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Received: 25 April 2018 Revised: 6 June 2018 Accepted: 7 June 2018

DOI: 10.1002/jac5.1026

CLINICAL PHARMACY FORUM

Past, present, and continued need for provider status legislation:


Navigating clinical practice with significant sustainability barriers
Jennifer Bingham Pharm.D.1 | Nicole Scovis Pharm.D.2 | Ann M. Taylor MPH2 |
Sandra Leal Pharm.D., MPH1

1
SinfoníaRx, Tucson, Arizona
2 The pharmacy profession has advanced remarkably, however, pharmacists have yet to obtain pro-
University of Arizona College of Pharmacy,
Tucson, Arizona vider status at the federal level. Establishing pharmacists as providers is imperative in light of the
Correspondence growing shortage of primary care providers and need to provide care for medically underserved
Jennifer Bingham, SinfoníaRx, 100 N Stone populations. Academic reform, professional development and legislation have all contributed to the
Avenue, Tucson, AZ 85701. furtherment of provider status. Yet, the cornerstone to obtaining this status lies in imminent
Email: jmbingham@sinfoniarx.com
changes at the health care and interprofessional collegial levels in conjunction with professional
perseverance and legislative action. These actions will help ensure pharmacists as integral partners
on collaborative health care teams in clinical service provision for managing patients' chronic condi-
tions and medications, to ultimately, improve access to quality care and patient health outcomes.

KEYWORDS

patient care, pharmacy, policy

1 | I N T RO D UC T I O N Association as pharmacists.1 He further advocated that physicians prac-


ticing pharmacy should receive appropriate training from master phar-
While the pharmacy profession has progressed considerably over the past macists. In the 20th century, Irving Rubin was a tireless campaigner for
two centuries, one hurdle still remains. Pharmacists have yet to obtain the profession.2 His efforts led to the employment of a pharmacist in
provider status at the federal level and thus, must continually advocate for the United States Capital, helping to advance the profession via
this recognition. Yet, the health care system is facing multiple challenges, increased visibility and advocacy at the federal level. He also was piv-
evidenced by the growing shortage of primary care providers and the otal in the development of the Oath of the Pharmacist.
need to provide care for medically underserved populations. Thus, estab-
lishing pharmacists as providers is of utmost importance and a critical step
in helping to address these challenges. To better understand the rationale
2.2 | Tumultuous Times For The Profession
for establishing pharmacists as providers and integrating them in to the The early 20th century was a tumultuous period for pharmacists who
health care team, it is important to reflect on some historical milestones often faced criticism regarding their professional scope of practice. In
leading to the evolution of pharmacy practice including advocacy and 1915, educator Abraham Flexner, well recognized for his vital role in
opposition, academic reform, professional development, legislative action, higher and medical education reform, declared that “pharmacy was
provider status, and health care system changes. not a profession. While the physician thinks; decides; and orders; the
pharmacist obeys….and does not originate.”3 Furthermore, the military
questioned whether pharmacy was an actual professional trade and
2 | PHARMACY ADVOCACY AND
consequently refrained from commissioning pharmacy officers.4
O P P OS I T I O N

2.1 | Pioneer pharmacy advocates 3 | ACADEMIC REFORM


In the 1800s, ethicist Edward Parrish proposed the importance of offi-
Early reform of the medical and dental curricula provided the impetus
cially recognizing apothecary members of the American Pharmaceutical
that spurred reform of the pharmaceutical curricula. Medical and dental

The copyright line for this article was changed on 23 August 2018 after original education changed as a result of the Flexner Report and Gies Report,
online publication. respectively.5 The landmark Elliott Report, officially known as the

32 © 2018 Pharmacotherapy Publications, Inc. wileyonlinelibrary.com/journal/jac5 J Am Coll Clin Pharm. 2018;1:32–37.


