Short title

This Act may be cited as the

Enhanced Health Care Value for All Act of 2007

Research on comparative effectiveness of health care items and services

(a)

Expansion of scope of research

Subsection (a) of section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173) is amended— (1)in paragraph (1)— (A)in subparagraph (A)— (i)by striking programs established under titles XVIII, XIX, and XXI of the Social Security Act and inserting Federal health care programs (as defined in subparagraph (C)); (ii)by striking shall conduct and support research and inserting shall conduct and support research, which may include clinical research,; (iii)in clause (i), by striking and at the end; (iv)in clause (ii), by striking the period at the end and inserting ; and; and (v)by adding at the end the following:

(iii)gaps in current research which may necessitate research beyond systematic reviews of existing evidence.

;

(B)by adding at the end the following new subparagraph:

(C)

Federal health care programs defined

For purposes of this section, the term Federal health care program means each of the following: (i)Any program established under title XVIII, XIX, or XXI of the Social Security Act. (ii)The Federal employees health benefits program under chapter 89 of title 5, United States Code. (iii)A health program operated under title 38, United States Code, by the Department of Veterans Affairs. (iv)The TRICARE program under chapter 55 of title 10, United States Code. (v)A medical care program of the Indian Health Service or of a tribal organization.

;

(2)in paragraph (2)— (A)in subparagraph (C)(i), by striking the programs established and inserting Federal health care programs, including the programs established; (B)in subparagraph (C)(ii), by striking and at the end; (C)in subparagraph (C)(iii), by striking the period at the end and inserting ; and; (D)by inserting after subparagraph (C) the following:

(iv)shall provide for education to physicians, other health care providers, and the public (including patients and consumers) about the information on comparative effectiveness that is available as a result of research funded under this section.

; and

(E)by adding at the end the following:

(D)

Comparative Effectiveness Advisory Board

(i)

In general

Effective as of the date of the enactment of the Enhanced Health Care Value for All Act of 2007, the stakeholder group consulted for purposes of subparagraph (C)(1) shall be known as the Comparative Effectiveness Advisory Board. Any reference in a law, map, regulation, document, paper, or other record of the United States to such stakeholder group shall be deemed to be a reference to the Comparative Effectiveness Advisory Board. (ii)

Composition of Board

The members of the Comparative Effectiveness Advisory Board shall consist of— (I)the Director of the Agency for Healthcare Research and Quality; and (II)up to 14 additional members who shall represent broad constituencies of stakeholders including clinicians, patients, researchers, third-party payers, consumers of Federal and State beneficiary programs, and health care industry professionals. (iii)

Appointment; terms

The Comptroller General of the United States shall appoint the members of the Comparative Effectiveness Advisory Board. Each member shall be appointed for a term of 2 years. The members appointed for the first term following the date of the enactment of the Enhanced Health Care Value for All Act of 2007 shall be appointed not later than 90 days after such date of enactment. Any member serving on the Advisory Board as of the date of the enactment of the Enhanced Health Care Value for All Act of 2007 may continuing serving through the end of the member’s term. (iv)

Conflicts of interest

In appointing the members of the Comparative Effectiveness Advisory Board (and the members of any panel that reports to the Board), the Comptroller General of the United States shall take into consideration any financial conflicts of interest. (E)

Additional authorities

In addition to any authorities vested in the Comparative Effectiveness Advisory Board as of the day before the date of the enactment of the Enhanced Health Care Value for All Act of 2007, the Comparative Effectiveness Advisory Board shall have the following authorities: (i)To provide input on research priorities. (ii)To recommend how to organize research funded under this section taking into consideration the full range of appropriate methodologies, including randomized control trials, practical clinical trials, observation studies, and synthesis of existing research. (iii)To make recommendations on how findings resulting from research funded under this section should be described, presented, and disseminated. (iv)To make recommendations to the Congress and the Secretary, not later than 2 years after the date of the enactment of the Enhanced Health Care Value for All Act of 2007, regarding the establishment of one or more federally-funded research and development centers. (v)To identify, consistent with subparagraph (C)(i), highest priorities (such as treatments that are highly utilized or are for high-cost, chronic illnesses) for research, demonstrations, and evaluations to support and improve Federal health care programs. (vi)To ensure that such priorities are in accordance with the principles described in subparagraph (F). (vii)To establish a clinical peer review advisory panel (comprised of methodologists, health service researchers, and medical experts) for each such priority to advise the Secretary on validating the science and methods used to conduct comparative effectiveness studies. (F)

