcare professionals, our viewpoints and passion for our communities are important perspectives to our elected leaders. Take this moment to reach out to your elected leaders regarding the issues above, or any issue you are passionate about. Our collective voice and vision for a better healthcare system is exactly what needs to be shared during these times of great potential.

Budget Reconciliation and the Possibility for Pharmacy

This week you’re going to hear the same two phrases… a lot. Budget resolution and budget reconciliation. We’ve provided an overview of The Budget Reconciliation Process in a previous blog post, but this time we wanted to get a bit more in depth, especially since a closely divided Congress may end up using the reconciliation process more frequently as a way to pass substantial health policy. 

The Budget Resolution

Earlier this week, the House Committee on the Budget released the 2021 Budget Resolution, a framework that will guide Congress as it seeks to pass President Biden’s American Rescue Plan, a $1.9 trillion proposal aimed at responding to the pandemic and providing economic security for those affected by its consequences.  

Simply put, the main purpose of the budget resolution is to define a process by which Congress will consider budget-related legislation that addresses federal spending, revenue, and debt. While it is true that Congress is required to pass a budget for each fiscal year (October 1 – September 30), this process rarely happens in one bill. Usually, there are multiple budgetary measures that establish fiscal policy. 

The Budget Process 

Usually the budget process begins at the beginning of each calendar year (January-February), with the President submitting a budget proposal to Congress. While the President’s budget does not have any legal authority, the submission is intended to reflect the President’s policy priorities for the following fiscal year, and offers a series of recommendations related to funding federal programs and changes in revenue (e.g. taxes). This budget also gives Congress a good idea of what the President will or will not sign when the final budget passes both chambers and requires a signature from the President. 

After submission of the budget proposal, Congress sets to issue a budget resolution. It is important to remember that the budget resolution itself does not go to the President and cannot become law. The budget resolution instead is an agreement between both chambers of Congress on what the federal budget ought to be and the funding levels delegated to each category of federal spending (e.g. National Defense, Medicare, Social Services, etc.) While it does not have the effect of law, the budget resolution is enforceable in Congress and can be used to contest legislation that is being introduced based on the resolution. 

The Budget Reconciliation Process 

Sometimes, the budget resolution will include reconciliation instructions that direct Committees to enact legislation within each committee’s jurisdiction to meet agreed upon changes in revenue, spending, or the national debt. These instructions are incredibly specific in that they identify specific committees in Congress, and how much spending needs to be reduced or increased, on programs within that Committee’s jurisdiction. The Committee then has full autonomy on policy changes it takes to meet that target. These policies are then usually bundled together into an Omnibus package and passed through both houses. Omnibus may be an unfamiliar word, but you likely better know past Omnibus bills by their acronyms, like COBRA 85 (Consolidated Omnibus Budget Reconciliation Act of 1985).

One unique aspect of the budget reconciliation process is the fact that unlike regular order legislation, the bills passed through reconciliation are limited to 20 hours of debate and only require 51 votes in the Senate. Usually, bills considered by the Senate have no time limits and require 60 votes to end debate – known as cloture – to be considered for a vote. Because of this rule, the minority party in the Senate can often block bills from being brought up for consideration by threatening to filibuster the bill. The reconciliation process prevents that from happening. 

The reconciliation process has been used 26 times by Congress, the most recent being the Tax Cuts and Jobs Act, which passed both houses of Congress and was signed into law in 2017.  

Limits to the Reconciliation Process 

So if Congress has a method to pass votes with simple majorities in both houses, why doesn’t the majority party use it more often? There are predominantly two reasons. First, the reconciliation process is often seen as incredibly partisan. If one party controls both chambers of Congress, they technically do not have to work with anyone in the other party to enact major policies, as long as they get enough votes to cross a simple majority. This is often seen as divisive and can prevent members from working together on other legislation in the future. As divided as the country is today, Congress does still work together to get meaningful legislation passed (e.g. Surprise Medical Billing). 

