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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 ...

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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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...Commentary transplantation pharmacy practice model the expansion of building a business plan accredited residency programs to support allows discipline continue grow and achieve increasingly higher standards excellence for services provided both living do nors recipients eric m tichy nicole pilch lonnie d smith as has become angela q maldonado david j taber on behalf regulated cost american society care risen excellent patient community health graft survival rates are no longer just system pharmacists section clinical specialists goals but now federally scientists immunology network mandated therefore lead college ers identify need strengthen research their am syst pharm teams sustain outcomes it is critical that they overcome com harmacists have been part step in evolution training mon stumbling blocks ability multidisciplinary trans ensures phar translate available evidence an p plantation team more macy residents meeting specific individual site abil than four decades first article ...

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