42 U.S.C. § 1395rr : US Code - Section 1395RR: End stage renal disease program

Search 42 U.S.C. § 1395rr : US Code - Section 1395RR: End stage renal disease program

(a) Type, duration, and scope of benefits
The benefits provided by parts A and B of this subchapter shall
include benefits for individuals who have been determined to have
end stage renal disease as provided in section 426-1 of this title,
and benefits for kidney donors as provided in subsection (d) of
this section. Notwithstanding any other provision of this
subchapter, the type, duration, and scope of the benefit provided
by parts A and B of this subchapter with respect to individuals who
have been determined to have end stage renal disease and who are
entitled to such benefits without regard to section 426-1 of this
title shall in no case be less than the type, duration, and scope
of the benefits so provided for individuals entitled to such
benefits solely by reason of that section.
(b) Payments with respect to services; dialysis; regulations;
physicians' services; target reimbursement rates; home dialysis
supplies and equipment; self-care home dialysis support services;
self-care dialysis units; hepatitis B vaccine
(1) Payments under this subchapter with respect to services, in
addition to services for which payment would otherwise be made
under this subchapter, furnished to individuals who have been
determined to have end stage renal disease shall include (A)
payments on behalf of such individuals to providers of services and
renal dialysis facilities which meet such requirements as the
Secretary shall by regulation prescribe for institutional dialysis
services and supplies (including self-dialysis services in a self-
care dialysis unit maintained by the provider or facility),
transplantation services, self-care home dialysis support services
which are furnished by the provider or facility, and routine
professional services performed by a physician during a maintenance
dialysis episode if payments for his other professional services
furnished to an individual who has end stage renal disease are made
on the basis specified in paragraph (3)(A) of this subsection, (B)
payments to or on behalf of such individuals for home dialysis
supplies and equipment, and (C) payments to a supplier of home
dialysis supplies and equipment that is not a provider of services,
a renal dialysis facility, or a physician for self-administered
erythropoietin as described in section 1395x(s)(2)(P) (!1) of this
title if the Secretary finds that the patient receiving such drug
from such a supplier can safely and effectively administer the drug
(in accordance with the applicable methods and standards
established by the Secretary pursuant to such section). The
requirements prescribed by the Secretary under subparagraph (A)
shall include requirements for a minimum utilization rate for
transplantations.
(2)(A) With respect to payments for dialysis services furnished
by providers of services and renal dialysis facilities to
individuals determined to have end stage renal disease for which
payments may be made under part B of this subchapter, such payments
(unless otherwise provided in this section) shall be equal to 80
percent of the amounts determined in accordance with subparagraph
(B); and with respect to payments for services for which payments
may be made under part A of this subchapter, the amounts of such
payments (which amounts shall not exceed, in respect to costs in
procuring organs attributable to payments made to an organ
procurement agency or histocompatibility laboratory, the costs
incurred by that agency or laboratory) shall be determined in
accordance with section 1395x(v) of this title or section 1395ww of
this title (if applicable). Payments shall be made to a renal
dialysis facility only if it agrees to accept such payments as
payment in full for covered services, except for payment by the
individual of 20 percent of the estimated amounts for such services
calculated on the basis established by the Secretary under
subparagraph (B) and the deductible amount imposed by section
1395l(b) of this title.
(B) The Secretary shall prescribe in regulations any methods and
procedures to (i) determine the costs incurred by providers of
services and renal dialysis facilities in furnishing covered
services to individuals determined to have end stage renal disease,
and (ii) determine, on a cost-related basis or other economical and
equitable basis (including any basis authorized under section
1395x(v) of this title) and consistent with any regulations
promulgated under paragraph (7), the amounts of payments to be made
for part B services furnished by such providers and facilities to
such individuals.
(C) Such regulations, in the case of services furnished by
proprietary providers and facilities (other than hospital
outpatient departments) may include, if the Secretary finds it
feasible and appropriate, provision for recognition of a reasonable
rate of return on equity capital, providing such rate of return
does not exceed the rate of return stipulated in section
1395x(v)(1)(B) of this title.
