Comparative Effectiveness Research

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

Abstract

The American Recovery and Reinvestment Act of 2009 provides an innovative plan to support comparative effectiveness research through AHRQ and the NIH, as well as creating a Federal Council to coordinate comparative effectiveness research efforts. The goal of the proposal is to reduce costs and improve quality in medical care in the US. Democrats have been very supportive, but Republicans and drug and device manufacturers are concerned about the impact on the private sector.

Purpose of health policy or idea

The American Recovery and Reinvestment Act of 2009 (ARRA) includes a provision that increases funding for comparative effectiveness (CE) research through the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH). The Bill allocated US$ 1.1 billion and also establishes the Federal Coordinating Council for Comparative Effectiveness ("the Council"). The Council's purpose is to foster coordination of research in comparative effectiveness and other health services aimed at reducing duplication of efforts in these areas. The Council will also be responsible for assisting agencies in funding and conducting CE research, as well as presenting semi-annual reports to the President and Congress on strategies to address infrastructure needs and current organizational spending on CE research (ARRA 2009). 

The goal of this legislation is to increase funding for research that compares existing treatments, and tests new treatments against existing methods. In so doing, the hope is that a body of evidence will be built that will help physicians and other care providers decide which treatments are the most likely to benefit their patients. The legislation specifically precludes the Council from making coverage or reimbursement decisions. It also has no authority over clinical practice guidelines.

If successfully implemented, the expectation is that comparative effectiveness research will reduce costs by identifying treatments that are not effective, or are less effective than other available options. Though coverage decisions are not to be made based on comparative effectiveness findings, the hope is that these findings will encourage care providers to avoid perscribing less-effective treatments, naturally culling the field of treatments. Adverse events may also be averted, and harms to patients mitigated if the research shows that a treatment is more harmful to patients than a comparable alternative. 

Main points

Main objectives

To fund this effort, Congress appropriated US$700 million to be funneled through AHRQ.  At least US$400 million of this amount is earmarked for the NIH to fund CE research.  An additional US$400 million is available to the Secretary of Health and Human Services (HHS) to fund CE research in addition to that funded by AHRQ and NIH.  As much as US$1.5 million of the Secretary of HHS budget is intended to support an Institute of Medicine (IOM) report on the current state of comparative effectiveness research and areas of national priority for research.

The Bill additionally creates the Federal Coordinating Council for Comparative Effectiveness, whose purpose is to coordinate comparative effectiveness research across agencies and report to Congress and the President on ongoing research and infrstructure needs. 

Type of incentives

The comparative effectiveness (CE) part of the Stimulus Bill uses financial incentives in the form of a US$1.1 billion investment in comparative effectiveness research.  Additional support is provided for the Council for Comparative Effectiveness to coordinate CE research efforts fosters and incentivizes research in this arena.

Groups affected

Researchers, Providers, Government, Manufacturers, Patients/Consumers, Media

Innovationsgrad	traditionell		innovativ
Kontroversität	unumstritten		kontrovers
Strukturelle Wirkung	marginal		fundamental
Medienpräsenz	sehr gering		sehr hoch
Übertragbarkeit	sehr systemabhängig		systemneutral

Though the idea of comparative effectiveness research in medical care has been around for many years, and has been employed by governments like the UK, structural support for such research in the US is innovative. Additional funding for CE research will help to develop a strong knowledge base off which further investments can be based, and from which providers can learn.    

Political and economic background

The American Recovery and Reinvestment Act of 2009, also know as the Stimulus Bill or H.R. 1, was the first act of the new 111th Congress. It responded to a severe downturn in the economy marked by a collapse of the financial sector and housing markets, followed by subsequent crises in other sectors, such as the American auto industry. The contents of this Bill were significantly affected by the change in administration as Barack Obama took office as President.  While President-Elect, President Obama was active in negotiations over the Stimulus Bill language. His commitment to health reform, and the support from Democrats in Congress, is clearly evident in the language of the Bill, which includes sweeping changes to the health sector in addition to investing in comparative effectiveness research. Comparative effectiveness is one part of a larger health reform effort (also see report Increasing HIT through the Economics Stimulus Bill (13) 2009).

