[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