[Federal Register Volume 60, Number 52 (Friday, March 17, 1995)]
[Proposed Rules]
[Pages 14403-14408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6561]



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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

RIN 0720-AA28
[DOD 6010.8-R]


Civilian Health and Medical Program of the Uniformed Services 
(CHAMPUS); Transplants

AGENCY: Office of the Secretary, DoD.

ACTION: Proposed rule.

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SUMMARY: This rule proposes to establish coverage for heart-lung, 
single or double lung, and combined liver-kidney transplantation for 
those patients who meet specific patient selection criteria; establish 
preauthorization requirements for heart, liver, heart-lung, single or 
double lung, combined liver-kidney transplantation, high dose 
chemotherapy and stem cell transplantation, and air ambulance (in 
conjunction with lung or heart-lung transplantation preauthorizations); 
extend coverage of cardiac rehabilitation to those patients who have 
had heart valve surgery, heart or heart-lung transplantation, authorize 
an exception to the ambulance benefit to allow organ transplantation 
candidates to be transported to a certified CHAMPUS organ transplant 
center instead of the closest appropriate facility, and authorize 
pulmonary rehabilitation for beneficiaries whose conditions are 
considered appropriate for pulmonary rehabilitation according to 
guidelines adopted by the Director, OCHAMPUS, or a designee, recognize 
certain transplant centers that meet specific criteria as an authorized 
CHAMPUS institutional provider, and clarify the CHAMPUS position on 
consortium programs for organ transplantation to allow individual 
hospitals which are members of a consortium to use the combined 
(pooled) experience and survival data of the consortium team to meet 
CHAMPUS requirements for authorization as a certified CHAMPUS organ 
transplant center.

DATES: Comments must be received on or before May 16, 1995.

ADDRESSES: All comments concerning this proposed rule should be 
addressed to the Office of the Civilian Health and Medical Program of 
the Uniformed Services (OCHAMPUS), Program Development Branch, Aurora, 
CO 80045-6900.

FOR FURTHER INFORMATION CONTACT: Marty Maxey, OCHAMPUS, Program 
Development Branch, telephone (303) 361-1227.