(D) For purposes of section 1395oo of this title, a renal
dialysis facility shall be treated as a provider of services.
(3) With respect to payments for physicians' services furnished
to individuals determined to have end stage renal disease, the
Secretary shall pay 80 percent of the amounts calculated for such
services -
(A) on a reasonable charge basis (but may, in such case, make
payment on the basis of the prevailing charges of other
physicians for comparable services or, for services furnished on
or after January 1, 1992, on the basis described in section 1395w-
4 of this title) except that payment may not be made under this
subparagraph for routine services furnished during a maintenance
dialysis episode, or
(B) on a comprehensive monthly fee or other basis (which
effectively encourages the efficient delivery of dialysis
services and provides incentives for the increased use of home
dialysis) for an aggregate of services provided over a period of
time (as defined in regulations).
(4)(A) Pursuant to agreements with approved providers of services
and renal dialysis facilities, the Secretary may make payments to
such providers and facilities for the cost of home dialysis
supplies and equipment and self-care home dialysis support services
furnished to patients whose self-care home dialysis is under the
direct supervision of such provider or facility, on the basis of a
target reimbursement rate (as defined in paragraph (6)) or on the
basis of a method established under paragraph (7).
(B) The Secretary shall make payments to a supplier of home
dialysis supplies and equipment furnished to a patient whose self-
care home dialysis is not under the direct supervision of an
approved provider of services or renal dialysis facility only in
accordance with a written agreement under which -
(i) the patient certifies that the supplier is the sole
provider of such supplies and equipment to the patient,
(ii) the supplier agrees to receive payment for the cost of
such supplies and equipment only on an assignment-related basis,
and
(iii) the supplier certifies that it has entered into a written
agreement with an approved provider of services or renal dialysis
facility under which such provider or facility agrees to furnish
to such patient all self-care home dialysis support services and
all other necessary dialysis services and supplies, including
institutional dialysis services and supplies and emergency
services.
(5) An agreement under paragraph (4) shall require, in accordance
with regulations prescribed by the Secretary, that the provider or
facility will -
(A) assume full responsibility for directly obtaining or
arranging for the provision of -
(i) such medically necessary dialysis equipment as is
prescribed by the attending physician;
(ii) dialysis equipment maintenance and repair services;
(iii) the purchase and delivery of all necessary medical
supplies; and
(iv) where necessary, the services of trained home dialysis
aides;
(B) perform all such administrative functions and maintain such
information and records as the Secretary may require to verify
the transactions and arrangements described in subparagraph (A);
(C) submit such cost reports, data, and information as the
Secretary may require with respect to the costs incurred for
equipment, supplies, and services furnished to the facility's
home dialysis patient population; and
(D) provide for full access for the Secretary to all such
records, data, and information as he may require to perform his
functions under this section.
(6) The Secretary shall establish, for each calendar year,
commencing with January 1, 1979, a target reimbursement rate for
home dialysis which shall be adjusted for regional variations in
the cost of providing home dialysis. In establishing such a rate,
the Secretary shall include -
(A) the Secretary's estimate of the cost of providing medically
necessary home dialysis supplies and equipment;
(B) an allowance, in an amount determined by the Secretary, to
cover the cost of providing personnel to aid in home dialysis;
and
(C) an allowance, in an amount determined by the Secretary, to
cover administrative costs and to provide an incentive for the
efficient delivery of home dialysis;
but in no event (except as may be provided in regulations under
paragraph (7)) shall such target rate exceed 75 percent of the
national average payment, adjusted for regional variations, for
maintenance dialysis services furnished in approved providers and
facilities during the preceding fiscal year. Any such target rate
so established shall be utilized, without renegotiation of the
rate, throughout the calendar year for which it is established.
During the last quarter of each calendar year, the Secretary shall
establish a home dialysis target reimbursement rate for the next
calendar year based on the most recent data available to the
Secretary at the time. In establishing any rate under this
paragraph, the Secretary may utilize a competitive-bid procedure, a
prenegotiated rate procedure, or any other procedure (including
methods established under paragraph (7)) which the Secretary
determines is appropriate and feasible in order to carry out this
paragraph in an effective and efficient manner.
