By John Reichard, CQ HealthBeat Editor
March 19, 2009 -- The conversation heated up this week in Washington over comparative effectiveness research—but it proceeded in very different ways in different parts of town.
On Capitol Hill and outside Union Station earlier in the week, Consumers Union, publisher of Consumer Reports, trumpeted the research in its very practical, straightforward way, distributing a "Best Drugs for Less" edition of the magazine that names alternatives to high-priced drugs and says "these aren't the least expensive drugs, they're the best ones."
Meanwhile, over at the Humphrey Building, Health and Human Services officials too sought to call attention to comparative effectiveness studies, announcing Thursday the names of members of a new council to oversee a part of the $1.1 billion in such studies funded by the economic stimulus package recently signed into law by President Obama. But there, officials danced away from the obvious—that payers might use the findings as the basis of coverage decisions, in many instances, perhaps, to cover lower cost products and services.
The point of the research, said Agency for Healthcare Research and Quality (AHRQ) Director Carolyn Clancy and HHS senior adviser Neera Tanden, is to arm doctors and patients with information to help them pick the best treatment for a particular medical condition. When a reporter asked Clancy whether she expected payers to use the findings, she wouldn't bite. "How it will be used I don't think we can talk about until we have more information," she said.
Clancy emphasized that the work her agency has done in recent years to identify the best treatments rarely, if ever, points to one approach as being great and another terrible. "It's much, much, more nuanced than that," she said.
In the months leading up to the current overhaul debate, Democrats and Republicans were more likely to refer to the studies as one of the few approaches with a real chance of bringing down spending growth without harming medical outcomes. Peter Orszag, then the director of the Congressional Budget Office and now the White House budget director, said using financial incentives to encourage doctors to use services and products identified by the research as the treatments that work best would eventually bring down spending growth.
But as the overhaul debate has gotten under way, criticism is becoming more vocal that the research could be used to ration care. A week ago, a coalition that said it represents manufacturers, patients, doctors, and certain medical researchers, called bureaucrats making decisions on comparative effectiveness research, or "CER," a "recipe for disaster."
If big payers deny coverage of less cost-effective products it could thwart innovation and medical progress, said members of the coalition, called the Partnership to Improve Patient Care. And the research may be misused to deny access by minorities and the disabled to needed treatments, said the coalition.
Tanden, counselor to the office of the HHS secretary, emphasized that the 15 federal employees named to the new "Federal Coordinating Council for Comparative Effectiveness Research" represent the interests of minorities and the disabled. She said the council wants the research to look at people in "sub-populations," including minorities, the disabled, and people with mental illnesses.
HHS said in a press release Thursday that the council "will not recommend clinical guidelines for payment, coverage or treatment." It will offer office on research priorities for the $400 million in stimulus funds allotted to the office of the HHS secretary for comparative effectiveness studies while coordinating with AHRQ and NIH and their research under the stimulus legislation. AHRQ gets $300 million and NIH $400 million.
Members include Garth N. Graham, HHS deputy assistant secretary for minority health, Michael Marge, acting director of the HHS Office on Disability, and Peter Delany, director of the Office of Applied Studies at the Substance Abuse and Mental Health Services Administration. Other members include representatives of the National Institutes of Health, the Veterans Administration and the Department of Defense, along with Clancy, Tanden, and Ezekiel J. Emanuel, special adviser for health policy at the White House Office of Management and Budget.
By law, membership of the council is limited to federal employees. But HHS spokeswoman Jenny Backus said in the news release that "President Obama is committed to openness and transparency and the Coordinating Council will host open meetings and a listening session as it begins its important work." Clancy said that the first listening session will be held April 14 but dates for other meetings haven't been announced. The council along with NIH and AHRQ faces a July 30 deadline for completion of an "operations plan" for the $1.1 billion in research.
Lobbies representing manufacturers responded politely to the announcement naming council members. "The economic stimulus law made an important footprint in the health care debate by providing significant funds" for the research, said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America. "As the Administration continues to implement this initiative, we expect it will be done with transparency, openness, accountability and public input in how research priorities are set," added Johnson.
Tony Coelho, chairman of the Partnership to Improve Patient Care, praised the inclusion of representatives of the minority and disabled communities. If the council "provides all health care stakeholders with a voice at the table and focuses on patient needs, our health care system will be well on its way to reform that benefits all Americans."
But Rep. Wally Herger of California, the top Republican on the House Ways and Means Health Subcommittee, issued a statement late Thursday saying "this is yet another incremental move by supporters of government run health care to take medical decisions out of the hands of doctors and patients and put them in the hands of bureaucrats." Herger said he will introduce legislation to "ensure that patients are protected."
But Consumers Union in its new publication described comparative effectiveness research as a way to get patients information on the best drugs while saving individual consumers "hundreds to thousands of dollars a year." It gave advice on lower cost alternatives for some 20 common medical conditions, emphasizing that the advice "is not meant to replace your doctor's judgment." So "use this guide to help you talk with your doctor, not as a substitute for his or her advice."
Consumers Union issued a warning about the dangers of not giving the public information on proven, cost-effective alternatives, releasing the results of a new poll that found 28 percent of Americans take "potentially dangerous actions to save money, such as not filling prescriptions, skipping dosages, and cutting pills in half without the approval of their doctor." Subway passengers exiting the Union Station metro stop near the Capitol were given copies of the "Best Drugs for Less" edition and a display inside the train station featured giant pills running on treadmills to underscore the point that drugs need to be compared rigorously to determine how they stack up against each other.
