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PUBLIC LAW 104-191—AUG. 21, 1996
110 STAT. 2007
(b) AGREEMENTS WITH PEER REVIEW ORGANIZATIONS.—Section
1876(i)(7)(A) (42 U.S.C. 1395mm(i)(7)(A)) is amended by striking
"an agreement" and inserting "a written agreement".
(c) EFFECTIVE DATE.— The amendments made by this section
shall apply with respect to contract years beginning on or after
January 1, 1997.
SEC. 216. ADDITIONAL EXCEPTION TO ANTI-KICKBACK PENALTIES
FOR RISK-SHARING ARRANGEMENTS.
(a) IN GENERAL. —Section 1128B(b)(3) (42 U.S.C. 1320a-
7b(b)(3)) is amended—
(1) by striking "and" at the end of subparagraph (D);
(2) by striking the period at the end of subparagraph (E)
and inserting "; and"; and
(3) by adding at the end the following new subparagraph:
"(F) any remuneration between an organization and an
individual or entity providing items or services, or a combination thereof, pursuant to a written agreement between the
organization and the individual or entity if the organization
is an eligible organization under section 1876 or if the written
agreement, through a risk-sharing arrangement, places the
individual or entity at substantial financial risk for the cost
or utilization of the items or services, or a combination thereof,
which the individual or entity is obligated to provide.".
(b) NEGOTIATED RULEMAKING FOR RISK-SHARING EXCEPTION. —
(1) ESTABLISHMENT.—
(A) IN GENERAL.— The Secretary of Health and Human
Services (in this subsection referred to as the "Secretary")
shall establish, on an expedited basis and using a negotiated rulemaking process under subchapter 3 of chapter
5 of title 5, United States Code, standards relating to
the exception for risk-sharing arrangements to the antikickback penalties described in section 1128B(b)(3)(F) of
the Social Security Act, as added by subsection (a).
(B) FACTORS TO CONSIDER.—In establishing standards
relating to the exception for risk-sharing arrangements
to the anti-kickback penalties under subparagraph (A), the
Secretary—
(i) shall consult with the Attorney General and
representatives of the hospital, physician, other health
practitioner, and health plan communities, and other
interested parties; and
(ii) shall take into account—
(I) the level of risk appropriate to the size
and type of arrangement;
(II) the frequency of assessment and distribution of incentives;
(III) the level of capital contribution; and
(IV) the extent to which the risk-sharing
arrsingement provides incentives to control the cost
and quality of health care services.
(2) PUBLICATION OF NOTICE.— In carrying out the rulemaking process under this subsection, the Secretary shall publish the notice provided for under section 564(a) of title 5,
United States Code, by not later than 45 days after the date
of the enactment of this Act.
42 USC 1395mm
note.
42 USC 1320a-
7b note.
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