Mary Ellen Schneider

In addition to the presidential candidates, other players in the health care arena are also unveiling their own detailed plans to provide health care coverage for all or most Americans.

The Commonwealth Fund's proposal, called “Building Blocks,” seeks to cover 44 of the 48 million Americans estimated to be uninsured in 2008. At the center of the proposal is a national health insurance connector that would allow small businesses and individuals without large employer insurance to shop for a health plan.

The connector would feature private plans and a “Medicare Extra” option. The latter would offer monthly premiums of $259 for individuals and $702 for families, 30% lower than the average premium charged to employers today, said the Commonwealth Fund, a private foundation that supports research on health policy reform.

The plan also calls for expanding Medicaid and the State Children's Health Insurance Plan to cover all adults and children below 150% of the federal poverty level and would include individual and employer mandates for health coverage.

Using modeling from the Lewin Group, the Commonwealth Fund estimated the proposal would add $15 billion to current total health spending in the United States during the first year and about $218 billion over 10 years. But it could save $1.6 trillion over 10 years if it is combined with other reforms such as changing Medicare payments to hospitals and physicians, investing in better health information technology, allowing Medicare to negotiate drug prices, and improving public health.

In the meantime, the Healthcare Leadership Council, a coalition of hospitals, health plans, and pharmaceutical and device manufacturers that aims to improve the quality and affordability of health care, has brought forward its own market-based proposal aimed at covering all Americans. Called “Closing the Gap,” it calls for subsidies and tax breaks to help individuals afford coverage, improving health care quality through health information technology and care coordination, and realigning the financial incentives in the health care system to pay for value.

The plan calls for the government to provide premium subsidies to help employees afford their employer-sponsored insurance premiums and for the same tax breaks to be applied to individually purchased health insurance as applied to employer-sponsored coverage. The group did not endorse individual mandates.

The plan also calls for a move away from a payment system that rewards physicians and hospitals for the volume of services provided, instead paying for evidence-based care and prevention, said Dr. Denis Cortese, chair of the Healthcare Leadership Council and president and chief executive officer of the Mayo Clinic, at a press briefing to release the plan.

In addition to the presidential candidates, other players in the health care arena are also unveiling their own detailed plans to provide health care coverage for all or most Americans.

The Commonwealth Fund's proposal, called “Building Blocks,” seeks to cover 44 of the 48 million Americans estimated to be uninsured in 2008. At the center of the proposal is a national health insurance connector that would allow small businesses and individuals without large employer insurance to shop for a health plan.

The connector would feature private plans and a “Medicare Extra” option. The latter would offer monthly premiums of $259 for individuals and $702 for families, 30% lower than the average premium charged to employers today, said the Commonwealth Fund, a private foundation that supports research on health policy reform.

The plan also calls for expanding Medicaid and the State Children's Health Insurance Plan to cover all adults and children below 150% of the federal poverty level and would include individual and employer mandates for health coverage.

Using modeling from the Lewin Group, the Commonwealth Fund estimated the proposal would add $15 billion to current total health spending in the United States during the first year and about $218 billion over 10 years. But it could save $1.6 trillion over 10 years if it is combined with other reforms such as changing Medicare payments to hospitals and physicians, investing in better health information technology, allowing Medicare to negotiate drug prices, and improving public health.

In the meantime, the Healthcare Leadership Council, a coalition of hospitals, health plans, and pharmaceutical and device manufacturers that aims to improve the quality and affordability of health care, has brought forward its own market-based proposal aimed at covering all Americans. Called “Closing the Gap,” it calls for subsidies and tax breaks to help individuals afford coverage, improving health care quality through health information technology and care coordination, and realigning the financial incentives in the health care system to pay for value.

The plan calls for the government to provide premium subsidies to help employees afford their employer-sponsored insurance premiums and for the same tax breaks to be applied to individually purchased health insurance as applied to employer-sponsored coverage. The group did not endorse individual mandates.

The plan also calls for a move away from a payment system that rewards physicians and hospitals for the volume of services provided, instead paying for evidence-based care and prevention, said Dr. Denis Cortese, chair of the Healthcare Leadership Council and president and chief executive officer of the Mayo Clinic, at a press briefing to release the plan.

In addition to the presidential candidates, other players in the health care arena are also unveiling their own detailed plans to provide health care coverage for all or most Americans.

The Commonwealth Fund's proposal, called “Building Blocks,” seeks to cover 44 of the 48 million Americans estimated to be uninsured in 2008. At the center of the proposal is a national health insurance connector that would allow small businesses and individuals without large employer insurance to shop for a health plan.

The connector would feature private plans and a “Medicare Extra” option. The latter would offer monthly premiums of $259 for individuals and $702 for families, 30% lower than the average premium charged to employers today, said the Commonwealth Fund, a private foundation that supports research on health policy reform.

The plan also calls for expanding Medicaid and the State Children's Health Insurance Plan to cover all adults and children below 150% of the federal poverty level and would include individual and employer mandates for health coverage.

Using modeling from the Lewin Group, the Commonwealth Fund estimated the proposal would add $15 billion to current total health spending in the United States during the first year and about $218 billion over 10 years. But it could save $1.6 trillion over 10 years if it is combined with other reforms such as changing Medicare payments to hospitals and physicians, investing in better health information technology, allowing Medicare to negotiate drug prices, and improving public health.

In the meantime, the Healthcare Leadership Council, a coalition of hospitals, health plans, and pharmaceutical and device manufacturers that aims to improve the quality and affordability of health care, has brought forward its own market-based proposal aimed at covering all Americans. Called “Closing the Gap,” it calls for subsidies and tax breaks to help individuals afford coverage, improving health care quality through health information technology and care coordination, and realigning the financial incentives in the health care system to pay for value.

The plan calls for the government to provide premium subsidies to help employees afford their employer-sponsored insurance premiums and for the same tax breaks to be applied to individually purchased health insurance as applied to employer-sponsored coverage. The group did not endorse individual mandates.

The plan also calls for a move away from a payment system that rewards physicians and hospitals for the volume of services provided, instead paying for evidence-based care and prevention, said Dr. Denis Cortese, chair of the Healthcare Leadership Council and president and chief executive officer of the Mayo Clinic, at a press briefing to release the plan.

CHICAGO — Colorectal cancer patients whose tumors contain the wild-type KRAS gene responded better to treatment with cetuximab plus chemo- therapy than did patients with tumor KRAS mutations, according to data presented during a plenary presentation at the annual meeting of the American Society of Clinical Oncology.

More patients with wild-type KRAS tumors responded to cetuximab (Erbitux) plus the FOLFIRI (leucovorin, fluorouracil, and irinotecan) chemotherapy regimen (59%) than to FOLFIRI alone (43%), reported Dr. Eric Van Cutsem, the lead study author and professor of medicine at the University Hospital Gasthuisberg in Leuven, Belgium. The findings are based on a further analysis of data from the Cetuximab Combined with Irinotecan First-Line Therapy for Metastatic Colorectal Cancer (CRYSTAL) trial, which was presented at last year's ASCO meeting.

The original CRYSTAL trial data indicated that metastatic colorectal cancer patients who received a combination of cetuximab and FOLFIRI had a 15% reduced risk of disease progression. The researchers subsequently asked why some patients benefited from the regimen and others did not, Dr. Van Cutsem said.

