Regional Meeting Southeast May 20th 2013 Sean Singh Vice President

Mission The Hemophilia Alliance provides member Hemophilia Treatment Centers with resources and services to sustain the Comprehensive Care Model for individuals with bleeding and clotting disorders We are successful when our member Hemophilia Treatment Centers can effectively provide their full range of services to all individuals with bleeding and clotting disorders. Vision www.hemoalliance.org info@hemoalliance.org

Who is the Hemophilia Alliance and what do we do? Program Income Compliance Audits How can we help? www.hemoalliance.org info@hemoalliance.org

Who is the Hemophilia Alliance? Non-Profit Member Organization established in 1999 92 members (103 registered 340B programs) All regions represented www.hemoalliance.org info@hemoalliance.org

What does the Alliance do? The Hemophilia Alliance provides member Hemophilia Treatment Centers with resources and services to sustain the Comprehensive Care Model for individuals with bleeding and clotting disorders Government and Legal Support Payer Support 340B support Advocacy Medicaid Consultant Manufacturer Relationships Community Support - Grants www.hemoalliance.org info@hemoalliance.org

Regional Structure New England Northern States MidAtlantic Southeast Great Lakes Northern States Great Plains Mountain States Western States

Southeast Region Members Georgia Hemophilia of Georgia, Inc. Florida All Children's Hospital Hemophilia Treatment Center Miami Comprehensive Hemophilia Center - Pediatrics Nemours Children's Clinic University of South Florida - Adult North Carolina University of North Carolina at Chapel Hill Kentucky Brown Cancer Center University of Kentucky Hemophilia Treatment Center Tennessee St. Jude Children's Research Hospital Vanderbilt University Medical Center www.hemoalliance.org info@hemoalliance.org

Southeast Region NON-Members Florida St. Joseph's Children's Hospital North Carolina East Carolina University Wake Forest University School of Medicine South Carolina Palmetto Health Richland Alabama Children's Rehabilitation Services www.hemoalliance.org info@hemoalliance.org

Southeast Region Funded Programs WITHOUT 340B Programs Alabama University of Alabama Birmingham Medical Center Mississippi University of Mississippi Medical Center Clinic for Bleeding and Clotting Disorders Kentucky Norton Kosair Children's Medical Center Tennessee East Tennessee Comprehensive Hemophilia Center University of Tennessee - Memphis www.hemoalliance.org info@hemoalliance.org

Program Income Who is the Hemophilia Alliance and what do we do? Compliance Audits How can we help? www.hemoalliance.org info@hemoalliance.org

What Revenue of HTC is Included? It is the position of HRSA that any and all revenue earned by the HTC is considered program income It is considered “earned as a result” of the award and sub award Fees collected by the HTC for services, camps, physical therapy, social therapy, and other programs for women and children Medicaid and Medicare payments Private Insurance payments 340B and non-340B revenue from Factor www.hemoalliance.org info@hemoalliance.org

How is Program Income Restricted May only be spent on: Patient Care Education Supportive services necessary to provide comprehensive care to patients Stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services H.R. Rep. No. 102-384, at p. 12 (1992) Further eligible project and program objectives www.hemoalliance.org info@hemoalliance.org

How is Program Income to be Used? ADDITIVE: HRSA allows HTCs to add the program income to the amount included in the award and sub award 45 CFR 74.24(b)(1): (a) The standards set forth in this section shall be used to account for program income related to projects financed in whole or in part with Federal funds. (b) Except as provided below in paragraph (h) of this section, program income earned during the project period shall be retained by the recipient and, in accordance with the terms and conditions of the award, shall be used in one or more of the following ways: (1) Added to funds committed to the project or program, and used to further eligible project or program objectives; www.hemoalliance.org info@hemoalliance.org

