Alicia Ault

WASHINGTON — Concerned about frequent rehospitalizations and readmissions to skilled nursing facilities, the Medicare Payment Advisory Commission recently debated whether to recommend that payments for the hospital and postacute care be bundled together.

Analysis of data from 2004 to 2006 showed that 63% of skilled nursing facility (SNF) patients were admitted to a hospital, then discharged back to an SNF; 31% had two or more SNF-hospital-SNF cycles, MedPAC staff member Carol Carter reported at a recent meeting of the commission.

A previous report by the Health and Human Services Department's Office of Inspector General found that patients who had three or more such cycles had a lower quality of care, said Ms. Carter, who added that the OIG estimated the cost to Medicare of frequent hospital readmissions from SNFs at $3.5 billion in 2007.

The MedPAC analysis also found that patients who had repeat hospitalizations and readmissions to SNFs were more likely to be dual-eligible for Medicare and Medicaid and more likely to be sicker than other patients. Of the readmitted patients, 51% were dual-eligible, compared with 33% of those who did not have repeat visits. Patients who had four or more hospital-SNF stay cycles during the 2-year period were also more likely to be classified as clinically complex than were nonrepeat patients, Ms. Carter said.

Of repeat patients, 74% were hospitalized for what were classified as “potentially avoidable” conditions, such as heart failure, respiratory infections, and urinary tract infections, she said.

Repeat hospital-SNF visits were much higher for patients in freestanding SNFs and in for-profit SNFs, Ms. Carter said.

She suggested that it was probably not possible—or desirable—to eliminate all hospital readmissions. But she recommended aligning payment incentives between the SNFs and hospitals, saying that each entity could, under the current system, be rewarded for admissions to their facilities. She also said that SNFs can often convert patients from lower-paying Medicaid to higher-paying Medicare after a long hospital stay.

Ms. Carter suggested that the Centers for Medicare and Medicaid Services start publicly reporting rehospitalization and readmission rates, and that the agency consider using potentially avoidable rehospitalizations as a pay-for-performance measure.

Finally, she recommended bundling payments for the hospital and the SNF, following the same path that MedPAC has recommended for hospitals in an attempt to hold inpatient and outpatient providers accountable for readmissions.

Some commissioners questioned whether “potentially avoidable” hospitalizations had been validated as a performance measure, noting that in some cases, an SNF might just have a bad case mix.

Commissioner Peter Butler, executive vice president and chief operating officer of Rush University Medical Center in Chicago, disagreed that hospitals had a financial incentive to seek out the readmissions. “For the most part, hospitals don't want these patients,” he said, noting that they were often medically complex and rarely profitable.

Dr. Thomas Dean, chief of staff at Avera Weskota Memorial Medical Center in Wessington Springs, S.D., said he agreed with Mr. Butler that these patients were rarely desirable and were generally not profitable.

Commissioner Michael Chernew said that the payment incentives were “perverse” and that they might induce “churning” of patients from the nursing home to the hospital and back. But Mr. Chernew, a professor in the department of health care policy at Harvard Medical School, Boston, said that holding SNFs and hospitals accountable for readmissions might not be the optimal route to change.

Larry Lane, a vice president at Genesis HealthCare, a for-profit SNF and assisted living company, said that the commission should not “demonize” for-profit ownership. Speaking during the public section of the meeting, Mr. Lane said that 15%–18% of his company's hospitalizations are within 3 days of an SNF admission, suggesting that those patients are being prematurely discharged from the hospital.

Mr. Lane also warned against a “stampede” toward bundling.

MedPAC did not say when it would again take up the issue of rehospitalized SNF patients.

WASHINGTON — Concerned about frequent rehospitalizations and readmissions to skilled nursing facilities, the Medicare Payment Advisory Commission recently debated whether to recommend that payments for the hospital and postacute care be bundled together.

Analysis of data from 2004 to 2006 showed that 63% of skilled nursing facility (SNF) patients were admitted to a hospital, then discharged back to an SNF; 31% had two or more SNF-hospital-SNF cycles, MedPAC staff member Carol Carter reported at a recent meeting of the commission.

A previous report by the Health and Human Services Department's Office of Inspector General found that patients who had three or more such cycles had a lower quality of care, said Ms. Carter, who added that the OIG estimated the cost to Medicare of frequent hospital readmissions from SNFs at $3.5 billion in 2007.

The MedPAC analysis also found that patients who had repeat hospitalizations and readmissions to SNFs were more likely to be dual-eligible for Medicare and Medicaid and more likely to be sicker than other patients. Of the readmitted patients, 51% were dual-eligible, compared with 33% of those who did not have repeat visits. Patients who had four or more hospital-SNF stay cycles during the 2-year period were also more likely to be classified as clinically complex than were nonrepeat patients, Ms. Carter said.

Of repeat patients, 74% were hospitalized for what were classified as “potentially avoidable” conditions, such as heart failure, respiratory infections, and urinary tract infections, she said.

Repeat hospital-SNF visits were much higher for patients in freestanding SNFs and in for-profit SNFs, Ms. Carter said.

She suggested that it was probably not possible—or desirable—to eliminate all hospital readmissions. But she recommended aligning payment incentives between the SNFs and hospitals, saying that each entity could, under the current system, be rewarded for admissions to their facilities. She also said that SNFs can often convert patients from lower-paying Medicaid to higher-paying Medicare after a long hospital stay.

Ms. Carter suggested that the Centers for Medicare and Medicaid Services start publicly reporting rehospitalization and readmission rates, and that the agency consider using potentially avoidable rehospitalizations as a pay-for-performance measure.

Finally, she recommended bundling payments for the hospital and the SNF, following the same path that MedPAC has recommended for hospitals in an attempt to hold inpatient and outpatient providers accountable for readmissions.

Some commissioners questioned whether “potentially avoidable” hospitalizations had been validated as a performance measure, noting that in some cases, an SNF might just have a bad case mix.

Commissioner Peter Butler, executive vice president and chief operating officer of Rush University Medical Center in Chicago, disagreed that hospitals had a financial incentive to seek out the readmissions. “For the most part, hospitals don't want these patients,” he said, noting that they were often medically complex and rarely profitable.

Dr. Thomas Dean, chief of staff at Avera Weskota Memorial Medical Center in Wessington Springs, S.D., said he agreed with Mr. Butler that these patients were rarely desirable and were generally not profitable.

Commissioner Michael Chernew said that the payment incentives were “perverse” and that they might induce “churning” of patients from the nursing home to the hospital and back. But Mr. Chernew, a professor in the department of health care policy at Harvard Medical School, Boston, said that holding SNFs and hospitals accountable for readmissions might not be the optimal route to change.

Larry Lane, a vice president at Genesis HealthCare, a for-profit SNF and assisted living company, said that the commission should not “demonize” for-profit ownership. Speaking during the public section of the meeting, Mr. Lane said that 15%–18% of his company's hospitalizations are within 3 days of an SNF admission, suggesting that those patients are being prematurely discharged from the hospital.

Mr. Lane also warned against a “stampede” toward bundling.

MedPAC did not say when it would again take up the issue of rehospitalized SNF patients.

WASHINGTON — Concerned about frequent rehospitalizations and readmissions to skilled nursing facilities, the Medicare Payment Advisory Commission recently debated whether to recommend that payments for the hospital and postacute care be bundled together.

Analysis of data from 2004 to 2006 showed that 63% of skilled nursing facility (SNF) patients were admitted to a hospital, then discharged back to an SNF; 31% had two or more SNF-hospital-SNF cycles, MedPAC staff member Carol Carter reported at a recent meeting of the commission.

A previous report by the Health and Human Services Department's Office of Inspector General found that patients who had three or more such cycles had a lower quality of care, said Ms. Carter, who added that the OIG estimated the cost to Medicare of frequent hospital readmissions from SNFs at $3.5 billion in 2007.

The MedPAC analysis also found that patients who had repeat hospitalizations and readmissions to SNFs were more likely to be dual-eligible for Medicare and Medicaid and more likely to be sicker than other patients. Of the readmitted patients, 51% were dual-eligible, compared with 33% of those who did not have repeat visits. Patients who had four or more hospital-SNF stay cycles during the 2-year period were also more likely to be classified as clinically complex than were nonrepeat patients, Ms. Carter said.

Of repeat patients, 74% were hospitalized for what were classified as “potentially avoidable” conditions, such as heart failure, respiratory infections, and urinary tract infections, she said.

Repeat hospital-SNF visits were much higher for patients in freestanding SNFs and in for-profit SNFs, Ms. Carter said.

She suggested that it was probably not possible—or desirable—to eliminate all hospital readmissions. But she recommended aligning payment incentives between the SNFs and hospitals, saying that each entity could, under the current system, be rewarded for admissions to their facilities. She also said that SNFs can often convert patients from lower-paying Medicaid to higher-paying Medicare after a long hospital stay.

Ms. Carter suggested that the Centers for Medicare and Medicaid Services start publicly reporting rehospitalization and readmission rates, and that the agency consider using potentially avoidable rehospitalizations as a pay-for-performance measure.

Finally, she recommended bundling payments for the hospital and the SNF, following the same path that MedPAC has recommended for hospitals in an attempt to hold inpatient and outpatient providers accountable for readmissions.

Some commissioners questioned whether “potentially avoidable” hospitalizations had been validated as a performance measure, noting that in some cases, an SNF might just have a bad case mix.

Commissioner Peter Butler, executive vice president and chief operating officer of Rush University Medical Center in Chicago, disagreed that hospitals had a financial incentive to seek out the readmissions. “For the most part, hospitals don't want these patients,” he said, noting that they were often medically complex and rarely profitable.

Dr. Thomas Dean, chief of staff at Avera Weskota Memorial Medical Center in Wessington Springs, S.D., said he agreed with Mr. Butler that these patients were rarely desirable and were generally not profitable.

Commissioner Michael Chernew said that the payment incentives were “perverse” and that they might induce “churning” of patients from the nursing home to the hospital and back. But Mr. Chernew, a professor in the department of health care policy at Harvard Medical School, Boston, said that holding SNFs and hospitals accountable for readmissions might not be the optimal route to change.

Larry Lane, a vice president at Genesis HealthCare, a for-profit SNF and assisted living company, said that the commission should not “demonize” for-profit ownership. Speaking during the public section of the meeting, Mr. Lane said that 15%–18% of his company's hospitalizations are within 3 days of an SNF admission, suggesting that those patients are being prematurely discharged from the hospital.

Mr. Lane also warned against a “stampede” toward bundling.

MedPAC did not say when it would again take up the issue of rehospitalized SNF patients.

Even though the Bush administration has made it nearly impossible to expand the State Children's Health Insurance Program, and the economic downturn has put a squeeze on Medicaid budgets, many states are keeping children covered and some are even expanding eligibility, according to two new studies by Families USA.

Officials at the advocacy organization, based in Washington, said that at the end of 2007, 17 states were considering expanding coverage for children under SCHIP and Medicaid. But those plans were largely put on hold or scaled back because of President Bush's vetoes of the original SCHIP reauthorization package. A law authorizing the program at 2007 levels will expire in March 2009.

Another setback for states came in August 2007, when the Bush administration issued a directive that limited the SCHIP eligibility, going forward, of families with incomes at or below 250% of the federal poverty level.

That directive has remained essentially unchanged, although the Centers for Medicare and Medicaid Services announced in May that it would look at expansion programs on a case-by-case basis.

Expansion plans by New York and Ohio were rejected by CMS, but New York used state funds to expand coverage to children living in families with incomes up to 400% of the poverty level.

