Meeting Minutes, November 15, 2013

Contents

Summary
Call to Order and Approval of July 26, 2013, Meeting Summary
Director's Update
Update from Subcommittee on Strategic Direction
Public Comments
Affordable Care Act Implementation
Patient-Centered Outcomes Research Institute (PCORI)
Chairman's Wrap-Up and NAC Input
Adjournment

Summary

NAC Members Present

Bruce Siegel, M.D., M.P.H., America's Essential Hospitals (NAC Chair)
Gregory Baker, R.Ph., Take Care Employer Solutions Group
Mitra Behroozi, J.D., 1199SEIU Benefit and Pension Funds
Paul N. Casale, M.D., FACC, Lancaster General Hospital
Jane Durney Crowley, Catholic Health Partners (by phone)
Andrea Gelzer, M.D., M.S., FACP, The AmeriHealth Caritas Family of Companies
Leon L. Haley, Jr., M.D., M.H.S.A., FACEP, Emory Medical Care Foundation
Michael P. Johnson, P.T., Ph.D., OCS, Bayada Home Health Care
Carol Matyka, M.A., National Breast Cancer Coalition
Newell E. McElwee III, Pharm.D., M.S.P.H., Merck Global Medical Affairs
Andrea H. McGuire, M.D., M.B.A., Meridian Health Plan
Victor M. Montori, M.D., M.Sc., Mayo Clinic College of Medicine
Henry H. Ng, M.D., M.P.H., FAAP, FACP, MetroHealth Medical Center
David F. Penson, M.D., M.P.H., Vanderbilt University Medical Center
Christopher Queram, M.A., Wisconsin Collaborative for Healthcare Quality
Jean Rexford, Connecticut Center for Patient Safety
Henry P. Selker, M.D., M.S.P.H., Tufts Medical Center
Alan R. Spitzer, M.D., MEDNAX Services/Pediatrix Medical Group (by phone)
Jeffery Thompson, M.D., M.P.H., Mercer
Janet S. Wyatt, Ph.D., R.N., FAANP, Consultant, Pediatric Nursing Certification Board

Alternates Present

Sara J. Knight, Ph.D., U.S. Department of Veterans Affairs
Shari M. Ling, M.D., Centers for Medicare & Medicaid Services
Sandra L. Decker, Ph.D., National Center for Health Statistics

AHRQ Staff Members Present

Richard Kronick, Ph.D., Director
Boyce Ginieczki, Ph.D., Acting Deputy Director
Jaime Zimmerman, M.P.H., PMP, Designated Management Official
Karen Brooks, CMP, NAC Coordinator

Return to Contents

Call to Order and Approval of July 26, 2013, Meeting Summary

Bruce Siegel, M.D., M.P.H., Chair, National Advisory Council (NAC), Agency for Healthcare Research and Quality (AHRQ), called the group to order at 8:30 a.m. and welcomed the NAC members, invited speakers, visitors, and viewers of the Webcast. He asked the NAC members to introduce themselves.

Dr. Siegel referred to the draft minutes of the previous NAC meeting (July 26, 2013) and asked for changes and approval. The NAC members approved the July 26, 2013, meeting minutes with no changes.

Dr. Siegel introduced Richard Kronick, Ph.D., the newly appointed AHRQ Director.

Return to Contents

Director's Update

Richard Kronick, Ph.D., AHRQ Director

Dr. Kronick welcomed the NAC members, speakers, and other attendees and viewers. He thanked them for their support during the transitional period of his early tenure, and he extolled the great work of the Agency.

Dr. Kronick envisioned two main areas of effort in the days ahead: creating a clear focus and message for the Agency's activities—defining what it does—and developing stronger collaborations among other entities within the U.S. Department of Health and Human Services (HHS) and among outside organizations and institutions. He recognized the Agency's broad goals of improving health care and ensuring that the best medical research evidence is being used.

Dr. Kronick reviewed his professional history. He joined HHS in January 2010 as Deputy Assistant Secretary for Planning and Evaluation, overseeing the Office of Health Policy. Prior to that, he conducted health policy research in academia and in Federal and State governments. He was Professor and Chief of the Division of Health Care Sciences in the Department of Family and Preventive Medicine at the University of California, San Diego. Before that he served as Director of Policy and Reimbursement for the Medicaid Division of the Massachusetts Department of Public Welfare.

Very recently, Dr. Kronick, working at the Office of Health Policy, has been pursuing changes in Medicare policy and rule-making for physician payment. As one result, the Centers for Medicare & Medicaid Services (CMS) has proposed paying for chronic care coordination management services, beginning in 2015.

