Mary Ellen Schneider

FDA to Review Bisphenol-A

Advisers to the Food and Drug Administration are planning to review evidence on the safety of bisphenol-A (BPA) in plastic and release their findings this fall. The FDA's chief scientist, Dr. Frank M. Torti, recently requested that the agency's Science Board establish a subcommittee tasked with assessing BPA. FDA officials have been monitoring literature on the safety of BPA, which is found in some baby bottles and food containers, for many years and began a formal review in 2007. Earlier this year, FDA officials formed a task force to review all current research on BPA. “The FDA Task Force is assembling an inventory of FDA-regulated products that contain BPA and we are exploring what is known about the safety of this substance in those products,” Dr. Torti said in a statement. In the meantime, the National Toxicology Program, part of the National Institutes of Health, issued a draft report in April stating that the results of animal studies on BPA raise “some concern” about developmental effects in humans.

NYC Reports High Herpes Rate

About 26% of adults aged 20–49 years living in New York City are infected with herpes simplex virus type 2 (HSV-2), compared with 19% nationally, according to data released by the New York City Department of Health and Mental Hygiene. In New York, HSV-2 was more likely among women, blacks, and men who have sex with men. For example, 36% of women had HSV-2, compared with 19% of men, and 49% of blacks had the infection, compared with 14% of whites. The data come from the New York City Health and Nutrition Examination Survey, which includes information from in-depth interviews, physical exams, and laboratory testing. The data were collected in 2004 from adults aged 20 and older. Of the 1,999 individuals who enrolled in the survey, researchers obtained HSV-2 test results from 1,780 individuals.

Mass. Uninsured Rate Cut

In the first year after Massachusetts implemented its health insurance coverage expansion and reforms, the uninsured rate among adults in the state dropped by almost half, from 13% to just over 7%, according to an Urban Institute study published online in Health Affairs. The study also showed that access to care for low-income Massachusetts adults has increased, and the share of adults with high out-of-pocket health care costs and problems paying medical bills has dropped. In addition, the study's author found no evidence that the expansion of publicly subsidized coverage has “crowded out” employer-sponsored coverage. The reforms, enacted in April 2006, included an expansion of Medicaid, state subsidies for low-income residents to purchase health insurance, and a new purchasing arrangement for private health insurance. Under the reforms, most uninsured individuals must purchase insurance or pay a penalty to the state.

Ryan White AIDS Audit

In light of news reports about embezzlement and financial mismanagement, two Republican members of Congress are calling on the Health and Human Services department's Office of Inspector General to conduct an audit of grantees of the Ryan White Comprehensive AIDS Resources Emergency Act. The investigation was requested by Rep. Joe Barton (R-Tex.), ranking member of the House Energy and Commerce Committee, and Rep. John Shimkus (R-Ill.), ranking member of the Energy and Commerce subcommittee on oversight and investigations. Specifically, the representatives raised concerns that there was a lack of monitoring of subgrantees under Title I and Title II of the act. The program was audited by the OIG in 2004, and investigators concluded that monitoring of subgrantees needed to be improved. Citing news reports in 2006 and 2007 of continued problems with the program, the representatives requested an updated audit.

Pregnant Women Gain More HIV Tx

More HIV-positive pregnant women in developing nations are being treated with antiretroviral therapy to prevent mother-to-child transmission, according to a joint report from the World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and UNICEF. In 2007, about one-third of pregnant women with HIV received antiretrovirals, up from 10% in 2004. The greatest increases in antiretroviral treatment were seen in sub-Saharan Africa. The report, which examines HIV/AIDS interventions around the world, also noted increases in HIV testing of pregnant women in developing nations. For example, in 2007 about 18% of pregnant women received an HIV test, compared with 10% in 2004. “We are seeing encouraging progress in the prevention of HIV transmission from mother to newborn,” UNICEF Executive Director Ann M. Veneman said in a statement.

FDA to Review Bisphenol-A

Advisers to the Food and Drug Administration are planning to review evidence on the safety of bisphenol-A (BPA) in plastic and release their findings this fall. The FDA's chief scientist, Dr. Frank M. Torti, recently requested that the agency's Science Board establish a subcommittee tasked with assessing BPA. FDA officials have been monitoring literature on the safety of BPA, which is found in some baby bottles and food containers, for many years and began a formal review in 2007. Earlier this year, FDA officials formed a task force to review all current research on BPA. “The FDA Task Force is assembling an inventory of FDA-regulated products that contain BPA and we are exploring what is known about the safety of this substance in those products,” Dr. Torti said in a statement. In the meantime, the National Toxicology Program, part of the National Institutes of Health, issued a draft report in April stating that the results of animal studies on BPA raise “some concern” about developmental effects in humans.

NYC Reports High Herpes Rate

About 26% of adults aged 20–49 years living in New York City are infected with herpes simplex virus type 2 (HSV-2), compared with 19% nationally, according to data released by the New York City Department of Health and Mental Hygiene. In New York, HSV-2 was more likely among women, blacks, and men who have sex with men. For example, 36% of women had HSV-2, compared with 19% of men, and 49% of blacks had the infection, compared with 14% of whites. The data come from the New York City Health and Nutrition Examination Survey, which includes information from in-depth interviews, physical exams, and laboratory testing. The data were collected in 2004 from adults aged 20 and older. Of the 1,999 individuals who enrolled in the survey, researchers obtained HSV-2 test results from 1,780 individuals.

Mass. Uninsured Rate Cut

In the first year after Massachusetts implemented its health insurance coverage expansion and reforms, the uninsured rate among adults in the state dropped by almost half, from 13% to just over 7%, according to an Urban Institute study published online in Health Affairs. The study also showed that access to care for low-income Massachusetts adults has increased, and the share of adults with high out-of-pocket health care costs and problems paying medical bills has dropped. In addition, the study's author found no evidence that the expansion of publicly subsidized coverage has “crowded out” employer-sponsored coverage. The reforms, enacted in April 2006, included an expansion of Medicaid, state subsidies for low-income residents to purchase health insurance, and a new purchasing arrangement for private health insurance. Under the reforms, most uninsured individuals must purchase insurance or pay a penalty to the state.

Ryan White AIDS Audit

In light of news reports about embezzlement and financial mismanagement, two Republican members of Congress are calling on the Health and Human Services department's Office of Inspector General to conduct an audit of grantees of the Ryan White Comprehensive AIDS Resources Emergency Act. The investigation was requested by Rep. Joe Barton (R-Tex.), ranking member of the House Energy and Commerce Committee, and Rep. John Shimkus (R-Ill.), ranking member of the Energy and Commerce subcommittee on oversight and investigations. Specifically, the representatives raised concerns that there was a lack of monitoring of subgrantees under Title I and Title II of the act. The program was audited by the OIG in 2004, and investigators concluded that monitoring of subgrantees needed to be improved. Citing news reports in 2006 and 2007 of continued problems with the program, the representatives requested an updated audit.

Pregnant Women Gain More HIV Tx

More HIV-positive pregnant women in developing nations are being treated with antiretroviral therapy to prevent mother-to-child transmission, according to a joint report from the World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and UNICEF. In 2007, about one-third of pregnant women with HIV received antiretrovirals, up from 10% in 2004. The greatest increases in antiretroviral treatment were seen in sub-Saharan Africa. The report, which examines HIV/AIDS interventions around the world, also noted increases in HIV testing of pregnant women in developing nations. For example, in 2007 about 18% of pregnant women received an HIV test, compared with 10% in 2004. “We are seeing encouraging progress in the prevention of HIV transmission from mother to newborn,” UNICEF Executive Director Ann M. Veneman said in a statement.

FDA to Review Bisphenol-A

Advisers to the Food and Drug Administration are planning to review evidence on the safety of bisphenol-A (BPA) in plastic and release their findings this fall. The FDA's chief scientist, Dr. Frank M. Torti, recently requested that the agency's Science Board establish a subcommittee tasked with assessing BPA. FDA officials have been monitoring literature on the safety of BPA, which is found in some baby bottles and food containers, for many years and began a formal review in 2007. Earlier this year, FDA officials formed a task force to review all current research on BPA. “The FDA Task Force is assembling an inventory of FDA-regulated products that contain BPA and we are exploring what is known about the safety of this substance in those products,” Dr. Torti said in a statement. In the meantime, the National Toxicology Program, part of the National Institutes of Health, issued a draft report in April stating that the results of animal studies on BPA raise “some concern” about developmental effects in humans.

NYC Reports High Herpes Rate

About 26% of adults aged 20–49 years living in New York City are infected with herpes simplex virus type 2 (HSV-2), compared with 19% nationally, according to data released by the New York City Department of Health and Mental Hygiene. In New York, HSV-2 was more likely among women, blacks, and men who have sex with men. For example, 36% of women had HSV-2, compared with 19% of men, and 49% of blacks had the infection, compared with 14% of whites. The data come from the New York City Health and Nutrition Examination Survey, which includes information from in-depth interviews, physical exams, and laboratory testing. The data were collected in 2004 from adults aged 20 and older. Of the 1,999 individuals who enrolled in the survey, researchers obtained HSV-2 test results from 1,780 individuals.

Mass. Uninsured Rate Cut

In the first year after Massachusetts implemented its health insurance coverage expansion and reforms, the uninsured rate among adults in the state dropped by almost half, from 13% to just over 7%, according to an Urban Institute study published online in Health Affairs. The study also showed that access to care for low-income Massachusetts adults has increased, and the share of adults with high out-of-pocket health care costs and problems paying medical bills has dropped. In addition, the study's author found no evidence that the expansion of publicly subsidized coverage has “crowded out” employer-sponsored coverage. The reforms, enacted in April 2006, included an expansion of Medicaid, state subsidies for low-income residents to purchase health insurance, and a new purchasing arrangement for private health insurance. Under the reforms, most uninsured individuals must purchase insurance or pay a penalty to the state.

Ryan White AIDS Audit

In light of news reports about embezzlement and financial mismanagement, two Republican members of Congress are calling on the Health and Human Services department's Office of Inspector General to conduct an audit of grantees of the Ryan White Comprehensive AIDS Resources Emergency Act. The investigation was requested by Rep. Joe Barton (R-Tex.), ranking member of the House Energy and Commerce Committee, and Rep. John Shimkus (R-Ill.), ranking member of the Energy and Commerce subcommittee on oversight and investigations. Specifically, the representatives raised concerns that there was a lack of monitoring of subgrantees under Title I and Title II of the act. The program was audited by the OIG in 2004, and investigators concluded that monitoring of subgrantees needed to be improved. Citing news reports in 2006 and 2007 of continued problems with the program, the representatives requested an updated audit.

Pregnant Women Gain More HIV Tx

More HIV-positive pregnant women in developing nations are being treated with antiretroviral therapy to prevent mother-to-child transmission, according to a joint report from the World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and UNICEF. In 2007, about one-third of pregnant women with HIV received antiretrovirals, up from 10% in 2004. The greatest increases in antiretroviral treatment were seen in sub-Saharan Africa. The report, which examines HIV/AIDS interventions around the world, also noted increases in HIV testing of pregnant women in developing nations. For example, in 2007 about 18% of pregnant women received an HIV test, compared with 10% in 2004. “We are seeing encouraging progress in the prevention of HIV transmission from mother to newborn,” UNICEF Executive Director Ann M. Veneman said in a statement.