BINGHAM ET AL. 33

General Report of the Pharmaceutical Survey,5 was created in the medication therapy management, collaborative pharmacy practice, the
1940s in response to a post-war health care system. The report assem- ordering, conducting, and interpretation of appropriate tests, and the
bled critical facts relating to then, present-day pharmaceutical educa- recommendation and administration of immunizations; and the
tion, practices, and trade. It also sought to reform the profession by responsibility for compounding and labeling of drugs and devices,
formulating proposals designed for the progressive betterment of proper and safe storage of drugs and devices, and maintenance of
pharmacy—a profession steadily striving to establish and maintain a dis- required records”.12 In 1994, the first vaccine administration training
tinctive place among the recognized health professions (ie, medicine, program was developed in response to the National Association of
dentistry).5 A major focus was to expand the profession's image and Board's of Pharmacy's efforts. Immediately following this initiative,
scope as a “health service” by restructuring college curricula. Finally, the first collaborative practice agreement was created allowing phar-
during the mid-20th century, the pharmacy profession embraced new macists to administer the influenza vaccine.2
opportunities to further promote and advance pharmacists via creation
of the first doctorate of pharmacy curricula. As such, the Millis Commis-
5.2 | Payment for pharmacist services
sion on Pharmacy recommended addition of academic clinical educa-
tion in recognition of pharmacists' expanding patient care roles.2 In 2002, the Pharmacy Provider Coalition was formed to advocate for
pharmacists to receive recognition and payment for their services pro-
vided to Medicare Part B members.13 It consisted of several organiza-
4 | PROFESSIONAL DEVELOPMENT tions, including the Academy of Managed Care Pharmacy, American
Association of Colleges of Pharmacy, ACCP, APhA, American Society
of Consultant Pharmacists, ASHP, and the College of Psychiatric and
4.1 | Expanding professional development
Neurologic Pharmacists.14 Despite incremental progress in establish-
opportunities
ing the role of pharmacists, the profession experienced a considerable
The American College of Clinical Pharmacy (ACCP) defines clinical setback in 2004 when Congress rejected the Medical Clinical Pharma-
pharmacy as a health science discipline whereby “pharmacists provide cists Practitioner Services Coverage Act. This Act would have given
patient care that optimizes medication therapy and promotes health, advanced practice-designated pharmacists the ability to bill Medicare
wellness, and disease prevention”.6 In the 1960s, the American Soci- Part B as mid-level providers, at 85% of physicians' reimbursement
ety of Health System Pharmacists (ASHP) joined forces to support the rate.15 Instead, this was the beginning of an uphill battle to prove to
advancement of clinical pharmacy.7 At roughly the same time in 1973, legislators that pharmacist-delivered services provided value on an
the American Pharmacists Association (APhA) also endorsed the con- acute level as well as on a long-term basis. A big win for the Pharma-
cept of clinical pharmacy in practice.4 cist Services Technical Advisory Coalition in 2005 was that the Ameri-
Shortly thereafter, the Board of Pharmaceutical Specialties, can Medical Association (AMA) added billing codes for Medication
founded in 1976, began recognizing pharmacists based on their phar- Therapy Management (MTM), yet no actual payment structure nor
macy practice specialty areas.8 During the 1980s, pharmacists contin- reimbursement was ever implemented based on these codes.
ued shifting their primary responsibilities from medication dispensers
to a more vast, clinically recognized role that included vaccine admin-
istration, patient assessment, and enhanced patient care responsibili- 6 | PROVIDER STATUS
ties.8 In 2000, the Accreditation Council for Pharmacy Education
announced the conversion to the doctor of pharmacy (Pharm.D.) as
6.1 | More setbacks for pharmacists
the sole entry-level degree for the profession, reflecting a paradigm
shift towards preparing pharmacists for more clinical responsibilities Pharmacists worked on state and national levels to overcome the afore-

