ADMINISTRATIVE CODE

TITLE 77: PUBLIC HEALTH
CHAPTER XII: EXPERIMENTAL ORGAN TRANSPLANTATION PROCEDURES BOARD
SUBCHAPTER a: EXPERIMENTAL ORGAN TRANSPLANTATION PROGRAM
PART 2800 TRANSPLANTATION PROGRAM

SUBPART A: DEFINITIONS

Section 2800.101 Definitions

Section 2800.102 Approved Transplantation Procedures

SUBPART B: APPLICATION REQUIREMENTS

Section 2800.201 Applications

Section 2800.202 Patient Information

Section 2800.203 Institutional Information

SUBPART C: APPROVAL OF ESTABLISHED PROGRAM

Section 2800.301 Determination of Established Program

SUBPART D: RECOMMENDATION FOR FUNDING

Section 2800.401 Determination of Funding

SUBPART E: EMERGENCY APPROVAL PROCEDURES

Section 2800.501 Emergency Approval Procedures

Section 2800.APPENDIX A Verification of Organ Transplantation Diagnosis and Legal Domicile

Section 2800.APPENDIX B Addendum I - Patient/Graft Survival Rates

Section 2800.APPENDIX C Addendum II - Facility Experience

Section 2800.APPENDIX D Experimental Organ Transplantation Program

SUBPART A: DEFINITIONS

TITLE 77: PUBLIC HEALTH
CHAPTER XII: EXPERIMENTAL ORGAN TRANSPLANTATION PROCEDURES BOARD
SUBCHAPTER a: EXPERIMENTAL ORGAN TRANSPLANTATION PROGRAM
PART 2800 TRANSPLANTATION PROGRAM
SECTION 2800.101 DEFINITIONS

Section 2800.101 Definitions

As used in this Part; the terms defined herein have the meanings ascribed to them in this Section:

"Act" refers to the Experimental Organ Transplantation Procedures Act (Ill. Rev. Stat. 1987, ch. 111½, par. 6601 et seq.).

"Board" refers to the Experimental Organ Transplantation Procedures Board and staff of the Department of Public Health assigned to the Experimental Organ Transplantation Procedures Program.

"Experimental" refers to those transplantation procedures for both single and multiple organs which are determined to be clinically viable and useful for the prolongation of life or vital functions by the majority of the Board and are not reimbursable by Medicare.

"Health insurance" refers to individual and group insurance, as defined in Ill. Rev. Stat. 1987, ch. 73, par. 616; health maintenance organizations (HMO's) as defined in the Ill. Rev. Stat. 1987, ch. 111½, par. 1402; recipients of the Illinois Department of Public Aid's Medical Assistance Program or Medicare coverage through the U.S. Department of Health and Human Services and those covered under the Civilian Health and Medical Program of the Armed Services (CHAMPUS) and those covered under any Federal, State or local government medical assistance programs (Section 4(b) of the Act) are also considered to have health insurance under the rules of this Part.

"Majority vote of the Board" means the affirmative vote of a majority of the members of the Board at a meeting at which a quorum is present.

"Organ Transplantation" means the implantation of a living (viable), functioning human organ or organ system for the purpose of maintaining all of, or a major part of, that organ function in the recipient. Permanent mechanical devices are excluded.

"Procedure" refers to an operation or those activities directly related to the transplantation. Pretransplant preparation consists of all services performed on the date of transplantation prior to the operation. Post surgical hospitalization and follow-up transplant related hospitalization deemed necessary by the transplant physician caring for the patient because of resulting complications will be covered for one year from the date of transplant; patients may reapply for additional funds up to the maximum of $200,000, including the original award, in subsequent years. Outpatient care, including pharmaceutical costs, is excluded.

"Professional fees" refers to any fees assessed for services rendered by medical professionals which are not included in the institutional cost data (See Section 2800.203).

"Screening team" refers to the three members of the Board appointed by the Chairman to review applications for referral to the full Board for final determination of eligibility.

