Improving Access to Care – Are Pharmacists the Answer?

Expanding the scope of practice for supplementary healthcare professionals, such as pharmacists, is a strategic response often used by states to combat public health emergencies.  For example, during the United States 2009 H1N1 Influenza Pandemic, many states expanded pharmacists’ scope of practice in order to administer the H1N1 vaccine.² Acknowledging the important role pharmacists play in frontline access to care, both the federal government and states have recently sought to expand pharmacists’ scope of practice in accordance with such strategy.

Current Efforts to Expand Pharmacist Scope of Practice

A pharmacist’s scope of practice is highly regulated and primarily determined on the state level. While professional standards may allow pharmacists to provide additional healthcare services, the ability of pharmacists to do so varies significantly across different states. For example, most states allow for collaborative practice agreements between pharmacists and physicians; however, some states (such as California, Idaho, Oregon, and Washington) have only recently begun to allow pharmacists to practice beyond their specific role of prescribing medications to perform other healthcare services, such as point of care diagnostic tests and administration of injectable medications.³

The pandemic has caused the federal government to acknowledge the importance of expanding pharmacist’s scope of practice. Healthcare functions such as diagnostic testing and basic childhood vaccination are noted as services that can be redirected to pharmacists to alleviate the strain on other healthcare providers. Published on March 17, 2020, the Secretary of Health and Human Services (HHS) issued a Declaration for medical countermeasures against COVID–19.⁴ Separate from HHS’s public health emergency declaration made on January 31, 2020,⁵ this Declaration was made under the authority of the Public Readiness and Emergency Preparedness Act (PREP Act), which authorizes the Secretary of HHS to issue a declaration to provide liability immunity to certain individuals and entities  (“qualified persons”) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures, except for claims involving “willful misconduct” as defined in the PREP Act.⁶

The third amendment to this Declaration, issued on August 24, 2020, identified pharmacists and pharmacy interns as “qualified persons” covered by this immunity when expanding their existing scope of practice to administer vaccines to adults to also include children between the ages of 3 and 18.⁷ This third amendment to the Declaration further clarified that the category of disease, health condition, or threat for which the Secretary recommends the administration or use of the medical countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.⁸

On October 20, 2020 the U.S. Department of HHS issued further guidance authorizing both qualified pharmacy technicians and state-authorized pharmacy interns to administer these vaccines.⁹

A Look at Florida’s Recent Law

Florida is an example of a state previously resistant to expansion where the scope of practice for a pharmacist has now been expanded substantially in anticipation of increased cases of COVID-19, among other conditions. Passed on March 11, 2020, Florida House Bill 389 expands the practice of pharmacy by offering pharmacists the ability to diagnose and treat certain patient conditions, such as chronic conditions and minor, non-chronic health conditions, under a protocol or agreement with a supervising physician.¹⁰ Specifically, Florida House Bill 386 enacts the following changes:

1)      Expanded Scope of Practice: Florida’s new law directly updates the “practice of the profession of pharmacy” definition in Fla. Stat. § 465.003(13). The definition is revised to include “initiating, modifying, or discontinuing drug therapy for a chronic health condition under a collaborative pharmacy practice agreement” and “the testing or screening for and treatment of minor, non-chronic health conditions pursuant to Section 465.1895.” The new law also adds language addressing the requirements and protocols which must be met by pharmacists before they may provide these new services. Previously, pharmacists were not permitted to treat chronic health conditions at all, and doing so was expressly prohibited. In 2019, the statute originally read that “…nothing in this subsection may be interpreted to permit an alteration of a prescriber’s directions, the diagnosis or treatment of any disease, the initiation of any drug therapy, the practice of medicine, or the practice of osteopathic medicine, unless otherwise permitted by law.”