(7) Subject to paragraph (12), the Secretary shall provide by
regulation for a method (or methods) for determining prospectively
the amounts of payments to be made for dialysis services furnished
by providers of services and renal dialysis facilities to
individuals in a facility and to such individuals at home. Such
method (or methods) shall provide for the prospective determination
of a rate (or rates) for each mode of care based on a single
composite weighted formula (which takes into account the mix of
patients who receive dialysis services at a facility or at home and
the relative costs of providing such services in such settings) for
hospital-based facilities and such a single composite weighted
formula for other renal dialysis facilities, or based on such other
method or combination of methods which differentiate between
hospital-based facilities and other renal dialysis facilities and
which the Secretary determines, after detailed analysis, will more
effectively encourage the more efficient delivery of dialysis
services and will provide greater incentives for increased use of
home dialysis than through the single composite weighted formulas.
The amount of a payment made under any method other than a method
based on a single composite weighted formula may not exceed the
amount (or, in the case of continuous cycling peritoneal dialysis,
130 percent of the amount) of the median payment that would have
been made under the formula for hospital-based facilities. Subject
to section 422(a)(2) of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000, the Secretary shall provide
for such exceptions to such methods as may be warranted by unusual
circumstances (including the special circumstances of sole
facilities located in isolated, rural areas and of pediatric
facilities). Each application for such an exception shall be deemed
to be approved unless the Secretary disapproves it by not later
than 60 working days after the date the application is filed. The
Secretary may provide that such method will serve in lieu of any
target reimbursement rate that would otherwise be established under
paragraph (6). The Secretary shall reduce the amount of each
composite rate payment under this paragraph for each treatment by
50 cents (subject to such adjustments as may be required to reflect
modes of dialysis other than hemodialysis) and provide for payment
of such amount to the organizations (designated under subsection
(c)(1)(A) of this section) for such organizations' necessary and
proper administrative costs incurred in carrying out the
responsibilities described in subsection (c)(2) of this section.
The Secretary shall provide that amounts paid under the previous
sentence shall be distributed to the organizations described in
subsection (c)(1)(A) of this section to ensure equitable treatment
of all such network organizations. The Secretary in distributing
any such payments to network organizations shall take into account -

(A) the geographic size of the network area;
(B) the number of providers of end stage renal disease services
in the network area;
(C) the number of individuals who are entitled to end stage
renal disease services in the network area; and
(D) the proportion of the aggregate administrative funds
collected in the network area.
The Secretary shall increase the amount of each composite rate
payment for dialysis services furnished during 2000 by 1.2 percent
above such composite rate payment amounts for such services
furnished on December 31, 1999, for such services furnished on or
after January 1, 2001, and before January 1, 2005, by 2.4 percent
above such composite rate payment amounts for such services
furnished on December 31, 2000, and for such services furnished on
or after January 1, 2005, by 1.6 percent above such composite rate
payment amounts for such services furnished on December 31, 2004.
(8) For purposes of this subchapter, the term "home dialysis
supplies and equipment" means medically necessary supplies and
equipment (including supportive equipment) required by an
individual suffering from end stage renal disease in connection
with renal dialysis carried out in his home (as defined in
regulations), including obtaining, installing, and maintaining such
equipment.
(9) For purposes of this subchapter, the term "self-care home
dialysis support services", to the extent permitted in regulation,
means -
(A) periodic monitoring of the patient's home adaptation,
including visits by qualified provider or facility personnel (as
defined in regulations), so long as this is done in accordance
with a plan prepared and periodically reviewed by a professional
team (as defined in regulations) including the individual's
physician;
(B) installation and maintenance of dialysis equipment;
(C) testing and appropriate treatment of the water; and
(D) such additional supportive services as the Secretary finds
appropriate and desirable.
(10) For purposes of this subchapter, the term "self-care
dialysis unit" means a renal dialysis facility or a distinct part
of such facility or of a provider of services, which has been
approved by the Secretary to make self-dialysis services, as
defined by the Secretary in regulations, available to individuals
who have been trained for self-dialysis. A self-care dialysis unit
must, at a minimum, furnish the services, equipment and supplies
needed for self-care dialysis, have patient-staff ratios which are
appropriate to self-dialysis (allowing for such appropriate lesser
degree of ongoing medical supervision and assistance of ancillary
personnel than is required for full care maintenance dialysis), and
meet such other requirements as the Secretary may prescribe with
respect to the quality and cost-effectiveness of services.
