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S. 2767 (is) To authorize the enforcement by State and local governments of certain Federal Communications Commission regulations regarding use of citizens band radio equipment. [Introduced in Senate] ...


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108th CONGRESS
  2d Session
                                S. 2766

To amend part D of title XVIII of the Social Security Act to authorize 
   the Secretary of Health and Human Services to negotiate for lower 
  prices for medicare prescription drugs and to eliminate the gap in 
  coverage of medicare prescription drug benefits, to reduce medical 
errors and increase the use of medical technology, to increase services 
in primary and preventive care by nonphysician providers, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 22, 2004

  Mr. Specter introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
To amend part D of title XVIII of the Social Security Act to authorize 
   the Secretary of Health and Human Services to negotiate for lower 
  prices for medicare prescription drugs and to eliminate the gap in 
  coverage of medicare prescription drug benefits, to reduce medical 
errors and increase the use of medical technology, to increase services 
in primary and preventive care by nonphysician providers, and for other 
                               purposes.

    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 ``Prescription Drug and Health 
Improvement Act of 2004''.

     TITLE I--IMPROVEMENTS UNDER MEDICARE PRESCRIPTION DRUG PROGRAM

SEC. 101. NEGOTIATING FAIR PRICES FOR MEDICARE PRESCRIPTION DRUGS.

    (a) In General.--Section 1860D-11 of the Social Security Act (42 
U.S.C. 1395w-111) is amended by striking subsection (i) (relating to 
noninterference) and by inserting the following:
    ``(i) Authority To Negotiate Prices With Manufacturers.--In order 
to ensure that beneficiaries enrolled under prescription drug plans and 
MA-PD plans pay the lowest possible price, the Secretary shall have 
authority similar to that of other Federal entities that purchase 
prescription drugs in bulk to negotiate contracts with manufacturers of 
covered part D drugs, consistent with the requirements and in 
furtherance of the goals of providing quality care and containing costs 
under this part.''.
    (b) Effective Date.--The amendment made by this section shall take 
effect as if included in the enactment of section 101 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (Public 
Law 108-173; 117 Stat. 2066).
    (c) HHS Reports Comparing Negotiated Prescription Drug Prices and 
Retail Prescription Drug Prices.--Beginning in 2006, the Secretary of 
Health and Human Services shall regularly, but in no case less often 
than quarterly, submit to Congress a report that compares the prices 
for covered part D drugs (as defined in section 1860D-2(e) of the 
Social Security Act (42 U.S.C. 1395w-102(e)) negotiated by the 
Secretary pursuant to section 1860D-11(i) of such Act (42 U.S.C. 1395w-
111(i)), as amended by subsection (a), with the average price a retail 
pharmacy would charge an individual who does not have health insurance 
coverage for purchasing the same strength, quantity, and dosage form of 
such covered part D drug.

SEC. 102. ELIMINATION OF GAP IN COVERAGE OF MEDICARE PRESCRIPTION DRUG 
              BENEFITS.

