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What’s your white bagging payment plan?

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UP FRONT

UP FRONT

Getting in sync with payors on this issue is key

What’s Your White-Bagging Strategy?

It would be an understatement to line of sight into the origin and handling established practices intended to say that hospital pharmacists are of a drug prior to receipt by the hospital, ensure patient safety.” disgruntled with the concepts of white raising significant concerns and creat- • “White bagging negatively impacts bagging and mandated restricted drug ing substantial challenges. These actions pharmacists’ ability to validate medidistribution models that commercial pay- pose significant risks to quality of care cation integrity and maintain overors include in their armamentarium of as providers have inadequate control in sight of storage and handling.” drug spending control tools. Some phar- ensuring patient access to high quality • “By sidestepping well-established macists have prohibited white bagging drugs, as well as the appropriate storage supply chain procedures, white bagat their facilities and diligently try to and handling of those [medications].” ging disrupts efforts to maintain avoid restricted drug distribution, per- The AMA statement (bit.ly/3rSU91h) adherence with protocols designed haps even closing formularies to those added that “these policies simply serve to ensure patient safety, quality, and to happen, a basic grasp of how payments affected products. Is this developing into to drive more revenue to health insurers continuity of care.” are made in this setting is required. a standoff between hospital pharmacists through their pharmacy benefit manage- Let’s start with the basics: Because and commercial payors? ment and specialty pharmacy lines of It’s All in the Contract collaborative practice agreements estab-

In my December 2020 column, “Ring- business.” Let’s turn our focus to another aspect of lish a formal relationship between the ing in the New Payment Year” (bit.ly/ ASHP has taken extensive action to white bagging and other restrictive payor pharmacist and the physician, your first 3vyaOt6), I suggested that payor require- address payer-mandated white bagging strategies that rarely, if ever, are addressed step is to understand the reimbursements will continue to increase. So it will with an advocacy agenda announced in the pharmacy literature: the business ment structure that governs physician be worthwhile to negotiate payments for March 18. The organization stated that: contracting relationships that your facil- payment. From a Medicare perspective the work done by pharmacy. The negotia- • “[It] stands opposed to payer-man- ity has established with the commercial and any commercial plans that follow tions could touch on anything from han- dated white bagging models that payors, including MA. These annual con- Medicare’s lead, this is found in the PFS dling fees for zero-priced (white-bagged) jeopardize optimal, safe, and effective tracts have been put into place to provide regulations. Some of those commercial drugs (sidebar) to any number of outpa- medication use.” the covered beneficiary (the patient) with plans may be the ones that cover your tient and ambulatory clinical services. • “Payer-mandated distribution models services that the hospital system offers— MA patients. Payment for office and outThe assumption is that there is a desire that require clinician-administered for example: ER visits, inpatient care, patient E/M visits should be a focus. at the facility for a workable solution that drugs to be dispensed exclusively via outpatient care including infusion clin- MLN Bulletins are an easy way to stay on provides some remuneration for its work third-party specialty pharmacies are ics, perhaps ambulatory services, labora- top of this, because they provide the key in handling and administrating, as well as placing patients at risk and threaten tory services, radiology services, and per- rule-set changes as well as background administering, the affected zero-priced to compromise organizations’ well- haps physical and occupational services, material and references just as they do drug products, albeit not the billed etc., depending on contract terms. for drugs and biologicals. For instance, revenue from the markup on the The covered beneficiary (patient) a recent publication addresses PFS paydrug that was lost. has signed up with this carrier for ment of office and outpatient E/M vis-