(Source: Amended at 12 Ill. Reg. 15550, effective September 16, 1988)

Section 2800.102 Approved Transplantation Procedures

The following transplantation procedures are eligible for funding under the Experimental Organ Transplantation Program:

a) Heart,

b) Heart/Lung,

c) Single Lung (for procedures performed after April 30, 1987),

d) Double Lung (for procedures performed after November 1, 1989),

e) Liver − Adult and for children's procedures performed after September 16, 1988

f) Pancreas (only whole and segmental grafts are eligible for funding), and

g) Pancreas/Kidney (only the pancreas portion is eligible for funding).

(Source: Amended at 13 Ill. Reg. 15993, effective November 1, 1989)

SUBPART B: APPLICATION REQUIREMENTS

Section 2800.201 Applications

a) All applications must come directly from a teaching hospital or affiliated medical center with an established and proven experimental organ transplantation program. (Section 4(b) of the Act.)

b) Facilities must submit yearly reapplications by June 1 for each state fiscal year in which participation is desired.

c) a transplantation institution located outside of the State of Illinois shall not be approved for participation under this program unless such institution is closer to the residence of the patient than is any approved Illinois Institution; or unless the required procedure is offered at the Out-Of-State Institution, and the procedure is not approved at any Institution located within the State. (Section 4(h) of the Act.)

(Source: Amended at 12 Ill. Reg. 15550, effective September 16, 1988)

Section 2800.202 Patient Information

a) The following patient medical information is required:

1) A diagnosis of the condition requiring the proposed transplantation with copies of all tests and applicable workups necessary to support this conclusion (Section 4(b) of the Act.)

2) A prognosis with and without the transplantation;

3) A description of the proposed experimental transplantation procedure;

4) An explanation of the urgency of the transplantation procedure;

5) The donor organ retrieval plan (only if it is not identical to the plan submitted as part of the institutional information under Section 2800.203(d));

6) The patient's past and present medical history including prior hospitalizations;

7) Identification of the patient's medical and surgical physician(s);

8) Psychosociological evaluation of the patient, (i.e., an evaluation of the patient's family support system, ability to comply with medical care and history of drug and alcohol use);

9) A statement signed by the patient and/or the patient's parent or guardian authorizing the release of all medical records and information to the Experimental Organ Transplantation Procedures Board and staff.

10) Certification by the applicant institution that the patient is an appropriate candidate for an organ transplant procedure at that institution and has been medically approved by their medical specialist in this field for this procedure. (Section 4(b) of the Act.)

11) A statement signed and notarized by the institution certifying that the patient was legally domiciled in Illinois when the pathophysiological state necessitating the organ transplantation procedure was determined and the patient continues to be legally domiciled in Illinois. (See Section 2800. Appendix A) (Section 4(b) of the Act.)

b) The following patient financial information is required:

1) Patient identification information (i.e., name, legal address, social security number, date of birth, place of birth, and name of guardian and/or closet relatives);

2) Documentation and explanation of all accident and health insurance coverage held by the patient;

(Source: Amended at 12 Ill. Reg. 15550, effective September 16, 1988)

Section 2800.203 Institutional Information

a) Narrative description of a multidisciplinary program with prior human experience in the specific proposed procedure(s);

b) Written protocols for patient evaluation, data collection, and clinical studies included in the program(s);

c) Institution Review Board (IRB) statement regarding the specific organ transplantation protocol(s);

d) Description of donor organ retrieval process(es);

e) Program progress reports and protocol revisions or reaffirmations as these occur;

f) Submission of the following financial data taken from the last audited "Hospital and Hospital Care Complex Cost Report Certification" FORM HCFA 2552 (Medicare Cost Report) or equivalent information if the applicant is not located in the United States. The cost information is adjusted for inflation using the latest available quarterly reports of Chase Econometrics and Data Resources Incorporated.

