[Title 42 CFR K]
[Code of Federal Regulations (annual edition) - October 1, 2008 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN]
[Subchapter K - HEALTH RESOURCES DEVELOPMENT]
[From the U.S. Government Printing Office]
42PUBLIC HEALTH12008-10-012008-10-01falseHEALTH RESOURCES DEVELOPMENTKSUBCHAPTER KPUBLIC HEALTHPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SUBCHAPTER K_HEALTH RESOURCES DEVELOPMENT
PART 121_ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK--Table of Contents
Sec.
121.1 Applicability.
121.2 Definitions.
121.3 The OPTN.
121.4 OPTN Policies: Secretarial review and appeals.
121.5 Listing requirements.
121.6 Organ procurement.
121.7 Identification of organ recipient.
121.8 Allocation of organs.
121.9 Designated transplant program requirements.
121.10 Reviews, evaluation, and enforcement.
121.11 Record maintenance and reporting requirements.
121.12 Advisory Committee on Organ Transplantation.
121.13 Definition of Human Organ Under section 301 of the National Organ
Transplant Act, as amended.
Authority: Sections 215, 371-376 of the Public Health Service Act
(42 U.S.C. 216, 273-274d); sections 1102, 1106, 1138 and 1871 of the
Social Security Act (42 U.S.C. 1302, 1306, 1320b-8 and 1395hh); and
section 301 of the National Organ Transplant Act, as amended (42 U.S.C.
274e).
Source: 63 FR 16332, Apr. 2, 1998, unless otherwise noted.
Sec. 121.1 Applicability.
(a) The provisions of this part, with the exception of Sec. 121.13,
apply to the operation of the Organ Procurement and Transplantation
Network (OPTN) and to the Scientific Registry.
(b) The provisions of Sec. 121.13 apply to the prohibition set
forth in section 301 of the National Organ Transplant Act, as amended.
(c) In accordance with section 1138 of the Social Security Act,
hospitals in which organ transplants are performed and which participate
in the programs under titles XVIII or XIX of the Social Security Act,
and organ procurement organizations designated under section 1138(b) of
the Social Security Act, are subject to the requirements of this part.
[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56658, Oct. 20, 1999; 72
FR 10618, Mar. 9, 2007]
Sec. 121.2 Definitions.
As used in this part--
Act means the Public Health Service Act, as amended.
Designated transplant program means a transplant program that has
been found to meet the requirements of Sec. 121.9.
Family member means a family member of a transplant candidate,
transplant recipient, or organ donor.
OPTN computer match program means a set of computer-based
instructions which compares data on a cadaveric organ donor with data on
transplant candidates on the waiting list and ranks the candidates
according to OPTN policies to determine the priority for allocating the
donor organ(s).
Organ means a human kidney, liver, heart, lung, pancreas, or
intestine (including the esophagus, stomach, small and/or large
intestine, or any portion of the gastrointestinal tract). Blood vessels
recovered from an organ donor during the recovery of such organ(s) are
considered part of an organ with which they are procured for purposes of
this part if the vessels are intended for use in organ transplantation
and labeled ``For use in organ transplantation only.''
Organ donor means a human being who is the source of an organ for
transplantation into another human being.
Organ procurement organization or OPO means an entity so designated
by the Secretary under section 1138(b) of the Social Security Act.
Organ procurement and transplantation network or OPTN means the
network established pursuant to section 372 of the Act.
Potential transplant recipient or potential recipient means a
transplant candidate who has been ranked by the OPTN computer match
program as the person to whom an organ from a specific cadaveric organ
donor is to be offered.
Scientific Registry means the registry of information on transplant
recipients established pursuant to section 373 of the Act.
[[Page 646]]
Secretary means the Secretary of Health and Human Services and any
official of the Department of Health and Human Services to whom the
authority involved has been delegated.
Transplant candidate means an individual who has been identified as
medically suited to benefit from an organ transplant and has been placed
on the waiting list by the individual's transplant program.
Transplant hospital means a hospital in which organ transplants are
performed.
Transplant physician means a physician who provides non-surgical
care and treatment to transplant patients before and after transplant.
Transplant program means a component within a transplant hospital
which provides transplantation of a particular type of organ.
Transplant recipient means a person who has received an organ
transplant.
Transplant surgeon means a physician who provides surgical care and
treatment to transplant recipients.
Waiting list means the OPTN computer-based list of transplant
candidates.
[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56658, Oct. 20, 1999; 72
FR 10619, Mar. 9, 2007; 72 FR 10925, Mar. 12, 2007]
Sec. 121.3 The OPTN.
(a) Organization of the OPTN. (1) The OPTN shall establish a Board
of Directors of whatever size the OPTN determines appropriate. The Board
of Directors shall include:
(i) Approximately 50 percent transplant surgeons or transplant
physicians;
(ii) At least 25 percent transplant candidates, transplant
recipients, organ donors and family members. These members should
represent the diversity of the population of transplant candidates,
transplant recipients, organ donors and family members served by the
OPTN including, to the extent practicable, the minority and gender
diversity of this population. These members shall not be employees of,
or have a similar relationship with OPOs, transplant centers, voluntary
health organizations, transplant coordinators, histocompatibility
experts, or other non-physician transplant professionals; however, the
Board may waive this requirement for not more than 50 percent of these
members; and
(iii) Representatives of OPOs, transplant hospitals, voluntary
health associations, transplant coordinators, histocompatibility
experts, non-physician transplant professionals, and the general public.
(2) The Board of Directors shall elect an Executive Committee from
the membership of the Board. The Executive Committee shall include at
least one general public member, one OPO representative, approximately
50 percent transplant surgeons and transplant physicians, and at least
25 percent transplant candidates, transplant recipients, organ donors,
and family members.
(3) The Board of Directors shall appoint an Executive Director of
the OPTN. The Executive Director may be reappointed upon the Board's
determination that the responsibilities of this position have been
accomplished successfully.
(4) The Board of Directors shall establish such other committees as
are necessary to perform the duties of the OPTN. Committees established
by the Board of Directors shall include:
(i) Representation by transplant coordinators, organ procurement
organizations, and transplant hospitals, and at least one transplant
candidate, transplant recipient, organ donor or family member; and
(ii) To the extent practicable, minority and gender representation
reflecting the diversity of the population of transplant candidates,
transplant recipients, organ donors and family members served by the
OPTN.
(b) Membership of the OPTN. (1) The OPTN shall admit and retain as
members the following:
(i) All organ procurement organizations;
(ii) Transplant hospitals participating in the Medicare or Medicaid
programs; and
(iii) Other organizations, institutions, and individuals that have
an interest in the fields of organ donation or transplantation.
(2) To apply for membership in the OPTN:
[[Page 647]]
(i) An OPO shall provide to the OPTN the name and address of the
OPO, and the latest year of designation under section 1138(b) of the
Social Security Act;
(ii) A transplant hospital shall provide to the OPTN the name and
address of the hospital, a list of its transplant programs by type of
organ; and
(iii) Any other organization, institution, or individual eligible
under paragraph (c)(1)(iii) of this section shall demonstrate to the
OPTN an interest in the fields of organ donation or transplantation.
(3) The OPTN shall accept or reject as members entities or
individuals described in paragraph (c)(1)(iii) of this section within 90
days.
(4) Applicants rejected for membership in the OPTN may appeal to the
Secretary. Appeals shall be submitted in writing within 30 days of
rejection of the application. The Secretary may:
(i) Deny the appeal; or
(ii) Direct the OPTN to take action consistent with the Secretary's
response to the appeal.
(c) Corporate status of the OPTN. (1) The OPTN shall be a private,
not-for-profit entity.
(2) The requirements of this section do not apply to any parent,
sponsoring, or affiliated organization of the OPTN, or to any activities
of the contracting organization that are not integral to the operation
of the OPTN. Such an organization is free to establish its own corporate
procedures.
(3) No OPTN member is required to become a member of any
organization that is a parent, sponsor, contractor, or affiliated
organization of the OPTN, to comply with the by-laws of any such
organization, or to assume any corporate duties or obligations of any
such organization.
(d) Effective date. The organization designated by the Secretary as
the OPTN shall have until June 30, 2000, or six months from its initial
designation as the OPTN, whichever is later, to meet the requirements of
this section, except that the Secretary may extend such period for good
cause.
[63 FR 16332, Apr. 2, 1998, as amended at 63 FR 35847, July 1, 1998; 64
FR 56658, Oct. 20, 1999]
Sec. 121.4 OPTN policies: Secretarial review and appeals.
(a) The OPTN Board of Directors shall be responsible for developing,
with the advice of the OPTN membership and other interested parties,
policies within the mission of the OPTN as set forth in section 372 of
the Act and the Secretary's contract for the operation of the OPTN,
including:
(1) Policies for the equitable allocation of cadaveric organs in
accordance with Sec. 121.8;
(2) Policies, consistent with recommendations of the Centers for
Disease Control and Prevention, for the testing of organ donors and
follow-up of transplant recipients to prevent the spread of infectious
diseases;
(3) Policies that reduce inequities resulting from socioeconomic
status, including, but not limited to:
(i) Ensuring that payment of the registration fee is not a barrier
to listing for patients who are unable to pay the fee;
(ii) Procedures for transplant hospitals to make reasonable efforts
to obtain from all available sources, financial resources for patients
unable to pay such that these patients have an opportunity to obtain a
transplant and necessary follow-up care;
(iii) Recommendations to private and public payers and service
providers on ways to improve coverage of organ transplantation and
necessary follow-up care; and
(iv) Reform of allocation policies based on assessment of their
cumulative effect on socioeconomic inequities;
(4) Policies regarding the training and experience of transplant
surgeons and transplant physicians in designated transplant programs as
required by Sec. 121.9;
(5) Policies for nominating officers and members of the Board of
Directors; and
(6) Policies on such other matters as the Secretary directs.
(b) The Board of Directors shall:
(1) Provide opportunity for the OPTN membership and other interested
parties to comment on proposed policies and shall take into account the
comments received in developing and
[[Page 648]]
adopting policies for implementation by the OPTN; and
(2) Provide to the Secretary, at least 60 days prior to their
proposed implementation, proposed policies it recommends to be
enforceable under Sec. 121.10 (including allocation policies). These
policies will not be enforceable until approved by the Secretary. The
Board of Directors shall also provide to the Secretary, at least 60 days
prior to their proposed implementation, proposed policies on such other
matters as the Secretary directs. The Secretary will refer significant
proposed policies to the Advisory Committee on Organ Transplantation
established under Sec. 121.12, and publish them in the Federal Register
for public comment. The Secretary also may seek the advice of the
Advisory Committee on Organ Transplantation established under Sec.
121.12 on other proposed policies, and publish them in the Federal
Register for public comment. The Secretary will determine whether the
proposed policies are consistent with the National Organ Transplant Act
and this part, taking into account the views of the Advisory Committee
and public comments. Based on this review, the Secretary may provide
comments to the OPTN. If the Secretary concludes that a proposed policy
is inconsistent with the National Organ Transplant Act or this part, the
Secretary may direct the OPTN to revise the proposed policy consistent
with the Secretary's direction. If the OPTN does not revise the proposed
policy in a timely manner, or if the Secretary concludes that the
proposed revision is inconsistent with the National Organ Transplant Act
or this part, the Secretary may take such other action as the Secretary
determines appropriate, but only after additional consultation with the
Advisory Committee on the proposed action.
(c) The OPTN Board of Directors shall provide the membership and the
Secretary with copies of its policies as they are adopted, and make them
available to the public upon request. The Secretary will publish lists
of OPTN policies in the Federal Register, indicating which ones are
enforceable under Sec. 121.10 or subject to potential sanctions of
section 1138 of the Social Security Act. The OPTN shall also
continuously maintain OPTN policies for public access on the Internet,
including current and proposed policies.
(d) Any interested individual or entity may submit to the Secretary
in writing critical comments related to the manner in which the OPTN is
carrying out its duties or Secretarial policies regarding the OPTN. Any
such comments shall include a statement of the basis for the comments.
The Secretary will seek, as appropriate, the comments of the OPTN on the
issues raised in the comments related to OPTN policies or practices.
Policies or practices that are the subject of critical comments remain
in effect during the Secretary's review, unless the Secretary directs
otherwise based on possible risk to the health of patients or to public
safety. The Secretary will consider the comments in light of the
National Organ Transplant Act and the regulations under this part and
may consult with the Advisory Committee on Organ Transplantation
established under Sec. 121.12. After this review, the Secretary may:
(1) Reject the comments;
(2) Direct the OPTN to revise the policies or practices consistent
with the Secretary's response to the comments; or
(3) Take such other action as the Secretary determines appropriate.
(e) The OPTN shall implement policies and shall:
(1) Provide information to OPTN members about these policies and the
rationale for them; and
(2) Update policies developed in accordance with this section to
accommodate scientific and technological advances.
[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56658, Oct. 20, 1999]
Sec. 121.5 Listing requirements.
(a) A transplant hospital which is an OPTN member may list
individuals, consistent with the OPTN's criteria under Sec.
121.8(b)(1), only for a designated transplant program.
(b) Transplant hospitals shall assure that individuals are placed on
the waiting list as soon as they are determined to be candidates for
transplantation.
[[Page 649]]
The OPTN shall advise transplant hospitals of the information needed for
such listing.
(c) An OPTN member shall pay a registration fee to the OPTN for each
transplant candidate it places on the waiting list. The amount of such
fee shall be calculated to cover (together with contract funds awarded
by the Secretary) the reasonable costs of operating the OPTN and shall
be determined by the OPTN with the approval of the Secretary. No less
often than annually, and whether or not a change is proposed, the OPTN
shall submit to the Secretary a statement of its proposed registration
fee, together with such supporting information as the Secretary finds
necessary to determine the reasonableness or adequacy of the fee
schedule and projected revenues. This submission is due at least three
months before the beginning of the OPTN's fiscal year. The Secretary
will approve, modify, or disapprove the amount of the fee within a
reasonable time of receiving the OPTN's submission.
[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56659, Oct. 20, 1999]
Sec. 121.6 Organ procurement.
The suitability of organs donated for transplantation shall be
determined as follows:
(a) Tests. An OPTN member procuring an organ shall assure that
laboratory tests and clinical examinations of potential organ donors are
performed to determine any contraindications for donor acceptance, in
accordance with policies established by the OPTN.
(b) HIV. The OPTN shall adopt and use standards for preventing the
acquisition of organs from individuals known to be infected with human
immunodeficiency virus.
(c) Acceptance criteria. Transplant programs shall establish
criteria for organ acceptance, and shall provide such criteria to the
OPTN and the OPOs with which they are affiliated.
[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56659, Oct. 20, 1999]
Sec. 121.7 Identification of organ recipient.
(a) List of potential transplant recipients. (1) An OPTN member
procuring an organ shall operate the OPTN computer match program within
such time as the OPTN may prescribe to identify and rank potential
recipients for each cadaveric organ procured.
(2) The rank order of potential recipients shall be determined for
each cadaveric organ using the organ specific allocation criteria
established in accordance with Sec. 121.8.
(3) When a donor or donor organ does not meet a transplant program's
donor acceptance criteria, as established under Sec. 121.6(c),
transplant candidates of that program shall not be ranked among
potential recipients of that organ and shall not appear on a roster of
potential recipients of that organ.
(b) Offer of organ for potential recipients. (1) Organs shall be
offered for potential recipients in accordance with policies developed
under Sec. 121.8 and implemented under Sec. 121.4.
(2) Organs may be offered only to potential recipients listed with
transplant programs having designated transplant programs of the same
type as the organ procured.
(3) An organ offer is made when all information necessary to
determine whether to transplant the organ into the potential recipient
has been given to the transplant hospital.
(4) A transplant program shall either accept or refuse the offered
organ for the designated potential recipient within such time as the
OPTN may prescribe. A transplant program shall document and provide to
the OPO and to the OPTN the reasons for refusal and shall maintain this
document for one year.
(c) Transportation of organ to potential recipient--(1)
Transportation. The OPTN member that procures a donated organ shall
arrange for transportation of the organ to the transplant hospital.
(2) Documentation. The OPTN member that is transporting an organ
shall assure that it is accompanied by written documentation of
activities conducted to determine the suitability of the organ donor and
shall maintain this document for one year.
[[Page 650]]
(3) Packaging. The OPTN member that is transporting an organ shall
assure that it is packaged in a manner that is designed to maintain the
viability of the organ.
(d) Receipt of an organ. Upon receipt of an organ, the transplant
hospital responsible for the potential recipient's care shall determine
whether to proceed with the transplant. In the event that an organ is
not transplanted into the potential recipient, the OPO which has a
written agreement with the transplant hospital must offer the organ for
another potential recipient in accordance with paragraph (b)(2) of this
section.
(e) Blood vessels considered part of an organ. A blood vessel that
is considered part of an organ under this part shall be subject to the
allocation requirements and policies pertaining to the organ with which
the blood vessel is procured until and unless the transplant center
receiving the organ determines that the blood vessel is not needed for
the transplantation of that organ.
(f) Wastage. Nothing in this section shall prohibit a transplant
program from transplanting an organ into any medically suitable
candidate if to do otherwise would result in the organ not being used
for transplantation. The transplant program shall notify the OPTN and
the OPO which made the organ offer of the circumstances justifying each
such action within such time as the OPTN may prescribe.
[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56659, Oct. 20, 1999; 72
FR 10925, Mar. 12, 2007]
Sec. 121.8 Allocation of organs.
(a) Policy development. The Board of Directors established under
Sec. 121.3 shall develop, in accordance with the policy development
process described in Sec. 121.4, policies for the equitable allocation
of cadaveric organs among potential recipients. Such allocation
policies:
(1) Shall be based on sound medical judgment;
(2) Shall seek to achieve the best use of donated organs;
(3) Shall preserve the ability of a transplant program to decline an
offer of an organ or not to use the organ for the potential recipient in
accordance with Sec. 121.7(b)(4)(d) and (e);
(4) Shall be specific for each organ type or combination of organ
types to be transplanted into a transplant candidate;
(5) Shall be designed to avoid wasting organs, to avoid futile
transplants, to promote patient access to transplantation, and to
promote the efficient management of organ placement;
(6) Shall be reviewed periodically and revised as appropriate;
(7) Shall include appropriate procedures to promote and review
compliance including, to the extent appropriate, prospective and
retrospective reviews of each transplant program's application of the
policies to patients listed or proposed to be listed at the program; and
(8) Shall not be based on the candidate's place of residence or
place of listing, except to the extent required by paragraphs (a)(1)-(5)
of this section.
