The Partnership to Improve Patient Care

Web site: www.improvepatientcare.org

About PIPC

Comparative effectiveness research (CER) seeks to "learn what works in health care" by comparing the patient health outcomes of different health care and treatment options. PIPC's Principles define a framework for CER policy that is centered on improving patient care. These principles address issues that are critically important to patients, providers and others in the health care community. These include focusing on quality improvement and patient health outcomes; communicating results rather than setting centralized coverage decisions, addressing the full range of information gaps that matter to patients, addressing differences in individual patient needs, and supporting continued medical advances.

News and Items of Interest

WEEKLY MEMBER UPDATE
July 30, 2010

Details on PIPC Patient-Centered CER Forum Posted

On July 22, PIPC held a forum titled "Delivering on Patient-Centered CER." The event focused on the next steps in achieving patient-centered comparative effectiveness research (CER) through implementation of the Patient Protection and Affordable Care Act’s CER provisions.

Video, photos, and materials from the event are now available online. You can access a background on the CER provisions of the health reform law that are key to patient-centeredness and why they are important, as well as other handouts. PIPC will be posting additional material from the event on its web site in the coming days.

Click here for the event materials.

GAO to Solicit PCORI Methodology Committee Nominations in September

The Affordable Care Act requires the Government Accountability Office (GAO) to appoint members for the Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee. According to GAO, they will release this official request for nominations in the Federal Register in September 2010; GAO had previously signaled they would be requesting nominations in July. We encourage you to start thinking of good candidates to submit to GAO.

The Methodology Committee will be composed of 15 members who are experts in scientific fields such as health services research, clinical research, comparative clinical effectiveness research, biostatistics, genomics, and research methodologies. The Committee will be responsible for developing and recommending methodological standards for research with specific criteria. PIPC will provide more detail on this in the coming weeks.

GAO has posted a brief description of the committee on its website. Click here to access that page.

Please feel free to share with Mary-Lacey Reuther names of possible candidates for this opportunity. PIPC plans to help support these nominees.

HHS Seeks Input on CER Inventory

As part of the Recovery Act, the Department of Health and Human Services Office of the Assistant Secretary for Planning Evaluation (ASPE) has announced plans to develop a national inventory of CER and CER-related information. ASPE is looking for input on approaches to developing the CER Inventory. Specifically, the comments should address the appropriate resources and approaches for developing the CER Inventory as opposed to methodology of CER or suggestions for particular studies. ASPE is seeking suggestions regarding sources of CER and ways to encourage participation in the inventory, comments related to categorizing content, and approaches to ensure the CER Inventory is useful and sustainable over time. The deadline for submitting comments is August 9, 2010.

PIPC is drafting comments and if members have thoughts on what to include please email them to Mary-Lacey Reuther. If your organization is planning on submitting comments, please share them with us.

Click here for more details.

AHRQ Announces Webcast on Health Outcomes of Carotid Revascularization

The Agency for Healthcare Research and Quality (AHRQ) will host a live Webcast on August 19 at 12:00 pm to release the findings from a study on health outcomes of carotid revascularization.

Click here for details on the Webcast.

PIPC Member Call

Please join us for the next PIPC Member Call. Chairman Tony Coelho will lead our discussion.

• Tuesday, August 3, at 4:30 p.m.
• Call in number is 1-888-820-9414 and the passcode is 7541120.
• Please call in 5-10 minutes early to allow time to go through the operator.

Letters supported by ICAN

Comparative Effectiveness Research (CER) and the Economic Stimulus Package

Letter to Chairman Inouye, Ranking Member Cochran,
Chairman Harkin and Ranking Member Specter

January 26, 2009

The Honorable Daniel Inouye, Chairman
The Honorable Thad Cochran, Ranking Member
Committee on Appropriations
The Capitol, S-131
Washington, DC 20510

The Honorable Tom Harkin, Chairman
The Honorable Arlen Specter, Ranking Member
Committee on Appropriations
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
131 Dirksen Senate Office Building
Washington, DC 20510

Dear Chairman Inouye, Ranking Member Cochran, Chairman Harkin and Ranking Member Specter:

Effectiveness information that reflects interactions among all various components of system has the greatest potential empower clinicians and patients make more appropriate decisions. In addition to comparing scientific treatment interventions, research should also on how innovations in care delivery models, such as disease management programs, may produce better health outcomes.