Alzheimer's: No. 6 Cause of Death

Alzheimer's disease has become the sixth leading cause of death in the United States, according to 2006 mortality data from the Centers for Disease Control and Prevention's National Center for Health Statistics. AD moved up from the seventh spot on the CDC's list of the 15 leading causes of death even though deaths from the disease dropped 0.9% to nearly 73,000 from the year before. “It is vitally important that we increase Alzheimer's research funding to slow or stop the progression of this devastating disease,” William Thies, Ph.D., vice president of medical and scientific relations at the Alzheimer's Association, said in a statement. The organization estimates that there are currently 5.2 million Americans living with Alzheimer's disease, and it predicts that by 2010 there will be nearly half a million new cases each year.

DEA Proposes Electronic Rx

Physicians would have the option of issuing prescriptions electronically for controlled substances under a proposed regulation issued by the U.S. Drug Enforcement Administration in late June. The idea is to allow physicians, pharmacists, and hospital staffs to use modern technology while still adhering to the government's system of controls for these prescriptions, according to the DEA. For example, the proposed rule contains a series of practitioner requirements, including that the physician must adopt procedures to protect passwords and other authentication tools against theft or loss. The DEA expects that the proposal could reduce paperwork for DEA registrants and potentially reduce forged prescriptions. “Our goal is to put in place an electronic prescribing system that is efficient [and] medically beneficial to patients and prescribers,” Joseph Rannazzisi, deputy assistant administrator for the Office of Diversion Control, said. The DEA will accept comments through Sept. 25.

DOD Improves TBI Screening

The Department of Defense is making progress on screening troops for traumatic brain injury (TBI) and on screening for mental health issues before deployment, but there are still gaps, according to a report released last month by the Government Accountability Office. The agency determined that clinicians have received inconsistent instructions on predeployment screening. During visits to three sites, for instance, investigators found that physicians did not know they were supposed to review medical records as part of the predeployment screen. The tracking of referrals is often hampered by a lack of electronic records and by the fact that National Guard and military reserve troops receive civilian care, said the agency. The military is doing better on TBI screening, said the GAO. Screening questions were added in January to postdeployment assessments; starting in July 2008, all troops will be assessed for mild TBI before they go overseas.

Physical Activity Guidelines Coming

Americans should engage in 2.5-5 hours per week of vigorous physical activity to maintain a healthy lifestyle, according to evidence-based recommendations from the Physical Activity Guidelines Advisory Committee. The committee was formed in June 2007 by the Health and Human Services secretary to review the existing scientific literature and develop a comprehensive set of physical activity recommendations. The committee's work will be used by DHHS to prepare a set of physical activity guidelines to be released later this year. The committee found that 2.5 hours a week of moderate to vigorous activity had been consistently observed to help lower the risk of low-cause mortality, coronary heart disease, stroke, hypertension, and type 2 diabetes in adults. But more activity is needed to significantly lower the rates of colon and breast cancer and to prevent unhealthy weight gain. The range required to achieve those outcomes is 3-5 hours per week of moderate to vigorous activity. The report is at

www.health.gov/PAguidelines

AMA Launches Report Card

The American Medical Association in June launched a campaign to cut waste from the insurance claims process with a new health insurer report card. “To diagnose the areas of greatest concern within the claims processing system, the AMA has developed its first online rating of health insurers,” said Dr. William Dolan, an AMA board member. The report card, based on a random sample pulled from more than 5 million services billed electronically to Medicare and seven health insurers, found that insurers reported to physicians the correct contracted payment rate only 62%-87% of the time. In addition, it found that there is extremely wide variation among payers as to how often they apply computer-generated edits to reduce payments—from a low of less than 0.5% to a high of more than 9%. Physicians spend as much as 14% of their total revenue to ensure accurate insurance payments for their services, according to the AMA.

Alzheimer's: No. 6 Cause of Death

Alzheimer's disease has become the sixth leading cause of death in the United States, according to 2006 mortality data from the Centers for Disease Control and Prevention's National Center for Health Statistics. AD moved up from the seventh spot on the CDC's list of the 15 leading causes of death even though deaths from the disease dropped 0.9% to nearly 73,000 from the year before. “It is vitally important that we increase Alzheimer's research funding to slow or stop the progression of this devastating disease,” William Thies, Ph.D., vice president of medical and scientific relations at the Alzheimer's Association, said in a statement. The organization estimates that there are currently 5.2 million Americans living with Alzheimer's disease, and it predicts that by 2010 there will be nearly half a million new cases each year.

DEA Proposes Electronic Rx

Physicians would have the option of issuing prescriptions electronically for controlled substances under a proposed regulation issued by the U.S. Drug Enforcement Administration in late June. The idea is to allow physicians, pharmacists, and hospital staffs to use modern technology while still adhering to the government's system of controls for these prescriptions, according to the DEA. For example, the proposed rule contains a series of practitioner requirements, including that the physician must adopt procedures to protect passwords and other authentication tools against theft or loss. The DEA expects that the proposal could reduce paperwork for DEA registrants and potentially reduce forged prescriptions. “Our goal is to put in place an electronic prescribing system that is efficient [and] medically beneficial to patients and prescribers,” Joseph Rannazzisi, deputy assistant administrator for the Office of Diversion Control, said. The DEA will accept comments through Sept. 25.

DOD Improves TBI Screening

The Department of Defense is making progress on screening troops for traumatic brain injury (TBI) and on screening for mental health issues before deployment, but there are still gaps, according to a report released last month by the Government Accountability Office. The agency determined that clinicians have received inconsistent instructions on predeployment screening. During visits to three sites, for instance, investigators found that physicians did not know they were supposed to review medical records as part of the predeployment screen. The tracking of referrals is often hampered by a lack of electronic records and by the fact that National Guard and military reserve troops receive civilian care, said the agency. The military is doing better on TBI screening, said the GAO. Screening questions were added in January to postdeployment assessments; starting in July 2008, all troops will be assessed for mild TBI before they go overseas.

Physical Activity Guidelines Coming

Americans should engage in 2.5-5 hours per week of vigorous physical activity to maintain a healthy lifestyle, according to evidence-based recommendations from the Physical Activity Guidelines Advisory Committee. The committee was formed in June 2007 by the Health and Human Services secretary to review the existing scientific literature and develop a comprehensive set of physical activity recommendations. The committee's work will be used by DHHS to prepare a set of physical activity guidelines to be released later this year. The committee found that 2.5 hours a week of moderate to vigorous activity had been consistently observed to help lower the risk of low-cause mortality, coronary heart disease, stroke, hypertension, and type 2 diabetes in adults. But more activity is needed to significantly lower the rates of colon and breast cancer and to prevent unhealthy weight gain. The range required to achieve those outcomes is 3-5 hours per week of moderate to vigorous activity. The report is at

www.health.gov/PAguidelines

AMA Launches Report Card

The American Medical Association in June launched a campaign to cut waste from the insurance claims process with a new health insurer report card. “To diagnose the areas of greatest concern within the claims processing system, the AMA has developed its first online rating of health insurers,” said Dr. William Dolan, an AMA board member. The report card, based on a random sample pulled from more than 5 million services billed electronically to Medicare and seven health insurers, found that insurers reported to physicians the correct contracted payment rate only 62%-87% of the time. In addition, it found that there is extremely wide variation among payers as to how often they apply computer-generated edits to reduce payments—from a low of less than 0.5% to a high of more than 9%. Physicians spend as much as 14% of their total revenue to ensure accurate insurance payments for their services, according to the AMA.

Alzheimer's: No. 6 Cause of Death

Alzheimer's disease has become the sixth leading cause of death in the United States, according to 2006 mortality data from the Centers for Disease Control and Prevention's National Center for Health Statistics. AD moved up from the seventh spot on the CDC's list of the 15 leading causes of death even though deaths from the disease dropped 0.9% to nearly 73,000 from the year before. “It is vitally important that we increase Alzheimer's research funding to slow or stop the progression of this devastating disease,” William Thies, Ph.D., vice president of medical and scientific relations at the Alzheimer's Association, said in a statement. The organization estimates that there are currently 5.2 million Americans living with Alzheimer's disease, and it predicts that by 2010 there will be nearly half a million new cases each year.

DEA Proposes Electronic Rx

Physicians would have the option of issuing prescriptions electronically for controlled substances under a proposed regulation issued by the U.S. Drug Enforcement Administration in late June. The idea is to allow physicians, pharmacists, and hospital staffs to use modern technology while still adhering to the government's system of controls for these prescriptions, according to the DEA. For example, the proposed rule contains a series of practitioner requirements, including that the physician must adopt procedures to protect passwords and other authentication tools against theft or loss. The DEA expects that the proposal could reduce paperwork for DEA registrants and potentially reduce forged prescriptions. “Our goal is to put in place an electronic prescribing system that is efficient [and] medically beneficial to patients and prescribers,” Joseph Rannazzisi, deputy assistant administrator for the Office of Diversion Control, said. The DEA will accept comments through Sept. 25.

DOD Improves TBI Screening

The Department of Defense is making progress on screening troops for traumatic brain injury (TBI) and on screening for mental health issues before deployment, but there are still gaps, according to a report released last month by the Government Accountability Office. The agency determined that clinicians have received inconsistent instructions on predeployment screening. During visits to three sites, for instance, investigators found that physicians did not know they were supposed to review medical records as part of the predeployment screen. The tracking of referrals is often hampered by a lack of electronic records and by the fact that National Guard and military reserve troops receive civilian care, said the agency. The military is doing better on TBI screening, said the GAO. Screening questions were added in January to postdeployment assessments; starting in July 2008, all troops will be assessed for mild TBI before they go overseas.

Physical Activity Guidelines Coming

Americans should engage in 2.5-5 hours per week of vigorous physical activity to maintain a healthy lifestyle, according to evidence-based recommendations from the Physical Activity Guidelines Advisory Committee. The committee was formed in June 2007 by the Health and Human Services secretary to review the existing scientific literature and develop a comprehensive set of physical activity recommendations. The committee's work will be used by DHHS to prepare a set of physical activity guidelines to be released later this year. The committee found that 2.5 hours a week of moderate to vigorous activity had been consistently observed to help lower the risk of low-cause mortality, coronary heart disease, stroke, hypertension, and type 2 diabetes in adults. But more activity is needed to significantly lower the rates of colon and breast cancer and to prevent unhealthy weight gain. The range required to achieve those outcomes is 3-5 hours per week of moderate to vigorous activity. The report is at

www.health.gov/PAguidelines

AMA Launches Report Card

The American Medical Association in June launched a campaign to cut waste from the insurance claims process with a new health insurer report card. “To diagnose the areas of greatest concern within the claims processing system, the AMA has developed its first online rating of health insurers,” said Dr. William Dolan, an AMA board member. The report card, based on a random sample pulled from more than 5 million services billed electronically to Medicare and seven health insurers, found that insurers reported to physicians the correct contracted payment rate only 62%-87% of the time. In addition, it found that there is extremely wide variation among payers as to how often they apply computer-generated edits to reduce payments—from a low of less than 0.5% to a high of more than 9%. Physicians spend as much as 14% of their total revenue to ensure accurate insurance payments for their services, according to the AMA.

With Sen. Barack Obama (D-Ill.) set to become the Democrat's presidential nominee, experts are scrutinizing his health care reform plans.

The centerpiece of Sen. Obama's plan is a public-private system that would allow people to remain in their employer-sponsored health plans while offering the uninsured the chance to purchase either a private or government-sponsored plan.