Dr. Kronick read the following new mission statement for AHRQ, which features some nuances that differ from previous mission statements:

"To produce evidence to make health care safer, of higher quality, more accessible, and more affordable and to work with HHS and other partners to make sure that the evidence is understood and used."

Dr. Kronick described the following four main priorities for AHRQ, with each priority focused on evidence:

• To support efforts in patient-centered outcomes research (PCOR).
• To make health care safer.
• To increase accessibility to health care by evaluating the expansion of coverage within the Affordable Care Act.
• To improve health care affordability, efficiency, and cost transparency.

He provided examples of projects at AHRQ that have been addressing those priorities. AHRQ is being funded to mid-January 2014 under the current continuing resolution. The Agency has a FY2014 base of $465 million, with $365.4 million from the PHS Evaluation Fund and $99.7 million from the Patient-Centered Outcomes Research Trust Fund (PCORTF).

Seven NAC members were attending for a final time before rotating off the committee. They are Mitra Behroozi, J.D.; Paul N. Casale, M.D., FACC; Andrea H. McGuire, M.D., M.B.A.; Christopher Queram, M.A.; Alan R. Spitzer, M.D.; Jeffery Thompson, M.D., M.P.H.; and Janet S. Wyatt, Ph.D., R.N., FAANP.

Recent AHRQ Activities

Dr. Kronick provided updates on AHRQ programs.

• AHRQ released 11 new funding opportunity announcements (FOAs). These research grants are offered under the FY2014 AHRQ appropriation and the PCORTF (one is sponsored by the Patient-Centered Outcomes Research Institute [PCORI]). The FOAs include research on treatment options for uterine fibrosis, PCOR mentored research, methodological challenges in research for patients with multiple chronic conditions, and prevention and management of health care-associated infections.
• A new AHRQ toolkit focuses on safe care in medical offices. It features step-by-step instructions to improve processes for tracking, reporting, and following up on laboratory test results.
• The Comprehensive Unit-based Safety Program (CUSP) has continued to expand. The Catheter-Associated Urinary Tract Infections (CAUTI) project has recruited more than 850 hospitals and more than 1,300 hospital units in 37 States, District of Columbia, and Puerto Rico. Results after 14 months indicate a 16-percent reduction in the CAUTI rate. Other areas of emphasis include surgical site infections in hospitals and ambulatory surgical centers, ventilator-associated pneumonia, and long-term care facilities.
• AHRQ released a large report titled Health IT-Enabled Quality Measurement, which supports health care reform. It informs readers of current initiatives, prioritizes efforts, and presents the stakeholder perspective.
• AHRQ soon will release a how-to guide titled Health Assessments in Primary Care. The guide combines best evidence for successful implementation of health assessments in the primary care setting with tools to help clinicians decide which health assessments to use. It instructs in the integration of assessment into daily workflow.
• The U.S. Preventive Services Task Force (USPSTF) published a report to Congress titled High Priority Evidence Gaps for Clinical Preventive Services. The report highlights five priority areas for improving the health of older adults, who can benefit from the use of research on clinical preventive services.
• Evidence-based Practice Centers (EPCs) have produced a number of systematic reviews and methods reports. Examples of review topics are stroke prevention in atrial fibrillation, antiplatelet treatment, and treatment of tinnitus. Examples of methods report topics are continuous outcomes in quantitative synthesis and risk of bias and confounding in observational studies.
• AHRQ will continue to support the Electronic Data Methods (EDM) Forum for 3 years. The work has produced two recent supplements in Medical Care and the first of a series of new special issues of eGEMs.
• A subcommittee of the NAC (SNAC) has been discussing the retirement of some of the 20 initial child core set measures for health care quality. The effort is being supported by 23 external experts.
• The Healthcare Cost and Utilization Project (HCUP) produced a report of the five most expensive conditions treated in U.S. hospitals. The conditions are septicemia, osteoarthritis (e.g., knee and hip replacement), complication of implant or graft, newborn infants, and acute myocardial infarction.
• Data from the Medical Expenditure Panel Survey (MEPS) indicated that, in the MEPS civilian, noninstitutionalized population, the public share of total spending on health care was 55.4 percent in 2007. Investigators analyzed the data to determine incidence of public spending by age and income. The data showed, for example, a steady amount of spending through Medicaid/CHIP throughout the lifespan for the population as a whole.
• An article in the The Washington Post used AHRQ information in a story about the 1 percent of the population responsible for about 21 percent of medical expenditures (in 2010).

