Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

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 options work best for distinct populations with specific health problems.

• Improving Healthcare Systems – focusing on ways to improve healthcare services, such as the coordination of care for patients with multiple chronic conditions.
• Communication and Dissemination – examining ways to provide information to patients so that they can make informed healthcare decisions with clinicians.
• Addressing Disparities – assuring that research addresses the healthcare needs of all patient populations since treatments may not work equally well for everyone.
• Accelerating Patient-Centered and Methodological Research – including patients and caregivers in the design of research that is quick, safe, and efficient.

Note that PCORI is not specifying or prioritizing any particular condition or disease for research, although it may do so in the future. Public comments on the priorities and agenda will be accepted until March 15, 2012, or at various public forums planned during the comment period, including a "National Patient and Stakeholder Dialogue" in Washington D.C. scheduled on February 27. After the comment period closes, PCORI will report on the public feedback and the PCORI Board of Governors will vote on the priorities and agenda. PCORI expects to issue its first funding announcements in May.

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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 patient-centered outcomes research (PCOR), and inform the development of a future PCORI research agenda. The eight initial topics for the PCORI pilot projects include developing/identifying, testing, and/or evaluating:

1. Methods to inform the process of establishing and updating national priorities for PCOR.
2. Methods for bringing together patients, caregivers, clinicians and non-traditional partners in all stages of a multi-stakeholder research process, from the generation and prioritization of research questions to the conduct and analysis of a study to dissemination of study results.
3. Approaches for translating research findings into changes in health care practices.
4. Approaches that could systematically, without bias, identify gaps in evidence that most affect low-income populations; minorities; children; elderly; women; people with disabilities, multiple medical conditions, rare conditions, and other vulnerable populations.
5. Predictive outcomes instruments of interest to patients.
6. Methods for researching behaviors, lifestyles, and choices within patient control that may influence outcomes.
7. Methods for studying the patient-clinician interaction in situations where multiple options for prevention, diagnosis, or treatment exist.
8. Methods to assess strategies that respect patient autonomy and promote informed decision-making, incorporating the best healthcare knowledge into the application of care.

Note that this request is for input on the pilot project topics, not a request for applications (RFA) for pilot project grants; PCORI expects to issue an RFA for pilot project grants in late September. Comments on the topics will be accepted until August 31, 2011. 

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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 health care options.” PCOR answers the following patient-focused questions: Given my personal characteristics, conditions and preferences, what should I expect will happen to me? What are my options and what are the benefits and harms of those options? What can I do to improve the outcomes that are most important to me? How can the health care system improve my chances of achieving the outcomes I prefer?” Under the working definition, in order to answer these questions, PCOR: (1) assesses the benefits and harms of preventive, diagnostic, therapeutic, or health delivery system interventions to inform decision making, highlighting comparisons and outcomes that matter to people; (2) is inclusive of an individual's preferences, autonomy and needs, focusing on outcomes that people notice and care about such as survival, function, symptoms, and health-related quality of life; (3) incorporates a wide variety of settings and diversity of participants to address individual differences and barriers to implementation and dissemination; and (4) investigates (or may investigate) optimizing outcomes while addressing burden to individuals, resources, and other stakeholder perspectives. Comments will be accepted until September 2, 2011.

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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 and the general purpose of the funding (no funding had been obligated under the ACA's comparative effectiveness provision as of April 25, 2011).

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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.  

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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" planning grants.

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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 standards intended to ensure the objective, transparent development of trustworthy clinical practice guidelines. In “Finding What Works in Health Care: Standards for Systematic Reviews,” the IOM recommends 21 standards to ensure scientifically-valid, high-quality systematic reviews of the comparative effectiveness of medical or surgical interventions. The goal of the reports is to improve health quality and outcomes by improving the information available on which to base health-related decisions.

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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.  

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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, and to assist practitioners, patients and policymakers to come to the right personalized decisions.” Among other things, the conference will review case studies on particular treatments for medical conditions that pose difficult questions about what kinds of research, methods, and analyses should be used to address limitations in current evidence for interventions and tests being examined by decision-making bodies. The registration deadline is November 17, 2010.

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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.

