Medical costs and pharmaceutical price inflation are increasing at unsustainable rates in the United States. This economic reality is driving healthcare payers to demand that health professionals improve population health by transitioning from volume- to value-based reimbursement structures. To succeed in this new paradigm, patient outcomes must be improved in a cost-effective manner. To manage population health effectively, it is essential to optimize interdisciplinary care by ensuring that all team members practice “at the top of their license.” A popular strategy to achieve the dual aims of population health management and care team optimization is the implementation of the patient-centered medical home (PCMH).
In the PCMH model, the physician is the “quarterback” who diagnoses patients and guides the healthcare team to improve patient outcomes.1 The pharmacist’s role is to serve as the medication expert, optimizing drug therapy for patients with chronic diseases such as diabetes mellitus, hypertension, asthma, and hyperlipidemia.2
Due to their demonstrated success in improving markers of health, pharmacists are increasingly recognized as a critical part of the PCMH team. This professional acknowledgment is evidenced by a growing number of endorsements, such as the 2015 report “The Expanding Role of Pharmacists in a Transformed Health Care System,” by the National Governors Association,3 which called for the full utilization of pharmacists as patient care providers. Additionally, a 2011 report to the U.S. surgeon general titled “Improving Patient and Health System Outcomes through Advanced Pharmacy Practice” endorsed the increased use of pharmacists as healthcare providers through collaborative practice arrangements in a variety of clinical settings.4
To fully achieve their potential on interdisciplinary care teams, pharmacists must have the legal authority to efficiently and effectively manage their patients’ drug therapy. The American Society of Health-System Pharmacists, the National Community Pharmacists Association, the National Association of Chain Drug Stores, and the American Pharmacists Association are facilitating pharmacists’ ability to function in emerging practice roles by advocating for the passage of a national provider status law.5 Such a law would grant pharmacists the ability to bill Medicare for their services. This is a noble goal and one worthy of support. However, the nonfinancial impediments to advanced pharmacy practice, such as barriers to “dependent prescribing,” or collaborative practice, lie within the constraints imposed by state practice acts rather than federal law.6 In addition, federal legislation enables pharmacists to perform only the services they are legally authorized to perform pursuant to state scope of practice laws.
To ensure that pharmacists reach their potential in population health management, state scope of practice acts must be made less restrictive. The most effective way to achieve this goal is through professional activism targeting state legislatures.
Collaborative practice, or collaborative drug therapy management (CDTM), involves “a collaborative practice agreement between one or more physicians and pharmacists wherein qualified pharmacists working within the context of a defined protocol are permitted to assume professional responsibility for performing patient assessments; ordering drug therapy-related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regimens.”7 Pharmacists’ ability to practice within these agreements varies widely from state to state.
Multiple states, including California and North Carolina, have had success in advancing pharmacy practice by updating state laws that govern collaborative practice.8,9 Several years ago, such successes inspired Ohio pharmacists to pursue a legislative solution to remove legal and bureaucratic barriers to optimal care and improve a pharmacist’s ability to manage therapy within a collaborative agreement.
Ohio pharmacists were recently successful in improving their state’s collaborative practice law. On March 23, 2016, Ohio House Bill 188 (H.B. 188) went into effect. This law allows Ohio pharmacists—for the first time—to add, modify, and discontinue drug therapy and to order appropriate laboratory tests within the scope of the consultation agreement without the requirement of cosignature by a qualifying physician. The law also includes a provision on dispensing of emergency prescriptions. This newly enacted law has the potential to broadly improve patient care across the state.
History of collaborative practice agreements
Healthcare delivery has evolved from a physician-centered model, in which other practitioners played ancillary roles, to one that uses the expertise of clinicians in a broad array of disciplines. This progression has resulted in the need for coordination in the practitioner community. Today, virtually all states allow CDTM agreements in some form.10 The advanced practice that these arrangements allow has become a catalyst for increased pharmacist involvement in direct patient care activities. Once viewed as a locus of professional “turf battles,” CDTM agreements are now considered an essential component of modern-day healthcare delivery.
The scope of CDTM agreements has evolved over the years to include provisions such as authority to order laboratory tests and to prescribe and administer immunizations. These services were once available to patients only through physicians.
