Pub. L. 108-173, tit. VI, subtit. D, sec. 641
DEMONSTRATION PROJECT FOR COVERAGE OF CERTAIN PRESCRIPTION DRUGS AND BIOLOGICALS.
SEC. 641. DEMONSTRATION PROJECT FOR COVERAGE OF CERTAIN PRESCRIPTION DRUGS AND BIOLOGICALS.(a) Demonstration Project.—The Secretary shall conduct a demonstration project under part B of title XVIII of the Social Security Act under which payment is made for drugs or biologicals that are prescribed as replacements for drugs and biologicals described in section 1861(s)(2)(A) or 1861(s)(2)(Q) of such Act (42 U.S.C. 1395x(s)(2)(A), 1395x(s)(2)(Q)), or both, for which payment is made under such part. Such project shall provide for cost-sharing applicable with respect to such drugs or biologicals in the same manner as cost-sharing applies with respect to part D drugs under standard prescription drug coverage (as defined in section 1860D–2(b) of the Social Security Act, as added by section 101(a)).(b) Demonstration Project Sites.—The project established under this section shall be conducted in sites selected by the Secretary.(c) Duration.—The Secretary shall conduct the demonstration project for the 2-year period beginning on the date that is 90 117 STAT. 2322 days after the date of the enactment of this Act, but in no case may the project extend beyond December 31, 2005.(d) Limitation.—Under the demonstration project over the duration of the project, the Secretary may not provide—(1) coverage for more than 50,000 patients; and(2) more than $500,000,000 in funding.(e) Report.—Not later than July 1, 2006, the Secretary shall submit to Congress a report on the project. The report shall include an evaluation of patient access to care and patient outcomes under the project, as well as an analysis of the cost effectiveness of the project, including an evaluation of the costs savings (if any) to the medicare program attributable to reduced physicians’ services and hospital outpatient departments services for administration of the biological.