In an effort to answer this question, they performed a retrospective analysis of the intent-to-treat population of the CRYSTAL trial. Using archived tumor material, the researchers were able to perform quantitative polymerase chain reaction-based KRAS mutation analysis of codons 12/13 for 540 patients from among the original 1,198 patients included in the trial. The research team disclosed receiving research funding from Merck & Co. and other financial relationships with the company, which markets cetuximab outside the United States and Canada.

KRAS tumor mutations were detected in about 35% of patients; about 65% of patients had KRAS wild type tumors. There were no significant differences in the baseline demographics between the wild-type KRAS tumor patients and the mutant KRAS group, Dr. Van Cutsem said.

Among the patients with wild-type KRAS tumors compared, the researchers found a significant benefit in favor of the cetuximab-FOLFIRI combination, compared with treatment with FOLFIRI alone. There was a 32% decreased risk for disease progression (hazard ratio 0.68) for combination therapy, which was statistically significant.

The median progression-free survival was 8.7 months for KRAS wild type patients treated with FOLFIRI only and 9.9 months for KRAS wild type patients treated with cetuximab plus FOLFIRI. In addition, among KRAS wild type patients, the progression-free survival rate at 1 year was 25% for FOLFIRI alone and 43% for the cetuximab-FOLFIRI combination.

Cetuximab made no difference in progression-free survival for the mutant KRAS population. “The benefit here was confined to the patients with the KRAS wild type tumor,” Dr. Van Cutsem said.

The evaluation of patient response to treatment, a secondary end point of the study, revealed that 59% of wild-type KRAS patients responded to treatment with cetuximab and FOLFIRI, compared with 43% of patients who responded to FOLFIRI alone. There was no significant difference in overall response between the treatment groups for patients with KRAS mutations.

The researchers also analyzed side effects and found no new signals of toxicity.

The results are consistent with previous research findings, Dr. Van Cutsem said. Several retrospective studies have shown that benefit from cetuximab was confined to KRAS wild type patients. Those with mutant tumors do not benefit from anti-epidermal growth factor receptor antibodies, these studies have found. “The data we report here today are in agreement with the biolog.”

Given the predictive value of the KRAS gene, Dr. Van Cutsem recommended that KRAS testing should become part of routine clinical practice. By knowing in advance if there is a KRAS mutation, physicians can avoid exposing patients to the unnecessary side effects of a treatment that will not be effective, he said.

KRAS testing should be fairly simple for clinicians, he said, because they can do it using archived tumor samples without performing fresh biopsies. Effective polymerase chain reaction-based assays are already commercially available.

Routine use of KRAS testing also got some recent support in Europe when the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion on Merck's application to expand the use of cetuximab. The committee recommended the use of cetuximab in patients who have metastatic colorectal cancer with KRAS wild type tumors. The recommendation was for use in combination with chemotherapy and alone in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

The results of the CRYSTAL trial analysis, combined with other recent studies that point to the predictive value of KRAS mutation status, support routine KRAS testing for patients with metastatic colorectal cancer who are being considered for treatment with epidermal growth factor receptor inhibitors, Dr. S. Gail Eckhardt, head of medical oncology at the University of Colorado Cancer Center in Aurora, said during a discussion.

However, more research is needed to see if these results are applicable in other diseases where epidermal growth factor receptor inhibitor therapy is being used, she said.

CHICAGO — Colorectal cancer patients whose tumors contain the wild-type KRAS gene responded better to treatment with cetuximab plus chemo- therapy than did patients with tumor KRAS mutations, according to data presented during a plenary presentation at the annual meeting of the American Society of Clinical Oncology.

More patients with wild-type KRAS tumors responded to cetuximab (Erbitux) plus the FOLFIRI (leucovorin, fluorouracil, and irinotecan) chemotherapy regimen (59%) than to FOLFIRI alone (43%), reported Dr. Eric Van Cutsem, the lead study author and professor of medicine at the University Hospital Gasthuisberg in Leuven, Belgium. The findings are based on a further analysis of data from the Cetuximab Combined with Irinotecan First-Line Therapy for Metastatic Colorectal Cancer (CRYSTAL) trial, which was presented at last year's ASCO meeting.

The original CRYSTAL trial data indicated that metastatic colorectal cancer patients who received a combination of cetuximab and FOLFIRI had a 15% reduced risk of disease progression. The researchers subsequently asked why some patients benefited from the regimen and others did not, Dr. Van Cutsem said.

In an effort to answer this question, they performed a retrospective analysis of the intent-to-treat population of the CRYSTAL trial. Using archived tumor material, the researchers were able to perform quantitative polymerase chain reaction-based KRAS mutation analysis of codons 12/13 for 540 patients from among the original 1,198 patients included in the trial. The research team disclosed receiving research funding from Merck & Co. and other financial relationships with the company, which markets cetuximab outside the United States and Canada.

KRAS tumor mutations were detected in about 35% of patients; about 65% of patients had KRAS wild type tumors. There were no significant differences in the baseline demographics between the wild-type KRAS tumor patients and the mutant KRAS group, Dr. Van Cutsem said.

Among the patients with wild-type KRAS tumors compared, the researchers found a significant benefit in favor of the cetuximab-FOLFIRI combination, compared with treatment with FOLFIRI alone. There was a 32% decreased risk for disease progression (hazard ratio 0.68) for combination therapy, which was statistically significant.

The median progression-free survival was 8.7 months for KRAS wild type patients treated with FOLFIRI only and 9.9 months for KRAS wild type patients treated with cetuximab plus FOLFIRI. In addition, among KRAS wild type patients, the progression-free survival rate at 1 year was 25% for FOLFIRI alone and 43% for the cetuximab-FOLFIRI combination.

Cetuximab made no difference in progression-free survival for the mutant KRAS population. “The benefit here was confined to the patients with the KRAS wild type tumor,” Dr. Van Cutsem said.

The evaluation of patient response to treatment, a secondary end point of the study, revealed that 59% of wild-type KRAS patients responded to treatment with cetuximab and FOLFIRI, compared with 43% of patients who responded to FOLFIRI alone. There was no significant difference in overall response between the treatment groups for patients with KRAS mutations.

The researchers also analyzed side effects and found no new signals of toxicity.

The results are consistent with previous research findings, Dr. Van Cutsem said. Several retrospective studies have shown that benefit from cetuximab was confined to KRAS wild type patients. Those with mutant tumors do not benefit from anti-epidermal growth factor receptor antibodies, these studies have found. “The data we report here today are in agreement with the biolog.”

Given the predictive value of the KRAS gene, Dr. Van Cutsem recommended that KRAS testing should become part of routine clinical practice. By knowing in advance if there is a KRAS mutation, physicians can avoid exposing patients to the unnecessary side effects of a treatment that will not be effective, he said.

KRAS testing should be fairly simple for clinicians, he said, because they can do it using archived tumor samples without performing fresh biopsies. Effective polymerase chain reaction-based assays are already commercially available.

Routine use of KRAS testing also got some recent support in Europe when the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion on Merck's application to expand the use of cetuximab. The committee recommended the use of cetuximab in patients who have metastatic colorectal cancer with KRAS wild type tumors. The recommendation was for use in combination with chemotherapy and alone in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

The results of the CRYSTAL trial analysis, combined with other recent studies that point to the predictive value of KRAS mutation status, support routine KRAS testing for patients with metastatic colorectal cancer who are being considered for treatment with epidermal growth factor receptor inhibitors, Dr. S. Gail Eckhardt, head of medical oncology at the University of Colorado Cancer Center in Aurora, said during a discussion.

