List of Subjects in 42 CFR Part 1001
Administrative practice and procedure, Fraud, Grant programs--
health, Health facilities, Health professions, Maternal and child
health, Medicaid, Medicare.
[[Page 56644]]
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Accordingly, 42 CFR part 1001 would be amended as set forth below:
PART 1001--[AMENDED]
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1. The authority citation for part 1001 continues to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7, 1320a-7b, 1395u(j),
1395u(k), 1395y(d), 1395y(e), 1395cc(b)(2)(D), (E) and (F), and
1395hh; and sec. 2455, Pub.L. 103-355, 108 Stat. 3327 (31 U.S.C.
6101 note).
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2. Section 1001.952 is amended by republishing the introductory
paragraph for this section and by adding a new paragraph (w) to read as
follows:
Sec. 1001.952 Exceptions.
The following payment practices shall not be treated as a criminal
offense under section 1128B of the Act and shall not serve as the basis
for an exclusion:
* * * * *
(w) Health centers. As used in section 1128B of the Act,
``remuneration'' does not include the transfer of any goods, items,
services, donations or loans (whether the donation or loan is in cash
or in-kind), or combination thereof from an individual or entity to a
health center (as defined in this paragraph), as long as the following
nine standards are met--
(1) (i) The transfer is made pursuant to a contract, lease, grant,
loan, or other agreement that--
(A) Is set out in writing;
(B) Is signed by the parties; and
(C) Covers, and specifies the amount of, all goods, items,
services, donations, or loans to be provided by the individual or
entity to the health center.
(ii) The amount of goods, items, services, donations, or loans
specified in the agreement in accordance with paragraph (w)(1)(i)(C) of
this section may be a fixed sum, fixed percentage, or set forth by a
fixed methodology. The amount may not be conditioned on the volume or
value of Federal health care program business generated between the
parties. The written agreement will be deemed to cover all goods,
items, services, donations, or loans provided by the individual or
entity to the health center as required by paragraph (w)(1)(i)(C) of
this section if all separate agreements between the individual or
entity and the health center incorporate each other by reference or if
they cross-reference a master list of agreements that is maintained
centrally, is kept up to date, and is available for review by the
Secretary upon request. The master list should be maintained in a
manner that preserves the historical record of arrangements.
(2) The goods, items, services, donations, or loans are medical or
clinical in nature or relate directly to services provided by the
health center as part of the scope of the health center's section 330
grant (including, by way of example, billing services, administrative
support services, technology support, and enabling services, such as
case management, transportation, and translation services, that are
within the scope of the grant).
(3) The health center reasonably expects the arrangement to
contribute meaningfully to the health center's ability to maintain or
increase the availability, or enhance the quality, of services provided
to a medically underserved population served by the health center, and
the health center documents the basis for the reasonable expectation
prior to entering the arrangement. The documentation must be made
available to the Secretary upon request.
(4) At reasonable intervals, but at least annually, the health
center must re-evaluate the arrangement to ensure that the arrangement
is expected to continue to satisfy the standard set forth in paragraph
(w)(3) of this section, and must document the re-evaluation
contemporaneously. The documentation must be made available to the
Secretary upon request. Arrangements must not be renewed or
renegotiated unless the health center reasonably expects the standard
set forth in paragraph (w)(3) of this section to be satisfied in the
next agreement term. Renewed or renegotiated agreements must comply
with the requirements of paragraph (w)(3) of this section.
(5) The individual or entity does not (i) Require the health center
(or its affiliated health care professionals) to refer patients to a
particular individual or entity, or (ii) restrict the health center (or
its affiliated health care professionals) from referring patients to
any individual or entity.
(6) Individuals and entities that offer to furnish goods, items, or
services without charge or at a reduced charge to the health center
must furnish such goods, items, or services to all patients from the
health center who clinically qualify for the goods, items, or services,
regardless of the patient's payor status or ability to pay. The
individual or entity may impose reasonable limits on the aggregate
volume or value of the goods, items, or services furnished under the
arrangement with the health center, provided such limits do not take
into account a patient's payor status or ability to pay.
(7) The agreement must not restrict the health center's ability, if
it chooses, to enter into agreements with other providers or suppliers
of comparable goods, items, or services, or with other lenders or
donors. Where a health center has multiple individuals or entities
willing to offer comparable remuneration, the health center must employ
a reasonable methodology to determine which individuals or entities to
select and must document its determination. In making these
determinations, health centers should look to the procurement standards
for recipients of Federal grants set forth in 45 CFR 74.40 through
74.48.
(8) The health center must provide effective notification to
patients of their freedom to choose any willing provider or supplier.
In addition, the health center must disclose the existence and nature
of an agreement under paragraph (w)(1) of this section to any patient
who inquires. The health center must provide such notification or
disclosure in a timely fashion and in a manner reasonably calculated to
be effective and understood by the patient.
(9) The health center may, at its option, elect to require that an
individual or entity charge a referred health center patient the same
rate it charges other similarly situated patients not referred by the
health center or that the individual or entity charge a referred health
center patient a reduced rate (where the discount applies to the total
charge and not just to the cost-sharing portion owed by an insured
patient).
For purposes of this paragraph, the term ``health center'' means a
Federally Qualified Health Center under section 1905(l)(2)(B)(i) or
1905(l)(2)(B)(ii) of the Act, and ``medically underserved population''
means a medically underserved population as defined in regulations at
42 CFR 51c.102(e).
* * * * *
Dated: May 8, 2007.
Daniel R. Levinson,
Inspector General.
Approved: June 27, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. E7-19636 Filed 10-3-07; 8:45 am]
BILLING CODE 4152-01-P