(b) Allocation performance goals. Allocation policies shall be
designed to achieve equitable allocation of organs among patients
consistent with paragraph (a) of this section through the following
performance goals:
(1) Standardizing the criteria for determining suitable transplant
candidates through the use of minimum criteria (expressed, to the extent
possible, through objective and measurable medical criteria) for adding
individuals to, and removing candidates from, organ transplant waiting
lists;
(2) Setting priority rankings expressed, to the extent possible,
through objective and measurable medical criteria, for patients or
categories of patients who are medically suitable candidates for
transplantation to receive transplants. These rankings shall be ordered
from most to least medically urgent (taking into account, in accordance
with paragraph (a) of this section, and in particular in accordance with
sound medical judgment, that life sustaining technology allows
alternative approaches to setting priority ranking for patients). There
shall be a sufficient number of categories (if categories are used) to
avoid grouping together patients with substantially different medical
urgency;
[[Page 651]]
(3) Distributing organs over as broad a geographic area as feasible
under paragraphs (a)(1)-(5) of this section, and in order of decreasing
medical urgency; and
(4) Applying appropriate performance indicators to assess transplant
program performance under paragraphs (c)(2)(i) and (c)(2)(ii) of this
section and reducing the inter-transplant program variance to as small
as can reasonably be achieved in any performance indicator under
paragraph (c)(2)(iii) of this section as the Board determines
appropriate, and under paragraph (c)(2)(iv) of this section. If the
performance indicator ``waiting time in status'' is used for allocation
purposes, the OPTN shall seek to reduce the inter-transplant program
variance in this indicator, as well as in other selected performance
indicators, to as small as can reasonably be achieved, unless to do so
would result in transplanting less medically urgent patients or less
medically urgent patients within a category of patients.
(c) Allocation performance indicators. (1) Each organ-specific
allocation policy shall include performance indicators. These indicators
must measure how well each policy is:
(i) Achieving the performance goals set out in paragraph (b) of this
section; and
(ii) Giving patients, their families, their physicians, and others
timely and accurate information to assess the performance of transplant
programs.
(2) Performance indicators shall include:
(i) Baseline data on how closely the results of current allocation
policies approach the performance goals established under paragraph (b)
of this section;
(ii) With respect to any proposed change, the amount of projected
improvement in approaching the performance goals established under
paragraph (b) of this section;
(iii) Such other indicators as the Board may propose and the
Secretary approves; and
(iv) Such other indicators as the Secretary may require.
(3) For each organ-specific allocation policy, the OPTN shall
provide to the Secretary data to assist the Secretary in assessing organ
procurement and allocation, access to transplantation, the effect of
allocation policies on programs performing different volumes of
transplants, and the performance of OPOs and the OPTN contractor. Such
data shall be required on performance by organ and status category,
including program-specific data, OPO-specific data, data by program
size, and data aggregated by organ procurement area, OPTN region, the
Nation as a whole, and such other geographic areas as the Secretary may
designate. Such data shall include the following measures of inter-
transplant program variation: risk-adjusted total life-years pre-and
post-transplant, risk-adjusted patient and graft survival rates
following transplantation, risk-adjusted waiting time and risk-adjusted
transplantation rates, as well as data regarding patients whose status
or medical urgency was misclassified and patients who were
inappropriately kept off a waiting list or retained on a waiting list.
Such data shall cover such intervals of time, and be presented using
confidence intervals or other measures of variance, as may be required
to avoid spurious results or erroneous interpretation due to small
numbers of patients covered.
(d) Transition patient protections--(1) General. When the OPTN
revises organ allocation policies under this section, it shall consider
whether to adopt transition procedures that would treat people on the
waiting list and awaiting transplantation prior to the adoption or
effective date of the revised policies no less favorably than they would
have been treated under the previous policies. The transition procedures
shall be transmitted to the Secretary for review together with the
revised allocation policies.
(2) Special rule for initial revision of liver allocation policies.
When the OPTN transmits to the Secretary its initial revision of the
liver allocation policies, as directed by paragraph (e)(1) of this
section, it shall include transition procedures that, to the extent
feasible, treat each individual on the waiting list and awaiting
transplantation on October 20, 1999 no less favorably than he or she
would have been treated had the revised liver allocation policies not
[[Page 652]]
become effective. These transition procedures may be limited in duration
or applied only to individuals with greater than average medical urgency
if this would significantly improve administration of the list or if
such limitations would be applied only after accommodating a substantial
preponderance of those disadvantaged by the change in the policies.
(e) Deadlines for initial reviews. (1) The OPTN shall conduct an
initial review of existing allocation policies and, except as provided
in paragraph (e)(2) of this section, no later than November 16, 2000
shall transmit initial revised policies to meet the requirements of
paragraphs (a) and (b) of this section, together with supporting
documentation to the Secretary for review in accordance with Sec.
121.4.
(2) No later than March 16, 2000 the OPTN shall transmit revised
policies and supporting documentation for liver allocation to meet the
requirements of paragraphs (a) and (b) of this section to the Secretary
for review in accordance with Sec. 121.4. The OPTN may transmit these
materials without seeking further public comment under Sec. 121.4(b).
(f) Secretarial review of policies, performance indicators, and
transition patient protections. The OPTN's transmittal to the Secretary
of proposed allocation policies and performance indicators shall include
such supporting material, including the results of model-based computer
simulations, as the Secretary may require to assess the likely effects
of policy changes and as are necessary to demonstrate that the proposed
policies comply with the performance indicators and transition
procedures of paragraphs (c) and (d) of this section.
(g) Variances. The OPTN may develop, in accordance with Sec. 121.4,
experimental policies that test methods of improving allocation. All
such experimental policies shall be accompanied by a research design and
include data collection and analysis plans. Such variances shall be time
limited. Entities or individuals objecting to variances may appeal to
the Secretary under the procedures of Sec. 121.4.
(h) Directed donation. Nothing in this section shall prohibit the
allocation of an organ to a recipient named by those authorized to make
the donation.
[64 FR 56659, Oct. 20, 1999, as amended at 64 FR 71626, Dec. 21, 1999]
Sec. 121.9 Designated transplant program requirements.
(a) To receive organs for transplantation, a transplant program in a
hospital that is a member of the OPTN shall abide by these rules and
shall:
(1) Be a transplant program approved by the Secretary for
reimbursement under Medicare; or
(2) Be an organ transplant program which has adequate resources to
provide transplant services to its patients and agrees promptly to
notify the OPTN and patients awaiting transplants if it becomes inactive
and which:
(i) Has letters of agreement or contracts with an OPO;
(ii) Has on site a transplant surgeon qualified in accordance with
policies developed under Sec. 121.4;
(iii) Has on site a transplant physician qualified in accordance
with policies developed under Sec. 121.4;
(iv) Has available operating and recovery room resources, intensive
care resources and surgical beds and transplant program personnel;
(v) Shows evidence of collaborative involvement with experts in the
fields of radiology, infectious disease, pathology, immunology,
anesthesiology, physical therapy and rehabilitation medicine,
histocompatibility, and immunogenetics and, as appropriate, hepatology,
pediatrics, nephrology with dialysis capability, and pulmonary medicine
with respiratory therapy support;
(vi) Has immediate access to microbiology, clinical chemistry,
histocompatibility testing, radiology, and blood banking services, as
well as the capacity to monitor treatment with immunosuppressive drugs;
and
(vii) Makes available psychiatric and social support services for
transplant candidates, transplant recipients, and their families; or
(3) Be a transplant program in a Department of Veterans Affairs,
Department of Defense, or other Federal hospital.
[[Page 653]]
(b) To apply to be a designated transplant program, transplant
programs shall provide to the OPTN such documents as the OPTN may
require which show that they meet the requirements of Sec. 121.9(a)
(1), (2), or (3).
(c) The OPTN shall, within 90 days, accept or reject applications to
be a designated transplant program.
(d) Applicants rejected for designation may appeal to the Secretary.
Appeals shall be submitted in writing within 30 days of rejection of the
application. The Secretary may:
(1) Deny the appeal; or
(2) Direct the OPTN to take action consistent with the Secretary's
response to the appeal.
[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56660, Oct. 20, 1999]
Sec. 121.10 Reviews, evaluation, and enforcement.
(a) Review and evaluation by the Secretary. The Secretary or her/his
designee may perform any reviews and evaluations of member OPOs and
transplant programs which the Secretary deems necessary to carry out
her/his responsibilities under the Public Health Service Act and the
Social Security Act.
(b) Review and evaluation by the OPTN. (1) The OPTN shall design
appropriate plans and procedures, including survey instruments, a peer
review process, and data systems, for purposes of:
(i) Reviewing applications submitted under Sec. 121.3(c) for
membership in the OPTN;
(ii) Reviewing applications submitted under Sec. 121.9(b) to be a
designated transplant program; and
(iii) Conducting ongoing and periodic reviews and evaluations of
each member OPO and transplant hospital for compliance with these rules
and OPTN policies.
(2) Upon the approval of the Secretary, the OPTN shall furnish
review plans and procedures, including survey instruments and a
description of data systems, to each member OPO and transplant hospital.
The OPTN shall furnish any revisions of these documents to member OPOs
and hospitals, after approval by the Secretary, prior to their
implementation.
(3) At the request of the Secretary, the OPTN shall conduct special
reviews of OPOs and transplant programs, where the Secretary has reason
to believe that such entities may not be in compliance with these rules
or OPTN policies or may be acting in a manner which poses a risk to the
health of patients or to public safety. The OPTN shall conduct these
reviews in accordance with such schedules as the Secretary specifies and
shall make periodic reports to the Secretary of progress on such reviews
and on other reviews conducted under the requirements of this paragraph.
(4) The OPTN shall notify the Secretary in a manner prescribed by
the Secretary within 3 days of all committee and Board of Directors
meetings in which transplant hospital and OPO compliance with these
regulations or OPTN policies is considered.
(c) Enforcement of OPTN rules--(1) OPTN recommendations. The Board
of Directors shall advise the Secretary of the results of any reviews
and evaluations conducted under paragraph (b)(1)(iii) or paragraph
(b)(3) of this section which, in the opinion of the Board, indicate
noncompliance with these rules or OPTN policies, or indicate a risk to
the health of patients or to the public safety, and shall provide any
recommendations for appropriate action by the Secretary. Appropriate
action may include removal of designation as a transplant program under
Sec. 121.9, termination of a transplant hospital's participation in
Medicare or Medicaid, termination of a transplant hospital's
reimbursement under Medicare and Medicaid, termination of an OPO's
reimbursement under Medicare and Medicaid, if the noncompliance is with
a policy designated by the Secretary as covered by section 1138 of the
Social Security Act, or such other compliance or enforcement measures
contained in policies developed under Sec. 121.4.
(2) Secretary's action on recommendations. Upon the Secretary's
review of the Board of Directors' recommendations, the Secretary may:
(i) Request further information from the Board of Directors or the
alleged violator, or both;
[[Page 654]]
(ii) Decline to accept the recommendation;
(iii) Accept the recommendation, and notify the alleged violator of
the Secretary's decision; or
(iv) Take such other action as the Secretary deems necessary.
[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56661, Oct. 20, 1999]
Sec. 121.11 Record maintenance and reporting requirements.
(a) Record maintenance. Records shall be maintained and made
available subject to OPTN policies and applicable limitations based on
personal privacy as follows:
(1) The OPTN and the Scientific Registry, as appropriate, shall:
(i) Maintain and operate an automated system for managing
information about transplant candidates, transplant recipients, and
organ donors, including a computerized list of individuals waiting for
transplants;
(ii) Maintain records of all transplant candidates, all organ donors
and all transplant recipients;
(iii) Operate, maintain, receive, publish, and transmit such records
and information electronically, to the extent feasible, except when hard
copy is requested; and
(iv) In making information available, provide manuals, forms, flow
charts, operating instructions, or other explanatory materials as
necessary to understand, interpret, and use the information accurately
and efficiently.
(2) Organ procurement organizations and transplant programs--(i)
Maintenance of records. All OPOs and transplant programs shall maintain
such records pertaining to each potential donor identified, each organ
retrieved, each recipient transplanted and such other transplantation-
related matters as the Secretary deems necessary to carry out her/his
responsibilities under the Act. The OPO or transplant program shall
maintain these records for seven years.
(ii) Access to facilities and records. OPOs and transplant hospitals
shall permit the Secretary and the Comptroller General, or their
designees, to inspect facilities and records pertaining to any aspect of
services performed related to organ donation and transplantation.
(b) Reporting requirements. (1) The OPTN and the Scientific
Registry, as appropriate, shall:
(i) In addition to special reports which the Secretary may require,
submit to the Secretary a report not less than once every fiscal year on
a schedule prescribed by the Secretary. The report shall include the
following information in a form prescribed by the Secretary:
(A) Information that the Secretary prescribes as necessary to assess
the effectiveness of the Nation's organ donation, procurement and
transplantation system;
(B) Information that the Secretary deems necessary for the report to
Congress required by Section 376 of the Act; and,
(C) Any other information that the Secretary prescribes.
(ii) Provide to the Scientific Registry data on transplant
candidates and recipients, and other information that the Secretary
deems appropriate. The information shall be provided in the form and on
the schedule prescribed by the Secretary;
(iii) Provide to the Secretary any data that the Secretary requests;
(iv) Make available to the public timely and accurate program-
specific information on the performance of transplant programs. This
shall include free dissemination over the Internet, and shall be
presented, explained, and organized as necessary to understand,
interpret, and use the information accurately and efficiently. These
data shall be updated no less frequently than every six months (or such
longer period as the Secretary determines would provide more useful
information to patients, their families, and their physicians), and
shall include risk-adjusted probabilities of receiving a transplant or
dying while awaiting a transplant, risk-adjusted graft and patient
survival following the transplant, and risk-adjusted overall survival
following listing for such intervals as the Secretary shall prescribe.
These data shall include confidence intervals or other measures that
provide information on the extent to which chance
[[Page 655]]
may influence transplant program-specific results. Such data shall also
include such other cost or performance information as the Secretary may
specify, including but not limited to transplant program-specific
information on waiting time within medical status, organ wastage, and
refusal of organ offers. These data shall also be presented no more than
six months later than the period to which they apply;
(v) Respond to reasonable requests from the public for data needed
for bona fide research or analysis purposes, to the extent that the
OPTN's or Scientific Registry's resources permit, or as directed by the
Secretary. The OPTN or the Scientific Registry may impose reasonable
charges for the separable costs of responding to such requests. Patient-
identified data may be made available to bona fide researchers upon a
showing that the research design requires such data for matching or
other purposes, and that appropriate confidentiality protections,
including destruction of patient identifiers upon completion of
matching, will be followed. All requests shall be processed
expeditiously, with data normally made available within 30 days from the
date of request;
(vi) Respond to reasonable requests from the public for data needed
to assess the performance of the OPTN or Scientific Registry, to assess
individual transplant programs, or for other purposes. The OPTN or
Scientific Registry may impose charges for the separable costs of
responding to such requests. An estimate of such charges shall be
provided to the requester before processing the request. All requests
should be processed expeditiously, with data normally made available
within 30 days from the date of request; and
(vii) Provide data to an OPTN member, without charge, that has been
assembled, stored, or transformed from data originally supplied by that
member.
(2) An organ procurement organization or transplant hospital shall,
as specified from time to time by the Secretary, submit to the OPTN, to
the Scientific Registry, as appropriate, and to the Secretary
information regarding transplantation candidates, transplant recipients,
donors of organs, transplant program costs and performance, and other
information that the Secretary deems appropriate. Such information shall
be in the form required and shall be submitted in accordance with the
schedule prescribed. No restrictions on subsequent redisclosure may be
imposed by any organ procurement organization or transplant hospital.
(c) Public access to data. The Secretary may release to the public
information collected under this section when the Secretary determines
that the public interest will be served by such release. The information
which may be released includes, but is not limited to, information on
the comparative costs and patient outcomes at each transplant program
affiliated with the OPTN, transplant program personnel, information
regarding instances in which transplant programs refuse offers of organs
to their patients, information regarding characteristics of individual
transplant programs, information regarding waiting time at individual
transplant programs, and such other data as the Secretary determines
will provide information to patients, their families, and their
physicians that will assist them in making decisions regarding
transplantation.
[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56661, Oct. 20, 1999]
Sec. 121.12 Advisory Committee on Organ Transplantation.
The Secretary will establish, consistent with the Federal Advisory
Committee Act, the Advisory Committee on Organ Transplantation. The
Secretary may seek the comments of the Advisory Committee on proposed
OPTN policies and such other matters as the Secretary determines.
[64 FR 56661, Oct. 20, 1999]
Sec. 121.13 Definition of Human Organ Under section 301 of the National Organ
Transplant Act, as amended.
``Human organ,'' as covered by section 301 of the National Organ
Transplant Act, as amended, means the human (including fetal) kidney,
liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, skin, and
intestine,
[[Page 656]]
including the esophagus, stomach, small and/or large intestine, or any
portion of the gastrointestinal tract.
[72 FR 10619, Mar. 9, 2007]
PART 124_MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION--Table of Contents
Subpart A_Project Grants for Public Medical Facility Construction and
Modernization
Sec.
124.1 Applicability.
124.2 Definitions.
124.3 Eligibility.
124.4 Application.
124.5 Grant evaluation and award.
124.6 Grant payments.
124.7 Use of grant funds.
124.8 Grantee accountability.
124.9 Nondiscrimination.
124.10 Additional conditions.
124.11 Applicability of 45 CFR part 74.
Subparts B-E [Reserved]
Subpart F_Reasonable Volume of Uncompensated Services To Persons Unable
to Pay
124.501 Applicability.
124.502 Definitions.
124.503 Compliance level.
124.504 Notice of availability of uncompensated services.
124.505 Eligibility criteria.
124.506 Allocation of services; plan requirement.
124.507 Written determinations of eligibility.
124.508 Cessation of uncompensated services.
124.509 Reporting requirements.
124.510 Record maintenance requirements.
124.511 Investigation and determination of compliance.
124.512 Enforcement.
124.513 Public facility compliance alternative.
124.514 Compliance alternative for facilities with small annual
obligations.
124.515 Compliance alternative for community health centers, migrant
health centers and certain National Health Service Corps
sites.
124.516 Charitable facility compliance alternative.
124.517 Unrestricted availability compliance alternative for Title VI-
assisted facilities.
124.518 Agreements with State agencies.
Subpart G_Community Service
124.601 Applicability.
124.602 Definitions.
124.603 Provision of services.
124.604 Posted notice.
124.605 Reporting and record maintenance requirements.
124.606 Investigation and enforcement.
124.607 Agreements with State agencies.
Appendix to Subpart G--Interim Procedures and Criteria for Review by
Health Systems Agencies of Applications Under Section 1625 of
the Public Health Service Act
Subpart H_Recovery of Grant Funds
124.701 Applicability.
124.702 Definitions.
124.703 Federal right of recovery.
124.704 Notification of sale, transfer, or change of use.
124.705 Amount of recovery.
124.706 Calculation of interest.
124.707 Waiver of recovery where facility is sold or transferred to a
proprietary entity.
