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COMMENTARY Transplantation pharmacy practice model
COMMENTARY
. The expansion of the
Building a business plan accredited
transplantation residency programs
to support a transplantation pharmacy allows the discipline to continue to
grow and achieve increasingly higher
practice model standards of excellence for pharmacy
services provided to both living do-
nors and recipients.
Eric M. Tichy, NicolE A. Pilch, loNNiE D. SMiTh, As transplantation has become
ANgElA Q. MAlDoNADo, AND DAviD J. TAbEr, oN bEhAlf increasingly regulated, the cost of
of ThE AMEricAN SociETy of TrANSPlANTATioN PhArMAcy care has risen. Excellent patient and
coMMuNiTy of PrAcTicE, ThE AMEricAN SociETy of hEAlTh- graft survival rates are no longer just
SySTEM PhArMAciSTS SEcTioN of cliNicAl SPEciAliSTS AND clinical goals but are now federally
SciENTiSTS TrANSPlANTATioN/iMMuNology NETwork, AND mandated. Therefore, as clinical lead-
ThE AMEricAN collEgE of cliNicAl PhArMAcy iMMuNology/ ers identify the need to strengthen
TrANSPlANTATioN PrAcTicE AND rESEArch NETwork their transplantation pharmacy
Am J Health-Syst Pharm. 2014; 71:751-7 teams to sustain excellent outcomes,
it is critical that they overcome com-
harmacists have been part of step in the evolution of training, as mon stumbling blocks: the ability
the multidisciplinary trans- it ensures that transplantation phar- to translate available evidence to an
P
plantation care team for more macy residents are meeting specific individual practice site and the abil-
than four decades. The first article standards and receiving the highest ity to develop a strong business case
detailing the pharmacist’s role on quality of training. The number to convince financial decision mak-
the transplantation team was pub- of PGY2 transplantation residency ers to support the establishment or
1 Since programs has increased dramatically
lished in this journal in 1976. expansion of transplantation phar-
the 1970s, a pharmacist’s presence in the past 10 years, growing from 4
macy services. Herein, we describe
within the transplantation team has fewer than 6 programs to almost 30 business planning aspects that can be
transitioned from a novelty, to a programs in 2013, and the major- used by pharmacy clinicians, manag-
standard of clinical care, and, most ity of these programs are now ASHP ers, and leaders to implement new or
recently, to a federally mandated
position.
In 2011, a description of the phar-
macist’s role as part of the multidis- Eric M. Tichy, Pharm.D., BCPS, is Senior Professor of Surgery, Medical University of
ciplinary transplantation team was Clinical Pharmacy Specialist, Solid Organ South Carolina.
published as a White Paper in the Transplant, and Director, Postgraduate Year Address correspondence to Dr. Tichy
2 Pharmacy Residency—Transplant, Depart- (eric.tichy@ynhh.org).
2
American Journal of Transplantation. ment of Pharmacy, Yale-New Haven Hospital, Edward Zavala, M.B.A., and Jennifer Milton,
icole A. Pilch, Pharm.D.,
The paper outlined the roles of the New Haven, CT. N B.S.N., M.B.A., CCTC, are acknowledged for
pharmacist in the inpatient, am- M.S.C.R., BCPS, is Clinical Specialist, Solid their critical review of this manuscript.
Organ Transplantation, and Clinical Assis- This article represents the opinion of the
bulatory care, and research settings tant Professor, Department of Pharmacy and Immunology/Transplantation Practice and
and described the training required Clinical Sciences, South Carolina College of Research Network of the American College of
to be competent in these settings. Pharmacy, Medical University of South Caro- Clinical Pharmacy (ACCP). It does not neces-
onnie D. Smith, Pharm.D.,
lina, Charleston. L sarily represent an official ACCP commentary,
Moreover, the American Society of is Manager, Department of Solid Organ guideline, or statement of policy or position.
Health-System Pharmacists (ASHP) Transplant, and Director, Postgraduate Year 2 The authors have declared no potential
has recognized the field of trans- Pharmacy Residency—Transplant, University conflicts of interest.
of Utah Hospitals and Clinics, Salt Lake City.
plantation pharmacy by endorsing ngela Q. Maldonado, Pharm.D., BCPS,
A Copyright © 2014, American Society of
and accrediting postgraduate year 2 is Clinical Pharmacy Specialist—Transplant Health-System Pharmacists, Inc. All rights
(PGY2) residency training programs Services, Vidant Medical Center, Greenville, reserved. 1079-2082/14/0501-0751$06.00.