Ohio is using state money to cover children who can't get private health coverage, but the expansion is not through Medicaid or SCHIP, according to the Families USA report, “Detour on the Road to Kids Coverage: Administration Creates Roadblocks, So States Seek Alternative Routes.”

Ohio also raised eligibility to the federal ceiling (250% of the poverty level).

Indiana, Louisiana, Oklahoma, and Wisconsin had planned to raise eligibility for their programs to 300% of the poverty level, but have now scaled that back to 250%, according to the Detour report. Finally, North Carolina, Washington state, and West Virginia also had expansion plans, but have not yet submitted them to CMS, according to the report. It is not clear yet how those states will proceed.

Despite the CMS directive and the bleak economic outlook, some states—including Colorado, Florida, Iowa, and Kansas—are planning to expand coverage next year. The expansions in Iowa and Kansas, however, depend on a reauthorization of the SCHIP program, according to the Detour report.

There also may be a ballot measure in Montana in the fall aimed at increasing eligibility from 175% to 250% of the poverty level.

California is currently wrangling over the state's budget, which included an increase in cost sharing for SCHIP (which is called “Healthy Families” in California) as well as reduced Medicaid coverage for parents.

Rhode Island is also looking at paring back its SCHIP coverage in fiscal 2009 and increasing cost sharing for families.

“States are committed to covering kids, but they are clearly hampered by the roadblocks the administration has put up,” said Families USA senior policy analyst Jenny Sullivan during a briefing with reporters.

Most states are also feeling the pinch as tax revenues recede while Medicaid costs—increasingly a larger proportion of most state budgets—continue to rise, according to the second Families USA report, “Precarious Position: States Must Balance Declining Revenues With a Growing Need for Medicaid.”

The report found that 16 states and Puerto Rico are looking at budget deficits in fiscal year 2008, and 29 states and the District of Columbia are looking at shortfalls in fiscal 2009.

Increasing unemployment means that more Americans will turn to Medicaid for health coverage for them and their children, the organization said. The Medicaid report cited a study by the Kaiser Family Foundation showing that each 1% rise in unemployment increased Medicaid and SCHIP enrollment by 1 million, leaving states with an additional $1.4 billion obligation.

In California, Gov. Arnold Schwarzenegger (R) has proposed $1 billion in Medicaid and SCHIP cuts. That means the state would lose an additional $1 billion in federal matching funds—a danger that all states face as they look to balance their budgets through Medicaid cuts, according to the Medicaid report.

Mississippi is also considering Medicaid cuts in a special legislative session. Maine instituted some cost-sharing measures; New Jersey is considering shifting more of the burden onto Medicaid recipients. In Rhode Island's 2008 budget, eligibility was reduced for parents and cost sharing was increased; premium payments based on income are required, and the state is looking at further cuts in 2009, according to the report.

Families USA is pushing for federal relief, such as a temporary increase in the matching rate that is given to states for Medicaid.

Congress passed such a temporary fix in 2003, and several bills have been introduced in this congressional session. But it is unclear whether a proposed fix could make it out of Congress this year, a Families USA staffer said during the briefing.

Even though the Bush administration has made it nearly impossible to expand the State Children's Health Insurance Program, and the economic downturn has put a squeeze on Medicaid budgets, many states are keeping children covered and some are even expanding eligibility, according to two new studies by Families USA.

Officials at the advocacy organization, based in Washington, said that at the end of 2007, 17 states were considering expanding coverage for children under SCHIP and Medicaid. But those plans were largely put on hold or scaled back because of President Bush's vetoes of the original SCHIP reauthorization package. A law authorizing the program at 2007 levels will expire in March 2009.

Another setback for states came in August 2007, when the Bush administration issued a directive that limited the SCHIP eligibility, going forward, of families with incomes at or below 250% of the federal poverty level.

That directive has remained essentially unchanged, although the Centers for Medicare and Medicaid Services announced in May that it would look at expansion programs on a case-by-case basis.

Expansion plans by New York and Ohio were rejected by CMS, but New York used state funds to expand coverage to children living in families with incomes up to 400% of the poverty level.

Ohio is using state money to cover children who can't get private health coverage, but the expansion is not through Medicaid or SCHIP, according to the Families USA report, “Detour on the Road to Kids Coverage: Administration Creates Roadblocks, So States Seek Alternative Routes.”

Ohio also raised eligibility to the federal ceiling (250% of the poverty level).

Indiana, Louisiana, Oklahoma, and Wisconsin had planned to raise eligibility for their programs to 300% of the poverty level, but have now scaled that back to 250%, according to the Detour report. Finally, North Carolina, Washington state, and West Virginia also had expansion plans, but have not yet submitted them to CMS, according to the report. It is not clear yet how those states will proceed.

Despite the CMS directive and the bleak economic outlook, some states—including Colorado, Florida, Iowa, and Kansas—are planning to expand coverage next year. The expansions in Iowa and Kansas, however, depend on a reauthorization of the SCHIP program, according to the Detour report.

There also may be a ballot measure in Montana in the fall aimed at increasing eligibility from 175% to 250% of the poverty level.

California is currently wrangling over the state's budget, which included an increase in cost sharing for SCHIP (which is called “Healthy Families” in California) as well as reduced Medicaid coverage for parents.

Rhode Island is also looking at paring back its SCHIP coverage in fiscal 2009 and increasing cost sharing for families.

“States are committed to covering kids, but they are clearly hampered by the roadblocks the administration has put up,” said Families USA senior policy analyst Jenny Sullivan during a briefing with reporters.

Most states are also feeling the pinch as tax revenues recede while Medicaid costs—increasingly a larger proportion of most state budgets—continue to rise, according to the second Families USA report, “Precarious Position: States Must Balance Declining Revenues With a Growing Need for Medicaid.”

The report found that 16 states and Puerto Rico are looking at budget deficits in fiscal year 2008, and 29 states and the District of Columbia are looking at shortfalls in fiscal 2009.

Increasing unemployment means that more Americans will turn to Medicaid for health coverage for them and their children, the organization said. The Medicaid report cited a study by the Kaiser Family Foundation showing that each 1% rise in unemployment increased Medicaid and SCHIP enrollment by 1 million, leaving states with an additional $1.4 billion obligation.

In California, Gov. Arnold Schwarzenegger (R) has proposed $1 billion in Medicaid and SCHIP cuts. That means the state would lose an additional $1 billion in federal matching funds—a danger that all states face as they look to balance their budgets through Medicaid cuts, according to the Medicaid report.

Mississippi is also considering Medicaid cuts in a special legislative session. Maine instituted some cost-sharing measures; New Jersey is considering shifting more of the burden onto Medicaid recipients. In Rhode Island's 2008 budget, eligibility was reduced for parents and cost sharing was increased; premium payments based on income are required, and the state is looking at further cuts in 2009, according to the report.

Families USA is pushing for federal relief, such as a temporary increase in the matching rate that is given to states for Medicaid.

Congress passed such a temporary fix in 2003, and several bills have been introduced in this congressional session. But it is unclear whether a proposed fix could make it out of Congress this year, a Families USA staffer said during the briefing.

Even though the Bush administration has made it nearly impossible to expand the State Children's Health Insurance Program, and the economic downturn has put a squeeze on Medicaid budgets, many states are keeping children covered and some are even expanding eligibility, according to two new studies by Families USA.

Officials at the advocacy organization, based in Washington, said that at the end of 2007, 17 states were considering expanding coverage for children under SCHIP and Medicaid. But those plans were largely put on hold or scaled back because of President Bush's vetoes of the original SCHIP reauthorization package. A law authorizing the program at 2007 levels will expire in March 2009.

Another setback for states came in August 2007, when the Bush administration issued a directive that limited the SCHIP eligibility, going forward, of families with incomes at or below 250% of the federal poverty level.

That directive has remained essentially unchanged, although the Centers for Medicare and Medicaid Services announced in May that it would look at expansion programs on a case-by-case basis.

Expansion plans by New York and Ohio were rejected by CMS, but New York used state funds to expand coverage to children living in families with incomes up to 400% of the poverty level.

Ohio is using state money to cover children who can't get private health coverage, but the expansion is not through Medicaid or SCHIP, according to the Families USA report, “Detour on the Road to Kids Coverage: Administration Creates Roadblocks, So States Seek Alternative Routes.”

Ohio also raised eligibility to the federal ceiling (250% of the poverty level).

Indiana, Louisiana, Oklahoma, and Wisconsin had planned to raise eligibility for their programs to 300% of the poverty level, but have now scaled that back to 250%, according to the Detour report. Finally, North Carolina, Washington state, and West Virginia also had expansion plans, but have not yet submitted them to CMS, according to the report. It is not clear yet how those states will proceed.

Despite the CMS directive and the bleak economic outlook, some states—including Colorado, Florida, Iowa, and Kansas—are planning to expand coverage next year. The expansions in Iowa and Kansas, however, depend on a reauthorization of the SCHIP program, according to the Detour report.

There also may be a ballot measure in Montana in the fall aimed at increasing eligibility from 175% to 250% of the poverty level.

California is currently wrangling over the state's budget, which included an increase in cost sharing for SCHIP (which is called “Healthy Families” in California) as well as reduced Medicaid coverage for parents.

Rhode Island is also looking at paring back its SCHIP coverage in fiscal 2009 and increasing cost sharing for families.

“States are committed to covering kids, but they are clearly hampered by the roadblocks the administration has put up,” said Families USA senior policy analyst Jenny Sullivan during a briefing with reporters.

Most states are also feeling the pinch as tax revenues recede while Medicaid costs—increasingly a larger proportion of most state budgets—continue to rise, according to the second Families USA report, “Precarious Position: States Must Balance Declining Revenues With a Growing Need for Medicaid.”

The report found that 16 states and Puerto Rico are looking at budget deficits in fiscal year 2008, and 29 states and the District of Columbia are looking at shortfalls in fiscal 2009.

Increasing unemployment means that more Americans will turn to Medicaid for health coverage for them and their children, the organization said. The Medicaid report cited a study by the Kaiser Family Foundation showing that each 1% rise in unemployment increased Medicaid and SCHIP enrollment by 1 million, leaving states with an additional $1.4 billion obligation.

In California, Gov. Arnold Schwarzenegger (R) has proposed $1 billion in Medicaid and SCHIP cuts. That means the state would lose an additional $1 billion in federal matching funds—a danger that all states face as they look to balance their budgets through Medicaid cuts, according to the Medicaid report.

Mississippi is also considering Medicaid cuts in a special legislative session. Maine instituted some cost-sharing measures; New Jersey is considering shifting more of the burden onto Medicaid recipients. In Rhode Island's 2008 budget, eligibility was reduced for parents and cost sharing was increased; premium payments based on income are required, and the state is looking at further cuts in 2009, according to the report.

Families USA is pushing for federal relief, such as a temporary increase in the matching rate that is given to states for Medicaid.

Congress passed such a temporary fix in 2003, and several bills have been introduced in this congressional session. But it is unclear whether a proposed fix could make it out of Congress this year, a Families USA staffer said during the briefing.

Experts serving on the Food and Drug Administration's advisory committees are now subject to new rules aimed at ensuring that they do not have conflicts of interest that could bias their decisions.

In early August, the FDA issued four final guidance documents and a draft guidance outlining how it plans to handle conflicts of interest among members of advisory committees, which review the safety and efficacy of drugs, medical devices, diagnostic tests, and other products and ingredients that the agency regulates.

In a separate move, the agency said that it plans to make it easier to find documents before and after advisory committee meetings by improving how it posts meeting information on its Web site.

Guidance documents represent the agency's current thinking on a topic, but carry less weight than does a regulation. The FDA has no power to enforce guidance documents, which manufacturers and the agency generally use as rules of thumb.