2)      Addition of Collaborative Pharmacy Practice Agreements and Requirements: In order to enable and regulate the new services a pharmacist can perform, Florida’s law creates an arrangement referred to as a collaborative pharmacy practice agreement. A collaborative pharmacy practice agreement is an agreement where a physician authorizes a pharmacist to provide specified patient care services. These agreements will allow pharmacists to initiate, modify, or discontinue drug therapy for specific conditions such as arthritis, asthma, chronic obstructive pulmonary diseases, type 2 diabetes, HIV or AIDS, and obesity. Despite being able to treat these conditions, pharmacists may not modify or discontinue a patient’s medicinal drugs prescribed by a healthcare practitioner with whom they do not have a collaborative pharmacy practice agreement. The supervisory function of the collaborative pharmacy practice agreement remains the key part of the legislation that allows the pharmacist’s practice to expand.

3)      Testing and Treatment of Minor, Non-Chronic Health Conditions Under Written Protocols: Florida’s new legislation adds Fla. Stat § 465.1895, which allows pharmacists, pursuant to an established written protocol with a Florida-licensed supervising physician, to test, screen for, and treat minor, non-chronic health conditions, including influenza, streptococcus, lice, various skin conditions, and minor, uncomplicated infections. The written protocol is separate from a collaborative pharmacy practice agreement, but retains the same supervisory feature. The protocol must also include explicit terms and conditions of the pharmacist’s role, must be appropriate to the pharmacist’s training, and must be submitted to Florida’s Board of Pharmacy.

Challenges to Pharmacist Reimbursement: Not Uniform Across States

While the Florida law provides explicit direction on how pharmacists can expand their practice, the law fails to elaborate how payment will be ensured. On September 11, 2020, the Florida Board of Pharmacy published proposed regulations that specify the requirements for pharmacists willing to expand their scope of practice pursuant to the new legislation.¹¹ The rules were incorporated into an application process, known as the Collaborative Practice Certification (CPC) process, and were finalized on October 28, 2020. Unfortunately, the regulations (and subsequently, the application) still left looming the critical question of how pharmacists will be paid for providing these expanded services. Often commercial payors follow the path of these governmental programs, which opens the door to great uncertainty as to whether private payors in Florida will allow the pharmacists to directly submit claims for medical services pursuant to the new legislation.

In contrast, some states that sought to expand the pharmacist’s scope of practice in 2020 have included reimbursement methodologies in similarly passed legislation. For example, Kentucky Senate Bill 50 establishes pharmacy reimbursement methodologies under the state’s Medicaid Program.¹²

Without a clear reimbursement method available on the state level, pharmacists often rely on commercial payors for payment, negotiating specific contracts to recognize the expanded scope of practice and validate their services. Unfortunately, commercial payors do not uniformly recognize pharmacists as healthcare providers, and such reimbursement likely varies by plan. Ultimately, the challenges pharmacists may face when securing reimbursement may discourage them from expanding their practice.

Policy Considerations In Expanding The Scope Of Practice

There is a myriad of different stakeholders that states need to consider when seeking to expand the practice of pharmacy by enacting legislation. The American Pharmacists Association (APhA) recommends sweeping policy changes in order for states to effectively utilize their pharmacists as front-line responders against COVID-19.¹³ Of the four policy recommendations APhA proposes, the (1) authorization of pharmacists to test, treat, and immunize patients and (2) availability for reimbursement for medical services are policy positions recent legislation is attempting to address. Reviewing Florida’s new legislation as an example, this underscores the need for accompanying legislation to address reimbursement, in order to effectively expand the scope of practice for pharmacists battling COVID-19.

At the same time, however, some professional associations, such as the American Medical Association (AMA), are strongly opposed to allowing pharmacists an expanded scope of practice, raising the concern that allowing for such expansion threatens patient safety.¹⁴ On August 21, 2020, AMA President Susan R. Bailey, M.D. issued a formal statement opposing the HHS declaration made under the PREP Act, which, as previously stated, allows pharmacists and pharmacy interns to administer vaccines to children between the ages of 3 and 18.¹⁵

According to the AMA, the organization is also working to impact state legislation by working with state medical societies to oppose efforts where COVID-19 is being used as the basis for pushing expanded scope of practice for non-physician providers. For example, in California the AMA advanced efforts to veto a bill to permit nurse practitioners to practice independently. This effort was not successful; California Governor Gavin Newsom signed bill AB-890 into law on September 29, 2020, which offers full practice authority to all nurse practitioners by 2023. 