(11)(A) Hepatitis B vaccine and its administration, when provided
to a patient determined to have end stage renal disease, shall not
be included as dialysis services for purposes of payment under any
prospective payment amount or comprehensive fee established under
this section. Payment for such vaccine and its administration shall
be made separately in accordance with section 1395l of this title.
(B) Erythropoietin, when provided to a patient determined to have
end stage renal disease, shall not be included as a dialysis
service for purposes of payment under any prospective payment
amount or comprehensive fee established under this section, and
subject to paragraphs (12) and (13) payment for such item shall be
made separately -
(i) in the case of erythropoietin provided by a physician, in
accordance with section 1395l of this title; and
(ii) in the case of erythropoietin provided by a provider of
services, renal dialysis facility, or other supplier of home
dialysis supplies and equipment -
(I) for erythropoietin provided during 1994, in an amount
equal to $10 per thousand units (rounded to the nearest 100
units), and
(II) for erythropoietin provided during a subsequent year, in
an amount determined to be appropriate by the Secretary, except
that such amount may not exceed the amount determined under
this clause for the previous year increased by the percentage
increase (if any) in the implicit price deflator for gross
national product (as published by the Department of Commerce)
for the second quarter of the preceding year over the implicit
price deflator for the second quarter of the second preceding
year.
(C) The amount payable to a supplier of home dialysis supplies
and equipment that is not a provider of services, a renal dialysis
facility, or a physician for erythropoietin shall be determined in
the same manner as the amount payable to a renal dialysis facility
for such item.
(12)(A) In lieu of payment under paragraph (7) beginning with
services furnished on January 1, 2005, the Secretary shall
establish a basic case-mix adjusted prospective payment system for
dialysis services furnished by providers of services and renal
dialysis facilities in a year to individuals in a facility and to
such individuals at home. The case-mix under such system shall be
for a limited number of patient characteristics.
(B) The system described in subparagraph (A) shall include -
(i) the services comprising the composite rate established
under paragraph (7); and
(ii) the difference between payment amounts under this
subchapter for separately billed drugs and biologicals (including
erythropoietin) and acquisition costs of such drugs and
biologicals, as determined by the Inspector General reports to
the Secretary as required by section 623(c) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 -
(I) beginning with 2005, for such drugs and biologicals for
which a billing code exists prior to January 1, 2004; and
(II) beginning with 2007, for such drugs and biologicals for
which a billing code does not exist prior to January 1, 2004,
adjusted to 2005, or 2007, respectively, as determined to be
appropriate by the Secretary.
(C)(i) In applying subparagraph (B)(ii) for 2005, such payment
amounts under this subchapter shall be determined using the
methodology specified in paragraph (13)(A)(i).
(ii) For 2006, the Secretary shall provide for an adjustment to
the payments under clause (i) to reflect the difference between the
payment amounts using the methodology under paragraph (13)(A)(i)
and the payment amount determined using the methodology applied by
the Secretary under paragraph (13)(A)(iii) of such paragraph, as
estimated by the Secretary.
(D) The Secretary shall adjust the payment rates under such
system by a geographic index as the Secretary determines to be
appropriate. If the Secretary applies a geographic index under this
paragraph that differs from the index applied under paragraph (7)
the Secretary shall phase-in the application of the index under
this paragraph over a multiyear period.
(E)(i) Such system shall be designed to result in the same
aggregate amount of expenditures for such services, as estimated by
the Secretary, as would have been made for 2005 if this paragraph
did not apply.
(ii) The adjustment made under subparagraph (B)(ii)(II) shall be
done in a manner to result in the same aggregate amount of
expenditures after such adjustment as would otherwise have been
made for such services for 2006 or 2007, respectively, as estimated
by the Secretary, if this paragraph did not apply.