The newest guidance documents will help ensure that the FDA "is getting the highest quality scientific advice, while at the same time preserving public trust in our decisions," Randall Lutter, Ph.D., the FDA's deputy commissioner for policy, said in a teleconference briefing with reporters.

In the past, the agency has asked advisers to disclose potential conflicts of interest, but there was no monetary limit. Each potential conflict was weighed individually, and waivers were granted based on whether the adviser's expertise was considered necessary for a particular meeting.

With the new guidance, the agency sets a dollar limit on advisers' financial interests. If an adviser—or his or her spouse or minor child—has interests of at least $50,000 in an entity that would be directly or indirectly affected by the outcome of a particular meeting, the adviser would be barred from participating. Advisers with interests less than $50,000 will be allowed to participate and vote, unless they are found to have a significant conflict of interest.

An advocate who has been critical of the FDA's conflict of interest policy for advisers said that the $50,000 cap is too high.

"The FDA wants us to believe that an advisory committee member can receive $49,999 from a company and still make an unbiased decision. I don't buy it and the research doesn't support it," said Diana Zuckerman, Ph.D., president of the National Research Center for Women and Families, an advocacy organization in Washington.

She and another agency critic, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, both expressed concern that the new guidance would still allow advisers with conflicts to vote. Those advisers will be granted waivers if they are determined to provide essential expertise. This is not much of a change from current policy, according to Dr. Wolfe and Dr. Zuckerman.

But the FDA said that the Food and Drug Administration Amendments Act of 2007, which was signed into law last year, limits the number of waivers it is allowed to grant.

In another guidance, the agency said that it will require simultaneous voting by all committee members. Advisers at some meetings have begun using an electronic voting system to ensure that panel members don't influence the votes of those who succeed them in voting; the votes are conducted privately, and then broadcast immediately afterward on a screen. Dr. Wolfe said that when he has seen the voting system in action, "it worked well and served the stated purpose."

He also praised the agency's proposed guidance to set out a more definitive policy on when a product should be referred to an advisory committee for review.

The FDA also is changing the administrative process for advisory committee meetings. The agency will formally notify a sponsoring company 55 days in advance that a meeting has been scheduled. Also, the FDA will post materials relating to the meeting on its Web site no later than 2 full days in advance of the meeting.

Experts serving on the Food and Drug Administration's advisory committees are now subject to new rules aimed at ensuring that they do not have conflicts of interest that could bias their decisions.

In early August, the FDA issued four final guidance documents and a draft guidance outlining how it plans to handle conflicts of interest among members of advisory committees, which review the safety and efficacy of drugs, medical devices, diagnostic tests, and other products and ingredients that the agency regulates.

In a separate move, the agency said that it plans to make it easier to find documents before and after advisory committee meetings by improving how it posts meeting information on its Web site.

Guidance documents represent the agency's current thinking on a topic, but carry less weight than does a regulation. The FDA has no power to enforce guidance documents, which manufacturers and the agency generally use as rules of thumb.

The newest guidance documents will help ensure that the FDA "is getting the highest quality scientific advice, while at the same time preserving public trust in our decisions," Randall Lutter, Ph.D., the FDA's deputy commissioner for policy, said in a teleconference briefing with reporters.

In the past, the agency has asked advisers to disclose potential conflicts of interest, but there was no monetary limit. Each potential conflict was weighed individually, and waivers were granted based on whether the adviser's expertise was considered necessary for a particular meeting.

With the new guidance, the agency sets a dollar limit on advisers' financial interests. If an adviser—or his or her spouse or minor child—has interests of at least $50,000 in an entity that would be directly or indirectly affected by the outcome of a particular meeting, the adviser would be barred from participating. Advisers with interests less than $50,000 will be allowed to participate and vote, unless they are found to have a significant conflict of interest.

An advocate who has been critical of the FDA's conflict of interest policy for advisers said that the $50,000 cap is too high.

"The FDA wants us to believe that an advisory committee member can receive $49,999 from a company and still make an unbiased decision. I don't buy it and the research doesn't support it," said Diana Zuckerman, Ph.D., president of the National Research Center for Women and Families, an advocacy organization in Washington.

She and another agency critic, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, both expressed concern that the new guidance would still allow advisers with conflicts to vote. Those advisers will be granted waivers if they are determined to provide essential expertise. This is not much of a change from current policy, according to Dr. Wolfe and Dr. Zuckerman.

But the FDA said that the Food and Drug Administration Amendments Act of 2007, which was signed into law last year, limits the number of waivers it is allowed to grant.

In another guidance, the agency said that it will require simultaneous voting by all committee members. Advisers at some meetings have begun using an electronic voting system to ensure that panel members don't influence the votes of those who succeed them in voting; the votes are conducted privately, and then broadcast immediately afterward on a screen. Dr. Wolfe said that when he has seen the voting system in action, "it worked well and served the stated purpose."

He also praised the agency's proposed guidance to set out a more definitive policy on when a product should be referred to an advisory committee for review.

The FDA also is changing the administrative process for advisory committee meetings. The agency will formally notify a sponsoring company 55 days in advance that a meeting has been scheduled. Also, the FDA will post materials relating to the meeting on its Web site no later than 2 full days in advance of the meeting.

Experts serving on the Food and Drug Administration's advisory committees are now subject to new rules aimed at ensuring that they do not have conflicts of interest that could bias their decisions.

In early August, the FDA issued four final guidance documents and a draft guidance outlining how it plans to handle conflicts of interest among members of advisory committees, which review the safety and efficacy of drugs, medical devices, diagnostic tests, and other products and ingredients that the agency regulates.

In a separate move, the agency said that it plans to make it easier to find documents before and after advisory committee meetings by improving how it posts meeting information on its Web site.

Guidance documents represent the agency's current thinking on a topic, but carry less weight than does a regulation. The FDA has no power to enforce guidance documents, which manufacturers and the agency generally use as rules of thumb.

The newest guidance documents will help ensure that the FDA "is getting the highest quality scientific advice, while at the same time preserving public trust in our decisions," Randall Lutter, Ph.D., the FDA's deputy commissioner for policy, said in a teleconference briefing with reporters.

In the past, the agency has asked advisers to disclose potential conflicts of interest, but there was no monetary limit. Each potential conflict was weighed individually, and waivers were granted based on whether the adviser's expertise was considered necessary for a particular meeting.

With the new guidance, the agency sets a dollar limit on advisers' financial interests. If an adviser—or his or her spouse or minor child—has interests of at least $50,000 in an entity that would be directly or indirectly affected by the outcome of a particular meeting, the adviser would be barred from participating. Advisers with interests less than $50,000 will be allowed to participate and vote, unless they are found to have a significant conflict of interest.

An advocate who has been critical of the FDA's conflict of interest policy for advisers said that the $50,000 cap is too high.

"The FDA wants us to believe that an advisory committee member can receive $49,999 from a company and still make an unbiased decision. I don't buy it and the research doesn't support it," said Diana Zuckerman, Ph.D., president of the National Research Center for Women and Families, an advocacy organization in Washington.

She and another agency critic, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, both expressed concern that the new guidance would still allow advisers with conflicts to vote. Those advisers will be granted waivers if they are determined to provide essential expertise. This is not much of a change from current policy, according to Dr. Wolfe and Dr. Zuckerman.

But the FDA said that the Food and Drug Administration Amendments Act of 2007, which was signed into law last year, limits the number of waivers it is allowed to grant.

In another guidance, the agency said that it will require simultaneous voting by all committee members. Advisers at some meetings have begun using an electronic voting system to ensure that panel members don't influence the votes of those who succeed them in voting; the votes are conducted privately, and then broadcast immediately afterward on a screen. Dr. Wolfe said that when he has seen the voting system in action, "it worked well and served the stated purpose."

He also praised the agency's proposed guidance to set out a more definitive policy on when a product should be referred to an advisory committee for review.

The FDA also is changing the administrative process for advisory committee meetings. The agency will formally notify a sponsoring company 55 days in advance that a meeting has been scheduled. Also, the FDA will post materials relating to the meeting on its Web site no later than 2 full days in advance of the meeting.

Sunscreen Label Delay Decried

Lawmakers are urging the Food and Drug Administration to release comprehensive sunscreen labeling that has been in the works for several years. Sen. Christopher Dodd (D-Conn.) and Sen. Jack Reed (D-R.I.) introduced a bill to require the FDA to issue final sunscreen rules by February 2009. The Sunscreen Labeling Protection Act of 2008 (S. 3425) is not the senators' first foray into the labeling controversy, as they have called for sunscreen rules since early 2006. "The FDA's current standards for sunscreen testing and labeling leave Americans with a false sense of security about whether their sunscreen protects them from harmful UVA rays," Sen. Dodd said in a statement. The senator said the legislation is supported by the American Cancer Society, the Melanoma Research Foundation, Citizens for Sun Protection, the Environmental Working Group, and sunscreen manufacturers Banana Boat and Hawaiian Tropic. Connecticut Attorney General Richard Blumenthal joined the senators, sending a letter to FDA Commissioner Andrew von Eschenbach calling for an immediate implementation of the rules proposed by the agency in August 2007. Mr. Blumenthal had petitioned the FDA to propose and implement sunscreen standards in May 2007.

FDA Seizes Hydroquinone

The FDA seized $24 million worth of unapproved drugs, including several hydroquinone cream products, from a St. Louis manufacturer. The agency took the action after an inspection of several plants owned by KV Pharmaceutical Co. The FDA determined that KV was not complying with a May 2007 notice requiring companies to stop manufacturing timed-release products containing guaifenesin and to stop shipping those products by November 2007. That notice was part of a larger effort by the FDA to begin removing unapproved drug products from the market. The FDA inspection found that KV was also manufacturing many other unapproved products, including hydroquinone 4% cream and hydroquinone 4% cream with sunscreen. KV issued a statement saying that the guaifenesin products had been manufactured by a company it acquired and that it was set to dispose of them. The company also said in a statement that it "will continue its cooperation with the FDA in bringing this matter to final resolution."

Survey: Only 15% Get Skin Exams

In a national survey, only 15% of American workers reported ever having a head-to-toe skin exam. Only 8% of those who had seen a physician in the past year reported having had such an exam, according to a study published in the July issue of the Journal of the American Academy of Dermatology. Researchers from the University of Miami and the University of North Carolina, Chapel Hill, analyzed data from the 2000 and 2005 National Health Interview Survey, an annual, in-person survey conducted by the National Center for Health Statistics. Based on their analysis, they estimated that 106 million workers have never been fully examined by a dermatologist or any other physician. Farm workers and blue-collar workers had the lowest screening rates. In 2005, only 2% of farm workers and 5% of blue-collar workers reported a skin exam in the previous 12 months, compared with 10% of white-collar workers. Blue-collar workers also had the lowest lifetime screening rates, ranging from 3% to 9%, compared with 11%–32% for white-collar professions. "The rate of reporting skin cancer screening was lowest for high-risk occupations most likely to experience increased sun exposures," wrote the authors. The research was supported in part by the National Institute of Occupational Safety and Health.

Stiefel Completes Acquisition

Stiefel Laboratories has completed its purchase of Barrier Therapeutics, a Princeton, N.J.-based company that has three topical products on the market, Xolegel, Vusion, and Solage. "Barrier's innovative products and pipeline are a very valuable addition to Stiefel," company CEO Charles W. Stiefel said in a statement. With the purchase of Barrier, Stiefel adds a development portfolio that includes products for onychomycosis, psoriasis, acne, skin allergies, and acute fungal infections. The family-owned Stiefel claims to be the world's largest dermatologic specialty pharmaceutical company. It does not publicly report sales or earnings.