However, more research is needed to see if these results are applicable in other diseases where epidermal growth factor receptor inhibitor therapy is being used, she said.

CHICAGO — Colorectal cancer patients whose tumors contain the wild-type KRAS gene responded better to treatment with cetuximab plus chemo- therapy than did patients with tumor KRAS mutations, according to data presented during a plenary presentation at the annual meeting of the American Society of Clinical Oncology.

More patients with wild-type KRAS tumors responded to cetuximab (Erbitux) plus the FOLFIRI (leucovorin, fluorouracil, and irinotecan) chemotherapy regimen (59%) than to FOLFIRI alone (43%), reported Dr. Eric Van Cutsem, the lead study author and professor of medicine at the University Hospital Gasthuisberg in Leuven, Belgium. The findings are based on a further analysis of data from the Cetuximab Combined with Irinotecan First-Line Therapy for Metastatic Colorectal Cancer (CRYSTAL) trial, which was presented at last year's ASCO meeting.

The original CRYSTAL trial data indicated that metastatic colorectal cancer patients who received a combination of cetuximab and FOLFIRI had a 15% reduced risk of disease progression. The researchers subsequently asked why some patients benefited from the regimen and others did not, Dr. Van Cutsem said.

In an effort to answer this question, they performed a retrospective analysis of the intent-to-treat population of the CRYSTAL trial. Using archived tumor material, the researchers were able to perform quantitative polymerase chain reaction-based KRAS mutation analysis of codons 12/13 for 540 patients from among the original 1,198 patients included in the trial. The research team disclosed receiving research funding from Merck & Co. and other financial relationships with the company, which markets cetuximab outside the United States and Canada.

KRAS tumor mutations were detected in about 35% of patients; about 65% of patients had KRAS wild type tumors. There were no significant differences in the baseline demographics between the wild-type KRAS tumor patients and the mutant KRAS group, Dr. Van Cutsem said.

Among the patients with wild-type KRAS tumors compared, the researchers found a significant benefit in favor of the cetuximab-FOLFIRI combination, compared with treatment with FOLFIRI alone. There was a 32% decreased risk for disease progression (hazard ratio 0.68) for combination therapy, which was statistically significant.

The median progression-free survival was 8.7 months for KRAS wild type patients treated with FOLFIRI only and 9.9 months for KRAS wild type patients treated with cetuximab plus FOLFIRI. In addition, among KRAS wild type patients, the progression-free survival rate at 1 year was 25% for FOLFIRI alone and 43% for the cetuximab-FOLFIRI combination.

Cetuximab made no difference in progression-free survival for the mutant KRAS population. “The benefit here was confined to the patients with the KRAS wild type tumor,” Dr. Van Cutsem said.

The evaluation of patient response to treatment, a secondary end point of the study, revealed that 59% of wild-type KRAS patients responded to treatment with cetuximab and FOLFIRI, compared with 43% of patients who responded to FOLFIRI alone. There was no significant difference in overall response between the treatment groups for patients with KRAS mutations.

The researchers also analyzed side effects and found no new signals of toxicity.

The results are consistent with previous research findings, Dr. Van Cutsem said. Several retrospective studies have shown that benefit from cetuximab was confined to KRAS wild type patients. Those with mutant tumors do not benefit from anti-epidermal growth factor receptor antibodies, these studies have found. “The data we report here today are in agreement with the biolog.”

Given the predictive value of the KRAS gene, Dr. Van Cutsem recommended that KRAS testing should become part of routine clinical practice. By knowing in advance if there is a KRAS mutation, physicians can avoid exposing patients to the unnecessary side effects of a treatment that will not be effective, he said.

KRAS testing should be fairly simple for clinicians, he said, because they can do it using archived tumor samples without performing fresh biopsies. Effective polymerase chain reaction-based assays are already commercially available.

Routine use of KRAS testing also got some recent support in Europe when the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion on Merck's application to expand the use of cetuximab. The committee recommended the use of cetuximab in patients who have metastatic colorectal cancer with KRAS wild type tumors. The recommendation was for use in combination with chemotherapy and alone in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

The results of the CRYSTAL trial analysis, combined with other recent studies that point to the predictive value of KRAS mutation status, support routine KRAS testing for patients with metastatic colorectal cancer who are being considered for treatment with epidermal growth factor receptor inhibitors, Dr. S. Gail Eckhardt, head of medical oncology at the University of Colorado Cancer Center in Aurora, said during a discussion.

However, more research is needed to see if these results are applicable in other diseases where epidermal growth factor receptor inhibitor therapy is being used, she said.

Physicians now have nine options for submitting quality data to Medicare under the Physician Quality Reporting Initiative.

The new options include three ways to submit claims-based data and six registry-based methods for reporting (see box). For example, physicians will have the option of reporting data on groups of related clinical measures or individual measures and they can report for a full or half year. Officials at the Centers for Medicare and Medicaid Services announced the changes in April.

Under the Physician Quality Reporting Initiative (PQRI), launched last July, physicians can earn up to a 1.5% bonus on all of their total allowed Medicare charges for covered services for reporting on certain quality measures to CMS.

“We are encouraged by the success of the program so far, and with the new options for data reporting, more health professionals should take advantage of the reporting system,” the acting administrator of the CMS, Kerry Weems, said in a statement.

In the meantime, physicians who reported data in 2007 are still waiting for their bonus checks and feedback on their performance. CMS accepted 2007 data until the end of February and is currently analyzing the information. CMS officials expect to provide results and bonus payments to physicians in mid-July.

Preliminary data show that in 2007, more than 100,000 physicians and other eligible professionals submitted quality data at least once to the voluntary reporting program. CMS estimates that about half of those who participated in 2007 will receive an incentive payment.

In 2007, CMS officials selected 74 quality measures to be used across various specialties. If three or more measures applied, physicians had to report on at least three measures for at least 80% of applicable patients. If fewer than three measures were applicable, physicians had to report on each measure for at least 80% of the eligible patients. All reporting was claims based and covered the period from July 1 to Dec. 31, 2007.

This year, CMS has expanded the list of measures to 119, with 117 clinical measures and 2 structural measures. The structural measures relate to e-prescribing and electronic health record adoption and use.

CMS will also allow physicians to report on their clinical interactions for a full year from Jan. 1 to Dec. 31, 2008, or a half-year starting on July 1. Those physicians who haven't started reporting yet should still consider the full-year option, Dr. Michael T. Rapp, director of the quality measurement and health assessment group at CMS, said during a CMS-sponsored provider call on PQRI. Because 60 of the measures require only once-a-year reporting, physicians could still meet the 80% threshold if they started in May or June, he said.

CMS is also allowing providers to report either individual measures or “measures groups.” CMS has created four measures groups with at least four measures each. The groups include diabetes, end-stage renal disease, chronic kidney disease, and preventive care.

For example, the end-stage renal disease group includes four measures: vascular access for hemodialysis patients, influenza vaccination, plan of care for patients with anemia, and plan of care for inadequate hemodialysis. In order to quality for payment using measures groups, physicians have to submit data for each of the measures in the group.