124.708 Waiver of recovery--good cause for other use of facility.
124.709 Withdrawal of waiver.
Authority: Secs. 215, 1602, 1625, Public Health Service Act (42
U.S.C. 216, 300o-1, 300r), unless otherwise noted.
Source: 42 FR 62270, Dec. 9, 1977, unless otherwise noted.
Subpart A_Project Grants for Public Medical Facility Construction and
Modernization
Sec. 124.1 Applicability.
The regulations of this subpart are applicable to grants under
section 1625 of the Public Health Service Act for construction and
modernization projects designed to:
(a) Eliminate or prevent imminent safety hazards as defined by
Federal, State or local fire, building, or life safety codes or
regulations, or
(b) Avoid noncompliance with State or voluntary licensure or
accreditation standards.
Sec. 124.2 Definitions.
As used in this subpart:
(a) Act means the Public Health Service Act, as amended.
(b) Construction means construction of new buildings and initial
equipment of such buildings and, in any case in
[[Page 657]]
which it will help to provide a service not previously provided in the
community, equipment of any buildings. It includes architect's fees, but
excludes the cost of off-site improvements and, except with respect to
public health centers, the cost of the acquistion of land.
(c) Cost means the amount found by the Secretary to be necessary for
construction or modernization under a project, except that such term
does not include any amount found by the Secretary to be attributable to
expansion of the bed capacity of any facility.
(d) Equipment means those items which are necessary for the
functioning of the facility but does not include items of current
operating expense such as food, fuel, pharmaceuticals, dressings, paper,
printed forms, and housekeeping supplies.
(e) Facility for long-term care means a facility (including a
skilled nursing care or intermediate care facility), providing inpatient
care for convalescent or chronic disease patients who require skilled
nursing or intermediate care and related medical services:
(1) Which is a hospital (other than a hospital primarily for the
care and treatment of mentally ill or tuberculosis patients) or is
operated in connection with a hospital, or
(2) In which such care and medical services are prescribed by, or
are performed under the general direction of, persons licensed to
practice medicine or surgery in the State.
(f) Health systems agency means an agency which has been
conditionally or fully designated pursuant to section 1515 of the Act
and 42 CFR part 122.
(g) Hospital includes general, tuberculosis, and other types of
hospitals, and related facilities such as laboratories, outpatient
departments, nurses' home facilities, extended care facilities,
facilities related to programs for home health services, self-care
units, and central service facilities, operated in connection with
hospitals, and education or training facilities for health professional
personnel operated as an integral part of a hospital, but does not
include any facility furnishing primarily domiciliary care.
(h) Major repair means those repairs to an existing building,
excluding routine maintenance, which restore the building to a sound
state, the cost of which is a least 10 percent of plant value or
$200,000, whichever is greater. Plant value means the historic book
value of the building at the time of application for assistance under
this subpart.
(i) Medical facility means a hospital, public health center,
outpatient medical facility, rehabilitation facility, or a facility for
long-term care.
(j) Modernization means the alteration, expansion (excluding
expansion which increases bed capacity), major repair, remodeling,
replacement, and renovation of existing buildings (including initial
equipment thereof), and the replacement of obsolete equipment of
existing buildings, including energy conservation projects.
(k) Outpatient medical facility means a facility, located in or
apart from a hospital, for the diagnosis or diagnosis and treatment of
ambulatory patients (including ambulatory inpatients):
(1) Which is operated in connection with a hospital, or
(2) In which patient care of a specialized nature (such as in an eye
clinic, dental clinic, or ambulatory surgical center) is provided under
the professional supervision of persons licensed to practice medicine or
surgery in the State, or in the case of dental diagnosis or treatment,
under the professional supervision of persons licensed to practice
dentistry in the State, or
(3) Which offers to patients not requiring hospitalization the
services of licensed physicians in various medical specialties, and
which provides to its patients a reasonably full range of diagnostic and
treatment services.
(l) Public health center means a publicly owned facility for the
provision of public health services, including related facilities such
as laboratories, clinics, and administrative offices operated in
connection with such a facility.
(m) Quasi-public corporation means a private, nonprofit corporation
which has been formally given one or more governmental powers by a
general-purpose unit of government to enable it to carry out its work.
[[Page 658]]
(n) Rehabilitation facility means a facility which is operated for
the primary purpose of assisting in the rehabilitation of disabled
persons through an integrated program of medical evaluation and
services, and psychological, social, or vocational evaluation and
services, under competent professional supervision, and in the case of
which the major portion of the required evaluation and services is
furnished within the facility; and either the facility is operated in
connection with a hospital, or all medical and related health services
are prescribed by, or are under the general direction of persons
licensed to practice medicine or surgery in the State.
(o) Secretary means the Secretary of Health and Human Services and
any other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
(p) State means any one of the several States, the Commonwealth of
Puerto Rico, Guam, American Samoa, the Trust Territory of the Pacific
Islands, the Virgin Islands, and the District of Columbia.
(q) State health planning and development agency or State Agency
means the agency of a State government which has been conditionally or
fully designated under section 1521 of the Act and 42 CFR part 123.
(r) Title means a fee simple, or such other estate or interest in
the project site (including a leasehold on which the rental does not
exceed 4 percent of the value of the land) as the Secretary finds
sufficient to assure undisturbed use and possession for the purpose of
construction or modernization and operation of the project for a period
of not less than twenty years.
(s) Urban or rural poverty area means a census tract, census county
division, or minor civil division, as applicable, in which the
percentage of the residents with incomes below the poverty level, as
defined by the Secretary of Commerce is not less than the percentage
derived in accordance with the following sentence. This percentage shall
be derived so that the percentage of the total population of the United
States residing in all such areas is equal to the percentage of the
total population of the United States with incomes below such poverty
level, plus five percent.
Sec. 124.3 Eligibility.
(a) Eligible applicants. A grant under section 1625 may only be made
to a State or political subdivision of a State, including any city,
town, county, borough, hospital district authority, or public or quasi-
public corporation for a project described in paragraph (b) of this
section for a medical facility owned, operated, or owned and operated by
the State or political subdivision.
(b) Eligible project. A grant under section 1625 may be made only
for a construction and/or modernization project designed to:
(1) Eliminate or prevent safety hazards which under Federal, State,
and/or local fire, building or life safety codes or regulations, will,
in the judgment of the Secretary result in one or more of the following:
(i) Loss of licensure for the facility.
(ii) Closing of all or a substantial part of the facility,
(iii) Loss of eligibility for reimbursement under title XVIII or
title XIX of the Social Security Act; or
(2) Avoid noncompliance with State licensure or voluntary
accreditation standards where noncompliance will, in the judgment of the
Secretary, result in one or both of the following:
(i) Loss of licensure for the facility,
(ii) Loss of accreditation resulting in loss of eligibility for
reimbursement under title XVIII or title XIX of the Social Security Act.
Sec. 124.4 Application.
An application for a grant under this subpart must be submitted
directly to the Secretary at such time and in such form and manner as
the Secretary may prescribe. The application must be executed by an
individual authorized to act for the applicant and assume on behalf of
the applicant the obligations imposed by the Act, this subpart, and the
terms and conditions of the grant. The application must contain the
following:
(a) A description of the site of the project.
[[Page 659]]
(b) A full description, with all appropriate documentation, of:
(1) The imminent safety hazards, licensure and/or accreditation
problems of the facility;
(2) The type and amount of assistance sought under this subpart;
(3) The construction of modernization project for which funds are
sought, describing how it will remedy the problems described pursuant to
paragraph (b)(1) of this section, with a complete schedule for the
proposed construction or modernization; and
(4) How failure to remedy the problems described pursuant to
paragraph (b) (1) of this section will affect the population served by
the facility.
(c) In the case of a modernization project for continuation of
existing health services, a finding by the State Agency of the continued
need for such services. In the case of a construction or modernization
project for new health services, a finding by the State Agency of the
need for such services. The finding of need shall be based on the
following criteria:
(1) In a State which has a program approved by the Secretary under
section 1523(a)(4)(B) of the Act, a State certificate of need program,
or a program under section 1122 of the Social Security Act, the State
Agency shall use the criteria used in conducting reviews under such
program. In a State which has more than one such program, the State
Agency shall use the criteria of one of the programs and notify the
Secretary of the program criteria used.
(2) In a State which does not have a program approved by the
Secretary under section 1523(a)(4)(B) of the Act, a State certificate of
need program or a program under section 1122 of the Social Security Act,
the State Agency shall base its finding of need on the following
criteria:
(i) Whether the proposed project is needed or projected as necessary
to meet the needs in the community in terms of health services required;
Provided, That projects for highly specialized services (such as open-
heart surgery, renal transplantation, or radiation therapy) which will
draw from patient populations outside the community in which the project
is situated will receive appropriate consideration;
(ii) Whether the proposed project can be adquately staffed and
operated when completed;
(iii) Whether the proposed capital expenditure is economically
feasible and can be accommodated in the patient charge structure of the
health facility without unreasonable increases; and
(iv) Whether the project will foster cost containment or improved
quality of care through improved efficiency and productivity, including
promotion of cost-effective factors such as ambulatory care, preventive
health care services, home health care, and design and construction
economies, or through increased competition between different health
services delivery systems.
(d) [Reserved]
(e) An assurance that adequate financial support will be available
for completion of the project, supported by a detailed project budget
satisfactory to the Secretary which includes all existing and
anticipated sources of funds for the project.
(f) An assurance that adequate financial support will be available
for maintenance and operation of the project when completed, supported
by budgets and detailed expenditure and revenue information satisfactory
to the Secretary for both the facility and the applicant for the past
three fiscal years and budget and projections of expenditures and
revenue for the future three fiscal years. Where a certificate of need
or a favorable finding under section 1122 of the Social Security Act is
required in order for the project to operate and/or receive
reimbursement from governmental programs for health services provided,
assurance from the applicant satisfactory to the Secretary that the
applicant will submit, consistent with the provisions of Sec. 124.5(d),
any such required certificates of need and/or section 1122 finding.
(g) An assurance that the applicant would not be able to complete
the project without the grant applied for, supported by a description of
all efforts to obtain funds needed to complete the project and the
results of such efforts.
(h) An assurance that all times after the application is approved
there will
[[Page 660]]
be made available in the facility or portion thereof to be constructed
or modernized, a reasonable volume of services to persons unable to pay
therefor. The applicant shall comply with the standards and procedures
of 42 CFR 53.111, except as the Secretary may prescribe pursuant to
section 1602(6) of the Act. The functions of the State Agency designated
under section 604 of the Act under 42 CFR 53.111 will be performed by
the Secretary, except to the extent they are otherwise assigned.
(i) An assurance that at all times after the application is approved
the facility or portion thereof to be constructed or modernized will be
made available to all persons residing or employed in the area served by
the facility. The applicant shall comply with the standards and
procedures of 42 CFR 53.113, except as the Secretary may prescribe
pursuant to section 1602(6) of the Act. The functions of the State
Agency designated under section 604 of the Act under 42 CFR 53.113 will
be performed by the Secretary, except to the extent they are otherwise
assigned.
(j) An assurance that title to the project site is or will be vested
in one or more of the entities filing the application or in a public or
other nonprofit entity which is to operate the facility on completion of
the project, with such documentation as the Secretary may require.
(k) In the case of an application for construction or modernization
of an outpatient medical facility, an assurance, supported by a written
transfer agreement (or written documentation that such agreement will be
obtained) with identified hospitals, that the services of a general
hospital will be available to patients at such facility who are in need
of hospital care.
(l) Evidence that: (1) The appropriate health systems agency has
been given the opportunity to review the application in accordance with
section 1513(e) of the Act and the requirements of the appendix to this
subpart, with the result of any such review.
(2) The application has been reviewed in accordance with the
applicable requirements of OMB Circular A-95.
(m) An analysis satisfactory to the Secretary and such other
information and materials as the Secretary may require concerning the
environmental impact of the proposed construction or modernization
project.
(n) An assessment satisfactory to the Secretary of the project site
in light of the considerations set forth in Executive Order 11296 (31 FR
10663, August 10, 1966) concerning the evaluation of flood hazards in
locating Federally supported facilities.
(o) In the case of a project which involves the displacement of
persons or businesses, an assurance that the applicant will comply with
the applicable provisions of the Uniform Relocation Assistance and Real
Property Acquisition Policies Act of 1970 (42 U.S.C. 4601 et seq.).
(p)(1) An assurance that all laborers and mechanics employed by
contractors or subcontractors in the performance of work on a project
will be paid wages at rates not less than those prevailing on similar
construction in the locality as determined by the Secretary of Labor in
accordance with the Act of March 3, 1931 (40 U.S.C. 276a-276a-5, known
as the Davis-Bacon Act); and
(2) An assurance that the following conditions and provisions will
be included in all construction contracts:
(i) The provisions of ``DHHS Requirements for Federally Assisted
Construction Contracts Regarding Labor Standards and Equal Employment
Opportunity,'' Form DHHS 514 (rev. July 1976) (issued by the Office of
Grants and Procurement Management, U.S. Department of Health and Human
Services) pertaining to the Davis-Bacon Act, the Contract Work Hours
Standards Act, and the Copeland Act (Anti-Kickback) regulations except
in the case of contracts in the amount of $2,000 or less; and pertaining
to Executive Order 11246, September 24, 1965 (30 FR 12319), relating to
nondiscrimination in construction contract employment except in the case
of contracts in the amount of $10,000 or less, and
(ii) Representatives of the Secretary will have access at all
reasonable times to work wherever it is in preparation or progress, and
the contractor shall provide proper facilities for such access and
inspection.
[[Page 661]]
(q) Such other information as the Secretary may require.
[42 FR 62270, Dec. 9, 1977, as amended at 49 FR 33021, Aug. 20, 1984]
Sec. 124.5 Grant evaluation and award.
(a)(1) Within the limits of funds available for such purpose, the
Secretary may award grants under this subpart for project costs to
applicants with approvable applications therefor which will, in his
judgment, best promote the purposes of section 1625 of the Act, taking
into consideration:
(i) The severity and seriousness of the safety hazard, licensure or
accreditation problem or problems.
(ii) The relative need of the population to be served for the
services to be provided, including the availability of alternatives for
meeting the need.
(iii) The financial need of the applicant.
(iv) The extent to which the facility will serve persons below the
poverty level, as determined by the Secretary of Commerce.
(v) The extent to which the project will foster cost containment or
improve the quality of care through enhanced efficiency and
productivity.
(2) Priority for funding shall be based on the extent to which
services will be made available relative to the cost of the project.
(b) The amount of any grant under this subpart may not exceed 75
percent of the cost of the project for which the grant is made unless
the project is located in an area determined by the Secretary to be an
urban or rural poverty area, in which case the grant may, as determined
by the Secretary, cover up to 100 percent of such costs.
(c) If an applicant has not entered into a legally enforceable fixed
price contract for the project for which funds are awarded under this
subpart within 180 days of the date of the grant award, the grant award
will automatically become null and void.
(d) Where a grant has been awarded to an applicant under this
subpart on the condition that any applicable certificates of need and
section 1122 finding required under Sec. 124.4(f) will be provided, if
such certificates and finding have not been received by the Secretary
within 180 days of the grant award, the grant award will automatically
become null and void.
Sec. 124.6 Grant payments.
Grant payments shall be made to the applicant in accordance with the
requirements of subpart K of 45 CFR part 74.
Sec. 124.7 Use of grant funds.
Any funds granted pursuant to this subpart, as well as funds assured
by the applicant for the project, shall be expended solely for carrying
out the approved project in accordance with section 1625 of the Act, the
regulations of this subpart, the terms and conditions of the grant
award, and the applicable cost principles prescribed by subpart Q of 45
CFR part 74.
Sec. 124.8 Grantee accountability.
(a) Records requirements. (1) Applicants who have received Federal
assistance under this subpart shall maintain, in accounting records
which are separate from the records of all other funds, records which
fully disclose the following:
(i) The amount of all payments received from the Secretary under
this subpart,
(ii) Amounts and sources of all funds, in addition to funds received
under this subpart, applied to the construction or modernization project
funded under this subpart,
(iii) Disposition of all funds for the construction or modernization
project funded under this subpart,
(iv) Total cost of the project approved under this subpart, and
(2) Upon request, applicants shall make such records, books, papers,
or other documents available to the Secretary and the Comptroller
General of the United States or any of their duly authorized
representatives which, in their opinion, may be related or pertinent to
the grant under this subpart.
(b) Annual financial statement. An applicant who receives grant
assistance under this subpart shall, not later than 120 days after the
end of its fiscal year, unless a longer period is approved by the
Secretary for good cause shown, file an annual financial statement which
meets the requirements of section 1634 of the Act.
[[Page 662]]
Sec. 124.9 Nondiscrimination.
(a) Attention is called to the requirements of title VI of the Civil
Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) and in that
particular section 601 of such Act which provides that no person in the
United States shall, on the grounds of race, color or national origin be
excluded from participation in, be denied the benefits of, or be
subjected to discrimination under any program or activity receiving
Federal financial assistance. A regulation implementing such title VI,
which is applicable to grants made under this subpart, has been issued
by the Secretary with the approval of the President (45 CFR part 80).
(b) Attention is called to the requirements of section 504 of the
Rehabilitation Act of 1973, as amended, which provides that no otherwise
qualified handicapped individual in the United States shall, solely by
reason of the handicap, be excluded from participation in, be denied the
benefits of, or be subjected to discrimination under any program or
activity receiving Federal financial assistance. A regulation
implementing section 504 has been issued (45 CFR part 84 (42 FR 22676,
May 4, 1977)).
(c) All portions and services of the entire facility for the
construction or modernization of which, or in connection with which aid
under the Act is sought must be made available without discrimination on
account of creed and the applicant may not discriminate against any
qualified person on account of creed with respect to the privilege of
professional practice in the facility.
(d) Attention is also called to the requirements of title IX of the
Education amendments of 1972 and in particular to section 901 of such
Act (20 U.S.C. 1681) which provides that no person in the United States
shall, on the basis of sex be excluded from participation in, be denied
the benefits of, or be subjected to discrimination under any education
program or activity receiving Federal financial assistance (45 CFR part
86).
(e) Each construction contract is subject to the condition that the
applicant shall comply with the requirements of section 321 of the
Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and
Rehabilitation Act of 1970, as amended, which provides that alcohol
abusers and alcoholics who are suffering from medical conditions shall
not be discriminated against in admission or treatment, solely because
of their alcohol abuse or alcoholism by any private or public general
hospital that receives support in any form from any federally funded
program.
(f) Each construction contract is subject to the condition that the
applicant shall comply with the requirements of section 407 of the Drug
Abuse Office and Treatment Act of 1972, as amended, which provides that
drug abusers who are suffering from medical conditions shall not be
discriminated against because of their drug abuse or drug dependence, by
any private or public general hospital that receives support in any form
from any federally funded program.
Sec. 124.10 Additional conditions.