Feds Scrutinize Generic Maker

India's Ranbaxy Inc., one of the top 10 generic drug makers in the world, is being investigated by various arms of the federal government for allegedly introducing "adulterated or misbranded products" into the U.S. market. The company's auditor, Parexel Consulting, is also under scrutiny. According to a subpoena for documents filed in the U.S. District Court for the District of Maryland by the Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy submitted false information to the FDA on sterility and bioequivalence, covered up good manufacturing practice violations, and defrauded Medicare. Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) said that they will formally investigate the Ranbaxy situation. "If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago," said Rep. Dingell. "I would like to know whether FDA officials knew about these allegations and what, if any, action was taken."

Sunscreen Label Delay Decried

Lawmakers are urging the Food and Drug Administration to release comprehensive sunscreen labeling that has been in the works for several years. Sen. Christopher Dodd (D-Conn.) and Sen. Jack Reed (D-R.I.) introduced a bill to require the FDA to issue final sunscreen rules by February 2009. The Sunscreen Labeling Protection Act of 2008 (S. 3425) is not the senators' first foray into the labeling controversy, as they have called for sunscreen rules since early 2006. "The FDA's current standards for sunscreen testing and labeling leave Americans with a false sense of security about whether their sunscreen protects them from harmful UVA rays," Sen. Dodd said in a statement. The senator said the legislation is supported by the American Cancer Society, the Melanoma Research Foundation, Citizens for Sun Protection, the Environmental Working Group, and sunscreen manufacturers Banana Boat and Hawaiian Tropic. Connecticut Attorney General Richard Blumenthal joined the senators, sending a letter to FDA Commissioner Andrew von Eschenbach calling for an immediate implementation of the rules proposed by the agency in August 2007. Mr. Blumenthal had petitioned the FDA to propose and implement sunscreen standards in May 2007.

FDA Seizes Hydroquinone

The FDA seized $24 million worth of unapproved drugs, including several hydroquinone cream products, from a St. Louis manufacturer. The agency took the action after an inspection of several plants owned by KV Pharmaceutical Co. The FDA determined that KV was not complying with a May 2007 notice requiring companies to stop manufacturing timed-release products containing guaifenesin and to stop shipping those products by November 2007. That notice was part of a larger effort by the FDA to begin removing unapproved drug products from the market. The FDA inspection found that KV was also manufacturing many other unapproved products, including hydroquinone 4% cream and hydroquinone 4% cream with sunscreen. KV issued a statement saying that the guaifenesin products had been manufactured by a company it acquired and that it was set to dispose of them. The company also said in a statement that it "will continue its cooperation with the FDA in bringing this matter to final resolution."

Survey: Only 15% Get Skin Exams

In a national survey, only 15% of American workers reported ever having a head-to-toe skin exam. Only 8% of those who had seen a physician in the past year reported having had such an exam, according to a study published in the July issue of the Journal of the American Academy of Dermatology. Researchers from the University of Miami and the University of North Carolina, Chapel Hill, analyzed data from the 2000 and 2005 National Health Interview Survey, an annual, in-person survey conducted by the National Center for Health Statistics. Based on their analysis, they estimated that 106 million workers have never been fully examined by a dermatologist or any other physician. Farm workers and blue-collar workers had the lowest screening rates. In 2005, only 2% of farm workers and 5% of blue-collar workers reported a skin exam in the previous 12 months, compared with 10% of white-collar workers. Blue-collar workers also had the lowest lifetime screening rates, ranging from 3% to 9%, compared with 11%–32% for white-collar professions. "The rate of reporting skin cancer screening was lowest for high-risk occupations most likely to experience increased sun exposures," wrote the authors. The research was supported in part by the National Institute of Occupational Safety and Health.

Stiefel Completes Acquisition

Stiefel Laboratories has completed its purchase of Barrier Therapeutics, a Princeton, N.J.-based company that has three topical products on the market, Xolegel, Vusion, and Solage. "Barrier's innovative products and pipeline are a very valuable addition to Stiefel," company CEO Charles W. Stiefel said in a statement. With the purchase of Barrier, Stiefel adds a development portfolio that includes products for onychomycosis, psoriasis, acne, skin allergies, and acute fungal infections. The family-owned Stiefel claims to be the world's largest dermatologic specialty pharmaceutical company. It does not publicly report sales or earnings.

Feds Scrutinize Generic Maker

India's Ranbaxy Inc., one of the top 10 generic drug makers in the world, is being investigated by various arms of the federal government for allegedly introducing "adulterated or misbranded products" into the U.S. market. The company's auditor, Parexel Consulting, is also under scrutiny. According to a subpoena for documents filed in the U.S. District Court for the District of Maryland by the Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy submitted false information to the FDA on sterility and bioequivalence, covered up good manufacturing practice violations, and defrauded Medicare. Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) said that they will formally investigate the Ranbaxy situation. "If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago," said Rep. Dingell. "I would like to know whether FDA officials knew about these allegations and what, if any, action was taken."

Sunscreen Label Delay Decried

Lawmakers are urging the Food and Drug Administration to release comprehensive sunscreen labeling that has been in the works for several years. Sen. Christopher Dodd (D-Conn.) and Sen. Jack Reed (D-R.I.) introduced a bill to require the FDA to issue final sunscreen rules by February 2009. The Sunscreen Labeling Protection Act of 2008 (S. 3425) is not the senators' first foray into the labeling controversy, as they have called for sunscreen rules since early 2006. "The FDA's current standards for sunscreen testing and labeling leave Americans with a false sense of security about whether their sunscreen protects them from harmful UVA rays," Sen. Dodd said in a statement. The senator said the legislation is supported by the American Cancer Society, the Melanoma Research Foundation, Citizens for Sun Protection, the Environmental Working Group, and sunscreen manufacturers Banana Boat and Hawaiian Tropic. Connecticut Attorney General Richard Blumenthal joined the senators, sending a letter to FDA Commissioner Andrew von Eschenbach calling for an immediate implementation of the rules proposed by the agency in August 2007. Mr. Blumenthal had petitioned the FDA to propose and implement sunscreen standards in May 2007.

FDA Seizes Hydroquinone

The FDA seized $24 million worth of unapproved drugs, including several hydroquinone cream products, from a St. Louis manufacturer. The agency took the action after an inspection of several plants owned by KV Pharmaceutical Co. The FDA determined that KV was not complying with a May 2007 notice requiring companies to stop manufacturing timed-release products containing guaifenesin and to stop shipping those products by November 2007. That notice was part of a larger effort by the FDA to begin removing unapproved drug products from the market. The FDA inspection found that KV was also manufacturing many other unapproved products, including hydroquinone 4% cream and hydroquinone 4% cream with sunscreen. KV issued a statement saying that the guaifenesin products had been manufactured by a company it acquired and that it was set to dispose of them. The company also said in a statement that it "will continue its cooperation with the FDA in bringing this matter to final resolution."

Survey: Only 15% Get Skin Exams

In a national survey, only 15% of American workers reported ever having a head-to-toe skin exam. Only 8% of those who had seen a physician in the past year reported having had such an exam, according to a study published in the July issue of the Journal of the American Academy of Dermatology. Researchers from the University of Miami and the University of North Carolina, Chapel Hill, analyzed data from the 2000 and 2005 National Health Interview Survey, an annual, in-person survey conducted by the National Center for Health Statistics. Based on their analysis, they estimated that 106 million workers have never been fully examined by a dermatologist or any other physician. Farm workers and blue-collar workers had the lowest screening rates. In 2005, only 2% of farm workers and 5% of blue-collar workers reported a skin exam in the previous 12 months, compared with 10% of white-collar workers. Blue-collar workers also had the lowest lifetime screening rates, ranging from 3% to 9%, compared with 11%–32% for white-collar professions. "The rate of reporting skin cancer screening was lowest for high-risk occupations most likely to experience increased sun exposures," wrote the authors. The research was supported in part by the National Institute of Occupational Safety and Health.

Stiefel Completes Acquisition

Stiefel Laboratories has completed its purchase of Barrier Therapeutics, a Princeton, N.J.-based company that has three topical products on the market, Xolegel, Vusion, and Solage. "Barrier's innovative products and pipeline are a very valuable addition to Stiefel," company CEO Charles W. Stiefel said in a statement. With the purchase of Barrier, Stiefel adds a development portfolio that includes products for onychomycosis, psoriasis, acne, skin allergies, and acute fungal infections. The family-owned Stiefel claims to be the world's largest dermatologic specialty pharmaceutical company. It does not publicly report sales or earnings.

Feds Scrutinize Generic Maker

India's Ranbaxy Inc., one of the top 10 generic drug makers in the world, is being investigated by various arms of the federal government for allegedly introducing "adulterated or misbranded products" into the U.S. market. The company's auditor, Parexel Consulting, is also under scrutiny. According to a subpoena for documents filed in the U.S. District Court for the District of Maryland by the Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy submitted false information to the FDA on sterility and bioequivalence, covered up good manufacturing practice violations, and defrauded Medicare. Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) said that they will formally investigate the Ranbaxy situation. "If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago," said Rep. Dingell. "I would like to know whether FDA officials knew about these allegations and what, if any, action was taken."

Democrats and Republicans are so confident about the chances of some type of health reform in the next administration that staff meetings and hearings geared toward crafting legislation have been going on in earnest in both the House and the Senate, with the goal of being ready to go in January, according to advocates and policy watchers.

Many health policy analysts have compared and contrasted this election cycle with that of 1992, which sent Bill Clinton to the White House and launched the Clintons' health care reform efforts.

Both elections—1992 and 2008—feature a high level of public concern about access to health care and its costs, said Len Nichols, an analyst at the New America Foundation, a nonpartisan public policy institute.

For instance, a Harris Interactive survey conducted for the Commonwealth Fund in May found that 82% of Americans think the health system should be fundamentally changed or completely rebuilt.

But the differences between the two elections are striking in a positive way, said Mr. Nichols in an interview.

First, the two major candidates themselves have acknowledged that cost is an overriding concern, he said. Also, a common theme is the use of private markets, which he called "evidence, I would say, of moderation" and, perhaps, the proposals' better legislative traction.

Both candidates—Sen. Barack Obama (D-Ill.) and Sen. John McCain (R-Ariz.)—have also learned that "no president is going to send [to Congress] a 1,400-page health bill written in a hotel room by 300 wonks," Mr. Nichols said.

Instead, "Congress is going to own this [effort] far earlier and deeper than before," he said, adding, "It's still going to require a lot of presidential leadership. But the Congress has to be an equal, more than it has before."

Several proposals are likely starting points for congressional negotiations with the new administration, he said. First is the Healthy Americans Act, introduced in January 2007 by Sen. Ron Wyden (D-Ore.) and Sen. Bob Bennett (R-Utah). It has 16 cosponsors from both parties, including Sen. Chuck Grassley (R-Iowa), the Finance Committee's ranking minority member.

The bill is being championed in the House by Rep. Debbie Wasserman Schultz (D-Fla.) and Rep. Jo Ann Emerson (R-Mo.). Rep. Wasserman Schultz is important "because she's a rising star and has impeccable liberal credentials," said Mr. Nichols.

In a paper published in the May/June 2008 issue of the policy journal Health Affairs (2008;27:689–92), Sen. Wyden and Sen. Bennett said they saw "signs of an ideological truce" on the Hill, with agreement that there is a need for the Democratic-backed universal coverage and the Republican-supported desire for market forces to promote competition and innovation. "The Healthy Americans Act strikes a balance between these ideals," they wrote.

The bill would require individuals to purchase insurance for themselves and their dependent children, and would require insurers to offer a prescribed package of benefits. It would subsidize coverage for Americans with incomes up to 400% of the federal poverty level. Employers would convert benefit dollars into salary; such compensation would be tax free, with the goal that the money would be used to purchase coverage.

Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, held a health care summit in mid-June. Staff from the Finance Committee and the Health, Education, Labor and Pensions Committee, led by Sen. Edward M. Kennedy (D-Mass.), have been coordinating meetings with those two panels and the Budget Committee, Mr. Pollack said in an interview.

The House is not as far along in preparing for health reform, but staffers on the committees with jurisdiction over health care have been meeting, said Mr. Pollack.

"I think there's significant movement underway in anticipation of health care reform being a top domestic priority," he said. But, "I don't think any of the proposals that have come out so far are going to be the proposals," added Mr. Pollack.

Instead, the expectation is that a health reform bill will be developed during the transition period between November and January, he said.

Democrats and Republicans are so confident about the chances of some type of health reform in the next administration that staff meetings and hearings geared toward crafting legislation have been going on in earnest in both the House and the Senate, with the goal of being ready to go in January, according to advocates and policy watchers.

Many health policy analysts have compared and contrasted this election cycle with that of 1992, which sent Bill Clinton to the White House and launched the Clintons' health care reform efforts.

Both elections—1992 and 2008—feature a high level of public concern about access to health care and its costs, said Len Nichols, an analyst at the New America Foundation, a nonpartisan public policy institute.

For instance, a Harris Interactive survey conducted for the Commonwealth Fund in May found that 82% of Americans think the health system should be fundamentally changed or completely rebuilt.

But the differences between the two elections are striking in a positive way, said Mr. Nichols in an interview.

First, the two major candidates themselves have acknowledged that cost is an overriding concern, he said. Also, a common theme is the use of private markets, which he called "evidence, I would say, of moderation" and, perhaps, the proposals' better legislative traction.

Both candidates—Sen. Barack Obama (D-Ill.) and Sen. John McCain (R-Ariz.)—have also learned that "no president is going to send [to Congress] a 1,400-page health bill written in a hotel room by 300 wonks," Mr. Nichols said.

Instead, "Congress is going to own this [effort] far earlier and deeper than before," he said, adding, "It's still going to require a lot of presidential leadership. But the Congress has to be an equal, more than it has before."

Several proposals are likely starting points for congressional negotiations with the new administration, he said. First is the Healthy Americans Act, introduced in January 2007 by Sen. Ron Wyden (D-Ore.) and Sen. Bob Bennett (R-Utah). It has 16 cosponsors from both parties, including Sen. Chuck Grassley (R-Iowa), the Finance Committee's ranking minority member.

The bill is being championed in the House by Rep. Debbie Wasserman Schultz (D-Fla.) and Rep. Jo Ann Emerson (R-Mo.). Rep. Wasserman Schultz is important "because she's a rising star and has impeccable liberal credentials," said Mr. Nichols.

In a paper published in the May/June 2008 issue of the policy journal Health Affairs (2008;27:689–92), Sen. Wyden and Sen. Bennett said they saw "signs of an ideological truce" on the Hill, with agreement that there is a need for the Democratic-backed universal coverage and the Republican-supported desire for market forces to promote competition and innovation. "The Healthy Americans Act strikes a balance between these ideals," they wrote.

The bill would require individuals to purchase insurance for themselves and their dependent children, and would require insurers to offer a prescribed package of benefits. It would subsidize coverage for Americans with incomes up to 400% of the federal poverty level. Employers would convert benefit dollars into salary; such compensation would be tax free, with the goal that the money would be used to purchase coverage.

Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, held a health care summit in mid-June. Staff from the Finance Committee and the Health, Education, Labor and Pensions Committee, led by Sen. Edward M. Kennedy (D-Mass.), have been coordinating meetings with those two panels and the Budget Committee, Mr. Pollack said in an interview.

The House is not as far along in preparing for health reform, but staffers on the committees with jurisdiction over health care have been meeting, said Mr. Pollack.

"I think there's significant movement underway in anticipation of health care reform being a top domestic priority," he said. But, "I don't think any of the proposals that have come out so far are going to be the proposals," added Mr. Pollack.

Instead, the expectation is that a health reform bill will be developed during the transition period between November and January, he said.

Democrats and Republicans are so confident about the chances of some type of health reform in the next administration that staff meetings and hearings geared toward crafting legislation have been going on in earnest in both the House and the Senate, with the goal of being ready to go in January, according to advocates and policy watchers.

Many health policy analysts have compared and contrasted this election cycle with that of 1992, which sent Bill Clinton to the White House and launched the Clintons' health care reform efforts.

Both elections—1992 and 2008—feature a high level of public concern about access to health care and its costs, said Len Nichols, an analyst at the New America Foundation, a nonpartisan public policy institute.

For instance, a Harris Interactive survey conducted for the Commonwealth Fund in May found that 82% of Americans think the health system should be fundamentally changed or completely rebuilt.

But the differences between the two elections are striking in a positive way, said Mr. Nichols in an interview.

First, the two major candidates themselves have acknowledged that cost is an overriding concern, he said. Also, a common theme is the use of private markets, which he called "evidence, I would say, of moderation" and, perhaps, the proposals' better legislative traction.

Both candidates—Sen. Barack Obama (D-Ill.) and Sen. John McCain (R-Ariz.)—have also learned that "no president is going to send [to Congress] a 1,400-page health bill written in a hotel room by 300 wonks," Mr. Nichols said.

Instead, "Congress is going to own this [effort] far earlier and deeper than before," he said, adding, "It's still going to require a lot of presidential leadership. But the Congress has to be an equal, more than it has before."

Several proposals are likely starting points for congressional negotiations with the new administration, he said. First is the Healthy Americans Act, introduced in January 2007 by Sen. Ron Wyden (D-Ore.) and Sen. Bob Bennett (R-Utah). It has 16 cosponsors from both parties, including Sen. Chuck Grassley (R-Iowa), the Finance Committee's ranking minority member.

The bill is being championed in the House by Rep. Debbie Wasserman Schultz (D-Fla.) and Rep. Jo Ann Emerson (R-Mo.). Rep. Wasserman Schultz is important "because she's a rising star and has impeccable liberal credentials," said Mr. Nichols.

In a paper published in the May/June 2008 issue of the policy journal Health Affairs (2008;27:689–92), Sen. Wyden and Sen. Bennett said they saw "signs of an ideological truce" on the Hill, with agreement that there is a need for the Democratic-backed universal coverage and the Republican-supported desire for market forces to promote competition and innovation. "The Healthy Americans Act strikes a balance between these ideals," they wrote.

The bill would require individuals to purchase insurance for themselves and their dependent children, and would require insurers to offer a prescribed package of benefits. It would subsidize coverage for Americans with incomes up to 400% of the federal poverty level. Employers would convert benefit dollars into salary; such compensation would be tax free, with the goal that the money would be used to purchase coverage.

Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, held a health care summit in mid-June. Staff from the Finance Committee and the Health, Education, Labor and Pensions Committee, led by Sen. Edward M. Kennedy (D-Mass.), have been coordinating meetings with those two panels and the Budget Committee, Mr. Pollack said in an interview.

The House is not as far along in preparing for health reform, but staffers on the committees with jurisdiction over health care have been meeting, said Mr. Pollack.

"I think there's significant movement underway in anticipation of health care reform being a top domestic priority," he said. But, "I don't think any of the proposals that have come out so far are going to be the proposals," added Mr. Pollack.

Instead, the expectation is that a health reform bill will be developed during the transition period between November and January, he said.

SAN FRANCISCO — With a new president and a likely Democratic majority in the House and Senate, conditions will be ripe for health reform in early 2009, a bipartisan group of political insiders predicts.

The Democrats who spoke at Institute 2008, a meeting sponsored by America's Health Insurance Plans, were most certain of impending change. One Republican said he was optimistic, and two of his colleagues hedged their bets.

“I think something's going to happen in the next Congress,” said former Sen. John Breaux (D-La.). Sen. Breaux noted that Congress is likely to be “dramatically different” next year.

Terry McAuliffe, longtime aide to former President Clinton and Sen. Hillary Clinton (D-N.Y.), pointed out that 100 seats are up for grabs in the House and Senate.

He predicted that Democrats would take at least four to seven of the Senate seats and garner a majority in both houses of Congress.

Why is this important?

Traditionally, Democrats have called for bigger reforms and more government intervention, and Democratic presidential candidate Sen. Barack Obama (D-Ill.) is following that lead, Mr. McAuliffe said.

Despite concerns over the economy, energy prices, and taxes, “Health care will be the number one domestic issue” in the presidential campaign and in the Congress early next year because “it affects everybody,” he predicted. (See related editorial, page 9.)

“I do think health care will be still at the top of the list of things that need to get done,” agreed Sen. Breaux.

Tommy G. Thompson, who served as Health and Human Services secretary under President George W. Bush, agreed with the Democrats that health reform was likely next year.

He said he was optimistic because candidates for the House and Senate and both presidential contenders were talking about reform. “That tells me that 2009 is going to be the biggest year we've ever had,” said Mr. Thompson, who is also a former governor of Wisconsin.

He said there were many pressing issues to address, including a looming shortage of physicians and nurses and the predicted bankruptcy of the Medicare Hospital Insurance Trust Fund in the next 5-10 years.

Former Sen. Bill Frist (R-Tenn.) agreed with Mr. Thompson that the Medicare trust fund would get lawmakers' attention early in the next Congress.

But, Sen. Frist opined, “I'm not quite as optimistic that we'll see reform.”

Sen. Frist said he does not think health care reform will be a priority until the American people make it one. In 1993, during the last major attempt at reform, 42% of Americans said the old system needed to be scrapped; “today we're at 34%.”

And, he said, the cost of adding coverage will have to be addressed, which could create some unsettling political realities.

Dan Bartlett, who served as President George W. Bush's communications director and counselor, agreed, noting that Sen. Obama had not been discussing details of his health proposals in the early going on the campaign trail.

Like Sen. Frist, Mr. Bartlett said he did not see reform as an imperative.

“I don't see the mandate coming out of this election,” he said, adding, “I think you'll see incremental change, but I don't think you'll see radical change.”

SAN FRANCISCO — With a new president and a likely Democratic majority in the House and Senate, conditions will be ripe for health reform in early 2009, a bipartisan group of political insiders predicts.

The Democrats who spoke at Institute 2008, a meeting sponsored by America's Health Insurance Plans, were most certain of impending change. One Republican said he was optimistic, and two of his colleagues hedged their bets.

“I think something's going to happen in the next Congress,” said former Sen. John Breaux (D-La.). Sen. Breaux noted that Congress is likely to be “dramatically different” next year.

Terry McAuliffe, longtime aide to former President Clinton and Sen. Hillary Clinton (D-N.Y.), pointed out that 100 seats are up for grabs in the House and Senate.

He predicted that Democrats would take at least four to seven of the Senate seats and garner a majority in both houses of Congress.

Why is this important?

Traditionally, Democrats have called for bigger reforms and more government intervention, and Democratic presidential candidate Sen. Barack Obama (D-Ill.) is following that lead, Mr. McAuliffe said.

Despite concerns over the economy, energy prices, and taxes, “Health care will be the number one domestic issue” in the presidential campaign and in the Congress early next year because “it affects everybody,” he predicted. (See related editorial, page 9.)

“I do think health care will be still at the top of the list of things that need to get done,” agreed Sen. Breaux.

Tommy G. Thompson, who served as Health and Human Services secretary under President George W. Bush, agreed with the Democrats that health reform was likely next year.

He said he was optimistic because candidates for the House and Senate and both presidential contenders were talking about reform. “That tells me that 2009 is going to be the biggest year we've ever had,” said Mr. Thompson, who is also a former governor of Wisconsin.

