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1 Electronic Thesis and Dissertations UCLA Peer Reviewed Title: Design for an Evaluation of Hemophilia Treatment Center 340B Drug Pricing Programs Author: Baker, Judith Rochelle Acceptance Date: 2013 Series: UCLA Electronic Theses and Dissertations Degree: D.P.H., Health Services 0427UCLA Advisor(s): Needleman, Jack Committee: Ganz, Patricia A., Inkelas, Moira, Nugent, Diane, Yano, Elizabeth M. Permalink: https://escholarship.org/uc/item/01p6s37v Abstract: Copyright Information: All rights reserved unless otherwise indicated. Contact the author or original publisher for any necessary permissions. escholarship is not the copyright owner for deposited works. Learn more at escholarship provides open access, scholarly publishing services to the University of California and delivers a dynamic research platform to scholars worldwide.

2 UNIVERSITY OF CALIFORNIA Los Angeles Design for an Evaluation of Hemophilia Treatment Center 340B Drug Pricing Programs A dissertation submitted in partial satisfaction of the requirements for the degree Doctor of Public Health by Judith Rochelle Baker 2013

3 Copyright by Judith Rochelle Baker 2013

4 ABSTRACT OF THE DISSERTATION Design for an Evaluation of Hemophilia Treatment Center 340B Drug Pricing Programs by Judith Rochelle Baker Doctor of Public Health University of California, Los Angeles, 2013 Professor Jack Needleman, Chair Problem: Hemophilia is a debilitating, incurable, potentially fatal and catastrophically expensive rare bleeding disorder. Care provided by the US network of 130 regionally organized Hemophilia Treatment Centers (HTC) reduces disorder related mortality, morbidity, and costs. Unfortunately, HTC funding streams and levels have diminished. To generate revenue to meet rising demands, over two-thirds of HTCs operate outpatient pharmacies using federally discounted 340B prices. However, 340B programs in the HTC setting have never been evaluated. Little is known whether HTC 340B programs are working as intended; about variations and determinants of adoption and implementation; demographic and clinical trends of people enrolled; and patterns of revenue generation and reinvestment per Congressional intent. The objective of this dissertation is to devise a plan to evaluate HTC 340B Discount Drug Pricing programs. The proposed evaluation aims to examine and explain 340B program adoption and implementation patterns within HTC regions; to assess the impact of 340B ii

5 adoption on HTC financial resources, capacity and services; and to project the implications of potential 340B program loss on HTC functioning. Methods: The proposed plan for evaluation uses a mixed methods approach, and is guided by the Consolidated Framework for Implementation Research. The design compares 340B adoption, implementation, and impact over time; and solicits future projections, using the HTC as the chief unit of analysis. Data sources include archival retrieval of federal, state, regional, HTC, and HTC host institution documents; new semi-structured qualitative interviews with stakeholders, and a new organizational survey to assess organizational structure and process influences on 340B adoption and implementation. The evaluation s results should be disseminated through a full report, executive summary, and a brief written for a lay audience. Summary of findings: If conducted, the proposed plan for evaluation will provide policymakers and other stakeholders with evidence regarding the adoption, implementation, and impacts of 340B on Hemophilia Treatment Center financial resources, capacity, and services. This evidence will enhance transparency, illuminate organizational and environmental determinants of 340B initiation and dissemination, inform the national 340B debate, and contribute to improved decision making at patient, clinician, and policy levels. iii

6 The dissertation of Judith Rochelle Baker is approved. Patricia A. Ganz Moira Inkelas Diane Nugent Elizabeth M. Yano Jack Needleman, Committee Chair University of California, Los Angeles 2013 iv

7 Table of Contents LIST OF TABLES... vi LIST OF FIGURES... vii LIST OF ACRONYMS... viii Acknowledgements... ix VITA... x CHAPTER 1: INTRODUCTION B Drug Pricing Program... 4 Aspects of HTCs and 340B Programs That Need to Be Considered in Designing an Evaluation... 7 Clinical Trends in Hemophilia and Von Willebrand Disease and Organization of Care During 340B Implementation...12 CHAPTER 2: CONCEPTUAL FRAMEWORK: Consolidated Framework for Implementation Research Applying CFIR Constructs and Subcategories to HTC 340B Context...22 CHAPTER 3: METHODS Introduction...31 Evaluation Sequence...36 Proposed Methodology: Using Preliminary Data from One HTC Region:...37 AIM 1: To examine and explain the patterns of 340B adoption and implementation within HTC regions...40 AIM 2: To assess the impact of adoption of 340B programs on Hemophilia Treatment Center financial resources...56 AIM 3: To assess the impact of adoption of 340B programs HTC capacity and services AIM 4: To project the implications of potential 340B loss on HTC capacity and services...72 Data source descriptions...73 CHAPTER 4: DISCUSSION AND CONCLUSIONS Summary: Design for HTC 340B Evaluation...78 Benefits of the Proposed Evaluation to Stakeholders...79 Feasibility of conducting the evaluation as designed...82 LIST OF APPENDICES REFERENCES v

8 LIST OF TABLES TABLE 1: HEMOPHILIA TREATMENT CENTER 340B PROGRAM AS A COMPLEX INTERVENTION... 8 TABLE 2: PRIMARY INSURANCE AMONG US HEMOPHILIA TREATMENT CENTER PATIENTS, TABLE 3: CFIR CONSTRUCTS, SUBCATEGORIES, DEFINITIONS AND ILLUSTRATIVE CONCEPTS APPLIED TO HTC 340B PROGRAM TABLE 4: AIMS AND EVALUATION QUESTIONS TABLE 5: CFIR CONCEPTS AND SUBCATEGORIES MAPPED TO AIMS AND EVALUATION QUESTIONS TABLE 6: DATA SOURCES: EXISTING TABLE 7: DATA SOURCES: NEW TABLE 8: WESTERN STATES REGIONAL HEMOPHILIA NETWORK: ORGANIZATIONAL CHARACTERISTICS TABLE 9: MULTIPLE REGRESSION MODEL: TIME VARYING AND NON-TIME VARYING COVARIATES POTENTIALLY INFLUENCING HTC 340B ADOPTION AIM 1A TABLE 10: 340B TECHNICAL ASSISTANCE SEMINARS, WESTERN STATES REGIONAL HEMOPHILIA NETWORK, TABLE 11: CALIFORNIA FEE FOR SERVICE MEDICAID FACTOR VENDORS, CALIFORNIANS RECEIVING FACTOR, PROPORTION OF FACTOR CLAIMS AND REIMBURSEMENT ATTRIBUTABLE TO HTC 340B PROGRAMS, FY 02/03 - FY 11/ TABLE 12: EVALUATION QUESTION 2A AND 2B SHELL TABLE CHANGES IN HEMOPHILIA TREATMENT CENTER FUNDING SOURCES AND LEVELS OF PRE/POST 340B IMPLEMENTATION, YEAR XX TO YEAR YY TABLE 13: HRSA HEMOPHILIA TREATMENT CENTER GRANTEES: FEDERAL COMPREHENSIVE CARE GRANT AWARD, PROGRAM INCOME, AND OTHER FUNDING SOURCES, US TABLE 14: HEMOPHILIA TREATMENT CENTER340B NET PROGRAM USE CHANGES SHELL TABLE TABLE 15: MULTIPLE REGRESSION MODEL: TIME VARYING AND NON-TIME VARYING CO-VARIATES POTENTIALLY INFLUENCING USE OF HTC 340B NET PROGRAM INCOME TABLE 16: PATIENT EXPERIENCE OF HEMOPHILIA TREATMENT CENTER CARE, WESTERN STATES REGIONAL HEMOPHILIA NETWORK REGIONAL LEVEL DATA, 2005/2006 AND TABLE 17: DESIGN FOR HTC 340B EVALUATION BENEFITS TO STAKEHOLDERS vi

9 LIST OF FIGURES FIGURE 1: CONSOLIDATED FRAMEWORK FOR IMPLEMENTATION RESEARCH.21 FIGURE 2: CFIR APPLIED TO PROPOSED EVALUATION OF HTC 340B PROGRAMS.. 27 FIGURE 3: PERCENT PRIMARY INSURANCE COVERAGE OF INDIVIDUALS WITH HEMOPHILIA A AND B OBTAINING CARE AT HTC BY REGION AND US.32 FIGURE 4: PRIMARY INSURANCE (%): WESTERN STATES REGIONAL HEMOPHILIA TREATMENT CENTER NETWORK PATIENTS, 1994, 2002, FIGURE 5: HEMOPHILIA TREATMENT CENTERS OPERATING 340B PROGRAMS WESTERN STATES REGIONAL HEMOPHILIA NETWORK 41 FIGURE 6: TIMELINE - HTC 340B ADOPTION AND SPREAD FIELD PILOT, WESTERN STATES REGIONAL HTC NETWORK, FIGURE 7: PROPORTION OF WESTERN STATES REGIONAL HEMOPHILIA CENTER PATIENTS WITH HEMOPHILIA A & B, VON WILLEBRAND DISEASE 2 & 3 ENROLLED IN HTC 340B PROGRAM FY 05/06 FY 11/12 50 FIGURE 8: NUMBER OF PATIENTS ENROLLED IN 340B PROGRAM AT WSRHN BY PRIMARY INSURANCE AS MEDICAID OR NON-MEDICAID, FY 05/06 FY FIGURE 9: PATIENTS ENROLLED IN 340B PROGRAM AT WSRHN BY PROPORTION OF PRIMARY INSURANCE AS MEDICAID OR NON-MEDICAID, FY 05/06 FY 11/ FIGURE 10: HRSA HEMOPHILIA TREATMENT CENTER GRANT FUNDING, US FIGURE 11: HRSA HEMOPHILIA TREATMENT CENTER GRANTEES: FEDERAL COMPREHENSIVE CARE GRANT AWARD VS. PROGRAM INCOME IN MILLIONS FIGURE 12: HRSA COMPREHENSIVE CARE GRANT AWARD, WSRHN FIGURE 13: 340B NET PROGRAM INCOME GENERATED, WSRHN, FY 05/06 FY 11/ FIGURE 14: WSRHN ACTIVE BLEEDING DISORDER PATIENTS: TOTAL AND FEMALE 1997, 2002, FIGURE 15: WSRHN BLEEDING DISORDER PATIENTS BY DIAGNOSIS 1997, 2002, FIGURE 16: WSRHN BLEEDING DISORDER PATIENTS BY AGE 1997, 2002, FIGURE 17: WSRHN BLEEDING DISORDER PATIENTS - % PATIENTS BY RACE/ETHNICITY, 1997, 2002, FIGURE 18: WSRHN BLEEDING DISORDER PATIENTS - % PATIENTS AGE <13 BY RACE / ETHNICITY, 1997, 2002, 2010, FIGURE 19: 340B NET PROGRAM INCOME USED TO EXPAND STAFF CAPACITY AND SERVICES, WSRHN, FY 05/06 FY 11/12 66 FIGURE 20: PROPORTIONAL USE OF HTC 340B NET PROGRAM INCOME: WSRHN, 05/06 11/ vii

10 LIST OF ACRONYMS 340B Section 340B of the US Public Health Services Act, AKA the 340B Discount Drug Pricing Program CCDS Comprehensive Care Data Set CCS California Children s Services CDC US Centers for Disease Control and Prevention, Department of Health and Human Services CFIR Consolidated Framework for Implementation Research CY Calendar Year DGIS Discretionary Grant Information System EQ Evaluation Question Factor Clotting Factor Concentrate FRP Factor Replacement Product Report FVIII Factor 8 deficiency = Hemophilia A most common form of hemophilia FIX Factor 9 deficiency = Hemophilia B second most common form of hemophilia FY Fiscal Year GHPP Genetically Handicapped Persons Program HCV Hepatitis C Virus HDS Hemophilia Data Set HIV Human Immunodeficiency Virus HRSA US Health Resources and Services Administration, Department of Health and Human Services HTC Hemophilia Treatment Center MCHB Maternal and Child Health Bureau, part of HRSA OIG Office of Inspector General OPA Office of Pharmacy Affairs OSS Organizational Structure Survey PHS Public Health Service Region IX California, Hawaii, Nevada, Guam a US Hemophilia Treatment Center Region (AKA WSRHN) RC Regional Coordinator RD Regional Director USHTCN United States Hemophilia Treatment Center Network VWD Von Willebrand Disease WSRHN Western States Regional Hemophilia Network (AKA Region IX) viii

11 Acknowledgements Heartfelt thanks to my Committee Chair Jack Needleman for his keen analytic insights, and commitment to strengthen my scholarship. Thanks to Hector Rodriguez for conceptualizing the initial structure of this work as my initial Committee Chair. Thanks to my other Committee members: Elizabeth M. Yano for sharing her impressive evaluation expertise and offering invaluable guidance; Diane Nugent for her insights into Hemophilia Treatment Centers and 340B programs; Moira Inkelas for her advice on framing the policy matters; and Patricia Ganz for input on the broader 340B issues. I could not ask for a finer Committee. No work of this nature is a solo endeavor. Thanks to the generosity of: Physicians, Nurses, Social Workers, Physical Therapists, and Pharmacists in the Western States Hemophilia Treatment Center /Region IX for sharing clinical and 340B knowledge. Colleagues who gave feedback on the design for evaluation, the evaluation instruments, 340B operations and contexts: Val Bias, Annette von Drygalski, Susan Karp, Marion Koerper, Fred Nishioka, Mary Pham, Joe Pugliese, James Riddel, Derek Robertson, and Courtney Thornburg. Sarah Archenbronn, Ben Abramson, Luis Aguiniga, Lyly Tran for assist with the Patient Satisfaction Survey data entry. Paul Pontrelli for sharing California Medicaid data. My Doctoral cohort: Robin Flint, Sherry Grace, Sara Lin, Beena Patel; Beth Glenn for skilled advising. Encouraging colleagues and friends: Adeena Ascher, Judy Consales, Jonathan Goldsmith, the late Kathy Johnson, Carol Kasper, Alane Simons Katzew, Penny Kyler, Anne Meyering, Paul Monahan, Michelle Popowitz, Mike Soucie, Elaine Takahashi, and Susan Weller; the Hemophilia Treatment Center Regional Coordinators, particularly Brenda Riske, and Robina Ingram Rich, John Drake, and the late Tami Wood Lively. My parents Fern and Herb Baker; my brothers Marc, Art, and Steve and son Daniel for their cheerleading. And Mary for her loving support. ix

