Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
Recent Congressional hearings focusing on health policy topics include the following:
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On March 6-7, 2014, the Medicare Payment Advisory Commission (MedPAC) is meeting to discuss a number of Medicare payment and policy issues, including: site-neutral payments for select conditions treated in inpatient rehabilitation facilities and skilled nursing facilities; developing payment policies to promote the use of services based on clinical evidence; measuring quality in Medicare delivery…
On April 23, 2013, the Patient-Centered Outcomes Research Institute (PCORI) is hosting a roundtable discussion on “Building a National Data Infrastructure to Advance Patient-Centered Comparative Effectiveness Research.” The event will focus on the challenges and opportunities in creating such a research infrastructure and how PCORI’s investments can provide unique value. The registration deadline is April…
The Patient-Centered Outcomes Research Institute (PCORI) was established by the ACA to support federal comparative effectiveness research efforts. PCORI is seeking nominees for four new advisory panels to make non-binding recommendations to assist PCORI in identifying research priorities and refining its agenda. The advisory panels will focus on addressing disparities; assessing prevention, diagnosis, and treatment…
The Patient-Centered Outcomes Research Institute (PCORI) has announced a series of workshops intended to obtain input from patients, caregivers, and other stakeholders on PCORI’s draft process for generating and selecting specific research topics:
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The Patient-Centered Outcomes Research Institute (PCORI) is seeking comments on its draft Methodology Report, proposing standards for the conduct of patient-centered outcomes research. The report covers, among other things, the rationale for standards for patient-centeredness, prioritizing topics for research; choosing a study design; and for designing, conducting, and reporting research (including standards for adaptive and…
The Patient-Centered Outcomes Research Institute Board (PCORI), which was established by the ACA, has announced that it is seeking applicants for $120 million in funding for comparative effectiveness research projects involving: (1) Assessment of prevention, diagnosis, and treatment options; (2) improving healthcare systems; (3) communication and dissemination; and (4) addressing disparities.
The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program is sponsoring a symposium/webcast on original research methods for comparative effectiveness (CER) and patient-centered outcomes research (PCOR) in Rockville, Maryland on June 12 and 13, 2012. AHRQ is inviting the submission of papers, presentations, and abstracts for the symposium, titled “From Efficacy to…
On January 23, 2011, the ACA’s Patient-Centered Outcomes Research Institute (PCORI) released its first draft National Priorities for Research and Research Agenda, which will be used to guide funding announcements for comparative clinical effectiveness research. The proposed national priorities for research are as follows:
Comparative Assessments of Prevention, Diagnosis, and Treatment Options — determining which…
The Patient-Centered Outcomes Research Institute (PCORI), which was established by the ACA, is seeking public feedback on eight initial topics for a series of “Tier 1” pilot projects. The pilot projects are intended to help PCORI set national priorities for research, support the development of novel methods or collection of preliminary data that can advance…
The Patient-Centered Outcomes Research Institute (PCORI), established by the ACA, is seeking public comment on its working definition of “Patient-Centered Outcomes Research” (PCOR) to help focus the panel’s comparative effectiveness efforts. Under the working definition, PCOR “helps people make informed health care decisions and allows their voice to be heard in assessing the value of…
The Government Accountability Office (GAO) has issued a report entitled “HHS Research Awards: Use of Recovery Act and Patient Protection and Affordable Care Act Funds for Comparative Effectiveness Research.” The report includes a more than 40-page listing of all comparative effectiveness research grants issued under the Recovery Act, including the entities that have received funding…
On May 16, 2011, the Patient-Centered Outcomes Research Institute (PCORI) — created by the ACA to spearhead federal comparative effectiveness research — announced the selection of Joe V. Selby, M.D., M.P.H., as the first PCORI executive director. Dr. Selby is a family physician, clinical epidemiologist and health services researcher.
The Patient-Centered Outcomes Research Institute (PCORI) has begun to meet to discuss its strategy for comparative effectiveness research under the ACA. Several reports also have been posted to the PCORI website, including a Program Development Committee report that highlights planned actions, such as an environmental scan of current comparative effectiveness research initiatives and "tier 1" …
The Institute of Medicine has issued two reports mandated by the Medicare Improvement for Patients and Providers Act that are designed to enhance the quality and reliability of clinical practice guidelines and systematic reviews of the evidence base for health care services. In “Clinical Practice Guidelines We Can Trust,” the IOM recommends eight…
The Government Accountability Office (GAO) has announced the appointment of 15 members to the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI). The Committee is charged with helping PCORI develop methodological standards and guidance for comparative clinical effectiveness research.
On December 2-3, 2010, the National Institutes of Health and the Agency for Healthcare Research and Quality are co-sponsoring a conference on “Methodological Challenges in Comparative Effectiveness Research.” The meeting will explore new methodologic, design and evidentiary approaches that can help “ensure the credibility, validity and reliability of applicable research findings to a diverse population,…
The Government Accountability Office (GAO) has announced appointments to the Board of Governors for the new Patient-Centered Outcomes Research Institute (PCORI), as authorized by the ACA. The GAO still is accepting nominees for the PCORI Methodology Committee; the deadline for those nominations is October 29, 2010.
On October 12, 2010, the Agency for Healthcare Research and Quality (AHRQ) is hosting a free web conference on “Integrating Comparative Effectiveness Research into Everyday Practice.” The conference will feature presentations on the “Role of CER in Health Care Improvement,” “AHRQ’s Existing CER Resources on Diabetes and Cardiac Conditions,” and “Examples of Incorporating CER Into…
This post was written by Paul Sheives and Areta Kupchyk.
The FDA and CMS have entered into a Memorandum of Understanding (MOU), effective June 25, 2010, to promote collaboration and enhance knowledge and efficiency by sharing information and expertise. In particular, the MOU highlights the agencies’ “common needs for evaluating the safety, efficacy,…
