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OPTN Charter & Bylaws Proposal September 5, 2003 PowerPoint Presentation
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OPTN Charter & Bylaws Proposal September 5, 2003 - PowerPoint PPT Presentation


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OPTN Charter & Bylaws Proposal September 5, 2003. Why Develop an OPTN Charter & Bylaws?. OPTN Contract Requires Board of Directors to Develop a Charter & Bylaws Specific to the OPTN & Separate from UNOS’ Articles of Incorporation & Bylaws.

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why develop an optn charter bylaws
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.
major differences between unos optn bylaws transplant hospital membership
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.
major differences between unos optn bylaws transplant hospital membership1
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.
major differences between unos optn bylaws transplant hospital membership2
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.
major differences between unos optn bylaws opo membership
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.
major differences between unos optn bylaws histocompatibility laboratory membership
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).
major differences between unos optn bylaws other organization individual membership
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.
major differences between unos optn bylaws other organization individual membership1
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.
major differences between unos optn bylaws other organization individual membership2
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.
major differences between unos optn bylaws other organization individual membership3
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).
major differences between unos optn bylaws other organization individual membership4
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).
major differences between unos optn bylaws membership voting
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).
major differences between unos optn bylaws membership voting1
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
member voting summary footnotes slide 3 of 3
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.
policy development enforcement options
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.
policy development enforcement options1
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
policy development enforcement options2
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.
amending optn charter or bylaws
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.