Joe didn t I tell you that Dan was never, ever to present at our meetings? didn t invite him I thought you did!

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2 Joe didn t I tell you that Dan was never, ever to present at our meetings? Sean Er, huh I didn t invite him I thought you did!

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4 Does this depict how you are all feeling after lunch and during afternoon presentations?

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6 Nine Years and Counting UNC Hemophilia Treatment Center Pharmacy The Hemophilia Alliance Fall Meeting Seattle, WA September 20 th, 2016

7 1 ST ANNUAL NC HEMOPHILIA TREATMENT CENTER SUMMIT June 7 th, 2016 Chapel Hill, North Carolina

8 WELCOME & INTRODUCTIONS East Carolina University Darla Liles, MD Arlette Whitaker, RN Becky Gardner Charmaine Bond, SW Todd Jackson, PharmD Brett Erwin, MPH Wake Forest University Health System Katharine Batt, MD Natalia Dixon, MD Anita Smith, PFNP Rhonda Blackwell Gavin Magaha, PharmD

9 WELCOME & INTRODUCTIONS UNC-Chapel Hillsity of North Carolina Nigel Key, MD Gail Van Name, RN Christine Hill Dan Dalton, MS, RPh Linda Raftery Ryan Terrell Hemophilia of Georgia Ruth Brown

10 TODAY S AGENDA Review of Hemophilia Treatment Centers Review of UNC Hemophilia Treatment Center Pharmacy Overview of pharmacy services 340B compliance & audits Hemophilia Alliance & various service providers Product review Payers and changes ahead Use of program income Questions & Answers Goals

11 HEMOPHILIA TREATMENT CENTERS Hemophilia Treatment Centers (HTC) Launched as an National Hemophilia Foundation (NHF) campaign in Congress authorizes nationwide network, initially 25 centers around the country Grant funded by Maternal Child Health Bureau (MCHB) under the US Health Services and Resources Administration (HRSA) 1987 Centers for Disease Control (CDC) provides funding due to HIV crisis 1995 CDC administration questions need to continue funding since HIV is now a non-issue

12 HEMOPHILIA TREATMENT CENTERS CDC continued grant funding for surveillance of joint disease, secondary complications, protecting the blood supply from potential threats Between 2000 and 2010, some hospitals began regarding HTCs as losses, with some saying their centers had to close Approximately $4,900, grant funding per year/142 HTCs = ~ $34, annually per HTC Program income from sale of 340B factor product can be reinvested into the HTC model

13 HEMOPHILIA TREATMENT CENTERS Have been the model for the delivery of integrated, multi-disciplinary, comprehensive care for nearly four decades MASAC (Medical and Scientific Advisory Council) has established seven core team members and seven extended core team members Core Team Program coordinator Hemophilia nurse coordinator Medical director Physical therapist Psychosocial professional Case manager Secretary Extended Core Team Coagulation lab director Pharmacist Dentist Genetics counselor Orthopedist OB/GYN Infectious disease/nutritionists Recommendations/Standards-and-Criteria-for-the-Care-of-Persons-with-Congenital-Bleeding-Disorders

14 COVERED ENTITIES HRSA OPA website ( Covered entities HM covered entity dates Covered Entity 340B ID Start Date UNC HM December 1 st, 1992 WFUHS HM January 1 st, 2009 ECU HM October 1 st, 2012

15 COVERED ENTITIES & 340B ELIGIBILITY Covered Entity Pharmacy Start Dates University of North Carolina HM /01/1992 February 18, 2008 Wake Forest University Health Systems HM /01/2009 East Carolina University HM /01/2012

16 COVERED ENTITIES & 340B ELIGIBILITY Covered Entity Pharmacy Start Dates University of North Carolina HM /01/1992 February 18, 2008 Wake Forest University Health Systems HM /01/2009 October 4, 2012 East Carolina University HM /01/2012 July 1, 2013