Eligible professionals will also be able to report to clinical registries instead of submitting claims directly to CMS. Physicians would report data to the registry, which would in turn report to CMS. Currently, CMS is testing submission from registries and plans to publish a list of qualified registries in late August.

Despite the late announcement of qualified registries, physicians can still consider full-year participation with this option, Dr. Rapp said, because data are often submitted to registries months after the clinical encounter has occurred.

It appears that the changes will make it easier to report data, said Dr. James King, president of the American Academy of Family Physicians. “We want to be able to get our data in.”

However, more details will be needed on registry-based reporting, said Brian Whitman, who monitors regulatory and insurer affairs at the American College of Physicians. The extent to which internists will be able to use registry-based reporting will be unclear until CMS releases the list of participating registries in late August, he said. While subspecialties such as thoracic surgery do have well-established registries, there is not a registry commonly used by all internists at this point, he said.

Another unanswered question is how CMS will ensure that the data being submitted by registries are accurate, Mr. Whitman said.

Options Involve Claims-Based and Registry-Based Reporting

Three of the nine options outlined by the Centers for Medicare and Medicaid Services for reporting data to PQRI in 2008 allow claims-based reporting. Here are details on the claim-based option:

▸ Physicians can choose to report on individual measures for a full year from Jan. 1 to Dec. 31, 2008. Under this option, physicians with three or more applicable measures would report on at least three measures for at least 80% of their patients. Those with fewer than three applicable measures would report on all of those measures for at least 80% of their eligible patients.

▸ Physicians also can choose from two reporting approaches for the half-year reporting period from July 1 to Dec. 31. Physicians could report on all measures in a measures group for 15 consecutive patients with the relevant condition or 80% of eligible patients.

Six options are registry-based:

▸ CMS will allow three reporting options for a full-year reporting period. Those who chose to report on individual measures must report on 80% of applicable cases for a minimum of three measures. Physicians can also report on a measures group for 30 consecutive patients with the applicable condition or 80% of the applicable cases.

▸ CMS also has established three reporting options for reporting to a registry for a half-year from July 1 to Dec. 31. For example, physicians could report on individual measures for 80% of applicable cases for a minimum of three measures. It also is possible to report for a half-year using measures groups. For example, physicians can report on a measures group for 15 consecutive patients with the applicable condition or 80% of applicable cases.

More information about the different reporting options is available online at

www.cms.hhs.gov/pqri

Physicians now have nine options for submitting quality data to Medicare under the Physician Quality Reporting Initiative.

The new options include three ways to submit claims-based data and six registry-based methods for reporting (see box). For example, physicians will have the option of reporting data on groups of related clinical measures or individual measures and they can report for a full or half year. Officials at the Centers for Medicare and Medicaid Services announced the changes in April.

Under the Physician Quality Reporting Initiative (PQRI), launched last July, physicians can earn up to a 1.5% bonus on all of their total allowed Medicare charges for covered services for reporting on certain quality measures to CMS.

“We are encouraged by the success of the program so far, and with the new options for data reporting, more health professionals should take advantage of the reporting system,” the acting administrator of the CMS, Kerry Weems, said in a statement.

In the meantime, physicians who reported data in 2007 are still waiting for their bonus checks and feedback on their performance. CMS accepted 2007 data until the end of February and is currently analyzing the information. CMS officials expect to provide results and bonus payments to physicians in mid-July.

Preliminary data show that in 2007, more than 100,000 physicians and other eligible professionals submitted quality data at least once to the voluntary reporting program. CMS estimates that about half of those who participated in 2007 will receive an incentive payment.

In 2007, CMS officials selected 74 quality measures to be used across various specialties. If three or more measures applied, physicians had to report on at least three measures for at least 80% of applicable patients. If fewer than three measures were applicable, physicians had to report on each measure for at least 80% of the eligible patients. All reporting was claims based and covered the period from July 1 to Dec. 31, 2007.

This year, CMS has expanded the list of measures to 119, with 117 clinical measures and 2 structural measures. The structural measures relate to e-prescribing and electronic health record adoption and use.

CMS will also allow physicians to report on their clinical interactions for a full year from Jan. 1 to Dec. 31, 2008, or a half-year starting on July 1. Those physicians who haven't started reporting yet should still consider the full-year option, Dr. Michael T. Rapp, director of the quality measurement and health assessment group at CMS, said during a CMS-sponsored provider call on PQRI. Because 60 of the measures require only once-a-year reporting, physicians could still meet the 80% threshold if they started in May or June, he said.

CMS is also allowing providers to report either individual measures or “measures groups.” CMS has created four measures groups with at least four measures each. The groups include diabetes, end-stage renal disease, chronic kidney disease, and preventive care.

For example, the end-stage renal disease group includes four measures: vascular access for hemodialysis patients, influenza vaccination, plan of care for patients with anemia, and plan of care for inadequate hemodialysis. In order to quality for payment using measures groups, physicians have to submit data for each of the measures in the group.

Eligible professionals will also be able to report to clinical registries instead of submitting claims directly to CMS. Physicians would report data to the registry, which would in turn report to CMS. Currently, CMS is testing submission from registries and plans to publish a list of qualified registries in late August.

Despite the late announcement of qualified registries, physicians can still consider full-year participation with this option, Dr. Rapp said, because data are often submitted to registries months after the clinical encounter has occurred.

It appears that the changes will make it easier to report data, said Dr. James King, president of the American Academy of Family Physicians. “We want to be able to get our data in.”

However, more details will be needed on registry-based reporting, said Brian Whitman, who monitors regulatory and insurer affairs at the American College of Physicians. The extent to which internists will be able to use registry-based reporting will be unclear until CMS releases the list of participating registries in late August, he said. While subspecialties such as thoracic surgery do have well-established registries, there is not a registry commonly used by all internists at this point, he said.

Another unanswered question is how CMS will ensure that the data being submitted by registries are accurate, Mr. Whitman said.

Options Involve Claims-Based and Registry-Based Reporting

Three of the nine options outlined by the Centers for Medicare and Medicaid Services for reporting data to PQRI in 2008 allow claims-based reporting. Here are details on the claim-based option:

▸ Physicians can choose to report on individual measures for a full year from Jan. 1 to Dec. 31, 2008. Under this option, physicians with three or more applicable measures would report on at least three measures for at least 80% of their patients. Those with fewer than three applicable measures would report on all of those measures for at least 80% of their eligible patients.

▸ Physicians also can choose from two reporting approaches for the half-year reporting period from July 1 to Dec. 31. Physicians could report on all measures in a measures group for 15 consecutive patients with the relevant condition or 80% of eligible patients.

Six options are registry-based:

▸ CMS will allow three reporting options for a full-year reporting period. Those who chose to report on individual measures must report on 80% of applicable cases for a minimum of three measures. Physicians can also report on a measures group for 30 consecutive patients with the applicable condition or 80% of the applicable cases.

▸ CMS also has established three reporting options for reporting to a registry for a half-year from July 1 to Dec. 31. For example, physicians could report on individual measures for 80% of applicable cases for a minimum of three measures. It also is possible to report for a half-year using measures groups. For example, physicians can report on a measures group for 15 consecutive patients with the applicable condition or 80% of applicable cases.