For the government-sponsored plan, the proposal uses as a model the Federal Employees Health Benefits Program—the system available to federal employees and to Congress. For those who want to purchase insurance on the private market, Sen. Obama proposes a National Health Insurance Exchange. All plans offered through the exchange would be required to offer at least the same coverage as the government-sponsored plan and adhere to the same quality and efficiency standards.

Under the Obama plan, employers that do not offer or contribute to employee health coverage must pay a percentage of their payroll toward the cost of the government health plan. There would be an exemption for some small employers.

The proposal also calls for expanding eligibility for Medicaid and the State Children's Health Insurance Program. The government would offer subsidies to individuals who do not quality for Medicaid or SCHIP but still needed financial assistance to purchase health insurance.

Sen. Obama also would guarantee that no American could be turned down for health insurance because of illness or a preexisting condition. However, his proposal stops short of requiring all Americans to purchase coverage. Instead, the plan mandates coverage for children only.

The other half of Sen. Obama's plan is aimed at reducing premiums and decreasing overall health system costs. Under his plan, the federal government would reimburse employer-sponsored health plans for a portion of the cost of catastrophic health events above a certain threshold. In exchange, the plans would have to use the savings to reduce the cost of premiums.

Cost control also is addressed in the Obama plan, with electronic health records playing a big role. The candidate proposes to spend $10 billion a year for the next 5 years in an effort to encourage widespread adoption of EHRs. The idea is that the investment would reap savings through increased efficiencies since paper records are more costly to store and process than are electronic ones, according to the Obama campaign. The plan also seeks to control costs through greater regulation of insurance companies and by allowing the federal government to negotiate drug prices.

The Obama campaign estimates that the reforms they are proposing would save the average family about $2,500 a year in medical expenses.

But the plan continues to face critics. Grace-Marie Turner, president of the Galen Institute, an organization that favors free-market approaches to health care, said she is concerned that the government-sponsored program would be underpriced and crowd out the private insurance options the same way that Medicare has crowded out private insurance in the over-65 market. “That is not a level playing field,” said Ms. Turner, who also is an adviser to the presidential campaign of Sen. John McCain (R-Ariz.).

Ms. Turner also criticized Sen. Obama's plan to have the federal government take on a portion of the costs of catastrophic health costs in employer-sponsored health plans. This type of approach would require the government to be heavily involved in auditing health care expenditures, she said.

On the left, Dr. Don McCanne, senior health policy fellow with Physicians for a National Health Program, said the plan “falls far, far, short” for continuing to use the private health insurance industry. His organization favors the elimination of private plans.

The concern with providing a government-sponsored plan in competition with private plans is that it would be subjected to adverse selection and the premiums would become unaffordable, Dr. McCanne said. The only way around that would be to provide additional funding through taxes or to have some method of risk pool transfer, in which the private plans with healthier beneficiaries would shift funds to pay for higher risk individuals. But Dr. Jack Lewin, CEO of the American College of Cardiology, said that maintaining the private system is politically smart.

One of the drawbacks of Sen. McCain's plan is that it has the potential to destabilize the existing employer-based coverage system, he said. While it might be a good idea to move away from that system, that should be a gradual process, he said.

Dr. Lewin also praised the Obama plan for starting with coverage for children. However, after the mandate for universal coverage of children, the plan's details are somewhat murky, he said. For example, Sen. Obama's plan commits to improving quality and efficiency in the system but doesn't define how it would be done, he said.

Sen. Obama also has been vague about subsidies, requirements on businesses, and the interaction of the public and private plans, said Len Nichols, director of the health policy program at the New America Foundation, a nonpartisan public policy institute.

In any case, Sen. Obama's plan is likely to get a warm reception in Congress next year, Mr. Nichols predicted. The debate over SCHIP has started the conversation about the need for universal coverage and at the same time a majority of Americans are worried about the affordability of health insurance, he said.

Sen. Obama estimates his plan would save the average family $2,500 per year.

With Sen. Barack Obama (D-Ill.) set to become the Democrat's presidential nominee, experts are scrutinizing his health care reform plans.

The centerpiece of Sen. Obama's plan is a public-private system that would allow people to remain in their employer-sponsored health plans while offering the uninsured the chance to purchase either a private or government-sponsored plan.

For the government-sponsored plan, the proposal uses as a model the Federal Employees Health Benefits Program—the system available to federal employees and to Congress. For those who want to purchase insurance on the private market, Sen. Obama proposes a National Health Insurance Exchange. All plans offered through the exchange would be required to offer at least the same coverage as the government-sponsored plan and adhere to the same quality and efficiency standards.

Under the Obama plan, employers that do not offer or contribute to employee health coverage must pay a percentage of their payroll toward the cost of the government health plan. There would be an exemption for some small employers.

The proposal also calls for expanding eligibility for Medicaid and the State Children's Health Insurance Program. The government would offer subsidies to individuals who do not quality for Medicaid or SCHIP but still needed financial assistance to purchase health insurance.

Sen. Obama also would guarantee that no American could be turned down for health insurance because of illness or a preexisting condition. However, his proposal stops short of requiring all Americans to purchase coverage. Instead, the plan mandates coverage for children only.

The other half of Sen. Obama's plan is aimed at reducing premiums and decreasing overall health system costs. Under his plan, the federal government would reimburse employer-sponsored health plans for a portion of the cost of catastrophic health events above a certain threshold. In exchange, the plans would have to use the savings to reduce the cost of premiums.

Cost control also is addressed in the Obama plan, with electronic health records playing a big role. The candidate proposes to spend $10 billion a year for the next 5 years in an effort to encourage widespread adoption of EHRs. The idea is that the investment would reap savings through increased efficiencies since paper records are more costly to store and process than are electronic ones, according to the Obama campaign. The plan also seeks to control costs through greater regulation of insurance companies and by allowing the federal government to negotiate drug prices.

The Obama campaign estimates that the reforms they are proposing would save the average family about $2,500 a year in medical expenses.

But the plan continues to face critics. Grace-Marie Turner, president of the Galen Institute, an organization that favors free-market approaches to health care, said she is concerned that the government-sponsored program would be underpriced and crowd out the private insurance options the same way that Medicare has crowded out private insurance in the over-65 market. “That is not a level playing field,” said Ms. Turner, who also is an adviser to the presidential campaign of Sen. John McCain (R-Ariz.).

Ms. Turner also criticized Sen. Obama's plan to have the federal government take on a portion of the costs of catastrophic health costs in employer-sponsored health plans. This type of approach would require the government to be heavily involved in auditing health care expenditures, she said.

On the left, Dr. Don McCanne, senior health policy fellow with Physicians for a National Health Program, said the plan “falls far, far, short” for continuing to use the private health insurance industry. His organization favors the elimination of private plans.

The concern with providing a government-sponsored plan in competition with private plans is that it would be subjected to adverse selection and the premiums would become unaffordable, Dr. McCanne said. The only way around that would be to provide additional funding through taxes or to have some method of risk pool transfer, in which the private plans with healthier beneficiaries would shift funds to pay for higher risk individuals. But Dr. Jack Lewin, CEO of the American College of Cardiology, said that maintaining the private system is politically smart.

One of the drawbacks of Sen. McCain's plan is that it has the potential to destabilize the existing employer-based coverage system, he said. While it might be a good idea to move away from that system, that should be a gradual process, he said.

Dr. Lewin also praised the Obama plan for starting with coverage for children. However, after the mandate for universal coverage of children, the plan's details are somewhat murky, he said. For example, Sen. Obama's plan commits to improving quality and efficiency in the system but doesn't define how it would be done, he said.

Sen. Obama also has been vague about subsidies, requirements on businesses, and the interaction of the public and private plans, said Len Nichols, director of the health policy program at the New America Foundation, a nonpartisan public policy institute.

In any case, Sen. Obama's plan is likely to get a warm reception in Congress next year, Mr. Nichols predicted. The debate over SCHIP has started the conversation about the need for universal coverage and at the same time a majority of Americans are worried about the affordability of health insurance, he said.

Sen. Obama estimates his plan would save the average family $2,500 per year.

With Sen. Barack Obama (D-Ill.) set to become the Democrat's presidential nominee, experts are scrutinizing his health care reform plans.

The centerpiece of Sen. Obama's plan is a public-private system that would allow people to remain in their employer-sponsored health plans while offering the uninsured the chance to purchase either a private or government-sponsored plan.

For the government-sponsored plan, the proposal uses as a model the Federal Employees Health Benefits Program—the system available to federal employees and to Congress. For those who want to purchase insurance on the private market, Sen. Obama proposes a National Health Insurance Exchange. All plans offered through the exchange would be required to offer at least the same coverage as the government-sponsored plan and adhere to the same quality and efficiency standards.

Under the Obama plan, employers that do not offer or contribute to employee health coverage must pay a percentage of their payroll toward the cost of the government health plan. There would be an exemption for some small employers.

The proposal also calls for expanding eligibility for Medicaid and the State Children's Health Insurance Program. The government would offer subsidies to individuals who do not quality for Medicaid or SCHIP but still needed financial assistance to purchase health insurance.

Sen. Obama also would guarantee that no American could be turned down for health insurance because of illness or a preexisting condition. However, his proposal stops short of requiring all Americans to purchase coverage. Instead, the plan mandates coverage for children only.

The other half of Sen. Obama's plan is aimed at reducing premiums and decreasing overall health system costs. Under his plan, the federal government would reimburse employer-sponsored health plans for a portion of the cost of catastrophic health events above a certain threshold. In exchange, the plans would have to use the savings to reduce the cost of premiums.

Cost control also is addressed in the Obama plan, with electronic health records playing a big role. The candidate proposes to spend $10 billion a year for the next 5 years in an effort to encourage widespread adoption of EHRs. The idea is that the investment would reap savings through increased efficiencies since paper records are more costly to store and process than are electronic ones, according to the Obama campaign. The plan also seeks to control costs through greater regulation of insurance companies and by allowing the federal government to negotiate drug prices.

The Obama campaign estimates that the reforms they are proposing would save the average family about $2,500 a year in medical expenses.

But the plan continues to face critics. Grace-Marie Turner, president of the Galen Institute, an organization that favors free-market approaches to health care, said she is concerned that the government-sponsored program would be underpriced and crowd out the private insurance options the same way that Medicare has crowded out private insurance in the over-65 market. “That is not a level playing field,” said Ms. Turner, who also is an adviser to the presidential campaign of Sen. John McCain (R-Ariz.).

Ms. Turner also criticized Sen. Obama's plan to have the federal government take on a portion of the costs of catastrophic health costs in employer-sponsored health plans. This type of approach would require the government to be heavily involved in auditing health care expenditures, she said.

On the left, Dr. Don McCanne, senior health policy fellow with Physicians for a National Health Program, said the plan “falls far, far, short” for continuing to use the private health insurance industry. His organization favors the elimination of private plans.

The concern with providing a government-sponsored plan in competition with private plans is that it would be subjected to adverse selection and the premiums would become unaffordable, Dr. McCanne said. The only way around that would be to provide additional funding through taxes or to have some method of risk pool transfer, in which the private plans with healthier beneficiaries would shift funds to pay for higher risk individuals. But Dr. Jack Lewin, CEO of the American College of Cardiology, said that maintaining the private system is politically smart.

One of the drawbacks of Sen. McCain's plan is that it has the potential to destabilize the existing employer-based coverage system, he said. While it might be a good idea to move away from that system, that should be a gradual process, he said.

Dr. Lewin also praised the Obama plan for starting with coverage for children. However, after the mandate for universal coverage of children, the plan's details are somewhat murky, he said. For example, Sen. Obama's plan commits to improving quality and efficiency in the system but doesn't define how it would be done, he said.