1) Basic Provider Information: (Worksheet S: S1, Part I and II, S2 Part I and II);

2) Cost Detail: Breakdown to Wage (Non-Wage): (Worksheet A: 46 [Reclassification] and A8 [Adjustment to Expenses], A8-1 [Summary of related organization − provider-based physician costs included in cost report.]);

3) Cost Detail: General Service Costs: (Worksheet B: Part I);

4) Cost Detail: Allocation of Capital-Related Costs: (Worksheet B: Part II);

5) Cost Allocation: Statistical Basis: (Worksheet Bl);

6) Departmental Cost Distribution: (Worksheet C: Cl);

7) Cost Apportionment: Inpatient, Outpatient, Medical Education: (Worksheet D: Part I, II and III).

g) Calculate the following costs using the financial information submitted to the Board:

1) Regular Room: $ per day.

2) Operating Room: $ per hour.

3) Intensive Care Unit: $ per day.

4) Anesthesiology: $ per hour.

5) Professional Fees: $ .

(Source: Amended at 12 Ill. Reg. 15550, effective September 16, 1988)

SUBPART C: APPROVAL OF ESTABLISHED PROGRAM

Section 2800.301 Determination of Established Program

The Board shall consider the following criteria in determining whether to approve a transplantation program:

a) Whether the teaching hospital or affiliated medical center has a multidisciplinary program;

b) Whether the transplantation program has a surgeon who has previously performed the procedure for which approval is requested at least six times or a team at the applicant institution which has prior experience with at least six such procedures;

c) Whether the application contains all the information requested by the rules of this part;

d) Whether the teaching hospital or affiliated medical center has complied with the provisions of the rules of this Part.

SUBPART D: RECOMMENDATION FOR FUNDING

Section 2800.401 Determination of Funding

a) Upon receipt and review of all information required under Subpart B of this Part, the screening teams shall recommend further evaluation by the full Board for eligibility of applicants who met the criteria set forth in this Section. Patient applications that meet the criteria set forth in this Section and are approved by all three members of the screening team after receipt and review of all information required under Subpart B of this Part shall be given final approval in emergency situations which will be reaffirmed by the full Board at the next scheduled meeting. If there is disagreement among the members of the screening team, the application will be presented to the full Board for discussion at the next meeting.

1) Patient was legally domiciled in Illinois when the pathophysiological state necessitating the transplantation procedure was originally identified and the patient continues to be legally domiciled in Illinois. (Section 4(b) of the Act.)

2) Patient has limitations, gaps, or exclusions in his accident and health insurance. (Section 4(b) of the Act.), (i.e., Any difference between the patient's insurance coverage and the costs of an experimental transplantation procedure. However, if an institution accepts reimbursement for a patient's transplantation procedure from the Illinois Department of Public Aid's Medical Assistance Program, then no limitation, gap or exclusion exists under this program and the rules of this Part).

3) The center has an established and proven experimental transplantation program approved by the Board under Section 2800.301 of this Part.

4) The proposed procedure for which payment is requested is not performed prior to July 1, 1985.

b) If substantial change (e.g., worsening of the condition requiring the transplant, or immediate availability of a donor organ) in the needs of any patient occurs after the applicant has filed the necessary application forms and information, the applicant shall submit a report of the change and may ask for a reevaluation of the patient's status by submitting a new application.

c) The Board will recommend payment of an award under the Experimental Organ Transplantation Program for applicants receiving a majority vote of the Board members. The level of the award will be determined by the difference between the patient's insurance coverage and the cost of the procedure, not including professional fees, based upon the cost reports and financial information submitted under Section 2800.203 of this Part. If the amount owed for an approved transplant procedure is less than 5 percent of the total charge for the procedure or less than 5 percent of the $200,000 maximum, full reimbursement will be made on the lesser amount. The Board will recommend funding for professional fees at a maximum level of 10 percent of the award for the procedure. (Section 4(d) of the Act.) The maximum level of payment recommended by the Board for live donor acquisition charges will be $10,000. (Section 4(f) of the Act.)

d) No one individual applicant shall be eligible to receive more than a total of $200,000 under this program. (Section 4(f) of the Act.)

e) No payments shall be made for complications or follow-up hospitalization for a donor of an organ transplanted under this program. (Section 4(f) of the Act.)