The Secretary may impose additional conditions prior to or at the
time of any grant award when in the Secretary's judgment such conditions
are necessary to assure or protect advancement of the project in
accordance with the purposes of the Act and the regulations of this
subpart or the conservation of grant funds.
Sec. 124.11 Applicability of 45 CFR part 74.
The provisions of 45 CFR part 74, establishing uniform
administrative requirements and cost principles, shall apply to all
grants under this subpart to State and local governments as those terms
are defined in subpart A of that part 74, except to the extent
inconsistent with this subpart. The relevant provisions of the following
subparts of part 74 shall also apply to grants to all other grantee
organizations under this subpart.
45 CFR Part 74
Subpart:
A General.
B Cash depositories.
C Bonding and insurance.
F Grant-related income.
G Matching and cost sharing.
L Budget revision procedures.
[[Page 663]]
M Grant closeout, suspension, and termination.
O Property.
P Procurement standards.
Q Cost principles.
Subparts B-E [Reserved]
Subpart F_Reasonable Volume of Uncompensated Services to Persons Unable
To Pay
Authority: 42 U.S.C. 216; 42 U.S.C. 300s(3).
Source: 52 FR 46031, Dec. 3, 1987, unless otherwise noted.
Sec. 124.501 Applicability.
(a) The provisions of this subpart apply to any recipient of Federal
assistance under title VI or XVI of the Public Health Service Act that
gave an assurance that it would make available, in the facility or
portion of the facility constructed, modernized or converted with that
assistance, a reasonable volume of services to persons unable to pay for
the services.
(b) The provisions of this subpart apply to facilities for the
following periods:
(1) Facilities assisted under title VI. Except as otherwise herein
provided, a facility assisted under title VI of the Act shall provide
uncompensated services at the annual compliance level required by Sec.
124.503(a) for:
(i) Twenty years after the completion of construction, in the case
of a facility for which the Secretary provided grant assistance under
section 606 of the Act; or
(ii) The period from completion of construction until the amount of
a direct loan under sections 610 and 623 of the Act, or the amount of a
loan with respect to which the Secretary provided a guarantee and
interest subsidy under section 623 of the Act, is repaid, in the case of
a facility for which such a loan was made.
(iii) ``Completion of construction'' means:
(A) The date on which the Secretary determines the facility was
opened for service;
(B) If the opening date is not available, it means the date on which
the Secretary approved the final part of the facility's application for
assistance under title VI of the Act;
(C) If the date of final approval is not available, it means
whatever date the Secretary determines most reasonably approximates the
date of final approval.
(2) Facilities assisted under title XVI. The provisions of this
subpart apply to a facility assisted under title XVI of the Act at all
times following the Secretary's approval of the facility's application
for assistance under title XVI, except that if the facility does not at
the time of that approval provide health services, the assurance applies
at all times following the facility's initial provision of health
services to patients, as determined by the Secretary.
Sec. 124.502 Definitions.
As used in this subpart--
(a) Act means the Public Health Service Act, as amended.
(b) Allowable credit for services provided to a specific patient
means the lesser of the facility's usual charge for those services, or
the usual charge multiplied by the percentage which the total allowable
cost as reported by the facility in the facility's preceding fiscal year
under title XVIII of the Social Security Act (42 U.S.C. 1395, et seq.)
and the implementing regulations (42 CFR part 413) bears to the
facility's total patient revenues for the year.
(c) Applicant means a person who requests uncompensated services or
on whose behalf uncompensated services are requested.
(d) CPI means the National Consumer Price Index for medical care.
(e) Facility means an entity that received assistance under title VI
or XVI of the Act and provided an assurance that it would provide a
reasonable volume of services to persons unable to pay for the services.
(f) Federal assistance means assistance received by the facility
under title VI or title XVI of the Act and any assistance supplementary
to that title VI or title XVI assistance received by the facility under
any of the following acts: the District of Columbia Medical Facilities
Construction Act of 1968, 82 Stat. 631 (Pub. L. 90-457); the Public
Works Acceleration Act of 1962 (42 U.S.C. 2641, et seq.); the Public
Works
[[Page 664]]
and Economic Development Act of 1965 (42 U.S.C. 3121, et seq.); the
Appalachian Regional Development Act of 1965, as amended (40 U.S.C.
App.); the Local Public Works Capital Development and Investment Act of
1976 (Pub. L. 94-369). In the case of a loan guaranteed by the Secretary
with an interest subsidy, the amount of Federal assistance under title
VI or title XVI for a fiscal year is the total amount of the interest
subsidy that the Secretary will have paid by the close of that fiscal
year, as well as any other payments which the Secretary has made as of
the beginning of the fiscal year on behalf of the facility in connection
with the loan guarantee or the direct loan which has been sold.
(g) Fiscal year means the facility's fiscal year.
(h) Nursing home means a facility which received Federal assistance
for and operates as a facility for long-term care as defined at, as
applicable, section 645(h) or section 1624(6) of the Act.
(i) Operating costs for any fiscal year means the total operating
expenses of a facility as set forth in an audited financial statement,
minus the amount of reimbursement, if any, received (or if not received,
claimed) in that year under titles XVIII and XIX of the Social Security
Act.
(j) Persons unable to pay means persons who meet the eligibility
criteria set out in Sec. 124.505.
(k) Request for uncompensated services means any indication by or on
behalf of an individual seeking services of the facility of the
individual's inability to pay for services. A request for uncompensated
services may be made at any time, including following institution of a
collection action against the individual.
(l) Secretary means the Secretary of Health and Human Services or
[his or her] delegatee.
(m) Uncompensated services means:
(1) For facilities other than those certified under Sec. 124.513,
Sec. 124.514, Sec. 124.515, or Sec. 124.516, health services that are
made available to persons unable to pay for them without charge or at a
charge which is less than the allowable credit for those services. The
amount of uncompensated services provided in a fiscal year is the total
allowable credit for services less the amount charged for the services
following an eligibility determination. Excluded are services provided
more than 96 hours following notification to the facility by a quality
improvement organization that it disapproved the services under section
1155(a)(1) or section 1154(a)(1) of the Social Security Act.
(2) For facilities certified under Sec. 124.513, Sec. 124.514,
Sec. 124.515, or Sec. 124.516, services as defined in paragraph (m)(1)
of this section and services that are made available to persons unable
to pay for them under programs described by the documentation provided
under Sec. 124.513(c)(2), Sec. 124.514(c)(2), or Sec. 124.516(c)(2),
as applicable, or pursuant to the terms of the applicable grant or
agreement as provided in Sec. 124.515. Except as provided in Sec.
124.516, excluded are services reimbursed by Medicare, Medicaid, or
other third party programs, including services for which reimbursement
was provided as payment in full, and services provided more than 96
hours following notification to the facility by a quality improvement
organization that it disapproved the services under section 1155(a)(1)
or section 1154(a)(1) of the Social Security Act.
[52 FR 46031, Dec. 3, 1987, as amended at 59 FR 44639, Aug. 30, 1994]
Sec. 124.503 Compliance level.
(a) Annual compliance level. Subject to the provisions of this
subpart, a facility is in compliance with its assurance to provide a
reasonable volume of services to persons unable to pay if it provides
for the fiscal year uncompensated services at a level not less than the
lesser of--
(1) Three percent of its operating costs for the most recent fiscal
year for which an audited financial statement is available;
(2) Ten percent of all Federal assistance provided to or on behalf
of the facility, adjusted by a percentage equal to the percentage change
in the CPI between the year in which the facility received assistance or
1979, whichever is later, and the most recent year for which a published
index is available.
(b) Deficits. If in any fiscal year a facility fails to meet its
annual compliance level, it shall provide uncompensated services in an
amount sufficient to make up that deficit in subsequent
[[Page 665]]
years, and its period of obligation shall be extended until the deficit
is made up.
(1) Types of deficits. For purposes of determining the timing and
amount of any deficit make-up, there are two types of deficits:
(i) Justifiable deficits. A justifiable deficit is one in which the
facility did not meet its annual compliance level due to either
financial inability (as determined under Sec. 124.511(c)) or, although
otherwise in compliance with this subpart, a lack of eligible applicants
for uncompensated services during the fiscal year.
(ii) Noncompliance deficits. A noncompliance deficit is one in which
the facility failed to meet its annual compliance level due to
noncompliance with this subpart.
(2) Timing of deficit make-up--(i) Justifiable deficits. (A) A
facility assisted under title VI of the Act may make up a justifiable
deficit at any time during its period of obligation or in the year (or
years, if necessary) immediately following its period of obligation.
(B) A facility assisted under title XVI of the Act is not required
to make up a justifiable deficit.
(ii) Noncompliance deficits. (A) A facility must begin to make up a
noncompliance deficit in the fiscal year following the finding of
noncompliance by the Secretary.
(B) A facility which claimed financial inability under Sec.
124.509(a)(2)(iii) and is found by the Secretary, pursuant to Sec.
124.511(c), to have been financially able to provide uncompensated
services in the year in which the deficit was incurred shall begin to
make up the deficit beginning in the fiscal year following the
Secretary's finding.
(C) A facility required to make up a noncompliance deficit but which
is determined by the Secretary, pursuant to Sec. 124.511(c), to be
financially unable to do so in the year following the Secretary's
finding of noncompliance shall make up the deficit in accordance with a
schedule set by the Secretary.
(3) Deficit make-up amount. (i) The amount of a deficit in any
fiscal year is the difference between the facility's annual compliance
level for that year and the amount of uncompensated services provided in
that year.
(ii) The amount of a justifiable deficit must be adjusted by a
percentage equal to the percentage change in the CPI between the CPI
available in the fiscal year in which the deficit was incurred and the
CPI available in the fiscal year in which it was made up.
(iii) An amount equal to the result of dividing the amount of any
noncompliance deficit for a fiscal year by the number of years of
obligation remaining and adjusting it by a percentage equal to the
percentage change in the CPI between the CPI available in the fiscal
year in which the deficit was incurred and the CPI available in the
fiscal year in which it was made up shall be added to a facility's
annual compliance level for each fiscal year following the fiscal year
of the finding of noncompliance.
(4) Affirmative action plan for precluding future deficits. Except
where a facility reports to the Secretary in accordance with Sec.
124.509(a)(2)(iii) that it was financially unable to provide
uncompensated services at the annual compliance level, a facility that
fails to meet its annual compliance level in any fiscal year shall, in
the following year, develop and implement a plan of action that can
reasonably be expected to enable the facility to meet its annual
compliance level. Such actions may include special notice to the
community through newspaper, radio, and television, or expansion of
service to Category B, or, with respect to nursing homes, Category C,
persons. The Secretary may require changes to the plan. Where a facility
fails to comply with this section, the Secretary may require it to make
up the deficit in the fiscal year following the year in which it was
required to institute the plan.
(c) Excesses. (1) Except for facilities certified under Sec.
124.513, Sec. 124.514, Sec. 124.515, Sec. 124.516, or Sec. 124.517,
if a facility provides in a fiscal year uncompensated services in an
amount exceeding its annual compliance level, it may apply the amount of
excess to reduce its annual compliance level in any subsequent fiscal
year. The facility may use any excess amount to reduce its annual
compliance level only if the services in excess of the annual compliance
level are provided in accordance with the requirements of this subpart.
[[Page 666]]
(2) Calculation and adjustment of excess. (i) The amount of an
excess in uncompensated services in any fiscal year is the difference
between the amount of uncompensated services the facility provided in
that year and the facility's annual compliance level for that year.
(ii) The amount of any excess compliance applied to reduce a
facility's annual compliance level must be adjusted by a percentage
equal to the percentage change in the CPI between the CPI available in
the fiscal year in which the facility provided the excess, and the CPI
available in the fiscal year in which the facility applies the excess to
reduce its annual compliance level or satisfy its remaining obligation.
(3) Except as provided in subparagraph (1) of this paragraph, a
facility assisted under title VI may in any fiscal year apply the amount
of excess credited under this paragraph to satisfy the remainder of its
obligation to provide uncompensated services. A facility's remaining
obligation is determined as follows:
(i) Where the annual compliance level in such fiscal year is
established under paragraph (a)(2) of this section, the remaining
obligation is:
(A) For grant assistance, 10 percent of each grant under obligation,
multiplied by the number of years remaining in its period of obligation,
adjusted as provided for in paragraph (a)(2) of this section, plus any
deficits required to be made up and less any unused excesses accrued in
prior years; and
(B) For loan assistance, the facility's annual compliance level
multiplied by the number of years remaining in the scheduled life of the
loan, plus the sum of 10 percent of each yearly cumulative total of
additional interest subsidy or other payments (which the Secretary will
have made in connection with the guaranteed loan or a direct loan which
has been sold) in each subsequent year remaining in the scheduled life
of the loan, plus any deficits required to be made up, and less any
unused excesses accrued in prior years; or
(ii) Where the annual compliance level in such fiscal year is
established under paragraph (a)(1) of this section, the remaining
obligation is the average of the facility's annual compliance levels in
the previous three years, multiplied by the number of years remaining in
its period of obligation, plus any deficits required to be made up under
this section, and less any unused excesses accrued in prior years.
[52 FR 46031, Dec. 3, 1987; 52 FR 48362, Dec. 21, 1987, as amended at 60
FR 16756, Mar. 31, 1995; 66 FR 49266, Sept. 26, 2001]
Sec. 124.504 Notice of availability of uncompensated services.
(a) Published notice. A facility shall publish in a newspaper of
general circulation in its area notice of its uncompensated services
obligation before the beginning of its fiscal year. The notice shall
include:
(1) The plan of allocation the facility proposes to adopt;
(2) The amount of uncompensated services the facility intends to
make available in the fiscal year or a statement that the facility will
provide uncompensated services to all persons unable to pay who request
uncompensated services;
(3) An explanation, if the amount of uncompensated services the
facility intends to make available in a fiscal year is less than the
annual compliance level. If a facility has satisfied its remaining
uncompensated services obligation since the last published notice under
this paragraph, or will satisfy the remaining obligation during the
fiscal year, the explanation must include this information; and
(4) A statement inviting interested parties to comment on the
allocation plan.
(b) Posted notice. (1) The facility shall post notices, which the
Secretary supplies in English and Spanish, in appropriate areas in the
facility, including but not limited to the admissions areas, the
business office, and the emergency room.
(2) If in the service area of the facility the ``usual language of
households'' of ten percent or more of the population according to the
most recent figures published by the Bureau of the Census is other than
English or Spanish, the facility shall translate the notice into that
language and post the translated notice on signs substantially similar
in size and legibility to and posted with those supplied under paragraph
(b)(1) of this section.
[[Page 667]]
(3) The facility shall make reasonable efforts to communicate the
contents of the posted notice to persons who it has reason to believe
cannot read the notice.
(c) Individual written notice. (1) In any period during a fiscal
year in which uncompensated services are available in the facility, the
facility shall provide individual written notice of the availability of
uncompensated services to each person who seeks services in the facility
on behalf of himself or another. The individual written notice must:
(i) State that the facility is required by law to provide a
reasonable amount of care without or below charge to people who cannot
afford care;
(ii) Set forth the criteria the facility uses for determining
eligibility for uncompensated services (in accordance with the financial
eligibility criteria and the allocation plan);
(iii) State the location in the facility where anyone seeking
uncompensated services may request them; and
(iv) State that the facility will make a written determination of
whether the person will receive uncompensated services, and the date by
or period within which the determination will be made.
(2) The facility shall provide the individual written notice before
providing services, except where the emergency nature of the services
provided makes prior notice impractical. If this exception applies, the
facility shall provide the individual written notice to the next of kin
or to the patient as soon as practical, but not later than when first
presenting a bill for services.
(3) The facility shall make reasonable efforts to communicate the
contents of the individual written notice to persons who it has reason
to believe cannot read the notice.
Sec. 124.505 Eligibility criteria.
(a) A person unable to pay for health services is a person who--
(1) Is not covered, or receives services not covered, under a third-
party insurer or governmental program, except where the person is not
covered because the facility fails to participate in a program in which
it is required to participate by Sec. 124.603(c);
(2) Falls into one of the following categories:
(i) Category A--A person whose annual individual or family income,
as applicable, is not greater than the current poverty line issued by
the Secretary pursuant to 42 U.S.C. 9902 that applies to the individual
or family. The facility shall provide uncompensated services to persons
in Category A without charge.
(ii) Category B--A person whose annual individual or family income,
as applicable, is greater than but not more than twice the poverty line
issued by the Secretary pursuant to 42 U.S.C. 9902 that applies to the
individual or family. If persons in Category B are included in the
allocation plan, the facility shall provide uncompensated services to
these persons without charge, or in accordance with a schedule of
charges as specified in the allocation plan.
(iii) Category C--With respect only to persons seeking or receiving
nursing home services, a person whose annual or family income, as
applicable, is more than twice but not greater than three times the
poverty line issued by the Secretary pursuant to 42 U.S.C. 9902 that
applies to the individual or family. If persons in Category C are
included in the allocation plan, the facility shall provide
uncompensated services to these persons without charge, or in accordance
with a schedule of charges as specified in the allocation plan; and
(3) Requests services within the facility's allocation plan in
effect at the time of the request.
(b) For purposes of determining eligibility for uncompensated
services, revisions of the poverty line are effective 60 days from the
date of their publication in the Federal Register.
(c) A person is eligible for uncompensated services if the person's
individual or family annual income, as applicable, is at or below the
level established under paragraph (a)(2) of this section, when
calculated by either of the following methods:
(1) Multiplying by four the person's or family's income, as
applicable, for the three months preceding the request for uncompensated
services;
[[Page 668]]
(2) Using the person's or family's income, as applicable, for the
twelve months preceding the request for uncompensated services.
[52 FR 46031, Dec. 3, 1987, as amended at 60 FR 16756, Mar. 31, 1995]
Sec. 124.506 Allocation of services; plan requirement.
(a)(1) A facility shall provide its uncompensated services in
accordance with a plan that sets out the method by which the facility
will distribute its uncompensated services among persons unable to pay.
The plan must:
(i) State the type of services that will be made available;
(ii) Specify the method, if any, for distributing those services in
different periods of the year;
(iii) State whether Category B or, in the case of nursing homes
only, Category C persons will be provided uncompensated services, and if
so, whether the services will be available without charge or at a
reduced charge;
(iv) If services will be made available to Category B persons at a
reduced charge, specify the method used for reducing charges, and
provide that the method is applicable to all persons in Category B;
(v) With respect to nursing homes only, if services will be made
available to Category C persons at a reduced charge, specify the method
used for reducing charges, provided that such method may not result in
greater reductions than those afforded to Category B persons, and
provide that this method is applicable to all persons in Category C; and
(vi) Provide that the facility provides uncompensated services to
all persons eligible under the plan who request uncompensated services.
(2) A facility must adopt an allocation plan that meets the
requirements of paragraph (a) by publishing the plan in a newspaper of
general circulation in its area. The plan may take effect no earlier
than 60 days following the date of publication.