12 EDUCATION M.H.S.A. VITA JUDITH R. BAKER MHSA The Center for Inherited Blood Disorders, Orange, CA and University of California Los Angeles, Department of Pediatric Hematology/Oncology University of Michigan, School of Public Health, Master of Health Services Administration, Department of Health Management and Policy B.Sc. Michigan State University, Bachelor of Social Science, Magna Cum Laude, PROFESSIONAL EXPERIENCE 2012 Director of Public Health, The Center for Inherited Blood Disorders, Orange County, CA. Administrative Director, HRSA Western States Region Hemophilia Network, UCLA Administrative Director, Federal Hemophilia Treatment Centers/Region IX, UCLA, Los Angeles, CA Regional Coordinator, Federal Hemophilia Treatment Centers/Region IX Program Coordinator, AIDS Help & Prevention, Region IX Hemophilia Treatment Centers, Los Angeles, CA Executive Director, Long-term Outcomes of Very Low Birth Weight Infants, NICHD, RWJF, Philadelphia, PA Program Specialist, Maternity and Infant Care, Philadelphia Department of Public Health, Philadelphia, PA. PUBLICATIONS: Peer review 1. MC McCormick, JR Baker, J Brooks-Gunn, et al, Cohort Reconstruction: Which Infants can be restudied at School Age? Pediatric and Perinatal Epidemiology. 1991; 5: RV Zabala, JR Baker. Guam's Quest for Improved Hemophilia Care. Pacific Health Dialog. 2002; 9(2): JR Baker, SO Crudder, B Riske, V Bias, A Forsberg, A Model for a Regional System of Care to Promote the Health and Well-Being of People with Rare Chronic Genetic Disorders. Am J Public Health. 2005; 95: JH Drake, JM Soucie, SC Cutter, AD Forsberg, JR Baker, BK Riske. High School Completion Rates among Individuals with Hemophilia. American Journal of Preventive Medicine. 2010; 38(4S): S489-S JR Baker, BK Riske, M Voutsis, S Cutter, R Presley. Insurance, Home Therapy, and Prophylaxis in US Youth with Severe Hemophilia. American Journal of Preventive Medicine 2011; 41(6S4): S PE Monahan, JR Baker, BK Riske, JM Soucie. Physical functioning in boys with hemophilia in the United States American Journal of Preventive Medicine. 2011; 41(6S4): S ZY Zhou, BK Riske, A Forsberg, M Ullman, JR Baker, M Koerper R Curtis, M Lou, J Wu, K Johnson. Self-Reported Barriers to Hemophilia Care in People with Factor VIII Deficiency. American Journal of Preventive Medicine. 2011; 41(6S4): S346-S VR Byams, PA Kouides, R Kulkarni, JR Baker, DL Brown, JC Gill, et al. Surveillance of Females with Inherited Bleeding Disorders in United States Hemophilia Treatment Centers. Haemophilia. 2011; 17(Suppl.1): S6-S ZY Zhou, J Wu, JR Baker, R Curtis, A Forsberg, H Huszti, M Koerper, M Lou, R Miller, K Parish, B Riske, A Shapiro, M Ullman, K Johnson. Hemophilia Utilization Group Study - Part Va (HUGS Va): Design, Methods and Baseline Data. Haemophilia. 2011; 17(5): JR Baker, B Riske, JH Drake, AD Forsberg, R Atwood, M Voutsis, R Shearer. U.S. Hemophilia Treatment Center population trends : patient diagnoses, demographics, health services utilization. Haemophilia. 2013; 19: doi: /j x x

13 HONORS AND AWARDS Meritorious Service Award, National Hemophilia Foundation, 2005 Distinguished Service Award, Federal Food and Drug Administration, 2008 Best Poster Award, 1 st and 2 nd National Conferences on Blood Disorders and Public Health, 2010 and 2012 Ruth Roemer Scholarship, UCLA School of Public Health, HRSA Child and Family Health Leadership Traineeship, UCLA School of Public Health, Delta Omega Honorary Society in Public Health, PROFESSIONAL ACTIVITIES (selected) World Federation of Hemophilia - Co-Chair, Pacific Rim Hemophilia Workshop 1997, Honolulu, HI: 300 clinicians from 30 nations US Food and Drug Administration - Member, Blood Products Advisory Committee, US Centers for Disease Control - Co-Chair, Bleeding Disorders Socioeconomic Health Status Work Group, US Health Resources and Services Administration Advisory Committee, National Hemophilia Coordinating Center, American Thrombosis and Hemostasis Network - Healthy People 2020 Work Group on Blood Disorders and Blood Safety, 2009 National Hemophilia Foundation - Women s Bleeding Disorder Task Force, ; National Policy Summit, 2012 Hemophilia Utilization Group Study - External Advisory Committee , Steering Committee 2013 PRESENTATIONS (selected) U.S. Outreach to Women with Bleeding Disorders, XXIV International Congress, World Federation of Hemophilia, Montreal, Canada, 1998 Pacific Partnerships for Rare Disorders: The Region IX Hemophilia Model. Global Public Health Conference, Honolulu, HI Regional Systems of Care for Persons with Rare Genetic Disorders. Symposium Chair and Presenter, Centers for Disease Control and Prevention s National Center on Birth Defects and Developmental Disabilities Conference. Washington. DC, 2004 Strengthening Healthy Communities for MCH Populations with Rare Disorders, Association of Maternal and Child Health Programs Annual Conference. Arlington, VA, 2007 Aligning Hemophilia Treatment Center Future Goals/Objectives with Federal Public Health Initiatives. CDC/HRSA Hemophilia Center Regional Directors and Coordinators Meeting. New Orleans, LA, 2010 Reducing Medicaid Spending on Catastrophically Expensive Blood Disorders. National Conference on Blood Disorders in Public Health. Atlanta, GA, 2010 The Future of the Blood Disorders Workforce Non-Physicians. Closing Plenary Panel. 2nd National Conference on Blood Disorders in Public Health. Atlanta, GA, 2012 FILMS PRODUCED Executive Producer, 34-minute documentary Blood Roots: Hemophilia Treatment Center Pioneers in Comprehensive Health Care (2010). International debut at World Federation of Hemophilia Congress, Buenos Aires, Argentina (2010). American Public Health Association 2011 Convention, Washington, DC; National Hemophilia Foundation s 2011 Convention, Chicago, IL; the 2 nd National Conference on Blood Disorders in Public Health, Atlanta, GA 2012; distributed nationwide. Executive Producer, Hemophilia Treatment Centers: Improving care, reducing costs. 7-minute video for insurers and policy makers, The Hemophilia Alliance Conference January 2011 Las Vegas, NV; the 2 nd National Conference on Blood Disorders in Public Health, Atlanta, GA 2012; distributed nationwide. xi

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15 CHAPTER 1: INTRODUCTION The objective of this dissertation is to develop a plan to evaluate the 340B Discount Drug Pricing programs (340B) that are operated by Hemophilia Treatment Centers (HTC) in the US. The proposed evaluation will provide policymakers and others actively engaged in delivering health care services to Americans with hemophilia and other inherited bleeding disorders with evidence regarding the adoption, implementation and impacts of 340B on Hemophilia Treatment Center financial resources, capacity, and services. The proposed evaluation will also examine the impact of the loss of 340B funding on HTC capacity to provide specialty care for all Americans with suspected and diagnosed genetic blood clotting disorders. The evaluation has four specific aims: 1. To examine and explain the patterns of 340B program adoption and implementation within HTC regions 2. To assess the impact of adoption of 340B programs on Hemophilia Treatment Center (HTC) financial resources 3. To assess the impact of adoption of 340B programs on HTC capacity and services 4. To project the implications of potential 340B program loss on HTC capacity and services The 340B program, the nature of hemophilia and related diseases, their treatment, and treatment financing are complicated but provide the context for this evaluation. To set the stage for understanding 340B in the hemophilia context, I open this chapter by sketching hemophilia s public health significance. Before presenting the conceptual framework for the evaluation in Chapter 2, this chapter continues with three sections. The first, 340B Drug Pricing Program examines 340B History, Purpose, and Growing Accountability; 340B Evaluation; and 340B Operations. The second section, Aspects of HTCs and 340B Programs that Need to be Considered in Designing an Evaluation examines the HTC 340B Program as a Complex Intervention, Competition, 340B Debates, Expansion of 340B to Additional Facilities Under the 2

16 Affordable Care Act, and how a Rigorous Plan for HTC 340B Evaluation Should Enhance 340B Oversight. The third section, Clinical Trends in Hemophilia and Von Willebrand Disease and HTC Organization of Care During 340B Implementation examines Clinical Trends; Multidimensional Challenges of Hemophilia Needing Consideration for Use of 340B Revenues to Meet Patient Needs; Organization of Care; HTCs as Safety Net Providers; HTC Business Model, Reimbursement Misalignment, and concludes by examining increasing HTC Patient Population amidst workforce shortages. Significance: Hemophilia is a debilitating, incurable, potentially fatal and catastrophically expensive rare genetic bleeding disorder. The average annual cost of medication ( factor ) is about $240,000 1 ; factor costs about $1.00/unit, and is needed for a lifetime. Stakeholders estimate that the 2 3 billion units of factor are sold annually in the US. 2 Hemophilia can be inherited by multiple family members over generations, increasing familial burden exponentially. Since hemophilia is rare, a consistent volume of patients is needed for physicians to develop and sustain clinical expertise, and for hospitals to justify investing in specialized diagnostic equipment and staff. To reduce the public health burdens of hemophilia, for nearly 40 years, the federal Health Resources and Services Administration (HRSA) nurtured the development of a network of 130 regionalized Hemophilia Treatment Centers (HTC). HTC care is multidisciplinary, and associated with 40% reductions in mortality (Soucie et al., 2000), 40% 60% fewer hospitalizations (Soucie et al., 2001) and lower costs (Bryant-Wimp et al., 2009). In 1990, HRSA mandated all HTC regions appoint a Regional Director and Coordinator to provide strategic leadership, direction and grants oversight. 1 Depending upon disease severity, co-morbidities, size of individual and dosing the cost for an individual can be double or half that figure. 2 Personal communication, Derek Robertson, JD, MBA, VP Regulatory Affairs, Apogenics, Inc. 08/02/13; and Joe Pugliese, The Hemophilia Alliance Presentation What Negotiation?? at the 13th Annual 340B Coalition Conference, July

17 Despite these achievements, traditional HTC funding streams have narrowed and funding levels have declined. Stakeholders report that HTCs have become more financially dependent on revenues from their 340B programs (The Lewin Group, 2012). Yet 340B programs at HTCs have never been evaluated. Little is known about whether 340B programs at HTCs are working as intended; about variations and determinants in operational efficiencies, about demographic and clinical trends of people enrolled; about patterns of revenue generation and reinvestment and whether these are consistent with Congressional intent. This proposed design for evaluating HTC 340B programs would address these knowledge gaps. This new knowledge afforded by the conduct of the proposed evaluation will help quantify HTC 340B program impact, enhance transparency, identify opportunities to maximize operational efficiencies, and improve decision making at patient, operations, and policy levels. 340B Drug Pricing Program 340B History, Purpose, and Growing Accountability: The 340B Drug Pricing Program is a major 20 year old federal initiative that requires manufacturers to reduce outpatient drug prices for selected organizations ( covered entities ) which provide healthcare to vulnerable populations. 3 The 130 HTCs that have a HRSA grant to provide Comprehensive Hemophilia Diagnosis and Treatment services are among the 340B covered entities. HRSA and its Office of Pharmacy (OPA) jointly administer 340B; over 21,000 entities participate nationwide. OPA estimates about $6 billion in outpatient drugs are purchased annually at 340B prices. 4 Drug manufacturers set the 340B price, based on the average manufacturers price which changes quarterly. 3 PL The Veteran's Health Care Act (VHCA) of 1992, Sec. 602 subpart VII, Sec. 340B to Part D of Title III 4 K. Pedley, PharmD, MS, Director, OPA, HRSA Information Session, 340B Drug Pricing Program. Undated Presentation accessed 07/12/13 4

18 Congress described 340B s goal as, to enable these entities to stretch scarce Federal resources as far possible, reaching more eligible patients, and providing more comprehensive services B prices are 20% 50% less than non-340b priced drugs (GAO, 2011). Covered entities generate revenue by billing insurance at negotiated rates. 6 Net revenue, program income is the balance after subtracting the costs of purchasing factor and 340B pharmacy operations. Program income must be used per Congressional intent: to care for more patients and expand services, 340B benefits are not restricted to the individuals who are enrolled in 340B. Rather, benefits accrue to the covered entity s entire patient population. 340B Evaluation: As noted earlier, HTCs are but one of many safety net providers that, as Congressionally designated covered entities, are eligible to purchase outpatient drugs at 340B prices. The impact of 340B programs have been assessed by a number of these organizations. These include the National Association of Community Health Centers, the Safety Net Hospitals for Pharmaceutical Access, and Federal Family Planning Programs (Schmitz R et al., 2004; Schur C et al., 2007; The Lewin Group et al., 2009; Wallack MC et al., 2011). However, the 340B evaluations promulgated by these organizations solely assessed 340B s impact on their particular covered entity group. While about 100 or over two thirds -- of the 130 HTCs operates a 340B program, 7 340B programs in the HTC setting have never been systematically evaluated. Unlike the UK and Canada, the US has no formal governance structure with resources to shape strategic direction for the US HTC Network. Consequently, data on HTC 340B program impact and determinants is not systematically collected. 5 House Commerce Committee s report on the legislation which added section 340B to the Public Health Services Act (H.R. Rept ,102nd cong., 2d Sess., pt. 2, at 12(1992)). 6 For commercial insurance, some 340B programs bill at Medicare Allowable rates. For Medicaid, 340B programs are required to bill at acquisition cost plus a reasonable dispensing fee that is set by the State Medicaid agency. 7 accessed June 20,

19 340B Operations: Starting and sustaining a 340B program is a multifaceted undertaking, requiring business acumen and legal, financial and human resources. Complying with state and federal requirements is problematic as rules governing 340B are scattered in statutes, regulations, guidelines, letters, federal cost principals, and policy releases. 8 Demands for 340B accountability and transparency are rising, making the proposed plan for evaluation timely. HRSA delegated general HTC 340B program oversight responsibility to Regional HTC leadership in This entails being informed about regional HTC 340B characteristics, fostering economic and effective operations, and reporting (HRSA, 2005). Federal regulations hold HTC grant recipients accountable to the regional grantee for the use of funds provided, including 340B program income. 9 Recent Congressional inquiry motivated HRSA to enhance its 340B Program oversight role. 10 Documenting impact became an agency-wide emphasis, and is explicitly stated in the new HRSA Hemophilia Grant requirements. 11 New Affordable Care Act s (ACA) Program Integrity initiatives include 340B audits that are conducted by HRSA and OPA. 12 Hemophilia s profile of low volume/high costs per patient likely pose heightened risks to HTC host institutions that are interested in starting and operating a 340B program. Hospital financial risk is high: hospitals must front funds to purchase sufficient drug from the manufacturer and wait, sometimes 1.5 years until they get reimbursed by the patient s insurance company. Reimbursement can lag 6 24 months, depending upon payer. Securing insurance authorization prior to drug shipment is critical; without authorization, insurance will not pay. Some Centers staff suggest that hiring a vigilant billing agent who has good people skills is needed to get acquainted with each insurer s case manager for high cost patients. 8 HRSA s National Hemophilia (HTC) Program Leadership is compiling these into a single document to facilitate understanding of and adherence to policy. Personal Communication, Katherine McLaughlin, HRSA NHP Program Officer, March 20, OMB Circular A CFR Letter from Senator Charles Grassley to HRSA Administrator Mary Wakefield 10/21/ HRSA National Hemophilia Program: Overview and Update, Kathryn McLaughlin, MPH, March Manufacturers are also entitled to audit 340B covered entities. As federal grant recipients, most HTC institutions are also subject to annual A-133 audits which can encompass a 340B program. 6