Discussion

Dr. Siegel encouraged the NAC members to consider the issue of health equity as they contemplate the four main priorities of AHRQ. Victor M. Montori, M.D., M.Sc., stressed the importance of considering the perspective of the patient, especially in addressing chronic conditions. The concept of patient-centeredness is embedded in PCOR, yet it should be considered generally. Evidence does not necessarily tell one how to proceed. That fact suggests the importance of studying resource use and decisionmaking.

Harry P. Selker, M.D., M.S.P.H., applauded the new AHRQ mission statement. He encouraged AHRQ to help articulate what the Affordable Care Act (ACA) is doing. He stated a need to understand the risks and benefits of insurance bundling and shifts in large-scale programs over time. Dr. Kronick added the need to determine accountability mechanisms.

Dr. Thompson called for more discussion of employer-based health care, for example, issues in making decisions about products.

Andrea Gelzer, M.D., M.S., FACP, called for a focus on scalability and sustainability. Dr. Kronick agreed, citing the need to spread evidence.

Newell E. McElwee III, Pharm.D., M.S.P.H., noted the development and use of organizational frameworks for health care delivery, and he stated a need to stress the area involving patient experiences and patient engagement. Dr. Kronick added that a NAC subcommittee would be making recommendations in this area soon.

Michael P. Johnson, P.T., Ph.D., OCS, encouraged AHRQ to expand from consideration of primary care physicians and practices to other types of providers. In general, emphasis ought to shift to include function as well as disease. The issues of the fourth priority—affordability, efficiency, and cost transparency—should be addressed in areas both inside and outside institutions.

Jean Rexford noted that, for infection reporting in the States, public access to information has driven important work. Access to data is increasing. Ms. Rexford called for discussions about the culture of patient safety and care quality and liability reform. Dr. Kronick noted that liability reform, including lower contentiousness, would derive from successes in reducing errors and harm.

Christopher Queram, M.A., noted two challenges in voluntary reporting—the reluctance of payers and providers to expose allowed amounts and the restrictions in the use of Medicare data. The ACA provides no mechanisms for generating revenue based on the use of data. Dr. Kronick cited concerns about privacy of data.

Return to Contents

Update from Subcommittee on Strategic Direction

Michael P. Johnson, P.T., Ph.D., OCS, and Helen W. Haskell, Co-Chairs

Ms. Haskell presented a strategic framework for AHRQ, including a main focus and goals, as developed by the subcommittee. A purpose of the subcommittee is to advise the NAC on leadership, future direction, and research priorities. The group developed the following focus:

"Advancing health services research that informs patients, clinicians, providers, payers, purchasers, public policymakers, the U.S. Department of Health and Human Services, and other parts of the Federal Government on ways to advance the health goals of individuals and their communities."

The subcommittee offered a main goal by suggesting that AHRQ research focus on overall health care system performance, in collaboration with others, in ways that:

• Engage patients, families, and communities to advance their goals for health.
• Focus on quality, with a particular emphasis on patient safety.
• Enhance the value and affordability of health care.
• Promote the translation of evidence into patient-centered practice.

The focus and goals represent the views of the subcommittee and are not binding on the Agency. Dr. Johnson added that the subcommittee members stressed the essential goal of AHRQ in advancing health services research to improve the decisions we make about health care. The subcommittee members recommended that their tenure continue so that they can proceed to discuss and determine operational features within the focus and goals.

Discussion

Dr. Siegel asked the NAC members to consider whether the subcommittee's term should be extended. He recognized, in the focus and goals, aspects of synergy and alignment with the AHRQ Director's priorities. Those priorities respond more directly to the elements of the ACA. Carol Matyka, M.A., noted that the subcommittee discussed the ACA and considered how to address it. The subcommittee members agreed that AHRQ would have a broader appeal if it is not seen to be aligned with a particular action (such as the ACA). They focused on the idea of patient-centeredness.

Dr. Kronick stated that it is conceivable that AHRQ activities might produce results that are counter to some ideas within the ACA leadership. Regardless, AHRQ must be engaged in an evaluation of the ACA, especially studying the effects of coverage expansion. The Agency must provide evidence that helps people to make informed decisions.

Dr. Montori reported that the subcommittee also discussed ways to support the Agency's mission. How might we ensure that the value of AHRQ is appreciated? Ms. Behroozi cited threats to defund AHRQ. How might a sense of redundancy and bureaucracy be reduced? AHRQ is unique. It features both functional and aspirational aspects. Its work should be distinguished from that of PCORI, which funds research into what does and does not work. AHRQ has a stronger focus on issues such as training, methods, and dissemination.