March 19, 2009 -- The conversation heated up this week in Washington over comparative effectiveness research—but it proceeded in very different ways in different parts of town.
On Capitol Hill and outside Union Station earlier in the week, Consumers Union, publisher of Consumer Reports, trumpeted the research in its very practical, straightforward way, distributing a "Best Drugs for Less" edition of the magazine that names alternatives to high-priced drugs and says "these aren't the least expensive drugs, they're the best ones."
Meanwhile, over at the Humphrey Building, Health and Human Services officials too sought to call attention to comparative effectiveness studies, announcing Thursday the names of members of a new council to oversee a part of the $1.1 billion in such studies funded by the economic stimulus package recently signed into law by President Obama. But there, officials danced away from the obvious—that payers might use the findings as the basis of coverage decisions, in many instances, perhaps, to cover lower cost products and services.
The point of the research, said Agency for Healthcare Research and Quality (AHRQ) Director Carolyn Clancy and HHS senior adviser Neera Tanden, is to arm doctors and patients with information to help them pick the best treatment for a particular medical condition. When a reporter asked Clancy whether she expected payers to use the findings, she wouldn't bite. "How it will be used I don't think we can talk about until we have more information," she said.
Clancy emphasized that the work her agency has done in recent years to identify the best treatments rarely, if ever, points to one approach as being great and another terrible. "It's much, much, more nuanced than that," she said.
In the months leading up to the current overhaul debate, Democrats and Republicans were more likely to refer to the studies as one of the few approaches with a real chance of bringing down spending growth without harming medical outcomes. Peter Orszag, then the director of the Congressional Budget Office and now the White House budget director, said using financial incentives to encourage doctors to use services and products identified by the research as the treatments that work best would eventually bring down spending growth.
But as the overhaul debate has gotten under way, criticism is becoming more vocal that the research could be used to ration care. A week ago, a coalition that said it represents manufacturers, patients, doctors, and certain medical researchers, called bureaucrats making decisions on comparative effectiveness research, or "CER," a "recipe for disaster."
If big payers deny coverage of less cost-effective products it could thwart innovation and medical progress, said members of the coalition, called the Partnership to Improve Patient Care. And the research may be misused to deny access by minorities and the disabled to needed treatments, said the coalition.
Tanden, counselor to the office of the HHS secretary, emphasized that the 15 federal employees named to the new "Federal Coordinating Council for Comparative Effectiveness Research" represent the interests of minorities and the disabled. She said the council wants the research to look at people in "sub-populations," including minorities, the disabled, and people with mental illnesses.
HHS said in a press release Thursday that the council "will not recommend clinical guidelines for payment, coverage or treatment." It will offer office on research priorities for the $400 million in stimulus funds allotted to the office of the HHS secretary for comparative effectiveness studies while coordinating with AHRQ and NIH and their research under the stimulus legislation. AHRQ gets $300 million and NIH $400 million.
Members include Garth N. Graham, HHS deputy assistant secretary for minority health, Michael Marge, acting director of the HHS Office on Disability, and Peter Delany, director of the Office of Applied Studies at the Substance Abuse and Mental Health Services Administration. Other members include representatives of the National Institutes of Health, the Veterans Administration and the Department of Defense, along with Clancy, Tanden, and Ezekiel J. Emanuel, special adviser for health policy at the White House Office of Management and Budget.
By law, membership of the council is limited to federal employees. But HHS spokeswoman Jenny Backus said in the news release that "President Obama is committed to openness and transparency and the Coordinating Council will host open meetings and a listening session as it begins its important work." Clancy said that the first listening session will be held April 14 but dates for other meetings haven't been announced. The council along with NIH and AHRQ faces a July 30 deadline for completion of an "operations plan" for the $1.1 billion in research.
Lobbies representing manufacturers responded politely to the announcement naming council members. "The economic stimulus law made an important footprint in the health care debate by providing significant funds" for the research, said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America. "As the Administration continues to implement this initiative, we expect it will be done with transparency, openness, accountability and public input in how research priorities are set," added Johnson.
Tony Coelho, chairman of the Partnership to Improve Patient Care, praised the inclusion of representatives of the minority and disabled communities. If the council "provides all health care stakeholders with a voice at the table and focuses on patient needs, our health care system will be well on its way to reform that benefits all Americans."
But Rep. Wally Herger of California, the top Republican on the House Ways and Means Health Subcommittee, issued a statement late Thursday saying "this is yet another incremental move by supporters of government run health care to take medical decisions out of the hands of doctors and patients and put them in the hands of bureaucrats." Herger said he will introduce legislation to "ensure that patients are protected."
But Consumers Union in its new publication described comparative effectiveness research as a way to get patients information on the best drugs while saving individual consumers "hundreds to thousands of dollars a year." It gave advice on lower cost alternatives for some 20 common medical conditions, emphasizing that the advice "is not meant to replace your doctor's judgment." So "use this guide to help you talk with your doctor, not as a substitute for his or her advice."
Consumers Union issued a warning about the dangers of not giving the public information on proven, cost-effective alternatives, releasing the results of a new poll that found 28 percent of Americans take "potentially dangerous actions to save money, such as not filling prescriptions, skipping dosages, and cutting pills in half without the approval of their doctor." Subway passengers exiting the Union Station metro stop near the Capitol were given copies of the "Best Drugs for Less" edition and a display inside the train station featured giant pills running on treadmills to underscore the point that drugs need to be compared rigorously to determine how they stack up against each other.