Principles

Research conducted or supported under this section shall be in accordance with the following principles: (i)

Independence

The setting of the agenda and use of the research shall be insulated from inappropriate political or stakeholder influence. (ii)

Scientific credibility

The methods for conducting the research shall be scientifically based. (iii)

Transparency

All aspects of the prioritization of research, the conduct of the research, and any recommendations based on the research shall be carried out in a transparent manner. (iv)

Inclusion of input from stakeholders

Patients, providers, health care consumer representatives, health industry representatives, and lawmakers shall be consulted regarding priorities and dissemination of the research.

;

(3)in paragraph (3)(C), by adding at the end the following:

(iii)

Updates

The Secretary shall make available and disseminate updated evaluations, syntheses, and findings under this subparagraph not less than every 6 months.

; and

(4)in paragraph (4)(A), by striking the programs established under titles XVIII, XIX, and XXI of the Social Security Act and inserting the Federal health care programs. (b)

Reports to Congress

Such section is further amended— (1)by redesignating subsection (e) as subsection (f); and (2)by inserting after subsection (d) the following:

(e)

Reports

Not later than 1 year after the date of the enactment of the Enhanced Health Care Value for All Act of 2007, and annually thereafter, the Secretary, in consultation with the Comparative Effectiveness Advisory Board, shall submit to Congress a report on the activities conducted under this section. The report submitted under this subsection in 2012 shall include a description of the total activities conducted under this section since the date of the enactment of the Enhanced Health Care Value for All Act of 2007, including— (1)an evaluation of the return on the investment in the program conducted under this section, including the overall cost of the program, the scientific knowledge created through the program, and the ways in which such knowledge has been used; (2)an evaluation of any backlog of unfunded research projects; and (3)an assessment of— (A)how the program is working; (B)the governance structure of the program; (C)the ability of the program to include public comment and patient perspectives in priority setting; and (D)the ability of the program to disseminate findings and conclusions.

Health Care Comparative Effectiveness Research Trust Fund; financing for Trust Fund

(a)

Establishment of trust fund

(1)

In General

Subchapter A of chapter 98 of the Internal Revenue Code of 1986 (relating to trust fund code) is amended by adding at the end the following new section:

9511.

Health Care Comparative Effectiveness Research Trust Fund

(a)

Creation of Trust Fund

There is established in the Treasury of the United States a trust fund to be known as the Health Care Comparative Effectiveness Research Trust Fund (hereinafter in this section referred to as the Trust Fund), consisting of such amounts as may be appropriated or credited to such Trust Fund as provided in this section and section 9602(b). (b)

Transfers to Fund

There are hereby appropriated to the Trust Fund the following: (1)Amounts equivalent to the net revenues received in the Treasury from the fees imposed under subchapter B of chapter 34 (relating to fees on health insurance and self-insured plans). (2)Subject to subsection (c)(2), for each fiscal year beginning with fiscal year 2008, amounts determined by the Secretary of Health and Human Services to be equivalent to fair share amount determined under subsection (c) multiplied by the average number of individuals entitled to benefits under part A, or enrolled under part B, of title XVIII of the Social Security Act during such fiscal year.