Sen. Obama also has been vague about subsidies, requirements on businesses, and the interaction of the public and private plans, said Len Nichols, director of the health policy program at the New America Foundation, a nonpartisan public policy institute.

In any case, Sen. Obama's plan is likely to get a warm reception in Congress next year, Mr. Nichols predicted. The debate over SCHIP has started the conversation about the need for universal coverage and at the same time a majority of Americans are worried about the affordability of health insurance, he said.

Sen. Obama estimates his plan would save the average family $2,500 per year.

The strategic plan is available at www.hhs.gov/healthit

If the feds have it their way, 40% of physician offices will use certified electronic health records by 2012 as part of a strategic plan for coordinating the federal government's health IT efforts over the next 4 years.

About 14% of physicians had adopted some form of health information technology (IT) by 2007, according to the Office of the National Coordinator for Health Information Technology, which released the strategic plan. Specifically, the plan calls for removing business barriers and disincentives for adoption of electronic health records (EHRs) and providing training and technical assistance.

For example, the plan says that by next year information on low-cost and effective provider support on EHR adoption should be available online.

The plan also calls for increasing the health IT workforce by training more standards developers, ensuring vendors are trained in the implementation of health IT tools, and training physicians and other health care providers in informatics.

It also highlights the need to address physician concerns about liability risks related to the exchange of electronic health information.

In addition to issues related to adoption, the plan lays out goals for achieving patient-focused health care through electronic health record access, and enabling the use of electronic health data to benefit public health, research, and emergency preparedness.

“[The plan] establishes the next generation of health IT milestones to harness the power of information technology to help transform health and care in this country,” Dr. Robert Kolodner, national coordinator for health information technology, said in a statement.

The goals are all positive, said Dr. Steven Waldren, director of the Center for Health Information Technology at the American Academy of Family Physicians, but the plan does not place enough emphasis on the need to provide financial incentives to physicians for purchasing and using electronic health record systems, he said.

“The real bottom line is getting the payment reform that is needed in health care today,” Dr. Waldren said.

The strategic plan represents a “reasonable approach” going forward and gives a sense of how to achieve the President's objective of greater access to EHRs, commented Dan Rode, vice president of policy and government relations at the American Health Information Management Association.

However, many of the items don't have specific timetables for completion but will instead be reassessed in 2010, he said, leaving a lot to be accomplished before 2014.

And while the plan outlines the objectives envisioned by the current administration, the goals and strategies could change with a new president who may be proposing changes to the way health care is delivered, Mr. Rode said.

The plan was developed by the Office of the National Coordinator for Health IT in collaboration with 12 agencies within the Department of Health and Human Services, along with the departments of Commerce, Defense, and Veterans Affairs, and the Federal Communications Commission. The National Committee on Vital Statistics and the American Health Information Community also contributed to the plan.

The strategic plan is available at www.hhs.gov/healthit

If the feds have it their way, 40% of physician offices will use certified electronic health records by 2012 as part of a strategic plan for coordinating the federal government's health IT efforts over the next 4 years.

About 14% of physicians had adopted some form of health information technology (IT) by 2007, according to the Office of the National Coordinator for Health Information Technology, which released the strategic plan. Specifically, the plan calls for removing business barriers and disincentives for adoption of electronic health records (EHRs) and providing training and technical assistance.

For example, the plan says that by next year information on low-cost and effective provider support on EHR adoption should be available online.

The plan also calls for increasing the health IT workforce by training more standards developers, ensuring vendors are trained in the implementation of health IT tools, and training physicians and other health care providers in informatics.

It also highlights the need to address physician concerns about liability risks related to the exchange of electronic health information.

In addition to issues related to adoption, the plan lays out goals for achieving patient-focused health care through electronic health record access, and enabling the use of electronic health data to benefit public health, research, and emergency preparedness.

“[The plan] establishes the next generation of health IT milestones to harness the power of information technology to help transform health and care in this country,” Dr. Robert Kolodner, national coordinator for health information technology, said in a statement.

The goals are all positive, said Dr. Steven Waldren, director of the Center for Health Information Technology at the American Academy of Family Physicians, but the plan does not place enough emphasis on the need to provide financial incentives to physicians for purchasing and using electronic health record systems, he said.

“The real bottom line is getting the payment reform that is needed in health care today,” Dr. Waldren said.

The strategic plan represents a “reasonable approach” going forward and gives a sense of how to achieve the President's objective of greater access to EHRs, commented Dan Rode, vice president of policy and government relations at the American Health Information Management Association.

However, many of the items don't have specific timetables for completion but will instead be reassessed in 2010, he said, leaving a lot to be accomplished before 2014.

And while the plan outlines the objectives envisioned by the current administration, the goals and strategies could change with a new president who may be proposing changes to the way health care is delivered, Mr. Rode said.

The plan was developed by the Office of the National Coordinator for Health IT in collaboration with 12 agencies within the Department of Health and Human Services, along with the departments of Commerce, Defense, and Veterans Affairs, and the Federal Communications Commission. The National Committee on Vital Statistics and the American Health Information Community also contributed to the plan.

The strategic plan is available at www.hhs.gov/healthit

If the feds have it their way, 40% of physician offices will use certified electronic health records by 2012 as part of a strategic plan for coordinating the federal government's health IT efforts over the next 4 years.

About 14% of physicians had adopted some form of health information technology (IT) by 2007, according to the Office of the National Coordinator for Health Information Technology, which released the strategic plan. Specifically, the plan calls for removing business barriers and disincentives for adoption of electronic health records (EHRs) and providing training and technical assistance.

For example, the plan says that by next year information on low-cost and effective provider support on EHR adoption should be available online.

The plan also calls for increasing the health IT workforce by training more standards developers, ensuring vendors are trained in the implementation of health IT tools, and training physicians and other health care providers in informatics.

It also highlights the need to address physician concerns about liability risks related to the exchange of electronic health information.

In addition to issues related to adoption, the plan lays out goals for achieving patient-focused health care through electronic health record access, and enabling the use of electronic health data to benefit public health, research, and emergency preparedness.

“[The plan] establishes the next generation of health IT milestones to harness the power of information technology to help transform health and care in this country,” Dr. Robert Kolodner, national coordinator for health information technology, said in a statement.

The goals are all positive, said Dr. Steven Waldren, director of the Center for Health Information Technology at the American Academy of Family Physicians, but the plan does not place enough emphasis on the need to provide financial incentives to physicians for purchasing and using electronic health record systems, he said.

“The real bottom line is getting the payment reform that is needed in health care today,” Dr. Waldren said.

The strategic plan represents a “reasonable approach” going forward and gives a sense of how to achieve the President's objective of greater access to EHRs, commented Dan Rode, vice president of policy and government relations at the American Health Information Management Association.

However, many of the items don't have specific timetables for completion but will instead be reassessed in 2010, he said, leaving a lot to be accomplished before 2014.

And while the plan outlines the objectives envisioned by the current administration, the goals and strategies could change with a new president who may be proposing changes to the way health care is delivered, Mr. Rode said.

The plan was developed by the Office of the National Coordinator for Health IT in collaboration with 12 agencies within the Department of Health and Human Services, along with the departments of Commerce, Defense, and Veterans Affairs, and the Federal Communications Commission. The National Committee on Vital Statistics and the American Health Information Community also contributed to the plan.

New RA Quality Measures Drafted

The National Committee for Quality Assurance, the American Medical Association, and Mathematica Policy Research Inc. have released a draft set of 22 clinical measures that assess physician performance in rheumatoid arthritis; palliative and end-of-life care; endoscopy and polyp surveillance; and chronic wound care. When made final, the measures will be submitted to the Centers for Medicare and Medicaid Services for possible inclusion in its pay-for-reporting program, according to NCQA. The measures also could be used in other quality improvement initiatives, in maintenance of certification programs, or as part of pay-for-performance programs. The development of the measures will help CMS officials and others “drive quality improvement,” Margaret E. O'Kane, NCQA president, said in a statement. The draft set six measures related to rheumatoid arthritis, which were developed in collaboration with the American College of Rheumatology.

Feds Seek Help in Bone Campaign

The federal government is reaching out to organizations that promote bone health and girls' health to help to increase national awareness of behaviors that contribute to good bone health in girls. The Department of Health and Human Services' Office of Women's Health recently issued a request for groups to offer advice on the development and dissemination of campaign materials related to the National Bone Health Campaign. The campaign is aimed at helping girls increase their calcium and vitamin D consumption and weight-bearing physical activity with the goal of building strong bones. The national social marketing campaign will target girls, parents, and health care providers.

Vioxx Victories

Merck & Co. cannot be sued for the cost of medical monitoring associated with past use of Vioxx (rofecoxib), according to a recent ruling from the New Jersey Supreme Court. That court overruled an appellate court and found that individuals who used Vioxx, but had not suffered an injury related to the drug, could not sue the company for the cost of monitoring, such as electrocardiograms or follow-up cardiology consultations. Merck also scored a victory in Texas when a state appeals court overturned a 2005 jury verdict against the company. In that case, Ernst v. Merck, the jury had originally awarded the plaintiff more than $24 million in compensatory damages and $229 million in punitive damages. The punitive damages award had already been reduced to $1.65 million under a Texas law that limits punitive damages.

AHIP Proposes Reform Plan

The United States could reduce total health care spending by $145 billion in the next 7 years while improving the quality of patient care by implementing five proposals, according to a plan from the industry group America's Health Insurance Plans. The AHIP plan endorsed a combination of measures to improve the U.S. health care system and save money, including prevention; better disease management and care coordination; a move to electronic transactions; a transition to a value-based payment system; and new technology. The group also called for replacing the current medical liability system with dispute resolution that would put in place an objective, independent administrative process to provide a quick and fair end to disputes and promote evidence-based medicine. AHIP President and CEO Karen Ignagni said that most pieces of her group's proposal now are in use by health insurance companies. “Plans have made measurable progress, but the nation needs a coordinated approach across the public and private sectors to maximize the impact of these strategies,” she said in a statement.

CMS Outlines Hospice Rights

CMS has made final regulations that give Medicare beneficiaries with terminal illnesses the right to determine how they receive end-of-life care. The provisions, contained in an overhaul of regulations governing the hospice industry, include explicit language on patient rights that had not existed under the previous regulations, CMS said. According to the new rule, patients who choose hospice or palliative care over curative treatment are entitled to such things as participation in their treatment plan, the right to effective pain management, the right to refuse treatment, and the right to choose their own physician. CMS noted that although many hospice patients already are active in their own treatment plans, this regulation is the first to set out a detailed list of patient rights. “End-of-life care has changed markedly in the past 25 years and it is time to update our regulations to reflect advances in medicine and hospice industry practices as well as patient rights,” said CMS Acting Administrator Kerry Weems in a statement.

New RA Quality Measures Drafted

The National Committee for Quality Assurance, the American Medical Association, and Mathematica Policy Research Inc. have released a draft set of 22 clinical measures that assess physician performance in rheumatoid arthritis; palliative and end-of-life care; endoscopy and polyp surveillance; and chronic wound care. When made final, the measures will be submitted to the Centers for Medicare and Medicaid Services for possible inclusion in its pay-for-reporting program, according to NCQA. The measures also could be used in other quality improvement initiatives, in maintenance of certification programs, or as part of pay-for-performance programs. The development of the measures will help CMS officials and others “drive quality improvement,” Margaret E. O'Kane, NCQA president, said in a statement. The draft set six measures related to rheumatoid arthritis, which were developed in collaboration with the American College of Rheumatology.