More information about the different reporting options is available online at

www.cms.hhs.gov/pqri

Physicians now have nine options for submitting quality data to Medicare under the Physician Quality Reporting Initiative.

The new options include three ways to submit claims-based data and six registry-based methods for reporting (see box). For example, physicians will have the option of reporting data on groups of related clinical measures or individual measures and they can report for a full or half year. Officials at the Centers for Medicare and Medicaid Services announced the changes in April.

Under the Physician Quality Reporting Initiative (PQRI), launched last July, physicians can earn up to a 1.5% bonus on all of their total allowed Medicare charges for covered services for reporting on certain quality measures to CMS.

“We are encouraged by the success of the program so far, and with the new options for data reporting, more health professionals should take advantage of the reporting system,” the acting administrator of the CMS, Kerry Weems, said in a statement.

In the meantime, physicians who reported data in 2007 are still waiting for their bonus checks and feedback on their performance. CMS accepted 2007 data until the end of February and is currently analyzing the information. CMS officials expect to provide results and bonus payments to physicians in mid-July.

Preliminary data show that in 2007, more than 100,000 physicians and other eligible professionals submitted quality data at least once to the voluntary reporting program. CMS estimates that about half of those who participated in 2007 will receive an incentive payment.

In 2007, CMS officials selected 74 quality measures to be used across various specialties. If three or more measures applied, physicians had to report on at least three measures for at least 80% of applicable patients. If fewer than three measures were applicable, physicians had to report on each measure for at least 80% of the eligible patients. All reporting was claims based and covered the period from July 1 to Dec. 31, 2007.

This year, CMS has expanded the list of measures to 119, with 117 clinical measures and 2 structural measures. The structural measures relate to e-prescribing and electronic health record adoption and use.

CMS will also allow physicians to report on their clinical interactions for a full year from Jan. 1 to Dec. 31, 2008, or a half-year starting on July 1. Those physicians who haven't started reporting yet should still consider the full-year option, Dr. Michael T. Rapp, director of the quality measurement and health assessment group at CMS, said during a CMS-sponsored provider call on PQRI. Because 60 of the measures require only once-a-year reporting, physicians could still meet the 80% threshold if they started in May or June, he said.

CMS is also allowing providers to report either individual measures or “measures groups.” CMS has created four measures groups with at least four measures each. The groups include diabetes, end-stage renal disease, chronic kidney disease, and preventive care.

For example, the end-stage renal disease group includes four measures: vascular access for hemodialysis patients, influenza vaccination, plan of care for patients with anemia, and plan of care for inadequate hemodialysis. In order to quality for payment using measures groups, physicians have to submit data for each of the measures in the group.

Eligible professionals will also be able to report to clinical registries instead of submitting claims directly to CMS. Physicians would report data to the registry, which would in turn report to CMS. Currently, CMS is testing submission from registries and plans to publish a list of qualified registries in late August.

Despite the late announcement of qualified registries, physicians can still consider full-year participation with this option, Dr. Rapp said, because data are often submitted to registries months after the clinical encounter has occurred.

It appears that the changes will make it easier to report data, said Dr. James King, president of the American Academy of Family Physicians. “We want to be able to get our data in.”

However, more details will be needed on registry-based reporting, said Brian Whitman, who monitors regulatory and insurer affairs at the American College of Physicians. The extent to which internists will be able to use registry-based reporting will be unclear until CMS releases the list of participating registries in late August, he said. While subspecialties such as thoracic surgery do have well-established registries, there is not a registry commonly used by all internists at this point, he said.

Another unanswered question is how CMS will ensure that the data being submitted by registries are accurate, Mr. Whitman said.

Options Involve Claims-Based and Registry-Based Reporting

Three of the nine options outlined by the Centers for Medicare and Medicaid Services for reporting data to PQRI in 2008 allow claims-based reporting. Here are details on the claim-based option:

▸ Physicians can choose to report on individual measures for a full year from Jan. 1 to Dec. 31, 2008. Under this option, physicians with three or more applicable measures would report on at least three measures for at least 80% of their patients. Those with fewer than three applicable measures would report on all of those measures for at least 80% of their eligible patients.

▸ Physicians also can choose from two reporting approaches for the half-year reporting period from July 1 to Dec. 31. Physicians could report on all measures in a measures group for 15 consecutive patients with the relevant condition or 80% of eligible patients.

Six options are registry-based:

▸ CMS will allow three reporting options for a full-year reporting period. Those who chose to report on individual measures must report on 80% of applicable cases for a minimum of three measures. Physicians can also report on a measures group for 30 consecutive patients with the applicable condition or 80% of the applicable cases.

▸ CMS also has established three reporting options for reporting to a registry for a half-year from July 1 to Dec. 31. For example, physicians could report on individual measures for 80% of applicable cases for a minimum of three measures. It also is possible to report for a half-year using measures groups. For example, physicians can report on a measures group for 15 consecutive patients with the applicable condition or 80% of applicable cases.

More information about the different reporting options is available online at

www.cms.hhs.gov/pqri

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. Specifically, the plan calls for removing business barriers and disincentives for adoption of 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.

“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, said Dan Rode, vice president of policy and government relations at the American Health Information Management Association. But many of the items don't have timetables for completion but will instead be reassessed in 2010, he said, leaving much 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 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. Specifically, the plan calls for removing business barriers and disincentives for adoption of 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.

“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, said Dan Rode, vice president of policy and government relations at the American Health Information Management Association. But many of the items don't have timetables for completion but will instead be reassessed in 2010, he said, leaving much 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 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. Specifically, the plan calls for removing business barriers and disincentives for adoption of 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.

“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, said Dan Rode, vice president of policy and government relations at the American Health Information Management Association. But many of the items don't have timetables for completion but will instead be reassessed in 2010, he said, leaving much 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 strategic plan is available online at www.hhs.gov/healthit

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 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 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 or taking tests under assumed names, 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, said Dr. Matthew Taylor, director of adult clinical genetics at the University of Colorado in Denver. 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 and 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.

Potential discrimination in life insurance and long-term disability insurance also needs to be addressed, Ms. Terry said. “This is a first-step bill for sure.”

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 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 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 or taking tests under assumed names, 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, said Dr. Matthew Taylor, director of adult clinical genetics at the University of Colorado in Denver. 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 and 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.

Potential discrimination in life insurance and long-term disability insurance also needs to be addressed, Ms. Terry said. “This is a first-step bill for sure.”

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 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 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 or taking tests under assumed names, 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, said Dr. Matthew Taylor, director of adult clinical genetics at the University of Colorado in Denver. 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 and 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.

Potential discrimination in life insurance and long-term disability insurance also needs to be addressed, Ms. Terry said. “This is a first-step bill for sure.”

The study is available online at www.hschange.org/CONTENT/1015

The federal government's relaxation of self-referral and antikickback laws has had a “modest” effect in encouraging hospitals to subsidize physician purchases of electronic medical record systems, according to an analysis by the Center for Studying Health System Change.

Some hospitals are proceeding slowly, offering subsidies for acquisition of electronic medical record (EMR) software to small groups of closely affiliated physicians, while other hospitals are offering physicians only IT support services or extending their vendor discounts, according to the analysis of 24 hospitals. The analysis was funded by the Robert Wood Johnson Foundation.

