Debates Continue About Pharmacists’ Provider Status

“Education matters much more than convenience,” wrote Timothy M. Smith, a contributing news writer for the American Medical Association (AMA), in an article published by the organization in early February 2024. In the article, Smith discusses “scope creep,” which the AMA defines as “scope-of-practice expansions that threaten patient safety.” The AMA states that allowing nonphysicians—including pharmacists, nurse practitioners, and physician assistants, among others—“to diagnose and treat patients without any physician oversight is a step in the wrong direction,” and urges legislators to keep physicians as the “leaders of the health care team.”^1,2

After the publication of Smith’s article, the American Society of Health-System Pharmacists (ASHP), the American Pharmacists Association (APhA), and the American Association of Colleges of Pharmacy (AACP) released statements in opposition, with APhA and AACP stating that the initial publication is “arrogant, self-centered, and out of touch.”^3,4

The ASHP statement read: “As we know well, [the AMA’s] views do not necessarily reflect the collective views of all physicians. Pharmacists, like physicians, are licensed autonomous health care professionals who have an ethical obligation to do what is in the best interest of patients and the public. Pharmacists are obligated to ensure that medication therapy is optimal, safe, and effective and is based on the best science. We do this in partnership with physicians, nurses, and other licensed health care providers.”⁵

The fight against scope creep—or provider status, known among pharmacists—is not new. In fact, the AMA launched the AMA Scope of Practice Partnership in 2006, which is used to combat the scope of practice expansions among nonphysicians.² Every member of the care team is essential to patients, but agreement on roles has been in question by all parties involved—specifically, who should be reimbursed for what?

“Pharmacists being able to practice and bill for encounters with patients regardless of the setting of care is the single most important evolution in multiple generations for the sustainability of the profession,” Troy Trygstad, PharmD, PhD, MBA, editor-in-chief of Pharmacy Times, said in an interview. “What first started with academics telling us that we needed to do it, then turned into a pandemic that revealed the possibilities, [and has] now turned into an imperative to survive.”

As of now, provider status for pharmacists seems inevitable, especially after the acceleration of advocacy efforts due to the COVID-19 pandemic, but the reality is murky. The views of the AMA are not unfounded, but agreement on what pharmacists can provide remains in question. What exactly is provider status, and what are pharmacists asking for?

HOW THE EVOLVING PHARMACY PRACTICE BROUGHT US TO PROVIDER STATUS

Health care providers include physicians, physician assistants, nurse practitioners, certified nurse midwives, clinical psychologists, dietitians, social workers, and more under federal recognition. However, pharmacists are not considered a provider—at least not yet. Although pharmacists can provide services, which in some cases includes vaccination and point-of-care services, under federal law, pharmacists are not eligible for cognitive services reimbursement, according to commentary in the Journal of the American Pharmacists Association.⁵

The pharmacy role first expanded in the late 20th century by establishing collaborative practice agreements (CPAs), which are the basis between the formal agreements of physicians and pharmacists.⁶ The agreement establishes that the “pharmacist assumes responsibility for specific patient care functions that are otherwise beyond their typical ‘scope of practice,’” as long as it is aligned with their education and training.However, state laws and regulations around CPAs vary, depending on where a health care member practices.⁷

Prior to CPAs, the Durham-Humphrey Amendment of 1951 and the Federal Food, Drug, and Cosmetic Act of 1983 legally separated the roles for physicians and pharmacists, which made it illegal for pharmacists to fill a prescription without authorization from a physician. APhA, known as the American Pharmaceutical Association at the time, developed a code of ethics that also established the prescriber as the only health care member to discuss a therapeutic approach with the patient. Patients would go to a pharmacy and receive their prescription, but the pharmacists could not discuss the contents of the prescription and, in some cases, could not label the bottle with the drug information.⁶

The first CPA was established under the Indian Health Service, focusing on practices and patients in Native American communities, and since then, there have been many developments in CPAs. As of 2016, all 50 states had active CPAs, but the agreements range from the pharmacist’s ability to “commence, modify, monitor, and discontinue medication therapies” and order laboratory tests.⁷