20 Other critical 340B operational processes include: ordering drug from the manufacturer (a 340B requirement), HTC nursing clinical assessment, using an in-house or contract pharmacy (the latter requiring obtaining, reviewing and evaluating bids and ongoing performance), contracting with commercial insurance companies, contracting with home nursing services, reviewing financials with billing agents, creating a budget to identify priority allowable areas for using net program income, educating and marketing to payers and patients. Aspects of HTCs and 340B Programs That Need to Be Considered in Designing an Evaluation HTC 340B Program as a Complex Intervention: Evaluation of the HTC 340B program must be designed with a recognition that the operational breadth and depth of these programs make them a complex intervention (Craig et al., 2013). Defining features of complex interventions are the volume, difficulty, and/or variability of interacting components; behaviors required to deliver and receive the intervention; organizational levels; outcome variability; and flexibility to tailor the intervention. HTC Stakeholders indicate that they and their host institutions face multiple choices, need substantial financial resources and information before arriving at a 340B adoption decision, after which comes a series of complex implementation steps in order to set up and sustain a 340B program. Table 1 translates HTC 340B program into the complex intervention constructs. The figure focuses primarily on the numerous public and private stakeholders at multiple levels starting with the patient and family and moving to include clinicians and their organizations, to State and Federal agencies, commercial players who make and distribute factor, and patient advocacy agencies. To start and operate an HTC 340B program requires skilled negotiation, cooperation and alignment among this dynamic cast. 7

21 Table 1: Hemophilia Treatment Center 340B Program as a Complex Intervention Complex Intervention Feature A. Numbers of interacting components - Stakeholders B. Numbers and difficulty of behaviors required to deliver and receive the intervention C. Numbers of groups and/or agency levels involved HTC 340B Program Patients and families with rare, genetic, costly chronic blood disorders Hemophilia Treatment Center Teams Host Hospitals (Academic, Community) Medical Schools, Freestanding clinics Outpatient Pharmacy within hospital and contract pharmacy Public and private insurers and their managed care networks State Pharmacy regulations Federal government: Congress, HRSA, OPA, OIG Factor manufacturers Commercial factor vendors Pharmacy Benefit Managers Home Nursing services 340B management services organizations Hemophilia patient support organizations and 340B Community Advisory Boards Home treatment of factor concentrate Diagnosis/management of rare genetic blood disorders; comprehensive hemophilia team based service requirements, HRSA care grant goals/objectives Business negotiations with hospital leadership: legal, financing, administration Outpatient pharmacy operations: State and Federal regulations for 340B entities, purchasing high priced biologics for small patient base, inventory management, dispensing temperature sensitive biologics throughout US, insurance contracting and reimbursement, marketing, accounting legal, strategic planning Group Purchasing Organizations Pediatric home nursing infusion skills - geographic availability and capability Public/private insurance reimbursement rates, contracting, policy re: 340B rules/regulations re: cost principals, program income reporting Factor manufacturers: product shortages, price negotiations Pharmacy Benefit Managers, Public/Private Managed Care, Limits on patient access to HTC for clinical care and/or outpatient pharmacy State regulations re: pharmacy practice Federal HRSA, OPA, OIG rules/regulations: cost principals, reporting Commercial factor vendors: competition Level of endorsement from patient support organization Ethics 130 Hemophilia Treatment Centers and 130 Host Institutions 50,000+ persons with bleeding and clotting disorders US Public: Congress, Federal and State Agencies and Payers Pharmaceutical industry All Stakeholders indicated in A 8

22 Table 1: Hemophilia Treatment Center 340B Program as a Complex Intervention (Cont.) Complex Intervention Feature D. High variability in outcomes E. Degree of flexibility to tailor the intervention HTC 340B Program Predictors, mediators, moderators of HTC 340B adoption & implementation o HTC Host institution organizational structure and processes o HTC size, patient insurance mix, o State Medicaid reimbursement and contracting o Regional 340B Technical Assistance o Competition: Managed care, commercial factor vendor and pharmacy benefit manager market penetration Outcomes in HTC adoption and implementation o Early vs. late 340B adoption o % of HTCs operating a 340B program within region o Size of HTC 340B program: numbers of patients enrolled, net revenue generated annually and over time o Use of HTC net program income to increase staff and service capacity to serve more patients and provide more comprehensive services Ability to use >1 contract pharmacy or pharmacy co-located in host institution Existence of policies requiring patients to call HTC Nurse to reorder factor to enhance clinical management vs. patient re-order directly from pharmacy Operations HTC and/or host institution responsibility or outsourced to management services agency, o Marketing o Contracting with payers o Obtaining insurance authorization o Dispensing drug o Billing Competition: Stakeholders indicate increasing competition for HTC activities: both clinical care but particularly 340B is significant and growing. While 80% of Americans with hemophilia obtain their care at HTCs, the reasons for why the balance obtain their bleeding disorder care outside the HTC network is not fully understood. Informants report that this is partly by choice, partly due to insurance restrictions, and other reasons. 13 Private and public insurance policies and practices can explicitly restrict patient access to the HTC for clinical care and/or 340B. For example, closed model Health Maintenance Organizations typically do not refer patients outside their network; being a covered entity s patient is a prerequisite to accessing 340B priced drug. Furthermore, all major commercial 13 A CDC funded study is investigating this question. 9

23 insurers increasingly require insured beneficiaries to obtain their drugs exclusively at Pharmacy benefit managers. On the public side, inadequate Medicaid reimbursement rates may be a disincentive for HTCs to start 340B programs. Medicaid contracting policies for factor vendors may allow sole source vendor statewide. 14 Medicaid managed care can limit patient access to HTCs and 340B. Competition from commercial factor vendors could also reduce HTC 340B adoption and spread (Kelley, 2009). National well-resourced pharmacies -- Walgreens and CVS Caremark recently entered the factor market. Commercial factor vendors owned by people with hemophilia, or which hire patients and family members as sales staff. offer a connection borne of shared experience that can be compelling. Expansion of 340B to Additional Facilities under the Affordable Care Act (ACA): There may be additional 340B policy impact on the health care delivery system due to implementation of the ACA. The ACA expanded 340B eligibility to several new types of facilities, including freestanding Children s Hospitals, freestanding Cancer Centers and Critical Access Hospitals (Conti et al., 2013; Traynor, 2011; Warren et al., 2013). A chief complaint by critics is that 340B prices should only be accessible to uninsured indigent patients, that the benefits are not reaching patients, that the requirements are ambiguous and oversight inadequate B supporters agree with oversight concerns and counter that chief complaint. 16 Key among the supporters counter explanations is that circumscribing the 340B program benefits solely to uninsured indigent patients intentionally distorts the purpose of the 340B program. Supporters explain that Congress did not intend to limit 340B program benefits to only uninsured indigent 14 State of California Department of Health Service s October 2010 Medi-Cal Provider Bulletin lists >40 factor vendors, this grew to 65 in Only 11 were HTC 340B programs in both time periods. 15 The 340B Drug Discount Program: A review and analysis of the 340B Program, Winter Safety Net Hospitals for Pharmaceutical Access, Setting the Record Straight on 340B: a response to critics, July

24 patients. Rather, Congress intended that the drug discounts and benefits of expanded services -- be available to all the patients of the 340B entities, recognizing that the 340B covered entities, by definition, are caring for vulnerable patients. This proposed plan for evaluation will provide the evidence of 340B benefit to HTC patients. Rigorous Plan for HTC 340B Evaluation Should Enhance HTC 340B Program Oversight: A rigorous plan for evaluation, if conducted as designed, should enhance HTC 340B oversight at the HTC, regional, and national levels. In 2005, HRSA delegated general 340B program oversight responsibility to the Regional HTC Director and Coordinator. Responsibilities include being informed about HTC 340B program characteristics, fostering economic and effective operations, and reporting (HRSA, 2005). Federal regulations hold HTC level HRSA grant recipients accountable to the regional grantee for the use of funds provided. 17 Attaining a uniform set of quantitative and qualitative measures of 340B impact, and impact determinants strengthens oversight. Creating uniform measures allows Regional leaders to compare 340B adoption and implementation across Centers with similar organizational characteristics, thereby improving regional level monitoring. Uniform measures can be converted into HTC 340B level profiles that provide feedback to HTC Directors and their host institutions, to form the basis for HTC level 340B improvement initiatives. The uniformity of measures also allows for aggregation at the national level, further advancing HTC 340B program oversight. HRSA Policy Clarifies the Use of HTC 340B Program Income: HRSA provided clarification on how HTCs could use 340B program income to achieve Congressional intent within the context of HTCs being a covered entity through receipt of the HRSA Comprehensive Hemophilia Care grant. HTCs must use 340B net program income to reinvest into the HTC to achieve the HRSA comprehensive care grant requirements. Following a 2000 Office of Inspector General report (OIG, 2003), HRSA clarified that program income should be used to 17 OMB Circular A CFR

25 further eligible program objectives. 18 A May 23, 2003 HRSA letter to the HTCS defines eligible program objectives as patient care, education, and supportive services necessary to provide comprehensive care to patients. HRSA defines the program as the approved HRSA grant. 19 Thus, the HRSA comprehensive hemophilia care grant guidance priorities, and approved grant goals, objectives, and activities at the regional level need be considered in creating a plan for evaluating HTC 340B program adoption, implementation, and impact. Clinical Trends in Hemophilia and Von Willebrand Disease and Organization of Care During 340B Implementation 340B net revenue must be reinvested into the HTC to serve more patients, and expand services per the HRSA comprehensive care grant objectives. Therefore, a plan for evaluating HTC 340B programs needs to be informed by trends associated with Hemophilia and Von Willebrand Disease. The plan for evaluation also needs to consider trends in the HTC healthcare delivery system occurring since Congress enacted the 340B legislation. Clinical Trends: Hemophilia and von Willebrand Disease are chronic inherited bleeding disorders that pose substantial burdens to affected individuals, caregivers and the public health system. Hemophilia stems from a missing protein (a clotting factor ) needed for blood to clot, occurs in about 1:5100 live male births (Soucie et al., 1998), affects about 20,000 Americans, mostly males, but females can also have the disorder (Byams et al., 2011). No family history is found in one third of cases (Srivastava et al., 2012). Von Willebrand Disease (VWD) is a common related inherited disorder that occurs in about 1:100 males and females equally, and is characterized by mucotaneous bleeding (Nichols et al., 2008). VWD is difficult to diagnose and under-recognized in females, causing avoidable morbidities (A. H. James et al., 2009). People with severe and moderate VWD also lack factor needed for blood clotting CFR 74.24(b)(1). 19 With prior HRSA approval, 340B program income can support research. 12

26 Multidimensional Challenges of Hemophilia Needing Consideration for Use of 340B Revenues to Meet Patient Needs: Hemophilia poses physical, psychosocial and economic challenges. In order to for a plan for HTC 340B program evaluation to assess impact, it is important to understand the patient needs for which expanded services are required. A plan for HTC 340B program evaluation should measures how program revenues are being used to enhance staff and service capacity to meet the physical, psychosocial, and economic challenges that are outlined below. Physical Challenges: Hallmark physical symptoms are spontaneous internal hemorrhages into the joints and soft tissues (Oldenburg et al., 2009). Blood born viruses are a chief complication. Over 2000 people with hemophilia contracted HIV (Evatt, 2007) and another 6000 contracted Hepatitis C over 30 year ago through contaminated treatments (Eyster et al., 1993; White, 2010). Many are co-infected (CDC, 2013); thousands more died. Inhibitory antibodies that render factor ineffective is a serious complication (Kempton et al., 2006) for which African-Americans and Hispanics are at higher risk (Aledort et al., 1998; Viel et al., 2009). Psychosocial Challenges: Hemophilia psychosocial challenges include adjustment to chronic illness (Wallander et al., 1988), social isolation born of low disease prevalence (Dellve et al., 2006), and increase risks for school (Shapiro et al., 2001), and work absenteeism (A. H. Miners et al., 2001) due to bleeding unpredictability. Economic Challenges: Treatment Costs pose serious economic burdens. Factor infused into a vein reduces or prevents bleeds. Prophylactic infusions preserve children s joint function over infusing after a bleed occurs, but at 2 3 times the cost (Gringeri et al., 2011; Johnson et al., 2011; Manco-Johnson et al., 2007). Factor comprises 45 90% of the cost of care. 20 Adult patients who treat prophylactically incur mean factor costs of $250,000 annually; double for 20 Depending on disease severity and co-morbidities 13

27 persons with an inhibitor (GAO, 2012; Globe et al., 2001; A. Miners, 2009; Tencer et al., 2007). While most insurance covers factor, few families could afford a 10% co-pay, prompting some to reduce employment to qualify for Medicaid, shifting costs to taxpayers (Zhou et al., 2011). Organization of Care: Federal legislation enacted nearly 40 years ago launched the nationwide development of comprehensive hemophilia diagnostic and treatment centers that utilize multidisciplinary teams to provide the array of preventive and treatment services needed to address hemophilia s physical, psycho-social and economic burdens (Baker et al., 2005; Grosse et al., 2009; Hoots, 2003). 21 Core HTC team members are: hematologist, nurse coordinator, social worker, and physical therapist; presaging emerging evidence documenting the benefits of multidisciplinary care (Bosch et al., 2009; Lemieux-Charles et al., 2006). HTC services span the outpatient, inpatient and community settings and include diagnosis, treatment, rehabilitation, education, counseling, care coordination, case management, outreach clinics, surveillance, research, pharmacy, and referral. HTC service criteria are outlined in national and international recommendations and guidelines (Foundation, 2002) and specified in the HRSA comprehensive hemophilia care grant guidance. Regional leaders foster structured networking opportunities to reduce HTC clinicians professional isolation, build their clinical skills, address common policy issues all with the goal of maximize care quality and reducing costs. A plan for HTC 340B program evaluation should measure how program revenues are being used to enhance staff and service capacity at both the HTC and regional levels. The goal of HTC care is to enhance patient and family functioning. HTCs extensively educate parents to recognize bleeds quickly and infuse immediately. Over 90% of young HTC patients with severe hemophilia self-infuse; nearly 80% prophylactically (Baker et al., 2011). Home treatment un-tethers the family from the HTC and hospital emergency room, facilitating school, work, and travel (Teitel et al., 2004). 21 The Public Health Service Act Establishing the Hemophilia Diagnostic and Treatment Center Program,"