Such involvement also is based their health insurance at what can its (CPT 99201-99215) to illustrate how on the assumption that hospital be a substantial sum. Imagine their Medicare generally adopts the new AMA pharmacists are willing to continue shock at arranging for services at coding, language and interpretive guidto be advocates for patient assis- your infusion clinic only to find that ance framework (go.cms.gov/3rVj18u; tance programs, working with their your pharmacy has denied the use of go.cms.gov/2QbfsgB). in-house financial navigators and expensive drugs that their insurance supporting agencies. Another piece carrier is willing to provide as zero- Promoting Wellness of this puzzle involves negotiating priced (white-bagged) drugs to you. COVID-19 cases are down, but the panwith pharmaceutical companies. Remember that you can negotiate What Is White What Is White They may very well have chosen this plan because of coverage of those demic is still with us. Amid those pressures, it’s all too easy for patients and the handling fees for these patientspecific zero-priced drugs, because Bagging? drugs that you are now blocking. My point is this: Refusing to work caregivers to forget about wellness. Are you part of the “Annual Wellness Visit” there is no billed revenue from their use. The functions of receiv- W hite bagging is the practice of having patient-specific medications or supwith white bagging isn’t a viable option. Whether it is the foremenor “Yearly Wellness Visit” that focuses on preventive health? Pharmacists are ing, storing, handling, prepar- plies delivered directly to the practice set- tioned contracting for handling fees uniquely qualified to perform a health ing and returning or disposing of ting (outpatient infusion center, physician for these medications or some oth- risk assessment and develop or update zero-priced patient-specific drugs office, hospital) for use by a specific patient. er strategy, work with your payors a personalized prevention plan for the is very similar to those for zero- The specialty pharmacy shipping the prod- to come up with a mutually ben- patients they routinely see while propriced white-bagged medications. uct directly to the practice site has already eficial solution. Also, remember that viding or managing their medications.

Many of the frustrations and con- billed the insurance company for the product this isn’t a decision that pharmacy And it’s a reimbursable service! For more cerns that hospital pharmacists have and collected the copay from the patient or should be making unilaterally with- information, visit go.cms.gov/3eNTLxs. about zero-priced drugs relate to secondary insurer. There is no opportunity for out the endorsement of the C-suite For details on how to properly provide the areas of supply chain, storage, the practice site to bill for the product; it is pre- and their disclosure of this decision and bill for Medicare preventive services, security and vetting of the products. paid or complimentary. The practice evolved to the health insurance carrier and visit go.cms.gov/3cyZ9Sg. These are valid concerns that need due to some insurance carriers mandating that all key stakeholders. to be addressed. They’re time-consuming and often can go against the grain of established departmental patients and providers use specialty pharmacies to obtain their medications. Manufacturersupported patient assistance programs and some FDA-assigned Risk Evaluation and MitCollaborative Practice Agreements Drug Exclusions Finally, a note on yet another oft-overlooked area of reimbursement: keeping standard operating procedures. igation Strategies programs also are cited as Payor relationships aren’t the only up with the latest version of the self-

In a March 8 white paper, the reasons why specialty pharmacies become the ones that hinge on effective negoti- administered Drug Exclusion list, which AMA addressed the issue by urging mandated source for prescription dispensing. ating; collaborative practice agree- took effect April 1, 2021. This is a vital regulators to prohibit health insur- (Clear bagging, a related process, is the term ments also require all stakeholders step in ensuring the accuracy of billing ance pharmacy policies that “limit used when the health care system supplies the to be equally involved and advocat- and reimbursement. For more guidance, the ability of hospital staff to have medications from its own specialty pharmacy.) ing for their interests. But for that see go.cms.gov/2QfP6u1. ■

“Reimbursement Matters” is a tool for maintaining your health system’s fiscal health. Please email the author at bonniekirschenbaum@ gmail.com with suggestions on reimbursement issues that you would like to see covered. Bonnie Kirschenbaum, MS, FASHP, FCSHP

A Reimbursement Lexicon

AMA, American Medical Association; CPT, Common Procedural Terminology; E/M, evaluation and management; MA, Medicare Advantage; MLN, Medicare Learning Network; PFS, Physician Fee Schedule

Across International

How do you see the role of an equipment supplier or manufacturer in fighting the COVID-19 pandemic, or any health emergency?

Every community and human being relies at some point on the health care infrastructure around them, and that infrastructure relies on professionals and the instruments they work with. The responsibility of a manufacturer and supplier is not only to offer something that meets equipment specifications, it is also about foreseeing equipment features that will make the daily tasks of health care workers easier and quicker to perform, so they can get more done every day. It also involves providing a support structure to make sure providers have all the tools they (and their patients) need. Temperature precision, uniformity so every sample (and thus patient) receives the same care conditions, medical-grade compliance to meet CDC and VFC guidelines as well as electrical and safety certification standards, and a robust quality assurance and control process are three pillars in the foundation of this effort, as well as a variety of features unique to us.

