42 U.S.C. § 299b–7 — Research on outcomes of health care items and services

(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.