Feds Seek Help in Bone Campaign

The federal government is reaching out to organizations that promote bone health and girls' health to help to increase national awareness of behaviors that contribute to good bone health in girls. The Department of Health and Human Services' Office of Women's Health recently issued a request for groups to offer advice on the development and dissemination of campaign materials related to the National Bone Health Campaign. The campaign is aimed at helping girls increase their calcium and vitamin D consumption and weight-bearing physical activity with the goal of building strong bones. The national social marketing campaign will target girls, parents, and health care providers.

Vioxx Victories

Merck & Co. cannot be sued for the cost of medical monitoring associated with past use of Vioxx (rofecoxib), according to a recent ruling from the New Jersey Supreme Court. That court overruled an appellate court and found that individuals who used Vioxx, but had not suffered an injury related to the drug, could not sue the company for the cost of monitoring, such as electrocardiograms or follow-up cardiology consultations. Merck also scored a victory in Texas when a state appeals court overturned a 2005 jury verdict against the company. In that case, Ernst v. Merck, the jury had originally awarded the plaintiff more than $24 million in compensatory damages and $229 million in punitive damages. The punitive damages award had already been reduced to $1.65 million under a Texas law that limits punitive damages.

AHIP Proposes Reform Plan

The United States could reduce total health care spending by $145 billion in the next 7 years while improving the quality of patient care by implementing five proposals, according to a plan from the industry group America's Health Insurance Plans. The AHIP plan endorsed a combination of measures to improve the U.S. health care system and save money, including prevention; better disease management and care coordination; a move to electronic transactions; a transition to a value-based payment system; and new technology. The group also called for replacing the current medical liability system with dispute resolution that would put in place an objective, independent administrative process to provide a quick and fair end to disputes and promote evidence-based medicine. AHIP President and CEO Karen Ignagni said that most pieces of her group's proposal now are in use by health insurance companies. “Plans have made measurable progress, but the nation needs a coordinated approach across the public and private sectors to maximize the impact of these strategies,” she said in a statement.

CMS Outlines Hospice Rights

CMS has made final regulations that give Medicare beneficiaries with terminal illnesses the right to determine how they receive end-of-life care. The provisions, contained in an overhaul of regulations governing the hospice industry, include explicit language on patient rights that had not existed under the previous regulations, CMS said. According to the new rule, patients who choose hospice or palliative care over curative treatment are entitled to such things as participation in their treatment plan, the right to effective pain management, the right to refuse treatment, and the right to choose their own physician. CMS noted that although many hospice patients already are active in their own treatment plans, this regulation is the first to set out a detailed list of patient rights. “End-of-life care has changed markedly in the past 25 years and it is time to update our regulations to reflect advances in medicine and hospice industry practices as well as patient rights,” said CMS Acting Administrator Kerry Weems in a statement.

New RA Quality Measures Drafted

The National Committee for Quality Assurance, the American Medical Association, and Mathematica Policy Research Inc. have released a draft set of 22 clinical measures that assess physician performance in rheumatoid arthritis; palliative and end-of-life care; endoscopy and polyp surveillance; and chronic wound care. When made final, the measures will be submitted to the Centers for Medicare and Medicaid Services for possible inclusion in its pay-for-reporting program, according to NCQA. The measures also could be used in other quality improvement initiatives, in maintenance of certification programs, or as part of pay-for-performance programs. The development of the measures will help CMS officials and others “drive quality improvement,” Margaret E. O'Kane, NCQA president, said in a statement. The draft set six measures related to rheumatoid arthritis, which were developed in collaboration with the American College of Rheumatology.

Feds Seek Help in Bone Campaign

The federal government is reaching out to organizations that promote bone health and girls' health to help to increase national awareness of behaviors that contribute to good bone health in girls. The Department of Health and Human Services' Office of Women's Health recently issued a request for groups to offer advice on the development and dissemination of campaign materials related to the National Bone Health Campaign. The campaign is aimed at helping girls increase their calcium and vitamin D consumption and weight-bearing physical activity with the goal of building strong bones. The national social marketing campaign will target girls, parents, and health care providers.

Vioxx Victories

Merck & Co. cannot be sued for the cost of medical monitoring associated with past use of Vioxx (rofecoxib), according to a recent ruling from the New Jersey Supreme Court. That court overruled an appellate court and found that individuals who used Vioxx, but had not suffered an injury related to the drug, could not sue the company for the cost of monitoring, such as electrocardiograms or follow-up cardiology consultations. Merck also scored a victory in Texas when a state appeals court overturned a 2005 jury verdict against the company. In that case, Ernst v. Merck, the jury had originally awarded the plaintiff more than $24 million in compensatory damages and $229 million in punitive damages. The punitive damages award had already been reduced to $1.65 million under a Texas law that limits punitive damages.

AHIP Proposes Reform Plan

The United States could reduce total health care spending by $145 billion in the next 7 years while improving the quality of patient care by implementing five proposals, according to a plan from the industry group America's Health Insurance Plans. The AHIP plan endorsed a combination of measures to improve the U.S. health care system and save money, including prevention; better disease management and care coordination; a move to electronic transactions; a transition to a value-based payment system; and new technology. The group also called for replacing the current medical liability system with dispute resolution that would put in place an objective, independent administrative process to provide a quick and fair end to disputes and promote evidence-based medicine. AHIP President and CEO Karen Ignagni said that most pieces of her group's proposal now are in use by health insurance companies. “Plans have made measurable progress, but the nation needs a coordinated approach across the public and private sectors to maximize the impact of these strategies,” she said in a statement.

CMS Outlines Hospice Rights

CMS has made final regulations that give Medicare beneficiaries with terminal illnesses the right to determine how they receive end-of-life care. The provisions, contained in an overhaul of regulations governing the hospice industry, include explicit language on patient rights that had not existed under the previous regulations, CMS said. According to the new rule, patients who choose hospice or palliative care over curative treatment are entitled to such things as participation in their treatment plan, the right to effective pain management, the right to refuse treatment, and the right to choose their own physician. CMS noted that although many hospice patients already are active in their own treatment plans, this regulation is the first to set out a detailed list of patient rights. “End-of-life care has changed markedly in the past 25 years and it is time to update our regulations to reflect advances in medicine and hospice industry practices as well as patient rights,” said CMS Acting Administrator Kerry Weems in a statement.

Patients will soon be able to undergo genetic testing without fear of discrimination from either their health insurers or their employers, thanks to a new law signed in May by President Bush.

The Genetic Information Nondiscrimination Act (H.R. 493), which passed both houses of Congress by wide margins, prohibits health insurers from using genetic information in determining eligibility or setting premiums and forbids employers from using that information for decisions about hiring, firing, job assignments, or promotions. The law also prohibits health insurers and employers from requesting or requiring that individuals take a genetic test. The health insurance provisions in the law will go into effect in 12 months, and the employment provisions will take effect in 18 months.

“Genetic testing holds great promise for improving public health, and patients must be able to trust that their genetic information will be protected from inappropriate and discriminatory uses,” Dr. Edward Langston, board chair of the American Medical Association, said in a statement. “This new law will allow patients to take advantage of scientific advances in genetics, such as screenings and therapies, without worrying that their personal health information could be used against them by insurers or employers.”

Supporters of the law are hailing it as the first civil rights legislation of the new millennium. In practice, experts say that it will mean that patients who might have been hesitant to undergo testing for fear of discrimination may be more willing. Some patients who would be good candidates for genetic testing have been refusing the tests, or in some cases taking them under an assumed name, said Sharon Terry, president of the Coalition for Genetic Fairness, and CEO of the Genetic Alliance.

The frequency of genetic discrimination has been difficult to document, but it's clear that fear of discrimination has been a barrier to genetic services for some patients, said Dr. Matthew Taylor, director of adult clinical genetics at the University of Colorado in Denver. For example, last year the Genetics and Public Policy Center at Johns Hopkins University, Baltimore, conducted a survey of 1,199 U.S. adults on genetic testing and discrimination. The researchers found that 92% of respondents expressed concern that the results of a genetic test for disease risk could be used against them in some way.

One of the biggest impacts of the law may be its potential to alleviate concerns about genetic discrimination among both patients and physicians, Dr. Taylor said.

Another area where the law is likely to have a significant impact is in research. Many informed consent forms for clinical trials include statements warning participants that they could be discriminated against on the basis of their genetic information, according to Ms. Terry. The Coalition for Genetic Fairness plans to mount an educational campaign to make patients and physicians aware of the new protections in the law in the hopes of increasing participation in research, she said.

The law was a long time coming, according to supporters. Legislation on genetic nondiscrimination was first introduced in 1995. The bill has had broad support in Congress for many years but couldn't get to the House floor under the Republican leadership, according to Susannah Baruch, associate director of the Genetics and Public Policy Center at Johns Hopkins University. The other change that propelled the legislation forward was the explosion in the number of genetic tests available, she said.

About 1,200 genetic tests can be used to identify thousands of health conditions, according to the Coalition for Genetic Fairness. Only about 100 genetic tests were available a decade ago.

Over time, the legislation has garnered support from a broad coalition of groups, including the health insurance industry. “With this landmark bipartisan legislation, Congress and the President have taken strong action to prohibit discrimination based on a person's genetic makeup and to protect patients' privacy as they pursue genetic evaluations,” Karen Ignagni, president and CEO of America's Health Insurance Plans, said in a statement. “This legislation also ensures that patients can continue to benefit from health plans' innovative early detection and care coordination programs that improve the safety and quality of care.”

But more work needs to be done, Ms. Terry said. The Coalition for Genetic Fairness has been working with Sen. Edward Kennedy (D.-Mass.) and Sen. Barack Obama (D.-Ill.) on better oversight for genetic testing in general. And the Agency for Healthcare Research and Quality recently issued a report calling for improvements to public health surveillance databases and health information technology used to monitor genetic tests.”

Patients will soon be able to undergo genetic testing without fear of discrimination from either their health insurers or their employers, thanks to a new law signed in May by President Bush.

The Genetic Information Nondiscrimination Act (H.R. 493), which passed both houses of Congress by wide margins, prohibits health insurers from using genetic information in determining eligibility or setting premiums and forbids employers from using that information for decisions about hiring, firing, job assignments, or promotions. The law also prohibits health insurers and employers from requesting or requiring that individuals take a genetic test. The health insurance provisions in the law will go into effect in 12 months, and the employment provisions will take effect in 18 months.

“Genetic testing holds great promise for improving public health, and patients must be able to trust that their genetic information will be protected from inappropriate and discriminatory uses,” Dr. Edward Langston, board chair of the American Medical Association, said in a statement. “This new law will allow patients to take advantage of scientific advances in genetics, such as screenings and therapies, without worrying that their personal health information could be used against them by insurers or employers.”

Supporters of the law are hailing it as the first civil rights legislation of the new millennium. In practice, experts say that it will mean that patients who might have been hesitant to undergo testing for fear of discrimination may be more willing. Some patients who would be good candidates for genetic testing have been refusing the tests, or in some cases taking them under an assumed name, said Sharon Terry, president of the Coalition for Genetic Fairness, and CEO of the Genetic Alliance.