SUPPLEMENTARY INFORMATION: OCHAMPUS has been actively following the 
development of organ transplantation for the past 10 years to define an 
established method of treatment for patients who have exhausted more 
conservative medical and surgical treatments. Following is an overview 
of the events which have led to the decision to allow CHAMPUS coverage 
for heart-lung, single or double lung, and combined liver-kidney 
transplantation:
     In November 1990, OCHAMPUS requested the Agency for Health 
Care Policy and Research (AHCPR) to conduct a technology assessment on 
the safety and efficacy of heart-lung and single or double lung 
transplantation. In response to our request, AHCPR informed OCHAMPUS 
that an assessment was already in progress as a result of a request by 
the Health Care Financing Administration (HCFA).
    Because of an increase in demand for heart-lung and single or 
double lung transplantation by the CHAMPUS beneficiary population, 
OCHAMPUS urged AHCPR to provide preliminary interim guidelines for 
heart-lung and single or double lung transplantation which could be 
used until finalization of their formal technology assessment. In 
response to this request, AHCPR asked the National Heart Lung and Blood 
Institute (NHLBI) to assist in the development of interim guidelines. 
On February 28, 1991, NHLBI completed the AHCPR request for preliminary 
[[Page 14404]] interim guidelines on heart-lung and single or double 
lung transplantation.
     In September 1992, CHAMPUS requested the AHCPR to conduct 
a technology assessment regarding the safety and efficacy of combined 
liver-kidney transplantation. The AHCPR technology assessment was 
completed on November 12, 1992. The findings of the AHCPR assessment 
indicated that combined liver-kidney transplantation is an effective 
intervention in improving survival in patients with end-stage renal and 
hepatic disease.
     By August 1993, AHCPR finalized the formal technology 
assessment on both heart-lung and single or double lung transplantation 
for HCFA and forwarded a copy to OCHAMPUS. The AHCPR assessments 
indicated that heart-lung and single or double lung transplantations 
were safe and effective treatment for patients meeting specific 
clinical criteria when performed by institutions having demonstrated 
certain levels of experience and success. The patient selection and 
institutional criteria recommended by the AHCPR technology assessments 
were very similar to the interim guidelines developed by NHLBI in 
February 1991.
    Due to the Presidential moratorium on publication of regulations, 
OCHAMPUS decided to proceed without rulemaking and to implement the 
recommendations of the interim guidelines for heart-lung and single or 
double lung transplantations from NHLBI and the final recommendations 
from AHCPR for combined liver-kidney transplantation to meet the 
increasing needs of the CAMPUS beneficiary population for coverage of 
these procedures. OCHAMPUS established effective dates of coverage 
based on NHLBI and AHCPR reports. OCHAMPUS adopted the following 
beginning dates of coverage for:
     Combined liver-kidney transplantation on November 12, 
1992.
     Heart-lung and single or double lung transplantations on 
February 28, 1991. However, CHAMPUS would consider retroactive coverage 
for any heart-lung; single or double lung transplantation performed at 
a facility which met the interim criteria established by NHLBI for both 
patient selection and facility certification criteria.
    OCHAMPUS is publishing this proposed rule to formally notify the 
public of the specific CHAMPUS requirements for coverage of benefits 
for heart-long, single or double lung and combined liver-kidney 
transplantations to include related services and supplies such as air 
ambulance in certain circumstances when determined to be medically 
necessary.
    This proposed rule also authorizes cardiac rehabilitation following 
heart valve surgery, heart and heart-lung transplantation, and 
pulmonary rehabilitation for beneficiaries who conditions are 
considered appropriate according to guidelines that will be implemented 
by the Director, OCHAMPUS, or a designee.
    In addition, this proposed rule outlines the specific requirements 
for providers who wish to be certified as a CHAMPUS approved organ 
transplant center including requirements for consortia programs. 
CHAMPUS recognizes that many facilities performing organ 
transplantations (particularly pediatric hospitals) are not able to 
meet CHAMPUS standards for certification as an authorized transplant 
center. However, CHAMPUS will allow facilities not able to meet the 
standards to qualify as a CHAMPUS authorized transplant center when 
they belong to a consortium program whose combined experience and 
survival data meet the CHAMPUS criteria for qualifying as a certified 
CHAMPUS organ transplant center.
    The specified definitions and procedures outlined in the rule for 
facilities to use in calculating survival rates for transplantation use 
a simpler format but are indential to those published by HCFA (52 FR 
10947, April 6, 1987).
    At this time, OCHAMPUS, wishing to protect beneficiaries from 
incurring out-of-pocket expenses as a result of noncovered care related 
to organ transplantation and to ensure the prudent expenditure of 
public funds, is proposing to require transplantation preauthorization 
for high dose chemotherapy and stem cell transplantation, all initial 
and retransplanted organs, except kidney and cornea, and 
preauthorization for air ambulance for heart-lung and single or double 
lung transplantation. The preauthorization requirement will protect 
both the beneficiary and the provider.

Regulatory Procedures

    OMB has determined that this is not a significant rule as defined 
by Executive Order 12866.
    The Regulatory Flexibility Act (RFA) requires that each federal 
agency prepare, and make available for public comment, a regulatory 
flexibility analysis when the agency issues regulations which would 
have a significant impact on a substantial number of small entities.
    This proposed rule will not involve any significant burden on 
OCHAMPUS beneficiaries or providers. Based on national statistics for 
heart-lung, single or double lung and combined liver-kidney 
transplantation, it is estimated that .005% or less of the 6 million 
CHAMPUS user population, will require a heart-lung, single or double 
lung, or a combined liver-kidney transplantation. The proposed rule 
will broaden the scope of CHAMPUS benefits while protecting the 
beneficiaries and providers from incurring additional costs.
    This rule represents an expansion of benefits under the CHAMPUS 
program, resulting in facility certification of transplant centers and 
narrative summaries for evaluation and assessment for preauthorization 
of transplantations. These transplant centers are accustomed to the 
proposed reporting requirements and would not review this as an 
administrative intrusion. Based on the above rationale, it is felt that 
proposed reporting requirements would not need to be reviewed by the 
Executive Office of Management and Budget under authority of the 
Paperwork Reduction Act of 1980 (44 U.S.C. 3501-3511).