rather than the traditional dispensing activities of yesteryear.9 mentioned sustainability barriers (eg, opposition towards recognizing
pharmacists as professionals in the 20th century and legislative setbacks
in the 21st century). However, the majority of pharmacist provider advo-
5 | LEGISLATION FOR PHARMACISTS AS cates incorrectly assumed the transition from fee-for-service models to
PROVIDERS value-based services would facilitate pharmacist provider status. More-
over, to add to these mounting challenges, the Affordable Care Act of
2010 defaulted to the Social Security Act, further excluding pharmacists
5.1 | Pharmacists' roles
as providers and making it impossible for them to bill for services.16
The expansion of the pharmacist's role in 1974 achieved a milestone Lastly, the lack of pharmacists actively advocating for these initiatives
when Medicare required skilled nursing facilities to provide monthly further limited progress towards provider status.
medication reviews by a “consultant pharmacist”.10 In 1990, the Fed-
eral Omnibus Budget Reconciliation Act was passed, further delineat-
6.2 | New Triumphs for Pharmacist Providers
ing pharmacists' role in performing drug utilization reviews as part of
their comprehensive medication regimen (eg, comprehensive medica- In 2009, after a nearly 5-year lapse in progress, the American Recov-
tion review [CMR]) and counseling patients.11 The Model State Phar- ery and Reinvestment Act included pharmacists and pharmacies as
macy Act further identified pharmacy practice—“to provide health care providers.17 However, the Act was unsuccessful in achiev-
pharmacist care in all areas of patient care, including primary care, ing acceptance of pharmacists as providers among their health care
34 BINGHAM ET AL.

professional peers and community as this expanded level of participa- preventative health care needs of patients especially as disease bur-
tion in provision of care was not widely considered part of a pharma- den increases with age.24
cist's scope of practice at that time. This lack of peer acceptance Moreover, the proportion of older adults residing in underserved
remains a much larger issue and one that potentially involves interpro- communities ranges from 25% to 58%, depending on the area.25 In
fessional education regarding pharmacists' expanded roles and rural settings, this shortage has become particularly dire, prompting
responsibilities, and ultimately, longer-term attitudinal change as well. government incentives for providers willing to practice in these under-
In 2010, the Patient Protection and Affordable Care Act gave served areas. To address this gap in clinical services, pharmacists are
13 now expanding their scope of practice into these areas using innova-
pharmacists the opportunity to provide home-based care services,
and receive reimbursement for provision of MTM services. In 2012, tive technologies to enable them to more effectively reach these
the Joint Commission of Pharmacy Practitioners leadership collabo- populations (eg, medication reconciliation, counseling, education).23
rated with several organizations to develop the “Principles for Improv-
ing Patient Health: The Pharmacist's Role”, a guide to support 7.3 | Pharmacists as integral partners on care team
provider status campaign efforts.18 In 2013, the Provider Status Task
Team-based care is essential to accomplish the breadth of care
Force was formed to develop strategic partnerships with the National
required. Professional organizations have endorsed team-based care
Health Council, the Council for Affordable Health Coverage, and the
as a solution to draw on the strengths of different professionals and
Center for Medicare and Medicaid Services.19 The newly formed
solve complex patient issues in an efficient and cost-effective
board developed a pharmacist provider status webpage (https://
way.26–28 As the primary care physician supply dwindles,29 the
www.pharmacist.com/provider-status-what-pharmacists-need-know-
demand for interprofessional team-based approaches in delivery of
now) along with volunteer and campaign opportunity activities. They
primary care services increases.30 Government agencies, such as the
further defined the value of pharmacists to legislators. The board con-
Centers for Medicare and Medicaid Services and the Centers for Dis-
tinued to converse with congressional committee members and staff
ease Control and Prevention, have specifically recommended pharma-
about the urgency of pharmacy-related issues, including provider sta-
cists as part of the interprofessional team for services such as
tus. The board held a Pharmacy Caucus Hill Brief on provider status cardiovascular disease prevention, Medication Therapy Management,
and highlighted the innovative and successful state-level effects of and opioid prescribing.31 Moreover, pharmacists play an integral role
supporting pharmacists' patient care services. 20 on collaborative health care teams in provision of clinical services to
In 2014, the Patient Access to Pharmacist's Care Coalition drafted help patients manage their chronic conditions and medications.32
a legislative proposal to broaden patient access to pharmacist-
delivered services, especially in medically underserved areas and/or
7.4 | Pharmacists as trusted medication experts
populations, as well as where shortages of health professionals
existed.20 The goal of the legislation was to increase access, improve With 6 to 10 years of education and training, pharmacists are
quality, and decrease cost. This proposal would amend the Social uniquely qualified to address management and monitoring of condi-
Security Act by delineating those practitioners who could participate tions requiring medications. Physicians report observing positive per-