Dr. Selker suggested that the rollout of the ACA is a national experiment. It represents an opportunity to learn what works. He reminded the group that AHRQ performs a great deal of work in addition to health services research. He encouraged AHRQ to leverage its wide-ranging research. More investigator-initiated research would be welcome. Regarding the meaning of investigator-initiated research in the context of AHRQ, Dr. Kronick noted that some of the Agency's funding opportunity announcements are quite broad.

Shari M. Ling, M.D., applauded the alignment of the subcommittee's focus statement and the AHRQ leadership's mission statement. Changing populations and health care gaps will be important.

Dr. Siegel asked for a motion and vote for approving the subcommittee's report and extending the subcommittee for 6 months. The motion was approved unanimously. Other past NAC members will be invited to join the group.

Return to Contents

Public Comment

Dr. Lisa Simpson, President of AcademyHealth, based in Washington, D.C., congratulated Dr. Kronick for his new appointment. She stated that her organization gave comments to AHRQ during the development of its mission statement and priorities, and she stressed that the Agency plays critical roles across a continuum of activities. Issues on which AHRQ might focus in upcoming days include costs and system performance. Dr. Simpson stressed the importance of how research is funded and how the research infrastructure operates. She called for any research that will lead to the timely release of health care data. We need data, training for researchers, methods, and human capital. Partnerships are important. Evidence must be used.

Return to Contents

Affordable Care Act Implementation

Michael M. Hash, Director, Office of Health Reform, U.S. Department of Health and Human Services

Mr. Hash also congratulated Dr. Kronick for his new appointment. Mr. Hash has been involved in the rollout of the ACA, and he reviewed work and progress in its implementation. He encouraged the NAC members to consider the big picture. The ACA has already offered benefits, for example, young adults remaining on their parents' health insurance policies. New protections are in place, for example, free preventive services and reductions in arbitrary policy recissions. Small group markets have been disciplined regarding the overuse of expenditures on overhead. As a result, consumers have received rebates.

The Department is taking aggressive steps to remedy the problems with the Web site that supports the health insurance marketplaces. A team of experts, including new individuals, has been engaged, and a contractor with expertise in managing such projects has been employed. A coordinated approach is beginning to pay off, such that specific problems have been identified and fixes begun. Front-end problems mostly have been corrected. There has been progress in the application process and response times.

Other issues, such as the uses of call centers, navigators, community groups, and private advocacy organizations, are being addressed. The Department feels that the site will work smoothly for a majority of users by the end of November. That is important, because users must choose health plans by December 15 to have insurance by January 1.

Mr. Hash noted that the program saw more than 1 million people complete applications to determine eligibility. He suggested that there are many reasons for not yet choosing a plan. The total enrollment was 106,000 at the time of his report. About 79,000 of those were in State-based marketplaces, and the others were in the federally facilitated marketplaces. Mr. Hash stated that the Department expects an increase in volume beginning in December.

Mr. Hash noted the announcement of President Obama on the previous day, calling for insurers to continue offering, for 1 year, plans that do not satisfy the requirements of the ACA. About 55 percent of insurers had already sent notices of the termination of such plans. The new rule would apply only to plans in effect by October. Insurers have been instructed to indicate what such plans lack.

Mr. Hash noted that the ACA features premium stabilization tools, which allow the government to help with certain losses that insurers might sustain. Other tools, such as reinsurance, can moderate risk for insurers. The Department expects increases in health care insurance premiums and health care costs each year as we move ahead.

Discussion

Dr. Kronick noted that some of the insurance products now offered are more attractive than people had imagined they would be. One challenge is the fact that many insurers are new to the individual marketplaces. There are challenges in getting consumers to the products, yet reporting of the problems has increased consumer awareness of the program.

Dr. McElwee asked how AHRQ might help with the implementation of the ACA, and Mr. Hash responded that the Agency could help to accelerate reform of the delivery system, for example, by analyzing approaches. Dr. Kronick added that AHRQ could evaluate the effects of coverage expansion. Ms. Rexford suggested that AHRQ study the use of correct (and incorrect) medications.

Dr. McGuire inquired about Medicaid expansion, and Dr. Hash responded that the ACA recommends that States move toward 133 percent of the poverty level for adults. However, that is optional for the States. Dr. Siegel noted new Medicaid models being implemented by some States. Much of Medicaid involves managed care. That some States are expanding Medicaid while others are not affords a natural experiment.