In the mid-1950s, the pharmacy profession shifted from simply dispensing to more clinical roles, incluing patient education, communication, and therapeutic guidance beyond what was previously allowed. When pharmacy services began to receive federal funding under Medicare, the Omnibus Budget Reconciliation Act of 1990 was created. The Act allowed pharmacists to begin conducting drug reviews of Medicare prescriptions and allowed pharmacists to discuss the therapeutic when the patient came to pick up their prescription. As a result, the PharmD was created as a parallel to the MD and other clinical doctoral degrees.⁶

In the early 2000s, the US House of Representatives and Senate passed legislation to recognize pharmacists as providers for Medicare patients and integrated pharmacists into health care teams.⁶

In 2020, the pharmacist’s role played a significant part in the COVID-19 pandemic. In an interview, Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA, editor-in-chief of Pharmacy Practice in Focus: Oncology, stated that the pandemic showed the impact pharmacists can have because they were on the frontlines and available to the community, especially when the vaccines became available.

“When you're in a health care system setting like [oncology], the clinical pharmacists that work alongside their providers are absolutely critical to patient outcomes, whether that be monitoring patient care plans [or] helping providers with complex treatment regimens; they are working at the very top of their license,” Mahmoudjafari said. “The scope of pharmacy has changed in a lot of ways in the fact that we can address health care concerns, access challenges, and optimize medication use. There's a lot that can be applied to increasing the scope of the pharmacist.”

AMA’S OPPOSITION TO PHARMACY SCOPE OF PRACTICE EXPANSION

One such example from the AMA is the organization’s opposition to pharmacists administering childhood vaccines. As part of the COVID-19 pandemic, the US Department of Health and Human Services (HHS) issued a declaration allowing pharmacists and pharmacy interns to administer vaccines to children 3 to 18 years old, stating that many states already allow pharmacists to administer vaccines to patients. The AMA argues that even with childhood vaccination rates suffering due to the pandemic, additional challenges would arise with pharmacists administering vaccines rather than physicians, such as decreased routine health exams, preventive care, early diagnoses, optimal therapy, and timely vaccinations.⁸

On November 10, 2014, an AMA Interim Meeting in Dallas discussed a range of topics including support for electronic cigarettes, increased use of sobriety checkpoints for deterring driving under the influence, and a policy that recognized the importance of pharmacists in vaccinating specific populations.⁹ The policy recognized “the important role of pharmacists in vaccinating target populations that lack access to a medical home or that otherwise are unlikely to receive immunizations through physician practices. The policy affirms that health professionals who administer vaccines have shared responsibilities to ensure that vaccination administration is documented in the patient medical record. Further, it calls on physicians and pharmacists to work together in the community to encourage patients to follow up with a primary care physician to ensure continuity of care.”⁹

It is clear that collaboration between multidisciplinary teams is the start to better patient care, regardless of role.

Despite this policy, the AMA makes the argument that pharmacists are already overworked, so adding additional responsibilities would mean that “not everything can be done well.” The author added that not only are pharmacists not trained to test for and treat respiratory-related illnesses, but that their burnout levels would jeopardize patient safety.¹⁰

However, the AMA has also reported the effects of burnout on physicians, including approximately 39.9% of physicians in a survey reporting high emotional exhaustion and 45.6% meeting the criteria for burnout.¹¹ The AMA identified collaboration as a way to combat physician burnout, including showing that teamwork is crucial in the workplace.¹²

The AMA has also recognized a program in North Carolina that uses embedded pharmacists in the care team to help care for patients who are incarcerated. Under a CPA, pharmacists specialize in specific disease states and pursue additional education and credentialing for the management of those areas. As comfort with pharmacists in the care team has grown, physicians expanded the services to comprehensive diabetes management.¹³

The AMA’s arguments against pharmacist provider status are not baseless, but it is clear that collaboration between multidisciplinary teams is the start to better patient care, regardless of role.

WHAT IS PROVIDER STATUS?