How is Program Income to be Used? WHAT DOES IT MEAN to commit to the project or program, and use to further eligible project or program objectives? More specifically, what is to be considered relevant to patient health, education, and supportive services necessary to provide comprehensive care to patients served by the HTCs HRSA-12-133, p. 24. www.hemoalliance.org info@hemoalliance.org

How May Program Income be Used? Bleeding and Clotting Disorders: Hemophilia, VWD, Thrombophilia Staff Salary (MD, RN, SW….) Programs to educate patients Social services Physical therapy Nutrition and exercise programs Children’s camps Women’s and men’s programs Dental services Factor programs and Contract Pharmacies Rent Renovations valued less than $150,000 www.hemoalliance.org info@hemoalliance.org

How May Program Income be Used? Training Local travel HTC indirect costs (no limit of 8%) Federally negotiated indirect cost rate Administrative Costs of Hosting institution allocable to HTC, reasonable, allowable under the applicable cost principles Must be COST based Facilities and Administrative costs of medical school directly allocable to hosting HTC Provision of Factor to low-income, uninsured, underinsured Research if approved by HRSA Foreign travel if approved by HRSA www.hemoalliance.org info@hemoalliance.org

Are There Exceptions? HTCs would like program guidance on commonly questioned areas: Patient Assistance Patient Travel Assistance- PPACA / OIG Report Travel to International Hemophilia Meetings Research on disease, treatment, and patient outcomes Allocable, allowable, reasonable costs of hosting institution Can patients bring their own factor products when in hospital or rehabilitation center? Can hospitals use Program Income to offset inpatient costs/loss? www.hemoalliance.org info@hemoalliance.org

Compliance Who is the Hemophilia Alliance and what do we do? Program Income Compliance Audits How can we help? www.hemoalliance.org info@hemoalliance.org

Covered Entity Responsibilities All information in 340B program database is complete, accurate, and correct Late July/Early August 340B program eligibility requirements have been met since listed Compliance with all 340B requirements and restrictions Diversion and duplicate discounts Maintenance of auditable records demonstrating compliance Systems and mechanisms are in place to reasonably ensure ongoing compliance OPA is contacted as soon as possible if there is a material breach by the CE CE’s with inaccurate or outdated information risk removal Source Presentation by LCDR Joshua Hardin, Recertification Manager www.hemoalliance.org info@hemoalliance.org

Covered Entity Responsibilities Recertification – update information on OPA website Eligibility requirements met Ensure contract pharmacy agreements comply with Federal Register Notice Need policies and procedures for 340B Compliance Need policies and procedures as recipient/subrecipient Need to be able to retrieve required reports and documents Appoint Compliance Officer Policies to identify errors – resolve with manufacturer or State Medicaid – self report to OPA Seek safe harbor with HHS OIG – after counsel consult www.hemoalliance.org info@hemoalliance.org

Covered Entity Responsibilities HTC Prime Recipient and Subrecipients that generate program income from all sources of revenue Is it spent in accordance with the terms of the grant? Reportable net program income is to be used for patient health, education, and supportive services necessary to provide comprehensive care to patients served by the HTCs Written policy on program income www.hemoalliance.org info@hemoalliance.org

Audits Who is the Hemophilia Alliance and what do we do? Program Income Compliance Audits How can we help? www.hemoalliance.org info@hemoalliance.org

HRSA Right to Audit AUDITING. A covered entity shall permit the Secretary and the manufacturer of a covered outpatient drug that is subject to an agreement under this subsection with the entity (acting in accordance with procedures established by the Secretary relating to the number, duration, and scope of audits) to audit at the Secretary’s or the manufacturer’s expense the records of the entity that directly pertain to the entity’s compliance with the requirements described in subparagraphs (A) or (B) with respect to drugs of the manufacturer. 42 USC 256b(a)(5)(C) www.hemoalliance.org info@hemoalliance.org