17 UNC HEMOPHILIA TREATMENT CENTER PHARMACY Space was identified and renovations were taken to prepare the future pharmacy space June 2007 Hemophilia of Georgia dispensed factor for UNC s first patient and Financial Shared Services submitted the claim to BCBS of NC Program manager was hired part-time October 15, 2007, full-time December 1, 2007

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21 UNC HEMOPHILIA TREATMENT CENTER PHARMACY NC Board of Pharmacy Limited Services permit issued February 18, 2008 Change of status submitted to OPA Discontinue contract pharmacy services under Hemophilia of Georgia Initiate in-house pharmacy services -UNC Hemophilia Treatment Center Pharmacy First patient serviced under UNC HTC Pharmacy May, 2008 (NC Medicaid) Hemophilia of Georgia provided insurance verification, claims submission and claims resolution throughout the remainder of 2008 Reimbursement services brought in-house January of 2009 Insurance claims were submitted on paper claims BCBS claims were entered on-line via Blue E-portal

22 UNC HEMOPHILIA TREATMENT CENTER PHARMACY CPR+ software and computer hardware were acquired All claims (major medical, pharmacy point of sale) are submitted electronically Contract pharmacy services WFUHS earliest start date 10/04/2012 ECU earliest start date 07/01/2013 Accreditation Specialty Pharmacy ACHC URAC Physical relocation of center & pharmacy Nov/Dec 2015

23 PHARMACY STAFF Dan Dalton Marshall Bowden Cherlona Walston Kathy Cooper Christine Hill

24 PHARMACY SERVICES Ordering, receiving, dispensing factor & medical supplies Shipping (using temperature controlled packaging) with tracking FedEx Priority overnight Courier (same day if needed) Nursing coordination as needed Reimbursement Major medical claims Pharmacy claims 340B compliance Attaining & maintaining compliance with accreditation standards

25 Nursing services Background Role within the UNC HTC Pharmacy OUTPATIENT NURSING COORDINATION Outpatient nursing coordination Assessing patient needs extension of HTC teaching/training Teaching (patient, caregiver, contract nursing agencies) Administration Line care Reimbursement for nursing services Referral Nursing agency bills payer Bundled Letters of agreement

26 REIMBURSEMENT Insurance Verification & eligibility Major medical benefits Pharmacy benefits Claim submission Electronic Paper Claims resolution Posting transactions Accounts receivables

27 FINANCIAL WAIVER Patients unable to pay their co-pay, co-insurance, etc., are eligible for consideration of a financial waiver Financial waiver application is provided Patient/caregiver must complete and return to pharmacy for review and approval Determinations are based upon systematic evaluation tied to federal poverty guidelines

28 MANUFACTURER ASSISTANCE PROGRAMS Manufacturer Co-pay Assistance programs Applicable only to patients covered with commercial insurance Government insurance programs (Medicare & Medicaid)are not eligible Co-pay assistance programs worth ~ $12,000 annually: Co-pays Out-of-pocket/deductibles Hospital charges Office charges Trial programs Compassionate care programs

29 SPECIALTY PHARMACY ACCREDITATION Accreditation for Health Care Commission (ACHC) 3 year period expires January 16, 2017 Utilization Review Commission for Accreditation (URAC) 3 year period expires February 1, 2019

30 340B COMPLIANCE Policies & procedures Separation of inventories Duplicate discounts Drug diversion Cannot give away expired product Self-audits Contract pharmacy audits Official HRSA audits

31 Diary entry, March 2015 just began family vacation and no sooner than we start to relax at the beach and put our feet up I receive s from our partners at Wake Forest Baptist Medical Center and East Carolina University

32 NOTIFICATION OF OFFICIAL HRSA AUDIT WFUHS & ECU notified of official HRSA audits - mid-march 2015 Partners and contract pharmacy provider begin preparation Checklist of essential elements 340B compliance policies & procedures HRSA OPA official documents and memorandums NC Medicaid memorandums & supporting documentation Data collection and organization