(b)(1) If in any fiscal year a facility fails to adopt and publish a
plan in accordance with paragraph (a) of this section, it shall provide
uncompensated services in accordance with the last plan it published in
a newspaper of general circulation in its area.
(2) If no plan was previously published in accordance with paragraph
(a)(2) of this section, the facility must provide uncompensated services
without charge to all applicants in Category A and Category B, and, with
respect to nursing homes, Category C, who request service in the
facility. This requirement applies until the facility ceases to provide
uncompensated services under Sec. 124.508 or until an allocation plan
published in accordance with paragraph (a)(2) of this section becomes
effective.
(c) A facility may revise its allocation plan during the fiscal year
by publishing the revised plan in a newspaper of general circulation in
the area it serves. A revised plan may take effect no earlier than 60
days following the date of publication.
[52 FR 46031, Dec. 3, 1987, as amended at 60 FR 16756, Mar. 31, 1995]
Sec. 124.507 Written determinations of eligibility.
(a) Determinations of eligibility must be in writing, be made in
accordance with this section, and a copy of the determination must be
provided to the applicant promptly.
(b) Content of determinations--(1) Favorable determinations. A
determination that an applicant is eligible must indicate:
(i) That the facility will provide uncompensated services at no
charge or at a specified charge less than the allowable credit for the
services;
(ii) The date on which services were requested;
(iii) The date on which the determination was made;
(iv) The applicant's individual or family income, as applicable, and
family size; and
(v) The date on which services were or will be first provided to the
applicant.
(2) Conditional determinations. (i) As a condition to providing
uncompensated services, a facility may:
(A) Require the applicant to furnish any information that is
reasonably necessary to substantiate eligibility; and
[[Page 669]]
(B) Require the applicant to apply for any benefits under third
party insurer or governmental programs to which he/she is or could be
entitled upon proper application.
(ii) A conditional determination must:
(A) Comply with paragraph (b)(1) of this section; and
(B) State the condition(s) under which the applicant will be found
eligible.
(iii) When a facility determines that the condition(s) upon which a
conditional determination was made has been met, or will not be met, it
shall make a favorable determination or denial on the request, as
appropriate, in accordance with this section.
(3) Denials. A facility must provide to each applicant denied the
uncompensated services requested, in whole or in part, a dated statement
of the reasons for the denial.
(c) Timing of determinations--(1) Preservice determinations. (i)
Facilities other than nursing homes shall make a determination of
eligibility within two working days following a request for
uncompensated services which is made before receipt of outpatient
services or before discharge for inpatient services;
(ii) Nursing homes shall make a determination of eligibility within
ten working days, but no later than two working days following the date
of admission, following a request for uncompensated services made prior
to admission.
(2) Postservice determinations. All facilities shall make a
determination of eligibility not later than the end of the first full
billing cycle following a request for uncompensated services which is
made after receipt of outpatient services, discharge for inpatient
services, or admission for nursing home services.
[52 FR 46031, Dec. 3, 1987; 52 FR 48362, Dec. 21, 1987]
Sec. 124.508 Cessation of uncompensated services.
(a) Facilities not certified under Sec. 124.513, Sec. 124.514,
Sec. 124.515, Sec. 124.516, or Sec. 124.517. Where a facility, other
than a facility certified under Sec. 124.513, Sec. 124.514, Sec.
124.515, Sec. 124.516, or Sec. 124.517, has maintained the records
required by Sec. 124.510(a) and determines based thereon that it has
met its annual compliance level for the fiscal year or the appropriate
level for the period specified in its allocation plan, it may, for the
remainder of that year or period:
(1) Cease providing uncompensated services;
(2) Cease providing individual notices in accordance with Sec.
124.504(c);
(3) Remove the posted notices required by Sec. 124.504(b); and
(4) Post an additional notice stating that it has satisfied its
obligation for the fiscal year or appropriate period and when additional
uncompensated services will be available.
(b) Facilities certified under Sec. 124.514. Where a facility
certified under Sec. 124.514 has maintained the records required by
Sec. 124.510(c) and determines based thereon that it has met its
compliance level, under Sec. 124.514(d), for the fiscal year, it may,
for the remainder of the fiscal year:
(1) Cease providing uncompensated services; and
(2) Discontinue providing notice pursuant to Sec. 124.514(b)(2).
[52 FR 46031, Dec. 3, 1987, as amended at 59 FR 44639, Aug. 30, 1994; 66
FR 49266, Sept. 26, 2001]
Sec. 124.509 Reporting requirements.
(a) Facilities not certified under Sec. 124.513, Sec. 124.514,
Sec. 124.515, Sec. 124.516, or Sec. 124.517.--(1) Timing of reports.
(i) A facility shall submit to the Secretary a report to assist the
Secretary in determining compliance with this subpart once every three
fiscal years, on a schedule to be prescribed by the Secretary.
(ii) A facility shall submit the required report more frequently
than once every three years under the following circumstances:
(A) If the facility determines that in the preceding fiscal year it
did not provide uncompensated services at the annual compliance level,
it shall submit a report.
(B) If the Secretary determines, and notifies the facility in
writing that a report is needed for proper administration of the
program, the facility shall submit a report within 90 days after
receiving notice from the Secretary, or
[[Page 670]]
within 90 days after the close of the fiscal year, whichever is later.
(iii) Except as specified in paragraph (a)(1)(ii)(B) of this
section, the reports required by this section shall be submitted within
90 days after the close of the fiscal year, unless a longer period is
approved by the Secretary for good cause.
(2) Content of report. The report must include the following
information in a form prescribed by the Secretary:
(i) Information that the Secretary prescribes to permit a
determination of whether a facility has met the annual compliance level
for the fiscal years covered by the report;
(ii) The date on which the notice required by Sec. 124.504(a) was
published, and the name of the newspaper that printed the notice;
(iii) If the amount of uncompensated services provided by the
facility in the preceding fiscal year was lower than the annual
compliance level, an explanation of why the facility did not meet the
required level. If the facility claims that it failed to meet the
required compliance level because it was financially unable to do so, it
shall explain and provide documentation prescribed by the Secretary;
(iv) If the facility is required to submit an affirmative action
plan, a copy of the plan.
(v) Other information that the Secretary prescribes.
(3) Institution of suit. Not later than 10 days after being served
with a summons or complaint the facility shall notify the HHS Regional
Health Administrator \1\ for the Region in which it is located of any
legal action brought against it alleging that it has failed to comply
with the requirements of this subpart.
---------------------------------------------------------------------------
\1\ The addresses of the HHS Regional Offices are set out in 45 CFR
5.31.
---------------------------------------------------------------------------
(b) Facilities certified under Sec. 124.513 or Sec. 124.516. A
facility certified under Sec. 124.513 or Sec. 124.516 shall comply
with paragraph (a)(3) of this section and shall submit within 90 days
after the close of its fiscal year, as appropriate:
(1) A certification, signed by the responsible official of the
facility, that there has been no material change in the factors upon
which the certification was based; or
(2) A certification, signed by the responsible official of the
facility and supported by appropriate documentation, that there has been
a material change in the factors upon which the certification was based.
(c) Facilities certified under Sec. 124.514. A facility certified
under Sec. 124.514 shall comply with paragraph (a)(3) of this section
and shall submit within 90 days after the close of its fiscal year, as
appropriate:
(1)(i) A certification, signed by the responsible official of the
facility, that there has been no material change in the factors upon
which the certification was based; or
(ii) A certification, signed by the responsible official of the
facility and supported by appropriate documentation, that there has been
a material change in the factors upon which the certification was based;
and
(2) A certification, signed by the responsible official of the
facility, of the amount of uncompensated services provided in the
previous fiscal year.
(d) Facilities certified under Sec. 124.515. A facility certified
under Sec. 124.515 shall submit such reports as are required by the
terms of its grant under section 329 or 330 or by its agreement under
section 334 of the Act, as applicable, at such intervals as the
Secretary may require.
(e) Facilities certified under Sec. 124.517. If a facility
certified under Sec. 124.517 ceases to provide uncompensated services
consistent with its certification under that section because of
financial inability, it shall report such cessation to the Secretary
within 90 days of the cessation and provide any documentation or
information relating to the provision or cessation of uncompensated
services that the Secretary may require.
(Approved by the Office of Management and Budget under control number
0915-0077)
[52 FR 46031, Dec. 3, 1987, as amended at 52 FR 48362, Dec. 21, 1987; 54
FR 52939, Dec. 26, 1989; 59 FR 44639, Aug. 30, 1994; 66 FR 49266, Sept.
26, 2001]
[[Page 671]]
Sec. 124.510 Record maintenance requirements.
(a) Facilities not certified under Sec. 124.513, Sec. 124.514,
Sec. 124.515, Sec. 124.516, or Sec. 124.517. (1) A facility shall
maintain, make available for public inspection consistent with personal
privacy, and provide to the Secretary on request, any records necessary
to document its compliance with the requirements of this subpart in any
fiscal year, including:
(i) Any documents from which the information required to be reported
under Sec. 124.509(a) was obtained;
(ii) Accounts which clearly segregate uncompensated services from
other accounts; and
(iii) Copies of written determinations of eligibility under Sec.
124.507.
(2) A facility shall retain the records maintained pursuant to
paragraph (a)(1) for three years after submission of the report required
by Sec. 124.509(a)(1), except where a longer period is required by the
Secretary, or until 180 days following the close of the Secretary's
assessment investigation under Sec. 124.511(b), whichever is less.
(3) A facility shall, within 60 days of the end of each fiscal year,
determine the amount of uncompensated services it provided in that
fiscal year. Documents that support the facility's determination shall
be made available to the public on request. If a report is or will be
filed under Sec. 124.509(a)(1), a facility may respond to a request by
providing a copy of the report to the requester.
(b) Facilities certified under Sec. 124.513, Sec. 124.514, Sec.
124.516, or Sec. 124.517. A facility certified under Sec. 124.513,
Sec. 124.514, Sec. 124.516, or Sec. 124.517 shall retain, make
available for public inspection consistent with personal privacy, and
provide to the Secretary on request any records necessary to document
compliance with the applicable requirements of this subpart in any
fiscal year, including those documents provided to the Secretary under
Sec. 124.513(c), Sec. 124.514(c), Sec. 124.516(c), or Sec.
124.517(b), as applicable. A facility shall maintain these records for
three years, except where a longer period is required as a result of an
investigation by the Secretary. In such cases, records must be kept
until 180 days following the close of the Secretary's assessment
investigation under Sec. 124.511(b).
(c) Facilities certified under Sec. 124.515. A facility certified
under Sec. 124.515 shall maintain the records required by its grant
under section 329 or section 330 or its agreement under section 334 of
the Act, as applicable, for such period of time as the grant agreement
may require.
(Information collection requirements in paragraphs (a) and (b) approved
by the Office of Management and Budget under control number 0915-0103)
[52 FR 46031, Dec. 3, 1987; 52 FR 48362, Dec. 21, 1987; 59 FR 44639,
Aug. 30, 1994; 66 FR 49266, Sept. 26, 2001]
Sec. 124.511 Investigation and determination of compliance.
(a) Complaints. A complaint that a facility is out of compliance
with the requirements of this subpart may be filed with the Secretary by
any person.
(1) A complaint is considered to be filed with the Secretary on the
date the following information is received in the Office of the HHS
Regional Health Administrator for the Region in which the facility is
located:
(i) The name and address of the person making the complaint or on
whose behalf the complaint is made;
(ii) The name and location of the facility;
(iii) The date or approximate date on which the event occurred; and
(iv) A statement of what actions the complainant considers to
violate the requirements of this subpart.
(2) The Secretary promptly provides a copy of the complaint to the
facility named in the complaint.
(3) When the Secretary investigates a facility, the facility,
including a facility certified under Sec. 124.513, Sec. 124.514, Sec.
124.515, Sec. 124.516, or Sec. 124.517, shall provide to the Secretary
on request any documents, records and other information concerning its
operation that relate to the requirements of this subpart. A facility
will be presumed to be out of compliance with its assurance unless it
supplies documentation sufficient to show compliance with the applicable
provisions of this subpart.
(4) Section 1627 of the Act provides that if the Secretary dimisses
a complaint or the Attorney General has not
[[Page 672]]
brought an action for compliance within six months from the date on
which the compliant is filed, the person filing it may bring a private
action to effectuate compliance with the assurance. If the Secretary
determines that he/she will be unable to issue a decision on a complaint
or otherwise take appropriate action within the six month period, the
Secretary may, based on priorities for the disposition of complaints
that are established to promote the most effective use of enforcement
resources, or on the request of the applicant, dismiss the complaint
without a finding as to compliance prior to the end of the six month
period, but no earlier than 45 days after the complaint is filed.
(b) Assessments. The Secretary periodically investigates and
assesses facilities to ascertain compliance with the requirements of
this subpart, including certification of the amount of uncompensated
services provided in a fiscal year or years, and provides guidance and
prescribes corrective action to correct noncompliance.
(1) Compliance after February 1, 1988. (i) The Secretary may certify
that a facility has substantially complied with its assurance for a
fiscal year or years, and such certification shall establish that the
facility provided the amount of uncompensated services certified for the
period covered by the certification.
(ii) A certification of substantial compliance shall be based on the
amount properly claimed by the facility pursuant to Sec. 124.509(a),
utilizing procedures determined by the Secretary to be sufficient to
establish that the facility has substantially complied with its
assurance for the period covered by the certification. The procedures
will include examination of individual account data to the extent deemed
necessary by the Secretary.
(iii) A certification of substantial compliance will be made where
the Secretary determines that, for the period covered by the
certification, the facility provided uncompensated services to eligible
persons who had equal opportunity to apply therefor. In making this
determination, the Secretary will consider, in descending order of
importance, whether--
(A) Corrective action prescribed pursuant to Sec. 124.512(b) has
been taken by the facility;
(B) Any noncompliance with the requirements of this subpart may be
remedied by corrective action under Sec. 124.512(b);
(C) The facility had procedures in place that complied with the
requirements of Sec. 124.504(c), Sec. 124.505, Sec. 124.507, Sec.
124.509, 125.510, Sec. 124.513(b)(2), Sec. 124.514(b)(2), Sec.
124.515, Sec. 124.516(b)(1) or (b)(2), as applicable, or Sec.
124.517(b), and systematically and correctly followed such procedures.
(2) Compliance prior to February 1, 1988. The Secretary will
determine the amount of creditable services provided prior to the
effective date of these rules using the compliance standards applicable
under the rules as promulgated on May 18, 1979, based on procedures
determined by the Secretary to be sufficient to establish that the
facility provided such amounts of uncompensated services in the
period(s) being assessed.
(c) Determinations of financial inability. In determining whether a
facility was or is financially able to meet its annual compliance level,
the Secretary will consider any comments submitted by interested
parties. In making this determination, the Secretary will consider
factors such as:
(1) The ratio of revenues to expenses;
(2) The occupancy rate;
(3) The ratio of current assets to current liabilities;
(4) The average cost per patient day;
(5) The number of days of operating expenses in accounts payable;
(6) The number of days of revenues in accounts receivable;
(7) The sinking fund (or depreciation fund) balance;
(8) The debt coverage ratio; and
(9) The availability of restricted or unrestricted funds (such as an
endowment) available for charitable use.
[52 FR 46031, Dec. 3, 1987; 52 FR 48362, Dec. 21, 1987; 53 FR 5576, Feb.
25, 1988; 59 FR 44639, Aug. 30, 1994; 66 FR 49266, Sept. 26, 2001]
Sec. 124.512 Enforcement.
(a) If the Secretary finds, based on his/her investigation under
Sec. 124.511, that a facility did not comply with the
[[Page 673]]
requirements of this subpart, the Secretary may take any action
authorized by law to secure compliance, including but not limited to,
voluntary agreement or a request to the Attorney General to bring an
action against the facility for specific performance.
(b) A facility, including a facility certified under Sec. 124.513,
Sec. 124.514, Sec. 124.516, or Sec. 124.517, that has denied
uncompensated services to any person because it failed to comply with
the requirements of this subpart will not be in compliance with its
assurance until it takes whatever steps are necessary to remedy fully
the noncompliance, including:
(1) Provision of uncompensated services to applicants improperly
denied;
(2) Repayment of amounts improperly collected from persons eligible
to receive uncompensated services; and
(3) Other corrective actions prescribed by the Secretary.
(c) The Secretary may disallow all of the uncompensated services
claimed in a fiscal year where the Secretary finds that the facility was
in substantial noncompliance with its assurance because it failed to:
(1) Have a system for providing notice to eligible persons as
required by Sec. 124.504(c), Sec. 124.513(b)(2), Sec. 124.514(b)(2),
Sec. 124.516 (b)(2)(ii)(A), or Sec. 124.517(b)(2), as applicable;
(2) Comply with the applicable reporting requirements of Sec.
124.509;
(3) Have a system for maintaining records of uncompensated services
provided in accordance with Sec. 124.510; or
(4) Take corrective action prescribed pursuant to paragraph (b) of
this section.
(d) In the absence of a finding of substantial compliance or
substantial noncompliance in a fiscal year, the Secretary may disallow
uncompensated services claimed by a facility in that fiscal year to the
extent that the Secretary finds that such services are not documented as
uncompensated services under Sec. 124.510 or are subject to
disallowance under Sec. 124.513(d) or Sec. 124.514(d), as applicable.
[52 FR 46031, Dec. 3, 1987, as amended at 59 FR 44639, Aug. 30, 1994; 66
FR 49266, Sept. 26, 2001]
Sec. 124.513 Public facility compliance alternative.
(a) Effect of certification. The Secretary may certify a facility
which meets the requirements of paragraphs (b) and (c) of this section
as a ``public facility''. A facility which is so certified is not
required to comply with this subpart except as otherwise herein
provided.
(b) Criteria for qualification. A public facility may qualify for
certification under this section if all of the following criteria are
met:
(1) It is a facility which is owned and operated by a unit of State
or local government or a quasi-public corporation as defined at 42 CFR
124.2(m).
(2) It provides health services without charge or at a substantially
reduced rate to persons who are determined by the facility to qualify
therefor under a program of discounted health services. A ``program of
discounted health services'' must provide for financial and other
objective eligibility criteria and procedures, including notice prior to
nonemergency service, that assure effective opportunity for all persons
to apply for and obtain a determination of eligibility for such
services, including a determination prior to service where requested;
provided that, such criteria and procedures are not required where the
facility makes all services available to all persons at no or nominal
charge.
(3)(i) It received, for the three most recent fiscal years, at least
10 percent of its total operating revenue (net patient revenue plus
other operating revenue, exclusive of any amounts received, or if not
received, claimed, as reimbursement under titles XVIII and XIX of the
Social Security Act) from State and local tax appropriations or other
State and local government revenues, or from a quasi-public corporation
as defined at 42 CFR 124.2(m), to cover operating deficits attributable
to the provision of discounted services; or
(ii) If provided, in each of the three most recent fiscal years,
uncompensated services under this subpart or under programs described by
the documentation provided under Sec. 124.513(c)(2) in an amount not
less than twice the annual compliance level computed under Sec.
