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42 U.S.C. § 299b–7 — Research on outcomes of health care items and services
Federal law — U.S. Code and appendices · legal_authorities
**(a) Research, demonstrations, and evaluations**
(1) **Improvement of effectiveness and efficiency**
(A) *In general* — To improve the quality, effectiveness, and efficiency of health care delivered pursuant to the programs established under titles XVIII, XIX, and XXI of the Social Security Act [[42 U.S.C. 1395](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395&num=0&edition=prelim) et seq., 1396 et seq., 1397aa et seq.], the Secretary 11 So in original. Probably should be followed by a comma. acting through the Director of the Agency for Healthcare Research and Quality (in this section referred to as the “Director”), shall conduct and support research to meet the priorities and requests for scientific evidence and information identified by such programs with respect to—
(i) the outcomes, comparative clinical effectiveness, and appropriateness of health care items and services (including prescription drugs); and
(ii) strategies for improving the efficiency and effectiveness of such programs, including the ways in which such items and services are organized, managed, and delivered under such programs.
(B) *Specification* — To respond to priorities and information requests in subparagraph (A), the Secretary may conduct or support, by grant, contract, or interagency agreement, research, demonstrations, evaluations, technology assessments, or other activities, including the provision of technical assistance, scientific expertise, or methodological assistance.
(2) **Priorities**
(A) *In general* — The Secretary shall establish a process to develop priorities that will guide the research, demonstrations, and evaluation activities undertaken pursuant to this section.
(B) *Initial list* — Not later than 6 months after Dece
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Source file: Laws/federal/codes/united-states-code/title-42/section-299b7-research-on-outcomes-of-health-care-items-and-services--9770a36b9f.md
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Source location: Title 42, Chapter 6A, § 299b–7; chapter-6a-public-health-service.md
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**(a) Research, demonstrations, and evaluations**
(1) **Improvement of effectiveness and efficiency**
(A) *In general* — To improve the quality, effectiveness, and efficiency of health care delivered pursuant to the programs established under titles XVIII, XIX, and XXI of the Social Security Act [[42 U.S.C. 1395](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395&num=0&edition=prelim) et seq., 1396 et seq., 1397aa et seq.], the Secretary 11 So in original. Probably should be followed by a comma. acting through the Director of the Agency for Healthcare Research and Quality (in this section referred to as the “Director”), shall conduct and support research to meet the priorities and requests for scientific evidence and information identified by such programs with respect to—
(i) the outcomes, comparative clinical effectiveness, and appropriateness of health care items and services (including prescription drugs); and
(ii) strategies for improving the efficiency and effectiveness of such programs, including the ways in which such items and services are organized, managed, and delivered under such programs.
(B) *Specification* — To respond to priorities and information requests in subparagraph (A), the Secretary may conduct or support, by grant, contract, or interagency agreement, research, demonstrations, evaluations, technology assessments, or other activities, including the provision of technical assistance, scientific expertise, or methodological assistance.
(2) **Priorities**
(A) *In general* — The Secretary shall establish a process to develop priorities that will guide the research, demonstrations, and evaluation activities undertaken pursuant to this section.
(B) *Initial list* — Not later than 6 months after December 8, 2003, the Secretary shall establish an initial list of priorities for research related to health care items and services (including prescription drugs).
(C) *Process* — In carrying out subparagraph (A), the Secretary—
(i) shall ensure that there is broad and ongoing consultation with relevant stakeholders in identifying the highest priorities for research, demonstrations, and evaluations to support and improve the programs established under titles XVIII, XIX, and XXI of the Social Security Act [[42 U.S.C. 1395](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395&num=0&edition=prelim) et seq., 1396 et seq., 1397aa et seq.];
(ii) may include health care items and services which impose a high cost on such programs, as well as those which may be underutilized or overutilized and which may significantly improve the prevention, treatment, or cure of diseases and conditions (including chronic conditions) which impose high direct or indirect costs on patients or society; and
(iii) shall ensure that the research and activities undertaken pursuant to this section are responsive to the specified priorities and are conducted in a timely manner.
(3) **Evaluation and synthesis of scientific evidence**
(A) *In general* — The Secretary shall—
(i) evaluate and synthesize available scientific evidence related to health care items and services (including prescription drugs) identified as priorities in accordance with paragraph (2) with respect to the comparative clinical effectiveness, outcomes, appropriateness, and provision of such items and services (including prescription drugs);
(ii) identify issues for which existing scientific evidence is insufficient with respect to such health care items and services (including prescription drugs);
(iii) disseminate to prescription drug plans and MA–PD plans under part D of title XVIII of the Social Security Act [[42 U.S.C. 1395w–101](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w-101&num=0&edition=prelim) et seq.], other health plans, and the public the findings made under clauses (i) and (ii); and
(iv) work in voluntary collaboration with public and private sector entities to facilitate the development of new scientific knowledge regarding health care items and services (including prescription drugs).