avid J. Taber, Pharm.D., BCPS, is
NC. D DOI 10.2146/ajhp130555
in this area.3 This is an important Director, Clinical Research, and Assistant
Am J Health-Syst Pharm—Vol 71 May 1, 2014 751
COMMENTARY Transplantation pharmacy practice model
expanded transplantation pharmacy if Medicare is to serve as the payer meeting these requirements have
service opportunities. for transplant patients. Every three been required to implement cor-
Regulatory requirement for years, CMS performs formal site rective action plans, often leading
transplantation pharmacy. The reviews at all CMS-approved trans- to the expansion of transplantation
need to demonstrate compliance plantation centers or those seeking pharmacy services or the addition of
with regulatory and practice require- to become CMS approved to ensure transplantation pharmacy personnel.
ments is a powerful motivating fac- that these centers meet the estab- The CMS regulations mandated
10
tor in health care. The requirement lished conditions of participation. that programs’ observed patient
of transplantation pharmacists’ The document specifically states “a and graft survival outcomes must
involvement is well codified in the transplantation center must identify fall within expected risk-adjusted
bylaws of the transplantation regu- a multidisciplinary transplantation outcomes. These outcomes data are
latory bodies as well as the practice team (composed of individuals from published twice yearly, and graft and
standards promulgated by profes- medicine, nursing, nutrition, social patient survival rates at one year have
sional associations.2,5,6 The Organ services, transplant coordination, become the gold standard used by
Procurement and Transplantation and pharmacology) and describe the regulators and payers to determine
Network (OPTN) is a unique public– responsibilities of each member of if transplantation centers are per-
private partnership that links all of the team.” The document does not forming at acceptable levels. This has
the professionals involved in organ specifically state that a pharmacist implications for center of excellence
7
donation and transplantation. The must be the team member from (COE) designation by commercial
OPTN is administered by the United pharmacology. However, in an open payers and may result in impaired
Network for Organ Sharing (UNOS) comment session, CMS did refer to access to transplantation for patients
13
under contract with the Department the UNOS bylaws for details on the who are not Medicare beneficiaries.
8
of Health and Human Services. specifications of the pharmacist in Thus, one-year patient and graft sur-
10
Bylaws developed by UNOS specify filling that role. An updated ver- vival rates have become paramount
the exact criteria that each transplan- sion of the interpretive guidelines to transplantation centers’ overall
11
tation program must follow in order was published in 2008. Important activity levels and financial health.
to be compliant with the standards. updates outlined in this document Therefore, drug-related complica-
These bylaws were amended in 2004 include the need for all members tions can have severe regulatory and
to recognize and identify the roles of the multidisciplinary team to multimillion-dollar consequences
and responsibilities of the pharma- document all activities in the medical to programs, as even one patient or
cist as an essential member of the record and to be involved with the graft loss in the first year can result
transplantation team. Specifically, care of both donors and recipients in sanctions or the loss of COE
these bylaws mandate that “all trans- throughout all distinct phases of designation.
plantation programs should identify the donation and transplantation Financial justification for clini-
one or more pharmacists who will be processes (i.e., pretransplantation cal pharmacy services. Although
responsible for providing pharma- evaluation phase before listing, peri- the transplantation pharmacist role
ceutical care to solid organ transplant operative period, immediate post- is mandated by regulations, the
9 The transplantation transplantation hospital admission,
recipients.” primary long-term measure of any
pharmacist should be the designated and discharge process). initiative in many health care organi-
member of the team to serve as the In addition to the updated inter- zations is the cost required to main-
drug information expert and should pretive guidelines, CMS published tain the service over time. Positive
be responsible for ensuring the ad- a set of documents in September financial performance should al-
herence to institutional protocols, 2008 to assist centers in planning for low for continued investment and
screening requirements, preventing surveys, specifying that the inpatient growth in the service line. Perhaps
drug interactions, and providing pharmacy will be toured and the the largest threat to transplantation
patient and caregiver education, designated transplantation pharma- pharmacy services is the relatively
4
along with additional responsibilities cist will be interviewed during the high salary of the pharmacist. The
12
as outlined by the transplantation CMS visit. To ensure proficiency, inherent challenge in justifying a
center.8 pharmacist personnel files are re- clinical pharmacy position from a
In addition to the UNOS require- viewed to evaluate the pharmacist’s financial standpoint is the difficulty
ments, the Centers for Medicare and transplantation-specific training, in quantifying direct and indirect
Medicaid Services (CMS) has con- current competency, and continuing outcomes attributable to pharma-