28 HTCs as Safety Net Providers: As HRSA safety net providers, HTCs care for patients regardless of income. Table 2 indicates they do. The high proportion of HTC patients primarily insured by Medicaid increases HTC vulnerability to Medicaid policy, including reimbursement rates, managed care and factor vendor contracting policies that can either promote or limit patient access to HTCs and 340B programs. Conversely, with 40% of US boys with severe hemophilia primarily insured by Medicaid, factor costs impact state budgets (OIG, 2011). In 2007 California Medicaid spent 6% ($139 million) of its budget on factor, placing factor 6th highest among top ten therapeutic classes by total expenditure, up from 10 th in Table 2: Primary Insurance among US Hemophilia Treatment Center Patients, 2011 Primary Insurance Youth with Severe Hemophilia Age 2 20 n = 3380 (Baker et al., 2011) Adult Men with hemophilia (all severities) Age n = Adult Men with hemophilia (all severities) Over age 55 n = % Commercial % Medicaid % Medicare % Other 6 NA NA % None 1 NA NA % Unknown TOTAL HTC Business Model: The hemophilia business model must take into account the complex combination of small patient volume, high per patient costs, high Medicaid penetration, unpredictable and potentially costly inpatient stays, 25 and reimbursement that is misaligned with the HTC promotion of outpatient, preventive, home based care. Optimal hemophilia management requires specialty coagulation laboratories and other services typically found only in tertiary care hospitals. Hence, most HTCs are virtual Centers, 22 California HealthCare Foundation, The Medi-Cal Prescription Drug Benefit: an Overview. December Unpublished CDC data. 24 Ibid. 25 Hospitals and emergency rooms are responsible for the costs of factor used during inpatient stays. 15

29 part of hematology/oncology departments, whose business models are linked with their host institutions. HTC revenue sources consist of institutional support, reimbursement from clinic billings; grants to conduct research, surveillance and comprehensive care; and, increasingly, the sale of outpatient drugs using federally discounted prices. However, US HTCs have no national organization to represent its strategic interests or monitor changes in funding levels and sources over time. Reimbursement Misalignment: Moreover, health care reimbursement rates favor inpatient hospital stays and poorly reimburse for outpatient and preventive health care such as self-infusion education, care coordination - which HTCs employ to avoid hospitalization and improve patient functioning. By reducing emergency room visits, HTC care eliminates the substantial cost of factor from hospital budgets (D. R. Globe et al., 2004; J. Soucie et al., 2001). Today, successful HTC utilization is an annual outpatient comprehensive evaluation, supported by intermittent telephone advice. Paradoxically, this success reduces the HTC s visibility within its institution, reduces hospital reimbursement income, and is not financially rewarded. Increasing HTC Patient Population amidst Workforce Shortages: Simultaneously with HTC leaders indicating declines in the levels and sources of HTC funding, several HTC patient population segments are growing, there is a shortage of board certified hematologists specializing in hemophilia, and few hematology fellowship training programs. A plan for HTC 340B program evaluation should measure how program revenues are being used to reduce HTC workforce shortages. The growth HTC populations include young adults; chronic long term HIV, HCV and coinfected survivors (Konkle, 2011);older adults (Konkle, 2012); females with VWD (A.H. James et al., 2009); and people with genetic platelet, clotting, and other rare bleeding disorders (Soucie et 16

30 al., 2010). 26 Today, US HTCs care for an average of nearly 400 Americans in all States and several territories with genetic bleeding and clotting disorders (Baker et al., 2013; Holtzclaw Williams, 2011). Stable and adequate funding is needed to sustain a trained workforce of hematology specialist teams to care for these growing patient populations (The Lewin Group, 2012). National shortages in diagnostic coagulation laboratories (Shahangian et al., 2005), in physicians specializing in non-malignant hematology, and in benign hematology training programs threaten the health of Americans with suspected and diagnosed genetic blood disorders (Goldenberg et al., 2012; Loren, 2009; Todd et al., 2004). Because 340B net revenue generated must be reinvested into the HTC, it is timely to devise a plan to evaluate 340B adoption, implementation and impact at HTCs. 26 In 2010 HTCs cared for nearly 14,000 persons with other rare genetic bleeding and clotting disorders, Hemophilia Data Set: Bleeding and Clotting Disorder Active Patients 2010, unpublished data. 17

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32 CHAPTER 2: CONCEPTUAL FRAMEWORK: Consolidated Framework for Implementation Research Introduction The proposed evaluation conceptualizes the HTC commitment to 340B as an adoption decision plus a series of implementation processes. HTCs in regions across the US determine for themselves whether and when they can proceed to make the adoption decision. Likewise, for HTC 340B program implementation to occur and succeed over time, the 130 HTCs negotiate a host of complex 340B processes with the many stakeholders identified in Table 1. As HTCs care for Americans with genetic blood disorders nationwide, there are area level differences in that may influence 340B program adoption and implementation. These differences include but are not limited to geography; patient race/ethnicity and socio-economic status; healthcare delivery human and financial resources; and the local competitive environment for factor sales. Hence there is value in assessing variations and determinants of optimal HTC 340B adoption and implementation. To structure the proposed evaluation, I recommend application of the Consolidated Framework for Implementation Research (CFIR)(Damschroder et al., 2009). CFIR offers a framework that helps evaluators think systematically about evaluation questions, measures and variables. In turn, these questions, variables and measures and can illuminate the multifaceted determinants that explain: Why do some complex interventions start and others do not? Why do some interventions work and others do not? Where do some interventions flourish more or less as compared to other organizations that adopt the same intervention (Clauser et al., 2012; EM Yano et al., 2012)? CFIR is useful for studying both the adoption and ongoing impact of implementing complex health program interventions. CFIR can be used to identify stakeholders at multiple 19

33 levels (adoption and implementation s who and where ). CFIR can also promote systematic thinking about adoption and implementation processes (the how, the how much and under what circumstances ). These strengths advance CFIR s fit for this proposed plan for evaluation. Furthermore, CFIR synergizes with the proposed design, which is considered an implementation evaluation (Grembowski, 2001). Implementation evaluations examine the scope and duration of an intervention s effects and influences in a broad array of environments, among differing health care providers, institutions, or settings. CFIR is a comprehensive framework devised to offer a practical and consistent use of constructs that influence implementation. CFIR consolidates key constructs from published implementation frameworks, models and theories into a single frame. CFIR can be used to guide evaluations that are conducted before (formative) an intervention is implemented, during (process and impact) or retrospectively (outcome). CFIR is rapidly becoming a common framework for evaluating implementation initiatives. CFIR s standard terminology for operationalizing evidence based implementation concepts can expedite nationwide adoption of this proposed design for evaluation. CFIR is organized into five constructs and 26 subcategories. Table 3 identifies these constructs and defines twelve relevant CFIR subcategories. Table 3 then then applies the subcategories to this plan for evaluation by noting illustrative concepts. These illustrative concepts will inform the creation of evaluation questions, measures, and variables that will be discussed in detail in Chapter 3. 20

34 Table 3: CFIR Constructs, Subcategories, Definitions and Illustrative Concepts Applied to HTC 340B Program CFIR Construct and Subcategory Intervention Relative Advantage Complexity Costs Outer Setting Patient needs and resources Cosmopolitanism External policies & incentives Inner Setting Structural Characteristics Networks & Communications Implementation Climate Readiness DEFINITION Stakeholders views regarding the advantage of implementing the intervention as opposed to a competing solution Perceived implementation difficulty: scope, duration, disruptiveness; number of steps Investments at start, duration, opportunity costs Extent to which barriers/facilitators to meeting needs are known and prioritized Degree to which an organization is networked with other external organizations Policies, regulations, guidelines, reporting requirements Size, age, units, decision making hierarchies Nature and quality of within agency ties Absorptive capacity for change, shared receptivity to intervention, intolerability of current situation, fit with values & workflow, extent to which innovation rewarded, supported, expected Engaging leaders, resources, information Application to HTC 340B Program Evaluation (illustrative concepts) Discounted outpatient drug program that is operated by HRSA and its Office of Pharmacy Affairs that is available to certain entities that provide health care services to vulnerable populations, e.g. Hemophilia Treatment Centers that receive a HRSA comprehensive hemophilia care grant. 340B versus status quo; prior factor sales, alternative sources of funding HTC Staff: pharmacy, billing, insurance, legal, negotiation, marketing, audit, compliance $ for start-up inventory, reimbursement delay, costs to meet federal compliance requirements, resources to build and maintain skilled 340B operations staff Knows changing patient demographic & clinical trends; data mgmt. Links outside HTC region re: 340B expertise Insurance mix, reimbursement rates, competition, HRSA grant priorities HTC Host institution type; HTC size and authority, ability to reinvest revenues Links within region Practice management chaotic, slack resources, improvement barriers Access to 340B regulatory information access Individuals Knowledge & beliefs about intervention. Pro/Con 340B, priorities, team commitment Process Engaging Executing Use of informal opinion leaders & champions, Carrying out implementation according to plan Attend 340B Educational Seminar Use income per guidelines CFIR creators portray the frame visually in Figure 1. 21

35 Figure 1: Consolidated Framework for Implementation Research Applying CFIR Constructs and Subcategories to HTC 340B Context Characteristics of 340B as an intervention, variation in the outer and inner settings in which the US HTCs operate, differences in individuals involved in startup and operations, and distinct regional processes may influence HTC 340B program adoption and impact. Therefore, a credible and optimal plan for evaluation needs to consider these diversities in the measures proposed, data available, analyses conducted, conclusions drawn, and recommendations. The next section describes how the CFIR constructs and subcategories can be applied to the proposed plan to evaluate HTC 340B adoption, implementation and impact. Nascent measurement areas that need be developed are identified. Measures and variables are discussed fully in Chapter 3. Construct I: Intervention. The intervention is a 340B program that is registered with the HRSA Office of Pharmacy Affairs specifically under the designation that indicates the covered entity receives a HRSA Comprehensive Hemophilia Diagnostic and Treatment Center grant (either directly or as a regional sub recipient). The word specifically is explicitly emphasized. Unlike other entities purchasing factor at 340B prices (e.g. Disproportionate Share Hospitals), only 340B programs that are registered with OPA under the HTC designation are subject to 22

36 Regional HTC leadership oversight. Only this specific designation requires covered entities to use program income to further the HRSA comprehensive hemophilia care grant objectives. Construct I: Intervention subcategory - Relative advantage. The plan for evaluation should include variables to measure HTC Director and host institutional stakeholder views regarding the benefits of operating a 340B program compared to the status quo (Gustafson et al., 2003). This perception may be influenced by a host institution s broader involvement with outpatient pharmacy or 340B. For example, some institutions hosting HTCs have sold factor for decades. Other host institution stakeholders may have 340B experience under the Affordable Care Act s extension of 340B eligibility to children s (Traynor, 2011) and cancer hospitals (Conti et al., 2013; Warren et al., 2013). This variation needs be measured. Construct I: Intervention: subcategory Complexity. The plan for evaluation should include variables that measure stakeholder perception of the level of complexity needed in starting and operating an outpatient pharmacy for HTCs that uses 340B prices. Novices could view 340B as expanding HTC scope of services into a completely new, radical, and risky area for which there is limited expertise. The copious 340B legal, financial, business, and related operational components may be perceived as disruptive to the primary HTC mission of diagnosis and treatment. Stakeholders may question the ethics of HTCs deriving factor sale revenues, as HTC physicians are the prescribers; thus adding complexity (The Lewin Group, 2012). All this needs be measured. Construct I: Intervention: subcategory Cost. The plan for evaluation should include variables related to fiscal resources. This includes the substantive funds to purchase the initial and ongoing inventory of factor and ancillary supplies. 27 The initial inventory can cost tens of thousands of dollars. Other cost issues needing variables are the extent to which delay in 27 e.g. needles, tourniquets, hazardous waste containers 23

37 obtaining reimbursement from insurers, the increasing costs to meet growing federal compliance requirements, and resources to build and maintain skilled 340B operations staff serve as barriers to HTC 340B adoption and implementation. Construct II: Outer Setting - subcategory Patient needs and resources. The plan for evaluation should include variables to measure resource sufficiency to track and strategically respond to trends in patient clinical, demographic, and health services utilization patterns to enhance service capacity to improve patient health outcomes. Construct II: Outer Setting - subcategory Cosmopolitanism. The plan for evaluation should include variables to measure the extent to which HTC Directors and other key stakeholders network with counterparts outside their regions and how this has influenced 340B start up and implementation. Construct II: Outer Setting - subcategory External policy and incentives. The plan for evaluation should include variables to measure the extent to which health policy and climate at local, State and Federal levels has influenced 340B adoption and implementation. This will include the local nature and level of patient support organization advocacy regarding 340B, competition from commercial factor vendors, managed care penetration, use of pharmacy benefit managers, Medicaid contracting, Medicare and Medicaid reimbursement rates, and HRSA/OPA 340B reporting and audit requirement burdens. Construct III: Inner Setting - subcategory Structural characteristics. The plan for evaluation should include variables to measure how heterogeneity between HTCs, HTC regions, and between HTC host institutions has influenced 340B adoption and implementation. Heterogeneity variables to develop at the HTC level include measures of patient clinical and demographic characteristics and organizational structure. s heterogeneity to measure includes 24

38 initiatives to provide 340B technical assistance, and type of HTC regional leadership agency. 28 Heterogeneity at the HTC Host institution level includes type e.g. academic versus community hospital, blood center, or freestanding clinic. A large well-resourced hospital may be better able to cover the unusually high start-up costs for initial 340B factor inventory (Schmitz R et al., 2004). Institution types likely differ in decision making processes, attitude toward innovation, risk, competition, and the perceived value of the HTC and 340B; all of which need be evaluated. Construct III: Inner Setting - subcategory Networks and communications. The plan for evaluation should include variables to evaluate how HTC regional network characteristics have influenced 340B adoption and spread. Communication likely varies depending upon the size of HTC regions. In HRSA s new HTC regional structure 29 regions can consist of 3 9 States and HTCs. How these differences impact 340B adoption and implementation need be measured. Construct III: Inner Setting - subcategory Implementation climate. The plan for evaluation should include variables to measure how HTC 340B program adoption and implementation has differed depending upon the level of organizational slack (Bourgeois, 1981) resource capacity for change. This would include key stakeholder time for planning, concurrence on the importance of 340B to HTC sustainability and expansion, alignment with values, and sufficient strategic and operational resources to absorb 340B operations into workflow. Construct III: Inner Setting - subcategory Readiness. The plan for evaluation should include variables to measure how differences in engaging HTC Directors and host institution senior leadership (e.g. Hospital administration, finance, contracting, pharmacy, marketing, legal, and key departmental chiefs) have influenced 340B adoption and implementation. 28 Most agencies that serve as regional core centers are HTCs. A few are not for profit patient support organizations, e.g. Hemophilia of Georgia, Inc.; The Hemophilia Foundation of Michigan and The Great Lakes Hemophilia Foundation, Inc. 29 Established 6/1/12 25