According to an article in US Pharmacist, provider status is defined as the legal recognition of various health care professionals who are eligible for reimbursement of patient services through Medicare Part B. Currently, the term health care providers federally encompasses physicians, physician assistants, nurse practitioners, certified nurse midwives, nurse anesthetists, clinical psychologists, physical and occupational therapists, registered dieticians/nutritionists, and social workers, but pharmacists are not recognized under the Social Security Act.¹⁴

Under Medicare Part D, pharmacists can receive reimbursement for dispensing medications or providing medication therapy management services. If federal provider status were to be provided to pharmacists, pharmacists could help make patient-centered clinical recommendations for physician-led teams, which would decrease health burden and expand access to patients, especially underserved populations.¹⁴

There are also clear distinctions between federal provider status and state-level provider status. As of February 2024, 19 states have some version of provider status, whether under Medicaid, commercial insurance, or both, for reimbursement coverage within the pharmacist’s scope of practice. Further, according to ASHP, states have dedicated pharmacists for clinical care, such as for the prevention and treatment of COVID-19 and influenza, the management of medications for opioid use disorder, and pre- and post-exposure prophylaxis for HIV.³

Under the Public Readiness and Emergency Preparedness (PREP) Act, pharmacists played a critical role in the COVID-19 pandemic, demonstrating the scope of their training and education, according to APhA and AACP. Pharmacists administered hundreds of thousands of COVID-19 testing and administered COVID-19 vaccines. Likewise, the organizations stated that influenza is also easily diagnosed with a point-of-care test, which could be expanded into the pharmacy to help initiate treatment quickly and reduce morbidity and mortality. However, the PREP Act only covers COVID-19-related testing and treatment.⁴

In July 2023, the Equitable Community Access to Pharmacist Services Act (ECAPSA) was introduced, establishing Medicare Part B reimbursements for services provided by pharmacists including testing for COVID-19, influenza, respiratory syncytial virus, and strep throat, as well as the treatment of COVID-19, influenza, and strep throat, and the administration of COVID-19 and influenza vaccines.¹⁴ The AMA opposed this bill, arguing that the expansion of scope of practice is “in a manner that threatens patient safety.” They also stated that the expansion would add to the responsibilities and add to the burnout of pharmacist, and said pharmacists’ training is not equivalent to the training of physicians and therefore insufficient for these responsibilities.¹⁰

According to a commentary by Jordan R. Covvey, PharmD, PhD, published in the Journal of the American Pharmacists Association, the ECAPSA focuses on limited services for acute areas without expanding pharmacist roles in other clinical areas. The legislation would remove barriers rather than mandate pharmacists provide specified services, the author said. Additionally, the author states that pharmacists have training that focuses on patient care, including proper medication use, treatment optimization, and how to monitor outcomes over time. The Accreditation Council for Pharmacy Education also requires that pharmacists are trained in human anatomy and physiology, pathology, and pathophysiology, as well as patient assessments.¹⁵

“Pharmacists are simply one part of the solution, a role which can be enhanced through education, collaboration, and advocacy,” Covvey said.¹⁵

In a statement from September 2024, Rear Admiral Kelly Battese, PharmD, MBA, chief pharmacist officer from the HHS Commissioned Corps, responded to the AMA’s concerns about scope creep. Battese stated that, “Since the 1930s, evidence-based practices across federal (i.e., Indian Health Service, Federal Bureau of Prisons, Immigration and Customs Enforcement, United States Coast Guard, Veteran’s Health Administration) health care settings have highlighted the profound impact of interprofessional collaborative practices toward improving patient outcomes across the health care landscape.”¹⁶

Pharmacists work in a variety of settings, far beyond community pharmacies. According to Battese, pharmacists go through 6 to 8 years of collegiate and doctoral-level training, which includes more than 1700 hours of hands-on experiential education in patient care. During the COVID-19 pandemic, pharmacists provided clinical interventions to more than 150 million patients, including test-to-treat, antibody therapeutics, vaccinations, and more.¹⁶

“We do not want your scope. Rather, we want your partnership and collaboration. We want everyone’s scope focused on the health of our nation. In the end, it's crucial that we come together, united in our efforts to combat disease and illness,” Battese wrote.¹⁶

Provider status is not limited to community pharmacies, as Mahmoudjafari pointed out. Health system settings operate differently than community settings due to patient needs. She added, “Our pharmacists are providing educational services that we can't bill for and so that sometimes goes by the wayside. When you think about provider status in the health system setting, being able to demonstrate revenue will help us continue to justify the presence of clinical pharmacists in the health care system, whereas right now, a lot of our justification comes from cost avoidance strategies. Being able to say, ‘having a pharmacist will generate X amount of revenue for work that we're already doing,’ just continues to justify the presence of a pharmacist in that clinical setting.”