(B) *Initial research* — The Secretary shall complete the evaluation and synthesis of the initial research required by the priority list developed under paragraph (2)(B) not later than 18 months after the development of such list.
(C) *Dissemination*
(i) *In general* — To enhance patient safety and the quality of health care, the Secretary shall make available and disseminate in appropriate formats to prescription drugs plans under part D, and MA–PD plans under part C, of title XVIII of the Social Security Act [[42 U.S.C. 1395w–101](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w-101&num=0&edition=prelim) et seq., 1395w–21 et seq.], other health plans, and the public the evaluations and syntheses prepared pursuant to subparagraph (A) and the findings of research conducted pursuant to paragraph (1). In carrying out this clause the Secretary, in order to facilitate the availability of such evaluations and syntheses or findings at every decision point in the health care system, shall—
(I) present such evaluations and syntheses or findings in a form that is easily understood by the individuals receiving health care items and services (including prescription drugs) under such plans and periodically assess that the requirements of this subclause have been met; and
(II) provide such evaluations and syntheses or findings and other relevant information through easily accessible and searchable electronic mechanisms, and in hard copy formats as appropriate.
(ii) *Rule of construction* — Nothing in this section shall be construed as—
(I) affecting the authority of the Secretary or the Commissioner of Food and Drugs under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.] or the Public Health Service Act [[42 U.S.C. 201](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim) et seq.]; or
(II) conferring any authority referred to in subclause (I) to the Director.
(D) *Accountability* — In carrying out this paragraph, the Secretary shall implement activities in a manner that—
(i) makes publicly available all scientific evidence relied upon and the methodologies employed, provided such evidence and method are not protected from public disclosure by [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim) or other applicable law so that the results of the research, analyses, or syntheses can be evaluated or replicated; and
(ii) ensures that any information needs and unresolved issues identified in subparagraph (A)(ii) are taken into account in priority-setting for future research conducted by the Secretary.
(4) **Confidentiality**
(A) *In general* — In making use of administrative, clinical, and program data and information developed or collected with respect to the programs established under titles XVIII, XIX, and XXI of the Social Security Act [[42 U.S.C. 1395](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395&num=0&edition=prelim) et seq., 1396 et seq., 1397aa et seq.], for purposes of carrying out the requirements of this section or the activities authorized under title IX of the Public Health Service Act ([42 U.S.C. 299](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section299&num=0&edition=prelim) et seq.), such data and information shall be protected in accordance with the confidentiality requirements of title IX of the Public Health Service Act.
(B) *Rule of construction* — Nothing in this section shall be construed to require or permit the disclosure of data provided to the Secretary that is otherwise protected from disclosure under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.], [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim), or other applicable law.
(5) **Evaluations** — The Secretary shall conduct and support evaluations of the activities carried out under this section to determine the extent to which such activities have had an effect on outcomes and utilization of health care items and services.
(6) **Improving information available to health care providers, patients, and policymakers** — Not later than 18 months after December 8, 2003, the Secretary shall identify options that could be undertaken in voluntary collaboration with private and public entities (as appropriate) for the—
(A) provision of more timely information through the programs established under titles XVIII, XIX, and XXI of the Social Security Act [[42 U.S.C. 1395](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395&num=0&edition=prelim) et seq., 1396 et seq., 1397aa et seq.], regarding the outcomes and quality of patient care, including clinical and patient-reported outcomes, especially with respect to interventions and conditions for which clinical trials would not be feasible or raise ethical concerns that are difficult to address;
(B) acceleration of the adoption of innovation and quality improvement under such programs; and
(C) development of management tools for the programs established under titles XIX and XXI of the Social Security Act [[42 U.S.C. 1396](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1396&num=0&edition=prelim) et seq., 1397aa et seq.], and with respect to the programs established under such titles, assess the feasibility of using administrative or claims data, to—
(i) improve oversight by State officials;
(ii) support Federal and State initiatives to improve the quality, safety, and efficiency of services provided under such programs; and
(iii) provide a basis for estimating the fiscal and coverage impact of Federal or State program and policy changes.
**(b) Recommendations**
(1) **Disclaimer** — In carrying out this section, the Director shall—
(A) not mandate national standards of clinical practice or quality health care standards; and
(B) include in any recommendations resulting from projects funded and published by the Director, a corresponding reference to the prohibition described in subparagraph (A).