The focus on comparative effectiveness in the Bill responds to the messages under which Barack Obama campaigned for the Presidency. In describing his overall healthcare goals, he included a plan to increase comparative effectiveness research, which aimed at reducing costs, reducing geographic variation, and improving outcomes of care.

Change of government

The Democratic majority in Congress and the support of the newly-elected President were central to the success of the Stimulus Bill overall, and were the reason language on comparative effectiveness was included in the broader bill.

Change based on an overall national health policy statement

The comparative effectiveness initiative in the Stimulus Bill is part of the overall healthcare plan set forth by Barack Obama during his Presidential campaign.

Purpose and process analysis

Current Process Stages

	Idee	Pilotprojekt	Strategiepapier	Gesetzgebung	Umsetzung	Evaluation	Veränderung/Richtungswechsel
Implemented in this survey?

Origins of health policy idea

The comparative effectiveness portion of the Stimulus Bill directly responds to the messages in Barack Obama's Presidential campaign, which were similar to those put forth by former Senator Tom Daschle, and those supported by then-Sen. Hillary Clinton (NYTimes, 2009). 

Comparative effectiveness is not a new idea internationally. In the UK, the National Institute for Health and Clinical Effectiveness (NICE) has been a model for comparative effectiveness in healthcare. Unlike NICE, though, the US entity (the Council) will not be empowered to make coverage decisions for medical care.

Initiators of idea/main actors

• Regierung: President Barack Obama and his administration were instrumental in supporting CE research.

• Parlament: The Democratically controlled Congress is largely responsible for inclusion of language on CE, and almost entirely responsible for passage of the Stimulus Bill more broadly.

• Leistungserbringer: The American Medical Association and American Academy of Family Physicians, along with other provider organizations, are strongly supportive of the comparative effectiveness provisions in the Stimulus Bill

• Kostenträger: America's Health Insurance Plans (AHIP), the leading insurance industry trade oragnization is strongly in favor of comparative effectiveness research as has been consistently in support of legislation.

• Patienten, Verbraucher: Workers unions, consumer groups, patient groups and others have come out in support of the comparative effectiveness language in the Stimulus Bill. Some concern was voiced by minority and women's groups to keep in mind the traditionally under-researched.

• Privatwirtschaft, privater Sektor: Manufacturers of medical drugs and devices are concerned about the effects of comparative effectiveness research on their products. They have made a statement to the FDA communicating their position.

• Medien: The media has had mixed reactions to the comparative effectiveness piece of the Stimulus Bill. Some have been strong supporters, others, particularly conservatives, have been strong opponents.

Approach of idea

The approach of the idea is described as:
renewed: Comparative effectiveness has been empolyed in other settings and other countries, most notably the UK's NICE. Its application in the United States is derivative.

Stakeholder positions

The comparative effectiveness portion of the Stimulus Bill has received strong support from the Democratic party, especially President Obama and his administration. This support has been further bolstered by support from may stakeholders: care providers (AMA, AAFP, ANA 2009), insurance companies (AHIP 2009), patient and consumer groups (SEIU, AARP, Consumer Reports 2009), and more.

Opposition has largely come from the drug and device indsutry and conservatives, both in Congress and throughout the broader population. The entire Stimulus Bill received only 3 votes from Republicans, all of whom were in the Senate. Comparative effectiveness in particular has been a concern for some conservative media personalities, who have made a point of expressing their concerns publicly (Limbaugh 2009, McCaughey 2009). Organizations like PhRMA have publicly expressed some support for comparative effectiveness, but have been opposed to Congressional action in this area. (PhRMA 2009)

Concerns largely run to the effect a national body of comparative effectiveness would have on coverage decisions, taking care out of the hands of physicians, and putting it into the hands of bureaucrats. Industry concerns are related to the impact of CE research on their products. The Bill specifically addresses the concerns about coverage decisions in precluding the Council from making decisions related to coverage, or in making recommendations on coverage decisions. However, some conservatives are still concerned that this marks the first step toward a system like that in Britain, where NICE is responsible for making coverage decisions based on effectiveness research.