List of Subjects in 32 CFR Part 199

    Claims, Handicapped, Health insurance, Military personnel.

    Accordingly, 32 CFR part 199 is proposed to be amended as follows:

PART 199--[AMENDED]

    1. The authority citation for part 199 is proposed to be revised to 
read as follows:

    Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.

    2. Section 199.4 is proposed to be amended by revising paragraphs 
(d)(3)(v)(B), (d)(3)(v)(D), and (e)(5) and by adding paragraphs 
(d)(3)(v)(E), (e)(18)(i)(F), (e)(18)(i)(G), and (e)(20) to read as 
follows:


Sec. 199.4  Basic program benefits.

* * * * *
    (d) * * *
    (3) * * *
    (v) * * *
    (B) Ambulance service cannot be used instead of taxi service and is 
not payable when the patient's condition would have permitted use of 
regular private transportation; nor is it payable when transport or 
transfer of a patient is primarily for the purpose of having the 
patient nearer to home, family, friends, or personal physician. Except 
as described in paragraph (d)(3)(v)(A) and (d)(3)(v)(E) of this section 
transport [[Page 14405]] must be to the closest appropriate facility by 
the least costly means.
* * * * *
    (D) Except as described in paragraph (d)(3)(v)(E) of this section 
ambulance service by other than land vehicles (such as a boat or 
airplane) may be considered only when the pickup point is inaccessible 
by a land vehicle, or when great distance or other obstacles are 
involved in transporting the patient to the nearest hospital with 
appropriate facilities and the patient's medical condition warrants 
speedy admission or is such that transfer by other means is 
contraindicated.
    (E) (i) Advanced life support air ambulance and certified advanced 
life support attendant are covered services for heart-lung; single or 
double lung transplantation candidates and may be preauthorized in 
conjunction with the preauthorization for the transplantation. Air 
ambulance transport for organ transplantation candidates other than 
heart-lung; single or double lung transplantation may be covered if 
determined to be medically necessary.
    (ii) Advanced life support air ambulance and certified advanced 
life support attendant shall be reimbursed subject to standard 
reimbursement methodologies.
* * * * *
    (e) * * *
    (5) Organ transplanation--(i) General. (A) CHAMPUS may cost-share 
medically necessary services and supplies related to organ transplants 
for:
    (1) Evaluation of a potential candidate's suitability for organ 
transplant, whether or not the patient is ultimately accepted as a 
candidate for transplant.
    (2) Pre- and post-transplant inpatient hospital and outpatient 
services.
    (3) Pre- and post-operative services of the transplant team.
    (4) Blood and blood products.
    (5) FDA approved immunosuppression drugs to include off-label uses 
when determined to be medically necessary and generally accepted 
practice within the general medical community, (i.e., non-
investigational).
    (6) Complications of the transplant procedure, including inpatient 
care, management of infection and rejection episodes.
    (7) Periodic evaluation and assessment of the successfully 
transplanted patient.
    (8) The donor acquisition team, including the costs of 
transportation to the location of the donor organ and transportation of 
the team and the donated organ to the location of the transplant 
center.
    (9) The maintenance of the viability of the donor organ after all 
existing legal requirements for excision of the donor organ have been 
met.
    (B) CHAMPUS benefits are payable for recipient costs when the 
recipient of the transplant is a beneficiary, whether or not the donor 
is a beneficiary.
    (C) Donor costs are payable when:
    (1) Both the donor and recipient are CHAMPUS beneficiaries.
    (2) The donor is a CHAMPUS beneficiary but the recipient is not.
    (3) The donor is the sponsor and the recipient is a beneficiary. 
(In such an event, donor costs are paid as a part of the beneficiary 
and recipient costs.)
