42 U.S.C. § 299b–7 — Research on outcomes of health care items and services
submitted 23 years ago by Pub. L. 108-173 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 1,555 words · no verdicts yet
This law tells the Secretary of Health and Human Services to study which health care treatments work best. The Agency for Healthcare Research and Quality sets priorities, shares findings, and protects patient data. Medicare cannot use this research to deny coverage of a drug.
(a) Research, demonstrations, and evaluations
The Secretary* of Health and Human Services, acting through the Director* of the Agency* for Healthcare Research and Quality, must study Medicare, Medicaid, and CHIP. The research must cover how well health care items and services (including prescription drugs) work, and how to make those programs run better — including how care is organized, managed, and delivered. The Secretary can pay for this work through grants, contracts, or agreements with other agencies, and can also offer technical help, expertise, or other assistance.
The Secretary must set up a process for deciding what to study first. Within 6 months of December 8, 2003, the Secretary had to publish an initial priority list. In building priorities, the Secretary must talk broadly and regularly with people affected by the research, may focus on items that cost a lot or are used too much or too little and that could meaningfully improve costly diseases and conditions, and must make sure the research actually answers the priorities and gets done on time.
The Secretary must review and pull together existing scientific evidence on the priority items, figure out where evidence is missing, share the findings with Medicare Part D drug* plans, Medicare Advantage drug plans, other health plans, and the public, and work with outside groups — on a voluntary basis — to build new knowledge. The first round of this evaluation work had to be finished within 18 months of the priority list. When sharing findings, the Secretary must write them so ordinary people can understand them, check periodically that this is happening, and make them available both online in searchable form and on paper as appropriate. None of this changes the FDA's or the Public Health Service* Act's existing authority, and it doesn't hand that authority to the Director either. The Secretary must also make public the evidence and methods behind this research, unless another law protects them from disclosure, so others can check or repeat the work — and must factor unanswered questions into future research priorities.
Data from Medicare, Medicaid, and CHIP used for this work must be protected the same way Title IX of the Public Health Service Act protects it. This section doesn't force or allow the Secretary to release data that other laws — like the Federal Food, Drug, and Cosmetic Act — otherwise keep private.
The Secretary must also evaluate whether this section's own activities are actually improving outcomes and how care is used.
By around June 2005 (18 months after December 8, 2003), the Secretary had to identify — working voluntarily with public and private groups — ways to: (A) give faster information on patient outcomes and quality of care, including clinical and patient-reported outcomes, especially for treatments where clinical trials are hard to run or raise ethical problems; (B) speed up the adoption of new, better approaches; and (C) build management tools for Medicaid and CHIP, including checking whether administrative or claims data could help states oversee their programs, support federal and state* quality and safety efforts, and predict the cost and coverage effects of policy changes.
(b) Recommendations
The Director may not set national standards for clinical practice or quality health care, and any published recommendations from Director-funded projects must say so plainly. All research, evaluation, and communication under this section must support the idea that doctors and patients need the best available evidence to make choices about care, providers, and delivery systems — while recognizing that different patient groups, patients, and doctors may prefer different things. Nothing here lets the Director force a national standard or a specific way of measuring or reporting quality.
(c) Research on dissemination
The Secretary, through the Director, may fund or conduct research on better ways to share the information described in subsection (a)(3)(C) with the public.
(d) Limitation on CMS
The Administrator* of the Centers for Medicare & Medicaid Services cannot use data collected under this section as a reason to deny coverage of a prescription drug.
(e) Authorization of appropriations
Congress authorized $50,000,000 for fiscal year 2004 for this section, and whatever amount is needed in every year after that.
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 et seq., 1396 et seq., 1397aa et seq.], the Secretary* 1 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—
the outcomes, comparative clinical effectiveness, and appropriateness of health care items and services (including prescription drugs); and
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.
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.
The Secretary shall establish a process to develop priorities that will guide the research, demonstrations, and evaluation activities undertaken pursuant to this section.
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).
In carrying out subparagraph (A), the Secretary—
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 et seq., 1396 et seq., 1397aa et seq.];
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
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.
The Secretary shall—
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);
identify issues for which existing scientific evidence is insufficient with respect to such health care items and services (including prescription drugs);
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 et seq.], other health plans, and the public the findings made under clauses (i) and (ii); and
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).
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.
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 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—
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
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.
Nothing in this section shall be construed as—
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 et seq.] or the Public Health Service* Act [42 U.S.C. 201 et seq.]; or
conferring any authority referred to in subclause (I) to the Director.
In carrying out this paragraph, the Secretary shall implement activities in a manner that—
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 or other applicable law so that the results of the research, analyses, or syntheses can be evaluated or replicated; and
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.
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 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 et seq.), such data and information shall be protected in accordance with the confidentiality requirements of title IX of the Public Health Service Act.
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 et seq.], section 1905 of title 18, or other applicable law.
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.
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—
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 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;
acceleration of the adoption of innovation and quality improvement under such programs; and
development of management tools for the programs established under titles XIX and XXI of the Social Security Act [42 U.S.C. 1396 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—
improve oversight by State* officials;
support Federal and State initiatives to improve the quality, safety, and efficiency of services provided under such programs; and
provide a basis for estimating the fiscal and coverage impact of Federal or State program and policy changes.
In carrying out this section, the Director shall—
not mandate national standards of clinical practice or quality health care standards; and
include in any recommendations resulting from projects funded and published by the Director, a corresponding reference to the prohibition described in subparagraph (A).
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.
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.
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).
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.
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.
Source credit: (Pub. L. 108–173, title X, § 1013, Dec. 8, 2003, 117 Stat. 2438.)
- 2003Enacted · Pub. L. 108-173 · 117 Stat. 2438
A history note hasn’t been published yet. The record shows enactment by Pub. L. 108-173 on 2003-12-08.
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