He said there were many pressing issues to address, including a looming shortage of physicians and nurses and the predicted bankruptcy of the Medicare Hospital Insurance Trust Fund in the next 5-10 years.

Former Sen. Bill Frist (R-Tenn.) agreed with Mr. Thompson that the Medicare trust fund would get lawmakers' attention early in the next Congress.

But, Sen. Frist opined, “I'm not quite as optimistic that we'll see reform.”

Sen. Frist said he does not think health care reform will be a priority until the American people make it one. In 1993, during the last major attempt at reform, 42% of Americans said the old system needed to be scrapped; “today we're at 34%.”

And, he said, the cost of adding coverage will have to be addressed, which could create some unsettling political realities.

Dan Bartlett, who served as President George W. Bush's communications director and counselor, agreed, noting that Sen. Obama had not been discussing details of his health proposals in the early going on the campaign trail.

Like Sen. Frist, Mr. Bartlett said he did not see reform as an imperative.

“I don't see the mandate coming out of this election,” he said, adding, “I think you'll see incremental change, but I don't think you'll see radical change.”

SAN FRANCISCO — With a new president and a likely Democratic majority in the House and Senate, conditions will be ripe for health reform in early 2009, a bipartisan group of political insiders predicts.

The Democrats who spoke at Institute 2008, a meeting sponsored by America's Health Insurance Plans, were most certain of impending change. One Republican said he was optimistic, and two of his colleagues hedged their bets.

“I think something's going to happen in the next Congress,” said former Sen. John Breaux (D-La.). Sen. Breaux noted that Congress is likely to be “dramatically different” next year.

Terry McAuliffe, longtime aide to former President Clinton and Sen. Hillary Clinton (D-N.Y.), pointed out that 100 seats are up for grabs in the House and Senate.

He predicted that Democrats would take at least four to seven of the Senate seats and garner a majority in both houses of Congress.

Why is this important?

Traditionally, Democrats have called for bigger reforms and more government intervention, and Democratic presidential candidate Sen. Barack Obama (D-Ill.) is following that lead, Mr. McAuliffe said.

Despite concerns over the economy, energy prices, and taxes, “Health care will be the number one domestic issue” in the presidential campaign and in the Congress early next year because “it affects everybody,” he predicted. (See related editorial, page 9.)

“I do think health care will be still at the top of the list of things that need to get done,” agreed Sen. Breaux.

Tommy G. Thompson, who served as Health and Human Services secretary under President George W. Bush, agreed with the Democrats that health reform was likely next year.

He said he was optimistic because candidates for the House and Senate and both presidential contenders were talking about reform. “That tells me that 2009 is going to be the biggest year we've ever had,” said Mr. Thompson, who is also a former governor of Wisconsin.

He said there were many pressing issues to address, including a looming shortage of physicians and nurses and the predicted bankruptcy of the Medicare Hospital Insurance Trust Fund in the next 5-10 years.

Former Sen. Bill Frist (R-Tenn.) agreed with Mr. Thompson that the Medicare trust fund would get lawmakers' attention early in the next Congress.

But, Sen. Frist opined, “I'm not quite as optimistic that we'll see reform.”

Sen. Frist said he does not think health care reform will be a priority until the American people make it one. In 1993, during the last major attempt at reform, 42% of Americans said the old system needed to be scrapped; “today we're at 34%.”

And, he said, the cost of adding coverage will have to be addressed, which could create some unsettling political realities.

Dan Bartlett, who served as President George W. Bush's communications director and counselor, agreed, noting that Sen. Obama had not been discussing details of his health proposals in the early going on the campaign trail.

Like Sen. Frist, Mr. Bartlett said he did not see reform as an imperative.

“I don't see the mandate coming out of this election,” he said, adding, “I think you'll see incremental change, but I don't think you'll see radical change.”

NEW ORLEANS — Getting reimbursed is the top concern for physicians who offer the human papillomavirus vaccine, according to a survey conducted by researchers at Brigham and Women's Hospital, Boston.

Using a Web-based tool, Brigham resident Emily M. Ko and her colleagues surveyed 1,488 physicians who practiced with the Partners HealthCare System from May to July 2007. The survey included physicians practicing in tertiary and community settings.

Overall, 424 physicians participated. Of these, 196 (46%) were internists, 104 (25%) were pediatricians, and 87 (21%) were ob.gyns. The remainder came from various specialties, including infectious disease, geriatrics, endocrinology, and emergency medicine, Dr. Ko reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.

Of those who participated, 80% said they offer the HPV vaccine. That included 92% of pediatricians, 81% of ob.gyns., and 78% of internists. According to the researchers, male physicians were 54% less likely to provide the vaccine than were female physicians. The survey did not ask questions that would determine why some physicians might be less likely to offer the vaccine, Dr. Ko said in an interview.

However, in citing barriers to vaccination, she noted that male physicians were six times more likely than female physicians to say that vaccination would keep patients from getting routine gynecologic exams or Pap smears.

Physicians based in community hospitals were twice as likely to offer the vaccine as were their colleagues at tertiary care facilities. Primary care physicians were 14 times more likely than were specialists to offer the shot.

Overall, survey participants cited reimbursement as the No. 1 hurdle to offering the vaccine.

In all, 95% of physicians said the vaccine would not promote promiscuity or decrease the use of condoms. Of the remainder, 3% were neutral on the issue, and 1.4% said that the vaccine might promote promiscuity, according to Dr. Ko.

There was no difference between genders or among specialties on the promiscuity issue. However, 7% of physicians said that parents might fear that vaccination would promote sexuality and promiscuity. This was not reported as one of the biggest barriers to vaccination, Dr. Ko said.

Dr. Ko reported no conflict of interest disclosures.

NEW ORLEANS — Getting reimbursed is the top concern for physicians who offer the human papillomavirus vaccine, according to a survey conducted by researchers at Brigham and Women's Hospital, Boston.

Using a Web-based tool, Brigham resident Emily M. Ko and her colleagues surveyed 1,488 physicians who practiced with the Partners HealthCare System from May to July 2007. The survey included physicians practicing in tertiary and community settings.

Overall, 424 physicians participated. Of these, 196 (46%) were internists, 104 (25%) were pediatricians, and 87 (21%) were ob.gyns. The remainder came from various specialties, including infectious disease, geriatrics, endocrinology, and emergency medicine, Dr. Ko reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.

Of those who participated, 80% said they offer the HPV vaccine. That included 92% of pediatricians, 81% of ob.gyns., and 78% of internists. According to the researchers, male physicians were 54% less likely to provide the vaccine than were female physicians. The survey did not ask questions that would determine why some physicians might be less likely to offer the vaccine, Dr. Ko said in an interview.

However, in citing barriers to vaccination, she noted that male physicians were six times more likely than female physicians to say that vaccination would keep patients from getting routine gynecologic exams or Pap smears.

Physicians based in community hospitals were twice as likely to offer the vaccine as were their colleagues at tertiary care facilities. Primary care physicians were 14 times more likely than were specialists to offer the shot.

Overall, survey participants cited reimbursement as the No. 1 hurdle to offering the vaccine.

In all, 95% of physicians said the vaccine would not promote promiscuity or decrease the use of condoms. Of the remainder, 3% were neutral on the issue, and 1.4% said that the vaccine might promote promiscuity, according to Dr. Ko.

There was no difference between genders or among specialties on the promiscuity issue. However, 7% of physicians said that parents might fear that vaccination would promote sexuality and promiscuity. This was not reported as one of the biggest barriers to vaccination, Dr. Ko said.

Dr. Ko reported no conflict of interest disclosures.

NEW ORLEANS — Getting reimbursed is the top concern for physicians who offer the human papillomavirus vaccine, according to a survey conducted by researchers at Brigham and Women's Hospital, Boston.

Using a Web-based tool, Brigham resident Emily M. Ko and her colleagues surveyed 1,488 physicians who practiced with the Partners HealthCare System from May to July 2007. The survey included physicians practicing in tertiary and community settings.

Overall, 424 physicians participated. Of these, 196 (46%) were internists, 104 (25%) were pediatricians, and 87 (21%) were ob.gyns. The remainder came from various specialties, including infectious disease, geriatrics, endocrinology, and emergency medicine, Dr. Ko reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.

Of those who participated, 80% said they offer the HPV vaccine. That included 92% of pediatricians, 81% of ob.gyns., and 78% of internists. According to the researchers, male physicians were 54% less likely to provide the vaccine than were female physicians. The survey did not ask questions that would determine why some physicians might be less likely to offer the vaccine, Dr. Ko said in an interview.

However, in citing barriers to vaccination, she noted that male physicians were six times more likely than female physicians to say that vaccination would keep patients from getting routine gynecologic exams or Pap smears.

Physicians based in community hospitals were twice as likely to offer the vaccine as were their colleagues at tertiary care facilities. Primary care physicians were 14 times more likely than were specialists to offer the shot.

Overall, survey participants cited reimbursement as the No. 1 hurdle to offering the vaccine.

In all, 95% of physicians said the vaccine would not promote promiscuity or decrease the use of condoms. Of the remainder, 3% were neutral on the issue, and 1.4% said that the vaccine might promote promiscuity, according to Dr. Ko.

There was no difference between genders or among specialties on the promiscuity issue. However, 7% of physicians said that parents might fear that vaccination would promote sexuality and promiscuity. This was not reported as one of the biggest barriers to vaccination, Dr. Ko said.

Dr. Ko reported no conflict of interest disclosures.

WASHINGTON — The nation's health care system will be overhauled in a substantive fashion in the early days of the next administration, promised advisers to both presidential candidates at a forum sponsored by the journal Health Affairs.

Although the economy has replaced health care as the top issue for voters, there is still a hunger for change, and economic and health concerns are linked, said Democratic and Republican pollsters at the same forum.

Sen. Ron Wyden (D-Ore.), who has pushed for health reform for years, agreed that early 2009 will be the right time. “At this point you almost don't want to hope again,” he said at the forum. But “this time, believe.”

He said that he has visited with 80 of 100 senators in the last few months and that all were motivated to reduce the cost of health care and to increase coverage for the uninsured.

Sen. Wyden and Sen. Bob Bennett (R-Utah) have promoted their Healthy Americans Act (S. 334) as a solution, but Sen. Wyden acknowledged that no one piece of legislation was likely to be the be-all and end-all.

Democratic pollster Celinda Lake said that voters view health care as a right and that in particular, women regarded it as a value. Women are concerned that health care not cost too much and that cost constraints not lead to any shortages that result in long waits for appointments or less time with a physician. And women are likely to be the voting bloc that decides the 2008 presidential election, Ms. Lake said.

On the other hand, those currently without health insurance are the least likely constituency of concern, she said, noting that the strongest predictor of not voting is being uninsured.

Americans strongly believe in personal responsibility, choice, peace of mind, and security. They also “want an American solution,” Ms. Lake said.

Most important, when it comes to health care, Americans are consumers, “not altruists,” she said. That means they want to know how much it's going to cost them to cover the uninsured. “There is a real desire for change and a dramatic concern about rising costs.”

Presidential candidate Sen. John McCain (R-Ariz.) seems to have tapped into these sentiments with his proposal to grant tax credits for health insurance plans, paying for wellness and eliminating waste in the system, Ms. Lake said.

Health care is inexorably linked with the economy—when the economy is bad, people worry about their health coverage, said William McInturff, a Republican pollster. In a poll his company conducted for the Robert Wood Johnson Foundation, the top two items cited to improve the economic situation for the average American were making health care more affordable and providing coverage for all Americans.