What are some of these unique features you refer to?

One example is the wide variety of data-logging and communication capabilities Across International offers to make audits and ensuring vaccines or other critical samples were properly stored and easily accessible for lab teams. The flagship RapidChill and Glacier –86° C freezers have onboard data-logging that can be exported via USB to track temperature over time, and offer the option of an additional 4-20 mA transmitter for communicating with existing systems in hospitals, freezer farms, pharmacies or drug discovery departments, as well as a la carte wireless data loggers that can provide text and email alerts if any alarms are triggered on any of Ai’s cold storage or heat treatment options. These ULT freezers suitable for Pfizer/BioNTech vaccines also have backup batteries to continue reading temperature during a power failure, as well as the DeepFreeze -40 C series suitable for the Moderna vaccine, and the Medical Pharmacy 2-8C refrigerators suitable for the Johnson & Johnson, AstraZeneca, Novavex, and others seeking FDA emergency use authorization.

This all makes sense for vaccines fresh from production or already delivered to where they will be administered to recipients at distribution centers, but how do these vaccines get from point A to Z?

That is a very good question, as many vaccines are unfortunately wasted (or even worse, administered to people anticipating their protective effects, and disappointed or even endangered when their quality has been compromised) due to mishandling in transportation. Across International applied another of our unique technologies, the VIP vacuum insulated panel made of Micro-Cellular Polyurethane insulation, to the Ai –70˚ C-rated 20-L shipping cube that retains the cooling power of dry ice for up to 72 hours until vaccines are safely delivered to long-term storage freezers or refrigerators. This same insulation technology, together with some other design features such as double seals, also earned several of the RapidChill –86˚ C freezers an Energy Star rating.

That brings up a great point that is important not to lose sight of in the pandemic panic: sustainability and the environment. Does Ai do anything else to contribute to this global initiative other than Energy Star–rated equipment?

Certainly, and any customer should question what the companies they buy from are doing for the environment and community around them. Not only does Across International construct our hardware for maximum temperature retention, accomplishing the goals of good, consistent chilling or heating performance as well as minimizing energy usage maintaining temperatures of the equipment or laboratory they are working in, but Ai uses only environmentally friendly CFC- and HCFC-free refrigerants, and the latest RapidChill lines use HC refrigerants that chill faster, use less energy and are readily available for recharge. Finally, Across International is a member of the NJ SEEDS Scholars Program board of trustees, helping to give the next generation of innovators the resources they need to get the education and opportunities to be successful in their career goals.

Earlier you mentioned a support structure to back your equipment. Can you tell us more about that?

All Across International equipment is supported by trained engineers available out of three locations in Livingston, N.J., Sparks, N.V., and Baywater, VIC Australia, and undergoes a strict inspection process both after manufacturing and before shipment. Every unit comes with a warranty including parts and labor from trained technicians, while many competitors simply send customers components and expect them to hire local repair technicians that may not be available as urgently as samples such as vaccines need them, and are unfamiliar with the equipment once they get there. Even surpassing industry-leading warranty guarantees, Ai is always there to support the timely answer of questions or quoting after-warranty repairs for no more than a reasonable fee that reflects what it costs. Scientists sense that Ai has the same values of customer satisfaction that they look for in a supplier and a partner in innovation.

COVID-19 VACCINE COLD STORAGE SOLUTIONS

- 860C ULTRA-LOW FREEZER LINE

-100C TO -400C MEDICAL FREEZER LINE

-700C ULTRA-COLD VACCINE SHIPPING CUBE LINE

20C TO 80C MEDICAL FREEZER LINE

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UCSF Health is deploying multiple strategies to reach underserved populations that may have limited access to vaccines, including partnering with Sutter Health to bolster drive-through vaccinations.