ditions of participation that every education related to transplanta- cotherapy interventions initiated by
transplantation program must meet tion. Transplantation centers not pharmacists. Therefore, we outline
752 Am J Health-Syst Pharm—Vol 71 May 1, 2014
COMMENTARY Transplantation pharmacy practice model
several opportunities to enhance activities. The capture of pretrans- and transplantation pharmacist
transplantation center revenue as plantation-related costs associated involvement have an opportunity to
well as cost-containment measures with personnel salaries is vital for generate revenue and reduce frag-
that can be utilized to justify trans- every transplantation center. Tools mentation of the health care delivery
plantation pharmacy services. These such as time studies are used to process by implementing transplan-
opportunities can be divided into quantify the amount of time that tation specialty pharmacy (TSP)
two categories: revenue generating transplantation coordinators, social prescription services. These services
(capturing transplantation-related workers, financial coordinators, and are initiated at the time of discharge
costs or charges, billing for services, administrative staff spend working after transplantation, and the goal is
filling prescriptions for transplant- in the pretransplantation phase or to create a system that allows patients
related medications in outpatient on donor management. These sal- to remain with their hospital’s out-
pharmacies) and cost avoidance ary costs are Medicare allowable patient (retail) pharmacy for refills
(reducing drug cost during inpatient and should be captured for partial and maintenance medications after
hospitalization, reducing outpatient reimbursement via the cost report. transplantation surgery. The contin-
medical costs, decreasing length of As both Medicare and UNOS have ually increasing cost of medications
hospital stay). implemented policy mandating the and the complexity of pharmacy
Medicare cost report. The largest participation of a transplantation billing and reimbursement have
primary payer of organ transplanta- pharmacist in the pretransplanta- discouraged many retail pharmacies
tion in the United States today is tion phase for recipients and in the from participating in the Medicare
Medicare. Medicare reimburses hos- care of living organ donors during all Part B or “specialty” market and have
pitals that are certified transplanta- phases, it is vital that transplantation allowed the business to be absorbed
tion centers for costs associated with centers include the salaries of phar- by specialty pharmacies and retail
the acquisition of organs for trans- macists, including PGY2 pharmacy chains. Over the past 30 years, “spe-
plantation to Medicare beneficiaries. residents, in these time studies. A cialty” pharmacy has done approxi-
Medicare covers organ acquisition substantial portion of a pharmacist’s mately $100 billion in business annu-
costs, which include all costs associ- salary can be offset and will vary ally and has become a major force in
16
ated with the organ donor and re- by each institution’s percentage of health care quality and innovation.
cipient before admission to a hospital Medicare-covered organ transplants, Immunosuppressive medications are
for the transplant operation (i.e., the number of donors managed, and often considered specialty pharmacy
pretransplantation services), as well the amount of pretransplantation medications with many payers, re-
as hospital inpatient costs associated pharmacist involvement.12-14 quiring a specific expertise in bill-
with the donor. At the end of each Billing for services. Although there ing and reimbursement that many
year, each transplantation center are a limited number of transplanta- health-system pharmacies do not
files a cost report that is reconciled tion pharmacists who are currently possess. Additional contracting re-
by Medicare to ensure that all costs pursuing this route, there is oppor- quirements and restrictions may also
are allowable as defined in Medicare tunity for pharmacists practicing apply to this subset of medications,
13 in the posttransplantation outpa- further complicating the dispensing
regulations and policy.
Notably, for pharmacy admin- tient phase to bill for their services. and reimbursement processes.
istrators who may not be familiar Maldonado and colleagues15 dem- Successfully capturing this out-
with the transplantation center cost onstrated that billing for outpatient patient business and referring pa-
report, the process is similar to the transplant pharmacy services using tients to a robust internal pharmacy
reimbursement process for postgrad- facility-fee or technical-fee billing program allow for the generation of
uate year one pharmacy residents. in one year (208 pharmacist visits) significant revenue and additional
Medicare requires that transplanta- resulted in increasing outpatient re- resources (often staffing). Successful
tion hospitals allocate only the por- imbursement by nearly $10,000, or transplantation pharmacies also
tion of costs that relate to the time roughly $100 per visit. This increase provide mail-order service, as this in-
spent on allowable organ acquisition in reimbursement, along with other creases the odds of retaining patients
activities (i.e., organ acquisition factors described herein, was used outside the immediate geographic
costs) on the Medicare cost report. to substantiate the case for clinical area and allows patients to remain
Institutions are required to use a pharmacy services in the outpatient within the system for long-term
reasonable basis to allocate costs to posttransplantation clinic. maintenance medication needs.