Dr. Johnson raised the issue of behavior, noting that the concept of value does not resonate with patients and clinicians. Perhaps President Obama should attempt to harness the enthusiasm of the early adopters. Mr. Hash agreed that this issue is critical.

Return to Contents

Patient-Centered Outcomes Research Institute (PCORI)

Joe V. Selby, M.D., M.P.H., PCORI

Dr. Selby, Executive Director, PCORI, described the institute as an advisory council for AHRQ, working in a complementary manner. PCORI was created by the ACA. It seeks to help people make informed decisions, to improve health care delivery, and to disseminate research findings. It uses engagement as a path to more useful research, for example, inviting patients to take part in peer review. PCORI researchers are required to engage stakeholders, who will help to disseminate results. The following are three main goals:

• To increase the quantity, quality, and timeliness of useful evidence to support health decisions.
• To speed implementation of PCOR evidence.
• To influence clinical and health care research funded by others in becoming more patient- centered.

National priorities for the institute include the assessment of options for prevention, diagnosis, and treatment, the improvement of health care systems, the dissemination of research results, the reduction of disparities, and the advancement of methodologies in patient-centered research.

PCORI uses two research funding mechanisms—broad solicitations and targeted announcements. There is a particular focus on research in decision support within comparative effectiveness. PCORI has funded 147 studies so far. The program is developing the PCORI National Patient-Centered Clinical Research Network, which will comprise networks for clinical data research and patient-powered research. Dr. Selby stressed the uniqueness of PCORI, with its focus on comparative effectiveness research. He distinguished that from the work of AHRQ, which is broader. Nevertheless, the two programs share interests in evidence synthesis, health information technology, dissemination of results, and more.

Discussion

NAC members inquired about potential overlap in the research supported by AHRQ and PCORI, including research in improved outcomes and research that compares treatments. Dr. Kronick saw overlap in efforts to make nursing homes safer and in studying affordability. He stated that AHRQ would continue to develop syntheses of evidence, including evidence from PCORI and elsewhere.

David F. Penson, M.D., M.P.H., suggested that it might not be important to separate strictly the responsibilities of the two institutions. AHRQ should train future researchers. Dr. Selby suggested that PCORI engage end-users of the health care system. That is part of the dissemination process and overlaps with the work of AHRQ. Uptake and implementation also are crucial.

Sara J. Knight, Ph.D., raised the issue of sustainability. Decision aids and other tools will always require updating. How will that come about? What should a business case look like? Dr. Selby noted that decision aids tend not to be used widely. Motivation as well as sustainability must be considered.

Henry H. Ng, M.D., M.P.H., FAAP, FACP, asked about the PCORI grants presented under the rubric of health disparities. Dr. Selby responded that the institute has a list of priority populations, for example, rural populations in need of telehealth programs. Dr. Ng encouraged PCORI and AHRQ to recognize a burden for sexual minority populations, such as homosexuals and transgenders, and to coordinate projects. Dr. Shelby stated that the institute welcomes all such research grant applications, although they must address comparative effectiveness.

Dr. Thompson cited the issue of continual safety concerns because of new technologies. Dr. Kronick noted that PCORI could fund research that indicates whether a new technology is an improvement over an older technology. The EPCs can perform syntheses of evidence, to the extent that the evidence exists.

Dr. Selker stressed the importance of understanding the business case, for example, when considering the use of decision supports. He noted that the amount of comparative effectiveness research and health services research supported by the National Institutes of Health will always be much greater than the amount supported by PCORI and AHRQ. PCORI and AHRQ can seek to investigate original perspectives in these areas.

Return to Contents

Chairman's Wrap-Up and Adjournment

Dr. Siegel remarked that Dr. Kronick's style likely would differ from that of Dr. Carolyn Clancy, the former AHRQ Director. For example, NAC members might be asked to weigh in on certain issues in different ways. The meeting agendas will follow such changes.

Dr. McGuire stated that this would be her last meeting and she had enjoyed it greatly. She encouraged the NAC members to continue to keep the patient at the forefront of consideration. Data must be used in actionable ways. A great strength of the NAC is the broad expertise among the members.

Dr. Wyatt stressed the importance of considering a large mix of health care providers—not only the clinicians. Ms. Behroozi agreed, applauding AHRQ for its history of addressing all providers. Dr. Selker stated that he appreciated the tone of this meeting, with the NAC members offering a good deal of advice on the issues. Dr. Casale thanked the Agency and encouraged it to continue to highlight patient safety, especially in ambulatory settings.

Return to Contents

Adjournment

Dr. Siegel stated that the next NAC meeting would take place on April 4, 2014. He adjourned the meeting.

Return to Contents