Lessons from the Ohio experience
A number of valuable lessons were learned from the successful campaign to secure enactment of major changes to Ohio’s collaborative practice law.
Rally pharmacists and state pharmacy societies
While nurses have been extremely successful in broadening their scope of practice, pharmacists have at times hindered their own success through fragmentation of message and objectives. With approximately 295,000 licensed pharmacists nationwide, including 12,000 in Ohio,11 it is challenging to create a strong and unified voice for the entire profession in order to be successful from an advocacy perspective. Unfortunately, differences in practice setting and specialty have resulted in competing priorities among pharmacy groups. To improve the potential for the Ohio bill’s success, Ohio pharmacists worked to unify the state pharmacy societies and rallied all pharmacists to fight for the ability to function at the top of their license regardless of practice site or professional society loyalty.
Although expansion of pharmacists’ scope of practice appeared to be widely supported by the entire pharmacy profession in Ohio, it became apparent in the first attempt to secure passage of a bill to modify the collaborative practice act that differences in expertise and priority were creating a confusing message for legislators. While many pharmacists spoke to their state senator or representative in support of the bill, the reasons for advocacy varied widely. Pharmacists were not consistently able to convey the impact of the bill outside of their practice specialty. To help create a unified voice, the strategy used by the Patient Access to Pharmacists’ Care Coalition12 was applied in creating a state partnership consisting of representatives of the Ohio Society of Health-System Pharmacists (OSHP), the Ohio Pharmacists Association (OPA), the Ohio College of Clinical Pharmacy, and the Council for Ohio Health Care Advocacy. This strategy has been implemented and described as successful in other states, such as Kansas.13
With a single vision for the legislative effort, Ohio pharmacists were able to establish the “must-haves” for the proposed legislation as well as items viewed as negotiable. Concise talking points were published for pharmacists to use when meeting with physicians or legislators. This consensus paved the way for an effective unification of pharmacists throughout the state. Improved understanding of and confidence in the message resulted in better engagement of frontline pharmacists than had been achieved during the previous (failed) attempt to modify the law through legislative action.
In Ohio, collaborative practice reforms were developed over the course of more than a decade. After years of refining proposed language, planting seeds with legislators, and creating issue briefs, OSHP and OPA sought out a sponsor for introduction of a formal bill in 2013; they had the luxury of being able to turn to a state senator who is also a respected community pharmacist, Senator Dave Burke (R-Marysville). This senator introduced the bill, which became Senate Bill 240 (S.B. 240) during Ohio’s 2013–14 legislative session.
S.B. 240 was developed through the senator’s office with pharmacists’ input. There was significant conflict between the pharmacy and medical communities on the bill. The disagreement centered on the issues of competencies and the granting of explicit prescribing authority to pharmacists. Despite strong opposition from the state medical associations, pharmacists pushed forward with lobbying in support of S.B. 240.
After fighting successfully to get hearings on the bill scheduled in the Senate Medicaid, Health and Human Services Committee of the Ohio senate, OSHP and OPA gathered several pharmacists and a single physician to provide testimony in support of the legislation. The proponents spoke to the medication expertise of pharmacists and of their unique qualifications to improve outcomes through enhanced drug therapy utilization.
The testimony was not well received by state legislators. They were not well versed in the educational background of pharmacists, the service-based skill sets they possess, or the evolving roles of pharmacists in the healthcare system. Legislators questioned the validity of the claim that medical doctors and osteopaths needed pharmacists on their teams in order to increase their own productivity and to practice at the top of their professional license. The lack of significant physician support ensured the premature demise of S.B. 240. The bill stalled after three hearings and never came up for a vote during the 2013–14 legislative session.
In 2015, pharmacy proponents worked with Senator Burke to adjust the language from S.B. 240 to make it more palatable to opponents such as the state medical societies by editing controversial language while maintaining the intent of the bill. The revised bill, S.B. 141, was introduced in the Ohio Senate with an additional joint sponsor, Senator Gayle Manning (R-North Ridgeville). Simultaneously, two state representatives were pursued to introduce a parallel bill in the Ohio House of Representatives. This pursuit paid off when a physician serving in the house, Representative Stephen Huffman (R-Tipp City) agreed to be one of the lead sponsors along with Representative Nathan Manning (R-North Ridgeville) and introduced H.B. 188.
