1. Regional Meeting Southeast May 20th 2013 Sean Singh Vice President

2. 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

3. Who is the Hemophilia Alliance and what do we do?
Program Income
Compliance
Audits
How can we help?

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

5. 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

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

7. 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

8. 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

9. 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

10. Program Income Who is the Hemophilia Alliance and what do we do?
Compliance
Audits
How can we help?

11. 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

12. 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 , at p. 12 (1992)
Further eligible project and program objectives

13. 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;

14. 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 , p. 24.

15. 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

16. 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

17. 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?

18. Compliance Who is the Hemophilia Alliance and what do we do?
Program Income
Compliance
Audits
How can we help?

19. 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

20. 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

21. 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

22. Audits Who is the Hemophilia Alliance and what do we do?
Program Income
Compliance
Audits
How can we help?

23. 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)

24. 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/FR htm

25. 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

26. How can we help? Who is the Hemophilia Alliance and what do we do?
Program Income
Compliance
Audits
How can we help?

27. 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 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.”

28. 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.

29. 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   The GPO Policy Release is available to you at:  If you have any questions, please contact the Hemophilia Alliance at

30. Reinvesting into the community
$1.4 million in grants through 2012
In 2013
$500,000 to the Hemophilia Alliance Foundation (
$400,000 to ATHN

31. Contact us for any help.

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