THE PHARMACIST’S PERSPECTIVE

In March 2022, AMA PresidentGerald E Harmon, MD, opposed the Biden Administration’s plan to include pharmacists as points of access for the test to treat initiative, stating that the plan “flaunts patient safety and risks significant negative health outcomes.” Harmon added that the approach would omit knowledge of the patient’s medical history, complexity of drug interactions, and management of negative reactions.¹⁷

Drug Topics Editorial Advisory Board members responded to the statement. James A. Jorgenson, RPh, MS, FASHP, CEO of Visante, stated, “We know that there is a significant amount of inequality in terms of health care access, and many people in rural or inner-city areas simply don't have ready access to physicians—but they do have access to their pharmacy. Delays from testing to physician access to treatment have the potential to lessen the impact of these medications.”¹⁷

Other members echoed these remarks, stating that pharmacies increase access and availability for patients, especially for time-sensitive treatment. Mohamed A. Jalloh, PharmD, BCPS, assistant professor at the Touro University California College of Pharmacy, added that pharmacists are already involved in a test to treat program for HIV, in which pharmacists can dispense HIV medication for post-exposure prophylaxis in California and New York. In California, pharmacists can also prescribe naloxone, birth control, smoking cessation agents, and travel health agents to patients.¹⁷

Additionally, Trygstad described the natural tendency for health care professionals to be protective over their roles. He said the AMA is not alone in being its protectionist stance, but sometimes advocacy comes along and moves professions into a new way of doing and seeing things.

“It really is a business construct, not a professional construct. There's not a lot of folks with a straight face that can say pharmacists can't do the things that are being asked of them. It's simply about business,” Trygstad said. “Ninety percent of all adult immunizations are now [administered in] a community pharmacy, and pharmacy has a better safety and track record with administration than any of the other care team members.”

Joseph Kalis, PharmD, BCOP, ambulatory oncology clinical pharmacy specialist at the University of Colorado Health, added that there is widespread agreement on what pharmacists should be doing in a specialty pharmacy setting or an ambulatory care setting, but not a lot of agreement about who is responsible for reimbursement.

“I think [what] provider status could really help streamline, or even simplify for a lot of health systems, is I would then be able to bill for the services I'm providing,” Kalis said. “Because a lot of the patient counseling, a lot of the discussions with physicians, the dose adjustments, etc., they're a lot harder to quantify.”

Mahmoudjafari added that she appreciates the concerns that the AMA has, especially to maintain the distinction between pharmacists, physicians, and other advanced practices for providers. She also said that it’s easy to take soundbites from the AMA and think that the organization is full of opposition.

“I would hope that the AMA recognizes the value of pharmacists,” Mahmoudjafari said. “I think when you read the statement, they do see that, but I think that they could expand some of that statement to understand the collaborative role that we play in patient care. We're definitely not looking to replace physicians, because I really see the pharmacist as maybe the third arm of an appropriate multidisciplinary care team.”

She said physicians are well versed in diagnosis and the appropriate laboratory tests patients need, whereas pharmacists are well suited to provide the information and knowledge about various medications and nurses are on the front line to administer the therapy for that patient in the health system setting. She concluded that each role plays a significant part in improving access to care and that collaboration is the way to move forward.

The AMA and ASHP have not responded to a request for comment.