    (a) In General.--Section 1860D-2(b) of the Social Security Act (42 
U.S.C. 1395w-102(b)) is amended by striking paragraph (3) and inserting 
the following:
            ``(3) Repealed.''.
    (b) Conforming Amendments.--
            (1) Section 1860D-2 of the Social Security Act (42 U.S.C. 
        1395w-102) is amended--
                    (A) in subsection (a)(2)(A)(i)(I), by striking ``, 
                or an increase in the initial coverage limit with 
                respect to covered part D drugs'';
                    (B) in subsection (b)(2)(A), by striking ``and up 
                to the initial coverage limit under paragraph (3)'';
                    (C) in subsection (b)(4)(C)(i)--
                            (i) by striking the comma after ``paragraph 
                        (1)'' and inserting ``and''; and
                            (ii) by striking ``, and for amounts for 
                        which benefits are not provided because of the 
                        application of the initial coverage limit 
                        described in paragraph (3)'';
                    (D) in subsection (c)(1), by striking subparagraph 
                (C); and
                    (E) in subsection (d)(1)(A), by striking ``or an 
                initial coverage limit (described in subsection 
                (b)(3))''.
            (2) Section 1860D-4(a)(4)(B) of the Social Security Act (42 
        U.S.C. 1395w-104(a)(4)(B)) is amended to read as follows:
                    ``(B) when prescription drug benefits are provided 
                under this part, a notice of the benefits in relation 
                to the annual out-of-pocket threshold for the current 
                year.''.
            (3)(A) Section 1860D-14(a) of the Social Security Act (42 
        U.S.C. 1395w-114(a)) is amended--
                    (i) in paragraph (1), by striking subparagraph (C) 
                and redesignating subparagraphs (D) and (E) as 
                subparagraphs (C) and (D), respectively;
                    (ii) in paragraph (2), by striking subparagraph (C) 
                and redesignating subparagraphs (D) and (E) as 
                subparagraphs (C) and (D), respectively; and
                    (iii) in paragraph (4)(A) in the matter preceding 
                clause (i), by striking ``paragraph (1)(D)(ii)'' and 
                inserting ``paragraph (1)(C)(ii)''.
            (B) Section 1860D-14(c)(1) of the Social Security Act (42 
        U.S.C. 1395w-114(c)(1)) is amended in the second sentence by 
        striking ``subsections (a)(1)(D) and (a)(2)(E)'' and inserting 
        ``subsections (a)(1)(C) and (a)(2)(D)''.
            (C) Section 1860D-15(e)(1)(B) of the Social Security Act 
        (42 U.S.C. 1395w-115(e)(1)(B)) is amended by striking 
        ``paragraphs (1)(D) and (2)(E)'' and inserting ``paragraphs 
        (1)(C) and (2)(D)''.
            (4)(A) Section 1860D-41(a)(6) of the Social Security Act 
        (42 U.S.C. 1395w-151(a)(6)) is amended by striking paragraph 
        (6) and redesignating paragraphs (7) through (18) as paragraphs 
        (6) through (17), respectively.
            (B) Section 1860D-1(a)(1)(A) of the Social Security Act (42 
        U.S.C. 1395w-101(a)(1)(A)) is amended by striking ``1860D-
        41(a)(14)'' and inserting ``1860D-41(a)(13)''.
    (c) Effective Date.--The amendments made by this section shall take 
effect as if included in the enactment of section 101 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (Public 
Law 108-173; 117 Stat. 2066).

  TITLE II--REDUCING MEDICAL ERRORS AND INCREASING THE USE OF MEDICAL 
                               TECHNOLOGY

SEC. 201. MEDICAL ERRORS REDUCTION.

    Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) 
is amended--
            (1) by redesignating part C as part D;
            (2) by redesignating sections 921 through 928, as sections 
        931 through 938, respectively;
            (3) in section 938(1) (as so redesignated), by striking 
        ``921'' and inserting ``931''; and
            (4) by inserting after part B the following:

                ``PART C--REDUCING ERRORS IN HEALTH CARE

``SEC. 921. DEFINITIONS.

    ``In this part:
            ``(1) Adverse event.--The term `adverse event' means an 
        injury resulting from medical management rather than the 
        underlying condition of the patient.
            ``(2) Error.--The term `error' means the failure of a 
        planned action to be completed as intended or the use of a 
        wrong plan to achieve the desired outcome.
            ``(3) Health care provider.--The term `health care 
        provider' means an individual or entity that provides medical 
        services and is a participant in a demonstration program under 
        this part.
            ``(4) Health care-related error.--The term `health care-
        related error' means a preventable adverse event related to a 
        health care intervention or a failure to intervene 
        appropriately.
            ``(5) Medication-related error.--The term `medication-
        related error' means a preventable adverse event related to the 
        administration of a medication.
            ``(6) Safety.--The term `safety' with respect to an 
        individual means that such individual has a right to be free 
        from preventable serious injury.
            ``(7) Sentinel event.--The term `sentinel event' means an 
        unexpected occurrence involving an individual that results in 
        death or serious physical injury that is unrelated to the 
        natural course of the individual's illness or underlying 
        condition.

``SEC. 922. ESTABLISHMENT OF STATE-BASED MEDICAL ERROR REPORTING 
              SYSTEMS.