124.503(a).
[[Page 674]]
(c) Procedures for certification. To be certified under this
section, a facility must submit to the Secretary, in addition to other
materials that the Secretary may from time to time require, copies of
the following:
(1) Audited financial statements or official State or local
government documents (such as annual reports or budget documents), for
the three most recent fiscal years, sufficient to show that the facility
meets the criteria in paragraph (b)(3)(i) or (ii) of this section.
(2) A complete description of its program(s) of discounted health
services, including charging and collection policies of the facility,
and eligibility criteria and notice and determination procedures used
under its program(s) of discounted services.
(d) Period of effectiveness. (1) A certification by the Secretary
under this section remains in effect until withdrawn. The Secretary may
disallow credit under this subpart when the Secretary determines that
there has been a material change in any factor upon which certification
was based or substantial noncompliance with this subpart. The Secretary
may withdraw certification where the change or noncompliance has not
been adequately remedied or otherwise continues.
(2) Deficits--(i) Title VI-assisted facilities with assessed
deficits. Where a facility assisted under title VI of the Act has been
assessed as having a deficit under Sec. 124.503(b) that has not been
made up prior to certification under this section, the facility may make
up that deficit by either--
(A) Demonstrating to the Secretary's satisfaction, that it met the
requirements of paragraph (b) of this section for each year in which a
deficit was assessed; or
(B) Providing an additional period of service under this section on
the basis of one (or portion of a) year of certification for each year
(or portion of a year) of deficit assessed. The period of obligation
applicable to the facility under Sec. 124.501(b) shall be extended
until the deficit is made up in accordance with the preceding sentence.
(ii) Title VI-assisted facilities which have not been assessed.
Where any period of compliance under this subpart of a facility assisted
under title VI of the Act has not been assessed, the facility will be
presumed to have no allowable credit for such period. The facility may
either--
(A) Make up such deficit in accordance with paragraph (d)(2)(i) of
this section; or
(B) Submit an independent certified audit, conducted in accordance
with procedures specified by the Secretary, of the facility's records
maintained pursuant to Sec. 124.510. If the audit establishes to the
Secretary's satisfaction that no, or a lesser, deficit exists for the
period in question, the facility will receive credit for the period so
justified. Any deficit which the Secretary determines still remains must
be made up in accordance with paragraph (d)(2)(i) of this section.
(iii) Title XVI-assisted facilities. (A) A facility assisted under
title XVI of the Act which has an assessed deficit which was not made up
prior to certification under this section shall make up that deficit in
accordance with paragraph (d)(2)(i)(A) of this section. If it cannot
make the showing required by that paragraph, it shall make up the
deficit when its certification under this section is withdrawn.
(B) A facility assisted under title XVI of the Act whose compliance
with this subpart has not been completely assessed will be presumed to
have no allowable credit for the unassessed period. The facility may
make up the deficit by--
(1) Following the procedure of subparagraph (d)(2)(iii)(A) of this
section; or
(2) Submitting an independent certified audit, conducted in
accordance with procedures specified by the Secretary, of the facility's
records maintained pursuant to Sec. 124.510. If the audit establishes
to the Secretary's satisfaction that no, or a lesser, deficit exists for
the period in question, the facility will receive credit for the period
so justified. Any deficit which the Secretary determines still remains
must be made up in accordance with paragraph (d)(2)(iii)(A) of this
section.
(Approved by the Office of Management and Budget under control number
0915-0103)
[52 FR 46031, Dec. 3, 1987; 52 FR 48362, Dec. 21, 1987]
[[Page 675]]
Sec. 124.514 Compliance alternative for facilities with small annual
obligations.
(a) Effect of certification. The Secretary may certify a facility
which meets the requirements of paragraphs (b) and (c) of this section
as a ``facility with a small annual obligation.'' A facility which is so
certified is not required to comply with this subpart except as
otherwise herein provided.
(b) Criteria for qualification. A facility may qualify for
certification under this section if all of the following criteria are
met:
(1)(i) Title VI-assisted facilities. (A) For the facility's fiscal
year in which this section becomes effective, the level, computed under
Sec. 124.503(c) (3), divided by the number of years remaining in its
period of obligation (including an additional year or portion of a year
for each year or portion of a year in which a deficit was incurred and
has not been made up), is not more than $10,000;
(B) For a subsequent fiscal year, the level computed under paragraph
(A) of this paragraph (b)(1)(i), is at or less than $10,000, adjusted by
a percentage equal to the percentage change in the CPI available in the
year in which this section becomes effective and the most recent year
for which a published index is available.
(ii) Title XVI-assisted facilities. (A) For the facility's fiscal
year in which this section becomes effective, the level under Sec.
124.503(a), plus the amount of any noncompliance deficits which have not
been made up, is at or less than $10,000.
(B) For a subsequent fiscal year, the level, computed under
paragraph (A) of this paragraph (b)(1)(ii), is at or less than $10,000,
adjusted as provided in paragraph (b)(1)(i)(B) of this section.
(2) It provides health services without charge or at a substantially
reduced rate to persons who are determined by the facility to qualify
threrefor under a program of discounted health services. A ``program of
discounted health services'' must provide for financial and other
objective eligibility criteria and procedures, including notice prior to
nonemergency service, that assure effective opportunity for all persons
to apply for and obtain a determination of eligibility for such
services, including a determination prior to service where requested;
Provided that, such criteria and procedures are not required where the
facility makes all services available to all persons at no or nominal
charge.
(c) Procedures for certification. To be certified under this
section, a facility must submit to the Secretary, in addition to other
materials that the Secretary may from time to time require, a complete
description of its program(s) of discounted health services, including
charging and collection policies of the facility, and eligibility
criteria and notice and determination precedures used under its
program(s) of discounted services.
(d) Period of effectiveness. A certification by the Secretary under
this section remains in effect until withdrawn. During the period in
which such certification is in effect, the facility must provide
uncompensated services in an amount not less than the level applicable
under paragraph (b)(1) of this section for each fiscal year. The
Secretary may disallow credit under this subpart when the Secretary
determines that there has been a material change in any factor upon
which certification was based or substantial noncompliance with this
subpart. The Secretary may withdraw certification where the change or
noncompliance cannot be or has not been adequately remedied or
noncompliance otherwise continues.
(e) Deficits. (1) Where the compliance level of a facility assisted
under title VI of the Act is computed under paragraph (b)(1)(i)(A) of
this section as including additional year(s) or a portion of a year, the
facility's period of obligation under this subpart shall be extended by
such additional period, until certification is withdrawn.
(2) Where a facility has been assessed as having a deficit under
Sec. 124.503(b) that has not been made up prior to withdrawal of
certification under this section or fails to provide services as
required by paragraph (d) of this section, the facility must make up the
[[Page 676]]
deficit in accordance with Sec. 124.503(b) following withdrawal of
certification.
(Approved by the Office of Management and Budget under control number
0915-0077)
[52 FR 46031, Dec. 3, 1987, as amended at 52 FR 48362, Dec. 21, 1987; 54
FR 52939, Dec. 26, 1989]
Sec. 124.515 Compliance alternative for community health centers, migrant
health centers and certain National Health Service Corps sites.
(a) Period of effectiveness. For each fiscal year for which a
facility that receives a grant to operate a community health center
under section 330 of the Act or a migrant health center under section
329 of the Act is in substantial compliance with the terms and
conditions of such grant relating to the provision of services at a
discount, the facility shall be certified as having met its annual
compliance level in accordance with the requirements of this subpart and
shall not be required otherwise to comply with the requirements of this
subpart for that fiscal year. This provision also applies to any
facility that has signed a memorandum of agreement with the Secretary
under section 334 of the Act if the services provided by the National
Health Service Corps professional(s) assigned pursuant to that agreement
constitute all of the medical services provided by the facility.
(b) Deficits--(1) Title VI-assisted facilities with assessed
deficits. Where a facility assisted under title VI of the Act has been
assessed as having a deficit under Sec. 124.503(b) that has not been
made up prior to certification under this section, the facility may make
up that deficit by either--
(i) Demonstrating to the Secretary's satisfaction that it met the
requirements of paragraph (a) of this section for each year in which a
deficit was assessed; or
(ii) Providing an additional period of service under this section on
the basis of one (or portion of a) year of certification for each year
(or portion of a year) of deficit assessed. The period of obligation
applicable to the facility under Sec. 124.501(b) shall be extended
until the deficit is made up in accordance with the preceding sentence.
(2) Title VI-assisted facilities which have not been assessed. Where
any period of compliance under this subpart of a facility assisted under
title VI of the Act has not been assessed, the facility will be presumed
to have no allowable credit for such period. The facility may either--
(i) Make up such deficit in accordance with paragraph (b)(1) of this
section; or
(ii) Submit an independent certified audit, conducted in accordance
with procedures specified by the Secretary, of the facility's records
maintained pursuant to Sec. 124.510. If the audit establishes to the
Secretary's satisfaction that no, or a lesser, deficit exists for the
period in question, the facility will receive credit for the period so
justified. Any deficit which the Secretary determines still remains must
be made up in accordance with paragraph (b)(1) of this section.
(3) Title XVI-assisted facilities. (i) A facility assisted under
title XVI of the Act which has an assessed deficit which was not made up
prior to certification under this section shall make up that deficit in
accordance with paragraph (b)(1)(i) of this section. If it cannot make
the showing required by that paragraph, it shall make up the deficit
when it is no longer certified under this section.
(ii) A facility assisted under title XVI of the Act whose compliance
with this subpart has not been completely assessed will be presumed to
have no allowable credit for the unassessed period. The facility may
make up the deficit by--
(A) Following the procedure of paragraph (b)(3)(i) of this section;
or
(B) Submitting an independent certified audit, conducted in
accordance with procedures specified by the Secretary, of the facility's
records maintained pursuant to Sec. 124.510. If the audit establishes
to the Secretary's satisfaction that no, or a lesser, deficit exists for
the period in question, the facility will receive credit for the period
so justified. Any deficit which the Secretary determines still remains
must be made
[[Page 677]]
up in accordance with paragraph (b)(3)(i) of this section.
(Approved by the Office of Management and Budget under control number
0915-0077)
[52 FR 46031, Dec. 3, 1987, as amended at 52 FR 48362, Dec. 21, 1987; 54
FR 52939, Dec. 26, 1989]
Sec. 124.516 Charitable facility compliance alternative.
(a) Effect of certification. The Secretary may certify as a
``charitable facility'' a facility which meets the applicable
requirements of this section. A facility which is certified or
provisionally certified as a charitable facility is not required to
comply with this subpart except as provided in this section.
(b) Methods of qualification for certification or provisional
certification. (1) A facility may qualify for certification under this
section if it meets the criteria of paragraph (c)(1) or paragraph (c)(2)
of this section.
(2) A facility may qualify for a provisional certification under
this section if it provides an assurance that meets the requirements of
paragraph (d)(2) of this section.
(c) Criteria for certification under paragraph (b)(1) of this
section. A facility may qualify for certification under paragraph (b)(1)
of this section if it met the criteria of either paragraph (c)(1) or
paragraph (c)(2) of this section for the fiscal year preceding the
request for certification. A facility that seeks certification under
paragraph (c)(2) of this section must also meet the requirements of
paragraph (c)(2)(i) or paragraph (c)(2)(ii) of this section during each
year of certification.
(1)(i) For facilities that are nursing homes: It received no monies
directly from patients with incomes up to triple the current poverty
line issued by the Secretary pursuant to 42 U.S.C. 9902, exclusive of
amounts charged or received for purposes of claiming reimbursement under
third party insurance or governmental programs, such as Medicaid or
Medicare deductible or co-insurance amounts.
(ii) For all other facilities. It received no monies directly from
patients with incomes up to double the current poverty line issued by
the Secretary pursuant to 42 U.S.C. 9902, exclusive of amounts charged
or received for purposes of claiming reimbursement under third party
insurance or governmental programs, such as Medicaid or Medicare
deductible or coinsurance amounts.
(2) It received at least 10 percent of its total operating revenue
(net patient revenue plus other operating revenue, exclusive of any
amounts received, or if not received, claimed, as reimbursement under
Medicaid or Medicare) from philanthropic sources to cover operating
deficits attributable to the provision of discounted services.
Philanthropic sources include private trusts, foundations, churches,
charitable organizations, state and/or local funding, and individual
donors; and either--
(i) Provides health services without charge or at a substantially
reduced rate (exclusive of amounts charged or received for purposes of
claiming reimbursement under third party insurance or governmental
programs, such as Medicaid or Medicare deductible or coinsurance
amounts) to persons who are determined by the facility to qualify for
such reduced charges under a program of discounted health services. A
``program of discounted health services'' must provide for financial and
other objective eligibility criteria and procedures, including notice
prior to nonemergency service, that assure effective opportunity for all
persons to apply for and obtain a determination of eligibility for such
services, including a determination prior to service where requested; or
(ii) Makes all services of the facility available to all persons at
no more than a nominal charge, exclusive of amounts charged or received
for purposes of claiming reimbursement under third party insurance or
governmental programs, such as Medicaid or Medicare deductible or
coinsurance amounts.
(d) Procedures for certification--(1) Certification under paragraph
(b)(1) of this section. To be certified under paragraph (b)(1) of this
section, a facility must submit to the Secretary, in addition to other
materials that the Secretary may from time to time require, copies of
the following:
(i) An audited financial statement for the fiscal year preceding the
request or
[[Page 678]]
other documents prescribed by the Secretary, sufficient to show that the
facility meets the criteria of paragraph (c)(1) or (c)(2) of this
section, as applicable;
(ii) Where a facility claims qualification under paragraph (c)(2)(i)
of this section, a complete description, and documentation where
requested, of its program of discounted health services, including
charging and collection policies of the facility, and eligibility
criteria and notice and determination procedures used under its
program(s) of discounted health services;
(iii) Where the facility claims qualification under paragraph (c)(1)
or paragraph (c)(2)(ii) of this section, a complete description, and
documentation where requested, of its admission, charging, and
collection policies.
(2) Provisional certification under paragraph (b)(2) of this
section. (i) In order to receive a provisional certification under
paragraph (b)(2) of this section, prior to the beginning of the fiscal
year for which provisional certification will be sought, the facility
must submit to the Secretary an assurance, together with such
documentation and in such form and manner as the Secretary may require,
that it will operate during the fiscal year a program that qualifies for
certification under paragraph (b)(1) of this section.
(ii) No later than 90 days following the end of the fiscal year in
which a facility has operated a provisionally certified program, the
facility must submit to the Secretary, the documentation required, as
applicable, under paragraph (d)(1) of this section.
(e) Period of effectiveness--(1) Certification under paragraph
(b)(1) of this section. A certification by the Secretary under paragraph
(b)(1) of this section remains in effect until withdrawn. The Secretary
may disallow credit under this subpart when the Secretary determines
that there has been a material change in any factor upon which
certification was based or substantial noncompliance with this section.
The Secretary may withdraw certification where the change or
noncompliance has not been, in the Secretary's judgment, adequately
remedied or otherwise continues.
(2) Provisional certification under paragraph (b)(2) of this
section. Where the Secretary is satisfied, based on the documentation
submitted by the facility in accordance with paragraph (d)(2)(ii) of
this section and any other information available to the Secretary, that
the facility has complied with the terms of its provisional
certification under paragraph (b)(2) of this section, the Secretary
shall certify the facility under paragraph (b)(1) of this section. If
the Secretary finds that the facility has not complied with the terms of
its provisional certification under paragraph (b)(2) of this section,
the facility will receive no credit towards its uncompensated services
obligation during the fiscal year of provisional certification.
(f) Deficits--(1) Title VI-assisted facilities--(i) Title VI-
assisted facilities with assessed deficits. Where a facility assisted
under title VI of the Act has been assessed as having a deficit under
Sec. 124.503(b) that has not been made up prior to certification under
paragraph (b)(1) of this section, the facility may make up that deficit
by either--
(A) Demonstrating to the Secretary's satisfaction that it met the
applicable requirements of paragraph (c) of this section for each year
in which a deficit was assessed; or
(B) Providing an additional period of service under this section on
the basis of one year (or portion of a year) of certification for each
year (or portion of a year) of deficit assessed. The period of
obligation applicable to the facility under Sec. 124.501(b) shall be
extended until the deficit is made up in accordance with the preceding
sentence.
(ii) Title VI-assisted facilities with unassessed deficits. Where
any period of compliance under this subpart of a facility assisted under
title VI of the Act has not been assessed, the facility will be presumed
to have no allowable credit for the unassessed period. The facility may
either--
(A) Make up such deficit in accordance with paragraph (f)(1)(i) of
this section; or
(B) Submit an independent certified audit, conducted in accordance
with procedures specified by the Secretary, of the facility's records
maintained
[[Page 679]]
pursuant to Sec. 124.510. If the audit establishes to the Secretary's
satisfaction that no, or a lesser, deficit exists for the period in
question, the facility will receive credit for the period so justified.
Any deficit which the Secretary determines still remains must be made up
in accordance with paragraph (f)(1)(i)(B) of this section.
(2) Title XVI-assisted facilities--(i) Title XVI-assisted facilities
with assessed deficits. A facility assisted under title XVI of the Act
which has an assessed deficit which was not made up prior to
certification under paragraph (b)(1) of this section shall make up that
deficit in accordance with paragraph (f)(1)(i) of this section. If it
cannot make the showing required by that paragraph, it shall make up the
deficit when its certification under paragraph (b)(1) of this section is
withdrawn.
(ii) Title XVI-assisted facilities with unassessed deficits. Where
any period of compliance under this subpart of a facility assisted under
title XVI of the Act has not been assessed, the facility will be
presumed to have no allowable credit for the unassessed period. The
facility may either--
(A) Make up such deficit in accordance with paragraph (f)(1)(i) of
this section; or
(B) Submit an independent certified audit, conducted in accordance
with procedures specified by the Secretary, of the facility's records
maintained pursuant to Sec. 124.510. If the audit establishes to the
Secretary's satisfaction that no, or a lesser, deficit exists for the
period in question, the facility will receive credit for the period so
justified. Any deficit which the Secretary determines still remains must
be made up in accordance with paragraph (f)(2)(i) of this section.
[66 FR 49267, Sept. 26, 2001]
Sec. 124.517 Unrestricted availability compliance alternative for Title VI-
assisted facilities.
(a) Effect of certification. The Secretary may certify a Title VI-
assisted facility which meets the requirements of paragraph (b) of this
section and the applicable requirements of this subpart as an
unrestricted availability facility. A facility which is so certified is
not required to comply with the requirements of this subpart, except as
provided in this section or elsewhere in this subpart.