39 Construct IV: Individuals. The plan for evaluation should include variables to evaluate how HTC and institution stakeholder access to information about 340B rules, regulations and resources have determined 340B of adoption. Construct V: Process - subcategory Engaging. The plan for evaluation should include variables to measure how using informal and formal champions and implementation leaders has influenced HTC 340B start up and implementation. Construct V: Process - subcategory Executing. The plan for evaluation should include variables to measure how the sufficiency of human and fiscal resources that are engaged to execute 340B operations at HTC, host institution, and regional levels influence HTC 340B start up and implementation. In sum, all five CFIR constructs and the selected subcategories facilitate a systematic plan for evaluating 340B adoption, implementation and impact. This CFIR guided plan is focused to embrace the relevant institutions, sectors, and time. Less robust conceptual frames might confine a design for evaluation to a single unit of analysis (e.g. the HTC), or single group of stakeholders (e.g. patients), or a single point in time. Other implementation evaluation frameworks were found informative. However many of their elements are incorporated into CFIR. Those frameworks include innovation diffusion (Greenhalgh et al., 2004), scale up and spread (EM Yano et al., 2012), realistic evaluation (Pawson et al., 2005), socially complex service interventions (Wolff, 2000), Context theory (Øvretveit, 2011), the regional version of the Chronic Care Model (Wagner et al., 2006), and Promoting Action in Research Implementation n Health (Kitson et al., 2008; Rycroft-Malone, Harvey, et al., 2002; Rycroft-Malone et al., 2004; Rycroft-Malone, Kitson, et al., 2002), and Diffusion of Innovations (Rogers, 1995). An illustration of how the five CFIR constructs and selected subcategories might be applied to a design for evaluating HTC 340B program adoption and implementation is shown 26

40 below. As compared to the classic CFIR scheme shown in Figure 1, this illustration intentionally uses jagged edges for the constructs outer setting and intervention. Jagged edges are a metaphor to depict the dynamic nature of the outer policy setting that can poke and prod HTCs either toward or away from 340B adoption. The increasing number of jagged edges on the adapted intervention cartoon means to suggest the growing complexity of 340B over time. Figure 2: CFIR applied to Proposed Evaluation of HTC 340B Programs Despite CFIR s many strengths, it is limited by not considering issues unique to implementing interventions in small or rare populations. While CFIR is not built around the context of rareness implementation, hemophilia is. Thus, I used rareness as a criterion to select CFIR elements for the plan for evaluation. Rareness -- defined as the low prevalence -- characterizes hemophilia and other genetic disorders. The US defines a disease as rare if it affects less than 200,000 persons. The National Institutes of Health identifies about 7000 rare disorders which collectively affect 27

41 25-30 million - or one in ten Americans. 30 Rareness poses unique public health challenges to devising optimal health care services, policies, and infrastructures including the adoption and impact assessment of complex innovations, such as 340B (Atrash et al., 2010; Holtzclaw Williams, 2011). Rareness implies scarcity of resources and capacity. There is limited access to diagnostic testing and treatment facilities, to healthcare workforce with expertise; (Schieppati et al., 2008) isolation of affected individuals, families and their dedicated health care professionals; recruitment struggles to power random controlled trials that are favored in evidence rankings (Griggs et al., 2009) and disenfranchisement by pharmaceutical industry (Scheindlin, 2006). Rare disorder stakeholders are dispersed by space and time. HTCs are located throughout the continental US, Alaska, Guam (Zabala et al., 2002) and Puerto Rico (Santiago et al., 1999). Some HTC regions span the international date-line, the Canadian to Mexican borders, and multiple time zones. This increases costs and reduces opportunities for in person collaboration and real time teleconferencing. Small patient numbers inherent in rare disorder populations also reduces organizational slack: few HTCs are large enough achieve financial sustainability based solely on the care of their bleeding disorder patients. Most HTC Directors are board certified hematologist/oncologists affiliated with hospital based hematology/oncology departments at academic medical centers. These physicians often care for people who have cancer, as well as genetic blood diseases. This multiplicity of responsibilities can inhibit the development of the deep understanding and uninterrupted focus needed to launch and sustain a complex intervention such as 340B

42 In sum, CFIR constructs and subcategories spur evaluators to think systematically about possible influences of complex innovation adoption, implementation and impact. Specifically, CFIR motivates evaluators to identify the multiple sectors and processes to include in proposed assessments to reduce potential measurement gaps. Chapter three will operationalize the CFIR motivated constructs and subcategories into Aims, evaluation questions, methods, measures, variables, and analytic approaches. For each Aim and evaluation question, Chapter 3 will showcase preliminary results of the design for evaluation. The preliminary results will demonstrate feasibility of the analytic plan, and/or show that data are adequate to address the evaluation question. 29

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44 CHAPTER 3: METHODS Introduction This proposed evaluation plan creates an evaluation framework that is appropriate to the context of the 340B implementation. A mixed-methods approach is recommended for applying CFIR to the question of 340B policy impact on care delivery. Mixed methods strategies integrate qualitative and quantitative data from many sources to expand understanding of phenomena (Creswell JW et al., 2011). While the proposed design for evaluation is primarily retrospective, it will examine current phenomena and assess future projections from a range of stakeholders. The methods section opens with rationale, guided by CFIR, to focus the proposed evaluation at the regional level. Next, tables specify AIMS, evaluation questions, and data sources. I then describe the evaluation sequence. Next, I introduce the Western States Regional Hemophilia Network (WSRHN) as the site to test the proposed design s proof of concept. AIMs and evaluation question follow. For each evaluation question, I identify the respective CFIR constructs and subcategories to derive an answer, and articulate the methods, sampling plan, data sources, measures, variables, and analytic strategy. For each evaluation question section, I provide preliminary analyses form the Western State Regional Hemophilia Treatment Centers that can serve as a test of the feasibility of the proposed plan for evaluation, when data are available for this purpose. Chapter 3 ends with a description of data sources. CFIR Informs the Contextual Importance of HTC Regions: While the HTC is the chief unit of analysis, the regional level has contextual importance. Regional drivers are linked with all five CFIR domains. First, individual HTCs become eligible to purchase factor at 340B discounted prices only because they either directly or through subcontract - receive one of HRSA s regional comprehensive hemophilia care grants [CFIR construct Intervention]. Regional HTC leaders are responsible for fostering and monitoring comprehensive care and 31

45 340B programs in their catchment area [CFIR - Processes]. Collaboration is high among regional HTCs clinicians in research, clinical consultation on complex cases [CFIR Inner Setting], Executive Committee service, clinical and patient education, and policy advocacy [CFIR Inner and Outer Settings]. Furthermore, some of the newest HTC Directors received their hematology training in fellowship programs operated by senior level HTC Directors within their home region [CFIR Inner Setting], due to the dwindling number of such fellowship programs. All these structured opportunities for substantive interaction can deepen withinregion networking among HTC Directors, who, with HTC Nurse Coordinators, are key 340B decision makers [CFIR Individual Characteristics]. State health policy issues [CFIR Outer Context] regarding HTC access and factor sales further strengthen HTC Directors intraregional ties. These include patient insurance mix, Medicaid reimbursement rates, public and private insurance contracting for clinical care and/or factor dispensing, managed care market penetration, and the competition from commercial factor vendors. Figure 3 demonstrates the variation in patient insurance mix by HTC region for over 19,000 US residents with hemophilia who obtain care at the 130 HRSA supported HTCs. Figure 3: Percent Primary Insurance Coverage of Individuals with Hemophilia A and B obtaining care at Hemophilia Treatment Center by Region (I-X) and US Source: CDC Universal Data Collection, n = 19,025 unduplicated individuals obtaining care at 130 US Hemophilia Treatment Centers ; data reflects most recent HTC visit. For 1283 persons (6%), more than one insurance type was listed. https://www2a.cdc.gov/ncbddd/htcweb/udc_report/udc_report.asp accessed 08/23/13. 32

46 HTC Directors collaborate with counterparts nationwide on professional society committees, and research consortia. However, on balance, the decisions of individual HTC Directors regarding 340B adoption and implementation are hypothesized to be influenced more by intra-regional leadership and State policy, thus reinforcing the regional as an important focus for this design for evaluation. A 2012 change in the configuration of the HTC regions may pose implementation challenges to conducting the proposed evaluation as designed. In 2012, HRSA reduced the number of regions from 12 to 8, requiring the merger of 8 pairs of contiguous regions into four. HRSA s new regional configuration includes four regions that have been intact for over twenty plus years, and four regions that are adjusting to the new larger geographic areas. The merged regions add workload to the regional leadership, requiring them to develop new relationships with State Medicaid agencies and a new group of HTCs. Therefore, this reconfiguration may limit access to some archival records that are required for the proposed evaluation, triggering the need to adjust sampling plans and statistical analyses. However, because of the long standing regional leadership relationships, this challenge does not appear insurmountable. This regional focus is reflected in the AIMS and evaluation questions, shown in Table 4. Table 5 maps the CFIR concepts and subcategories to the AIMs and evaluation questions. 33

47 Table 4: AIMS and Evaluation Questions AIM 1: To examine and explain the patterns of 340B program adoption and implementation within HTC regions 1a. What has been the pattern of adoption and implementation of 340B programs by HTCs in each region? 1b. What organizational, financial and other dynamics influenced which Centers were early adopters, adopters, late adopters, non-adopters? 1c. Once a 340B program is operational, what have been the patterns of patient enrollment? 1d. What influenced the patterns of 340B patient enrollment across Centers? AIM 2: To assess the impact of adoption of 340B programs on HTC financial resources 2a. What were the levels and sources of funding for HTCs before they adopted the 340B program? 2b. How has 340B implementation changed HTC funding levels and sources? AIM 3: To assess the impact of adoption of 340B programs HTC capacity and services 3a. How are HTC patient clinical and demographic characteristics changing in each region? 3b. How have HTCs used 340B program income to change staffing and services? 3c. What are the determinants of variations in the use of 340B program income? 3d. What has been the patient experience of care before and after 340B program implementation? AIM 4 To project the implications of potential 340B program loss on HTC capacity and services 4a. How do stakeholders characterize the benefits of 340B? 4b. How do stakeholders characterize the implications of potential 340B loss on HTC capacity and services? Table 5: CFIR Concepts and subcategories Mapped to AIMs and Evaluation Questions AIM INTERVENTION OUTER CONTEXT INNER CONTEXT INDIVIDUAL PROCESSES Relative Patient Needs & Cosmopolitan External Policies Structure Network Climate Advantage Complexity Costs Resources Ready Knowledge & beliefs Engaging Executing 1A X X X X X X X X X X X X X 1B X X X X X X X X X X X X X 1C X X X X X X X X X X X X X 1D X X X X X X X X X X X X X 2A X X X 2B X X X X X X X X X X X 3A X X 3B X X X X X X X X 3C X 3D X X X X X 4A X X X X X X X X X X X 4B X X X X X X X X X 34

48 Data Sources: The plan for evaluation involves numerous existing and three newly developed data sources Data sources are summarized below in 6 and 7, and fully described at the end of this chapter. Table 6: Data Sources: Existing Existing Data Sources Factor Replacement Product (FRP) Report Synopsis Type of Data Level of Data Annual de-identified HTC level data on factor sales programs operated by HRSA HTC grant recipients that access 340B discount prices. # patients enrolled in HTC 340B Program: Medicaid/non-Medicaid $ Expended for Pharmacy Operations $ Program Income earned, net revenue spent for personnel, other, indirects Hemophilia Treatment Center and aggregated regionally Hemophilia Data Set Annual de-identified HTC level registry of genetic bleeding and clotting disorders Clinical: diagnoses, severity, comorbidities Demographic: gender, race/ethnicity age, Service utilization: diagnostic and annual comprehensive exams, PCP linkage, home therapy Mortality Hemophilia Treatment Center and aggregated regionally for annual report to HRSA and other federal/state stakeholders HRSA Comprehensive Hemophilia Care Grant: Notice of Award, Budget, Progress Report Annual: HRSA regional grant award level, budget and progress on goals and objectives $ Total regional award per project period $ HTC level HRSA grant budgets: Salary/benefits, supplies, equipment, travel, contractual, other Narrative progress on accomplishing HRSA goals/objectives including number of HTCs operating 340B programs. Notice of Award and progress report = regional Budget = Hemophilia Treatment Center and aggregated regionally Discretionary Grant Information System (DGIS) Programmatic and fiscal data on HRSA s 900 grantee agencies Grant budgets and expenditures Individuals served by age & gender Progress on HRSA performance objectives Program income National Medicaid 340B Technical Assistance Seminars HTC Patient Satisfaction Surveys CDC UDC Universal Data Collection Surveillance System to Monitor Hemophilia Complications Western States/Region IX Comprehensive Care Data Set 32 Annual de-identified programmatic and claims data Annual registrants and formal evaluations Periodic de-identified selfreport of HTC care. English/Spanish Prospective de-identified registry enrolling >27,000 patients at >130 HTCs Annual de-identified HTC level registry of genetic bleeding disorders Beneficiaries receiving factor, factor vendors, factor expenses by vendor type: 340B or commercial Participation by discipline and HTC Ratings of conference meeting objectives Team based care, visit time adequacy, knowledge of blood disorder, medication access, value, satisfaction Clinical, demographic, quality of life, joint range of motion measures, school/work absenteeism, health services utilization Modules on babies, females, inhibitors Longitudinal tracking of patients serially reenrolled Clinical: Inhibitors Demographic: Primary Insurance, Employment, Primary Language, Interpreter Needed Service utilization: diagnostic exams, Carrier testing State Region Region > 50%use collect uniform data Hemophilia Treatment Center, aggregated regionally and nationally Hemophilia Treatment Center and aggregated regionally for annual report to HRSA and other federal/state stakeholders 32 Region specific; several HTC regions have unique data sets 35

49 Table 7: Data Sources: New New Data Sources Synopsis Type of Data Level of Data Semi-structured Interview 340B adoption at HTCs Qualitative interview of stakeholders at HTCs and host institutions who planned and started 340B programs Questions and probes mapped to all five CFIR constructs and selected categories to elicit themes influencing 340B adoption and implementation trends Individual Semi Structured Interview Implications of potential 340B loss Qualitative interview of broad array of HTC and/or 340B stakeholders Questions and probed mapped to all five CFIR constructs and selected categories to elicit themes that characterize stakeholder heterogeneity in perception of 340B benefits and implications of potential loss of 340B Individual Revised Factor Replacement Product (FRP) Report Data Collection Form Annual de-identified HTC level data on factor sales programs operated by HRSA HTC grant recipients that access 340B discount prices. # patients enrolled in 340B by primary insurer = Medicaid and non- Medicaid $ program income expended for pharmacy operations $ net program income to support HTC and Regional staff ($, FTE, position x 340B and other funding source) $ net program income for HRSA grant related services x type HTC aggregated regionally Evaluation Sequence: The proposed evaluation should take place in three stages, based on data source. In the first stage the evaluator should obtain and conduct preliminary analyses of archival data. In the second stage, the evaluator should conduct the organizational survey. In the third stage the evaluator should conduct the qualitative stakeholder interviews. The rationale for this staging is as follows. Preliminary results from the archival data analyses may lead to refinements in both the organizational survey and the stakeholder interview guides. Similarly, preliminary results from the organizational survey analyses may lead to refinements in the stakeholder interview guide. Furthermore, conducting the organizational survey before the stakeholder interviews can reduce the risk of response bias among the small subset of stakeholders (to be interviewed for AIM 1) who also should be asked to complete the organizational survey. The interviews for AIMS 1 and 4 can occur contiguously for the subset of stakeholders participating in both. 36