(2) **Requirement for implementation** — Research, evaluation, and communication activities performed pursuant to this section shall reflect the principle that clinicians and patients should have the best available evidence upon which to make choices in health care items and services, in providers, and in health care delivery systems, recognizing that patient subpopulations and patient and physician preferences may vary.
(3) **Rule of construction** — Nothing in this section shall be construed to provide the Director with authority to mandate a national standard or require a specific approach to quality measurement and reporting.
**(c) Research with respect to dissemination** The Secretary, acting through the Director, may conduct or support research with respect to improving methods of disseminating information in accordance with subsection (a)(3)(C).
**(d) Limitation on CMS** The Administrator of the Centers for Medicare & Medicaid Services may not use data obtained in accordance with this section to withhold coverage of a prescription drug.
**(e) Authorization of appropriations** There is authorized to be appropriated to carry out this section, $50,000,000 for fiscal year 2004, and such sums as may be necessary for each fiscal year thereafter.
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** There is established within the Public Health Service an agency to be known as the Agency for Healthcare Research and Quality, which shall be headed by a director appointed by the Secretary. The Secretary shall carry out this subchapter acting through the Director.
**(b) Mission** The purpose of the Agency is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health system practices, including the prevention of diseases and other health conditions. The Agency shall promote health care quality improvement by conducting and supporting—
(1) research that develops and presents scientific evidence regarding all aspects of health care, including—
(A) the development and assessment of methods for enhancing patient participation in their own care and for facilitating shared patient-physician decision-making;
(B) the outcomes, effectiveness, and cost-effectiveness of health care practices, including preventive measures and long-term care;
(C) existing and innovative technologies;
(D) the costs and utilization of, and access to health care;
(E) the ways in which health care services are organized, delivered, and financed and the interaction and impact of these factors on the quality of patient care;
(F) methods for measuring quality and strategies for improving quality; and
(G) ways in which patients, consumers, purchasers, and practitioners acquire new information about best practices and health benefits, the determinants and impact of their use of this information;
(2) the synthesis and dissemination of available scientific evidence for use by patients, consu
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 299
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** When used in this chapter—
(1) The term “State”, except where otherwise provided, includes the District of Columbia and the Commonwealth of Puerto Rico, and when used in subchapters IV, V, VII, XI, XIX, and XXI includes the Virgin Islands and Guam. Such term when used in subchapters III, IX, and XII also includes the Virgin Islands. Such term when used in subchapter V and in part B of this subchapter also includes American Samoa, the Northern Mariana Islands, and the Trust Territory of the Pacific Islands. Such term when used in subchapters XIX and XXI also includes the Northern Mariana Islands and American Samoa. In the case of Puerto Rico, the Virgin Islands, and Guam, subchapters I, X, and XIV, and subchapter XVI (as in effect without regard to the amendment made by section 301 of the Social Security Amendments of 1972) shall continue to apply, and the term “State” when used in such subchapters (but not in subchapter XVI as in effect pursuant to such amendment after December 31, 1973) includes Puerto Rico, the Virgin Islands, and Guam. Such term when used in subchapter XX also includes the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands. Such term when used in subchapter IV also includes American Samoa.
(2) The term “United States” when used in a geographical sense means, except where otherwise provided, the States.
(3) The term “person” means an individual, a trust or estate, a partnership, or a corporation.
(4) The term “corporation” includes associations, joint-stock companies, and insurance companies.
(5) The term “shareholder” includes a member in an association, joint-stock company, or insurance company.
(6) The term “Secretary”, except when the context otherwise requires, means the Secretary of Health and Human Services.
(
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment** There is hereby established the Medicaid and CHIP Payment and Access Commission (in this section referred to as “MACPAC”).
**(b) Duties**
(1) **Review of access policies for all States and annual reports** — MACPAC shall—
(A) review policies of the Medicaid program established under this subchapter (in this section referred to as “Medicaid”) and the State Children’s Health Insurance Program established under subchapter XXI (in this section referred to as “CHIP”) affecting access to covered items and services, including topics described in paragraph (2);
(B) make recommendations to Congress, the Secretary, and States concerning such access policies;
(C) by not later than March 15 of each year (beginning with 2010), submit a report to Congress containing the results of such reviews and MACPAC’s recommendations concerning such policies; and
(D) by not later than June 15 of each year (beginning with 2010), submit a report to Congress containing an examination of issues affecting Medicaid and CHIP, including the implications of changes in health care delivery in the United States and in the market for health care services on such programs.
