OPTN Charter & Bylaws Proposal September 5, 2003

1. OPTN Charter & Bylaws Proposal September 5, 2003

2. Why Develop anOPTN Charter & Bylaws? • OPTN Contract Requires Board of Directors to Develop a Charter & Bylaws Specific to the OPTN & Separate from UNOS’ Articles of Incorporation & Bylaws. • Must Conform with Requirements under NOTA, the OPTN Final Rule, and the OPTN Contract.

3. Major Differences between UNOS & OPTN Bylaws - Transplant Hospital Membership • UNOS Bylaws Require that a Transplant Program within a Member Hospital: • Be Active and Meet Training/Experience Criteria for the Program’s Primary Transplant Physician & Surgeon, • Meet Criteria for Facility and Ancillary Service Support, and • Participate in Assessment of the Program’s Transplant Survival Outcomes. • OPTN Bylaws are Consistent with Final Rule Provisions, Reflecting Participation in Medicare/Medicaid as Criteria for Transplant Hospital Membership.

4. Major Differences between UNOS & OPTN Bylaws – Transplant Hospital Membership • OPTN Bylaws Define Hospital Membership Separately from Ability of Individual Organ-Specific Programs within a Member Institution to Perform Transplants. • To Perform Transplants, a Program must (1) be part of a Member Hospital, and (2) Qualify as a Designated Transplant Program, which includes the following Criteria: • Approved as Participating Medicare Transplant Program for Particular Organ, or • Part of a Federal Hospital, or • Meets Qualifications Defined in the Bylaws, including Requirements for Remaining Active & Primary Physician and Surgeon Requirements • OPTN Bylaws Define Physician & Surgeon Requirements Generally, Allowing Flexibility in Modifying Specifics over Time.

5. Major Differences between UNOS & OPTN Bylaws – Transplant Hospital Membership • OPTN Bylaws Continue a Role for the OPTN in Some Level of Oversight over Survival Rates, Changes in Key Personnel, & Status of Centers as Active or Inactive • Degree of Oversight and Authority to Act in the Event of Non-Compliance is Different Depending upon whether Transplant Program Qualifies to Receive Organs by (i) Medicare Participation or Location within a Federal Hospital, or (ii) OPTN Requirements.

6. Major Differences between UNOS & OPTN Bylaws – OPO Membership • UNOS Bylaws Require that OPOs be Independent Organizations, Serve Active Transplant Hospital(s), and Meet Enumerated Criteria based upon CMS Criteria for OPOs. • OPTN Bylaws are Consistent with Final Rule Provisions, Reflecting Designation by Secretary as Criteria for OPO Membership. • OPTN Bylaws Continue a Role for the OPTN in Some Level of Oversight over Organ Allocation, Changes in Key Personnel, & Review of Organ Donation Education Activities • Degree of Oversight and Authority to Act in the Event of Non-Compliance is Different for Organ Allocation versus other Types of Actions.

7. Major Differences between UNOS & OPTN Bylaws – Histocompatibility Laboratory Membership • UNOS and OPTN Bylaws Require Histocompatibility Laboratory Members to be Independent, Active Organizations and Establish Requirements/Standards for Personnel, Facilities, & Testing • OPTN Bylaws Define Major Elements of the Criteria Generally, Allowing Flexibility in Modifying Specifics over Time. • OPTN Bylaws Define Voting Privileges through Elected Histocompatibility Laboratory Member Electors (as further Described Later in Presentation).

8. Major Differences between UNOS & OPTN Bylaws – Other Organization & Individual Membership • UNOS Bylaws Include 3 Categories of “Public Members:” • Private, Non-Profit Voluntary Health Organizations Significantly Engaged on a National Scale in Promoting Organ Donation or Support or Service Activities to Transplant Recipients, Patients, or Family Members. Limited to 12 Total Members. • Private, Non-Profit Medical or Scientific Membership Organizations Interregional or National in Scope with Members involved in Organ Transplantation. Limited to 36 Total Members.

9. Major Differences between UNOS & OPTN Bylaws – Other Organization & Individual Membership • Individuals Representative of the General Public. Limited to 12 Total Members. • OPTN Bylaws Establish Parameters for Defining Organizations & Individuals with a Demonstrated Interest in the Fields of Organ Donation or Transplantation.

10. Major Differences between UNOS & OPTN Bylaws – Other Organization & Individual Membership • Other Organization Membership • OPTN Bylaws are Similar to Current Criteria for Private, Non-Profit Voluntary Health Organizations & Private, Non-Profit Medical or Scientific Membership Organizations without Limit on the Number Serving in this Capacity • Includes an Expanded Criterion for Organizations Supported by Letters of Recommendation from at Least 3 other Organizations, Each of which Meets Criteria for Membership • Includes a further Expanded Criterion for Donor Hospitals that Participate in Medicare/Medicaid, both For-Profit and Non-Profit • Voting Privileges are Defined through Elected Public Organization or Medical/Scientific Member Electors, as Applicable • Criterion regarding “National in Scope” Removed - Members are Assigned Voting Privileges only if They are Interregional or National in Scope.