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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 Clinical Practice.”  Registration is required to participate 
 

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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, utilization, coverage, payment, and clinical benefit of drugs, biologics, and medical devices.” Included among the action items in the MOU are the appointment of a liaison for each agency, the establishment of a joint agency meeting to discuss implementing the MOU, an agreement to set reasonable expectations on responses to requests for information, and the implementation of certain safeguards to protect the transmittal and use of trade secret and confidential information. 
 

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The HHS Office of the Assistant Secretary for Planning and Evaluation has published a notice seeking comments on the development of a national inventory of comparative effectiveness research (CER) and CER-related information. Comments should focus on appropriate resources and approaches for developing the CER Inventory, including sources of CER, ways to encourage participation, categorizing content, and approaches to ensure the CER Inventory is useful and sustainable over time. Comments are due August 9, 2010.

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The Government Accountability Office (GAO) is seeking nominations for the ACA’s Patient Centered Outcomes Research Institute Governing Board, which is charged with identifying national priorities for comparative effectiveness research.  Likewise, the GAO is seeking nominations for the National Health Care Workforce Commission, also established by the ACA.  Nominations for both panels are due June 30, 2010.

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The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program is soliciting applications for a total of $100 million in Recovery Act funding for AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness Grants. The purpose of the grants is to conduct large projects in comparative effectiveness aimed at generating new knowledge to help inform decision making in priority areas of clinical care. Research priorities highlighted in the funding announcement include: arthritis and non-traumatic joint disorders; cancer; cardiovascular disease; dementia; depression and other mental health disorders; developmental delays, attention-deficit hyperactivity disorder and autism; diabetes mellitus; functional limitations and disability; infectious diseases including HIV/AIDS; obesity; peptic ulcer disease and dyspepsia; pregnancy including pre-term birth; pulmonary disease/asthma; and substance abuse. Letters of intent are due November 18, 2009.  

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The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program has issued two reports that examine when AHRQ should update comparative effectiveness reviews (CERs). The first document is a draft research review on "Updating Comparative Effectiveness Reviews". This guidance sets forth a framework for identifying new evidence or evidence not considered in a previous CER, how the update process will be used, and how new data will be incorporated. Comments will be accepted until October 19, 2009. The second document is a final report entitled "Assessment of the Need to Update Comparative Effectiveness Reviews: Report of an Initial Rapid Program Assessment (2005-2009)." This document assesses whether previous CERs need to be updated and prioritizes those CERs for review.

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The Agency for Healthcare Research and Quality (AHRQ) has announced plans to solicit contracts for comparative effectiveness research projects with $300 million in ARRA funding. Separately, AHRQ has added two new chapters to its "Methods Guide for Comparative Effectiveness Reviews" under the AHRQ Effective Health Care Program: (1) Principles for Developing Guidance for Comparing Medical Interventions; and (2) Grading the Strength of a Body of Evidence when Comparing Medical Interventions. Other topics under development include: Avoiding Potential Biases when Comparing Medical Interventions; Updating Reports Comparing Medical Interventions; and Comparing Diagnostic Technologies.

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The Agency for Healthcare Research and Quality (AHRQ) has announced the availability of funding for the development of a clinical registry of orthopedic devices, drugs, and procedures, with an initial focus on hip and knee replacements.  The initiative seeks to enable comparative effectiveness and safety studies regarding various orthopedic procedures and devices.

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The American Recovery and Reinvestment Act (ARRA) included a major expansion of federal efforts to compare the effectiveness of different medical treatments, including more than $1 billion in funding for comparative effectiveness research (CER). Two federal panels recently released reports on CER priorities under the ARRA. First, the Federal Coordinating Council for Comparative Effectiveness Research issued its recommendations for a strategic framework for CER activity and investments. The Council recommended that the primary investment for CER funding should be data infrastructure (e.g., linking current data sources to enable answering CER questions, development of distributed electronic data networks and patient registries, and partnerships with the private sector). Other key areas for research identified by the Council are:

• Medical and assistive devices (e.g., comparing rehabilitative devices).
• Procedures and surgery (e.g., evaluating surgical options or surgery versus medical management).
• Diagnostic Testing (e.g. comparing imaging modalities for evaluating certain types of cancer).
• Behavioral change (e.g., developing and assessing smoking cessation programs).
• Delivery system strategies (e.g., testing two different discharge process care models on readmission rates or testing two different medical home models on preventing hospital admissions and improving quality of life).
• Prevention (e.g., comparing two interventions to prevent or decrease obesity, comparing strategies for reaching populations that do not access the health care system with prevention efforts).