In 2006, the Health and Human Services Department announced that it had created two safe harbors that would allow hospitals to subsidize up to 85% of the cost of EMR software and IT support services for physicians. For their part, physicians would be responsible for paying the full cost of the hardware required for the EMR system. The regulations are scheduled to sunset at the end of 2013.

The analysis by the Center for Studying Health System Change, which is based on in-depth interviews with executives at 24 hospitals, found that 11 of the 24 hospitals were considering offering some type of subsidy to physicians to help cover their EMR costs. The remaining 13 hospitals were not planning to provide direct subsidies to physicians, but some were considering extending their EMR vendor discounts or offering IT support services.

Hospitals that chose not to offer direct financial support to physicians cited differing reasons for the decision. For example, some hospitals opposed the idea of offering EMR subsidies to physicians.

Other hospitals said that granting access to vendor discounts was a sufficient incentive for physicians preparing to adopt EMRs. And still other hospitals were interested in providing the financial subsidies directly to physicians but couldn't afford to do so.

For those hospital executives who said that they were considering a direct EMR subsidy to physicians, improving patient care and forging closer relationships with referring physicians were the top reasons cited for moving forward with EMR assistance.

“Hospital executives expected physicians would be more likely to maintain, and even expand, their relationship with the hospital because of the improved efficiency from interoperability with the hospital's IT systems,” the researchers wrote.

One factor that appears not to be driving the trend toward hospital subsidies is interest on the part of physicians. The arrangement has some potential drawbacks for physicians, according to the analysis.

For example, under the safe harbor provisions, physicians are still responsible for 15% of the software costs and 100% of the hardware costs associated with setting up the EMR system.

Moreover, physicians using the hospital-sponsored EMR may have difficulty storing records for patients who are treated at other hospitals where the physicians provide care for patients. Also, the hospital-sponsored EMR could serve as a barrier if physicians later wanted to switch their hospital affiliations, according to the analysis.

“While hospitals have strategic incentives to provide support, particularly to tie referring physicians to their institution, the effects of the regulatory changes on physician EMR adoption will ultimately depend both on hospitals' willingness to provide support and physicians' acceptance of hospital assistance,” Joy M. Grossman, Ph.D., one of the study authors, said in a statement.

The study is available online at www.hschange.org/CONTENT/1015

The federal government's relaxation of self-referral and antikickback laws has had a “modest” effect in encouraging hospitals to subsidize physician purchases of electronic medical record systems, according to an analysis by the Center for Studying Health System Change.

Some hospitals are proceeding slowly, offering subsidies for acquisition of electronic medical record (EMR) software to small groups of closely affiliated physicians, while other hospitals are offering physicians only IT support services or extending their vendor discounts, according to the analysis of 24 hospitals. The analysis was funded by the Robert Wood Johnson Foundation.

In 2006, the Health and Human Services Department announced that it had created two safe harbors that would allow hospitals to subsidize up to 85% of the cost of EMR software and IT support services for physicians. For their part, physicians would be responsible for paying the full cost of the hardware required for the EMR system. The regulations are scheduled to sunset at the end of 2013.

The analysis by the Center for Studying Health System Change, which is based on in-depth interviews with executives at 24 hospitals, found that 11 of the 24 hospitals were considering offering some type of subsidy to physicians to help cover their EMR costs. The remaining 13 hospitals were not planning to provide direct subsidies to physicians, but some were considering extending their EMR vendor discounts or offering IT support services.

Hospitals that chose not to offer direct financial support to physicians cited differing reasons for the decision. For example, some hospitals opposed the idea of offering EMR subsidies to physicians.

Other hospitals said that granting access to vendor discounts was a sufficient incentive for physicians preparing to adopt EMRs. And still other hospitals were interested in providing the financial subsidies directly to physicians but couldn't afford to do so.

For those hospital executives who said that they were considering a direct EMR subsidy to physicians, improving patient care and forging closer relationships with referring physicians were the top reasons cited for moving forward with EMR assistance.

“Hospital executives expected physicians would be more likely to maintain, and even expand, their relationship with the hospital because of the improved efficiency from interoperability with the hospital's IT systems,” the researchers wrote.

One factor that appears not to be driving the trend toward hospital subsidies is interest on the part of physicians. The arrangement has some potential drawbacks for physicians, according to the analysis.

For example, under the safe harbor provisions, physicians are still responsible for 15% of the software costs and 100% of the hardware costs associated with setting up the EMR system.

Moreover, physicians using the hospital-sponsored EMR may have difficulty storing records for patients who are treated at other hospitals where the physicians provide care for patients. Also, the hospital-sponsored EMR could serve as a barrier if physicians later wanted to switch their hospital affiliations, according to the analysis.

“While hospitals have strategic incentives to provide support, particularly to tie referring physicians to their institution, the effects of the regulatory changes on physician EMR adoption will ultimately depend both on hospitals' willingness to provide support and physicians' acceptance of hospital assistance,” Joy M. Grossman, Ph.D., one of the study authors, said in a statement.

The study is available online at www.hschange.org/CONTENT/1015

The federal government's relaxation of self-referral and antikickback laws has had a “modest” effect in encouraging hospitals to subsidize physician purchases of electronic medical record systems, according to an analysis by the Center for Studying Health System Change.

Some hospitals are proceeding slowly, offering subsidies for acquisition of electronic medical record (EMR) software to small groups of closely affiliated physicians, while other hospitals are offering physicians only IT support services or extending their vendor discounts, according to the analysis of 24 hospitals. The analysis was funded by the Robert Wood Johnson Foundation.

In 2006, the Health and Human Services Department announced that it had created two safe harbors that would allow hospitals to subsidize up to 85% of the cost of EMR software and IT support services for physicians. For their part, physicians would be responsible for paying the full cost of the hardware required for the EMR system. The regulations are scheduled to sunset at the end of 2013.

The analysis by the Center for Studying Health System Change, which is based on in-depth interviews with executives at 24 hospitals, found that 11 of the 24 hospitals were considering offering some type of subsidy to physicians to help cover their EMR costs. The remaining 13 hospitals were not planning to provide direct subsidies to physicians, but some were considering extending their EMR vendor discounts or offering IT support services.

Hospitals that chose not to offer direct financial support to physicians cited differing reasons for the decision. For example, some hospitals opposed the idea of offering EMR subsidies to physicians.

Other hospitals said that granting access to vendor discounts was a sufficient incentive for physicians preparing to adopt EMRs. And still other hospitals were interested in providing the financial subsidies directly to physicians but couldn't afford to do so.

For those hospital executives who said that they were considering a direct EMR subsidy to physicians, improving patient care and forging closer relationships with referring physicians were the top reasons cited for moving forward with EMR assistance.

“Hospital executives expected physicians would be more likely to maintain, and even expand, their relationship with the hospital because of the improved efficiency from interoperability with the hospital's IT systems,” the researchers wrote.

One factor that appears not to be driving the trend toward hospital subsidies is interest on the part of physicians. The arrangement has some potential drawbacks for physicians, according to the analysis.

For example, under the safe harbor provisions, physicians are still responsible for 15% of the software costs and 100% of the hardware costs associated with setting up the EMR system.

Moreover, physicians using the hospital-sponsored EMR may have difficulty storing records for patients who are treated at other hospitals where the physicians provide care for patients. Also, the hospital-sponsored EMR could serve as a barrier if physicians later wanted to switch their hospital affiliations, according to the analysis.