(F) Beginning with 2006, the Secretary shall annually increase
the basic case-mix adjusted payment amounts established under this
paragraph, by an amount determined by -
(i) applying the estimated growth in expenditures for drugs and
biologicals (including erythropoietin) that are separately
billable to the component of the basic case-mix adjusted system
described in subparagraph (B)(ii); and
(ii) converting the amount determined in clause (i) to an
increase applicable to the basic case-mix adjusted payment
amounts established under subparagraph (B).
Nothing in this paragraph shall be construed as providing for an
update to the composite rate component of the basic case-mix
adjusted system under subparagraph (B).
(G) There shall be no administrative or judicial review under
section 1395ff of this title, section 1395oo of this title, or
otherwise, of the case-mix system, relative weights, payment
amounts, the geographic adjustment factor, or the update for the
system established under this paragraph, or the determination of
the difference between medicare payment amounts and acquisition
costs for separately billed drugs and biologicals (including
erythropoietin) under this paragraph and paragraph (13).
(13)(A) The payment amounts under this subchapter for separately
billed drugs and biologicals furnished in a year, beginning with
2004, are as follows:
(i) For such drugs and biologicals (other than erythropoietin)
furnished in 2004, the amount determined under section
1395u(o)(1)(A)(v) of this title for the drug or biological.
(ii) For such drugs and biologicals (including erythropoietin)
furnished in 2005, the acquisition cost of the drug or
biological, as determined by the Inspector General reports to the
Secretary as required by section 623(c) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003.
Insofar as the Inspector General has not determined the
acquisition cost with respect to a drug or biological, the
Secretary shall determine the payment amount for such drug or
biological.
(iii) For such drugs and biologicals (including erythropoietin)
furnished in 2006 and subsequent years, such acquisition cost or
the amount determined under section 1395w-3a of this title for
the drug or biological, as the Secretary may specify.
(B)(i) Drugs and biologicals (including erythropoietin) which
were separately billed under this subsection on the day before
December 8, 2003, shall continue to be separately billed on and
after such date.
(ii) Nothing in this paragraph, section 1395u(o) of this title,
section 1395w-3a of this title, or section 1395w-3b of this title
shall be construed as requiring or authorizing the bundling of
payment for drugs and biologicals into the basic case-mix adjusted
payment system under this paragraph.
(c) Renal disease network areas; coordinating councils, executive
committees, and medical review boards; national end stage renal
disease medical information system; functions of network
organizations
(1)(A)(i) For the purpose of assuring effective and efficient
administration of the benefits provided under this section, the
Secretary shall, in accordance with such criteria as he finds
necessary to assure the performance of the responsibilities and
functions specified in paragraph (2) -
(I) establish at least 17 end stage renal disease network
areas, and
(II) for each such area, designate a network administrative
organization which, in accordance with regulations of the
Secretary, shall establish (aa) a network council of renal
dialysis and transplant facilities located in the area and (bb) a
medical review board, which has a membership including at least
one patient representative and physicians, nurses, and social
workers engaged in treatment relating to end stage renal disease.
The Secretary shall publish in the Federal Register a description
of the geographic area that he determines, after consultation with
appropriate professional and patient organizations, constitutes
each network area and the criteria on the basis of which such
determination is made.
(ii)(I) In order to determine whether the Secretary should enter
into, continue, or terminate an agreement with a network
administrative organization designated for an area established
under clause (i), the Secretary shall develop and publish in the
Federal Register standards, criteria, and procedures to evaluate an
applicant organization's capabilities to perform (and, in the case
of an organization with which such an agreement is in effect,
actual performance of) the responsibilities described in paragraph
(2). The Secretary shall evaluate each applicant based on quality
and scope of services and may not accord more than 20 percent of
the weight of the evaluation to the element of price.
(II) An agreement with a network administrative organization may
be terminated by the Secretary only if he finds, after applying
such standards and criteria, that the organization has failed to
perform its prescribed responsibilities effectively and
efficiently. If such an agreement is to be terminated, the
Secretary shall select a successor to the agreement on the basis of
competitive bidding and in a manner that provides an orderly
transition.
(B) At least one patient representative shall serve as a member
of each network council and each medical review board.