The frequency of genetic discrimination has been difficult to document, but it's clear that fear of discrimination has been a barrier to genetic services for some patients, said Dr. Matthew Taylor, director of adult clinical genetics at the University of Colorado in Denver. For example, last year the Genetics and Public Policy Center at Johns Hopkins University, Baltimore, conducted a survey of 1,199 U.S. adults on genetic testing and discrimination. The researchers found that 92% of respondents expressed concern that the results of a genetic test for disease risk could be used against them in some way.

One of the biggest impacts of the law may be its potential to alleviate concerns about genetic discrimination among both patients and physicians, Dr. Taylor said.

Another area where the law is likely to have a significant impact is in research. Many informed consent forms for clinical trials include statements warning participants that they could be discriminated against on the basis of their genetic information, according to Ms. Terry. The Coalition for Genetic Fairness plans to mount an educational campaign to make patients and physicians aware of the new protections in the law in the hopes of increasing participation in research, she said.

The law was a long time coming, according to supporters. Legislation on genetic nondiscrimination was first introduced in 1995. The bill has had broad support in Congress for many years but couldn't get to the House floor under the Republican leadership, according to Susannah Baruch, associate director of the Genetics and Public Policy Center at Johns Hopkins University. The other change that propelled the legislation forward was the explosion in the number of genetic tests available, she said.

About 1,200 genetic tests can be used to identify thousands of health conditions, according to the Coalition for Genetic Fairness. Only about 100 genetic tests were available a decade ago.

Over time, the legislation has garnered support from a broad coalition of groups, including the health insurance industry. “With this landmark bipartisan legislation, Congress and the President have taken strong action to prohibit discrimination based on a person's genetic makeup and to protect patients' privacy as they pursue genetic evaluations,” Karen Ignagni, president and CEO of America's Health Insurance Plans, said in a statement. “This legislation also ensures that patients can continue to benefit from health plans' innovative early detection and care coordination programs that improve the safety and quality of care.”

But more work needs to be done, Ms. Terry said. The Coalition for Genetic Fairness has been working with Sen. Edward Kennedy (D.-Mass.) and Sen. Barack Obama (D.-Ill.) on better oversight for genetic testing in general. And the Agency for Healthcare Research and Quality recently issued a report calling for improvements to public health surveillance databases and health information technology used to monitor genetic tests.”

Patients will soon be able to undergo genetic testing without fear of discrimination from either their health insurers or their employers, thanks to a new law signed in May by President Bush.

The Genetic Information Nondiscrimination Act (H.R. 493), which passed both houses of Congress by wide margins, prohibits health insurers from using genetic information in determining eligibility or setting premiums and forbids employers from using that information for decisions about hiring, firing, job assignments, or promotions. The law also prohibits health insurers and employers from requesting or requiring that individuals take a genetic test. The health insurance provisions in the law will go into effect in 12 months, and the employment provisions will take effect in 18 months.

“Genetic testing holds great promise for improving public health, and patients must be able to trust that their genetic information will be protected from inappropriate and discriminatory uses,” Dr. Edward Langston, board chair of the American Medical Association, said in a statement. “This new law will allow patients to take advantage of scientific advances in genetics, such as screenings and therapies, without worrying that their personal health information could be used against them by insurers or employers.”

Supporters of the law are hailing it as the first civil rights legislation of the new millennium. In practice, experts say that it will mean that patients who might have been hesitant to undergo testing for fear of discrimination may be more willing. Some patients who would be good candidates for genetic testing have been refusing the tests, or in some cases taking them under an assumed name, said Sharon Terry, president of the Coalition for Genetic Fairness, and CEO of the Genetic Alliance.

The frequency of genetic discrimination has been difficult to document, but it's clear that fear of discrimination has been a barrier to genetic services for some patients, said Dr. Matthew Taylor, director of adult clinical genetics at the University of Colorado in Denver. For example, last year the Genetics and Public Policy Center at Johns Hopkins University, Baltimore, conducted a survey of 1,199 U.S. adults on genetic testing and discrimination. The researchers found that 92% of respondents expressed concern that the results of a genetic test for disease risk could be used against them in some way.

One of the biggest impacts of the law may be its potential to alleviate concerns about genetic discrimination among both patients and physicians, Dr. Taylor said.

Another area where the law is likely to have a significant impact is in research. Many informed consent forms for clinical trials include statements warning participants that they could be discriminated against on the basis of their genetic information, according to Ms. Terry. The Coalition for Genetic Fairness plans to mount an educational campaign to make patients and physicians aware of the new protections in the law in the hopes of increasing participation in research, she said.

The law was a long time coming, according to supporters. Legislation on genetic nondiscrimination was first introduced in 1995. The bill has had broad support in Congress for many years but couldn't get to the House floor under the Republican leadership, according to Susannah Baruch, associate director of the Genetics and Public Policy Center at Johns Hopkins University. The other change that propelled the legislation forward was the explosion in the number of genetic tests available, she said.

About 1,200 genetic tests can be used to identify thousands of health conditions, according to the Coalition for Genetic Fairness. Only about 100 genetic tests were available a decade ago.

Over time, the legislation has garnered support from a broad coalition of groups, including the health insurance industry. “With this landmark bipartisan legislation, Congress and the President have taken strong action to prohibit discrimination based on a person's genetic makeup and to protect patients' privacy as they pursue genetic evaluations,” Karen Ignagni, president and CEO of America's Health Insurance Plans, said in a statement. “This legislation also ensures that patients can continue to benefit from health plans' innovative early detection and care coordination programs that improve the safety and quality of care.”

But more work needs to be done, Ms. Terry said. The Coalition for Genetic Fairness has been working with Sen. Edward Kennedy (D.-Mass.) and Sen. Barack Obama (D.-Ill.) on better oversight for genetic testing in general. And the Agency for Healthcare Research and Quality recently issued a report calling for improvements to public health surveillance databases and health information technology used to monitor genetic tests.”

The Food and Drug Administration has developed a new national electronic surveillance system that will allow it to search and analyze claims data and other clinical databases for postmarket adverse events for drugs and medical devices.

The Sentinel Initiative is designed to bring safety concerns from approved drugs and other medical products to FDA's attention faster than the traditional MedWatch adverse event reporting system alone.

“We are moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market,” Health and Human Services Secretary Mike Leavitt said during a press conference to announce the initiative. “The result will be much-improved safety and protections for the American people.”

During the first phase of the project, FDA will rely on Medicare data. As part of a pilot collaboration with the Centers for Medicare and Medicaid Services, FDA officials will use the Sentinel system to query Medicare Part D prescription drug claims data, which will be linked to Medicare inpatient and outpatient claims data. The Part D database currently holds information on medications used by more than 25 million beneficiaries, according to HHS.

FDA will begin to look into the data in 30 days, following the publication of a final regulation that will allow federal agencies, states, and academic researchers to use claims data from the Part D program for safety research and quality initiatives.

Starting with the Medicare population will provide valuable data on the elderly and disabled population, said Kerry N. Weems, acting CMS administrator. Drug safety and efficacy data is usually limited in this group because they are excluded from clinical trials. This population also is at greater risk for medication side effects because of polypharmacy and many chronic diseases, according to CMS.

In the future, FDA officials hope to be able to query data from other government agencies, such as the Department of Defense and the Department of Veterans Affairs, as well as from large private health plans, said Dr. Andrew C. von Eschenbach, FDA commissioner.

He added that the Sentinel Initiative includes patient privacy protections. The system queries existing databases without actually acquiring the data. Essentially, the system asks questions and gets answers without identifying patient information, Dr. von Eschenbach said.

The Sentinel system will work in conjunction with the existing FDA surveillance systems. For example, if the FDA receives a report of an adverse event following the use of a drug, officials will be able to query data on a large number of subjects who have taken the drug. And, in the future, agency officials may even be able to compare data from patients taking the drug with a control group of similar patients who have not taken the drug. This will allow FDA officials to give physicians better information about what particular groups of patients may be at higher risk for a specific adverse event, said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.

“Although it won't answer all the questions, it will provide us with a tremendous new source of information,” Dr. Woodcock said.

The Institute of Medicine called on the FDA in a 2006 report to create an active surveillance system to improve the safety of drugs. In addition, the Food and Drug Administration Amendments Act of 2007 (FDAAA) directs the FDA to develop a proactive surveillance system.

The Sentinel Initiative has garnered the support of the Pharmaceutical Research and Manufacturers of America. The group issued a statement praising the movement from voluntary reporting alone to a system that incorporates proactive monitoring of drugs and other medical products. “This program should improve the efficiency of postmarket surveillance of medicines and, in the end, the beneficiaries will be the many patients using these products,” said Ken Johnson, senior vice president of PhRMA.

We are moving from a reactive dependence on voluntary reporting to a proactive surveillance of current products. MR. LEAVITT

The Food and Drug Administration has developed a new national electronic surveillance system that will allow it to search and analyze claims data and other clinical databases for postmarket adverse events for drugs and medical devices.

The Sentinel Initiative is designed to bring safety concerns from approved drugs and other medical products to FDA's attention faster than the traditional MedWatch adverse event reporting system alone.

“We are moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market,” Health and Human Services Secretary Mike Leavitt said during a press conference to announce the initiative. “The result will be much-improved safety and protections for the American people.”

During the first phase of the project, FDA will rely on Medicare data. As part of a pilot collaboration with the Centers for Medicare and Medicaid Services, FDA officials will use the Sentinel system to query Medicare Part D prescription drug claims data, which will be linked to Medicare inpatient and outpatient claims data. The Part D database currently holds information on medications used by more than 25 million beneficiaries, according to HHS.

FDA will begin to look into the data in 30 days, following the publication of a final regulation that will allow federal agencies, states, and academic researchers to use claims data from the Part D program for safety research and quality initiatives.

Starting with the Medicare population will provide valuable data on the elderly and disabled population, said Kerry N. Weems, acting CMS administrator. Drug safety and efficacy data is usually limited in this group because they are excluded from clinical trials. This population also is at greater risk for medication side effects because of polypharmacy and many chronic diseases, according to CMS.

In the future, FDA officials hope to be able to query data from other government agencies, such as the Department of Defense and the Department of Veterans Affairs, as well as from large private health plans, said Dr. Andrew C. von Eschenbach, FDA commissioner.

He added that the Sentinel Initiative includes patient privacy protections. The system queries existing databases without actually acquiring the data. Essentially, the system asks questions and gets answers without identifying patient information, Dr. von Eschenbach said.

The Sentinel system will work in conjunction with the existing FDA surveillance systems. For example, if the FDA receives a report of an adverse event following the use of a drug, officials will be able to query data on a large number of subjects who have taken the drug. And, in the future, agency officials may even be able to compare data from patients taking the drug with a control group of similar patients who have not taken the drug. This will allow FDA officials to give physicians better information about what particular groups of patients may be at higher risk for a specific adverse event, said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.

“Although it won't answer all the questions, it will provide us with a tremendous new source of information,” Dr. Woodcock said.

The Institute of Medicine called on the FDA in a 2006 report to create an active surveillance system to improve the safety of drugs. In addition, the Food and Drug Administration Amendments Act of 2007 (FDAAA) directs the FDA to develop a proactive surveillance system.

The Sentinel Initiative has garnered the support of the Pharmaceutical Research and Manufacturers of America. The group issued a statement praising the movement from voluntary reporting alone to a system that incorporates proactive monitoring of drugs and other medical products. “This program should improve the efficiency of postmarket surveillance of medicines and, in the end, the beneficiaries will be the many patients using these products,” said Ken Johnson, senior vice president of PhRMA.