33 HRSA AUDIT PREPARATION Data collection & organization Prescriptions with assigned Rx numbers Packing lists signed, dated & ID d as PHS Inventory Pharmacy computer work orders drug description, NDC, assay, quantity & total units Delivery confirmations FedEx & signed delivery tickets Systematic organization (spreadsheets, scanned documents) Covered entities upload data sets per request of HRSA auditor prior to on-site audits

34 HRSA ON-SITE AUDITS & VISITS June 23 rd - Wake Forest University Health System audit of HM covered entity June 24 th UNC Hemophilia Treatment Center Pharmacy site visit of contract pharmacy June 25 th East Carolina University audit of HM covered entity

35 35 HRSA AUDIT FINDINGS Covered Entity 340B ID State Findings Sanction Corrective Action with Audit Closure Date East Carolina University Wake Forest University Health Systems HM27384 NC No adverse findings HM27157 NC No adverse findings None None NA: Audit closure date 08/18/2015 NA: Audit closure date 08/07/2015

36 From: Jackson, Jeffrey Todd Sent: Wednesday, August 19, :05 AM To: Fadul, Nada A; Poole, Wayne; Witherington, Mitzi; Fuh, Beng; Gardner, Becky; Elnabtity, Manal; Howard, Melinda; Erwin, Brett; Liles, Darla; Dalton, Danny R Cc: Jowers, Brian; Benson, Nicholas H; Cunningham, Paul R G Subject: HRSA Reflection Most of you have had an opportunity to review the HRSA audit results and I hope you reflected upon the great job everyone did to attain this including yourself! This is the result of a remarkable team effort across many boundaries and demonstrates that patient care requires a team of dedicated individuals which we have. Many thanks and kudos to you all for the job you do in caring for the patients we serve! Sincerely, TJ J. Todd Jackson, PharmD Director, ECU Pharmacy Services East Carolina Brody School of Medicine

37 CVS CAREMARK AUDIT March 18, Baptist Hospital Specialty Pharmacy receives notification that CVS/Caremark will conduct an onsite audit of claims paid on April 12, 2016 April 6, UNC HTC Pharmacy is notified of pending audit Rx numbers listed on the audit document do not match any numbers generated by the UNC HTC Pharmacy Rx numbers of each claim have been reassigned by CVS/Caremark after submission of major medical claims to Aetna by UNC HTC pharmacy UNC analyzes data provided by WFUHS, matches line for line of each prescription dispensed and assembles supporting documentation

38 CVS CAREMARK AUDIT Supporting documents are retrieved & assembled in a systemic manner Prescriptions issued by provider with Rx numbers assigned by UNC HTC Pharmacy Confirmation of delivery (FedEx tracking notifications) Pharmacy work orders (signed and dated) detailing: Drug description National Drug Code (NDC) Units per vial Quantity of vials Total units 2 patients, 12 prescriptions, 45 dispensations, 45 delivery confirmations & 45 pharmacy work orders Entire packet is scanned and sent via secure 48 hours later

39 From: Brenda Chaney Sent: Tuesday, April 12, :29 PM To: Dalton, Dan Subject: CVS/Caremark Audit Dan, Just wanted to thank you and your team for all you re assistance in gathering the documentation. Our audit lasted for 30 minutes with 100% compliance. YEAH! Thank you again. Thanks, Brenda * Drug costs associated with these claims > 1.3 million dollars*

40 THE HEMOPHILIA ALLIANCE Staff Consultants Board of Directors Services Webinars

41 THE ALLIANCE PHARMACY Wholesale distribution Amicar Stimate trial program Contract Pharmacy To date, TAP is the only contract pharmacy listed for the UNC Hemophilia Treatment Center Pharmacy

42 NORTH CAROLINA MEDICAID Before January 31, 2012 Medicaid Carve-out Implications 340B products would have to be passed through at actual acquisition Reimbursement would be actual acquisition cost plus pharmacy dispensing fee Non-340B and 340B products were maintained as separate inventories Non-340B product billed to NC Medicaid 340B product billed to commercial insurers NC Medicaid seeks manufacturer drug rebates