    (4) The donor is neither a CHAMPUS beneficiary nor a sponsor, if 
the recipient is a CHAMPUS beneficiary. (Again, in such an event, donor 
costs are paid as a part of the beneficiary and recipient costs.)
    (D) If the donor is not a beneficiary, CHAMPUS benefits for donor 
costs are limited to those directly related to the transplant procedure 
itself and do not include any medical care costs related to other 
treatment of the donor, including complications.
    (E) CHAMPUS benefits will not be allowed for:
    (1) Expenses waived by the transplant center.
    (2) Services and supplies not provided in accordance with 
applicable program criteria.
    (3) Administration of an experimental or investigational 
immunosuppressant drug that is not FDA approved.
    (4) Pre- or post-transplant nonmedical expenses.
    (5) Transportation of an organ donor.
    (ii) Preauthorization requirements. The Director, OCHAMPUS, or a 
designee, is the preauthorizing authority for stem cell transplantation 
and all initial and retransplanted solid organs, except kidney and 
corneal. Preauthorization approval for stem cell, solid organ 
transplantations, and transportation by air ambulance (for lung or 
heart-lung transplantation patients) shall remain in effect as long as 
the beneficiary continues to meet the specific transplant criteria set 
forth herein, or until the approved transplant occurs.
    (iii) Kidney transplantation. (A) With specific reference to 
acquisition costs for kidneys, each hospital that performs kidney 
transplantations is required for Medicare purposes to develop for each 
year separate standard acquisition costs for kidneys obtained from live 
donors and kidneys obtained from cadavers. The standard acquisition 
costs for cadaver kidneys is compiled by dividing the total cost of 
cadaver kidneys acquired by the number of transplantations using 
cadaver kidneys. The standard acquisition cost for kidneys from live 
donors is compiled similarly using the total acquisition cost of 
kidneys from live donors and the number of transplantations using 
kidneys from live donors. All recipients of cadaver kidneys are charged 
the same standard cadaver kidney acquisition cost and all recipients of 
kidneys from live donors are charged the same standard live donor 
acquisition cost. The appropriate hospital standard kidney acquisition 
costs (live donor or cadaver) required for Medicare in every instance 
must be used as the acquisition cost for purposes of providing CHAMPUS 
benefits.
    (B) In most instances for costs related to kidney transplantation, 
Medicare (not CHAMPUS) benefits will be applicable. If a CHAMPUS 
beneficiary participates as a kidney donor for a Medicare beneficiary, 
Medicare will pay for expenses in connection with the kidney 
transplantation to include all reasonable preparatory, operation and 
postoperation recovery expenses associated with the donation 
(postoperative recovery expenses are limited to the actual period of 
recovery). (Refer to Sec. 199.3(e)(3)(vi), ``Eligibility.'')
    (iv) Liver transplantation.--(A) Patient selection criteria. On 
July 1, 1983, CHAMPUS benefits are payable for liver transplantation 
for beneficiaries who:
    (1) Are suffering from an irreversible liver process; and,
    (2) Have exhausted more conservative medical and surgical 
treatments; and,
    (3) Are approaching the terminal phase of their illness (e.g., 
death is imminent, irreversible damage to the central nervous system is 
inevitable, or the quality of life has deteriorated to unacceptable 
levels), and
    (4) Are considered appropriate for liver transplantation according 
to guidelines adopted by the Director, OCHAMPUS.
    (B) Contraindications. CHAMPUS shall not provide coverage for liver 
transplantation when any of the following contraindications exist;
    (1) Significant systemic or multisystemic disease (other than 
hepatic failure) which limits the possibility of full recovery and may 
compromise the function of the newly transplanted organ.
    (2) Active alcohol or other substance abuse.