The amounts appropriated under paragraph (2) shall be transferred from the Federal Hospital Insurance Trust Fund (established under section 1817 of the Social Security Act) and from the Federal Supplementary Medical Insurance Trust Fund (established under section 1841 of such Act), and from the Medicare Prescription Drug Account within such Trust Fund, in proportion (as estimated by the Secretary) to the total expenditures during such fiscal year that are made under title XVIIII of such Act from the respective trust fund or account.

(c)

Fair share amount

(1)

In general

The Secretary of Health and Human Services shall compute for each fiscal year (beginning with fiscal year 2008) a fair share amount under this subsection that is an amount that, when applied under this section and subchapter B of chapter 34 of the Internal Revenue Code of 1986, will result in revenues to the Trust Fund (taking into account any outstanding balance in the Trust Fund) for the fiscal year as follows: (A)for fiscal year 2008, $100,000,000; (B)for fiscal year 2009, $200,000,000; and (C)for each of fiscal years 2010 through 2012, $900,000,000. (2)

Limitation on Medicare funding

In no case shall the amount transferred under subsection (b)(2) for any fiscal year exceed $200,000,000. (d)

Expenditures From Fund

Amounts in the Trust Fund are available to the Secretary of Health and Human Services for carrying out section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. (e)

Net Revenues

For purposes of this section, the term net revenues means the amount estimated by the Secretary based on the excess of— (1)the fees received in the Treasury under subchapter B of chapter 34, over (2)the decrease in the tax imposed by chapter 1 resulting from the fees imposed by such subchapter.

(2)

Clerical Amendment

The table of sections for such subchapter A is amended by adding at the end thereof the following new item:

Sec. 9511. Health Care Comparative Effectiveness Research Trust Fund.

(b)

Financing for Fund from fees on insured and Self-Insured health plans

(1)

General Rule

Chapter 34 of the Internal Revenue Code of 1986 is amended by adding at the end the following new subchapter:

Insured and Self-Insured Health Plans

Sec. 4375. Health insurance.

Sec. 4376. Self-insured health plans.

Sec. 4377. Definitions and special rules.

4375.

Health insurance

(a)

Imposition of Fee

There is hereby imposed on each specified health insurance policy for each policy year a fee equal to the fair share amount determined under section 9511(c)(1) multiplied by the average number of lives covered under the policy. (b)

Liability for Fee

The fee imposed by subsection (a) shall be paid by the issuer of the policy. (c)

Specified Health Insurance Policy

For purposes of this section— (1)

In general

Except as otherwise provided in this section, the term specified health insurance policy means any accident or health insurance policy issued with respect to individuals residing in the United States. (2)

Exemption of certain policies

The term specified health insurance policy does not include any insurance policy if substantially all of the coverage provided under such policy relates to— (A)liabilities incurred under workers’ compensation laws, (B)tort liabilities, (C)liabilities relating to ownership or use of property, (D)credit insurance, (E)medicare supplemental coverage, or (F)such other similar liabilities as the Secretary may specify by regulations. (3)

Treatment of prepaid health coverage arrangements

(A)

In general

In the case of any arrangement described in subparagraph (B)— (i)such arrangement shall be treated as a specified health insurance policy, and (ii)the person referred to in such subparagraph shall be treated as the issuer. (B)

Description of arrangements

An arrangement is described in this subparagraph if under such arrangement fixed payments or premiums are received as consideration for any person’s agreement to provide or arrange for the provision of accident or health coverage to residents of the United States, regardless of how such coverage is provided or arranged to be provided.

4376.