appropriate cost centers for pretrans- Transplantation specialty phar- The University of Michigan recently
plantation-, posttransplantation-, macy. Hospitals and health sys- described its success in instituting
and nontransplantation-related tems with outpatient pharmacy a TSP that produced a $4.7 million
Am J Health-Syst Pharm—Vol 71 May 1, 2014 753
COMMENTARY Transplantation pharmacy practice model
17
margin in 2011 alone. Support into case rates or diagnostic-related Low-dose valganciclovir for cy-
from the transplantation center and groups. A majority of commercial tomegalovirus prophylaxis. Multiple
hospital leadership and having an payers extend the case rate to include publications have reported similar
educated pharmacy staff willing to up to the first three months after efficacy for cytomegalovirus pro-
embrace the hurdles and opportuni- transplantation. Programs must cau- phylaxis with valganciclovir at 450
ties available through a TSP service tiously examine their expenses to mg orally daily compared with val-
19-21 As the
line are critical elements to the suc- retain profitability. The medications ganciclovir 900 mg daily.
cess of a TSP. Institutions that have used within the field of transplanta- 2012 wholesale acquisition cost of
successfully developed a TSP service tion are very expensive, and many this medication alone was over $1800
line and maintained patients within have a narrow therapeutic range. for a one-month supply, this one in-
their own system have been able to Antibody stewardship. Oftentimes, tervention can lead to significant cost
use this revenue as financial justi- the antibody induction and rejection savings for both the patient and the
fication for maintaining and often treatment agents used associated transplantation center.
increasing clinical pharmacy services. with transplantation (antithymocyte Generic agents for maintenance
An important aspect of all phar- immune globulin, alemtuzumab, immunosuppression. The use of
macy programs today is the need to basiliximab, i.v. immune globulin, generic formulations of immuno-
provide resources and services for and rituximab) are within the top 20 suppressive agents, namely tacroli-
underfunded or unfunded patients. medications, in terms of annual costs, mus and mycophenolate mofetil, can
The expense of long-term medica- for hospital systems. Thus, the use of reduce out-of-pocket costs for the
tion needs after transplantation clinical pharmacy services to ensure patient while lowering the acquisi-
can result in patients going without the most efficient and effective use tion costs of these agents for health-
medications, stretching medications of these medications is important to systems. If the change from brand-
to be taken differently than pre- include in a business model aimed at name to generic products is made in
scribed, or foregoing other impor- expanding pharmacy services for this an appropriate and systematic fash-
tant household expenses to pay for population of patients. ion, with the rigor and monitoring
medications. Almost all manufactur- Multiple publications have dem- required of all drugs with a narrow
ers offer patient assistance programs onstrated the success of drug cost therapeutic range, brand-to-generic
that provide medication for free or avoidance programs in improving substitution can occur with similar
22-27
at significantly reduced costs after a the financial ability to care for trans- efficacy and toxicity.
financial disclosure and evaluation plantation patients. By shifting doses All told, there are numerous
process. These programs are fairly of the induction therapy agent rab- well-established strategies published
standardized across manufacturers, bit antithymocyte immune globulin in the literature to reduce costs
but with the level of documentation from the inpatient to the outpatient and increase net margins through
required and the responsibility of setting, McGillicuddy et al.18 dem- the efficient use of transplantation
continually updating eligibility ev- onstrated a $230,867 improvement medications. These strategies should
ery 6–12 months (depending on the in net margin for 85 patients over be an important part of the busi-
manufacturer), they can be resource a 14-month period, with no differ- ness model developed to justify and
intensive and difficult to staff with- ences in clinical outcomes (delayed increase comprehensive transplanta-
out dedicated resources. Creating graft function, acute rejection, graft tion pharmacy services. Strategies
a program that tracks the savings loss, or opportunistic infections) as should be tracked to ensure that they
of these medication expenses and compared with a historical control are implemented safely and that the
enables those resources to be put group. The same group of authors cost savings or revenue generation
toward dedicated patient assistance demonstrated significant cost savings can be accurately captured and used
and financial support team members by implementing a similar strategy to justify the new pharmacy services.
is critical for success. This model has (shifting the use of medications from Quality outcomes. From a phar-
been developed and tested in numer- the inpatient to the outpatient setting) macotherapy perspective, transplan-
ous health systems around the coun- with additional high-cost antibody tation recipients are among the most
try and provides a level of patient medications, including basiliximab complex of all inpatient populations
18 28
care and medication adherence that and rituximab. Thus, antibody to manage. Clinical transplantation
benefits both transplantation and stewardship strategies to maximize pharmacists combine the principles
pharmacy alike and positively im- the efficient use of high-cost antibody of several subspecialties to be ef-
pacts published outcomes data. therapy can have profound effects on fective members of the multidisci-
Drug cost avoidance. Payments the net margins of transplantation plinary transplantation patient care
for transplantation are packaged centers and hospital systems. team. This includes optimization of
754 Am J Health-Syst Pharm—Vol 71 May 1, 2014
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