(b) Criteria for qualification. A facility may qualify for
certification under this section if, for any fiscal year for which
certification is sought, it operates a compliant, fully expanded
uncompensated services program. Such a program must meet the following
criteria:
(1) It makes all services of the facility available without charge
to all persons requesting uncompensated services from the facility who
are eligible under Sec. 124.505, including all persons coming within
Category B and, if applicable, Category C.
(2) It complies with the notice and allocation plan requirements of
Sec. Sec. 124.504 and 124.506, except that all notices published or
provided must describe an allocation plan and program consistent with
paragraph (b)(1) of this section.
(3) It makes written determinations in accordance with Sec.
124.507, except that all favorable determinations must indicate that the
facility will provide uncompensated services at no charge.
(4) It provides uncompensated services consistent with the
requirements of this section for the entire fiscal year for which
certification is sought, except that a facility may
(i) Cease providing such services and still receive credit,
calculated in accordance with paragraph (d) of this section, where--
(A) The facility has completed its total uncompensated services
obligation, including making up any deficit; or
(B) The facility determines, and submits documentation which the
Secretary finds, taking into account the factors identified in Sec.
124.511(c), sufficient to establish that it is financially unable to
continue to meet the requirements of this section for the remainder of
the fiscal year; and
(ii) Receive a portion of a year's credit for the first partial year
in which it began operating a fully expanded program, as long as it
continued to operate the fully expanded program in subsequent years.
(c) Period of effectiveness. A certification by the Secretary under
this section remains in effect until withdrawn.
[[Page 680]]
The Secretary may withdraw certification under this section where the
Secretary determines the facility is in substantial noncompliance with
the requirements of paragraph (b) of this section and has not adequately
remedied or otherwise continues such noncompliance. Where the Secretary
withdraws certification for part or all of a fiscal year or years, no
credit may be granted for the period of unremedied substantial
noncompliance.
(d) Deficits. (1) Where a Title VI-assisted facility has been
assessed as having a deficit under Sec. 124.503(b) that has not been
made up prior to certification under this section, the facility may make
up the deficit by providing uncompensated services in accordance with
this section. The facility shall receive credit towards its deficit on
the basis of one year, or part thereof, of credit towards each ``deficit
year'' for each year, or part thereof, of operation in compliance with
this section and the applicable requirements of this subpart.
(2) The number of ``deficit years'' of a facility shall be
calculated as follows:
(i) Determine the number of years in the facility's total period of
obligation pursuant to Sec. 124.501;
(ii) Subtract the number of years in which the facility operated in
compliance with this section and the applicable requirements of this
subpart from the number of years derived under paragraph (d)(2)(i) of
this section;
(iii) For all years in which the facility did not operate in
compliance with this section, determine the ratio of the total
compliance levels applicable under Sec. 124.503(a) to the facility's
total deficit under Sec. 124.503(b);
(iv) Multiply the percentage derived under paragraph (d)(2)(iii) of
this section by the number of years under obligation pursuant to Sec.
124.501 but for which the facility did not operate in compliance with
this section;
(v) Subtract the number derived under paragraph (d)(2)(iv) of this
section from the number of years derived under paragraph (d)(2)(ii) of
this section;
(vi) If the facility is still within the period described in Sec.
124.501(b)(1), add the number of years derived under paragraph (d)(2)(v)
of this section to the end of the period of obligation, or if the
facility is beyond the period described in Sec. 124.501(b)(1), add the
number of years derived under paragraph (d)(2)(v) of this section to the
last year the facility operated in compliance with this section.
[66 FR 49268, Sept. 26, 2001]
Sec. 124.518 Agreements with State agencies.
(a) Where the Secretary finds that it will promote the purposes of
this subpart and the State agency is able and willing to do so, the
Secretary may enter into an agreement with an agency of a State to
assist in administering this subpart in the State. An agreement may be
terminated by the Secretary or the State agency on 60 days notice.
(b) Under an agreement the State agency will provide any assistance
the Secretary requests in any one or more of the following areas, as set
out in the agreement:
(1) Investigation of complaints regarding noncompliance;
(2) Monitoring compliance of facilities with the requirements of
this subpart;
(3) Review of reports submitted under Sec. 124.509, including
affirmative action plans;
(4) Making initial decisions for the Secretary with respect to
compliance, subject to appeal by any party to the Secretary, or review
by the Secretary on the Secretary's initiative; and
(5) Application of any sanctions available to it under State law
(such as license revocation or termination of State assistance) against
facilities determined to be out of compliance with the requirements of
this subpart.
(c) Nothing in this subpart precludes any State from taking any
action authorized by State law regarding the provision of uncompensated
services by facilities in the State as long as the action taken does not
prevent the Secretary from enforcing the requirements of this subpart.
[52 FR 46031, Dec. 3, 1987. Redesignated at 59 FR 44639, Aug. 30, 1994]
[[Page 681]]
Subpart G_Community Service
Authority: Secs. 215, 1525, 1602(6), Public Health Service Act as
amended; 58 Stat 690, 88 Stat. 2249, 2259; 42 U.S.C. 216, 300m-4, 300o-
1(6).
Source: 44 FR 29379, May 18, 1979, unless otherwise noted.
Sec. 124.601 Applicability.
The provisions of this subpart apply to any recipient of Federal
assistance under title VI or XVI of the Public Health Service Act that
has given an assurance that it would make the facility or portion
thereof assisted available to all persons residing (and, in the case of
title XVI assisted applicants, employed), in the territorial area it
serves. This assurance is referred to in this subpart as the ``community
service assurance.''
Sec. 124.602 Definitions.
As used in this subpart:
Act means the Public Health Service Act, as amended.
Facility means the an entity that received assistance under title VI
or title XVI of the Act and provided a community service assurance.
Fiscal year means facility's fiscal year.
Secretary means the Secretary of Health and Human Services or his
delegatee.
Service area means the geographic area designated as the area served
by the facility in the most recent State plan approved by the Secretary
under title VI, except that, at the request of the facility, the
Secretary may designate a different area proposed by the facility when
he determines that a different area is appropriate based on the criteria
in 42 CFR 53.1(d).
State agency means the agency of a state fully or conditionally
designated by the Secretary as the State health planning and development
agency of the State under section 1521 of the Act.
Sec. 124.603 Provision of services.
(a) General. (1) In order to comply with its community service
assurance, a facility shall make the services provided in the facility
or portion thereof constructed, modernized, or converted with Federal
assistance under title VI or XVI of the Act available to all persons
residing (and, in the case of facilities assisted under title XVI of the
Act, employed) in the facility's service area without discrimination on
the ground of race, color, national origin, creed, or any other ground
unrelated to an individual's need for the service or the availability of
the needed service in the facility. Subject to paragraph (b) (concerning
emergency services) a facility may deny services to persons who are
unable to pay for them unless those persons are required to be provided
uncompensated services under the provisions of Subpart F.
(2) A person is residing in the facility's service area for purposes
of this section if the person:
(i) Is living in the service area with the intention to remain there
permanently or for an indefinite period;
(ii) Is living in the service area for purposes of employment; or
(iii) Is living with a family member who resides in the service
area.
(b) Emergency services. (1) A facility may not deny emergency
services to any person who resides (or, in the case of facilities
assisted under title XVI of the Act, is employed) in the facility's
service area on the ground that the person is unable to pay for those
services.
(2) A facility may discharge a person that has received emergency
services, or may transfer the person to another facility able to provide
necessary services, when the appropriate medical personnel determine
that discharge or transfer will not subject the person to a substantial
risk of deterioration in medical condition.
(c) Third party payor programs. (1) The facility shall make
arrangements, if eligible to do so, for reimbursement for services with:
(i) Those principal State and local governmental third-party payors
that provide reimbursement for services that is not less than the actual
costs, as determined in accordance with accepted cost accounting
principles; and
(ii) Federal governmental third-party programs, such as medicare and
medicaid.
(2) The facility shall take any necessary steps to insure that
admission
[[Page 682]]
to and services of the facility are available to beneficiaries of the
governmental programs specified in paragraph (c)(1) of this section
without discrimination or preference because they are beneficiaries of
those programs.
(d) Exclusionary admissions policies. A facility is out of
compliance with its community service assurance if it uses an admission
policy that has the effect of excluding persons on a ground other than
those permitted under paragraph (a) of this section. Illustrative
applications of this requirement are described in the following
paragraphs:
(1) A facility has a policy or practice of admitting only those
patients who are referred by physicians with staff privileges at the
facility. If this policy or practice has the effect of excluding persons
who reside (or for title XVI facilities, are employed) in the community
from the facility because they do not have a private family doctor with
staff privileges at the facility, the facility would not be in
compliance with its assurance. The facility is not required to abolish
its staff physician admissions policy as a usual method for admission.
However, to be in compliance with its community service assurance it
must make alternative arrangements to assist area residents who would
otherwise be unable to gain admission to obtain services available in
the facility. Examples of alternative arrangements a facility might use
include:
(i) Authorizing the individual's physician, if licensed and
otherwise qualified, to treat the patient at the facility even though
the physician does not have staff privileges at the facility;
(ii) For those patients who have no physician, obtaining the
voluntary agreement of physicians with staff privileges at the facility
to accept referrals of such patients, perhaps on a rotating basis;
(iii) If an insufficient number of physicians with staff privileges
agree to participate in a referral arrangement, requiring acceptance of
referrals as a condition to obtaining or renewing staff privileges;
(iv) Establishing a hospital-based primary care clinic through which
patients needing hospitalization may be admitted; or
(v) Hiring or contracting with qualified physicians to treat
patients who do not have private physicians.
(2) A facility, as required, is a qualified provider under the title
XIX medicaid program, but few or none of the physicians with staff
privileges at the facility or in a particular department or sub-
department of the facility will treat medicaid patients. If the effect
is that some medicaid patients are excluded from the facility or from
any service provided in the facility, the facility is not in compliance
with its community service assurance. To be in compliance a facility
does not have to require all of its staff physicians to accept medicaid.
However, it must take steps to ensure that medicaid beneficiaries have
full access to all of its available services. Examples of steps that may
be taken include:
(i) Obtaining the voluntary agreement of a reasonable number of
physicians with staff privileges at the facility and in each department
or sub-department to accept referral of medicaid patients, perhaps on a
rotating basis;
(ii) If an insufficient number of physicians with staff privileges
agree to participate in a referral arrangement, requiring acceptance of
referrals as a condition to obtaining or renewing staff privileges;
(iii) Establishing a clinic through which medicaid beneficiaries
needing hospitalization may be admitted; or
(iv) Hiring or contracting with physicians to treat medicaid
patients.
(3) A facility requires advance deposits (pre-admission or pre-
service deposits) before admitting or serving patients. If the effect of
this practice is that some persons are denied admission or service or
face substantial delays in gaining admission or service solely because
they do not have the necessary cash on hand, this would constitute a
violation of the community service assurance. While the facility is not
required to forego the use of a deposit policy in all situations, it is
required to make alternative arrangements to ensure that persons who
probably can pay for the services are not denied them simply because
they do not have the available cash at the time services are requested.
For example, many employed persons and persons with other
[[Page 683]]
collateral do not have savings, but can pay hospital bills on an
installment basis, or can pay a small deposit. Such persons may not be
excluded from admission or denied services because of their inability to
pay a deposit.
Sec. 124.604 Posted notice.
(a) The facility shall post notices, which the Secretary supplies in
English and Spanish, in appropriate areas of the facility, including but
not limited to the admissions area, the business office and the
emergency room.
(b) If in the service area of the facility the ``usual language of
households'' of ten percent or more of the population, according to the
most recent figures published by the Bureau of the Census, is other than
English or Spanish, the facility shall translate the notice into that
language and post the translated notice on signs substantially similar
in size and legibility to, and posted with, those supplied under
paragraph (a) of this section.
(c) The facility shall make reasonable efforts to communicate the
contents of the posted notice to persons who it has reason to believe
cannot read the notice.
Sec. 124.605 Reporting and record maintenance requirements.
(a) Reporting requirements--(1) Timing of reports.(i) A facility
shall submit to the Secretary a report to assist the Secretary in
determining compliance with this subpart once every three fiscal years,
on a schedule to be prescribed by the Secretary. The report required by
this section shall be submitted not later than 90 days after the end of
the fiscal year, unless a longer period is approved by the Secretary for
good cause shown.
(ii) A facility shall also submit the required report whenever the
Secretary determines, and so notifies the facility in writing, that a
report is needed for proper administration of the program. In this
situation the facility shall submit the report specified in this section
for the filing of reports, within 90 days after receiving notice from
the Secretary, or within 90 days after the close of the fiscal year,
whichever is later.
(2) Content of report. The report must be submitted on a form
prescribed by the Secretary and must include information that the
Secretary prescribes to permit a determination of whether a facility has
met its obligations under this subpart.
(3) The facility shall provide a copy of any report to the HSA for
the area when submitting it to the Secretary.
(4) Institution of suit. Not later than 10 days after being served
with a summons or complaint, the applicant shall notify the Regional
Health Administrator for the Region of HHS in which it is located of any
legal action brought against it alleging that it has failed to comply
with the requirements of this subpart. \1\
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\1\ The addresses of the Regional Office of HHS are set out in 45
CFR 5.31.
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(b) Record maintenance requirements. (1) A facility shall maintain,
make available for public inspection consistent with personal privacy,
and provide to the Secretary on request, any records necessary to
document its compliance requirements of this subpart in any fiscal year,
including documents from which information required to be reported under
paragraph (a) of this section was obtained. A facility shall maintain
these records until 180 days following the close of the Secretary's
investigation under Sec. 124.606(a).
Sec. 124.606 Investigation and enforcement.
(a) Investigations. (1) The Secretary periodically investigates the
compliance of facilities with the requirements of this subpart, and
investigates complaints.
(2)(i) A complaint is filed with the Secretary on the date on which
the following information is received in the Office of the Regional
Health Administrator for the Region of HHS in which the facility is
located:
(A) The name and address of the person making the complaint or on
whose behalf the complaint is made;
(B) The name and location of the facility;
(C) The date or approximate date on which the event complained of
occurred, and
[[Page 684]]
(D) A statement of what actions the complainant considers to violate
the requirements of this subpart.
(ii) The Secretary promptly provides a copy of the complaint to each
facility named in the complaint.
(3) When the Secretary investigates a facility, the facility shall
provide to the Secretary on request any documents, records and other
information concerning its operations that relate to the requirements of
this subpart.
(4) The Act provides that if the Secretary dismisses a complaint or
the Attorney General has not brought an action for compliance within six
months from the date on which the complaint is filed, the person filing
it may bring a private action to effectuate compliance with the
assurance. If the Secretary determines that he will be unable to issue a
decision on a complaint or otherwise take appropriate action within the
six month period, he may, based on priorities for the disposition of
complaints that are established to promote the most effective use of
enforcement resources, or on the request of the complainant, dismiss the
complaint without a finding as to compliance prior to the end of the six
month period, but no earlier than 45 days after the complaint is filed.
(b) Enforcement. (1) If the Secretary finds, based on his
investigation under paragraph (a) of this section, that a facility did
not comply with the requirements of this subpart, he may take any action
authorized by law to secure compliance, including but not limited to
voluntary agreement or a request to the Attorney General to bring an
action against the facility for specific performance.
(2) If the Secretary finds, based on his investigation under
paragraph (a) of this section, that a facility has limited the
availability of its services in a manner proscribed by this subpart, he
may, in addition to any other action that he is authorized to take in
accordance with the Act, require the facility to establish an effective
affirmative action plan that in his judgment is designed to insure that
its services are made available in accordance with the requirements of
this subpart.
Sec. 124.607 Agreements with State agencies.
(a) Where the Secretary finds that it will promote the purposes of
this subpart, and the State agency is able and willing to do so, he may
enter into an agreement with the State agency for the State agency to
assist him in administering this subpart in the State.
(b) Under an agreement, the State agency will provide the Secretary
with any assistance he requests in any one or more of the following
areas, as set out in the agreement:
(1) Investigation of complaints of noncompliance;
(2) Monitoring the compliance of facilities with the requirements of
this subpart;
(3) Review of affirmative action plans submitted under Sec.
124.606(b);
(4) Review of reports submitted under Sec. 124.605;
(5) Making initial decisions for the Secretary with respect to
compliance, subject to appeal by any party to the Secretary or review by
the Secretary on his own initiative; and
(6) Application of any sanctions available to it under State law
(such as license revocation or termination of State assistance) against
facilities determined to be out of compliance with the requirements of
this subpart.
(c) A State agency may use funds received under section 1525 of the
Act to pay for expenses incurred in the course of carrying out this
agreement.
(d) Nothing in this subpart precludes any State from taking any
action authorized by State law regarding the provision of services by
any facility in the State as long as the action taken does not prevent
the Secretary from enforcing the requirements of this subpart.
Sec. Appendix to Subpart G of Part 124--Interim Procedures and Criteria
for Review by Health Systems Agencies of Applications Under Section 1625
of the Public Health Service Act
In performing reviews under section 1513 (e) of the Public Health
Service Act (42 U.S.C. 3001-2(c)) of applications for grants under
section 1625 of the Act, health systems agencies shall use the
procedures and criteria stated below. A health systems agency
[[Page 685]]
may not conduct such reviews until the procedures and criteria to be
used in conducting the reviews have been adopted by the agency and
published in newspapers of general circulation within the health service
area or other public information channels.
procedures
The procedures adopted and utilized by a health systems agency for
conducting reviews of applications for grants under section 1625 of the
Act shall include at least the following: 1. Except as provided below,
notification of the beginning of a review within seven days of the
receipt by the health systems agency of the application. Where the
application was received by the health systems agency prior to
publication of this subpart in the Federal Register, notification must
be made within seven days of the date on which the health systems agency
adopts its procedures and criteria. The notification shall include the
proposed schedule for the review, the period within which a public
hearing during the course of the review may be requested (which must be
a reasonable period from the transmittal of the written notification
required above), and the manner in which notification will be provided
of the time and place of any hearings so requested. Written notification
to members of the public may be provided through newspapers of general
circulation in the area and public information channels. Notification to
the applicant whose application is being reviewed and all other
applicants for assistance under section 1625 of the Act providing health
service in the health service area shall be by mail (which may be as
part of a newsletter). The health systems agency must simultaneously
notify the Federal funding agency of the beginning of the review.
2. Schedules for reviews which provide that such reviews shall not
exceed 60 days from the date of notification made in accordance with
paragraph 1 of this section to the date of the written findings made in
accordance with paragraph 4 of this section. This does not preclude a
health systems agency from conducting its review in less than 60 days.
3. Provision for applicants to submit to the health systems agency
(in such form and manner as the agency shall require) such information
as the agency deems necessary in order to conduct its review.