Self-Insured health plans

(a)

Imposition of Fee

In the case of any applicable self-insured health plan for each plan year, there is hereby imposed a fee equal to the fair share amount determined under section 9511(c)(1) multiplied by the average number of lives covered under the plan. (b)

Liability for Fee

(1)

In general

The fee imposed by subsection (a) shall be paid by the plan sponsor. (2)

Plan sponsor

For purposes of paragraph (1) the term plan sponsor means— (A)the employer in the case of a plan established or maintained by a single employer, (B)the employee organization in the case of a plan established or maintained by an employee organization, (C)in the case of— (i)a plan established or maintained by 2 or more employers or jointly by 1 or more employers and 1 or more employee organizations, (ii)a multiple employer welfare arrangement, or (iii)a voluntary employees’ beneficiary association described in section 501(c)(9),

the association, committee, joint board of trustees, or other similar group of representatives of the parties who establish or maintain the plan, or

(D)the cooperative or association described in subsection (c)(2)(F) in the case of a plan established or maintained by such a cooperative or association. (c)

Applicable Self-Insured Health Plan

For purposes of this section, the term applicable self-insured health plan means any plan for providing accident or health coverage if— (1)any portion of such coverage is provided other than through an insurance policy, and (2)such plan is established or maintained— (A)by one or more employers for the benefit of their employees or former employees, (B)by one or more employee organizations for the benefit of their members or former members, (C)jointly by 1 or more employers and 1 or more employee organizations for the benefit of employees or former employees, (D)by a voluntary employees’ beneficiary association described in section 501(c)(9), (E)by any organization described in section 501(c)(6), or (F)in the case of a plan not described in the preceding subparagraphs, by a multiple employer welfare arrangement (as defined in section 3(40) of Employee Retirement Income Security Act of 1974), a rural electric cooperative (as defined in section 3(40)(B)(iv) of such Act), or a rural telephone cooperative association (as defined in section 3(40)(B)(v) of such Act).

4377.

Definitions and special rules

(a)

Definitions

For purposes of this subchapter— (1)

Accident and health coverage

The term accident and health coverage means any coverage which, if provided by an insurance policy, would cause such policy to be a specified health insurance policy (as defined in section 4375(c)). (2)

Insurance policy

The term insurance policy means any policy or other instrument whereby a contract of insurance is issued, renewed, or extended. (3)

United States

The term United States includes any possession of the United States. (b)

Treatment of Governmental Entities

(1)

In general

For purposes of this subchapter— (A)the term person includes any governmental entity, and (B)notwithstanding any other law or rule of law, governmental entities shall not be exempt from the fees imposed by this subchapter except as provided in paragraph (2). (2)

Treatment of exempt governmental programs

In the case of an exempt governmental program, no fee shall be imposed under section 4375 or section 4376 on any covered life under such program. (3)

Exempt governmental program defined

For purposes of this subchapter, the term exempt governmental program means— (A)any insurance program established under title XVIII of the Social Security Act, (B)the medical assistance program established by title XIX or XXI of the Social Security Act, (C)any program established by Federal law for providing medical care (other than through insurance policies) to individuals (or the spouses and dependents thereof) by reason of such individuals being— (i)members of the Armed Forces of the United States, or (ii)veterans, and (D)any program established by Federal law for providing medical care (other than through insurance policies) to members of Indian tribes (as defined in section 4(d) of the Indian Health Care Improvement Act). (c)

Treatment as Tax

For purposes of subtitle F, the fees imposed by this subchapter shall be treated as if they were taxes. (d)

No Cover Over to Possessions

Notwithstanding any other provision of law, no amount collected under this subchapter shall be covered over to any possession of the United States.

(2)

Clerical Amendment

Chapter 34 of such Code is amended by striking the chapter heading and inserting the following:

TAXES ON CERTAIN INSURANCE POLICIES

Subchapter A. Policies issued by foreign insurers

Subchapter B. Insured and self-insured health plans

Policies Issued By Foreign Insurers

(3)

Effective Date

The amendments made by this section shall apply with respect to policies and plans for portions or policy or plan years beginning on or after October 1, 2007.