(Source: Amended at 12 Ill. Reg. 15550, effective September 16, 1988)

SUBPART E: EMERGENCY APPROVAL PROCEDURES

Section 2800.501 Emergency Approval Procedures

a) Applications for funding shall be considered by emergency screening teams assigned by the Chairman when the institution's referring physician documents through signed certification that the patient cannot wait until the next scheduled Board meeting for a determination and the transplant center making application has been previously approved by the full Board as having an established and proven experimental organ transplantation program. The emergency screening team may grant approval for transplantation procedures and recommend the funding levels under the procedures set forth in Section 2800.401 of this Part.

b) The full Board shall reaffirm the decision of the emergency screening team at the Board meeting following the emergency approval.

Section 2800.APPENDIX A Verification of Organ Transplantation Diagnosis and Legal Domicile

Section 2800.APPENDIX A Verification of Organ Transplantation Diagnosis and Legal Domicile

I hereby attest that to the best of my knowledge and as documented in the Patient's

medical records

was medically diagnosed as requiring an organ

(patient name)

transplantation on

that said Patient was a resident of the State of

(date of diagnosis)

Illinois on the date of diagnosis, living at a fixed address and with an intent to continuously reside in the State of Illinois; and that said Patient continues to reside in the State of Illinois at a fixed address and with the intent to remain a resident of the State of Illinois.

(Signature of Representative from

Applicant Institution)

Subscribed and Sworn to before me

this

day of

, 19

(Signature of Notary Public)

My Commission expires

, 19

*Also include other pertinent documentation verifying patient's legal residence, i.e. driver's license or tax form.

PART 2800

2161/1451b/SP

(Added at 11 Ill. Reg. 9118, effective April 30, 1987)

Section 2800.APPENDIX B Addendum I - Patient/Graft Survival Rates

PATIENT/GRAFT SURVIVAL RATES

FACILITY:

				TRANSPLANT PROGRAM
		(ORGAN)
		PERIOD COVERED*
SUMMARY
	No. of transplants	No. of Grafts Surviving	No. of Patients		No. of Patients Surviving
ADULTS
CHILDREN
TOTAL

Note: Also provide Actuarial Survival Rates (Kaplan-Meier technique). See Statistical Methods for Survival Data Analysis by Lee, E.T., Life-Time Learning Publication Division, Wadsworth Corporation, 1980.

*All patients in most recent twelve-month period.

(Source: Added at 12 Ill. Reg. 15550, effective September 16, 1988)

Section 2800.APPENDIX C Addendum II - Facility Experience

FACILITY:

TYPE OF TRANSPLANT:

PERIOD COVERED*:

PATIENT**	AGE	DISEASE	TRANSPLANT DATE	RETRANSPLANT	STATUS

*All patients in most recent twelve-month period.

**If funded by Experimental Organ Transplantation Program, indicate patient's name; otherwise use identifier only.

(Source: Added at 12 Ill. Reg. 15550, effective September 16, 1988)

Section 2800.APPENDIX D Experimental Organ Transplantation Program

PSYCHOSOCIAL ASSESSMENT FORM

DATE:

SOCIAL WORKER:

IDENTIFYING DATA:

PATIENT NAME:

AGE:

ADDRESS:

SEX:

MARITAL STATUS

[ ]

SEPARATED

PATIENT DIAGNOSIS:

CONSULT:

RECEIVED FROM:

DATE RECEIVED:

SOURCES OF INFORMATION:

PERSONAL/FAMILY HISTORY:

CURRENT SITUATION:

ATTITUDE TOWARD ILLNESS AND TRANSPLANT:

INTERPERSONAL ASSETS/RESOURCES:

IMPRESSION:

REFERRALS:

NOTE:

Include history of alcohol and substance abuse and prognosis for future abstinence as well as diagnosed mental health disorders and ability to comply with medical regimen.

Use additional sheets if necessary.

(Source: Added at 12 Ill. Reg. 15550, effective September 16, 1988)