“While hospitals have strategic incentives to provide support, particularly to tie referring physicians to their institution, the effects of the regulatory changes on physician EMR adoption will ultimately depend both on hospitals' willingness to provide support and physicians' acceptance of hospital assistance,” Joy M. Grossman, Ph.D., one of the study authors, said in a statement.

The Florida Supreme Court recently overturned a law that had given two Florida hospitals unique authority to disregard their medical staff bylaws.

In late August, the court threw out the St. Lucie County Hospital Governance Law, a 2003 law that applied to the two private hospitals in St. Lucie County, both owned by HCA Inc. of Nashville, Tenn.

Under the special law, the hospital board of directors' bylaws would prevail over the medical staff bylaws on any area of conflict related to medical staff privileges, quality assurance, peer review, and contracts for hospital-based services.

In Lawnwood Medical Center v. Randall Seeger, M.D. (president of the Lawnwood Medical Center medical staff), the Florida Supreme Court upheld a lower court ruling that found that the law was unconstitutional because it granted a “privilege to a private corporation” and violated the constitution's “equal protection” clause by creating two different classes of hospitals in the state.

The Florida Supreme Court concluded that the law granted the management of the hospital “almost absolute power in running the affairs of the hospital, essentially without meaningful regard for the recommendations or actions of the medical staff.”

Since the approval of the medical staff bylaws at the Lawnwood Regional Medical Center in 1993, there had been several disputes between the hospital management and the medical staff regarding issues such as peer review, resulting in multiple lawsuits. After years of conflict, the hospital management sought and received a legislative remedy in 2003.

In an unusual legal move, the hospital management filed a court action shortly after the law went into effect to have it declared “constitutional.” The law was rejected by a trial court and an appellate court before making its way to the Florida Supreme Court this year.

Officials at HCA Inc. are disappointed in the ruling and are reviewing the decision to determine possible next steps, said Nicole Baxter, a spokesperson for HCA.

The American Medical Association praised the decision. “Those bylaws represent a binding contract,” said Dr. Cecil B. Wilson, a board member of the AMA, which filed “friend of the court” briefs in opposition to the 2003 statute through its litigation center.

The AMA litigation center and the Florida Medical Association also provided financial support to defray the legal costs of the medical staff.

By superseding jointly approved bylaws, the hospital was doing a disservice to both its physician staff and patients, Dr. Wilson said. Ignoring medical staff input on issues such as credentialing can have serious implications for safety and quality of care, he said.

Dr. Wilson said the AMA is hopeful that the case will serve as an example around the country, where conflicts between hospital management and medical staffs are becoming more common as both groups try to discharge their responsibilities related to quality and patient safety.

The Florida Supreme Court recently overturned a law that had given two Florida hospitals unique authority to disregard their medical staff bylaws.

In late August, the court threw out the St. Lucie County Hospital Governance Law, a 2003 law that applied to the two private hospitals in St. Lucie County, both owned by HCA Inc. of Nashville, Tenn.

Under the special law, the hospital board of directors' bylaws would prevail over the medical staff bylaws on any area of conflict related to medical staff privileges, quality assurance, peer review, and contracts for hospital-based services.

In Lawnwood Medical Center v. Randall Seeger, M.D. (president of the Lawnwood Medical Center medical staff), the Florida Supreme Court upheld a lower court ruling that found that the law was unconstitutional because it granted a “privilege to a private corporation” and violated the constitution's “equal protection” clause by creating two different classes of hospitals in the state.

The Florida Supreme Court concluded that the law granted the management of the hospital “almost absolute power in running the affairs of the hospital, essentially without meaningful regard for the recommendations or actions of the medical staff.”

Since the approval of the medical staff bylaws at the Lawnwood Regional Medical Center in 1993, there had been several disputes between the hospital management and the medical staff regarding issues such as peer review, resulting in multiple lawsuits. After years of conflict, the hospital management sought and received a legislative remedy in 2003.

In an unusual legal move, the hospital management filed a court action shortly after the law went into effect to have it declared “constitutional.” The law was rejected by a trial court and an appellate court before making its way to the Florida Supreme Court this year.

Officials at HCA Inc. are disappointed in the ruling and are reviewing the decision to determine possible next steps, said Nicole Baxter, a spokesperson for HCA.

The American Medical Association praised the decision. “Those bylaws represent a binding contract,” said Dr. Cecil B. Wilson, a board member of the AMA, which filed “friend of the court” briefs in opposition to the 2003 statute through its litigation center.

The AMA litigation center and the Florida Medical Association also provided financial support to defray the legal costs of the medical staff.

By superseding jointly approved bylaws, the hospital was doing a disservice to both its physician staff and patients, Dr. Wilson said. Ignoring medical staff input on issues such as credentialing can have serious implications for safety and quality of care, he said.

Dr. Wilson said the AMA is hopeful that the case will serve as an example around the country, where conflicts between hospital management and medical staffs are becoming more common as both groups try to discharge their responsibilities related to quality and patient safety.

The Florida Supreme Court recently overturned a law that had given two Florida hospitals unique authority to disregard their medical staff bylaws.

In late August, the court threw out the St. Lucie County Hospital Governance Law, a 2003 law that applied to the two private hospitals in St. Lucie County, both owned by HCA Inc. of Nashville, Tenn.

Under the special law, the hospital board of directors' bylaws would prevail over the medical staff bylaws on any area of conflict related to medical staff privileges, quality assurance, peer review, and contracts for hospital-based services.

In Lawnwood Medical Center v. Randall Seeger, M.D. (president of the Lawnwood Medical Center medical staff), the Florida Supreme Court upheld a lower court ruling that found that the law was unconstitutional because it granted a “privilege to a private corporation” and violated the constitution's “equal protection” clause by creating two different classes of hospitals in the state.

The Florida Supreme Court concluded that the law granted the management of the hospital “almost absolute power in running the affairs of the hospital, essentially without meaningful regard for the recommendations or actions of the medical staff.”

Since the approval of the medical staff bylaws at the Lawnwood Regional Medical Center in 1993, there had been several disputes between the hospital management and the medical staff regarding issues such as peer review, resulting in multiple lawsuits. After years of conflict, the hospital management sought and received a legislative remedy in 2003.

In an unusual legal move, the hospital management filed a court action shortly after the law went into effect to have it declared “constitutional.” The law was rejected by a trial court and an appellate court before making its way to the Florida Supreme Court this year.

Officials at HCA Inc. are disappointed in the ruling and are reviewing the decision to determine possible next steps, said Nicole Baxter, a spokesperson for HCA.

The American Medical Association praised the decision. “Those bylaws represent a binding contract,” said Dr. Cecil B. Wilson, a board member of the AMA, which filed “friend of the court” briefs in opposition to the 2003 statute through its litigation center.

The AMA litigation center and the Florida Medical Association also provided financial support to defray the legal costs of the medical staff.

By superseding jointly approved bylaws, the hospital was doing a disservice to both its physician staff and patients, Dr. Wilson said. Ignoring medical staff input on issues such as credentialing can have serious implications for safety and quality of care, he said.

Dr. Wilson said the AMA is hopeful that the case will serve as an example around the country, where conflicts between hospital management and medical staffs are becoming more common as both groups try to discharge their responsibilities related to quality and patient safety.