Vaccine Inequities

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The challenge is a steep one, according to the initial data on vaccination access. In Maryland, for example, Black people make up 30% of the population and account for 33% of COVID-19 cases and 35% of deaths—yet as of Feb. 16, they represented only 17% of vaccinations, according to state-reported data on COVID-19 vaccinations gathered and analyzed by the Kaiser Family Foundation (bit.ly/3dSs9qz). In Ohio, Blacks make up 12% of the population, 13% of the COVID-19 cases and 12% of the deaths, but just 6% of those vaccinated. In Arizona, where Latinx people comprise 32% of the population, 36% of COVID-19 cases and 31% of the deaths, they accounted for just 13% of vaccinations. As for Texas, Latinx people make up 40% of the population, 42% of COVID-19 cases and 47% of deaths, yet they account for only 20% of those vaccinated.

The reasons for these inequities in vaccination rates are complex, experts told Pharmacy Practice News. But availability is looking like a significant factor. In many parts of the country, minorities have to travel farther to receive a vaccine than white people do, according to a new pharmacist-led study by investigators at the University of Pittsburgh Medical Center (UPMC).

Vaccine ‘Deserts’

Released in early February, the study, a white paper posted on the University of Pittsburgh’s website (bit.ly/37IDhCf), found that in 69 counties, Black Americans would need to travel farther to get to sites such as hospital outpatient departments, federally qualified health centers and rural health clinics, and community pharmacies that formed the early backbone of large-scale vaccination efforts. The study, which used a sample population and geographic data supplied by the National Council for Prescription Drug Programs, the Centers for Medicare and Medicaid Services, and the Health Resources and Services Administration, among others, found that some of the worst so-called “vaccine deserts” for Black people were in Georgia, Louisiana, Mississippi and South Carolina.

In Lee County, Ga., for example, Black Americans are 825% more likely to live more than 10 miles from a vaccination location than whites. In Madison County, Miss., the figure is 976%. And in Chilton County, Ala., it’s 1,193%, the study found.

But disparities are not limited to the rural South, according to lead investigator Lucas Berenbrok, PharmD, an assistant professor of pharmacy and therapeutics at UPMC School of Pharmacy. “Of those 69 counties, 23 are in urban areas, some are in the West and Southwest, and a few are in the Northeast,” Berenbrok said. “The point this analysis makes is that our existing health care infrastructure probably isn’t going to cut it in terms of achieving a good, equitable distribution of vaccines.”

Barenbrok stressed, however, that his team’s analysis was based on sites representing existing, traditional vaccination infrastructure; it did not include the kinds of mass vaccination sites that, as previously noted, are now being established at stadiums, community pharmacies and convention centers. But even once those sites start ramping up vaccine distribution, they cannot guarantee widespread access to traditionally underserved populations, he noted. “Our research suggests that the sites that are popping up need to pop up in underserved areas. Where population density is lower, mobile vaccine clinics would be a good use of resources to meet people where they are, and that’s something hospital and health system pharmacies could play an important role in.” (For an account of one pharmacy that has been sending out COVID-19 support vans to underserved neighborhoods, see “Heeding the Call of COVID” in the December issue of Pharmacy Practice News; bit.ly/3slpVDP.)

Pharmacies At the Ready

The UPMC study underscores that, even in communities where there is less access to care generally, pharmacies stand ready to fill the COVID-19 vaccination gap, said Tom Kraus, JD, the vice president of government relations for ASHP. “While it is absolutely a problem that there are fewer pharmacies in those communities, let’s take advantage of those that are there and leverage them as vaccination sites, while we also establish mass vaccination sites, partner with community organizations and have the government step in to supplement resources already on the ground.”

Kraus praised steps being taken by the Biden administration to bring the resources of the Federal Emergency Management Agency (FEMA) and Department of Defense to establish more vaccination sites in communities in need and to support logistics at those facilities. (In March, Biden promised enough COVID-19 vaccines to inoculate all adult Americans by the end of May.) “They are specifically allocating vaccine supplies to pharmacies in underserved communities, which is essential,” he said.

