109 HR 2685 IH: Medicare Prescription Drug Price Negotiation Act U.S. House of Representatives 2005-05-26 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
I 109th CONGRESS 1st Session H. R. 2685 IN THE HOUSE OF REPRESENTATIVES May 26, 2005 Mr. Larson of Connecticut (for himself, Mr. Grijalva, and Mr. Hinchey) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To provide for prescription drugs at reduced prices to Medicare beneficiaries.
1.
Short title
This Act may be cited as the Medicare Prescription Drug Price Negotiation Act.
2.
Availability of prescription drugs from participating manufacturers at negotiated prices
(a)
In general
Each participating manufacturer of a covered outpatient drug shall make available for purchase by any qualified Federal health care provider, by each pharmacy, and by each provider of services, physician, practitioner, and supplier under the medicare program such covered outpatient drug in the amount described in subsection (b) at the price described in subsection (c). (b)
Description of amount of drugs
The amount of a covered outpatient drug that a participating manufacturer shall make available for purchase under subsection (a) is the sum of— (1)an amount equal to the aggregate amount of the covered outpatient drug dispensed by pharmacies to Medicare beneficiaries; and (2)an amount equal to the aggregate amount of the covered outpatient drug dispensed through qualified Federal health care providers. (c)
Description of price
(1)
In general
The price at which a participating manufacturer shall make a covered outpatient drug available for purchase under subsection (a) is a price that the Secretary, in conjunction with the Secretary of Defense and the Secretary of Veterans Affairs, negotiate with the manufacturer. (2)
Promotion of breakthrough drugs
(A)
In general
In conducting negotiations with participating manufacturers under paragraph (1), the Secretary shall take into account the goal of promoting the development of breakthrough drugs. (B)
Definition
For purposes of this paragraph, a drug is a breakthrough drug if the Secretary determines it is a new product that will make a significant and major improvement by reducing physical or mental illness, reducing mortality, or reducing disability, and that no other product is available to enrollees that achieves similar results for the same condition. (d)
Enforcement
The United States shall debar a manufacturer of drugs or biologicals that does not comply with the provisions of this Act. (e)
Dispute resolution mechanism
The Secretary shall establish a mechanism (such as an ombudsman) for the resolution of disputes between Medicare beneficiaries and prescription drug resellers and drug manufacturers in order to protect such beneficiaries and to ensure that— (1)prescription drug resellers are not artifically increasing prices charged to Medicare beneficiaries (above those negotiated under subsection (c)) in places where there is less competition (such as in rural areas); and (2)such resellers are not colluding on prices in areas with more potential significant competition.
3.
Administration
The Secretary shall issue such regulations as may be necessary to implement this Act.
4.
Reports to Congress regarding effectiveness of Act
(a)
In general
Not later than 2 years after the date of the enactment of this Act, and annually thereafter, the Secretary shall report to the Congress regarding the effectiveness of this Act in— (1)protecting Medicare beneficiaries from discriminatory pricing by drug manufacturers, and (2)making prescription drugs available to Medicare beneficiaries at substantially reduced prices. (b)
Consultation
In preparing such reports, the Secretary shall consult with public health experts, affected industries, organizations representing consumers and older Americans, and other interested persons. (c)
Recommendations
The Secretary shall include in such reports any recommendations the Secretary considers appropriate for changes in this Act to further reduce the cost of covered outpatient drugs to Medicare beneficiaries.
5.
Definitions
In this Act: (1)
Provider of services
The term provider of services has the meaning given that term in section 1861(u) of the Social Security Act (42 U.S.C. 1395x(u)). (2)
Physician
The term physician has the meaning given that term in section 1861(r) of the Social Security Act (42 U.S.C. 1395x(r)). (3)
Practitioner
The term practitioner has the meaning given that term in section 1842(b)(18)(C) of the Social Security Act (42 U.S.C. 1395u(b)(18)(C)). (4)
Supplier
The term supplier has the meaning given that term under section 1842(o) of the Social Security Act (42 U.S.C. 1395u(o)). (5)
Covered outpatient drug
The term covered outpatient drug has the meaning given that term in section 1927(k)(2) of the Social Security Act (42 U.S.C. 1396r–8(k)(2)). (6)
Debar
The term debar means to exclude, pursuant to established administrative procedures, from Government contracting and subcontracting for a specified period of time commensurate with the seriousness of the failure or offense or the inadequacy of performance. (7)
Medicare beneficiary
The term Medicare beneficiary means an individual entitled to benefits under part A of title XVIII of the Social Security Act or enrolled under part B of such title, or both. (8)
Participating manufacturer
The term participating manufacturer means any manufacturer of drugs or biologicals that, on or after the date of the enactment of this title, enters into a contract or agreement with the United States for the sale or distribution of covered outpatient drugs to the United States. (9)
Secretary
The term Secretary means the Secretary of Health and Human Services.
6.
Effective date
The Secretary shall implement this Act as expeditiously as practicable and in a manner consistent with the obligations of the United States.
7.
Conforming amendment
Section 1860D–11 of the Social Security Act (42 U.S.C. 1395w–111) is amended by striking subsection (i) (relating to noninterference).