Heart Disease Education, Analysis, and Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require an application for approval or for investigation of a drug, device, or biological product to include information stratified by gender, race, and ethnicity, including any differences in safety and effectiveness. Requires the Secretary of Health and Human Services to: (1) withhold approval of such an application or place a clinical hold on an investigation if such information is not included; and (2) report to the scientific community and make information available to the public on such stratified data upon approval of an application.
Requires the Comptroller General to study the drug approval process to ensure compliance with this Act.
Requires the Secretary to require that all nonidentifiable patient safety work product reported to a patient safety database be stratified by gender.
Amends title XVIII (Medicare) the Social Security Act (SSA) to require the Secretary to make hospital quality data relating to the quality of care in inpatient settings available to the public stratified by gender.
Requires the Secretary, acting through the Director of the Agency for Healthcare Research and Quality (AHRQ), to report to Congress concerning the quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases.
Requires utilization and quality control peer review organizations to offer quality improvement assistance aimed at eliminating gender disparities.
Amends title IX (employment security provisions) of SSA to require that data be stratified by gender when collected and used in surveys evaluating whether Medicare providers meet applicable conditions of participation or coverage.
Provides for an educational campaign relating to heart disease, stroke, and cardiovascular diseases in women.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2278 Introduced in Senate (IS)]
109th CONGRESS
2d Session
S. 2278
To amend the Public Health Service Act to improve the prevention,
diagnosis, and treatment of heart disease, stroke, and other
cardiovascular diseases in women.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 14, 2006
Ms. Stabenow (for herself and Ms. Murkowski) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to improve the prevention,
diagnosis, and treatment of heart disease, stroke, and other
cardiovascular diseases in women.
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 ``Heart Disease Education, Analysis,
and Research, and Treatment for Women Act'' or the ``HEART for Women
Act''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Heart disease, stroke, and other cardiovascular
diseases are the leading cause of death among women.
(2) Despite being the number 1 killer, only 13 percent of
women are aware that cardiovascular diseases, including heart
disease and stroke, are their greatest health risk.
(3) Many minority women, including African American,
Hispanic, and Native American women, are at a higher risk of
death from heart disease, stroke, and other cardiovascular
diseases, but they are less likely to know of this risk.
(4) There is a pervasive lack of awareness among health
care providers that cardiovascular disease is the leading
killer of women.
(5) Women are less likely than men to receive certain
treatments for cardiovascular diseases, perhaps due to lack of
awareness and the presence of different symptoms in women than
in men.
(6) Women tend to experience later onset of heart disease
than men, and therefore more often suffer from multiple
conditions that mask symptoms of heart disease and complicate
treatment.
(7) Certain diagnostic tests for cardiovascular disease may
be less accurate in women than men.
(8) Drug effectiveness and metabolism differ in women and
men, impacting successful treatment of cardiovascular disease.
(9) In addition, stroke kills 2.3 times as many females as
does breast cancer. Nearly 61 percent of stroke-related deaths
occur in females. Studies have found gender differences in the
effects, diagnosis, and treatment of stroke. For instance--
(A) stroke severity is greater in women than in
men;
(B) women often receive fewer diagnostic tests and
intervention procedures than men; and
(C) strokes present treatment issues unique to
women.
SEC. 3. REPORTING OF GENDER DATA IN APPLICATIONS FOR DRUGS, BIOLOGICS,
AND DEVICES.
(a) New Drug Applications.--Section 505(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at the
end the following:
``(5)(A) Notwithstanding any other provision of this Act, the
applicant shall include in any submission to the Secretary pursuant to
this subsection, to the extent appropriate, information stratified by
gender, race and ethnicity, including any differences in safety and
effectiveness.
``(B) The Secretary shall withhold approval of an application if
the applicant fails to submit the required information described in
subparagraph (A).
``(C) The Secretary shall develop standards to ensure that
submissions to the Secretary pursuant to this subsection are adequately
reviewed to determine whether such submissions include the information
required under subparagraph (A).
``(D) Upon the approval under this subsection of an application for
a drug, the Secretary shall report to the scientific community and make
available to the public, in a timely manner, data regarding such drug
stratified by gender, race, and ethnicity.''.
(b) Investigational New Drug Applications.--Section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is amended--
(1) in paragraph (2), by inserting ``and paragraph (5)''
after ``Subject to paragraph (3)''; and
(2) by adding at the end the following:
``(5)(A) Notwithstanding any other provision of this Act, the
manufacturer or sponsor of an investigation of a new drug shall include
in any submission to the Secretary pursuant to this subsection on the
clinical investigation of the new drug and to the extent appropriate,
information stratified by gender, race, and ethnicity, including any
differences in safety and effectiveness.