Signs of Progress

The move to open mass COVID-19 vaccination sites has been done with at least an eye toward underserved populations. In March, four of the megasites opened in Florida—two in Orlando, one in Miami and one in Tampa. Each site has two smaller, mobile satellite sites that each can conduct 500 vaccinations per day in underserved areas. In addition, on Feb. 16, the first of several mass vaccination sites in California opened at California State University, Los Angeles (Cal State LA) and Oakland-Alameda Coliseum—in two of the areas’ most diverse and economically challenged communities. “[Cal State LA] serves communities that have been ravaged by the pandemic, including Boyle Heights, East Los Angeles, much of South Los Angeles and communities in Southeast Los Angeles County,” the university said in a statement.

The Oakland site is complemented by another megasite at a campus of the City College of San Francisco, operated by the city in partnership with the University of California, San Francisco (UCSF) Health, which opened on Jan. 22. “City College is in an area with a large Black and Latinx population, and is very accessible by public transportation,” Desi Kotis, PharmD, an associate dean of the UCSF School of Pharmacy and chief pharmacy executive for UCSF Health, told Pharmacy Practice News. “Our partner, Sutter Health, has also worked with the city to open pop-up clinics at our produce markets so that people working in the fields, in agriculture, have easy access to vaccines.”

UCSF Health is deploying multiple strategies to reach underserved populations who may have limited access to vaccines. “For example, for a group of our patients from Japantown, we sent a bus to bring them to the City College vaccination site,” Kotis said. “Lyft and Uber have also partnered with us in the city to get people to our drive-through vaccination sites.”

Kraus pointed out that hospitals that provide services to underserved communities are often safety net/340B institutions, which have been negatively affected by recent cuts to the federal 340B Drug Pricing Program. “The administration should be thinking about ways to leverage those 340B programs to support existing infrastructure and improve access to vaccination services,” he said.

IU Health Meets Inequities Head-On

Addressing racial and ethnic inequalities in vaccine access requires a variety of solutions for meeting specific community needs, noted Tate Trujillo, PharmD, the director of pharmacy for Indiana University Health. “Our hospital is in downtown Indianapolis, and the county hospital is also in a location that is accessible for much of our Black and Latinx population,” Trujillo said. “The bigger challenge is getting people registered for the vaccine. We have a statewide online vaccine scheduling system, but we recognize that some people in communities of color have limited access to these resources. So, we are planning to partner with community organizations and houses of worship to spend afternoons helping people sign up for appointments to get vaccinated, and answer their questions and address vaccine hesitancy at the same time.”

Blue Cross Blue Shield of Massachusetts is partnering with the state’s League of Community Health Centers to contribute $1 million to fund free rides to and from COVID-19 vaccination sites across the state to support community health centers, underserved communities and vulnerable populations. “First, we are doing quick interventions like our community health center and Lyft partnership and $1 million grant announced last week,” said Cedric Terrell, PharmD, MHA, the insurer’s chief pharmacy officer and vice president of health and medical management. “Lack of access to transportation is a significant barrier in communities hardest hit by COVID-19. Partnering with the community health centers will help more people get vaccinated.”

Kraus noted that the current, concerted efforts to respond to inequities in vaccine access must continue past the pandemic. “Those disparities won’t go away when the vaccine effort ends. We should be thinking about how we address them long term,” he said. “If we identify resources in communities that are good avenues in caring for patients, that doesn’t have to end with vaccines.”

If pharmacies are the sites of care available in otherwise underserved communities, “let’s figure out how we provide primary care solutions through these avenues,” Kraus said. “Let’s leverage the attention this issue is getting to address these disparities long term.”

The government also recognizes the n need to identify and eliminate health and social disparities that has resulted in disproportionately higher rates of exposure, illness, hospitalizations and death related to COVID-19 among minorities. The COVID-19 Health Equity Task Force was established in January to make recommendations to mitigate all of the inequities caused or exacerbated by the pandemic, including vaccination, according to Marcella Nunez-Smith, MD, who heads the taskforce. At a White House briefing in February, Nunez-Smith said the task force is focused on three key areas: testing, treatment and vaccination. —Gina Shaw

Significant disparities at P<0.05 Nonsignificant disparities at P<0.05

Figure. Counties where Black residents were more likely than white residents to have a driving distance more than 10 miles.

th t in c e a c p t a a

The sources reported no relevant fi nancial disclosures.