    (3) Malignancies metastasized to or extending beyond the margins of 
the liver; or
    (4) Life threatening or uncontrollable abdominal or systemic 
sepsis. [[Page 14406]] 
    (v) Combined liver-kidney transplantation--(A) Patient selection 
criteria. On November 12, 1992, CHAMPUS benefits are payable for 
combined liver-kidney transplantation for beneficiaries who:
    (1) Are suffering from concomitant, irreversible hepatic and renal 
failure; and
    (2) Have exhausted more conservative medical and surgical 
treatments for hepatic and renal failure; and
    (3) Have plans for long-term adherence to a disciplined medical 
regimen that are feasible and realistic; and
    (4) Are considered appropriate for combined liver-kidney 
transplantation according to guidelines adopted by the Director, 
OCHAMPUS.
    (B) Contraindications. CHAMPUS shall not provide coverage for 
combined liver-kidney transplantation when any of the following 
contraindications exist:
    (1) Significant systemic or multisystemic disease (other than 
hepatorenal failure) which limits the possibility of full recovery and 
may compromise the function of the newly transplanted organs.
    (2) Active alcohol or other substance abuse.
    (3) Malignancies metastasized to or extending beyond the margins of 
the liver and/or kidney.
    (4) Life threatening or uncontrollable abdominal or systemic 
sepsis.
    (vi) Heart transplantation: Patient selection criteria. On November 
7, 1986, CHAMPUS benefits are payable for heart transplantation for 
beneficiaries who:
    (A) Have an end-stage cardiac disease which has not responded to or 
no longer responds to other appropriate medical and surgical therapies 
which might be expected to yield both short- and long-term (3 to 5 
year) survival comparable to that of heart transplantation; and
    (B) Have a very poor prognosis as a result of poor cardiac 
functional status (e.g., less than a 25 percent likelihood of survival 
for six months); and
    (C) Have plans for long-term adherence to a disciplined medical 
regimen that are feasible and realistic.
    (D) Are considered appropriate for heart transplantation according 
to guidelines adopted by the director, OCHAMPUS.
    (vii) Heart-lung and lung transplantation: Patient selection 
criteria. On February 28, 1991, CHAMPUS benefits are payable for heart-
lung and lung transplantation for beneficiaries who:
    (A) Have irreversible, progressively disabling, end-stage pulmonary 
or cardiopulmonary disease (for example, less than a 50 percent 
likelihood of survival for 8 months). Prognosis otherwise must be good 
for both survival and rehabilitation.
    (B) Have tried or considered all other medical and surgical 
therapies that might have been expected to yield both short- and long-
term survival comparable to that of transplantation.
    (C) Have a realistic understanding of the range of clinical 
outcomes that may be encountered.
    (D) Have plans for long-term adherence to a disciplined medical 
regimen that are feasible and realistic.
    (E) Are considered appropriate for heart-lung or lung 
transplantation according to guidelines adopted by the Director, 
OCHAMPUS.
    (viii) High dose chemotherapy and stem cell transplantation. 
CHAMPUS benefits are payable for beneficiaries whose conditions are 
considered appropriate for high dose chemotherapy and stem cell 
transplantation according to guidelines adopted by the Director, 
OCHAMPUS, or a designee.
* * * * *
    (18) * * *
    (i) * * *
    (F) Heart valve surgery.
    (G) Heart or Heart-lung Transplantation.
* * * * *
    (20) Pulmonary rehabilitation. CHAMPUS benefits are payable for 
beneficiaries whose conditions are considered appropriate for pulmonary 
rehabilitation according to guidelines adopted by the Director, 
OCHAMPUS, or a designee.
* * * * *
    3. Section 199.6 is proposed to be amended by revising paragraph 
(b)(4)(ii), by removing paragraph (b)(4)(iii); and redesignating 
paragraphs (b)(4)(iv) through (b)(4)(xiv) as (b)(4)(iii) through 
(b)(4)(xiii) to read as follows:


Sec. 199.6  Authorized providers.

* * * * *
    (b) * * *
    (4) * * *
    (ii) Organ transplant centers--(A) Certification requirements. To 
obtain CHAMPUS approval as an organ transplant center, the center must 
have:
    (1) An active solid organ transplant program.
    (2) Participation in a donor organ procurement program and network.
    (3) An interdisciplinary team to determine the suitability of 
candidates for transplantation on an equitable basis.
    (4) An anesthesia team that is available at all times.
    (5) A nursing service team trained in the hemodynamic support of 
the patient and in managing immunosuppressed patients.
    (6) Pathology and immunology resources that are available for 
studying and reporting the pathological responses to transplantation.
    (7) Evidence that the center safeguards the rights and privacy of 
patients.
    (8) Continual compliance with State transplantation laws and 
regulations, if any.
    (9) Legal counsel familiar with transplantation laws and 
regulations.
    (B) Administrative requirement. A CHAMPUS authorized organ 
transplant center must provide a written statement to the certifying 
authority agreeing to the following administrative requirements:
    (1) Bill for all services and supplies related to the organ 
transplantation performed by its staff and bill for services rendered 
by the donor hospital after all existing legal requirements for 
excision of the donor organ are met.
    (2) Bill all donor services in the name of the CHAMPUS patient.
    (C) Reporting requirements. The transplant center must report to 
the certifying authority any decrease in actuarial survival rates below 
the actuarial survival rate established by CHAMPUS for initial facility 
certification.
    (D) Liver transplant centers. CHAMPUS shall provide coverage for 
liver transplantation procedures performed only by experienced 
transplant surgeons at centers complying with the provisions in 
paragraph (b)(4)(ii)(A) of this section. The transplant center must:
    (1) Have board eligible or board certified physicians and other 
experts in the fields of hepatology, pediatrics, infectious disease, 
nephrology with dialysis capability, pulmonary medicine with 
respiratory therapy support, pathology, immunology, and anesthesiology 
to complement a qualified transplant team.
    (2) Have a transplant surgeon that is specifically trained for 
liver grafting who can assemble and train a team to function 
successfully whenever a donor liver is available.
    (3) Have at least a 70 percent one year actuarial survival rate for 
10 cases as calculated using the Kaplan-Meier product limit method. At 
least a 70 percent one year actuarial survival rate for all subsequent 
liver transplants must be maintained for continued CHAMPUS approval.
    (E) Heart transplant centers. CHAMPUS shall provide coverage for 
heart transplantation procedures performed only by experienced 
[[Page 14407]] transplant procedures performed only by experienced 
transplant surgeons at centers complying with provisions in paragraph 
(b)(4)(ii)(A) of this section. The transplant center must:
    (1) Have experts in the fields of cardiology, cardiovascular 
surgery, anesthesiology, immunology, infectious disease, nursing, 
social services, and organ procurement to complement the transplant 
team.
    (2) Have an active cardiovascular medical and surgical program as 
evidenced by a minimum of 500 cardiac catheterization and coronary 
arteriograms and 250 open heart procedures per year.
    (3) Have an established heart transplant program with documented 
evidence of 12 or more heart transplants in each of the three 
consecutive preceding 12-month periods prior to the date of application 
(a total of 36 or more heart transplant procedures).
    (4) Demonstrate actuarial survival rates of 73 percent for one year 
and 65 percent for two years for patients who have had heart 
transplants since January 1, 1982 at that facility. The Kaplan-Meier 
product limit method shall be used to calculate actuarial survival.
    (5) CHAMPUS approval will lapse if either the number of heart 
transplants falls below 8 in 12 months or if the one-year actuarial 
survival rate falls below 60 percent for a consecutive 24-month period.
    (F) Lung transplant. This policy applies only to those centers 
seeking CHAMPUS certification for lung transplantation only. Centers 
seeking CHAMPUS certification as heart-lung transplant centers must 
meet additional requirements outlined in paragraph (b)(4)(ii)(H) of 
this section.
    (1) CHAMPUS shall provide coverage for lung transplant procedures 
performed only be experienced transplant surgeons at centers complying 
with the provisions outlined in paragraph (b)(4)(ii)(A) of this 
section, and meeting the following criteria:
    (2) The center must have:
    (i) Experts in the fields of cardiology, cardiovascular surgery, 
pulmonary disease, anesthesiology, immunology, infectious disease, 
nursing, social services, and organ procurement to complement the 
transplant team.
    (ii) Performed lung (single and/or double) transplantation in at 
least 10 patients within the 12 months prior to application and in at 
least an additional 10 patients prior thereto.
    (iii) Demonstrated Kaplan-Meier actuarial survival rates of no less 
than 65 percent at one-year post-transplant for patients who have 
undergone a lung transplantation at the center since January 1, 1987.
    (G) Heart-Lung and lung transplant. CHAMPUS shall provide coverage 
for heart-lung transplantation procedures performed only by experienced 
transplant surgeons at centers complying with the provisions outlined 
in paragraph (b)(4)(ii)(A) of this section, and meeting the following 
criteria:
    (1) The institutional and team experience shall be based upon all 
lung and heart-lung transplantations performed since January 1, 1987, 
both for transplant experience and actuarial survival rates.
    (2) To be accepted for lung transplantation (single and/or double), 
an institution and team must have:
    (i) Performed lung and/or heart-lung transplantation in at least 10 
patients within the 12 months prior to application and in at least an 
additional 10 patients prior thereto, and
    (ii) Achieved a documented Kaplan-Meier actuarial survival rate of 
no less than 65 percent at one-year.