4. Written findings which state the basis for the approval or
disapproval of the application by the health systems agency. Such
findings shall be sent to the applicant, the State health planning and
development agency (or agencies), and the Secretary, and shall be
available to other upon request.
5. Access by the general public to all such applications reviewed by
the health systems agency and to all other written materials pertinent
to the agency review.
6. Public hearings in the course of agency review, if requested by
one or more persons directly affected by the review. For purposes of
this paragraph, a ``person directly affected by the review'' is as
defined in 42 CFR 122.306 (a)(7).
criteria
The specific criteria adopted and utilized by a health systems of
this agency to conduct reviews of applications for grants under section
1625 of the Act shall include at least the following:
1. The relationship of the health services of the facility to the
applicable health systems plan and annual implementation plan.
2. The relationship of the health services of the facility to the
long-range development plan (if any) of the applicant.
3. The need that the population served or to be served by the
facility has for the health services of such facility.
4. The availability of alternative, less costly, or more effective
methods of providing the health services which the facility provides.
5. The relationship of the health services provided by the facility
to the existing health care system of the area.
6. The availability of resources (including health manpower,
management personnel, and funds for capital and operating needs) for the
provision of services by the facility and the availability of
alternative uses of such resources for the provision of other health
services.
7. The special needs and circumstances of those entities which
provide a substantial portion of their services or resources, or both,
to individuals not residing in the health service area in which the
entities are located or in adjacent health service areas. Such entities
may include medical and other health professions schools,
multidisciplinary clinics, and other speciality centers.
8. The special needs and circumstances of health maintenance
organizations for which assistance may be provided under title XIII.
9. The costs and methods of the proposed construction or
modernization, including the costs and methods of energy provision.
10. The probable impact of the project reviewed on the applicant's
costs of providing health services.
Subpart H_Recovery of Grant Funds
Authority: Secs. 609 and 1622 of the Public Health Service Act as
amended 98 Stat. 112 (42 U.S.C. 291i and 300s-1a).
Source: 51 FR 7939, Mar. 7, 1986, unless otherwise noted.
[[Page 686]]
Sec. 124.701 Applicability.
The provisions of this subpart apply to facilities with respect to
which grant funds were paid for construction or modernization--
(a) Under title VI or XVI of the Public Health Service Act; or
(b) Pursuant to the authority of the Secretary under any of the
following statutes:
(1) The Public Works Acceleration Act of 1962, Pub. L. 87-658 (42
U.S.C. 2641 et seq.);
(2) The District of Columbia Medical Facilities Construction Act of
1968, 82 Stat. 631 (Pub. L. 90-457);
(3) The Appalachian Regional Development Act of 1965, as amended (40
U.S.C. App.).
Sec. 124.702 Definitions.
As used in this subpart--
Act means the Public Health Service Act.
Department means the Department of Health and Human Services.
Expected useful life means the period of time during which the
structure may reasonably be expected to perform the function for which
it was designed or intended.
Facility means a facility with respect to which grant funds were
paid under any of the authorizations listed in Sec. 124.701.
Fiscal year means the facility's fiscal year.
Nonprofit, as applied to any facility, means a facility that is
owned and operated by one or more nonprofit corporations or associations
no part of the net earnings of which inures, or may lawfully inure, to
the benefit of any private shareholder or individual.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human Services
to whom the authority involved has been delegated.
State agency means (1) in the case of a facility with respect to
which a grant was made under title VI of the Public Health Service Act
or any of the statutes listed in Sec. 124.701(b), the State agency
designated pursuant to section 604 of the Public Health Service Act or
its successor agency, and (2) in the case of a facility with respect to
which a grant was made under title XVI of the Public Health Service Act,
the State health planning and development agency designated pursuant to
title XV of the Public Health Service Act.
Then value means the value of the facility on the date the facility
is sold, transferred or ceases to be used for a permissible use as
described in Sec. 124.704.
Sec. 124.703 Federal right of recovery.
(a) If any facility is at any time within 20 years after the
completion of the grant-assisted construction or modernization sold or
transferred to any entity which is either not qualified for a grant
under the statute pursuant to which the grant was awarded or not
approved as a transferee by the State agency, the United States shall be
entitled to recover on the basis of joint and several liability from any
transferor, transferee, or successive transferee of the facility an
amount determined in accordance with this subpart.
(b) If any facility at any time within 20 years after the completion
of the grant-assisted construction or modernization ceases to be a
public or other non-profit facility that would have been eligible for a
grant under the statute pursuant to which the grant was awarded, the
United States shall be entitled to recover from the owners of the
facility an amount determined in accordance with this subpart.
Sec. 124.704 Notification of sale, transfer, or change of use.
(a) The transferor of a facility that is sold or transferred as
described in Sec. 124.703(a), or the owner of a facility which ceases
to be a public or other nonprofit facility as described in Sec.
124.703(b), shall provide the Secretary written notice of such sale,
transfer, or other change not later than 10 days after the date on which
the sale, transfer, or change occurs.
(1) Transfer. For purposes of this subpart, a transfer occurs when a
facility is conveyed to another entity through lease, merger,
bankruptcy, foreclosure, or other arrangement.
(2) Cease to be. For purposes of this subpart,
(i) A facility ``ceases to be'' a facility for which a grant could
have been made under the statute pursuant to which
[[Page 687]]
the grant was awarded when it is no longer operated as such a facility;
and
(ii) A facility ``ceases to be a public or nonprofit facility'' when
an entity that is not a public or other non-profit corporation or
association assumes management responsibilities with respect to the
facility which, in the Secretary's judgment, are so pervasive as to
constitute operation of the facility. The manager will not be deemed to
be the operator of the facility if the management agreement contains
both of the following provisions:
The Board of Directors of the facility retains authority to
terminate the agreement at any time upon reasonable notice to the
contractor.
No employee of the contractor may be a member of the facility's
Board of Directors.
In the absence of either of these provisions the Secretary will consider
the degree of control granted to the managing organization over patient
admission, determination of what services will be provided, and charges
for services provided in the facility.
(b) Content of Notice. The notice required by paragraph (a) of this
section shall be sent to the Secretary by certified mail, and shall
contain or be accompanied by
(1) The date of the sale, transfer, or other event that gives rise
to the notice;
(2) Copies of any sales contracts, lease agreements, management
contracts or other documents pertinent to the event giving rise to the
notice;
(3) Estimates of current assets, current liabilities, book value of
equipment, the expected value of land on the new owner's books, and the
remaining depreciation for all fixed assets involved in the transaction
calculated on a straight line basis using commonly adopted expected
useful lifetimes.
(c) Failure to provide notice. Failure to provide the information
required by paragraph (b) of this section, will be considered failure to
provide the notice required by this section. In any case in which such
information has not been provided, the Secretary will, promptly upon
receiving an incomplete notice or otherwise discovering that a sale,
transfer or other event giving rise to a recovery may have occurred,
send a letter to the owner of the facility requesting the information
needed to calculate a recovery amount.
(Approved by the Office of Management and Budget under control number
0915-0099)
Sec. 124.705 Amount of recovery.
(a) Except as provided in Sec. 124.706, the amount that the United
States shall be entitled to recover under this subpart is that amount
bearing the same ratio to the then value of so much of the facility as
constituted an approved project (or projects) as the amount of Federal
participation bore to the cost of the construction or modernization
under such project (or projects).
(b) The then value of the facility will be based on:
(1) The transaction value in the case of an arms-length sale or
transfer, or
(2) A depreciated reproduction value in the absence of an arms-
length sale or transfer or if the buyer fails to provide, within 60 days
after the date of the Secretary's letter described in Sec. 124.704(c),
the information which, in the judgment of the Secretary, is necessary to
establish, adjust, and apportion a transaction value. As used in this
section, ``transaction value'' means in the case of a sale, the sale
price, and in the case of a lease, the value of the lease plus the
residual value of the facility at the termination of the lease (i.e.,
the reproduction value or, if appropriate, an alternative use value).
(c) The transaction value will be adjusted to account for the
purchase or lease of other assets and the assumption of liabilities
associated with the transaction. To determine the amount of Federal
recovery, the adjusted value will be apportioned to the grant-aided
assets by the ration of the remaining useful lifetime values of those
assets to the sum of the remaining useful lifetime values of all assets
not previously accounted for in adjusting the transaction value.
(d) A depreciated reproduction value will be established by
calculating a reproduction value using construction cost indexes or
current costs per square foot for construction, depending on which is
more relevant to the type of construction associated with the grant.
This reproduction value will then be adjusted by the ratio of the
remaining
[[Page 688]]
useful life to the total useful life for the assets involved.
(e) In calculating the recovery amount, the Secretary will include
as Federal participation any grant assistance received by the facility
under an authority listed in Sec. 124.701 and any assistance
supplementary to that assistance received for the construction or
modernization of the facility under the Public Works and Economic
Development Act of 1965 (42 U.S.C. 3121, et seq.) or the Local Public
Works Capital Development Act of 1976 (Pub. L. 94-369).
Sec. 124.706 Calculation of interest.
(a) In addition to the amount of recovery calculated under Sec.
124.705, the United States shall be entitled to recover interest on such
amount in accordance with this section at the rate determined by the
Secretary based on the average of the bond equivalent of the weekly
ninety-day U.S. Treasury bill auction rate for the quarter previous to
the quarter in which interest begins to accrue under this section.
(1) Change of status before July 18, 1984. For facilities that were
sold or transferred or which ceased to be public or other nonprofit
facilities before July 18, 1984, interest will be charged beginning
August 17, 1984, or 180 days after the date of such sale, transfer or
other, whichever is later, and ending on the date the amount the United
States is entitled to recover is collected.
(2) Change of status after July 17, 1984. For facilities that are
sold or transferred or which cease to be public or other nonprofit
facilities after July 17, 1984, interest will be charged beginning 180
days after receipt by the Department of the notice required under Sec.
124.704; Provided, That if such notice is not provided as prescribed,
interest will be charged beginning on the date of the sale, transfer, or
change of use, and ending on the date the amount which the United States
is entitled to recover is collected.
(b) The Secretary may waive interest charges that result from delays
caused solely by the Department.
Sec. 124.707 Waiver of recovery where facility is sold or transferred to a
proprietary entity.
(a) Conditions of the waiver. The Secretary may waive the recovery
rights of the United States arising under Sec. 124.703(a) if the entity
to which the facility was sold or transferred:
(1) Has filed a written request for the waiver within the time
limits prescribed by this section;
(2) Has established an irrevocable trust in accordance with this
section, in an amount equal to the greater of the amount that would
otherwise have been recovered pursuant to Sec. 124.705 (including
accrued interest as calculated under Sec. 124.706) or twice the cost of
the remaining uncompensated services obligation of the facility as of
the date of the change of status, that will be used by the entity only
to provide services to those unable to pay in accordance with the
requirements of subpart F of this part; and
(3) Has agreed to comply with the community service regulations set
out in subpart G of this part.
(b) Procedures for obtaining waiver. (1) Within 30 days after the
date of receipt of the information described in Sec. 124.704(b), the
Secretary will send a letter to the new owner of the facility advising
of the United States' right of recovery and the opportunity to obtain a
waiver. For the purpose of advising the new owner of the amount to be
placed in the irrevocable trust should the owner wish to obtain a
waiver, the letter will also state the dollar amount of the remaining
uncompensated care obligation and the amount that would be due under
Sec. 124.705, computed as follows:
(i) Computation of uncompensated care obligation. (A) For a facility
which changes status before the date that subpart F of this part is
effective for the facility, the remaining uncompensated services
obligation is zero.
(B) For a facility which changes status after the date that subpart
F of this part is effective for the facility, the Secretary will
multiply the annual compliance level, computed under the 10% method
specified in 42 CFR 124.503(a)(1)(ii), for the fiscal year in which the
change of status occurs times the number of years remaining
[[Page 689]]
in the facility's uncompensated services obligation. From this amount,
the Secretary will subtract amounts of excess or add amounts of deficit
for each fiscal year prior to the change of status for which the
Secretary has previously conducted an audit of uncompensated services
accounts. Excess and deficits will be adjusted by the percent change in
the National Consumer Price Index for Medical Care between the year in
which the excess or deficit occurred and the year in which the status
change occurred. For each fiscal year prior to the change of status
which the Secretary has not audited, the Secretary will add to the
remaining obligation an amount equal to the annual compliance level in
each such year adjusted by the percent change in the National Consumer
Price Index for Medical Care between that year and the year of the
status change. The amount computed as the total remaining obligation
will then be multiplied by two. If the transferee chooses to accept the
Secretary's calculation, no further assessments will be made of
uncompensated care provided prior to the change of status date. If the
transferee does not accept the calculation, the transferor or transferee
may hire, and may charge against the irrevocable trust established under
this section, an independent auditor to certify the compliance level and
any excess or deficit for the period from May 18, 1979, up to and
including the date of the change of status, using standard Departmental
procedures supplemented with instructions provided by the Secretary, and
submit the results in accordance with paragraph (b)(2)(ii) of this
section. The audit may be conducted for any years not included in a
previous site assessment conducted by the Department. If the Secretary
agrees that a change is appropriate, the Secretary will use this
information to adjust the calculation as set out in paragraph (b)(3) of
this section. If the independent auditor certifies that qualified care
was rendered either at the facility or at a replacement facility
operated by the transferee between the date of the change of status and
the date of establishment of the trust, and the Secretary agrees, the
post transfer level of care shall not affect the calculation of the
total remaining uncompensated care obligation to be doubled, but instead
shall be recognized as a credit to be drawn from the trust as provided
in paragraph (c)(1)(ii) of this section. In the case of a facility with
respect to which a grant was made under title XVI of the Act, the
remaining period of obligation will be the remainder of the expected
useful life of the facility, as follows: 40 years for buildings, 30
years for additions, 20 years for building renovations, 20 years for
fixed equipment and 12 years for major movable equipment.
(ii) Computation of recovery amount. The Secretary will determine
the recovery amount as provided in Sec. 124.705.
(2) Within 60 days following the date of the Secretary's letter
provided pursuant to paragraph (b)(1) of this section, the owner of the
facility shall notify the Secretary in writing that it either:
(i) Accepts the trust fund amount for the waiver as offered by the
Secretary;
(ii) Provides a detailed statement of an alternative determination
of the recovery amount or an independent audit of the remaining
uncompensated services obligation as described in paragraph (b)(1)(i) of
this section; or
(iii) Does not seek a waiver under Sec. 124.707. Failure to provide
a timely response to the Secretary under this subparagraph will be
considered an election not to seek the waiver.
(3) Within 30 days following the receipt of the owner's views
concerning the calculation, and after considering those views, the
Secretary will send a final letter providing the Secretary's
determination of twice the remaining uncompensated care obligation and
the recovery amount under Sec. 124.705. The amount to be placed in the
irrevocable trust will be the higher of those two figures. (See
paragraph (a)(2) of this section.)
(4) Within 30 days of the date of the final letter, the owner of the
facility shall notify the Secretary in writing whether or not it accepts
the terms of the waiver. Failure to provide timely notice to the
Secretary under this subparagraph will be considered an election not to
accept the waiver.
(c) Establishment of the trust. (1) Within 60 days of the date of
its acceptance of a waiver under paragraph (b)(2) or
[[Page 690]]
(b)(4) of this section, the owner shall begin delivering services to
those unable to pay in accordance with subpart F of this part under an
irrevocable trust established in the amount calculated pursuant to
paragraph (b) of this section. Provided, That
(i) The owner shall provide a copy of the trust documents to the
Secretary and no trust shall be considered established until the trust
documents have been approved by the Secretary; and
(ii) The owner may credit against the trust any uncompensated
services provided in accordance with subpart F of this part between the
date of the change of status of the facility and the establishment of
the trust. For an owner to receive the credit before the establishment
of the trust and deposit of funds therein, the auditor's report covering
the post-transfer period shall be submitted with the notification of
acceptance of the waiver, and in any event, not later than 30 days from
the date of the Secretary's final letter described in paragraph (b)(3)
of this section. Within 30 days following the receipt of the auditor's
report, the Secretary will notify the owner of the allowable credit, if
any. If the auditor's report is not timely submitted, the trust must be
established and fully funded, in accordance with the time limits imposed
by paragraph (c)(1) of this section, and the Secretary will notify the
owner of the allowable credit, if any, within 30 days of the date of the
establishment of the trust or within 30 days of the receipt of the
report, whichever is later.
(2) The trust shall be administered by a Trustee who is neither an
employee of the transferee nor an employee of a subsidiary or of the
parent institution of the transferee.
(3) The trust shall provide that the trust corpus and income may be
invested only in U.S. Government or U.S. Government insured securities.
(d) Use of the trust. The corpus and income of the irrevocable trust
shall be used to pay for the costs of uncompensated services, which may
include reasonable costs of establishing and administering the trust and
the cost of the independent audit described in paragraph (b)(1)(i) of
this section, until the trust is exhausted.
(Approved by the Office of Management and Budget under control number
0915-0099)
Sec. 124.708 Waiver of recovery--good cause for other use of facility.
The Secretary may for good cause waive the recovery rights of the
United States arising under Sec. 124.703(b). In determining whether
there is good cause under this section for releasing the applicant or
other owner of the facility from its obligation, the Secretary will take
into consideration the extent to which:
(a) The facility will be devoted by the applicant or other owner to
use for another public or nonprofit purpose whch will promote the
purpose of the Act;
(b) There are reasonable assurances that for the remainder of the
20-year period other public or nonprofit facilities not previously
utilized for the purpose for which the facility was constructed will be
so utilized and are substantially equivalent in nature and purpose.
(c) The facility has been acquired from an agency of the United
States (e.g., the Federal Housing Administration under its mortgage
insurance commitment program) which has made a reasonable effort to
dispose of it for operation as a public or nonprofit health care
facility.
[51 FR 7939, Mar. 7, 1986, as amended at 57 FR 8272, Mar. 9, 1992]
Sec. 124.709 Withdrawal of waiver.
(a) Any waiver granted under this subpart is conditioned upon the
recipient of the waiver carrying out the obligations imposed by Sec.
124.707 or Sec. 124.708 as applicable.
(b) The Secretary will monitor compliance with the community service
and uncompensated care obligations of any entity that receives a waiver.
(c) Should a recipient of a waiver fail to comply with the
applicable conditions, the Secretary will withdraw the waiver and seek
recovery based on the value of the facility on the date the right of
recovery first arose under Sec. 124.703.
[[Page 691]]
(d) No waiver will be withdrawn until the recipient has been
notified in writing by the Secretary of the noncompliance and has failed
to take corrective action within 90 days after the date of such notice.
(e) Should the waiver be withdrawn, the amount of the Government's
recovery will be the amount set out in the Secretary's determination
letter as described in Sec. 124.707 (b)(1) or (b)(3) as applicable plus
interest from the date of the notification sent in accordance with
paragraph (d) of this section.
PARTS 125-129 [RESERVED]
[[Page 692]]