in various delivery systems and payment models. sonal, patient, and health system outcomes with clinical pharmacy
services specifically related to increased access to care for patients,
improved disease outcomes, and decreased physician workload.32
7 | H EA L T H C A R E S YS TE M CH A N G ES Additionally, the AMA's STEPS Forward program to transform practice
improvement, encourages physicians to adopt strategies such as
embedding a clinical pharmacist within their practice.33 It is encourag-
7.1 | New demands for pharmacist services
ing to observe the AMA's commitment to establishing and maintaining
In 2015, the Pharmacy and Medically Underserved Areas Enhance-
provision of a team-based health care system.
ment Act was introduced to provide Medicare coverage and payment
for certain services: (1) provided by a pharmacist in a health-
7.5 | Pharmacist-related patient outcomes
professional shortage area; and (2) that were otherwise covered under
Medicare if they were provided by a physician.21 In 2017, the Act also When pharmacists are part of the interprofessional team, improve-
was presented to the 115th Congress and still awaits approval, as has ments in both clinical and economic outcomes are observed. Specifi-
been the case for several years now. cally, pharmacists can improve health outcomes and adherence to
long-term medication therapy.34 Furthermore, three pivotal articles
review primary compilations of evidence for positive pharmacy-
7.2 | Primary care provider shortage
related outcomes and thus, provide substantial and vital documenta-
The shortage of primary care providers coupled with an expanding tion in the continuing push for provider status.32,35,36
patient population, creates an environment whereby existing pro- A recent systematic review reported the effects of therapeutic,
viders are overloaded and unable to keep pace with the associated safety, and humanistic outcomes of pharmacy services; this compre-
demand for health care.22,23 During patient office visits, providers hensive review of nearly 300 studies indicated significant improve-
struggle to simultaneously address the acute, chronic, and ments in adverse effects, medication adherence, and chronic disease
BINGHAM ET AL. 35