Top of Your License

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New Mexico: 2 Advanced Practice Pharmacist Designations

New Mexico has two different advanced practice pharmacist licensures:

The Pharmacist Clinician (PhC) license. In place since 1993, the PhC allows pharmacists prescriptive authority under a collaborative drug management protocol, which includes laboratory and diagnostic ordering. They

participate in comprehensive disease management and can receive authorization from the Drug Enforcement Administration to prescribe controlled substances.

Independent pharmacist prescrip-

tive authority. This approach was established in 2001 in response to low immunization rates in the state. This designation is most commonly used in community pharmacy settings and narrower in scope, with a limited set of authorized drugs that includes adult and pediatric immunizations, hormonal contraception, tobacco cessation, tuberculosis testing and naloxone.

The protocols are individualized, but each practitioner must complete the state Board of Pharmacy–approved 60-hour assessment course and a 150hour direct care preceptorship with 300 patient contacts, supervised by a practitioner with prescriptive authority, according to Gretchen M. Ray, PharmD, an associate professor in the College of Pharmacy at the University of New Mexico Health Sciences Center, in Albuquerque.

“The individual PhCs’ protocol will include their purpose, scope of practice and procedures they can perform and conditions they can treat, and a list of policies, such as when the pharmacist clinician should contact the supervising physician,” Ray said during a session on advanced practice models at the American College of Clinical Pharmacy 2020 virtual annual meeting. “The supervisors do not need to be physically present when the pharmacist clinician is practicing, or even in the same city; they only must be available for contact by phone or electronic messaging. Under my own protocol, for example, each time I see a patient, I forward my notes to their primary care provider to facilitate continuity of care.”

Protocols for PhCs often extend beyond the primary disease states, allowing for flexibility if the pharmacist needs to make an adjustment to another medication. For example,

Ray shared the protocols for a PhC integrated into a family medicine clinic providing diabetes and cardiovascular risk reduction services.

In addition to the expected disease states, this PhC also is authorized to refill medications, provide drug dose adjustments and otherwise offer disease management for a range of other conditions, including osteoporosis, gastrointestinal disorders, chronic and acute pain and neuropathy, and respiratory disorders such as asthma and chronic obstructive pulmonary disease.

“So if a patient comes in for a diabetes medication and the pharmacist clinician notes that his creatinine clearance is at 45, and the gabapentin he is on has not been adjusted, that pharmacist can titrate that dose at the same time she is providing glycemic management,” Ray explained.

PhCs in New Mexico practice in a wide variety of clinical settings, ranging from heart failure and general cardiology clinics to neurology, rheumatology, endocrinology, hepatitis C, HIV, transgender health and geriatric clinics, among others, Ray said.

Many clinicians in the state remain unaware of the two types of advanced practice pharmacist designations. In a survey published in the Journal of the American Pharmacists Association, conducted in 2019 and completed by 634 physicians, osteopaths, nurse practitioners and physician assistants in New Mexico, Ray found that 78% of respondents were aware of the PhC designation and 75% would refer to a PhC if available, but only 32% knew about both types of licensure (J Am Pharm Assoc 2021;61[1]:101-108).

“There was high awareness for adult immunizations, but fewer people knew about pediatric immunizations and the other independent prescriptive authority pharmacists can obtain,” she said. “Only 41% of respondents knew about hormonal contraception, and 40% about tobacco cessation medication. But once they knew about this authority, their willingness to refer was much higher, with 71% willing to refer for hormonal contraception, 89% for tobacco cessation medication and 92% for naloxone.”

Following the Money

Reimbursement and cost has been a key barrier to broader adoption of topof-license clinical pharmacy practice in New Mexico, Ray said. That barrier was partly dismantled in March 2020, when the state legislature passed H.B. 42, the Pharmacist Prescriptive Authority Services Reimbursement Parity Act, which requires commercial insurance and state Medicaid to reimburse pharmacists with prescriptive authority at the standard contracted rate at which the plan reimburses other providers. “Lack of reimbursement from Medicare Part B will continue to remain a significant barrier to expansion of services, however,” she said. (Because they are still not recognized as providers under Medicare Part B, pharmacists cannot directly bill Medicare for most of their clinical services.)