(C) The Secretary shall, in regulations, prescribe requirements
with respect to membership in network organizations by individuals
(and the relatives of such individuals) (i) who have an ownership
or control interest in a facility or provider which furnishes
services referred to in section 1395x(s)(2)(F) of this title, or
(ii) who have received remuneration from any such facility or
provider in excess of such amounts as constitute reasonable
compensation for services (including time and effort relative to
the provision of professional medical services) or goods supplied
to such facility or provider; and such requirements shall provide
for the definition, disclosure, and, to the maximum extent
consistent with effective administration, prevention of potential
or actual financial or professional conflicts of interest with
respect to decisions concerning the appropriateness, nature, or
site of patient care.
(2) The network organizations of each network shall be
responsible, in addition to such other duties and functions as may
be prescribed by the Secretary, for -
(A) encouraging, consistent with sound medical practice, the
use of those treatment settings most compatible with the
successful rehabilitation of the patient and the participation of
patients, providers of services, and renal disease facilities in
vocational rehabilitation programs;
(B) developing criteria and standards relating to the quality
and appropriateness of patient care and with respect to working
with patients, facilities, and providers in encouraging
participation in vocational rehabilitation programs; and network
goals with respect to the placement of patients in self-care
settings and undergoing or preparing for transplantation;
(C) evaluating the procedure by which facilities and providers
in the network assess the appropriateness of patients for
proposed treatment modalities;
(D) implementing a procedure for evaluating and resolving
patient grievances;
(E) conducting on-site reviews of facilities and providers as
necessary (as determined by a medical review board or the
Secretary), utilizing standards of care established by the
network organization to assure proper medical care;
(F) collecting, validating, and analyzing such data as are
necessary to prepare the reports required by subparagraph (H) and
to assure the maintenance of the registry established under
paragraph (7);
(G) identifying facilities and providers that are not
cooperating toward meeting network goals and assisting such
facilities and providers in developing appropriate plans for
correction and reporting to the Secretary on facilities and
providers that are not providing appropriate medical care; and
(H) submitting an annual report to the Secretary on July 1 of
each year which shall include a full statement of the network's
goals, data on the network's performance in meeting its goals
(including data on the comparative performance of facilities and
providers with respect to the identification and placement of
suitable candidates in self-care settings and transplantation and
encouraging participation in vocational rehabilitation programs),
identification of those facilities that have consistently failed
to cooperate with network goals, and recommendations with respect
to the need for additional or alternative services or facilities
in the network in order to meet the network goals, including self-
dialysis training, transplantation, and organ procurement
facilities.
(3) Where the Secretary determines, on the basis of the data
contained in the network's annual report and such other relevant
data as may be available to him, that a facility or provider has
consistently failed to cooperate with network plans and goals or to
follow the recommendations of the medical review board, he may
terminate or withhold certification of such facility or provider
(for purposes of payment for services furnished to individuals with
end stage renal disease) until he determines that such provider or
facility is making reasonable and appropriate efforts to cooperate
with the network's plans and goals. If the Secretary determines
that the facility's or provider's failure to cooperate with network
plans and goals does not jeopardize patient health or safety or
justify termination of certification, he may instead, after
reasonable notice to the provider or facility and to the public,
impose such other sanctions as he determines to be appropriate,
which sanctions may include denial of reimbursement with respect to
some or all patients admitted to the facility after the date of
notice to the facility or provider, and graduated reduction in
reimbursement for all patients.
(4) The Secretary shall, in determining whether to certify
additional facilities or expansion of existing facilities within a
network, take into account the network's goals and performance as
reflected in the network's annual report.
(5) The Secretary, after consultation with appropriate
professional and planning organizations, shall provide such
guidelines with respect to the planning and delivery of renal
disease services as are necessary to assist network organizations
in their development of their respective networks' goals to promote
the optimum use of self-dialysis and transplantation by suitable
candidates for such modalities.