(2) **Specific topics to be reviewed** — Specifically, MACPAC shall review and assess the following:
(A) *Medicaid and CHIP payment policies* — Payment policies under Medicaid and CHIP, including—
(i) the factors affecting expenditures for the efficient provision of items and services in different sectors, including the process for updating payments to medical, dental, and health professionals, hospitals, residential and long-term care providers, providers of home and community based services, Federally-qualified health centers and rural health clinics, managed care entities, and providers of ot
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Federal law — U.S. Code and appendices · legal_authorities
Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the “Social Security Act”.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Conditions of participation; protection of individual rights; notification of State entities; use of home health aides; medical equipment; individual’s plan of care; compliance with Federal, State, and local laws and regulations** The conditions of participation that a home health agency is required to meet under this subsection are as follows:
(1) The agency protects and promotes the rights of each individual under its care, including each of the following rights:
(A) The right to be fully informed in advance about the care and treatment to be provided by the agency, to be fully informed in advance of any changes in the care or treatment to be provided by the agency that may affect the individual’s well-being, and (except with respect to an individual adjudged incompetent) to participate in planning care and treatment or changes in care or treatment.
(B) The right to voice grievances with respect to treatment or care that is (or fails to be) furnished without discrimination or reprisal for voicing grievances.
(C) The right to confidentiality of the clinical records described in section 1395x(o)(3) of this title.
(D) The right to have one’s property treated with respect.
(E) The right to be fully informed orally and in writing (in advance of coming under the care of the agency) of—
(i) all items and services furnished by (or under arrangements with) the agency for which payment may be made under this subchapter,
(ii) the coverage available for such items and services under this subchapter, subchapter XIX, and any other Federal program of which the agency is reasonably aware,
(iii) any charges for items and services not covered under this subchapter and any charges the individual may have to pay with respect to items and services furn
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Federal law — U.S. Code and appendices · legal_authorities
Page 30
TITLE 21—FOOD AND DRUGS
§ 301
Sec.
398.
Notices to States regarding imported food.
399.
Grants to enhance food safety.
399a.
Office of the Chief Scientist.
399b.
Office of Women’s Health.
399c.
Improving the training of State, local, terri-
torial, and tribal food safety officials.
399d.
Employee protections.
399e.
Nanotechnology.
399f.
Ensuring
adequate
information
regarding
pharmaceuticals for all populations, par-
ticularly underrepresented subpopulations,
including racial subgroups.
399g.
Food and Drug Administration Intercenter
Institutes.
399h.
National Centers of Excellence in Advanced
and Continuous Pharmaceutical Manufac-
turing.
399i.
Food and Drug Administration Working Cap-
ital Fund.
SUBCHAPTER I—SHORT TITLE
§ 301. Short title
This chapter may be cited as the Federal
Food, Drug, and Cosmetic Act.
(June 25, 1938, ch. 675, § 1, 52 Stat. 1040.)
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES
Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro-
vided that:
‘‘[SEC. 1] (a) The effective date of the following provi-
sions of the Federal Food, Drug, and Cosmetic Act is
hereby postponed until January 1, 1940: Sections 402(c)
[342(c) of this title]; 403(e)(1) [343(e)(1) of this title];
403(g), (h), (i), (j), and (k) [343(g) to (k) of this title];
501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g),
and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of
this title]; and 602(b) [362(b) of this title].
‘‘(b) The Secretary of Agriculture shall promulgate
regulations further postponing to July 1, 1940[,] the ef-
fective date of the provisions of sections 403(e)(1)
[343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g)
to (k)]; 502(b), (d), (
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
Page 2893
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 1395a
(i) shared savings and competitive bidding in FFS
Medicare;
(ii) use of MA-negotiated rates to set FFS Medicare
rates; and
(iii) novel approaches to information development
and sharing that may enable markets to lower cost and
improve quality for FFS Medicare beneficiaries.
SEC. 10. Reducing Obstacles to Improved Patient Care.
Within 1 year of the date of this order, the Secretary
shall propose regulatory changes to the Medicare pro-
gram to reduce the burden on providers and eliminate
regulations that create inefficiencies or otherwise un-
dermine patient outcomes.
SEC. 11. Maximizing Freedom for Medicare Patients and
Providers. (a) Within 180 days of the date of this order,
the Secretary, in coordination with the Commissioner
of Social Security, shall revise current rules or policies
to preserve the Social Security retirement insurance
benefits of seniors who choose not to receive benefits
under Medicare Part A, and propose other administra-
tive improvements to Medicare enrollment processes
for beneficiaries.
(b) Within 1 year of the date of this order, the Sec-
retary shall identify and remove unnecessary barriers
to private contracts that allow Medicare beneficiaries
to obtain the care of their choice and facilitate the de-
velopment of market-driven prices.
SEC. 12. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive de-
partment or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Man-
agement and Budget relating to budgetary, administra-
tive, or legislative proposals.
(b) This order shall be implemented consistent with
applicable law and subject to the
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 1395
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