North Carolina: CPPs Improve Outcomes, Patient Satisfaction

North Carolina is one of six states (joining California, Maine, Maryland, Montana and New York) and the District of Columbia that include certification by the Board of Pharmacy Specialties (BPS) as one of several qualifying credentials for an expanded scope of practice, according to the ACCP. These states use various titles for their advanced practice pharmacist designations; North Carolina’s is the Clinical Pharmacist Practitioner (CPP) license, established in 2001 as a collaboration between the state Board of Pharmacy and Board of Medicine.

Researchers have documented the value of North Carolina’s CPP license, which requires either board certification from the BPS, residency training plus two years of clinical experience, a PharmD plus three years of experience, or a Bachelor of Science in Pharmacy plus five years of experience and two certificate programs, as well as 35 hours of practice-relevant continuing education

annually. A 2018 study involving patients in a family-centered medical home model, seen in a transitions of care clinic, found that CPP involvement reduced hospital readmissions to 7.7% compared with 18.8% without CPP involvement (J Pharm

Pract 2018;31[2]:175-182). Earlier research found similarly significant improvements in hospital readmission rates (J Manag Care Spec Pharm 2015;21[3]:256-260), as well as high rates of patient satisfaction (J Manag Care Spec Pharm 2017;23[11]:1125-1129).

A Solid-Organ Transplant Program

Clinics within the UNC Health system that incorporate CPPs operate under a variety of models, said Christina Teeter Doligalski, PharmD, BCPS, CPP, a solidorgan transplant specialist. “In our transplant service, I am responsible for all primary care issues, triaging all lab follow-up in between visits—we may have patients coming in only once a month, but getting labs as much as twice a week—and the overall plan of care. But 90% of visits are multidisciplinary, with a collaborative discussion about immunosuppression. By contrast, endocrine clinic visits are 100% conducted by the CPP, who is responsible for initiation and adjustment of endocrine therapy only, with minimal between-visit triage,” Doligalski said at the ACCP virtual annual meeting.

There are multiple challenges to the CPP model, Doligalski acknowledged. “For the CPP, deep disease state–specific specialty knowledge is required to provide thorough and well-considered recommendations for patients. For the health system, the unique and disparate services mean that it’s almost impossible to have consistent metrics to apply to all clinics, and it’s also difficult to have an ‘elevator speech’ to sum up the importance of the program when talking to those outside of the pharmacy realm.”

Providers also may not understand the value of the CPP. “I’ve encountered situations with physicians who are incredibly pharmacy friendly, but who still don’t know what I as a CPP can do. I’m not just a drug information resource; I can actively

o be pharr even in be availectronic ocolfor bey a m t R i c d In st re ad ea co ga acu rat chr “

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annua A patien medic in a t ic, found reduced h 7.7% com out CPP

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can do. I’m not just a drug information resource; I can actively

manage pharmacotherapy for our patients,” Doligalski said.

To overcome challenges, she urged early, robust assessment and training for the new CPPs, along with mentor partnering with more seasoned CPPs; clearly defined metrics that can apply to all CPP clinics (e.g., the patient satisfaction and readmission measures described in the studies above), accompanied by clinicspecific metrics meaningful to both the health system and clinic leadership; and early and frequent communication with key providers about the CPP’s role and scope of practice.

“What has made our program so successful is that we go into each clinic and assess its specific needs, rather than rotating pharmacists between clinics and having them cross cover each other,” Doligalski said. “We’ve customized our CPP service to the needs of each clinic, which hopefully leads to enhanced patient and provider satisfaction as well as improved outcomes.”

With the help of residents in the health-system pharmacy administration and leadership residency program, Doligalski and her colleagues are developing clinic-specific metrics to assess those outcomes. “We’ve done a couple of small looks at individual clinics. In mine, for example, we did find decreased hospitalization rates and improvement in certain outcomes like blood pressure control and guidelinedirected medication therapy utilization, but since we are putting together a manuscript on that, we can’t release any more specific data right now.”