``(B) The Secretary shall place a clinical hold (as described in
paragraph (3)) on an investigation if the manufacturer or sponsor of
the investigation fails to submit the required information described in
subparagraph (A).
``(C) The Secretary shall develop standards that ensure that
submissions to the Secretary pursuant to this subsection on clinical
investigations of new drugs are adequately reviewed to determine
whether such submissions include the information required under this
paragraph.''.
(c) Abbreviated New Drug Applications.--Section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended--
(1) in paragraph (2)(A), by inserting before the period at
the end the following: ``, subject to paragraph (10)'';
(2) in paragraph (3)(A), by adding at the end the
following: ``The Secretary shall require such individuals who
review such applications to ensure that such applications
include the information on gender data required under paragraph
(10).'';
(3) in paragraph (4)--
(A) in subparagraph (J), by striking ``or'' after
the semicolon;
(B) in subparagraph (K), by striking the period at
the end and inserting ``; or''; and
(C) by adding at the end the following:
``(L) the application does not include appropriate
information stratified by gender, race, and ethnicity,
as required under paragraph (10).''; and
(4) by adding at the end the following:
``(10)(A) Notwithstanding any other provision of this Act, a person
shall include in any submission to the Secretary pursuant to this
subsection appropriate drug information stratified by gender, race, and
ethnicity, including any differences in safety and effectiveness.
``(B) The Secretary shall develop standards that ensure that
submissions to the Secretary pursuant to this subsection are adequately
reviewed to determine whether such submissions include the information
required under this paragraph.
``(11) Upon the approval under this subsection of an application
for a drug, the Secretary shall report to the scientific community and
make available to the public, in a timely manner, data regarding such
drug stratified by gender, race, and ethnicity.''.
(d) Premarket Approvals.--Section 515 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e) is amended--
(1) in subsection (c)--
(A) in paragraph (1)--
(i) in subparagraph (F), by striking
``and'' at the end;
(ii) in subparagraph (G), by striking the
period and inserting ``; and''; and
(iii) by adding at the end the following:
``(H) information regarding the device, to the extent
appropriate, stratified by gender, race and ethnicity,
including differences in safety and effectiveness.''; and
(B) by adding at the end the following:
``(5) The Secretary shall develop standards that ensure that
submissions to the Secretary pursuant to this subsection are adequately
reviewed to determine whether such submissions include the information
required under paragraph (1)(H).''; and
(2) in subsection (d)--
(A) in paragraph (1)--
(i) in subparagraph (D), by striking ``or''
at the end;
(ii) in subparagraph (E), by striking the
period and inserting ``; or''; and
(iii) by inserting after subparagraph (E),
the following:
``(F) the application does not contain, as appropriate, the
information required in subsection (c)(1)(H).''; and
(B) by adding at the end the following:
``(7) Upon the approval of an application under this section, the
Secretary shall report to the scientific community and make available
to the public, in a timely manner, data regarding such device
stratified by gender, race, and ethnicity.''.
(e) Investigational Device Exemptions.--Section 520(g)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)) is amended--
(1) in subparagraph (B), by adding at the end the
following:
``(iv) A requirement that any application include
information regarding the device, to the extent appropriate,
stratified by gender, race, and ethnicity, including
differences in safety and effectiveness.''; and
(2) by adding at the end the following:
``(d) The Secretary shall develop standards that ensure that
submissions to the Secretary pursuant to this subsection are adequately
reviewed to determine whether such submissions include the information
required under paragraph (B)(iv).''.
(f) Biological Product Licenses.--Section 351(a)(2) of the Public
Health Service Act (42 U.S.C. 262) is amended by adding at the end the
following:
``(D)(i) Notwithstanding any other provision of this Act, the
applicant shall include in any application to the Secretary pursuant to
this section appropriate information regarding the subject biological
product stratified by gender, race, and ethnicity, including
differences in safety and effectiveness.
``(ii) The Secretary shall develop standards that ensure that
submissions to the Secretary pursuant to this section are adequately
reviewed to determine whether such submissions include the information
required under paragraph (D)(i).
``(iii) Upon the approval of an application under this subsection,
the Secretary shall report to the scientific community and make
available to the public, in a timely manner, data regarding such
biological product stratified by gender, race, and ethnicity.''.
(g) GAO Study.--Not later than 2 years after the date of enactment
of this section, the Comptroller General of the United States shall
study the drug approval processes of the Food and Drug Administration
to ensure that the Food and Drug Administration is complying with the
amendments made by this section.
SEC. 4. GENDER-BASED REPORTING AND ANALYSIS OF PATIENT SAFETY DATA.