Separately, on June 30, 2009, the Institute of Medicine (IOM) released its ARRA-mandated report on "Initial National Priorities for Comparative Effectiveness Research," which identifies 100 heath topics that should get priority attention and funding under federal comparative effectiveness efforts. Priority topics include health delivery, health disparities, cardiovascular care, geriatrics, psychiatry, endocrinology, and oncology/hematology, among many others. The IOM cautions, however that comparative effectiveness research “will not yield real improvements unless the results are adopted by health care providers and organizations and integrated into clinical practice.”   A Washington Legal Foundation “Critical Legal Issues Working Paper Series” article by Reed Smith attorneys Areta Kupchyk and Kathleen McGuan entitled “Comparative Effectiveness: Refining the Standards for FDA Approval & CMS Coverage,” is available here.   

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AHRQ has posted a draft chapter 5 of the "Methods Guide for Comparative Effectiveness Reviews." The topic of the chapter is "Using Existing Systematic Reviews to Replace de Novo Processes in CERs," in which AHRQ proposes a five-step process to standardize the approach that Evidence-based Practice Centers use to decide whether existing systematic reviews might provide value. Comments will be accepted until June 26, 2009.

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On June 10, 2009, the Federal Coordinating Council for Comparative Effectiveness Research is holding a meeting in Washington D.C. to hear public comments on the Council's efforts to coordinate research and guide investments in comparative effectiveness research funded by the American Recovery and Reinvestment Act of 2009 (ARRA). The Council is soliciting comments on:

• What types of investments in infrastructure for comparative effectiveness research should the Coordinating Council consider?
• What criteria should the Coordinating Council consider when evaluating different investment options?
• What federal government activities in the area of comparative effectiveness research should the Coordinating Council focus its attention on?
• How can the Coordinating Council best foster integration of these activities across the programs managed by the Departments of Health and Human Services, Defense, and Veterans Affairs?
• What steps should the Coordinating Council consider to help ensure that public- and private-sector efforts in the area of comparative effectiveness research are mutually supportive?
• What information on the Coordinating Council’s activities would be most useful?

Individuals seeking to participate should register by June 8. In addition, the meeting will be web cast and individuals may participate by audioconference. 

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On May 26, 2009, the Federal Comparative Effectiveness Research Coordination Council announced that it is seeking comment on its draft definition of comparative effectiveness research and its draft prioritization criteria for comparative effectiveness research and investments. With regard to prioritization, the Council proposes to use the following criteria for determining “scientifically meritorious research and investments” potential impact (based on prevalence of condition, burden of disease, variability in outcomes, and costs of care); potential to evaluate comparative effectiveness in diverse populations and patient sub-populations; uncertainty within the clinical and public health communities regarding management decisions; addresses need or gap unlikely to be addressed through other funding mechanisms; and potential for multiplicative effect (e.g. lays foundation for future comparative effectiveness research or generates additional investment outside government).   Comments are being accepted but no comment deadline is specified.

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HHS has released a series of American Recovery and Reinvestment Act (ARRA) Implementation Plans, detailing how the department is addressing key aspects of the legislation. Specifically, the plans highlight the following areas: Improving and Preserving Health Care (including increases in the Medicaid Federal Medical Assistance Percentage); Accelerating the Adoption of Health Information Technology; Strengthening Scientific Research and Facilities; Improving Children and Community Services; Strengthening Community Healthcare Services; Supporting Comparative Effectiveness Research; Promoting Prevention and Wellness; and Improving Accountability and Information Technology Security. The updates include funding tables and discussions of objectives and planned activities, among other features.

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 AHRQ is hosting a Clinical and Comparative Effectiveness Research Methods symposium on June 1 - 2. The conference will include discussions on the future of federal comparative effectiveness efforts and emerging research methods.