Convince hospital leadership to lobby the state legislature
Nearly every state legislator has a hospital in his or her district. Because hospitals employ large numbers of voters, health systems can be very effective in lobbying. Convincing health systems to actively lobby for a bill is an effective way to move legislation forward.
Each year state bills with implications for health systems are introduced, and every year health systems prioritize which issues to support. In order to enlist the aid of their health system’s government relations teams or lobbyists in actively advocating for an initiative, health-system employees must get approval from their organization’s executive leadership. To achieve this aim for H.B. 188 at the Cleveland Clinic, a presentation and a report articulating the value of empowering pharmacists to more actively manage chronic diseases were created. The report summarized the relevant literature and centered on the value of multidisciplinary care in managing populations of patients. The audience assembled for the presentation included the chair of the department of medicine, the chief medical operations officer, the chief pharmacy officer, and the chief of government relations. The group universally endorsed active support for H.B. 188. That endorsement secured the approval of the health system’s chief executive officer. Lobbying for the bill was prioritized as the Cleveland Clinic’s top initiative for the 2014–15 Ohio legislative session, and the organization’s state lobbyist was tasked with securing passage of the bill.
Leverage hospitals’ influence with state medical societies
The Ohio State Medical Association (OSMA) and the Ohio Osteopathic Association have historically been supported by independent physician practitioners. As healthcare organizations merge and grow and as regulatory burdens mount, it is increasingly difficult for physicians, as businesspersons, to maintain an independent practice. As a result, many physicians are becoming employees of health systems. For example, the Cleveland Clinic has 49,166 employees and 3,432 physicians. Health systems like the Cleveland Clinic are increasingly supporting organizations such as state medical associations through payment for institutional memberships. Health systems now have substantial influence within these organizations, since they are major dues-paying partners.
Because Cleveland Clinic–affiliated physicians had a significant presence within the OSMA membership, institutional representatives and other influential physicians within the health system who understood the patient benefits of interdisciplinary care and collaborative practice were identified. These physicians communicated the benefits of the bill to their peers in state medical associations.
Foster collaboration by state pharmacy and medical societies
State medical associations are key gatekeepers for medical practice–related legislation in many states. Proponents of H.B. 188 realized that it was important that these influential groups, at a minimum, remain neutral during efforts to secure the bill’s passage. The medical groups initially opposed the bill, as some members were hesitant to support any legislation that would expand the definition of prescriber.
Unfamiliarity and a lack of communication can breed distrust among professional societies, which can develop into hostile relationships. To avoid this, OPA and OSHP worked to build familiarity, to “overcommunicate,” and to develop a positive relationship and a willingness to negotiate with the state medical associations. This flexibility ultimately overcame any lingering historical resistance to improving the Ohio collaborative practice act. Cooperation among disciplines is needed for successful creation or modification of a collaborative practice act.
Clearly understanding what is and is not negotiable is essential to success in any legislative initiative. While pharmacists’ preference was for H.B. 188 to contain language providing for and defining dependent prescribing, the “P word” (prescribe) was a sticking point that the medical associations viewed as insurmountable. Pharmacists’ willingness to be flexible resulted in a change to alternative wording: “adding, modifying, and discontinuing” drug therapy. Rather than letting a dispute over phrasing derail the bill, proponents resolved to compromise on the specific verbiage to help gain support for the bill’s intent.
With this change in language and with the assistance of the state’s health-system physicians, the state medical associations did not oppose the bill. In fact, they actively supported the bill, which was a major factor in its subsequent unanimous passage in both the Ohio house and senate. Pharmacists successfully made the case that members of the medical associations needed pharmacists to help them care for patients in rapidly approaching models of capitated global payment for population health services.