We are moving from a reactive dependence on voluntary reporting to a proactive surveillance of current products. MR. LEAVITT

The Food and Drug Administration has developed a new national electronic surveillance system that will allow it to search and analyze claims data and other clinical databases for postmarket adverse events for drugs and medical devices.

The Sentinel Initiative is designed to bring safety concerns from approved drugs and other medical products to FDA's attention faster than the traditional MedWatch adverse event reporting system alone.

“We are moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market,” Health and Human Services Secretary Mike Leavitt said during a press conference to announce the initiative. “The result will be much-improved safety and protections for the American people.”

During the first phase of the project, FDA will rely on Medicare data. As part of a pilot collaboration with the Centers for Medicare and Medicaid Services, FDA officials will use the Sentinel system to query Medicare Part D prescription drug claims data, which will be linked to Medicare inpatient and outpatient claims data. The Part D database currently holds information on medications used by more than 25 million beneficiaries, according to HHS.

FDA will begin to look into the data in 30 days, following the publication of a final regulation that will allow federal agencies, states, and academic researchers to use claims data from the Part D program for safety research and quality initiatives.

Starting with the Medicare population will provide valuable data on the elderly and disabled population, said Kerry N. Weems, acting CMS administrator. Drug safety and efficacy data is usually limited in this group because they are excluded from clinical trials. This population also is at greater risk for medication side effects because of polypharmacy and many chronic diseases, according to CMS.

In the future, FDA officials hope to be able to query data from other government agencies, such as the Department of Defense and the Department of Veterans Affairs, as well as from large private health plans, said Dr. Andrew C. von Eschenbach, FDA commissioner.

He added that the Sentinel Initiative includes patient privacy protections. The system queries existing databases without actually acquiring the data. Essentially, the system asks questions and gets answers without identifying patient information, Dr. von Eschenbach said.

The Sentinel system will work in conjunction with the existing FDA surveillance systems. For example, if the FDA receives a report of an adverse event following the use of a drug, officials will be able to query data on a large number of subjects who have taken the drug. And, in the future, agency officials may even be able to compare data from patients taking the drug with a control group of similar patients who have not taken the drug. This will allow FDA officials to give physicians better information about what particular groups of patients may be at higher risk for a specific adverse event, said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.

“Although it won't answer all the questions, it will provide us with a tremendous new source of information,” Dr. Woodcock said.

The Institute of Medicine called on the FDA in a 2006 report to create an active surveillance system to improve the safety of drugs. In addition, the Food and Drug Administration Amendments Act of 2007 (FDAAA) directs the FDA to develop a proactive surveillance system.

The Sentinel Initiative has garnered the support of the Pharmaceutical Research and Manufacturers of America. The group issued a statement praising the movement from voluntary reporting alone to a system that incorporates proactive monitoring of drugs and other medical products. “This program should improve the efficiency of postmarket surveillance of medicines and, in the end, the beneficiaries will be the many patients using these products,” said Ken Johnson, senior vice president of PhRMA.

We are moving from a reactive dependence on voluntary reporting to a proactive surveillance of current products. MR. LEAVITT

The Food and Drug Administration has developed a new national electronic surveillance system that will allow it to search and analyze claims data and other clinical databases for possible postmarket adverse events for drugs and medical devices.

The Sentinel Initiative is designed to bring safety concerns from approved drugs and other medical products to the FDA's attention faster than the traditional MedWatch adverse event reporting system alone.

“We are moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market,” Health and Human Services Secretary Mike Leavitt said during a press conference to announce the initiative. “The result will be much-improved safety and protections for the American people.”

During the first phase of the project, the FDA will rely on Medicare data. As part of a pilot collaboration with the Centers for Medicare and Medicaid Services, FDA officials will use the Sentinel system to query Medicare Part D prescription drug claims data, which will be linked to Medicare inpatient and outpatient claims data. The Part D database currently holds information on medications used by more than 25 million beneficiaries, according to Health and Human Services.

The FDA will begin to look into the data in 30 days, following the publication of a final regulation that will allow federal agencies, states, and academic researchers to use claims data from the Part D program for safety research and quality initiatives.

In the future, FDA officials hope to be able to query data from other government agencies, such as the Department of Defense and the Department of Veterans Affairs, as well as from large private health plans, said Dr. Andrew C. von Eschenbach, FDA commissioner. He added that the Sentinel Initiative includes patient privacy protections. The system queries existing databases without actually acquiring the data. Essentially, the system asks questions and gets answers without identifying patient information.

The Sentinel system will work in conjunction with the existing FDA surveillance systems. For example, if the FDA receives a report of an adverse event following the use of a drug, officials will be able to query data on a large number of subjects who have taken the drug. And, in the future, agency officials may even be able to compare data from patients taking the drug with a control group of similar patients who have not taken the drug. This will allow FDA officials to give physicians better information about what particular groups of patients may be at higher risk for a specific adverse event, said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.

The Food and Drug Administration has developed a new national electronic surveillance system that will allow it to search and analyze claims data and other clinical databases for possible postmarket adverse events for drugs and medical devices.

The Sentinel Initiative is designed to bring safety concerns from approved drugs and other medical products to the FDA's attention faster than the traditional MedWatch adverse event reporting system alone.

“We are moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market,” Health and Human Services Secretary Mike Leavitt said during a press conference to announce the initiative. “The result will be much-improved safety and protections for the American people.”

During the first phase of the project, the FDA will rely on Medicare data. As part of a pilot collaboration with the Centers for Medicare and Medicaid Services, FDA officials will use the Sentinel system to query Medicare Part D prescription drug claims data, which will be linked to Medicare inpatient and outpatient claims data. The Part D database currently holds information on medications used by more than 25 million beneficiaries, according to Health and Human Services.

The FDA will begin to look into the data in 30 days, following the publication of a final regulation that will allow federal agencies, states, and academic researchers to use claims data from the Part D program for safety research and quality initiatives.

In the future, FDA officials hope to be able to query data from other government agencies, such as the Department of Defense and the Department of Veterans Affairs, as well as from large private health plans, said Dr. Andrew C. von Eschenbach, FDA commissioner. He added that the Sentinel Initiative includes patient privacy protections. The system queries existing databases without actually acquiring the data. Essentially, the system asks questions and gets answers without identifying patient information.

The Sentinel system will work in conjunction with the existing FDA surveillance systems. For example, if the FDA receives a report of an adverse event following the use of a drug, officials will be able to query data on a large number of subjects who have taken the drug. And, in the future, agency officials may even be able to compare data from patients taking the drug with a control group of similar patients who have not taken the drug. This will allow FDA officials to give physicians better information about what particular groups of patients may be at higher risk for a specific adverse event, said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.

The Food and Drug Administration has developed a new national electronic surveillance system that will allow it to search and analyze claims data and other clinical databases for possible postmarket adverse events for drugs and medical devices.

The Sentinel Initiative is designed to bring safety concerns from approved drugs and other medical products to the FDA's attention faster than the traditional MedWatch adverse event reporting system alone.

“We are moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market,” Health and Human Services Secretary Mike Leavitt said during a press conference to announce the initiative. “The result will be much-improved safety and protections for the American people.”

During the first phase of the project, the FDA will rely on Medicare data. As part of a pilot collaboration with the Centers for Medicare and Medicaid Services, FDA officials will use the Sentinel system to query Medicare Part D prescription drug claims data, which will be linked to Medicare inpatient and outpatient claims data. The Part D database currently holds information on medications used by more than 25 million beneficiaries, according to Health and Human Services.

The FDA will begin to look into the data in 30 days, following the publication of a final regulation that will allow federal agencies, states, and academic researchers to use claims data from the Part D program for safety research and quality initiatives.

In the future, FDA officials hope to be able to query data from other government agencies, such as the Department of Defense and the Department of Veterans Affairs, as well as from large private health plans, said Dr. Andrew C. von Eschenbach, FDA commissioner. He added that the Sentinel Initiative includes patient privacy protections. The system queries existing databases without actually acquiring the data. Essentially, the system asks questions and gets answers without identifying patient information.

The Sentinel system will work in conjunction with the existing FDA surveillance systems. For example, if the FDA receives a report of an adverse event following the use of a drug, officials will be able to query data on a large number of subjects who have taken the drug. And, in the future, agency officials may even be able to compare data from patients taking the drug with a control group of similar patients who have not taken the drug. This will allow FDA officials to give physicians better information about what particular groups of patients may be at higher risk for a specific adverse event, said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.

The proposed rule was published in the Federal Register on July 7 and can be found at www.cms.hhs.gov/center/physician.asp

After several delays, Congress has acted to reverse a scheduled 10.6% cut to physician fees under Medicare and thus avert an estimated 5.4% cut that would have taken effect in January 2009.

The legislation (H.R. 6331), which passed the House and Senate by veto-proof margins in early July, extends the 0.5% increase in place for the first half of 2008 and provides a 1.1% update for 2009. The bill also includes controversial cuts to the Medicare Advantage program, authorizes increased bonus payments for the Physician Quality Reporting Initiative (PQRI), and delays implementation of the Competitive Acquisition Program for durable medical equipment. The Medicare Advantage cuts had been the basis for President Bush's threatened veto, which had not been issued at press time.

Meanwhile, officials at the Centers for Medicare and Medicaid Services released the 2009 Medicare Physician Fee Schedule proposed rule including new measures for the PQRI, new requirements for physicians offering diagnostic testing services, and plans to reevaluate services and supplies potentially valued incorrectly.

For the PQRI, Medicare's voluntary pay-for-reporting program, the agency is recommending 56 new measures for 2009, bringing the total number to 175. Officials at the Centers for Medicare and Medicaid Services also are proposing new “measures groups” that allow physicians to report on subsets of measures related to a particular clinical condition. For example, new measures groups for 2009 include coronary artery disease, coronary artery bypass surgery, HIV/AIDS, rheumatoid arthritis, care during surgery, and back pain.

In addition, CMS plans to begin allowing physicians to report on certain measures through electronic health records in 2009, pending successful testing this year.

Although the CMS proposal does not include bonus payments for physicians as part of the program, the pay fix legislation passed in Congress does. For 2009, physicians participating in PQRI will be eligible for bonuses of up to 2% of total allowable Medicare charges for successful reporting of measures. The legislation authorized additional bonuses of 2% for electronic prescribing quality measures.

The CMS proposal also would require physicians who perform diagnostic testing services to meet most of the quality and performance standards established for Independent Diagnostic Testing Facilities, including requiring a supervising physician to prove proficiency in the performance and interpretation of each diagnostic procedure and maintenance of an inventory of diagnostic testing equipment. The proposed rule also gives physicians a glimpse of the CMS thinking on the possible expansion of the agency's hospital-acquired conditions policy. Beginning Oct. 1, CMS will begin withholding payment to hospitals for certain conditions and infections acquired after admission.

While the agency did not propose any changes in policy, it wrote in the proposed rule that the hospital-acquired condition payment policy could be expanded into other settings, including hospital outpatient departments, skilled nursing facilities, and physician practices.

The proposed rule was published in the Federal Register on July 7 and can be found at www.cms.hhs.gov/center/physician.asp

After several delays, Congress has acted to reverse a scheduled 10.6% cut to physician fees under Medicare and thus avert an estimated 5.4% cut that would have taken effect in January 2009.

The legislation (H.R. 6331), which passed the House and Senate by veto-proof margins in early July, extends the 0.5% increase in place for the first half of 2008 and provides a 1.1% update for 2009. The bill also includes controversial cuts to the Medicare Advantage program, authorizes increased bonus payments for the Physician Quality Reporting Initiative (PQRI), and delays implementation of the Competitive Acquisition Program for durable medical equipment. The Medicare Advantage cuts had been the basis for President Bush's threatened veto, which had not been issued at press time.