    ``(a) In General.--The Secretary shall make grants available to 
States to enable such States to establish reporting systems designed to 
reduce medical errors and improve health care quality.
    ``(b) Requirement.--
            ``(1) In general.--To be eligible to receive a grant under 
        subsection (a), the State involved shall provide assurances to 
        the Secretary that amounts received under the grant will be 
        used to establish and implement a medical error reporting 
        system using guidelines (including guidelines relating to the 
        confidentiality of the reporting system) developed by the 
        Agency for Healthcare Research and Quality with input from 
        interested, non-governmental parties including patient, 
        consumer and health care provider groups.
            ``(2) Guidelines.--Not later than 90 days after the date of 
        enactment of this part, the Agency for Healthcare Research and 
        Quality shall develop and publish the guidelines described in 
        paragraph (1).
    ``(c) Data.--
            ``(1) Availability.--A State that receives a grant under 
        subsection (a) shall make the data provided to the medical 
        error reporting system involved available only to the Agency 
        for Healthcare Research and Quality and may not otherwise 
        disclose such information.
            ``(2) Confidentiality.--Nothing in this part shall be 
        construed to supersede any State law that is inconsistent with 
        this part.
    ``(d) Application.--To be eligible for a grant under this section, 
a State shall prepare and submit to the Secretary an application at 
such time, in such manner and containing, such information as the 
Secretary shall require.

``SEC. 923. DEMONSTRATION PROJECTS TO REDUCE MEDICAL ERRORS, IMPROVE 
              PATIENT SAFETY, AND EVALUATE REPORTING.

    ``(a) Establishment.--The Secretary, acting through the Director of 
the Agency for Healthcare Research and Quality and in conjunction with 
the Administrator of the Health Care Financing Administration, may 
establish a program under which funding will be provided for not less 
than 15 demonstration projects, to be competitively awarded, in health 
care facilities and organizations in geographically diverse locations, 
including rural and urban areas (as determined by the Secretary), to 
determine the causes of medical errors and to--
            ``(1) use technology, staff training, and other methods to 
        reduce such errors;
            ``(2) develop replicable models that minimize the frequency 
        and severity of medical errors;
            ``(3) develop mechanisms that encourage reporting, prompt 
        review, and corrective action with respect to medical errors; 
        and
            ``(4) develop methods to minimize any additional paperwork 
        burden on health care professionals.
    ``(b) Activities.--
            ``(1) In general.--A health care provider participating in 
        a demonstration project under subsection (a) shall--
                    ``(A) utilize all available and appropriate 
                technologies to reduce the probability of future 
                medical errors; and
                    ``(B) carry out other activities consistent with 
                subsection (a).
            ``(2) Reporting to patients.--In carrying out this section, 
        the Secretary shall ensure that--
                    ``(A) 5 of the demonstration projects permit the 
                voluntary reporting by participating health care 
                providers of any adverse events, sentinel events, 
                health care-related errors, or medication-related 
                errors to the Secretary;
                    ``(B) 5 of the demonstration projects require 
                participating health care providers to report any 
                adverse events, sentinel events, health care-related 
                errors, or medication-related errors to the Secretary; 
                and
                    ``(C) 5 of the demonstration projects require 
                participating health care providers to report any 
                adverse events, sentinel events, health care-related 
                errors, or medication-related errors to the Secretary 
and to the patient involved and a family member or guardian of the 
patient.
            ``(3) Confidentiality.--
                    ``(A) In general.--The Secretary and the 
                participating grantee organization shall ensure that 
                information reported under this section remains 
                confidential.
                    ``(B) Use.--The Secretary may use the information 
                reported under this section only for the purpose of 
                evaluating the ability to reduce errors in the delivery 
                of care. Such information shall not be used for 
                enforcement purposes.
                    ``(C) Disclosure.--The Secretary may not disclose 
                the information reported under this section.
                    ``(D) Nonadmissibility.--Information reported under 
                this section shall be privileged, confidential, shall 
                not be admissible as evidence or discoverable in any 
                civil or criminal action or proceeding or subject to 
                disclosure, and shall not be subject to the Freedom of 
                Information Act (5 U.S.C. App). This paragraph shall 
                apply to all information maintained by the reporting 
                entity and the entities who receive such reports.
    ``(c) Use of Technologies.--The Secretary shall encourage, as part 
of the demonstration projects conducted under subsection (a), the use 
of appropriate technologies to reduce medical errors, such as hand-held 
electronic prescription pads, training simulators for medical 
education, and bar-coding of prescription drugs and patient bracelets.
    ``(d) Database.--The Secretary shall provide for the establishment 
and operation of a national database of medical errors to be used as 
provided for by the Secretary. The information provided to the 

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