Actors and positions

Regierung
Obama Administration	sehr unterstützend		stark dagegen
Parlament
Democrats	sehr unterstützend		stark dagegen
Republicans	sehr unterstützend		stark dagegen
Leistungserbringer
America Medical Association	sehr unterstützend		stark dagegen
American Academy of Family Physicians	sehr unterstützend		stark dagegen
American Nurses Association	sehr unterstützend		stark dagegen
Kostenträger
America's Health Insurance Plans	sehr unterstützend		stark dagegen
Patienten, Verbraucher
Service Employees International Union (SEIU)	sehr unterstützend		stark dagegen
American Association of Retired Professionals (AARP)	sehr unterstützend		stark dagegen
Consumer Reports	sehr unterstützend		stark dagegen
Privatwirtschaft, privater Sektor
Pharmaceutical and Medical Devices Industry	sehr unterstützend		stark dagegen
Medien
New York Times	sehr unterstützend		stark dagegen
US News and World Report	sehr unterstützend		stark dagegen

Influences in policy making and legislation

The comparative effectiveness language in the Stimulus Bill is similar to language that has been put forth as legislation in Congress in recent years. The final language of the Bill includes the prohibition on coverage decision-making in response to concerns from Congressional representatives as well as the wider public. 

Success of the Stimulus Bill was driven by the power of the Democratic party, in Congress and the White House. Though there were frequent calls for bipartisanship on the Stimulus, in the end it as majority rule by Democrats that made passage of the legislation a possibility.    

Legislative outcome

success

Actors and influence

Regierung
Obama Administration	sehr groß		kein
Parlament
Democrats	sehr groß		kein
Republicans	sehr groß		kein
Leistungserbringer
America Medical Association	sehr groß		kein
American Academy of Family Physicians	sehr groß		kein
American Nurses Association	sehr groß		kein
Kostenträger
America's Health Insurance Plans	sehr groß		kein
Patienten, Verbraucher
Service Employees International Union (SEIU)	sehr groß		kein
American Association of Retired Professionals (AARP)	sehr groß		kein
Consumer Reports	sehr groß		kein
Privatwirtschaft, privater Sektor
Pharmaceutical and Medical Devices Industry	sehr groß		kein
Medien
New York Times	sehr groß		kein
US News and World Report	sehr groß		kein

Positions and Influences at a glance

Adoption and implementation

AHRQ, the NIH and the Secretary of Health and Human Services (HHS) now bear the burden of implementing the comparative effectiveness portion of the Stimulus Bill. The IOM, with funding from HHS, is expected to produce a report on areas of national priority for CE research by June 30, 2009. This will guide future funding of CE research, but implementation is already ongoing through the aforementioned agencies.

As implementation moves forward, the considerable support from stakeholders will be essential in successful identification of national priorities, in developing research proposals, and completing research on comparative effectiveness, and in making use of the information gained from CE research. Physicians, payers, drug and device manufacturers, and patients/consumers are likely to see a change in the way medical care is delivered, and their continued interest in and use of comparative effectiveness research will be an important support for implementation and sustainability.

Monitoring and evaluation

The Federal Council for Comparative Effectiveness is tasked with the duty to monitor comparative effectiveness research, particularly looking to avoid duplicative efforts. Additionally, the Council must report to the Congress and the President on the status of projects that have been funded, all of which will provide a mechanism for public oversight and evaluation.

Review mechanisms

Halbzeitevaluation, Abschlussevaluation (intern)

Dimensions of evaluation

Struktur, Prozess, Ergebnis

Results of evaluation

 n/a

Expected outcome

The strong support of many stakeholders in this process promises a high likelihood of success. Additionally, models of comparative effectiveness in other countries can help the Council avoid some of the historical pitfalls associated with this type of research. Continued support from Congress and the President will be essential in the implementation of the policy, and the strong push for healthcare reform more broadly suggests that this support will continue into the foreseeable future.