(6) It is the intent of the Congress that the maximum practical
number of patients who are medically, socially, and psychologically
suitable candidates for home dialysis or transplantation should be
so treated and that the maximum practical number of patients who
are suitable candidates for vocational rehabilitation services be
given access to such services and encouraged to return to gainful
employment. The Secretary shall consult with appropriate
professional and network organizations and consider available
evidence relating to developments in research, treatment methods,
and technology for home dialysis and transplantation.
(7) The Secretary shall establish a national end stage renal
disease registry the purpose of which shall be to assemble and
analyze the data reported by network organizations, transplant
centers, and other sources on all end stage renal disease patients
in a manner that will permit -
(A) the preparation of the annual report to the Congress
required under subsection (g) (!1) of this section;
(B) an identification of the economic impact, cost-
effectiveness, and medical efficacy of alternative modalities of
treatment;
(C) an evaluation with respect to the most appropriate
allocation of resources for the treatment and research into the
cause of end stage renal disease;
(D) the determination of patient mortality and morbidity rates,
and trends in such rates, and other indices of quality of care;
and
(E) such other analyses relating to the treatment and
management of end stage renal disease as will assist the Congress
in evaluating the end stage renal disease program under this
section.
The Secretary shall provide for such coordination of data
collection activities, and such consolidation of existing end stage
renal disease data systems, as is necessary to achieve the purpose
of such registry, shall determine the appropriate location of the
registry, and shall provide for the appointment of a professional
advisory group to assist the Secretary in the formulation of
policies and procedures relevant to the management of such
registry.
(8) The provisions of sections 1320c-6 and 1320c-9 of this title
shall apply with respect to network administrative organizations
(including such organizations as medical review boards) with which
the Secretary has entered into agreements under this subsection.
(d) Donors of kidney for transplant surgery
Notwithstanding any provision to the contrary in section 426 of
this title any individual who donates a kidney for transplant
surgery shall be entitled to benefits under parts A and B of this
subchapter with respect to such donation. Reimbursement for the
reasonable expenses incurred by such an individual with respect to
a kidney donation shall be made (without regard to the deductible,
premium, and coinsurance provisions of this subchapter), in such
manner as may be prescribed by the Secretary in regulations, for
all reasonable preparatory, operation, and postoperation recovery
expenses associated with such donation, including but not limited
to the expenses for which payment could be made if he were an
eligible individual for purposes of parts A and B of this
subchapter without regard to this subsection. Payments for
postoperation recovery expenses shall be limited to the actual
period of recovery.
(e) Reimbursement of providers, facilities, and nonprofit entities
for costs of artificial kidney and automated dialysis peritoneal
machines for home dialysis
(1) Notwithstanding any other provision of this subchapter, the
Secretary may, pursuant to agreements with approved providers of
services, renal dialysis facilities, and nonprofit entities which
the Secretary finds can furnish equipment economically and
efficiently, reimburse such providers, facilities, and nonprofit
entities (without regard to the deductible and coinsurance
provisions of this subchapter) for the reasonable cost of the
purchase, installation, maintenance and reconditioning for
subsequent use of artificial kidney and automated dialysis
peritoneal machines (including supportive equipment) which are to
be used exclusively by entitled individuals dialyzing at home.
(2) An agreement under this subsection shall require that the
provider, facility, or other entity will -
(A) make the equipment available for use only by entitled
individuals dialyzing at home;
(B) recondition the equipment, as needed, for reuse by such
individuals throughout the useful life of the equipment,
including modification of the equipment consistent with advances
in research and technology;
(C) provide for full access for the Secretary to all records
and information relating to the purchase, maintenance, and use of
the equipment; and
(D) submit such reports, data, and information as the Secretary
may require with respect to the cost, management, and use of the
equipment.
(3) For purposes of this section, the term "supportive equipment"
includes blood pumps, heparin pumps, bubble detectors, other alarm
systems, and such other items as the Secretary may determine are
medically necessary.
(f) Experiments, studies, and pilot projects
(1) The Secretary shall initiate and carry out, at selected
locations in the United States, pilot projects under which
financial assistance in the purchase of new or used durable medical
equipment for renal dialysis is provided to individuals suffering
from end stage renal disease at the time home dialysis is begun,
with provision for a trial period to assure successful adaptation
to home dialysis before the actual purchase of such equipment.