biomarkers.35 A 2011 report to the United States Surgeon General services. Attribution of pharmacists' roles in provision of services is
highlighted outcomes associated with clinical pharmacy services difficult to track, and one that reflects a break-even point in the cur-
including a comprehensive repository from clinical trials. In 2014, an rent FFS model is even more challenging. While having provider status
independent report commissioned by major pharmacy organizations is not essential, it could facilitate billing for the corresponding profes-
described pharmacist-delivered services and their impact since the sional fee. Incident-to-services are billed at the same rate as services
2011 report.36 This review included 171 recently published studies billed by a physician or non-physician provider and require direct
and found positive outcomes for improvements in low-density lipopro- supervision by a physician, defined as the presence of the physician in
tein cholesterol, hemoglobin A1C, blood pressure, immunization rates, the office suite to render assistance if necessary. Having a physician
and medication adherence; improved economic outcomes in care tran- onsite can pose particular challenges in rural, community settings and
sitions, including decreased hospitalizations, were also noted. telehealth sites, especially given the current shortage in non-urban
areas.25 Thus, there is increasing emphasis on utilizing innovative
methods to provide care to those in rural settings and telehealth is at
7.6 | Sustainability of pharmacist services
the forefront of this effort. CCM and TCM are aimed at this improved
The current health care payment model is moving toward value-based access to care with the expectation that services are largely delivered
care, yet it is still largely fee-for-service (FFS). According to the 2017 by telephone-based methods. When CCM and TCM are delivered as
CMS Financial Report, Medicare processes over 1 billion FFS claims incident-to-services, general rather than direct supervision is required
per year; an analysis of 2016 claims puts value-based alternative pay- thereby increasing patients' access to care and thus, offering more
ment model payments at 25% in terms of reimbursement.37 The opportunities for service provision by community or other geographi-
Health Care Payment Learning and Action Network's 2016 survey cally separated pharmacists. Based on the supervision requirements, it
found similar results, with 43% FFS payments, 28% FFS with rates remains unclear whether current methods will allow pharmacists to
adjusted for quality, and 29% based entirely on quality measure per- bill for providing telehealth services. Billing is allowed by “physician
formance.38 In Deloitte's 2017 Survey of US Health System chief extenders” (eg, nurse practitioners and physicians' assistants), yet,
executive officers, low implementation rates for value-based models pharmacists are not considered physician extenders under most pay-
have resulted in less emphasis on outcomes in favor of FFS as the cur- ment groups, calling into question this practice by pharmacists.38
39
rent financially sustainable model. With time and as incentives
increase, implementation rates are expected to improve. 7.9 | Continued importance of establishing provider
status
7.7 | Direct billing for clinical pharmacist services
Despite the urgent need and overwhelmingly positive results, phar-
Direct billing opportunities for pharmacist services in Medicare Part B macy services remain difficult to justify in the current health care sys-
40
are limited. Current Procedural Terminology codes, established spe- tem. Historically, and still today, college of pharmacy support has
cifically for pharmacy services, remain largely unpaid by most medical been a commonly used model for provision of clinical pharmacy ser-
carriers and government programs. Beyond these, revenue-generating vices. Yet, as funding for education has tightened in recent years, the
FFS opportunities for pharmacists include facility fees or physicians expectations have changed and faculty are increasingly expected to
billing incident to pharmacists' services for evaluation and manage- demonstrate financial sustainability for services. While grant support
ment codes, Chronic Care Management (CCM), Transitional Care has helped bridge this gap, with limited billable opportunities, long-
Management (TCM), diabetes self-management training, Medicare term sustainability remains elusive. Many pharmacy services are initi-
41 ated with grant funding or college of pharmacy support. A consistent
Annual Wellness Visits, and other services.
Two recent studies found that the most commonly reported Medi- barrier cited for these relationships continues to be payment for ser-
care Part B reimbursed services were immunization delivery, diabetes vices, as cost avoidance is a complex scenario to sell to health care
management, and hypertension screenings. 42,43
The most common administrators.
reported Medicare Part D services were CMR/targeted medication Based on experience, administrators continue to heavily insist on
review and medication adherence service.37 Additionally, a systematic FFS revenue generation to justify pharmacist positions. This may fur-
review of pharmacist-remunerated clinical care programs worldwide ther complicate the issue in providing team-based care, as attribution
found that most of the United States' programs focused on MTM or dis- of pharmacist impact in value-based care models is difficult to quan-

ease management services. CMR, adherence-directed interventions, tify. Without provider status, limited opportunities exist for revenue

patient education and monitoring, prescriber consultations, and MTM generation, particularly at sites where provider supervision is limited

were the most frequently reported FFS provided. 44 or in states that limit levels of service for payment of pharmacy ser-
vices. Finally, multiple measures are needed to propel broader reim-
bursement of pharmacist services forward including establishing
7.8 | Facility billing for pharmacist services
pharmacists as Medicare Part B providers, standardizing methods for
Facility billing is intended to cover the non-professional fees associ- billing for direct patient care provided by pharmacists at the state and
ated with care at a health care facility, and as such, do not usually federal levels, and improved collaboration between the pharmacy and
cover the costs of a pharmacist's time apart from the services pro- medical benefit facilitated via health information exchange between
vided. Multiple factors influence pharmacists' ability to bill for the pharmacist and health care team members.
36 BINGHAM ET AL.

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that-can-facilitate-broader-reimbursement-o.
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doi.org/10.1002/jac5.1026

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