11. Major Differences between UNOS & OPTN Bylaws – Other Organization & Individual Membership • Business Members • New Member Category, including, for example, Pharmaceutical Companies or other Entities that Engage in Business Activities with Transplant Hospitals, OPOs, or Histocompatibility Laboratories • No Voting Privileges (as further Described Later in Presentation).

12. Major Differences between UNOS & OPTN Bylaws – Other Organization & Individual Membership • Individual Members • OPTN Bylaws Refine Current Criteria for Individual Public Members • Former & Current Board/Committee Members • Transplant Candidates & Recipients, Donors, & Family Members • Former & Current Employees of Institutional Members and Former Employees of Government Agencies Involved in Organ Donation & Transplantation • Individuals Supported by Letters of Recommendation from at Least 3 Persons, Each of whom Meets Criteria for Membership. • OPTN Bylaws Eliminate Limit on the Number Serving in this Capacity • Voting Privileges are Defined through Elected Individual Member Electors (as further Described Later in Presentation).

13. Major Differences between UNOS & OPTN Bylaws – Membership Voting • OPTN Bylaws Retain Concept of Single Votes for Single Categories of Interest • Transplant Hospitals Limited to One Vote Regardless of Number of Transplant Programs Maintained or Patients Served • OPOs must be Independent from the Transplant Hospital(s) They Serve • Histocompatibility Laboratories must be Independent from the Transplant Hospital(s) They Serve • Voting Privileges are Defined through 33 Elected Histocompatibility Laboratory Member Electors (Each with One Vote).

14. Major Differences between UNOS & OPTN Bylaws – Membership Voting • Medical/Scientific Members (as a Class) Represented by 24 Medical/Scientific Member Electors (Each with One Vote) • Public Organization Members (as a Class) Represented by 12 Public Organization Member Electors (Each with One Vote) • Business Members Have No Vote • Individual Members (as a Class) Represented by 12 Individual Member Electors (Each with One Vote). • Mechanism Provided for Possible Expansion of Number of Member Electors for Each Membership Group Represented by Member Electors

15. Member Voting (Summary)Slide 1 of 3

16. Member Voting (Summary)Slide 2 of 3

17. Member Voting (Summary Footnotes)Slide 3 of 3 • Under OPTN Bylaws, a Transplant Hospital must have Received Approval as a Designated Transplant Program for at Least 1 Organ to Vote on OPTN Affairs. • Under UNOS Bylaws, an OPO must be Independent of the Transplant Hospitals it serves, which Must include 2 or More Transplant Hospitals, to Vote on OPTN Affairs. • Under UNOS Bylaws, a Histocompatibility Laboratory Must be Independent of the Transplant Hospitals it Serves, which Must Include 2 or more Transplant Hospitals, to Vote on OPTN Affairs.

18. Policy Development &Enforcement Options • Under UNOS Bylaws all Policies are Voluntary. • OPTN Bylaws Establish Protocol for Policies to become Mandatory • Recommended as Mandatory by the OPTN/UNOS Board of Directors & Approved as Such by the Secretary of DHHS • Otherwise, Policy Remains Voluntary.

19. Policy Development &Enforcement Options • Nature of the Policy (e.g., Approved by Secretary or not Approved by Secretary) Influences Degree of Enforcement Possible • Sanctions That May Be Applied for the Violation of Voluntary or Mandatory Policies, Without Approval from the Secretary of DHHS. Secretary Would Be Notified • Warning, Letter of Admonition, or Letter of Reprimand • Probation • Member Not in Good Standing

20. Policy Development &Enforcement Options • Additional Sanctions That May Be Applied Only for the Violation of Mandatory Policies: • Suspension of Member Privileges • Termination of OPTN Membership • Termination of Status as Designated Transplant Program, Termination of Participation in Medicare/Medicaid, Termination of Reimbursement under Medicare/Medicaid • These Three Additional Sanctions May Be Recommended by the Board of Directors But May Be Imposed Only by the Secretary of DHHS.

21. Amending OPTN Charter or Bylaws • Process • Effective upon Approval of Majority Vote of Board of Directors • Board of Directors Vote would be Preceded by Public Comment Period when Determined to be Standard Procedure or otherwise Appropriate • Board of Directors Vote would be Followed by Consideration by and Vote of the OPTN Membership, with Prospective Effect Only.