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HHS has announced that the Federal Coordinating Council for Comparative Effectiveness Research is holding a listening session in Chicago on May 13, 2009, and another session is planned for June 10 in Washington, D.C. 

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On April 14, 2009, the Federal Coordinating Council for Comparative Effectiveness Research will hold a public listening session regarding comparative effectiveness research and the Coordinating Council's activities. By way of background, the Council was authorized by the ARRA as part of a major expansion of federal efforts to compare the effectiveness of different medical treatments, including both infrastructure changes and an infusion of $1 billion in funding for comparative effectiveness research. The Council is charged with helping to coordinate and guide investments in comparative effectiveness research, advising the President and Congress on federal comparative effectiveness research infrastructure needs, and reviewing federal agency organizational expenditures for comparative effectiveness research. The registration deadline for the meeting is April 13. Written statements also may be submitted.

4/20/09 Update:  A webcast of the session is available.

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On March 19, 2009, HHS announced the members of the Federal Coordinating Council for Comparative Effectiveness Research. The Council was authorized by the American Recovery and Reinvestment Act (ARRA) as part of a major expansion of federal efforts to compare the effectiveness of different medical treatments, including both infrastructure changes and an infusion of $1 billion in funding for comparative effectiveness research. The Council is charged with helping to coordinate and guide investments in comparative effectiveness research, advising the President and Congress on federal comparative effectiveness research infrastructure needs, and reviewing federal agency organizational expenditures for comparative effectiveness research. The Council must report to the President and Congress by June 30, 2009 on current federal comparative effectiveness research and recommendations for research conducted under ARRA funding. The members of the Council are as follows:

• Anne Haddix, chief policy officer, Office of Strategy and Innovation, Centers for Disease Control and Prevention;
• Thomas Valuck, Medical Officer and Senior Adviser, CMS Center for Medicare Management;
• Peter Delany, Director, Office of Applied Studies, Substance Abuse and Mental Health Services Administration;
• Carolyn Clancy, Director, Agency for Healthcare Research and Quality;
• Deborah Parham Hopson, Associate Administrator, HIV/AIDS Bureau, Health Resources and Services Administration;
• David Hunt, Chief Medical Officer, Office of the National Coordinator for Health Information Technology;
• James Scanlon, Acting Assistant Secretary for Planning and Evaluation, HHS;
• Elizabeth Nabel, Director, National Heart, Lung, and Blood Institute, National Institutes of Health;
• Garth Graham, Deputy Assistant Secretary for Minority Health, Office of Minority Health, HHS;
• Jesse Goodman, Acting Chief Medical Officer, Food and Drug Administration, and Director, FDA Center for Biologics Evaluation and Research;
• Michael Marge, Acting Director, Office on Disability, HHS;
• Neera Tanden, Counselor, Office of the Secretary, HHS;
• Joel Kupersmith, Chief Research and Development Officer, Department of Veterans Affairs;
• Michael Kilpatrick, Director of Strategic Communications for the Military Health System, Department of Defense; and
• Ezekiel Emanuel, Special Advisor for Health Policy, Office of Management and Budget

In a related development, the Institute of Medicine is accepting public comments on priorities for comparative effectiveness research under the ARRA.  Stakeholders can submit answers to a questionnaire through March 27, 2009.

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The National Advisory Council for Healthcare Research and Quality will meet on April 3, 2009 to discuss Agency for Healthcare Research and Quality (AHRQ) initiatives, including the AHRQ budget for FY 2009, comparative effectiveness, and AHRQ activities under the American Recovery and Reinvestment Act (ARRA).

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On March 18, 2009, the Finance Committee is holding a hearing on “What is Health Care Quality and Who Decides?”. Also on March 18, 2009, the House Small Business Committee is holding a hearing on "The President's FY 2010 Budget and Medicare: How Will Small Providers be Impacted?" On March 24, the Senate Health, Education, Labor, and Pensions Committee is holding hearings to examine addressing insurance market reform in national health reform.

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This post was written by Karl A. Thallner, Jr., Carol C. Loepere, Debra A. McCurdy, Brad M. Rostolsky, Jacqueline B. Penrod, and Amie E. Schaadt.

On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the “ARRA”). The sweeping $790 billion economic stimulus package includes a number of health care policy provisions. Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.

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