50 Proposed Methodology: Using Preliminary Data from One HTC Region: In this design, we test the feasibility of several aspects of the proposed evaluation by conducting analyses from HTCs in the Western States Regional Hemophilia Network (WSRHN). In 2011, the WSRHN s fourteen HTCs cared for over 7000 people with genetic bleeding and clotting disorders throughout California, Hawaii, Nevada and the US Pacific (Appendix 1), representing about 13% of Americans with hemophilia. Table 8: Western States Regional Hemophilia Network: Organizational Characteristics HEMOPHILIA TREATMENT CENTER HOST INSTITUTION YEAR HRSA & CDC FUNDING HRSA CDC ACADEMIC AFFILIATION PATIENT POPULATION University of California Davis Yes Pediatric and Adult University of California San Francisco Yes Pediatric and Adult Children s Hospital Los Angeles Yes Pediatric and Adult Children s Hospital Oakland Yes Pediatric Orthopaedic Hospital Los Angeles Yes Adult Stanford University Yes Pediatric and Adult University of California, San Diego Yes Adult Center for Inherited Blood Disorders Yes Pediatric and Adult City of Hope Medical Center Yes Pediatric Rady Children s Hospital San Diego Yes Pediatric Hemophilia Treatment Center of Nevada No Pediatric and Adult Guam Comprehensive Hemophilia Care Program No Pediatric Children s Hospital Central California No Pediatric Kapiolani Medical Center Yes Pediatric The WSRHN is well suited to serve as the pilot to assess the feasibility of the evaluation for reasons both practical and innovative. Chief practical reasons are leadership stability and access to archival data, which facilitate entrée to 340B institutional history and archival documents. The current WSRHN Regional Director and Regional Coordinator have served in those roles since the 1990 s, spanning the life of the 340B program. Archival data available include the Hemophilia Data Set; Patient Satisfaction Surveys; Factor Replacement Product (FRP) Reports; HRSA Notice of Grant awards, progress reports and budgets; records from 340B Technical Assistance Seminars; and reports from the California Department of Health Service s Medicaid Pharmacy Policy Unit regarding 340B. Most field test data will be The HTC was based at Children s Hospital Orange County, in 2011 it became a not for profit freestanding community clinic. 37

51 aggregated regionally to adhere to anti-trust principals that prohibit disclosing individual HTC market share. HTC level data should be coded to remove organizational identifiers. This coding will be employed just for purposes of preliminary data in this document. Innovative characteristics justifying the choice of WSRHN for the field pilot are its novel series of regional 340B technical assistance seminars, California s Medicaid factor reimbursement method, high managed care market share, 34 the region s ethnically diverse minority majority demographics, and geographic span across the Pacific Ocean and International Date Line. The WSRHN is one of the largest, most diverse areas in the US. This poses distinct challenges for rare disorder innovation implementation and dissemination. California represents over 80% of the WSRHN s patient base, 35 and California health policies are often monitored and adapted by other States. Expanding the factor vendor market to HTCs, a potential driver of 340B adoption, was an intent of the California s Medicaid factor reimbursement rate policy change. 36 As payer mix and Medicaid factor reimbursement rates are hypothesized to influence 340B adoption and dissemination, the evaluator should conduct an analysis of the primary insurance in the field pilot region over time. The years 1994, 2002, and are proposed is the year closest to the passage of federal 340B legislation for which regional data are available, 2002 assess 340B trends one decade later; the three recent years give current trends. 34 In 2011, 42.9% of Californians were insured through managed care arrangements, the highest state HMO penetration rate in the US (vs. 22.5% USA). Source: Healthleaders, Inc., Special Data Request, June accessed June 5, WSRHN, Hemophilia Data Set Executive Summary compiled annually , unpublished. 36 California Welfare and Institution Code # enacted July 1,

52 Figure 4: Primary Insurance (%): Western States Regional Hemophilia Treatment Center Network Patients, 1994, 2002, The primary insurance patterns illustrate several trends. There is a growing reliance on two state programs that provide insurance coverage for Californians with catastrophic conditions California Children s Services (CCS) and Genetically Handicapped Persons Programs (GHPP): from 19% in 1994 to 25% in 2012 (average 20.2%). Primary reliance shifted from private to public insurance over the past decade. By 2012, individuals primarily insured by CCS, GHPP and/or Medicaid represented 51% of the WSRHN population. 37 Considering CCS/GHPP and Medicaid programs together is important for the design for HTC 340B program evaluation in this HTC region; in other regions, different characteristics may influence 340B adoption and implementation. All three programs use income as one eligibility criterion, so they have a high proportion of economically vulnerable beneficiaries. All three programs rely on public funding, so reducing the high cost of hemophilia care is a priority. Furthermore, CCS and GHPP use selected Medicaid policies notably clotting factor reimbursement rates. California s Medicaid reimbursement rates are among the lowest in the 37 This parallels Medicaid enrollment rates in the US HTC population enrolled in the CDC UDC Surveillance Project: of 7686 individuals with severe hemophilia A and 1425 with severe hemophilia B, 26% and 23% respectively were insured by straight (e.g. fee for service) Medicaid. https://www2a.cdc.gov/ncbddd/htcweb/udc_report/udc_view1.asp?para1=nation&para2=demoh&para3=&screenwidth=1920&screenheight=1080 accessed

53 US (Zuckerman et al., 2009). Collectively these issues support using the Western States as a real world test for the design for HTC 340B evaluation. AIM 1: To examine and explain the patterns of 340B adoption and implementation within HTC regions Starting a 340B program is not a random event. The selection elements that predispose which HTCs start 340B programs, when, and under what CFIR related inner and outer conditions need to be systematically examined in order to clarify the consequences of facilitating and hindering 340B adoption and implementation. Four Evaluation questions are posed to help address AIM 1. EVALUATION QUESTION AIM 1a: What has been the pattern of adoption of 340B programs by HTCs in each region? The 340B program has a twenty year history. HTCs were eligible from the start. The HTCs had a stable regional configuration throughout this time period fostering the availability of archival data. These structural elements permit a retrospective look of when HTCs began to adopt 340B. Plotting the timing of 340B start by region is a necessary first step to understand the changing and unchanging determinants of adoption patterns. The CFIR constructs and subcategories previously described underpin this question. To answer this first evaluation question, the evaluation should examine the time series (Campbell et al., 1963) of HTC 340B adoption. Evaluators should first plot the number and proportion HTCs that have started 340B programs by year, overall and by region, and then annotate the chart with key events that might have influenced individual HTCs to decide to adopt the program. The sampling plan is to include the entire population of HTCs within each region during the entire twenty year period ; this reduces selection and history bias. The data source is the HRSA Comprehensive Care Grant progress report. This report is currently available and retrievable depending on region. The measure is the time to adopt 40

54 340B. The unit of analysis should be the individual HTCs within a region. For this bivariate analysis, the independent variable X = year 340B started selling 340B priced factor; 38 the dependent variable Y = HTC identifier. The analysis is to display data as a regional time series map. An example of the type of display that would be useful in plotting trends is presented in Figure 5, for the Western States Regional Hemophilia Network. In this figure, O is placed in the column for each year that an HTC has a HRSA comprehensive hemophilia care grant, making the HTC an eligible 340B entity. For each year that an HTC operates a 340B program, an X is also placed in the cell. Figure 5: Hemophilia Treatment Centers Operating 340B Programs Western States Regional Hemophilia Network ` A O O O O O O O XO XO XO XO XO XO XO XO XO XO XO XO XO XO A B O O O O O O O O O XO XO XO XO XO XO XO XO XO XO XO XO B C O O O O O O O O O O XO XO XO XO XO XO XO XO XO XO XO C D O O O O O O O O O O O O XO XO XO XO XO XO XO XO XO D E O O O O O O O O O O O O XO XO XO XO XO XO XO XO XO E F O O O O O O O O O O O O O XO XO XO XO XO XO XO XO F G O O O O O O O O O O O O O XO XO XO XO XO XO XO XO G H O O O O O O O O O O O O O O XO XO XO XO XO XO XO H I O O O O O O O O O O O O O O O XO XO XO XO XO XO I J O O O O O O O O O O O O O O O O XO XO XO XO XO J K O O O O O O O O O O O O O O O O XO XO XO XO XO K L O O O O O O O O O O O O O O O O O O XO XO XO L M O O O O O O O O O O O O O O O O O O O O O M N O O O O O O O O O O O O O O O O O O O O O N Preliminary results of the evaluation efforts in the Western States HTC Region reveal four distinct phases. The time series map indicates a six year dearth phase ( ) when no HTC operated a pharmacy using 340B prices. Next was a five year early adopter period ( ) wherein three HTCs began 340B programs, raising the proportion of HTCs in this region that were operating a 340B program from 0% - 20%. In the five year cascade ( ) that followed, seven HTCs began 340B programs, bringing the proportion of HTCs operating a 340B program up to 71.4% by In nearly each of the cascade years, 38 Registration on the OPA website is a necessary precursor to selling outpatient drugs using 340B prices. It indicates that an entity is eligible to do and has successfully completed the registration process. But registration in itself is does not equate with the successful implementation of all the operational processes involved in drug sales. 41

55 340B became operation at one and sometimes two HTCs. One more HTC began a 340B program during the last, or late adopter phase ( ). By 2012, 340B was operational at twelve (85.7%) of the fourteen WSRHN HTCs. Furthermore, the map suggests 340B sustainability: once a 340B program started, it continued operating unabated. This time trend map of regional 340B adoption trends is useful: the metric provides a clear and comprehensive illustration and suggests that something(s) occurred to trigger the cascade period, warranting qualitative investigation via the next metric. HTC 340B adoption patterns likely vary by region, as an HTC 340B program is a complex intervention. Some regions may exhibit clusters of 340B adoption followed by seminal phenomena that appear to stimulate clusters of intermittent or steady adoption. A time series map spanning is thus a valuable first analytic step to obtain a regional 340B adoption and spread gestalt. To further address evaluation question 1a, the evaluator next should conduct multiple regression analyses with the year of adoption the dependent variable and characteristics of the Centers as explanatory variables to assess whether certain characteristics are associated with earlier or later adoption. The sample should include the entire population of HTCs within each region during the entire twenty year period The data sources are the CDC Universal Data Collection Surveillance (UDC) and the new organizational survey. The measure is the time to adopt 340B. Because early or late adoption may be influenced by both unchanging Center characteristics, such as type of institution that hosts an HTC (e.g. large academic medical center or small community hospital), and by historic events, such as changes in Medicaid payment policy, evaluators should use hazard models to model time to adoption with appropriate methods for incorporating time varying covariates into the model. The list of 42

56 variables to be included in the regression to reflect non-time varying differences in Centers and the historic events that should be coded as time varying covariates are listed in Table 9. Table 9: Multiple Regression Model: Time Varying and non-time Varying Covariates potentially influencing HTC 340B Adoption AIM 1a CFIR Construct Subcategory Intervention Relative Advantage Complexity Costs Outer Setting Patient needs/ resources External policy/incentives Inner Setting Time Varying Covariates % yes 340B can bring in resources to HTC % yes HTC clinical & admin staff and service sufficient to meet patient needs % Medicaid, % Uninsured % yes - Medicaid factor reimbursement rate is adequate Structural % HTC Director Tenure = <5 years, 5 10 years, 10> years % yes I consult with a knowledgeable Networks person in region about 340B % yes HTC too busy to make initiate Implementation Climate improvements % yes Human resources for 340B Readiness implementation is sufficient Individuals % yes 340B is valuable to HTC Processes % yes I consult with a knowledgeable person outside the region about 340B Engaging % yes attended >1 340B educational conference Non-Time Varying Covariates % yes have now or institution will provide sufficient resources to operate 340B program: line of credit, pharmacy, insurance authorization, billing, contracting with manufacturers and insurance, marketing, accounting % yes have sufficient $ for factor inventory % yes have separate refrigerator % Host institution academic medical center, community hospital, freestanding clinic % HTC patient base <100, , 300> EVALUATION QUESTION AIM 1b: What organizational, financial and other dynamics influenced which Hemophilia Treatment Centers were early adopters, adopters, late adopters, non-adopters? Implementation research increasingly reveals the influence of organizational determinants on innovation and health care quality (Fixsen et al., 2005; Flood, 1994). To understand the variation in timing and extent of implementation of 340B programs across HTCs, variations in organizational characteristics influencing adoption need to be studied 43

57 as part of the evaluation. The multivariate regression modeling described above will provide some insight into these issues but should be augmented with qualitative information that is more nuanced in capturing variations across the HTCs. The plan for evaluation should incorporate methods to capture financial information and other dynamics into the sampling plans, measures, data collection instruments and analyses. Definitions of adopter phases should be determined at the regional level, informed by local findings from the time series analyses. Organizational influences on 340B adoption should be assessed through examining data derived from a new organizational survey, new qualitative semi-structured interviews, and archival records from a 340B educational series. Organizational heterogeneity and changes over time: The evaluator should use a pre/post design to assess the range of organizational structures and processes, and how their change over time influences 340B adoption. The first time period should be the two years prior to HTC 340B adoption. The second time period should be current. The sampling plan should include all HTCs that operate a 340B program. The inclusion criterion for the adoption time period is the universe of regional HTC and host institution stakeholders directly engaged in HTC 340B planning and implementation. These comprise HTC Directors, Nurse Coordinators, and host institution officials from administration, finance, contracting, and pharmacy. As the 340B adoption could have occurred 20 years ago, sample attrition is a risk. Therefore, to identify the subset of sample members who have historic information about 340B adoption from the early 1990 s, the evaluator should solicit information from the Regional Directors and Coordinators (Coyne, 1997; Patton, 2005). The inclusion criteria for the current time period should be HTC Directors and host institution leaders with 340B decision making authority and operations responsibilities. 44

58 The evaluator should develop a new data source: an organizational survey that will provide more detailed and specific data about each HTC than is currently available from archived data. The evaluator should create this survey by identifying key domains and constructs, reliable and valid items and scales, by conducting cognitive interviews, and then pilot testing the instrument with representative respondents. The evaluator should consider adapting items and scales with demonstrated psychometric properties from surveys used by the Veterans Healthcare Administration (VA) to assess organizational structure and process predictors of innovation implementation. The VA surveys contain thirty common organizational structure and process characteristics (EM Yano, 2008). These characteristics represent size, academic affiliation, clinical service availability, leadership and authority, consultant availability, resource sufficiency, organizational climate, case mix, and staffing. See Appendix 2 for CFIR constructs mapped to organizational survey measures, variables, data sources and availability. The analysis should start with descriptive (univariate) statistics of the adoption and current time periods. The unit of analysis should be the individual HTCs, and analysis initially should be conducted region by region to allow patterns to be more easily observed. The evaluator should construct means and standard deviations for interval variables (e.g. FTE of HTC clinicians by discipline), percentages for nominal variables (e.g. institutional affiliation = academic medical center, community hospital or freestanding clinic), or ordinal variables (e.g. HTC Director Tenure = <5 years, 5 10 years, 10> years). Next, bivariate analyses should be conducted to examine changes in organizational characteristics over the two time periods: chisquare for categorical variables, and either t tests or Pearson s r for interval or ratio variables. Statistical tests should be conducted to determine statistically significant association between specific organizational characteristics and time of 340B adoption. The proposed dependent variable (Y) should be time (year) to HTC 340B program adoption. The proposed independent 45