Conclusion

The movement to expand the practice of non-physician healthcare providers is not without its challenges. Specifically with respect to pharmacists, COVID-19 offers an opportunity for states to expand their scope of practice while also addressing reimbursement obstacles. Nevertheless, as evidenced by the tug-of-war at play between associations representing medical doctors and associations representing pharmacists, there are continuing complexities which states and their licensed pharmacists will need to navigate as the expanded scope of practice of pharmacists continues to grow. 

Endnotes

1. Manolakis, P.G. &  Skelton, J.B., Pharmacists' Contributions to Primary Care in the United States Collaborating to Address Unmet Patient Care Needs: The Emerging Role for Pharmacists to Address the Shortage of Primary Care Providers, 74 AM. J. PHARM. EDUC. 1, 5 (2010).
2. See https://www.astho.org/uploadedFiles/Programs/Preparedness/Public_Health_Emergency_Law/Scope_of_   Practice (last accessed Dec. 28, 2020).
3. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789634/#B21-pharmacy-07-00106  (last accessed Feb. 11, 2021).
4. 85 Fed. Reg. 15198 (Mar. 17, 2020).
5. See https://www.hhs.gov/about/news/2020/01/31/secretary-azar-declares-public-health-emergency-us-2019-novel-coronavirus (last accessed Dec. 28, 2020).
6. 42 U.S.C. § 247d-6d.
7.  https://www.hhs.gov/sites/default/files/third-amendment-declaration.pdf  (last accessed Dec. 28, 2020).
8. Id. at 8.
9. See https://www.hhs.gov/sites/default/files/prep-act-guidance.pdf (last accessed Feb. 11, 2021).
10. H.B. 389, 2020 Leg., Reg. Sess. (Fla. 2020).
11. Fla. Admin. Rule 64B16-31.001 (2020).
12. S.B. 50, 2020 Leg., Reg. Sess. (Ky. 2020).
13. See https://www.pharmacist.com/sites/default/files/files/APHA%20Meeting%20Update/PHARMACISTS_COVID19-Final-3-20-20.pdf (last accessed Oct. 11, 2020).
14. See https://www.ama-assn.org/practice-management/payment-delivery-models/ama-opposes-hhs-move-expand-pharmacists-scope-practice   (last accessed  Oct. 11, 2020).
15. See https://www.hhs.gov/sites/default/files/third-amendment-declaration.pdf (last accessed Oct. 11, 2020).

About the Authors

Rupasri S. “Rupa” Lloyd is a Shareholder with GrayRobinson, P.A. in the firm’s healthcare practice. She specializes in healthcare operational, corporate, transactional, and regulatory matters, advising clients in many facets of their business, including privacy and data security, compliance with FDA and CDC regulations, fraud and abuse, corporate governance, labor relations, licensure and discipline, quality improvement and healthcare risk management. She routinely conducts due diligence including the preparation and negotiation of agreements in connection with telehealth, software licensing, electronic health records, practice sale and acquisition, medical equipment, real property leases, physician employment, and medical directorships. Ms. Lloyd can be reached by e-mail at [email protected] or on Twitter: @grayrobinsonlaw.

Jordan A. Ross is a law clerk with GrayRobinson, P.A. in the firm’s healthcare practice.  She is currently enrolled at the University of Pittsburgh School of Law in her third year, completing her juris doctorate together with an advanced certificate in health law.  While in law school she has also completed internships with the United States Department of Justice, Department of Health and Human Services, and the Department of Veteran’s Affairs. Ms. Ross can be reached at [email protected].