As researchers begin to employ the funds for comparative effectiveness, the expectation is that the information will be made publicly available and will be used by providers when making treatment decisions.

Impact of this policy

Qualität	kaum Einfluss		starker Einfluss
Gerechtigkeit	System weniger gerecht		System gerechter
Kosteneffizienz	sehr gering		sehr hoch

With continued support from Congress and the President, combined with support from researchers, providers, and payers, comparative effectiveness research and the Council for Comparative Effectiveness have the chance to create a stronger body of evidence from which providers can learn, and which they can use when recommending treatments for their patients.

References

Sources of Information

American Recovery and Reinvestment Act of 2009.  H.R.1.  111th Congress. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf.

U.S. to Compare Medical Treatments.  New York Times.  Feb 16, 2009. Pg A1.  www.nytimes.com/2009/02/16/health/policy/16health.html. 

Vandeventer, John.  Update: Health Care Provisions in the Economic Recovery Act.  2/12/2009. www.seiu.org/2009/02/update-health-care-provisions-in-the-economic-recovery-act.php.  

American Association of retured Professional (AARP).  Health Care and the Stimulus Plan. 2/18/09. http://bulletin.aarp.org/yourhealth/policy/articles/health_care_and_the0.html

Consumer Reports.  HHS names comparative effectiveness research team. 3/19/09.  http://blogs.consumerreports.org/reporter/economic-stimulus/?EXTKEY=I72RSE0.

American Medical Association (AMA).  Comparative Effectiveness Research. www.ama-assn.org/ama1/pub/upload/mm/399/hsr-comparative-effectiveness.pdf

American Academy of Family Physicians (AAFP).  Health IT, Primary Care Come Out Ahead in Massive Stimulus Bill: Approved Legislation Addresses Key AAFP Issues.  2/13/09. www.aafp.org/online/en/home/publications/news/news-now/government-medicine/20090213stimulus-passes.html

American Nurses Association. American Recovery & Reinvstment Act. www.nursingworld.org/MainMenuCategories/ANAPoliticalPower/Federal/ARRA.aspx

America's Health Insurance Plans. Patients Will Benefit from Comparative Effectiveness Funding in Stimulus Bill. 2/11/09. www.ahip.org/content/pressrelease.aspx?docid=25948

Rush Limbaugh. The March to Socialized Medicine Starts in Obama's Porkulus Bill.  2/9/09. www.rushlimbaugh.com/home/daily/site_020909/content/01125111.guest.html

Comparative Effectiveness Research as Patient Education Tool. US News and World Report. 3/23/09. http://health.usnews.com/blogs/on-health-and-money/2009/03/23/comparative-effectiveness-research-as-patient-education-tool.html

Industry Speaks Up as HHS Plans Comparative Effectiveness Research. FDANews Device Daily Bulletin. 4/3/09. http://fdanews.com/newsletter/article?issueId=12537&articleId=115943

PhRMA. Comparative Clinical Effectiveness Research Provision. An Important Step Forward for Patient Care. 2/11/09. www.phrma.org/news_room/press_releases/comparative_clinical_effectiveness_
research_provision_an_important_step_forward_for_patient_care/   

Ruin Your Health With the Obama Stimulus Plan: Betsy McCaughey. Bloomberg News. 2/9/09. www.bloomberg.com/apps/news?pid=20601039&refer=columnist_mccaughey&sid=aLzfDxfbwhzs  

Author/s and/or contributors to this survey

Holzer, Jessica and Gerard Anderson

 

Empfohlene Zitierweise für diesen Online-Artikel:

Holzer, Jessica and Gerard Anderson. "Comparative Effectiveness Research". Health Policy Monitor, April 2009. Available at http://www.hpm.org/survey/us/b13/4