59 variable (X) should be organizational characteristics. Preliminary information suggests this hypothesis: increased HTC Director tenure is associated with earlier 340B adoption. After the analysis of bivariate associations of individual variables with time to adoption, the evaluator should use appropriate multivariate methods to further analyze time to adoption. Because some of the variables that influence adoption vary over time, the evaluator should use hazard (time to event) models with time varying covariates. The variables that should be included in the model, non-time varying and time-varying, were identified in Table 9. Preliminary results of the evaluation effort for the organizational survey: As part of the field pilot, over ten key informants critiqued the first draft of the sampling plan, proposed topic areas, and measures. The informants include HTC Directors, Nurses, and Pharmacists; Regional Coordinators; National Hemophilia Foundation leadership; and HTC 340B experts -- their recommendations were incorporated. Qualitative semi-structured interviews: Data on the HTCs should also be collected through interviews of key parties, and semi-structured interviewing is recommended. Semistructured interviews foster understanding the how s and why s of phenomenon by listening to the actual actors involved, in their own words and observing non-verbals. (Coffey et al., 1996). The sampling plan should be identical to that described to conduct this evaluation question s organizational survey. This is a new data source. The evaluator should create an interview guide with questions and probes that are informed by CFIR constructs and subcategories relevant to organizational, financing, and other dynamics influencing HTC 340B program adoption. See Appendix 3 for a list of topic areas and illustrative questions mapped to the CFIR constructs, and Appendix 4 for the Interview Guide. The qualitative analytic methods should focus on identifying patterns. The evaluator should start with translating transcribed interviews 46

60 and non-verbals into analyzable data or codes whose content can be linked conceptually into patterns (Charmaz, 2006; Coffey et al., 1996; Saldaña, 2012). Preliminary results of the evaluation effort for the semi-structured interview: The same key informants discussed above critiqued the first iteration of the semi structured interview guide, and proposed sampling plan. Key informants judged the instruments contents comprehensive, and the burden level to be reasonable. Stakeholders recommended adding the commercial factor vendor sector into sampling plan, and refining selected measures, questions, and probes. Their recommendations were incorporated.. Patterns identified in the time trends chart also propelled modifications to the interview guide, reaffirming the benefits of the proposed sequence of first chart making then conducting semi-structured interviews. Preliminary results of the evaluation efforts: Data analysis from the preliminary design work to answer Evaluation Questions 1a and 1b were used to create this second run chart. It suggests that CFIR outer setting/policy dynamics, specifically a policy change in the California Medicaid factor reimbursement rate, and the execution of regional 340B Technical Assistance seminars influenced 340B adoption. 47

61 FIGURE 6: Timeline - HTC 340B Adoption and Spread Field Pilot, Western States Regional HTC Network, Educational Series: The evaluator should use a time series design to examine the influence of educational activities on 340B adoption. The evaluator should examine archival documents from regional 340B Technical Assistance seminars conducted to boost the knowledge and skills of HTC clinicians and host institutions about 340B legal, fiscal, and business operations. No sampling method should be used; the entire retrospective data set is available, based on region. The evaluator should use these data sources: seminar registration forms and formal post event evaluations. The measurements should be the proportion of each region s HTCs that attended the seminars, numbers of individuals who attended by discipline, and the total proportion of attenders reporting that the seminar provided valuable information. The unit of analysis should be the individual HTC. Bi-variate analyses should be conducted and arrayed as a table, with the independent variable X = HTC attendance and seminar value rating, and the dependent variable Y = year. Preliminary results of the evaluation effort follow. 48

62 Table 10: 340B Technical Assistance Seminars, Western States Regional Hemophilia Network, % HTCs Persons Attending MD Nurse Pharmacy Business Patient Leader State Health Dept. 39 % Rating Seminar as Valuable % % % % % % % % % % % % On average, 80% of the WSRHN HTCs sent representatives to each Seminar. The majority of the attenders were HTC Medical Directors, Nurses, Pharmacists, and, increasingly, business officials from finance, contracting, grants, purchasing, billing, and administration. California State Health Department leaders from Medicaid and the Children and Adults with Special Healthcare Needs Departments attended and presented as did from the patient support organization leaders. The formal evaluations document the seminars value. EVALUATION QUESTION AIM 1c: Once a 340B program is operational, what have been the patterns of patient enrollment? Stakeholders indicate that a 340B program needs to enroll a sufficient volume of HTC patients who have insurance that reimburses factor adequately. Adequate reimbursement for factor is needed to generate income that can then be used to build capacity and thereby serve more patients and expand services. Examining patterns of 340B patient enrollment contributes to the evaluation in various ways. It is the first step in assessing which CFIR constructs might influence growth barriers and facilitators. Answering this question also adds transparency to the HTC 340B landscape by revealing the HTC 340B factor market share. Stakeholders seek this transparency to address complaints that HTCs may be pressuring patients to enroll in 340B (The Lewin Group, 2012) = California Children s Medical Services; 2006 and 2008 = Medicaid Pharmacy Policy Unit 40 Including HTC Nurse and Administrator from neighboring region 49

63 The evaluator should use a time series design to examine the patterns of patient enrollment in 340B. The sampling plan should include the entire population of HTCs within each region. The evaluator should use two existing data sources which provide information on 340B enrollment, are national in scope, and can be aggregated at the individual HTC or regional levels. The data sources are: 1) The Factor Replacement Product (FRP) report and Hemophilia Data Set (HDS). Both data sets are currently available and retrievable depending on region. The measure is the proportion of HTC active patients diagnosed with hemophilia and VWD who are enrolled in 340B programs annually. There are two units of analysis: the individual HTC over time, and all HTCs within a region for each. In this bivariate analysis, the independent variable X = HRSA project period year and the dependent variable Y = proportion of people with hemophilia A & B, and VWD types 2 and 3 who are enrolled in 340B. The evaluator should include individuals with these disorders as their disease and/or severity dictates their consistent reliance on factor, making them most likely to be approached to enroll in a 340B program. Proportions are a better metric than raw numbers, particularly for rare disorders. Proportions provide context that a raw number (inherently small for rare disorders) does not. Moreover proportions are more comparable across units of measurement (e.g. HTC, region, or national). FRP data provide the numerator and HDS the denominator. These results give a regional average; changes should be calculated over time. Preliminary results of the evaluation efforts are portrayed in Figure 7. 50

64 Figure 7: Proportion of Western States Regional Hemophilia Center Patients with Hemophilia A & B, Von Willebrand Disease 2 & 3 Enrolled in HTC 340B program, FY 05/06 FY 11/12 41 The field pilot data suggest a pattern of slow and steady growth HTC 340B patient enrollment. Patient enrollment plateaued at 25% over the most recent four years; overall mean = 22% (entire seven years). These data provide evidence that HTC 340B programs do not dominate the factor vendor market in this region. EVALUATION QUESTION AIM 1d: What influenced the patterns of 340B patient enrollment across Hemophilia Treatment Centers? This evaluation question will assess determinants of patient enrollment in HTC 340B programs over time. This part of the evaluation plan will identify organizational characteristics and policy characteristics of states that are associated with patient volume in HTCs adopting 340B programs. This query is vital as the determinants that are associated with building and sustaining complex innovations may differ from the determinants that are associated with a complex innovations adoption. The evaluator should examine both CFIR Inner domain influences and CFIR Outer domain influences to answer this evaluation question. Inner - Organizational Influences: First, the evaluator should conduct a time series design to examine how organizational structure and process characteristics influence 340B 41 This HRSA project has a 12-month period starting June 1st. The Hemophilia Data Set is based on the calendar year. For this figure, the calendar year chosen to correspond to the HRSA project period is the earlier of the two years noted, e.g. CY 2005 corresponds to FY 05/06. 51

65 patient enrollment patterns over time. Stakeholders indicate that having sufficient and knowledgeable staff capacity dedicated to 340B operations is associated with 340B patient enrollment growth. The sampling plan should include the entire universe of HTCs operating 340B programs. The data source used should be the organizational survey to assess HTC host institution structures and processes. The measures and variables are in Appendix 2. The HTC is the unit of analysis. The analytic plan and preliminary results of the evaluation effort to create the organizational survey measures and variables were previously described. Outer - Policy Influence: Similarly, the evaluator should use a time series design to examine the influence of CFIR Outer/Policy constructs, namely insurance, on HTC 340B patient enrollment patterns. The high rates of Medicaid as primary insurer in the hemophilia population and the adequacy of Medicaid reimbursement rates are hypothesized to influence 340B growth. Medicaid is a proxy for area poverty, another important predictor of adoption and implementation. Furthermore, archival reports in the field pilot site document that inadequate Medicaid factor reimbursement rates in California drove some commercial factor vendors out of the market, and stymied HTC 340B adoption. 42 The sampling plan should include the entire universe of HTCs that operate a 340B program. The data source is the Factor Replacement Product (FRP) report. The measures should be numbers and proportions of patients enrolled in 340B by primary insurance = Medicaid, non-medicaid, and total. The HTC should be the unit of analysis. The independent variable X should be the numbers (or proportions) of patients enrolled in 340B by Medicaid/non-Medicaid. The dependent variable Y should be year for FY 05/06 FY 11/12. Those are the years in which uniform data is available nationally. Preliminary results of the evaluation effort (at the regional level) follow. 42 Tucker Alan Consultants, Inc. Report to State of California on Medicaid Factor Reimbursement rates, Unpublished Report,

66 Figure 8: Number of Patients Enrolled in 340B Program at Western States Hemophilia Treatment Centers by Primary Insurance as Medicaid or Non-Medicaid, FY 05/06 FY 11/12 These preliminary results reveal increases in HTC 340B patient enrollment in every year except one. 43 Enrollment nearly doubled over the seven year period. It rose to a peak of 624 individuals in twelve 340B programs in FY 11/12. Average annual patient 340B enrollment was 470 persons. Enrollment among patients primarily insured by Medicaid outpaced patients with other insurance coverage. Figure 9: Patients Enrolled in 340B Program at Western States Hemophilia Treatment Centers by Proportion of Primary Insurance as Medicaid or Non-Medicaid, FY 05/06 FY 11/12 43 Three of the time periods do not reflect a 12 -month period. FY 05/06 reflects 14 months and FY 06/07 represents 10 months, due to a change in the HRSA grant project period. FY 10/11 reflects 10 months due a change in the regional WSRHN grant. 53

67 These preliminary results reveal two patterns. The first is an increase in the proportion of patients primarily insured by Medicaid: from a low of 42% in FY 05/06 to a high of 64% in FY 11/12. Outer Incentives: Next the evaluator should use a time series design to examine other CFIR Outer Incentive influences on HTC 340B patient enrollment. Specifically the evaluator should assess market competition for dispensing outpatient factor concentrate, specifically to individuals primarily insured by Medicaid. The sampling plan should include all individuals with hemophilia A and B who are insured by Medicaid and who received a prescription for factor concentrate. The data sources should be State Health Department Medicaid claims and its contracted specialty pharmacy vendor website. The measures should be factor vendor market competition, potential Medicaid 340B enrollment, and 340B Medicaid Market share. For the pilot site, the independent variables X should be State fiscal years 02/03 10/11, a time period both pre/post California changed its factor reimbursement rate. The dependent variable Y should be the numbers of Medicaid Factor Vendors (total and 340B), number of Medicaid beneficiaries receiving factor, percent of total claims paid to HTC 340B programs, percent of total Medicaid factor dollars reimbursed to HTC 340B programs. Data should be analyzed using descriptive statistics, with State as unit of analysis. Preliminary results of the evaluation effort are below. Table 11: California Fee for Service Medicaid Factor Vendors, Californians Receiving Factor, Proportion of Factor Claims and Reimbursement attributable to HTC 340B Programs, FY 02/03 - FY 11/12 02/03 03/04 04/05 05/06 06/07 07/08 08/09 09/10 10/11 # Factor Vendors (340B + non-340b) NA NA # 340B Programs # Medicaid Beneficiaries receiving factor NA NA NA NA B as % of Total Factor Claims 6% 2% 6% 15% 17% NA 16% 22% 22% 340B as % of Total Medicaid Factor Dollars Reimbursed 3% 5% 9% 15% 19% NA 26% 20% 20% 54

68 Preliminary results of the evaluation effort illuminate several patterns. These data corroborate the Medicaid insured 340B enrollment trends in the FRP reports. The 80% commercial factor vendor market share of Medicaid factor claims and dollars reimbursed provides further evidence that HTC 340B programs are a minority player in California s Medicaid factor vendor market. Commercial factor vendors operating in California consistently outnumber the State s HTC 340B programs by about 5 to 1. The proportion of 340B programs receiving total factor claims doubled from 04/05 to 05/06, reinforcing the influence of California s 2004 Medicaid factor concentrate reimbursement rate change on HTC 340B adoption. One of the explicit policy objectives of that rate change was to expand the types of factor vendor choices available to beneficiaries. HTC host institutions vacated the Medicaid factor vendor market due to poor reimbursement. Historically, the reimbursement rate for factor for Californians insured by Medicaid, set in the 1970 s, was acquisition cost plus 1%. Over time, this rate posed problems, including the near complete withdrawal of HTCs and their host institutions from the factor vendor business by the early 1990 s. Commercial factor vendors also left the market. A Health Department commissioned study recommended alternative factor reimbursement methods (Tucker, 1996). The State enacted a new rate July 1, 2004: a ceiling of average sales price plus 20% (for commercial factor vendors) and acquisition price plus 20% for 340B vendors. 44 Qualitative Design Element : A semi-structured qualitative interview with stakeholders should be the final design element for evaluation question 1d. The evaluator should sample the entire universe of HTCs operating 340B programs. The data source should be the semistructured qualitative interview with Stakeholders. Questions and probes in the interview guide should elicit Stakeholder understanding about what influences patient enrollment into HTC 340B 44 Medi-Cal Reimbursement for Anti-hemophilic Blood Factors, California Regulatory Notice Register, Office of Administrative Law, July 9, 2004, page 933; and California Welfare and Institution Code ,