HRSA 340B Audit Focus “Duplicate Discounts” - manufacturers are prohibited to pay discounts or rebates under both the 340B Program and the Medicaid Drug Rebate Program [42 USC 256b(a)(5)] “Diversion” – resale of 340B drugs to a person who is not a patient of the entity is prohibited [42 USC 256b(a)(5)] Patient Definition Guidelines (61 Fed Reg 55156) Established relationship with patient and maintains records Individual receives health care services from health care professional employed, contracted, or other arrangements Person receives a health care service consistent with grant ftp://ftp.hrsa.gov/bphc/pdf/opa/FR10241996.htm www.hemoalliance.org info@hemoalliance.org

HRSA 340B Audit Focus Program Income generated – tracked, reported, restricted Policies and Procedures as recipient/subrecipient Financial Management Standards and internal controls Property Standards Procurement Standards Recordkeeping requirements Financial (SF 425) and Performance Reports Policies and Procedures to assure no diversion Patient records, tracking deliveries, utilization Policies and Procedures to assure no duplicate discount www.hemoalliance.org info@hemoalliance.org

How can we help? Who is the Hemophilia Alliance and what do we do? Program Income Compliance Audits How can we help? www.hemoalliance.org info@hemoalliance.org

GPO Exclusion HTC’S ACCESS TO THE HEMOPHILIA ALLIANCE GROUP PURCHASING ORGANIZATION CONTRACTS There has been some confusion regarding Hemophilia Treatment Centers’ (HTC) use of The Hemophilia Alliance’s group purchasing contracts since the recent release of HRSA 340B Drug Pricing Program Notice Release No. 2013-1 dated February 7, 2013, and its implementation. The covered entities restricted by law from the use of a group purchasing organization include disproportionate share hospitals, children’s hospitals, and freestanding cancer hospitals enrolled in the 340B Program. 42 USC § 256b(a)(4)(L)(iii) states that in order to participate in the 340B Program, these entities may not “obtain covered outpatient drugs through a group purchasing organization or other group purchasing arrangement.” www.hemoalliance.org info@hemoalliance.org

GPO Exclusion If the HTC is registered as a covered entity with Office of Pharmacy Affairs (OPA) with an “HM” designation, the HTC may use the Alliance group purchasing organization and participate in its contracts.  It is simultaneously possible for a disproportionate share hospital, children’s hospital, or cancer hospital that hosts the HTC to also be separately registered with OPA with its own identifying designation.  The hospitals may not access the Alliance Group Purchasing contracts through the HTC, or both may face sanctions.  In no circumstances may the HTC’s permitted use of a group purchasing organization be used to circumvent the GPO prohibition for a hospital and its outpatient clinics. www.hemoalliance.org info@hemoalliance.org

GPO Exclusion There is one additional way in which an HTC may access a group purchasing organization without possessing an HM designation.  If an HTC is: an off-site outpatient facility of a hospital subject to the GPO prohibition, but is not registered for the 340B program as a child site of a hospital, located at a separate address from the hospital, purchasing drugs from a separate pharmacy or wholesaler than the 340B participating parent, and the hospital maintains records demonstrating that any covered outpatient drugs purchased through the group purchasing organization of the HTC or otherwise transferred to the parent hospital or outpatient clinic.  OPA has posted this information at  http://www.hrsa.gov/opa/faqs/#gpo1/.  The GPO Policy Release is available to you at:  http://www.hrsa.gov/opa/index.html.  If you have any questions, please contact the Hemophilia Alliance at info@hemoalliance.org. www.hemoalliance.org info@hemoalliance.org

Reinvesting into the community $1.4 million in grants through 2012 In 2013 $500,000 to the Hemophilia Alliance Foundation (www.hemophiliaalliancefoundation.org) $400,000 to ATHN www.hemoalliance.org info@hemoalliance.org

Contact us for any help. www.hemoalliance.org info@hemoalliance.org

Thank You Sean@Hemoalliance.org Office: (727) 388-7326 Contact Details: Sean@Hemoalliance.org Office: (727) 388-7326 www.hemoalliance.org info@hemoalliance.org