Of all respondents to that survey, 67% said they thought the number of uninsured would increase in the next 6 months. That's the highest percentage since his firm began asking the question in 2001, Mr. McInturff said.

Candidates' proposals—such as mandates requiring individuals to have insurance, a focus on prevention, and repealing tax cuts to pay for coverage—resonated, with 35%-45% of survey respondents saying they'd heard or read about such ideas.

Mr. McInturff predicted that if Sen. McCain becomes president, the senator would remain committed to health reform.

“I'm not sure I understand how Sen. McCain would advance cost control,” said Dr. David Blumenthal, a senior adviser to Sen. Barack Obama's (D-Ill.) campaign.

The way to get affordability and value is to address cost and access, said Dr. Blumenthal, director of the Massachusetts General Hospital Institute for Health Policy, Boston. He is also professor of health care policy and Samuel O. Thier Professor of Medicine at Harvard Medical School in Boston.

Dr. Blumenthal said that it was relatively easy to curb spending in Medicare through budgetary caps, but that was not a good solution because it would just push the costs elsewhere.

Douglas Holtz-Eakin, a senior policy adviser to Sen. McCain's campaign, said that offering options to employer-sponsored health insurance could make Americans better consumers, and thus help drive down costs.

“You can achieve a stable, equitable system without dismantling the employer-based insurance market,” said Dr. Blumenthal, disagreeing. He noted that in the 2008 campaign, it appeared that Republicans and Democrats had “traded hats” when it came to health care.

Democrats want to build on what is already there, and Republicans are proposing more radical change, he said.

But all agreed that reform was coming.

“The next president will have to do health care reform, period,” said Mr. Holtz-Eakin, adding that the next president will also have to get any plan through Congress, “and it will have to be bipartisan.”

“Presidential leadership and vision will set an important tone and direction for the conversation,” Dr. Blumenthal said. “It's wildly premature to say what that conversation will be,” he continued, but added that Sen. Obama would stand by his promise to address health reform.

WASHINGTON — The nation's health care system will be overhauled in a substantive fashion in the early days of the next administration, promised advisers to both presidential candidates at a forum sponsored by the journal Health Affairs.

Although the economy has replaced health care as the top issue for voters, there is still a hunger for change, and economic and health concerns are linked, said Democratic and Republican pollsters at the same forum.

Sen. Ron Wyden (D-Ore.), who has pushed for health reform for years, agreed that early 2009 will be the right time. “At this point you almost don't want to hope again,” he said at the forum. But “this time, believe.”

He said that he has visited with 80 of 100 senators in the last few months and that all were motivated to reduce the cost of health care and to increase coverage for the uninsured.

Sen. Wyden and Sen. Bob Bennett (R-Utah) have promoted their Healthy Americans Act (S. 334) as a solution, but Sen. Wyden acknowledged that no one piece of legislation was likely to be the be-all and end-all.

Democratic pollster Celinda Lake said that voters view health care as a right and that in particular, women regarded it as a value. Women are concerned that health care not cost too much and that cost constraints not lead to any shortages that result in long waits for appointments or less time with a physician. And women are likely to be the voting bloc that decides the 2008 presidential election, Ms. Lake said.

On the other hand, those currently without health insurance are the least likely constituency of concern, she said, noting that the strongest predictor of not voting is being uninsured.

Americans strongly believe in personal responsibility, choice, peace of mind, and security. They also “want an American solution,” Ms. Lake said.

Most important, when it comes to health care, Americans are consumers, “not altruists,” she said. That means they want to know how much it's going to cost them to cover the uninsured. “There is a real desire for change and a dramatic concern about rising costs.”

Presidential candidate Sen. John McCain (R-Ariz.) seems to have tapped into these sentiments with his proposal to grant tax credits for health insurance plans, paying for wellness and eliminating waste in the system, Ms. Lake said.

Health care is inexorably linked with the economy—when the economy is bad, people worry about their health coverage, said William McInturff, a Republican pollster. In a poll his company conducted for the Robert Wood Johnson Foundation, the top two items cited to improve the economic situation for the average American were making health care more affordable and providing coverage for all Americans.

Of all respondents to that survey, 67% said they thought the number of uninsured would increase in the next 6 months. That's the highest percentage since his firm began asking the question in 2001, Mr. McInturff said.

Candidates' proposals—such as mandates requiring individuals to have insurance, a focus on prevention, and repealing tax cuts to pay for coverage—resonated, with 35%-45% of survey respondents saying they'd heard or read about such ideas.

Mr. McInturff predicted that if Sen. McCain becomes president, the senator would remain committed to health reform.

“I'm not sure I understand how Sen. McCain would advance cost control,” said Dr. David Blumenthal, a senior adviser to Sen. Barack Obama's (D-Ill.) campaign.

The way to get affordability and value is to address cost and access, said Dr. Blumenthal, director of the Massachusetts General Hospital Institute for Health Policy, Boston. He is also professor of health care policy and Samuel O. Thier Professor of Medicine at Harvard Medical School in Boston.

Dr. Blumenthal said that it was relatively easy to curb spending in Medicare through budgetary caps, but that was not a good solution because it would just push the costs elsewhere.

Douglas Holtz-Eakin, a senior policy adviser to Sen. McCain's campaign, said that offering options to employer-sponsored health insurance could make Americans better consumers, and thus help drive down costs.

“You can achieve a stable, equitable system without dismantling the employer-based insurance market,” said Dr. Blumenthal, disagreeing. He noted that in the 2008 campaign, it appeared that Republicans and Democrats had “traded hats” when it came to health care.

Democrats want to build on what is already there, and Republicans are proposing more radical change, he said.

But all agreed that reform was coming.

“The next president will have to do health care reform, period,” said Mr. Holtz-Eakin, adding that the next president will also have to get any plan through Congress, “and it will have to be bipartisan.”

“Presidential leadership and vision will set an important tone and direction for the conversation,” Dr. Blumenthal said. “It's wildly premature to say what that conversation will be,” he continued, but added that Sen. Obama would stand by his promise to address health reform.

WASHINGTON — The nation's health care system will be overhauled in a substantive fashion in the early days of the next administration, promised advisers to both presidential candidates at a forum sponsored by the journal Health Affairs.

Although the economy has replaced health care as the top issue for voters, there is still a hunger for change, and economic and health concerns are linked, said Democratic and Republican pollsters at the same forum.

Sen. Ron Wyden (D-Ore.), who has pushed for health reform for years, agreed that early 2009 will be the right time. “At this point you almost don't want to hope again,” he said at the forum. But “this time, believe.”

He said that he has visited with 80 of 100 senators in the last few months and that all were motivated to reduce the cost of health care and to increase coverage for the uninsured.

Sen. Wyden and Sen. Bob Bennett (R-Utah) have promoted their Healthy Americans Act (S. 334) as a solution, but Sen. Wyden acknowledged that no one piece of legislation was likely to be the be-all and end-all.

Democratic pollster Celinda Lake said that voters view health care as a right and that in particular, women regarded it as a value. Women are concerned that health care not cost too much and that cost constraints not lead to any shortages that result in long waits for appointments or less time with a physician. And women are likely to be the voting bloc that decides the 2008 presidential election, Ms. Lake said.

On the other hand, those currently without health insurance are the least likely constituency of concern, she said, noting that the strongest predictor of not voting is being uninsured.

Americans strongly believe in personal responsibility, choice, peace of mind, and security. They also “want an American solution,” Ms. Lake said.

Most important, when it comes to health care, Americans are consumers, “not altruists,” she said. That means they want to know how much it's going to cost them to cover the uninsured. “There is a real desire for change and a dramatic concern about rising costs.”

Presidential candidate Sen. John McCain (R-Ariz.) seems to have tapped into these sentiments with his proposal to grant tax credits for health insurance plans, paying for wellness and eliminating waste in the system, Ms. Lake said.

Health care is inexorably linked with the economy—when the economy is bad, people worry about their health coverage, said William McInturff, a Republican pollster. In a poll his company conducted for the Robert Wood Johnson Foundation, the top two items cited to improve the economic situation for the average American were making health care more affordable and providing coverage for all Americans.

Of all respondents to that survey, 67% said they thought the number of uninsured would increase in the next 6 months. That's the highest percentage since his firm began asking the question in 2001, Mr. McInturff said.

Candidates' proposals—such as mandates requiring individuals to have insurance, a focus on prevention, and repealing tax cuts to pay for coverage—resonated, with 35%-45% of survey respondents saying they'd heard or read about such ideas.

Mr. McInturff predicted that if Sen. McCain becomes president, the senator would remain committed to health reform.

“I'm not sure I understand how Sen. McCain would advance cost control,” said Dr. David Blumenthal, a senior adviser to Sen. Barack Obama's (D-Ill.) campaign.

The way to get affordability and value is to address cost and access, said Dr. Blumenthal, director of the Massachusetts General Hospital Institute for Health Policy, Boston. He is also professor of health care policy and Samuel O. Thier Professor of Medicine at Harvard Medical School in Boston.

Dr. Blumenthal said that it was relatively easy to curb spending in Medicare through budgetary caps, but that was not a good solution because it would just push the costs elsewhere.

Douglas Holtz-Eakin, a senior policy adviser to Sen. McCain's campaign, said that offering options to employer-sponsored health insurance could make Americans better consumers, and thus help drive down costs.

“You can achieve a stable, equitable system without dismantling the employer-based insurance market,” said Dr. Blumenthal, disagreeing. He noted that in the 2008 campaign, it appeared that Republicans and Democrats had “traded hats” when it came to health care.

Democrats want to build on what is already there, and Republicans are proposing more radical change, he said.

But all agreed that reform was coming.

“The next president will have to do health care reform, period,” said Mr. Holtz-Eakin, adding that the next president will also have to get any plan through Congress, “and it will have to be bipartisan.”

“Presidential leadership and vision will set an important tone and direction for the conversation,” Dr. Blumenthal said. “It's wildly premature to say what that conversation will be,” he continued, but added that Sen. Obama would stand by his promise to address health reform.

SAN DIEGO — As many as 18%-20% of cases of indeterminate acute liver failure may be the result of unrecognized acetaminophen toxicity, according to a presentation at the annual Digestive Disease Week.

The etiology is unknown in about 15% of cases of acute liver failure (ALF), said Dr. Niraj Khandelwal of the University of Texas, Dallas. Using a novel assay that detects acetaminophen (APAP) protein adducts, the Acute Liver Failure Study Group had determined in a previous study that adducts were present in 7 (19%) of 36 cases diagnosed as indeterminate ALF. The APAP adduct levels were comparable with those seen in patients with known acetaminophen overdose (Gastroenterology 2006;130:687).

To further evaluate indeterminate ALF, the authors conducted a larger study using a newer assay—high-performance liquid chromatography with electrochemical detection (HPLC-EC)—that is more efficient and more sensitive, Dr. Khandelwal said.

The assays were conducted on sera from 113 patients in the ALF Study Group registry. The serum samples were taken on the first or second day after admission and were collected from 1998 to 2006.

Of the 113, there were 32 with known APAP overdose, 93 who were adduct negative, and 20 (18%) who were adduct positive (defined using a cut point of 1 nmol/mL). Of those 20 patients, 9 (45%) died or received transplants and 11 (55%) spontaneously survived. Eight patients were given N-acetylcysteine (NAC), and six (75%) of those eight patients survived. Only 5 patients (42%) of the 11 who spontaneously survived did so without NAC.

The clinical and lab findings of the patients who had adducts equal to 1 nmol/mL or greater were consistent with findings—including very high aminotransferases, low bilirubin, and favorable outcome—for known APAP overdose patients. The median bilirubin level was 5.05 mg/dL, compared with 24.5 mg/dL for patients with negative adducts (1 nmol/mL or less).