69 programs. The analytic techniques were previously described. The preliminary results of the evaluation effort for the qualitative semi-structured interview sampling plan and interview protocol were outlined in section 1b. AIM 2: To assess the impact of adoption of 340B programs on Hemophilia Treatment Center financial resources. Stakeholders want to know how much income HTCs derive from 340B programs, how that varies by Center, how the income generated is used, how that varies and why, confirming this an important evaluation question (Kelley, 2009; OIG, 2003; The Lewin Group, 2012). EVALUATION QUESTION AIM 2a: What were the levels and sources of funding for the Hemophilia Treatment Centers prior to their adoption of the 340B program? The evaluator should use a pre/post design to evaluate quantitative changes in the levels and sources of funding for the HTCs before and after 340B adoption once data for both evaluation questions are collected. The evaluator should obtain both quantitative and qualitative data, necessitating different designs. To obtain historic and new data on funding sources and levels, the sampling plan should involve the entire universe of HTCs operating 340B programs. The evaluator should use both existing and new data sources. Quantitative design element archival data sources: The existing data sources should include archival records of HTC funding levels and sources: HTC budgets, clinic billings, grant notices of award, and the HRSA Discretionary Grant Information System (DGIS). The evaluator should measure dollars and proportion by source for HTC operations (e.g. staff, benefits, consultants, travel, supplies, equipment, space, other) both pre and post 340B adoption: The HTC is the unit of analysis; this should also be aggregated regionally and nationally. The evaluator should first conduct bivariate analyses by funding source to portray trends. Evaluators should array total revenues in dollars for an individual (coded) HTC using these 56

70 explanatory variables: Institutional Support, Clinic Billings, and Federal Grants (HRSA, CDC, Research, Other). Year pre 340B adoption should be arrayed as the dependent variable. Quantitative design element new organizational survey: The new data source that the evaluator should use is the organizational survey, previously described. The organizational survey structure and process measures are identified in Appendix 2. The evaluator should conduct a multiple regression to assess whether certain characteristics are associated with greater or lesser levels of funding, by source, pre-340b adoption. The evaluator should model funding levels and the proportion of funds from each payment source as dependent variables. The model should include a time trend variable, such as year, organizational, and other variables that might shift the level of funding (intercept), and how these variables interacted with the time trend to capture their influence on the overall trend or interruption of the trend due to specific events occurring over time. Individual indicator (dummy) variables for specific events like the adoption of the 340B program should be included in the models as main effects and interacted with the time trend variable to capture the impact of specific events, notably the 340B program but others as well, on the levels of spending and other dependent measures. It is hypothesized that greater or lesser levels and sources of pre-340b adoption funding may be influenced by both unchanging Center features, such as type of institution that hosts an HTC (e.g. large academic medical center or small community hospital), and by changing characteristics, such as HTC size, 45 age and HTC Director tenure. The list of explanatory variables that should be included in the regression were shown in Table 9 for Evaluation Question 1a. HTC is the unit of analysis; data should also be aggregated regionally and nationally. Data on levels and sources of funding from clinic billings, other grants and institutional support are available and retrievable, depending upon the individual HTC. 45 One unpublished assessment suggests that HTC size may influence 340B adoption: nearly 90% of the largest HTCs and 75% of midsize HTCs operated 340B programs in 2009, compared to 28% of the smallest HTCs (p=0.0001).characteristics of a National Healthcare Delivery Network: US Hemophilia Treatment Centers, Unpublished data. 57

71 Qualitative design element semi-structured interviews: The evaluator should conduct semi-structured interviews to gain a deeper understanding of levels and sources of HTC funding pre-340b adoption. The evaluator should sample the entire universe of HTCs operating 340B programs. The data source should be the semi-structured qualitative interview with Stakeholders. Questions and probes in the interview guide should elicit Stakeholder understanding about the levels and sources of funding pre-340b adoption. The analytic techniques were previously described. The preliminary results of the evaluation effort for the semi-structured interview sampling plan and protocol were outlined in evaluation question 1b. Preliminary results of evaluation efforts to answer evaluation question 2a will be presented together with preliminary results for evaluation question 2b to illustrate changes in both the levels and sources of funding pre/post 340B implementation. EVALUATION QUESTION AIM 2b: How has the presence of a 340B program changed the source and volume of funding for the Centers? The plan to answer this question builds upon the design elements proposed to answer Evaluation Question 2a. The design for the quantitative elements are pre/post. Evaluation 2a will examine the pre data, and Evaluation 2b the post data. The evaluator should use the samples and data sources for both 2a and 2b. The evaluator should conduct bivariate analyses using dollars pre and post 340B as the explanatory variables and changes in the proportions of revenue by source as the dependent variable. The pre-340b period should be one to two years prior to 340B adoption. The post period should be each year starting from 340B adoption based on the fiscal year of the host institution. The evaluator should adjust for inflation so the pre 340B dollars from a 1995 adopter will be equivalent to the pre 340B dollars of a 2005 adopter. The unit of analysis is the HTC. To account for differences in scale across Centers, the evaluator should stratify by size of enrollment in 340B program. 58

72 Preliminary Results of Evaluation Efforts for AIMS 2A and 2B: Shell Table 12 illustrates how data could be arrayed to assess changes in HTC funding sources and levels before and after implementing a 340B program. Table 12: Evaluation Question 2a and 2b Shell Table Changes in Hemophilia Treatment Center Funding Sources and Levels of Pre/Post 340B Implementation, Year XX to Year YY Pre 340B Post 340B % Change $ % $ % $ % Institutional Support Clinic Billings Grants HRSA CDC Other 340B 0 0 TOTAL Time trends from this evaluation element should be used to assess whether 340b has been an add-on or has replaced other funding sources. Figure 10: HRSA Comprehensive Hemophilia Treatment Center Grant Funding Levels, US Law Passed During this 18-year period, total HRSA grant funds to the 12 HTC regions ranged from $2.6 million in 1982 plateauing at a high of 6.8 million in 1992, dropping to $4 million in Sources: For data , Maternal and Child Health Bureau, Health Resources and Services Administration, US Department of Health and Human Services: Summary of Federal Appropriations for MCHB Bureau Program, (unpublished), February For data HRSA Discretionary Grant Information System. For 2012 data: February 2011 HRSA Presentation to Regional Hemophilia Treatment Center Leadership. 59

73 Table 13: HRSA Hemophilia Treatment Center Grantees: Federal Comprehensive Care Grant Award, Program Income, and Other Funding Sources, US HRSA Comprehensive Hemophilia Care Grant Award Program Income Generated by Hemophilia Treatment Centers 47 Other 48 Total 2007 $5,287,294 $28,068,647 $7,289,568 $40,645,509 13% 69.1% 18.0% 100% 2008 $5,233,096 $47,028,133 $10,803,516 $63,064, % 74.6% 17.2% 100% 2009 $4,951,554 $41,487,263 $613,565 $47,052, % 88.2% 1.3% 100% 2010 $4,859,848 $37,966,096 $45,868 $42,871, % 88.6% 0.1% 100% 2011 $6,825,555 $21,001,677 $1,799,322 $29,626, % 70.9% 6.1% 100% From , the HRSA Comprehensive Hemophilia Care grant award represented 13% of HTC funding sources (range 8% - 23%), and program income represented 78.3% (range 69 89%). In 2011, when approximately 90 HTCs operated a 340B program, the mean program income per HTC was $233,000. In contrast, the mean HRSA grant award for each of the 130 HTCs was $53,000. A visual display of the HRSA grant award versus program income is below. Figure 11: HRSA Hemophilia Treatment Center Grantees: Federal Comprehensive Care Grant Award vs. Program Income in Millions HTCs generate the majority of program income of all 900 HRSA grantees. For example, in 2009 HTCs generated over 90% of the $42.4 million reported as program income; most likely derived from factor sales using 340B prices 48 Other = Unobligated funds, local, State and Applicant funds. Source: HRSA Discretionary Grant Information System (DGIS). https://mchdata.hrsa.gov/dgisreports/financial/financialreports.aspx?report=fedfundbyprogram Accessed 06/30/

74 Figure 12: HRSA Comprehensive Care Grant Award, Western States Regional Hemophilia Network, in Thousands Figure 12 reveals flat HRSA hemophilia grant funding levels awarded to the Western States pilot, declining 30% from Figure 13: 340B Net Program Income Generated, Western States Regional HTC Network, FY 05/06 FY 11/ B net program income in the Western States HTC region grew steadily. A total of $60.7 million was generated over the seven project periods ($8.7 million average). The number of HTCs operating 340B programs nearly doubled over this time period, from 7 in FY 05/06 to 12 in FY 11/ The reporting periods for FY 07/08 09/10 and 11/12 reflect 12 month periods. FY 06/07 and 10/11 were each 10 month periods and FY 05/06 was a 14 month period. Deviations from a 12 month project period in the two earlier timeframes were due to administrative changes HRSA imposed on all US HTC Comprehensive Care grantees. The FY 10/11 foreshortened period is associated with a change in the WSRHN grantee institution. 61

75 AIM 3: To assess the impact of adoption of 340B programs HTC capacity and services. Congress deemed the intent of the 340B program as stretching scarce federal resources to all eligible covered entities to serve more patients and expand services. Therefore, this aim should be essential to the plan for evaluation. EVALUATION QUESTION AIM 3a: How are HTC patient clinical and demographic characteristics changing in each region? Patient clinical and demographic trends: Understanding patient clinical and demographic trends should be the evaluator s first step in assessing whether program revenues are directed at building or maintaining staff capacity and services to address emerging patient needs. To answer this question, the evaluator should conduct to conduct bivariate analyses to assess changes over time in selected clinical and demographic characteristics. The sample should be the entire universe of HTC patients by region. The data source should be the Hemophilia Data Set. The demographic measures should be age, gender, race/ethnicity; the clinical measures should be diagnosis and severity (mild, moderate, severe for hemophilia and Types 1, 2, or 3 for Von Willebrand Disease). The evaluation should measure changes in the patient populations treated in HTCs in the following categories: gender (male, female), age (<13, 13-21, >21), ethnicity (White, Black, Hispanic, Asian, and Other), diagnosis (Hemophilia, VWD, Other factor deficiency), and age <13 by ethnicity. Change over time should be tested in each category using repeated measure ANOVA. The years 1997, 2002, 2010, and 2011 refer to specific historic events represents the first full year after the availability of the effective HIV antiretroviral therapies benchmarks the ten year anniversary of the 340B law s enactment [and, for the pilot, two years the California Medicaid factor reimbursement rate change] and 2011 offer recent trends. Next, bivariate analyses should be conducted to examine changes in patient clinical and 62

76 demographic characteristics over the time periods. The HTC is the unit of analysis with data aggregated at the regional level. Preliminary Results of Evaluation Efforts: HTC population clinical and demographic trends in the pilot Western States Regional Hemophilia Network (WSRHN) characterize growth, diversity and emerging needs of subgroups. These data should inform the next step of the plan for evaluation: to examine how 340B revenues align with changes in HTC staff capacity and services to meet patient needs. Figure 14: WSRHN Active Bleeding Disorder Patients: Total and Female 1997, 2002, During these years, the WSRHN s served a growing and more ethnically and geographically diverse patient population, suggesting fulfillment HRSA priorities to expand access to vulnerable populations and 340B intent to serve more patients. The growth is likely associated with these historic events: decline in HIV mortality among infected patients due to use of HAART, and establishing HTCs in Hawaii, Guam, Nevada and underserved areas of California. 63

77 Figure 15: WSRHN Bleeding Disorder Patients by Diagnosis 1997, 2002, The number of patients with VWD at WSRHN HTCs grew over 200% from 1997 to VWD patients now nearly rival those with Hemophilia FVIII deficiency. These data would support using 340B program income to meet the comprehensive care needs of all populations, particularly addressing unique needs of VWD patients. Figure 16: WSRHN Bleeding Disorder Patients by Age 1997, 2002, 2010, 2011 From 1997 to 2011, patients aged rose by over 240%, children <13 years rose nearly 70% and adults by 51%. These data would support using 340B program income particularly for the comprehensive care needs of patients age

78 Figure 17: WSRHN Bleeding Disorder Patients - % Patients by Race/Ethnicity, 1997, 2002, 2010, 2011 Figure 17 illustrates that after 2002 the WSRHN patient population became a minority majority. These data would support using 340B program income to meet the comprehensive care needs of this region s Hispanic HTC populations. Figure 18: WSRHN Bleeding Disorder Patients - % Patients age <13 by Race / Ethnicity, 1997, 2002, 2010, 2011 These data indicate growth in the pediatric Hispanic population, and support using 340B program income to meet the needs of Hispanic families with young children. EVALUATION QUESTION AIM 3b: How have HTCs used 340B program income to change staffing and services? This aim is essential to the design for evaluation as it addresses another 340B program purpose: to provide more comprehensive services. Stakeholders call for 65

79 this information to be transparent to monitor that the 340B program is being implemented per Congressional intent. The levels of program income and shares of expenses used for direct costs should be examined over time, using pre/post comparison, with both absolute levels and the percent year to year change examined. The sampling plan should include the universe of HTCs that operate a 340B program. For the retrospective assessment, the data source should be the FRP report 06/07 FY 10/11 (Appendix 5); these years will allow for uniform data collection nationwide. The measures should be net program income expended over time. The dependent variables should be net program income in dollars expended for HTC staff, other, indirect costs, and total. The unit of analysis should be the HTC and aggregated at the region and nation levels. Bivariate analyses should be conducted. Preliminary results of the evaluation efforts for AIM 3b are below. Figure 19: 340B Net Program Income Used to Expand Staff Capacity and Services, Western States Regional HTC Network, FY 05/06 FY 11/12 50 Net program income expenditures to expand staff capacity and services grew as the numbers of HTCs starting 340B programs rose, from $2.6 million in FY 06/07 to a $12 million in 50 The reporting periods for FY 07/08 09/10 and 11/12 reflect 12 month periods. FY 06/07 and 10/11 were each 10 month periods and FY 05/06 was a 14 month period. Deviations from a 12 month project period in the two earlier timeframes were due to administrative changes HRSA imposed on all US HTC Comprehensive Care grantees. The FY 10/11 foreshortened period is associated with a change in the WSRHN grantee institution. 66

80 FY 11/12. Most net program income was spent to support HTC staff salaries and benefits, followed by supporting other services, and for indirect costs. Data are available but not easily retrievable to discern further details on HTC staffing and services. Proportional use of net program income is depicted in the Figure 20. Figure 20: Proportional Use of HTC 340B Net Program Income: Western States Regional Hemophilia Network, 05/06 11/12 On average, 53.6% of net program income was used to support HTC staff salaries and benefits (range 30% - 64%) and 23.7 supported other services (range 15% - 37%). Net program income spent on indirects fell from 38% in FY 05/06 to 11% in FY 11/12 (mean 20.1%). For the prospective assessment of net program income expenditures, the evaluator should use the same sampling plan: all HTCs operating a 340B program. The data source should be a proposed revised FRP report (Appendix 6). Regional HTC leadership are currently revising the FRP form. The revised report s measures will enable a detailed evaluation of HTC staff by discipline and comprehensive care services supported by 340B program income. For the analysis, the change over time will first be examined graphically, by plotting key data about HTC finances and operation first against calendar year, and second, against years prior to or since 340B adoption. The data series to be analyzed include: total program income, percent costs for direct expenses, salaries for staff, service volumes (e.g. patient programs, staff education, outreach, professional services; clinic operations, regional network services). The 67

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