Getting Paid for These Efforts

Reimbursement for CPP services in the UNC Health system takes one of two approaches. The physician-owned practices are able to employ “incident to” billing, in which nonphysician practitioners can bill for certain services under the provider’s National Provider Identifier number. “Our family medicine clinic, for example, is a physician-owned practice, and the physician sees the patient annually but then may want them to see the pharmacist in three months for medication management follow-up for conditions such as diabetes, hypertension and osteoporosis,” Doligalski said. “The pharmacist sees them independently and manages those disease states, and the billing is done as ‘incident to’ at varying levels of reimbursement depending on complexity.”

Where the hospital owns the clinic practice—as in the case of Doligalski’s transplant clinic and many others—CPP care is billed under facility fees. “The addition of a pharmacist to those visits allows for a higher level of facility fee billing,” she said. “That is typically not enough to cover the entire salary for the pharmacist, so the remainder has to be made up elsewhere.”

Illinois: A ProtocolBased Agreement

Unlike New Mexico and North Carolina, Illinois is one of several states that has not established specific advanced practice pharmacist designations. At the University of Illinois at Chicago (UIC), pharmacists operate under protocols that are approved by the medical staff. “A protocol includes predetermined criteria defining appropriate care and treatment so that a nonphysician can initiate orders to provide timely care and services to a patient,” explained Vicki Groo, PharmD, BCCP, a clinical associate professor of pharmacy at UIC. “All protocol orders must be signed by a physician/credentialed practitioner within 72 hours of the order.”

Such protocols are the foundation for the pharmacist-directed medication titration assistance clinic (MTAC) at UIC, developed as a resource to assist general cardiologists in implementing goal-directed medication therapy (GDMT) in heart failure patients with reduced ejection fraction, which has grown dramatically since it was first established in 2011.

“We began with four slots every other week, but we did not anticipate how many patients would be sent our way,” Groo said. “We rapidly increased to four slots weekly, then six, then seven, and in 2018 we added a second half-day as a new attending physician began to refer patients to us who had heart failure with preserved ejection fraction or primary hypertension.”

Pharmacists in the clinic are privileged under a protocol agreement established by the health system, which outlines the delegation of patient care functions, including initiating, modifying or discontinuing drug therapy, and ordering and/or interpreting lab tests. Content experts for the protocol include the prescribers who will be referring patients to the pharmacists.

In a 2018 study, patients in the MTAC had a higher rate of achieving their target or maximum tolerated dose of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and beta-blockers compared with those in the general cardiology clinic (64% vs. 40%; P=0.01) (Ann Pharmacother 2018;52[8]:724-732).

The pharmacist role at UIC has evolved over time, Groo said. “In 2019, the protocol was due for update and reapproval, and hospital administration wanted much more detail as to how the pharmacist [would] practice.” The protocol states that drug therapy adjustment or titration will be based on current clinical status (i.e., physical assessment and laboratory data), current medication regimen as well as physician preference, if documented in the progress note. It specifies that interventions may include adding, removing or adjusting doses, but that doses may be increased by no more than 100% at each visit. “We’re very pleased with our ability to achieve GDMT for heart failure patients, but there is more progress we could make,” Groo said, noting variability among cardiologists in referring to the clinic. “Among the general cardiologists, four refer to us regularly, seven occasionally, and five have never referred to us despite lots of advertising and outreach, and I’m sure they have heart failure patients in their clinics. Keep in mind, therapy for heart failure is only getting more complex.”

The clinic continues to expand, with a second PharmD recently added. “If you do a good job, your clinic will grow,” Groo said.

Lack of Nationwide Prover Status Still a Hindrance

As they practice under a hospitalbased agreement, the UIC pharmacists’ services also are billed under the facility fee. “It would be wonderful to have state-based provider authority designations like the CPP, or PhC they have in New Mexico,” Groo said. “We have definitely found ways to work at the top of our license and provide top-quality care under the existing system. But if pharmacists were given provider status nationwide under the Social Security Act, as ASHP and many other groups have been working toward, we would be able to participate in Medicare Part B and be fully and appropriately reimbursed for our services.”

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The sources reported no relevant fi nancial disclosures.

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