0990-0322_Attachment A

0990-0322_Attachment A.pdf

Safe Harbor for Federally Qualified Health Centers Arrangements

0990-0322_Attachment A

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Congress)

Bill Text - 108th Congress (2003-2004) - THOMAS (Library of

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Bill Text

108th Congress (2003-2004)
H.R.i.ENR
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H.R.l
Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(Enrolled Bill (final as Passed Both House and Senate) - ENR)
SEC. 431. PROVIDING SAFE HARBOR FOR CERTAIN COllABORATIVE
EFFORTS THAT BENEFIT MEDICAllY UNDERSERVED POPULATIONS.
(a) IN GENERAL- Section 1128B(b)(3) (42 U.S.c. 1320a-7(b)(3)), as amended by

section 101(e)(2), is amended--

(1) in subparagraph (F), by striking' and' after the semicolon at the end;
(2) in subparagraph (G), by striking the period at the end and inserting' ;

and'; and

(3) by adding at the end the following new subparagraph:

, (H) any remuneration between a health center entity described under

clause (i) or (ii) of section 1905(1)(2)(B) and any individual or entity
providing goods, items, services, donations, loans, or a combination

thereof, to such health center entity pursuant to a contract, lease,
grant, loan, or other agreement, if such agreement contributes to the
ability of the health center entity to maintain or increase the availability,
or enhance the quality, of services provided to a medically underserved
population served by the health center entity.'.
(b) RULEMAKING FOR EXCEPTION FOR HEALTH CENTER ENTITY ARRANGEMENTS-

(1) ESTABLISHMENT-

(A) IN GENERAL- The Secretary shall establish, on an expedited basis,
standards relating to the exception described in section 1128B(b)(3)(H)
of the Social Security Act, as added by subsection (a), for health center
entity arrangements to the antikickback penalties.
(B) FACTORS TO CONSIDER- The Secretary shall consider the following
factors, among others, in establishing standards relating to the

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Bill Text - 108th Congress (2003-2004) - THOMAS (Library of

Congress)

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exception for health center entity arrangements under subparagraph
(A) :

(i) Whether the arrangement between the health center entity and
the other party results in savings of Federal grant funds or

increased revenues to the health center entity.
(ii) Whether the arrangement between the health center entity and
the other party restricts or limits an individual's freedom of choice.

(iii) Whether the arrangement between the health center entity
and the other party protects a health care professional's

independent medical judgment regarding medically appropriate

treatment.
The Secretary may also include other standards and criteria that are

consistent with the intent of Congress in enacting the exception
established under this section.

(2) DEADLINE- Not later than 1 year after the date of the enactment of this
Act the Secretary shall publish final regulations establishing the standards
described in paragraph (1).

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