[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4161 Introduced in House (IH)]






108th CONGRESS
  2d Session
                                H. R. 4161

To amend the Public Health Service Act to revise and expand the section 
 340B program to improve the provision of discounts on drug purchases 
                   for certain safety net providers.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 2, 2004

   Mr. Rush introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to revise and expand the section 
 340B program to improve the provision of discounts on drug purchases 
                   for certain safety net providers.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``340B Program Revision and Expansion 
Act of 2004''.

SEC. 2. IMPROVEMENTS TO SECTION 340B PROGRAM.

    (a) Expansion of Covered Entities Receiving Discounted Prices.--
Subsection (a)(4) of section 340B of the Public Health Service Act (42 
U.S.C. 256b) is amended by adding at the end the following 
subparagraphs:
                    ``(M) An entity receiving funds under title V of 
                the Social Security Act (relating to maternal and child 
                health) for the provision of health services.
                    ``(N) An entity receiving funds under subpart I of 
                part B of title XIX of this Act (relating to 
                comprehensive mental health services) for the provision 
                of community mental health services.
                    ``(O) An entity receiving funds under subpart II of 
                such part B (relating to the prevention and treatment 
                of substance abuse) for the provision of treatment 
                services for substance abuse.''.
    (b) Extension of Discounts to Inpatient Drugs.--Subsection (b) of 
such section is amended by inserting before the period at the end the 
following: ``, except that the terms `covered outpatient drug' and 
`covered drug' include a drug provided in an inpatient setting''.
    (c) Elimination of Group Purchasing Prohibition for Certain 
Hospitals.--Subsection (a)(4)(L) of such section is amended--
            (1) by adding ``and'' at the end of clause (i);
            (2) by striking ``; and'' at the end of clause (ii) and 
        inserting a period; and
            (3) by striking clause (iii).
    (d) Permitting Use of Multiple Contract Pharmacies.--Such section 
is amended by adding at the end the following new subsection:
    ``(e) Permitting Use of Multiple Contract Pharmacies.--Nothing in 
this section shall be construed as prohibiting a covered entity from 
entering into contracts with more than one pharmacy for the provision 
of covered drugs, including such a contract that supplements the use of 
an in-house pharmacy arrangement or as requiring the approval of the 
Secretary for entering into such a contract.''.
    (e) Improvements in Program Administration.--Such section is 
further amended by adding at the end the following new subsection:
    ``(f) Improvements in Program Administration.--
            ``(1) In general.--The Secretary shall provide, from funds 
        appropriated under paragraph (2), for improvements in the 
        integrity and administration of the program under this section 
        in order to prevent abuse and misuse of discounted prices made 
        available under this section. Such improvements shall include 
        the following:
                    ``(A) The development of a system to verify the 
                accuracy of information regarding covered entities that 
                is listed on the website of the Department of Health 
                and Human Services relating to this section.
                    ``(B) The establishment of a third-party auditing 
                system by which covered entities and manufacturers are 
                regularly audited to ensure compliance with the 
                requirements of this section.
                    ``(C) The conduct of such audits under subsection 
                (a)(5)(C) that supplement the audits conducted under 
                subparagraph (B) as the Secretary finds appropriate and 
                the implementation of dispute resolution guidelines and 
                other compliance programs.
                    ``(D) The development of more detailed guidance 
                regarding the definition of section 340B patients and 
                describing options for billing under the medicaid 
                program under title XIX of the Social Security Act in 
                order to avoid duplicative discounts.
                    ``(E) The issuance of advisory opinions within 
                defined time periods in response to questions from 
                manufacturers or covered entities regarding the 
                application of the requirements of this section in 
                specific factual circumstances.
                    ``(F) Insofar as the Secretary deems it feasible, 
                providing access through the website of the Department 
                of Health and Human Services on the prices for covered 
                drugs made available under this section, but only in a 
                manner (such as through the use of password protection) 
                that limits such access to covered entities.
            ``(2) Authorization of appropriations.--There are 
        authorized to be appropriated for fiscal year 2005 and each 
        succeeding fiscal year such sums as may be necessary to carry 
        out paragraph (1).''.
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