Recruit physician champions
The failure of S.B. 240 during the 2013–14 session of the Ohio general assembly demonstrated the importance of gaining physician support and supportive testimony in efforts to modify the collaborative practice act. Two important problems can arise when pharmacists testify in support of “their own bill.” First, legislators want to understand the full impact of any healthcare bill on their constituents, and pharmacists’ testimony can sound self-serving. Second, pharmacists have little, if any, ability to overcome the opposition of physician organizations to a pharmacy-related bill through testimony alone. The experience in Ohio made it clear that, simply put, the “buy-in” of physicians was needed so that their professional organizations could appreciate the bill’s benefits and stop obstructing efforts to secure its passage. This physician member activism in support of the principles of interdisciplinary care disarmed the medical associations by convincing them that advanced pharmacy practice posed no threat to the medical profession.
At the time of the initiative to get H.B. 188 enacted, there were already pharmacists practicing under consultation agreements throughout the state, albeit under very restrictive requirements. These established relationships helped bill proponents quickly identify and target physicians who supported the legislation and were willing to write or testify on its behalf. Physicians from every metropolitan area in Ohio provided support for the bill, which lent credibility to help overcome legislators’ concerns. Having Representative Huffman (a physician) as a lead sponsor solidified the notion that the bill was good for patient care and physician practices.
The swell in physician support removed nearly every barrier to the bill’s success. Several physicians traveled to the state capital to testify in support of the bill in both house and senate committees. Both committees unanimously passed the bill out of committee after this testimony.
Find opportunity in adversity
Consultation agreements are not particularly exciting or attractive for legislators or their lay constituents. Due to an initial lack of societal enthusiasm and interest, legislators did not come under any real public pressure to modify the collaborative practice law. Recognition of this lack of motivation for Ohio lawmakers to advance H.B. 188 and S.B. 141 prompted OPA and proponents in the legislature to add provisions addressing another pharmacy-related issue to the legislation with the aim of helping to energize support for the bills.
Crises can shine a spotlight on problems, creating opportunities for change. As Breland14 suggested, “Always look for the opportunity that adversity and crisis may create. Management excellence is turning tragedy into opportunity.”
In 2014, a high-profile medication-related tragedy occurred in northeastern Ohio after a patient ran out of refills for his insulin and his physician could not be reached to authorize a refill.15 At the time, Ohio law permitted pharmacists to dispense only a 72-hour emergency supply of medication until a new prescription could be submitted; due to a prohibition against dispensing a partial vial of insulin, the patient’s pharmacy could not dispense a refill from available stock, and he developed diabetic complications and consequently died.
In light of that tragedy, OPA and Senator Burke engaged another senator who represented the district where the patient died. They added a provision to the bill to increase the emergency dispensing threshold to a 30-day supply or the smallest standard unit available to meet the patient’s needs. This addition drew broad support for the bill in the senate. In the house, the state representative from the patient’s district worked with the physician cosponsoring H.B. 188 to incorporate the same language into the bill.
The family of the patient testified before committees of the Ohio Senate and House of Representatives. The testimony was impactful, and legislators were unanimous in their support for modifying the law to ensure that future patients would not suffer a similar fate. This presented another great opportunity to showcase the vital role pharmacists play in their communities. It also created a firestorm of support and media coverage that propelled H.B. 188 forward.
In the end, both the emergency dispensing provisions and the collaborative practice–related changes were recognized as highly beneficial for patients with diabetes or other chronic diseases, even if some legislators may not have fully grasped the value of both aspects of the bill. However, the emergency dispensing addition was a key part of building public pressure to support passage of the legislation.
A positive outcome
S.B. 141 was introduced in the senate, and H.B. 188 was introduced in the house for consideration by the 2015–16 General Assembly. While the language used in H.B. 188 and S.B. 141 differed from that used in S.B. 240, the philosophy and end goals were similar. Both bills were unanimously approved, and the legislation was signed into law by Ohio Governor John Kasich.
National movements begin at the state level, and success breeds success. Momentum builds as more states implement legislation that advances pharmacy practice and improves patient care. Lessons learned from the legislative achievements and failures of pharmacists across the country help to create a road map of strategies worth sharing.
Legislative victory is dependent on many actions, including but not limited to promoting pharmacist engagement, identifying passionate and credible legislative sponsors, fostering collaboration among professional pharmacy and medical organizations, being relentless in mounting repeated attempts after setbacks, obtaining health-system leadership lobbying support, engaging physician champions, and recognizing and seizing opportunities as they present themselves.
The authors have declared no potential conflicts of interest.
- Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.