REFERENCES

1. Smith TM. What's the difference between pharmacists and physicians?. American Medical Association. February 5, 2024. Accessed October 31, 2024. https://www.ama-assn.org/practice-management/scope-practice/whats-difference-between-pharmacists-and-physicians

2. American Medical Association. Advocacy in action: fighting scope creep. June 5, 2024. Accessed October 31, 2024. https://www.ama-assn.org/practice-management/scope-practice/advocacy-action-fighting-scope-creep

3. American Society of Health-System Pharmacists. Pharmacists Are Essential and Partners on the Patient Care Team. February 28, 2024. Accessed October 31, 2024. https://www.ashp.org/about-ashp/ceo-blogs/recent-blogs/pharmacists-are-essential-and-partners-on-the-patient-care-team?loginreturnUrl=SSOCheckOnly

4. Houge MD, Vermeulen L. AMA statement on pharmacists is arrogant, self-centered, and out of touch. American Pharmacists Association, American Association of Colleges of Pharmacy. February 16, 2024. Accessed October 31, 2024. https://www.pharmacist.com/CEO-Blog/ama-statement-on-pharmacists-is-arrogant-self-centered-and-out-of-touch

5. Ali US, Hale GM, Santibañez M, Berger K, Baldwin K. Is now our time? History to provider status for allied health professions and the path for pharmacists. J Am Pharm Assoc (2003). 2023;63(5):1515-1520. doi:10.1016/j.japh.2023.07.005

6. Cernasev A, Aruru M, Clark S, et al. Empowering Public Health Pharmacy Practice-Moving from Collaborative Practice Agreements to Provider Status in the US. Pharmacy (Basel). 2021;9(1):57. Published 2021 Mar 9. doi:10.3390/pharmacy9010057

7. National Alliance of State Pharmacy Association. Pharmacist Collaborative Practice Agreements: Key Elements for Legislative and Regulatory Authority. Accessed October 31, 2024. https://www.accp.com/docs/positions/misc/NASPACPAWG.pdf

8. American Medical Association. From Ebola to e-cigarettes, delegates pass public health policy. November 10, 2014. Accessed October 31, 2024. https://www.ama-assn.org/house-delegates/ama-policies/ebola-e-cigarettes-delegates-pass-public-health-policy

9. Robeznieks A. AMA opposes HHS move to expand pharmacists’ scope of practice. American Medical Association. August 25, 2020. Accessed October 31, 2024.https://www.ama-assn.org/practice-management/scope-practice/ama-opposes-hhs-move-expand-pharmacists-scope-practice

10. O’Reilly KB. Don’t expand scope of practice for already overworked pharmacists. American Medical Association. May 16, 2023. Accessed November 4, 2024. https://www.ama-assn.org/practice-management/scope-practice/don-t-expand-scope-practice-already-overworked-pharmacists

11. Garvey G. More health care teamwork means less burnout: physician survey. American Medical Association. October 8, 2024. Accessed November 4, 2024. https://www.ama-assn.org/practice-management/physician-health/more-health-care-teamwork-means-less-burnout-physician-survey

12. Garvey G. In burnout battle, it’s on leaders to show how teamwork matters. American Medical Association. October 22, 2024. Accessed November 4, 2024. https://www.ama-assn.org/practice-management/physician-health/burnout-battle-it-s-leaders-show-how-teamwork-matters

13. Berg S. How embedded pharmacists can improve correctional health care. American Medical Association. July 12, 2020. Accessed November 4, 2024. https://www.ama-assn.org/practice-management/scope-practice/how-embedded-pharmacists-can-improve-correctional-health-care

14. Terri YC. Supporting Provider Status for Pharmacists. US Pharmacist. October 18, 2023. Accessed November 4, 2024. https://www.uspharmacist.com/article/supporting-provider-status-for-pharmacists

15. Covvey JR. Why can't we be friends? The manufactured fear of pharmacist "scope creep". J Am Pharm Assoc (2003). 2024;64(1):43-46. doi:10.1016/j.japh.2023.11.003

16. Battese KJ. Response Letter. September 30, 2024. Accessed November 5, 2024. https://www.ashp.org/-/media/assets/advocacy-issues/docs/2024/RDML-Battese-Response-09-30-2024.pdf

17. Biscaldi L. Drug Topics® Responds: AMA Statement on Test to Treat Initiative. Drug Topics. March 11, 2022. Accessed November 5, 2024. https://www.drugtopics.com/view/drug-topics-responds-ama-statement-on-test-to-treat-initiative