The study confirms previous data showing that as many as one in five patients with indeterminate ALF actually has unrecognized acetaminophen toxicity, Dr. Khandelwal said. Given these data and the lack of an adduct assay that can be used at the bedside in real time, NAC should be considered in patients with indeterminate ALF who match the biochemical profile for APAP overdose, he said.

Dr. Khandelwal had no disclosures.

SAN DIEGO — As many as 18%-20% of cases of indeterminate acute liver failure may be the result of unrecognized acetaminophen toxicity, according to a presentation at the annual Digestive Disease Week.

The etiology is unknown in about 15% of cases of acute liver failure (ALF), said Dr. Niraj Khandelwal of the University of Texas, Dallas. Using a novel assay that detects acetaminophen (APAP) protein adducts, the Acute Liver Failure Study Group had determined in a previous study that adducts were present in 7 (19%) of 36 cases diagnosed as indeterminate ALF. The APAP adduct levels were comparable with those seen in patients with known acetaminophen overdose (Gastroenterology 2006;130:687).

To further evaluate indeterminate ALF, the authors conducted a larger study using a newer assay—high-performance liquid chromatography with electrochemical detection (HPLC-EC)—that is more efficient and more sensitive, Dr. Khandelwal said.

The assays were conducted on sera from 113 patients in the ALF Study Group registry. The serum samples were taken on the first or second day after admission and were collected from 1998 to 2006.

Of the 113, there were 32 with known APAP overdose, 93 who were adduct negative, and 20 (18%) who were adduct positive (defined using a cut point of 1 nmol/mL). Of those 20 patients, 9 (45%) died or received transplants and 11 (55%) spontaneously survived. Eight patients were given N-acetylcysteine (NAC), and six (75%) of those eight patients survived. Only 5 patients (42%) of the 11 who spontaneously survived did so without NAC.

The clinical and lab findings of the patients who had adducts equal to 1 nmol/mL or greater were consistent with findings—including very high aminotransferases, low bilirubin, and favorable outcome—for known APAP overdose patients. The median bilirubin level was 5.05 mg/dL, compared with 24.5 mg/dL for patients with negative adducts (1 nmol/mL or less).

The study confirms previous data showing that as many as one in five patients with indeterminate ALF actually has unrecognized acetaminophen toxicity, Dr. Khandelwal said. Given these data and the lack of an adduct assay that can be used at the bedside in real time, NAC should be considered in patients with indeterminate ALF who match the biochemical profile for APAP overdose, he said.

Dr. Khandelwal had no disclosures.

SAN DIEGO — As many as 18%-20% of cases of indeterminate acute liver failure may be the result of unrecognized acetaminophen toxicity, according to a presentation at the annual Digestive Disease Week.

The etiology is unknown in about 15% of cases of acute liver failure (ALF), said Dr. Niraj Khandelwal of the University of Texas, Dallas. Using a novel assay that detects acetaminophen (APAP) protein adducts, the Acute Liver Failure Study Group had determined in a previous study that adducts were present in 7 (19%) of 36 cases diagnosed as indeterminate ALF. The APAP adduct levels were comparable with those seen in patients with known acetaminophen overdose (Gastroenterology 2006;130:687).

To further evaluate indeterminate ALF, the authors conducted a larger study using a newer assay—high-performance liquid chromatography with electrochemical detection (HPLC-EC)—that is more efficient and more sensitive, Dr. Khandelwal said.

The assays were conducted on sera from 113 patients in the ALF Study Group registry. The serum samples were taken on the first or second day after admission and were collected from 1998 to 2006.

Of the 113, there were 32 with known APAP overdose, 93 who were adduct negative, and 20 (18%) who were adduct positive (defined using a cut point of 1 nmol/mL). Of those 20 patients, 9 (45%) died or received transplants and 11 (55%) spontaneously survived. Eight patients were given N-acetylcysteine (NAC), and six (75%) of those eight patients survived. Only 5 patients (42%) of the 11 who spontaneously survived did so without NAC.

The clinical and lab findings of the patients who had adducts equal to 1 nmol/mL or greater were consistent with findings—including very high aminotransferases, low bilirubin, and favorable outcome—for known APAP overdose patients. The median bilirubin level was 5.05 mg/dL, compared with 24.5 mg/dL for patients with negative adducts (1 nmol/mL or less).

The study confirms previous data showing that as many as one in five patients with indeterminate ALF actually has unrecognized acetaminophen toxicity, Dr. Khandelwal said. Given these data and the lack of an adduct assay that can be used at the bedside in real time, NAC should be considered in patients with indeterminate ALF who match the biochemical profile for APAP overdose, he said.

Dr. Khandelwal had no disclosures.

SAN FRANCISCO — Roux-en-Y gastric bypass surgery is effective in helping people with type 2 diabetes meet the American Diabetes Association goals for hemoglobin A_1c, systolic blood pressure, and LDL cholesterol, according to a retrospective study presented at the annual meeting of the Endocrine Society.

Dr. Daniel Leslie of the University of Minnesota, Minneapolis, said that his study was the first to report on the effectiveness of Roux-en-Y in meeting treatment goals set by the American Diabetes Association (ADA) in 2004 for the management of type 2 diabetes.

Dr. Leslie and colleagues reviewed all Roux-en-Y gastric bypass procedures conducted at the University of Minnesota between 2001 and 2007. Of all the procedures, 85% were done laparoscopically. There were a total of 2,210 consecutive surgeries, and of those patients, 564 had type 2 diabetes.

But only 338 patients had all three measures—HbA_1c, systolic blood pressure, and LDL cholesterol—available at baseline. Only 169 patients had all three measures available both preoperatively and postoperatively, Dr. Leslie said.

The average age of the patients was 51 years; 79% (133) were women and 85% (143) were white. The average duration of diabetes was 9 years, although 39% (66) of the group had diabetes for more than 10 years. Patients were followed for an average of 26 months.

Dr. Leslie estimated that 32% (54) of the patients met the ADA goals after surgery. Only 9.5% (16) of patients had met those goals before gastric bypass. The duration of diabetes was not associated with meeting the goals.

The ADA goals included an HbA_1c of 7% or less, LDL cholesterol of 100 mg/dL or less, and systolic blood pressure of 130 mm Hg or less.

The HbA_1c value improved from 7.7% on average to 6.2% after the procedure. Systolic blood pressure dropped from an average of 136 mm Hg to 128 mm Hg. The use of oral antidiabetic medications and insulin dropped dramatically, Dr. Leslie noted.

Use of cholesterol-lowering and blood pressure-lowering drugs also fell, but the need for antihypertensives increased after about 24 months—a finding seen in other studies, Dr. Leslie said.

The mean body mass index dropped from 49 to 33 kg/m

“Gastric bypass is a useful tool for improving diabetes treatment goals,” said Dr. Leslie, although he noted that the study was not controlled.

Dr. Leslie disclosed that his surgery division receives grant support from Covidien AG and Ethicon Endo-Surgery Inc., but said that he does not personally receive any industry grants.

SAN FRANCISCO — Roux-en-Y gastric bypass surgery is effective in helping people with type 2 diabetes meet the American Diabetes Association goals for hemoglobin A_1c, systolic blood pressure, and LDL cholesterol, according to a retrospective study presented at the annual meeting of the Endocrine Society.

Dr. Daniel Leslie of the University of Minnesota, Minneapolis, said that his study was the first to report on the effectiveness of Roux-en-Y in meeting treatment goals set by the American Diabetes Association (ADA) in 2004 for the management of type 2 diabetes.

Dr. Leslie and colleagues reviewed all Roux-en-Y gastric bypass procedures conducted at the University of Minnesota between 2001 and 2007. Of all the procedures, 85% were done laparoscopically. There were a total of 2,210 consecutive surgeries, and of those patients, 564 had type 2 diabetes.

But only 338 patients had all three measures—HbA_1c, systolic blood pressure, and LDL cholesterol—available at baseline. Only 169 patients had all three measures available both preoperatively and postoperatively, Dr. Leslie said.

The average age of the patients was 51 years; 79% (133) were women and 85% (143) were white. The average duration of diabetes was 9 years, although 39% (66) of the group had diabetes for more than 10 years. Patients were followed for an average of 26 months.

Dr. Leslie estimated that 32% (54) of the patients met the ADA goals after surgery. Only 9.5% (16) of patients had met those goals before gastric bypass. The duration of diabetes was not associated with meeting the goals.

The ADA goals included an HbA_1c of 7% or less, LDL cholesterol of 100 mg/dL or less, and systolic blood pressure of 130 mm Hg or less.

The HbA_1c value improved from 7.7% on average to 6.2% after the procedure. Systolic blood pressure dropped from an average of 136 mm Hg to 128 mm Hg. The use of oral antidiabetic medications and insulin dropped dramatically, Dr. Leslie noted.

Use of cholesterol-lowering and blood pressure-lowering drugs also fell, but the need for antihypertensives increased after about 24 months—a finding seen in other studies, Dr. Leslie said.

The mean body mass index dropped from 49 to 33 kg/m

“Gastric bypass is a useful tool for improving diabetes treatment goals,” said Dr. Leslie, although he noted that the study was not controlled.

Dr. Leslie disclosed that his surgery division receives grant support from Covidien AG and Ethicon Endo-Surgery Inc., but said that he does not personally receive any industry grants.

SAN FRANCISCO — Roux-en-Y gastric bypass surgery is effective in helping people with type 2 diabetes meet the American Diabetes Association goals for hemoglobin A_1c, systolic blood pressure, and LDL cholesterol, according to a retrospective study presented at the annual meeting of the Endocrine Society.

Dr. Daniel Leslie of the University of Minnesota, Minneapolis, said that his study was the first to report on the effectiveness of Roux-en-Y in meeting treatment goals set by the American Diabetes Association (ADA) in 2004 for the management of type 2 diabetes.

Dr. Leslie and colleagues reviewed all Roux-en-Y gastric bypass procedures conducted at the University of Minnesota between 2001 and 2007. Of all the procedures, 85% were done laparoscopically. There were a total of 2,210 consecutive surgeries, and of those patients, 564 had type 2 diabetes.

But only 338 patients had all three measures—HbA_1c, systolic blood pressure, and LDL cholesterol—available at baseline. Only 169 patients had all three measures available both preoperatively and postoperatively, Dr. Leslie said.

The average age of the patients was 51 years; 79% (133) were women and 85% (143) were white. The average duration of diabetes was 9 years, although 39% (66) of the group had diabetes for more than 10 years. Patients were followed for an average of 26 months.

Dr. Leslie estimated that 32% (54) of the patients met the ADA goals after surgery. Only 9.5% (16) of patients had met those goals before gastric bypass. The duration of diabetes was not associated with meeting the goals.

The ADA goals included an HbA_1c of 7% or less, LDL cholesterol of 100 mg/dL or less, and systolic blood pressure of 130 mm Hg or less.

The HbA_1c value improved from 7.7% on average to 6.2% after the procedure. Systolic blood pressure dropped from an average of 136 mm Hg to 128 mm Hg. The use of oral antidiabetic medications and insulin dropped dramatically, Dr. Leslie noted.

Use of cholesterol-lowering and blood pressure-lowering drugs also fell, but the need for antihypertensives increased after about 24 months—a finding seen in other studies, Dr. Leslie said.

The mean body mass index dropped from 49 to 33 kg/m

“Gastric bypass is a useful tool for improving diabetes treatment goals,” said Dr. Leslie, although he noted that the study was not controlled.

Dr. Leslie disclosed that his surgery division receives grant support from Covidien AG and Ethicon Endo-Surgery Inc., but said that he does not personally receive any industry grants.