    (iii) Fulfilled existing facility certification criteria for heart 
transplantation (either Medicare or CHAMPUS); or fulfilled the CHAMPUS 
facility certification criteria for facilities applying only for lung 
transplantation as outlined in paragraph (b)(4)(ii)(G) of this section.
    (3) To be accepted for heart-lung transplantation, an institution 
and team must fulfill the CHAMPUS facility certification criteria for 
lung transplantation and the existing facility certification criteria 
(either Medicare of CHAMPUS) for heart transplantation.
    (H) Calculation of survival rates for transplantation. Each 
facility seeking CHAMPUS certification as a transplant center must 
calculate survival rates using the Kaplan-Meier (product-limit) 
technique utilizing the definitions and rules below. Each applicant 
facility must identify its Kaplan-Meier actuarial survival percentage 
at one year. Heart transplant facilities must also identify its Kaplan-
Meier actuarial survival percentage at two year point. Each applicant 
facility must also submit calculations to support the reported 
actuarial survival percentage.
    (1) Each applicant facility will report all transplantation 
experience from its inception at the facility, unless this section 
otherwise prescribes a starting date for the reporting of specific 
transplantation experience.
    (2) CHAMPUS recognizes the team experience gained in 
retransplantation. Therefore, retransplantation experience must be 
reported and calculated in the same manner as first transplantation 
experience.
    (3) All experience and survival rates must be reported as of a 
point in time that is no more than 90 days prior to the submission of 
the application for CHAMPUS certification. That date is referred to as 
the fiducial date.
    (4) Calculations assume survival only to (and censoring on) the 
date of last ascertained survival.
    (5) Patients who are not thought to be dead are considered ``lost 
to follow-up'' if they were:
    (i) Operated more than 120 days before the fiducial date, but have 
no ascertained survival within 60 days of the fiducial date; or
    (ii) Operated from 61 to 120 days before the fiducial date, but 
ascertained survival is less than 60 days from date of transplantation; 
or
    (iii) Operated within 60 days of the fiducial date, but not 
ascertained to have survived as of the fiducial date.
    (6) Survival must be calculated with the assumption that each 
patient in the ``lost to follow-up'' category died on or one day after 
the date of last ascertained survival.
    (7) Clearly defined and well justified secondary or alternate 
treatment of ``lost to follow-up'' may also be submitted, but primary 
attention will be given to the results using definitions and procedures 
specified above.
    (8) Facilities seeking certification for lung and/or heart-lung 
transplantation must report all lung and heart-lung transplantation 
experience beginning January 1, 1987. When facility experience is 
reported and the actuarial survival is calculated, lung and heart-lung 
transplantation experience must be combined to arrive at a single one 
year survival percentage.
    (I) Combined liver-kidney transplants. If the facility is 
authorized as a CHAMPUS (or Medicare) approved liver transplant center 
as outlined in paragraphs (b)(4)(ii)(B) and (b)(4)(ii)(E) of this 
section, the facility may be considered to be a CHAMPUS approved center 
to perform combined liver-kidney transplantations.
    (J) Organ transplant consortia. CHAMPUS shall approve individual 
organ transplant centers which meet the above provisions in paragraph 
(b)(4)(ii)(B) of this section, and would otherwise qualify as a 
CHAMPUS-authorized transplant center by:
    (1) Using the combined experience and actuarial survival data of a 
consortium of which a single transplant team rotates among member 
hospitals for purposes of meeting the certification requirements 
outlined in paragraphs (b)(4)(ii)(E), (b)(4)(ii)(F), (b)(4)(ii)(G), 
(b)(4)(ii)(H), and (b)(4)(ii)(I) of this [[Page 14408]] section, for 
liver, heart, lung, heart-lung and combined liver-kidney when,
    (i) The hospitals are under common control or have a formal 
affiliation arrangement with each other under the auspices of an 
organization such as a university or a legally-constituted medical 
research institute;
    (ii) The hospitals share resources by using the same personnel or 
services in their transplant programs. The individual physician members 
of the transplant team practice in all of the hospitals;
    (iii) The same organ procurement organization, immunology, and 
tissue typing services are used by all the hospitals; and
    (iv) The hospital submits its individual and combined experience 
and survival data to the CHAMPUS authorizing authority, and
    (v) If one of the hospitals is a pediatric transplant program, in 
addition to the requirements previously listed the following apply;
    (A) Although pediatric surgeons and pathologists are not required 
to practice in the adult hospital and vice versa, it can be documented 
that they otherwise function as members of the transplant team.
    (B) The facility must have other solid organ transplant program(s) 
that meet CHAMPUS criteria for certification based on actuarial 
survival rates and experience.
    (C) The surgeon responsible for the transplant is commonly involved 
in the type of surgery (i.e., related to hepatology, cardiology and 
pulmonary medicine) with children of the age and size in whom the 
transplant is being performed, and
    (D) If the program involves heart transplant, the facility must 
have an active pediatric cardiovascular medical and surgical program 
with a minimum of 150 cardiac catheterizations performed per year on 
patients in the pediatric range. A surgical case load of 200 operations 
per year should be performed in combined adult and pediatric programs: 
Of these, at least 100 operation per year (three of four should use 
extracorporeal circulation) should be on pediatric patients. In 
programs serving only a pediatric population, at least 100 cardiac 
surgical procedures (three of four should use extracorporeal 
circulation) should be performed per year.
* * * * *
    4. Section 199.7 is proposed to be amended by revising paragraph 
(f)(1)(ii) to read as follows:


Sec. 199.7  Claims submission, review, and payment.

* * * * *
    (f) * * *
    (1) * * *
    (ii) Time limit on preauthorization. Approved preauthorizations are 
valid for specific periods of time, appropriate for the circumstances 
presented and specified at the time the preauthorization is approved. 
In general, preauthorizations are valid for 30 days. If the 
preauthorized service or supplies are not obtained or commenced within 
the specified time limit, a new preauthorization is required before 
benefits may be extended. Special rules apply for organ, stem cell 
transplantation, and air ambulance (in conjunction with lung or heart-
lung transplantation preauthorizations) (refer to 
Sec. 199.4(e)(5)(ii)).
* * * * *
    5. Section 199.15 is proposed to be amended by revising paragraph 
(b)(4)(ii)(C) to read as follows:


Sec. 199.15  Quality and utilization review peer review organization 
program.

* * * * *
    (b) * * *
    (4) * * *
    (ii) * * *
    (C) An approved preauthorization shall state the number of days, 
appropriate for the type of care involved, for which it is valid. In 
general, preauthorizations will be valid for 30 days. If the services 
or supplies are not obtained within the number of days specified, a new 
preauthorization request is required. Special rules apply for organ, 
stem cell transplantation, and air ambulance (in conjunction with lung 
or heart-lung transplantation preauthorizations (refer to 
Sec. 199.4(e)(5)(ii)).
* * * * *
    Dated: March 13, 1995.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 95-6561 Filed 3-16-95; 8:45 am]
BILLING CODE 5000-04-M