Coordination of Health Services Research

(a)

Establishment

The Secretary of Health and Human Services shall establish a permanent council (in this section referred to as the Council) for the purpose of assisting the offices and agencies of the Department of Health and Human Services, the Department of Veterans Affairs, the Department of Defense, and any other department or agency to coordinate the conduct or support of health services research. Such coordination shall include advising each such office and agency— (1)on clarifying its policies regarding public access to data resulting from research conducted or supported by the office or agency, including the provision of reasons for not permitting any such data to be publicly disclosed; (2)on making such policies, as clarified, publicly available; and (3)on updating the publicly available versions of such policies to reflect any subsequent modifications; (b)

Membership

(1)

Number and appointment

The Council shall be composed of 20 members. One member shall be the Director of the Agency for Healthcare Research and Quality. The Director shall appoint the other members not later than 30 days after the enactment of this Act. (2)

Qualifications

(A)

In general

The members of the Council shall include one senior official from each of the following agencies: (i)The Veterans Health Administration. (ii)The Department of Defense Military Health Care System. (iii)The Centers for Disease Control and Prevention. (iv)The National Center for Health Statistics. (v)The National Institutes of Health. (vi)The Center for Medicare & Medicaid Services. (vii)The Federal Employees Health Benefits Program. (B)

National, philanthropic foundations

The members of the Council shall include 4 senior leaders from major national, philanthropic foundations that fund and use health services research. (C)

Stakeholders

The remaining members of the Council shall be representatives of other stakeholders in health services research, including private purchasers, health plans, hospitals and other health facilities, and health consumer groups. (D)

Period of appointment

Members of the Council shall be appointed for the life of the Council. Any vacancies shall not affect the power and duties of the Council and shall be filled in the same manner as the original appointment. (c)

Leadership

The Secretary of Health and Human Services shall appoint the chair of the Council. Not later than 15 days after the date on which all members of the Council have been appointed under section (b)(1), the Council chair shall designate a co-chair of the Council. The co-chair shall be the leader of a national foundation that funds health services research. (d)

Subcommittees

The Council may establish subcommittees to assist in carrying out its duties. (e)

Duties

(1)

Public meetings

Not later than 120 days after the designation of a co-chairperson under subsection (c), the Council shall hold public meetings with producers and users of health services research to examine— (A)the major infrastructure challenges facing the field of health services research; (B)the field’s research priorities over the next 5 years; (C)the current portfolio of health services research being funded; (D)ways to stimulate innovation in the field of health services research; and (E)ways in which the field of health services research might help to transform the health care system by 2020. (2)

Additional meetings

The Council may hold additional public meetings on subjects other than those listed in the paragraph (1) so long as the meetings are determined to be necessary by the Council in carrying out its duties. Additional meetings are not required to be completed within the time period specified in paragraph (1). (3)

Develop a strategic plan

Not later than 2 years after the meetings described in paragraph (1) and (2) are completed, the Council shall prepare and make public through the Internet and other channels a strategic plan for the field of health services research, which plan shall include the following: (A)A health services research agenda to address the Nation’s evolving health care priorities. (B)A plan for addressing the infrastructure needs of the field of health services research, including professional development for the next generation of researchers and improved methods and data. (C)A plan for fostering innovation in the field of health services research. (D)A uniform definition of health services research and standard research categories to be used across the funders of health services research in developing research budgets and reporting research expenditures. (f)

Annual report

Not later than 1 year after the publication of the Council’s strategic plan under subsection (e)(3), and annually thereafter, the Council shall report to the Congress on, and make public a detailed description of, the following: (1)The Council’s progress in implementing the strategic plan. (2)Organizational expenditures in health services research by the Federal agencies specified in subsection (b)(2)(A) according to the uniform definition and standard research categories developed by the Council. (g)

Detail of employees

Each Federal agency represented on the Council may, on a non-reimbursable basis, detail one employee to the Council. Each such detail shall last no more than 2 years. Any detail of an employee shall be without interruption or loss of civil services status or privilege. (h)

Contracting

The Director of the Agency for Healthcare Research and Quality may contract with an outside entity to assist the Council in holding public meetings, developing the strategic plan for the field of health services research, and fulfilling annual reporting requirements.