(2) The Secretary shall conduct experiments to evaluate methods
for reducing the costs of the end stage renal disease program. Such
experiments shall include (without being limited to) reimbursement
for nurses and dialysis technicians to assist with home dialysis,
and reimbursement to family members assisting with home dialysis.
(3) The Secretary shall conduct experiments to evaluate methods
of dietary control for reducing the costs of the end stage renal
disease program, including (without being limited to) the use of
protein-controlled products to delay the necessity for, or reduce
the frequency of, dialysis in the treatment of end stage renal
disease.
(4) The Secretary shall conduct a comprehensive study of methods
for increasing public participation in kidney donation and other
organ donation programs.
(5) The Secretary shall conduct a full and complete study of the
reimbursement of physicians for services furnished to patients with
end stage renal disease under this subchapter, giving particular
attention to the range of payments to physicians for such services,
the average amounts of such payments, and the number of hours
devoted to furnishing such services to patients at home, in renal
disease facilities, in hospitals, and elsewhere.
(6) The Secretary shall conduct a study of the number of patients
with end stage renal disease who are not eligible for benefits with
respect to such disease under this subchapter (by reason of this
section or otherwise), and of the economic impact of such
noneligibility of such individuals. Such study shall include
consideration of mechanisms whereby governmental and other health
plans might be instituted or modified to permit the purchase of
actuarially sound coverage for the costs of end stage renal
disease.
(7)(A) The Secretary shall establish protocols on standards and
conditions for the reuse of dialyzer filters for those facilities
and providers which voluntarily elect to reuse such filters.
(B) With respect to dialysis services furnished on or after
January 1, 1988 (or July 1, 1988, with respect to protocols that
relate to the reuse of bloodlines), no dialysis facility may reuse
dialysis supplies (other than dialyzer filters) unless the
Secretary has established a protocol with respect to the reuse of
such supplies and the facility follows the protocol so established.
(C) The Secretary shall incorporate protocols established under
this paragraph, and the requirement of subparagraph (B), into the
requirements for facilities prescribed under subsection (b)(1)(A)
of this section and failure to follow such a protocol or
requirement subjects such a facility to denial of participation in
the program established under this section and to denial of payment
for dialysis treatment not furnished in compliance with such a
protocol or in violation of such requirement.
(8) The Secretary shall submit to the Congress no later than
October 1, 1979, a full report on the experiments conducted under
paragraphs (1), (2), (3), and (7), and the studies under paragraphs
(4), (5), (6), and (7). Such report shall include any
recommendations for legislative changes which the Secretary finds
necessary or desirable as a result of such experiments and studies.
(g) Conditional approval of dialysis facilities; restriction-of-
payments notice to public and facility; notice and hearing;
judicial review
(1) In any case where the Secretary -
(A) finds that a renal dialysis facility is not in substantial
compliance with requirements for such facilities prescribed under
subsection (b)(1)(A) of this section,
(B) finds that the facility's deficiencies do not immediately
jeopardize the health and safety of patients, and
(C) has given the facility a reasonable opportunity to correct
its deficiencies,
the Secretary may, in lieu of terminating approval of the facility,
determine that payment under this subchapter shall be made to the
facility only for services furnished to individuals who were
patients of the facility before the effective date of the notice.
(2) The Secretary's decision to restrict payments under this
subsection shall be made effective only after such notice to the
public and to the facility as may be prescribed in regulations, and
shall remain in effect until (A) the Secretary finds that the
facility is in substantial compliance with the requirements under
subsection (b)(1)(A) of this section, or (B) the Secretary
terminates the agreement under this subchapter with the facility.
(3) A facility dissatisfied with a determination by the Secretary
under paragraph (1) shall be entitled to a hearing thereon by the
Secretary (after reasonable notice) to the same extent as is
provided in section 405(b) of this title, and to judicial review of
the Secretary's final decision after such hearing as is provided in
section 405(g) of this title, except that, in so applying such
sections and in applying section 405(l) of this title thereto, any
reference therein to the Commissioner of Social Security or the
Social Security Administration shall be considered a reference to
the Secretary or the Department of Health and Human Services,
respectively.