The other reason is the Byrd Rule. In the mid-1980s, the Senate adopted the Byrd rule to prevent any and all legislation from being added to a reconciliation bill as a result of vague instructions in the budget resolution. The Byrd rule prevents the inclusion of any extraneous provisions in reconciliation legislation and defines extraneous provisions if: 

  • It does not produce a budgetary change 
  • It produces a budgetary change outside of it’s instructions in the budget resolution 
  • It is outside of the jurisdiction of the Committee that proposed it 
  • It is the result of a non-budgetary component
  • It would increase the deficit beyond 10-years 
  • It changes Social Security 

Congress also has limits to the number of times reconciliation can be used. The Congressional Budget Act limits reconciliation instruction to only specific changes in spending, revenue, or debt. The Senate has often interpreted these limitations to mean that reconciliation can only be used to specify changes to each of these categories no more than once per fiscal year. In other words, if Congress passes a reconciliation bill that addresses spending, revenue, and the debt in one year, then they cannot use reconciliation again until the following year. 

What Can I Expect This Week

With the House Budget Committee releasing its version of the budget resolution, you can expect the Senate Budget Committee to release its version very soon (if not already by the time this post is published). Once these resolutions pass both chambers of Congress, committees will begin including provisions into a reconciliation bill that meet the instructions from the budget resolution. It is important to remember that the reconciliation instructions have been structured to meet the costs associated with President Biden’s American Rescue Plan. While the reconciliation instructions do not specify which policies the committees have to include, it is likely that the final bill will mirror the policy priorities set forth by the White House. 

Once the reconciliation provisions are finalized into one bill, Congress will set to debate. The House of Representatives will consider the bill under special rules to expedite the approval of the bill, while the Senate will consider the bill with a limit of 20 hours of debate. Once debate is over and the consideration of all amendments is complete, Congress will take a final vote. If it passes both Houses, the bill will head to President Biden’s desk some time in the next 1-2 weeks for his approval. 

How Does Pharmacy Fit Into This

While the American Rescue Plan does not call out pharmacists specifically, the plan does have significant implications for the profession. The President’s Plan calls for: 

  • $20 billion for a national vaccine program with the goal of vaccinating 150 million people within his first 100 days
  • Investment in community vaccination sites and mobile vaccination clinics to reach areas where there is inadequate access
  • $50 billion to scale up testing
  • Hiring 100,000 new public health workers to support in COVID response activities 
  • Strike teams to address outbreaks in long-term care facilities 
  • Additional funding to community health centers and IHS facilities to address health disparities 
  • $10 billion to expand domestic manufacturing for personal protective equipment
  • Subsidizing COBRA and expanding tax credits available through the Affordable Care Act
  • Investment in behavioral health services

Pharmacists, pharmacy technicians, student pharmacists, and pharmacy interns are vital resources that must be used to meet these goals. 

However, beyond this bill, reconciliation poses significant opportunities for pharmacy. Of the 26 bills that Congress has considered under the reconciliation process, there are numerous provisions that have brought about changes in payment and scope of practice for health care professionals. Furthermore, the reconciliation process could also be used to fund demonstration projects focused on pharmacist-provided services, later requiring the Secretary of Health and Human Services to issue a report to Congress on the cost-effectiveness of these programs and legislative recommendations. 

The Future of Provider Status Legislation 

It’s time to recognize that the main pathway to achieve provider status under Medicare Part B over the past decade, passage of the Pharmacy and Medically Underserved Areas Enhancement Act, is over. Despite multiple introductions and a majority of cosponsors in both the House of Representatives and the Senate, the effort has stalled due to concerns over the cost and opposition from the American Medical Association. While our national pharmacy associations continue to seek out additional opportunities engaging with the Centers for Medicare and Medicaid Services, we think that the reconciliation process could lay the groundwork for a new approach. 

What pharmacists can expect for health policy from a united government

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

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

Healthcare reform does not require one party control of the government

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

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

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

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

How a health bill may move through Congress

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

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

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

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

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

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

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

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

Final CMS rule changes that matter to pharmacists

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

Prescription Drug Card for Seniors

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

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

Prior Authorization – but not the one we hoped for

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

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

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

Changes to Medicare Advantage and Part D

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

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

New Leadership for CMS

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

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