Meanwhile, officials at the Centers for Medicare and Medicaid Services released the 2009 Medicare Physician Fee Schedule proposed rule including new measures for the PQRI, new requirements for physicians offering diagnostic testing services, and plans to reevaluate services and supplies potentially valued incorrectly.

For the PQRI, Medicare's voluntary pay-for-reporting program, the agency is recommending 56 new measures for 2009, bringing the total number to 175. Officials at the Centers for Medicare and Medicaid Services also are proposing new “measures groups” that allow physicians to report on subsets of measures related to a particular clinical condition. For example, new measures groups for 2009 include coronary artery disease, coronary artery bypass surgery, HIV/AIDS, rheumatoid arthritis, care during surgery, and back pain.

In addition, CMS plans to begin allowing physicians to report on certain measures through electronic health records in 2009, pending successful testing this year.

Although the CMS proposal does not include bonus payments for physicians as part of the program, the pay fix legislation passed in Congress does. For 2009, physicians participating in PQRI will be eligible for bonuses of up to 2% of total allowable Medicare charges for successful reporting of measures. The legislation authorized additional bonuses of 2% for electronic prescribing quality measures.

The CMS proposal also would require physicians who perform diagnostic testing services to meet most of the quality and performance standards established for Independent Diagnostic Testing Facilities, including requiring a supervising physician to prove proficiency in the performance and interpretation of each diagnostic procedure and maintenance of an inventory of diagnostic testing equipment. The proposed rule also gives physicians a glimpse of the CMS thinking on the possible expansion of the agency's hospital-acquired conditions policy. Beginning Oct. 1, CMS will begin withholding payment to hospitals for certain conditions and infections acquired after admission.

While the agency did not propose any changes in policy, it wrote in the proposed rule that the hospital-acquired condition payment policy could be expanded into other settings, including hospital outpatient departments, skilled nursing facilities, and physician practices.

The proposed rule was published in the Federal Register on July 7 and can be found at www.cms.hhs.gov/center/physician.asp

After several delays, Congress has acted to reverse a scheduled 10.6% cut to physician fees under Medicare and thus avert an estimated 5.4% cut that would have taken effect in January 2009.

The legislation (H.R. 6331), which passed the House and Senate by veto-proof margins in early July, extends the 0.5% increase in place for the first half of 2008 and provides a 1.1% update for 2009. The bill also includes controversial cuts to the Medicare Advantage program, authorizes increased bonus payments for the Physician Quality Reporting Initiative (PQRI), and delays implementation of the Competitive Acquisition Program for durable medical equipment. The Medicare Advantage cuts had been the basis for President Bush's threatened veto, which had not been issued at press time.

Meanwhile, officials at the Centers for Medicare and Medicaid Services released the 2009 Medicare Physician Fee Schedule proposed rule including new measures for the PQRI, new requirements for physicians offering diagnostic testing services, and plans to reevaluate services and supplies potentially valued incorrectly.

For the PQRI, Medicare's voluntary pay-for-reporting program, the agency is recommending 56 new measures for 2009, bringing the total number to 175. Officials at the Centers for Medicare and Medicaid Services also are proposing new “measures groups” that allow physicians to report on subsets of measures related to a particular clinical condition. For example, new measures groups for 2009 include coronary artery disease, coronary artery bypass surgery, HIV/AIDS, rheumatoid arthritis, care during surgery, and back pain.

In addition, CMS plans to begin allowing physicians to report on certain measures through electronic health records in 2009, pending successful testing this year.

Although the CMS proposal does not include bonus payments for physicians as part of the program, the pay fix legislation passed in Congress does. For 2009, physicians participating in PQRI will be eligible for bonuses of up to 2% of total allowable Medicare charges for successful reporting of measures. The legislation authorized additional bonuses of 2% for electronic prescribing quality measures.

The CMS proposal also would require physicians who perform diagnostic testing services to meet most of the quality and performance standards established for Independent Diagnostic Testing Facilities, including requiring a supervising physician to prove proficiency in the performance and interpretation of each diagnostic procedure and maintenance of an inventory of diagnostic testing equipment. The proposed rule also gives physicians a glimpse of the CMS thinking on the possible expansion of the agency's hospital-acquired conditions policy. Beginning Oct. 1, CMS will begin withholding payment to hospitals for certain conditions and infections acquired after admission.

While the agency did not propose any changes in policy, it wrote in the proposed rule that the hospital-acquired condition payment policy could be expanded into other settings, including hospital outpatient departments, skilled nursing facilities, and physician practices.

If the feds have it their way, 40% of physician offices will be using certified electronic health records by 2012.

The goal is part of a strategic plan for coordinating the federal government's health IT efforts over the next 4 years, and seeks to further progress toward President Bush's goal, set out in 2004, that the majority of Americans to have access to an electronic health record (EHR) by 2014.

About 14% of physicians had adopted some form of health information technology (IT) by 2007, according to the Office of the National Coordinator for Health Information Technology, which released the strategic plan. The plan calls for removing business barriers and disincentives for adoption of EHRs and providing training and technical assistance. For example, it says by next year, information on low-cost and effective provider support on EHR adoption should be available online.

The plan also calls for increasing the health IT workforce by training more standards developers, ensuring vendors are trained in the implementation of health IT tools, and training physicians and other providers in informatics. It also highlights the need to address physician concerns about liability risks related to the exchange of electronic health information.

In addition to issues related to adoption, the plan lays out goals for achieving patient-focused health care through electronic health record access, and enabling the use of electronic health data to benefit public health, research, and emergency preparedness.

“[The plan] establishes the next generation of health IT milestones to harness the power of information technology to help transform health and care in this country,” Dr. Robert Kolodner, national coordinator for health information technology, said in a statement.

The goals are all positive, said Dr. Steven Waldren, director of the Center for Health Information Technology at the American Academy of Family Physicians, but the plan does not sufficiently emphasize the need to provide financial incentives to physicians for purchasing and using electronic health record systems. “The real bottom line is getting the payment reform that is needed in health care today.”

The strategic plan represents a “reasonable approach” going forward and gives a sense of how to achieve the President's objective of greater access to EHRs, said Dan Rode, vice president of policy and government relations at the American Health Information Management Association. Many of the items don't have specific timetables for completion but will instead be reassessed in 2010, he said, leaving a lot to be accomplished before 2014.

And while the plan outlines the objectives envisioned by the current administration, the goals and strategies could change with a new president who may be proposing changes to the way health care is delivered, Mr. Rode said.

The plan was developed by the Office of the National Coordinator for Health IT in collaboration with 12 agencies within HHS, and the Departments of Commerce, Defense, and Veterans Affairs, and the Federal Communications Commission. The National Committee on Vital Statistics and the American Health Information Community also contributed.

The strategic plan is available online at www.hhs.gov/healthit

If the feds have it their way, 40% of physician offices will be using certified electronic health records by 2012.

The goal is part of a strategic plan for coordinating the federal government's health IT efforts over the next 4 years, and seeks to further progress toward President Bush's goal, set out in 2004, that the majority of Americans to have access to an electronic health record (EHR) by 2014.

About 14% of physicians had adopted some form of health information technology (IT) by 2007, according to the Office of the National Coordinator for Health Information Technology, which released the strategic plan. The plan calls for removing business barriers and disincentives for adoption of EHRs and providing training and technical assistance. For example, it says by next year, information on low-cost and effective provider support on EHR adoption should be available online.

The plan also calls for increasing the health IT workforce by training more standards developers, ensuring vendors are trained in the implementation of health IT tools, and training physicians and other providers in informatics. It also highlights the need to address physician concerns about liability risks related to the exchange of electronic health information.

In addition to issues related to adoption, the plan lays out goals for achieving patient-focused health care through electronic health record access, and enabling the use of electronic health data to benefit public health, research, and emergency preparedness.

“[The plan] establishes the next generation of health IT milestones to harness the power of information technology to help transform health and care in this country,” Dr. Robert Kolodner, national coordinator for health information technology, said in a statement.

The goals are all positive, said Dr. Steven Waldren, director of the Center for Health Information Technology at the American Academy of Family Physicians, but the plan does not sufficiently emphasize the need to provide financial incentives to physicians for purchasing and using electronic health record systems. “The real bottom line is getting the payment reform that is needed in health care today.”

The strategic plan represents a “reasonable approach” going forward and gives a sense of how to achieve the President's objective of greater access to EHRs, said Dan Rode, vice president of policy and government relations at the American Health Information Management Association. Many of the items don't have specific timetables for completion but will instead be reassessed in 2010, he said, leaving a lot to be accomplished before 2014.

And while the plan outlines the objectives envisioned by the current administration, the goals and strategies could change with a new president who may be proposing changes to the way health care is delivered, Mr. Rode said.

The plan was developed by the Office of the National Coordinator for Health IT in collaboration with 12 agencies within HHS, and the Departments of Commerce, Defense, and Veterans Affairs, and the Federal Communications Commission. The National Committee on Vital Statistics and the American Health Information Community also contributed.

The strategic plan is available online at www.hhs.gov/healthit

If the feds have it their way, 40% of physician offices will be using certified electronic health records by 2012.

The goal is part of a strategic plan for coordinating the federal government's health IT efforts over the next 4 years, and seeks to further progress toward President Bush's goal, set out in 2004, that the majority of Americans to have access to an electronic health record (EHR) by 2014.

About 14% of physicians had adopted some form of health information technology (IT) by 2007, according to the Office of the National Coordinator for Health Information Technology, which released the strategic plan. The plan calls for removing business barriers and disincentives for adoption of EHRs and providing training and technical assistance. For example, it says by next year, information on low-cost and effective provider support on EHR adoption should be available online.

The plan also calls for increasing the health IT workforce by training more standards developers, ensuring vendors are trained in the implementation of health IT tools, and training physicians and other providers in informatics. It also highlights the need to address physician concerns about liability risks related to the exchange of electronic health information.

In addition to issues related to adoption, the plan lays out goals for achieving patient-focused health care through electronic health record access, and enabling the use of electronic health data to benefit public health, research, and emergency preparedness.

“[The plan] establishes the next generation of health IT milestones to harness the power of information technology to help transform health and care in this country,” Dr. Robert Kolodner, national coordinator for health information technology, said in a statement.

The goals are all positive, said Dr. Steven Waldren, director of the Center for Health Information Technology at the American Academy of Family Physicians, but the plan does not sufficiently emphasize the need to provide financial incentives to physicians for purchasing and using electronic health record systems. “The real bottom line is getting the payment reform that is needed in health care today.”

The strategic plan represents a “reasonable approach” going forward and gives a sense of how to achieve the President's objective of greater access to EHRs, said Dan Rode, vice president of policy and government relations at the American Health Information Management Association. Many of the items don't have specific timetables for completion but will instead be reassessed in 2010, he said, leaving a lot to be accomplished before 2014.

And while the plan outlines the objectives envisioned by the current administration, the goals and strategies could change with a new president who may be proposing changes to the way health care is delivered, Mr. Rode said.

The plan was developed by the Office of the National Coordinator for Health IT in collaboration with 12 agencies within HHS, and the Departments of Commerce, Defense, and Veterans Affairs, and the Federal Communications Commission. The National Committee on Vital Statistics and the American Health Information Community also contributed.

The strategic plan is available online at www.hhs.gov/healthit