(a) Data Standards.--Section 923(b) of the Public Health Service
Act (as amended by the Patient Safety and Quality Improvement Act of
2005 (Public law 109-41)) is amended by adding at the end the
following: ``The Secretary shall provide that all nonidentifiable
patient safety work product reported to and among the network of
patient safety databases be stratified by gender.''.
(b) Use of Information.--Section 923(c) of the Public Health
Service Act (as amended by the Patient Safety and Quality Improvement
Act of 2005 (Public law 109-41)) is amended by adding at the end the
following: ``Such analyses take into account data that specifically
relates to women and any disparities between treatment and the quality
of care between males and females.''.
SEC. 5. REPORTING OF HOSPITAL QUALITY DATA BY GENDER.
Section 1886(b)(3)(B)(iv)(II) of the Social Security Act (42 U.S.C.
1395ww(b)(3)(B)(vii)(II)), as amended by section 501 of the Medicare
Prescription Drug, Improvement, and modernization Act of 2003 (Public
law 108-173), is amended by adding at the end the following: ``The
Secretary shall make such data available to the public, in a form and
manner that stratifies the data by gender.''.
SEC. 6. QUALITY OF CARE REPORTS BY THE AGENCY FOR HEALTHCARE RESEARCH
AND QUALITY.
Section 903 of the Public Health Service Act (42 U.S.C. 299a-1) is
amended--
(1) in subsection (b)(1)(B), by inserting before the
semicolon the following: ``, including quality of and access to
care for women with heart disease, stroke, and other
cardiovascular disease''; and
(2) in subsection (c), by adding at the end the following:
``(4) Annual report on women and heart disease.--Not later
than September 30, 2006, and annually thereafter, the
Secretary, acting through the Director, shall prepare and
submit to Congress a report concerning the findings related to
the quality of and access to care for women with heart disease,
stroke, and other cardiovascular diseases. The report shall
contain recommendations for eliminating disparities in, and
improving the treatment of, heart disease, stroke, and other
cardiovascular diseases in women.''.
SEC. 7. ANALYSIS OF DATA BY QUALITY IMPROVEMENT ORGANIZATIONS.
Section 1154(a) of the Social Security Act (42 U.S.C. 1320c-3(a))
is amended by adding at the end the following:
``(18) The organization shall execute its responsibilities
under subparagraphs (A) and (B) of paragraph (1) by offering to
providers, practitioners, Medicare Advantage organizations
under part C, and prescription drug sponsors offering
prescription drug plans under part D quality improvement
assistance aimed at eliminating gender disparities in the
quality of care for women, particularly minority women, who
suffer from heart disease, stroke, and other cardiovascular
diseases. For purposes of this part and title XVIII, the
functions described in this paragraph shall be treated as a
review function.''.
SEC. 8. REPORTS BY ACCREDITING ORGANIZATIONS.
The Social Security Act is amended by inserting after section 1808
(42 U.S.C. 1395b-9) the following:
``SEC. 1809. STRATIFICATION OF DATA BY GENDER IN APPLYING CONDITIONS OF
PARTICIPATION AND CONDITIONS OF COVERAGE.
``The Secretary shall ensure that data are stratified by gender
when collected and used in surveys evaluating whether providers meet
the applicable conditions of participation or conditions of coverage
under parts A, B, C, and D of this title. When determined feasible by
the Secretary, such data shall be stratified by gender when reported to
the public or otherwise made available to the public.''.
SEC. 9. EDUCATIONAL CAMPAIGNS.
(a) Distribution of Educational Material Through the Center for
Beneficiary Choices.--The Secretary of Health and Human Services,
acting through the Center for Beneficiary Choices of the Centers for
Medicare & Medicaid Services, shall develop and distribute to female
medicare beneficiaries, physicians, and other appropriate healthcare
professionals educational materials relating to the prevention,
diagnosis, and treatment of heart disease, stroke, and cardiovascular
diseases in women. The Center for Beneficiary Choices may carry out
this subsection through contracts with public and private nonprofit
entities.
(b) Healthcare Professional Educational Campaign.--The Secretary of
Health and Human Services, acting through the Bureau of Health
Professions of the Health Resources and Services Administration, shall
conduct an education and awareness campaign for physicians and other
healthcare professionals relating to the prevention, diagnosis, and
treatment of heart disease, stroke, and other cardiovascular diseases
in women. The Bureau of Health Professions may carry out this
subsection through contracts with public and private nonprofit
entities.
SEC. 10. EXTENSION OF WISEWOMAN.
There are authorized to be appropriated such sums as may be
necessary for each fiscal year to enable the Director of the Centers
for Disease Control and Prevention to implement Well-Integrated
Screening and Evaluation for Women Across the Nation (WISEWOMAN)
program projects in all State and territories, which may include
projects among Indian tribes.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S1176-1177)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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