43 NORTH CAROLINA MEDICAID After January 31, 2012 The NC Medicaid Hemophilia Specialty Pharmacy program & NC Medicaid 340B Hemophilia Specialty Pharmacy program go into effect Reimbursement rates for home care pharmacy providers were lowered modestly NC Medicaid allowed an enhanced dispensing fee for 340B factor products Requirements to participate in these programs include, but are not limited to: Initial and annual on-site assessments Quarterly reporting of data to CCNC Accreditation (either JCAHO, ACHC, or URAC)

44 John Stancil, Jr., RPh Director of Pharmacy & Ancillary Services North Carolina Department of Health and Human Services Division of Medical Assistance Jennifer Murray, PharmD, CGP Myers and Stauffer Michael Sharp, RPh SharpRx Pharmaceutical Consultation Services

45 BLUE CROSS BLUE SHIELD OF NC Before January 1, 2016 most factor claims were billed under the medical benefit After January 1, BCBS of NC transferred the processing of medical claims to the pharmacy benefit for many, but not all of its insurance plans Impact of these changes Different reimbursement rates Different co-payments BCBS NC Specialty Pharmacy Network Plans not impacted by this change include but at not limited to: BCBS Federal BCBS out of state Medicare Advantage Plans

46 MEDICARE Medicare allowable = upper limit or maximum reimbursable Medicare reimburses at 80% of allowable Medicare with secondary payers Medicaid Aetna UHC Tricare Not allowed in network for primary coverage, however, as a secondary may pay the remaining 20%

47 NEW PRODUCTS BENEFITS & CHALLENGES Evolution of factor concentrate products Plasma-derived products Recombinant products Prolonged half-life products Compliance Costs Reimbursement

48 SPECIALTY PHARMACY MARKET GROWTH Fastest-growing pharmacy segment - over 300 medications classified as specialty pharmaceuticals The costs associated with specialty pharmaceuticals are expected to escalate, as medications become more focused and personalized Estimates predict that by the year 2018, 8 of the top 10 medications will be specialty pharmaceuticals The growing cost of specialty pharmacy is it sustainable? Am J Manage Care. Available at: Published February 18, 2013; The 2013 Drug Trend Report. Express Scripts: The Lab Web site. Available at: file:///c:/users/lmangione.asim/downloads/express%20scripts%202013%20drug%20trend%20report.pdf. Published April 2014; Available from: Evaluate Pharma World View. Evaluate Ltd Web site. Available at: aspx.

49 2014 SPECIALTY PHARMACY DATA Commercial health plans spent 13% more per member in 2014 vs 2013 Driven by a 31% increase in spending for specialty drugs Specialty drugs were 1% of prescriptions but represented 31% of total drug spend (in 2014) Express Scripts 2014 Drug Trend Report.

50 SPECIALTY DRUGS - FROM MEDICAL TO PHARMACY BENEFIT Comparisons are easier when medications are on the same benefit. Elimination of traditional buy and bill Using NDC code instead of J-Code Pharmacy management cost controls come into play Prior authorization Utilization review Preferred networks Tiered pricing, etc Hybrid models Wehrwein P. Should specialty drugs be shifted from medical to pharmacy benefit? Managed Care Magazine. January Available at: Accessed April 9,2015.

51 CHALLENGES & OPPORTUNITIES Centers for Medicare and Medicaid Services (CMS) Impact on Medicaid Impact on Medicare Part B Pharmacy Benefit Managers (PBM) Express Scripts Caremark Reimbursement models in general Pressures within and outside the HCS (Accredo & various contract Rx models) Novel therapies

52 CHALLENGES & OPPORTUNITIES Relationships NC Medicaid BCBS of NC Aetna Accreditation Data driven outcomes Collaboration with our HCS in North Carolina 4 th HTC in North Carolina??

53 PROGRAM INCOME Definition of program income Use of program income

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