We are writing to urge you to ensure that any comparative effectiveness research (CER) included in the economic stimulus package establish a legislative framework that is strong and patient-centered. The goal of CER should be to arm individual patients and their doctors with the best available information to help assess the relative clinical outcomes of various treatment strategies and alternatives, recognizing that this will vary with circumstances. When used appropriately, comparative clinical effectiveness information can serve as a valuable tool that can contribute to improving health care delivery and outcomes by informing clinical decision making. By focusing on quality of patient care, such research also can help us achieve better health care value. However, we are very concerned that the House legislation and accompanying report language could have unintended and negative effects for patients, providers and medical innovators, leading to restrictions on patients’ access to treatments and physicians’ and other providers’ ability to deliver care that best meets the needs of the individual patient. Rather, we believe any provisions related to comparative effectiveness should:

• Focus CER on comparative clinical benefit, rather than cost-effectiveness.
  Any legislation should state that funding will be used only to support clinical comparative effectiveness research, and define clinical comparative effectiveness as research evaluating and comparing the clinical effectiveness of two or more medical treatments, services, items and care processes and management. Additionally, CER should not encourage a generalized, "one-size fits all" approach. Rather, it is necessary to design studies and communicate results in ways that reflect variation in individual patient needs, that help patients and doctors make informed choices, and account for differences among patients including co-morbidities, sex, race and ethnicity. Recognizing these differences is important to allowing patients optimal treatment today and to encouraging the development of innovative targeted therapies which will advance personalized medicine.
• Be conducted through an open and transparent process that allows for patients, providers and other stakeholders to participate equally in governance and input, starting from the research planning stage.
  There are many challenges in successfully conducting and communicating high-quality, patient-centered CER. Therefore, comparative effectiveness programs should include transparent decision-making procedures and broad stakeholder representation to enhance the credibility and usefulness of such studies.
• Ensure that research supports providers in delivering the best possible care to their patients. To maintain a focus on patient and provider needs, the research entity should not engage in making policy recommendations or coverage decisions.
  Patients may respond differently to the same intervention and the needs of the individual must be taken into consideration. Imposing rigid, federally-proscribed practice guidelines, which fail to recognize such variations, among patients can lead to poor patient outcomes and increased health care costs.

Comparative effectiveness information that reflects interactions among all of the various components of the health care system has the greatest potential to empower clinicians and patients to make more appropriate decisions. In addition to comparing scientific treatment interventions, research should also focus on how innovations in care delivery models, such as disease management programs, may produce better health outcomes.

We look forward to working with you to create a system that improves information about clinical outcomes, ensures that patients continue to have access to life-saving treatments and the tools necessary to advance a better quality of life for all Americans. Thank you for your consideration.

Sincerely,

AACSA Foundation
The AIDS Institute
Alliance for Aging Research
Alliance for Better Medicine
Alliance for Patient Access
Alpha-1 Association
Alpha-1 Foundation
American Association for Cancer Research
American Association for Respiratory Care
American Association of Neurological Surgeons (AANS)
American Association of Orthopaedic Surgeons
American Association of People with Disabilities
American Autoimmune Related Diseases Association
American College of Obstetricians and Gynecologists
American Institute for Medical and Biological Engineering (AIMBE)
American Osteopathic Association
Association of Clinical Research Organizations (ACRO)
Association of Reproductive Health Professionals
Asthma and Allergy Foundation of America
Autism Society of America
Breast Cancer Network of Strength
C3: Colorectal Cancer Coalition
Californians for Cures
Celiac Disease Center at Columbia University
Children's Tumor Foundation
Coalition of State Rheumatology Organizations
Colon Cancer Alliance
Congress of Neurological Surgeons (CNS)
COPD Foundation
Cure Arthritis Now
Cutaneous Lymphoma Foundation
Easter Seals
FasterCures
Foundation for Sarcoidosis Research
Friends of Cancer Research
GBS/CIDP Foundation International
The Government Accountability Project
Interamerican College of Physicians & Surgeons, Inc.
Intercultural Cancer Council Caucus
International Cancer Advocacy Network (ICAN)
International Myeloma Foundation
Kidney Cancer Association
Lung Cancer Circle of Hope
Malecare Cancer Support
Men's Health Network
Muscular Dystrophy Association
National Alliance for Hispanic Health
National Alliance on Mental Illness
National Alopecia Areata Foundation
National Foundation for Ectodermal Dysplasias
National Hemophilia Foundation
National Kidney Foundation
National Spinal Cord Injury Association
Ovarian Cancer National Alliance
Plasma Protein Therapeutics Association
Prostate Cancer International, Inc.
Prostate Health Education Network, Inc. (PHEN)
RetireSafe
Society for Women’s Health Research
Tuberous Sclerosis Alliance
United Spinal Association
Us TOO International Prostate Cancer Education and Support Network
VHL Family Alliance
Virginia Prostate Cancer Coalition
Vital Options International
ZERO - The Project to End Prostate Cancer

cc: The Honorable Max Baucus
The Honorable Kent Conrad
The Honorable Charles Grassley
The Honorable Edward Kennedy
The Honorable Michael Enzi
The Honorable Harry Reid
The Honorable Mitch McConnell

Back to top.