The Joint Commission, which provides the standard in hospital accreditation in the United States, will soon be subjected to greater federal oversight.

Congress recently eliminated the Joint Commission's “unique deeming authority” for hospitals as part of the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331), which was enacted in July. That means that the Joint Commission, like other accrediting bodies, will need to apply to the Centers for Medicare and Medicaid Services for its accredited hospitals to be deemed to have met the conditions of participation in Medicare. Previously, the Joint Commission's deeming authority had been automatic and was not subject to oversight by CMS.

Officials at the Joint Commission supported the intention of the change, and plan to apply to CMS for hospital deeming authority. The Joint Commission and other accrediting bodies already apply to CMS for deeming authority in other areas, such as home care, laboratory, and ambulatory surgery accreditation programs.

Under the new law, the Joint Commission will have 24 months to apply to CMS for deeming authority and to be recognized. During the transition period, accredited hospitals will not be affected by this change, according to the Joint Commission.

“The Joint Commission anticipates a seamless transition,” said Ken Powers, a spokesman for the organization.

In recent years, some members of Congress have tried unsuccessfully to eliminate the Joint Commission's unique deeming authority. In 2004, the U.S. Government Accountability Office (GAO) issued a report that called on Congress to consider giving CMS greater authority over the Joint Commission's hospital accreditation program. GAO investigators examined state agency validation surveys for 500 hospitals accredited by the Joint Commission and found that the commission had missed most of the serious deficiencies picked up during the state reviews.

The Joint Commission, which provides the standard in hospital accreditation in the United States, will soon be subjected to greater federal oversight.

Congress recently eliminated the Joint Commission's “unique deeming authority” for hospitals as part of the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331), which was enacted in July. That means that the Joint Commission, like other accrediting bodies, will need to apply to the Centers for Medicare and Medicaid Services for its accredited hospitals to be deemed to have met the conditions of participation in Medicare. Previously, the Joint Commission's deeming authority had been automatic and was not subject to oversight by CMS.

Officials at the Joint Commission supported the intention of the change, and plan to apply to CMS for hospital deeming authority. The Joint Commission and other accrediting bodies already apply to CMS for deeming authority in other areas, such as home care, laboratory, and ambulatory surgery accreditation programs.

Under the new law, the Joint Commission will have 24 months to apply to CMS for deeming authority and to be recognized. During the transition period, accredited hospitals will not be affected by this change, according to the Joint Commission.

“The Joint Commission anticipates a seamless transition,” said Ken Powers, a spokesman for the organization.

In recent years, some members of Congress have tried unsuccessfully to eliminate the Joint Commission's unique deeming authority. In 2004, the U.S. Government Accountability Office (GAO) issued a report that called on Congress to consider giving CMS greater authority over the Joint Commission's hospital accreditation program. GAO investigators examined state agency validation surveys for 500 hospitals accredited by the Joint Commission and found that the commission had missed most of the serious deficiencies picked up during the state reviews.

The Joint Commission, which provides the standard in hospital accreditation in the United States, will soon be subjected to greater federal oversight.

Congress recently eliminated the Joint Commission's “unique deeming authority” for hospitals as part of the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331), which was enacted in July. That means that the Joint Commission, like other accrediting bodies, will need to apply to the Centers for Medicare and Medicaid Services for its accredited hospitals to be deemed to have met the conditions of participation in Medicare. Previously, the Joint Commission's deeming authority had been automatic and was not subject to oversight by CMS.

Officials at the Joint Commission supported the intention of the change, and plan to apply to CMS for hospital deeming authority. The Joint Commission and other accrediting bodies already apply to CMS for deeming authority in other areas, such as home care, laboratory, and ambulatory surgery accreditation programs.

Under the new law, the Joint Commission will have 24 months to apply to CMS for deeming authority and to be recognized. During the transition period, accredited hospitals will not be affected by this change, according to the Joint Commission.

“The Joint Commission anticipates a seamless transition,” said Ken Powers, a spokesman for the organization.

In recent years, some members of Congress have tried unsuccessfully to eliminate the Joint Commission's unique deeming authority. In 2004, the U.S. Government Accountability Office (GAO) issued a report that called on Congress to consider giving CMS greater authority over the Joint Commission's hospital accreditation program. GAO investigators examined state agency validation surveys for 500 hospitals accredited by the Joint Commission and found that the commission had missed most of the serious deficiencies picked up during the state reviews.

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 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 data 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, the system will provide valuable data on the elderly and disabled population, said Kerry N. Weems, acting CMS administrator. Drug safety and efficacy data are usually limited in this group because the elderly and disabled often 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, 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 FDA 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.

"Clearly, 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.

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 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 data 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, the system will provide valuable data on the elderly and disabled population, said Kerry N. Weems, acting CMS administrator. Drug safety and efficacy data are usually limited in this group because the elderly and disabled often 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, 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 FDA 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.

"Clearly, 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.

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 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 data 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, the system will provide valuable data on the elderly and disabled population, said Kerry N. Weems, acting CMS administrator. Drug safety and efficacy data are usually limited in this group because the elderly and disabled often 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, 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 FDA 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.

"Clearly, 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.

ACOG Down on Home Genetic Tests

At-home genetic testing should be discouraged because of the potential for patients to misinterpret the test or get an inaccurate result, the American College of Obstetricians and Gynecologists' Committee on Genetics and Committee on Ethics said in a recent policy statement. Genetic testing should be performed only after a consultation with a qualified health care professional and a referral to a genetic counselor or medical geneticist may be necessary in the case of complex testing, according to the policy. “Appropriate pretest and posttest counseling should be provided, including a discussion of the risks, benefits, and limitations of the testing,” ACOG advised.

MDs Don't Recruit Research Subjects

Nearly 95% of Americans in a recent survey said that their physician has never spoken to them about participating in a medical research study. The survey results, released by the Society for Women's Health Research, also found that less than 10% of respondents had ever participated in such a study. Further, women were less likely than men to know that research opportunities were available. About 73% of women were aware of research opportunities, compared with 83% of men who were surveyed. Women were also more likely to say that they were too old or too sick to participate in research, according to the study. For example, 7.2% of women said that their age made them hesitant to participate in clinical research, compared with 2.4% of men. “Women 65 and older are among the fastest growing segments of our population, and we have very little health research data on them,” Sherry Marts, Ph.D., vice president of scientific affairs for the society, said in a statement. “This lack of information is an area of great need and growing concern.” The telephone survey included responses from 2,028 U.S. adults.

Women Favor Medical Home

More than half of American women in a recent survey said they had difficulty navigating the health care system. The survey, commissioned by the American Academy of Family Physicians, found that women aged 18-34 years had the most trouble obtaining health care services, with 74% saying it was at least somewhat difficult. But most women support the concept of the patient-centered medical home. More than two-thirds of women surveyed said that being able to obtain same-day appointments for acute illnesses was important to them. And 62% said that having one physician to coordinate all their care was important. “A system that is difficult to navigate and relies on patients to deliver tests and communicate diagnoses leads to fragmented care, duplication of tests, and sometimes unnecessary procedures—all of which steadily drive up the cost of health care for the nation as a whole,” Dr. James King, AAFP president, said in a statement. The online survey of 1,270 adult women was conducted by Harris Interactive.

Doubt Cast on Health IT Savings

Health information technology, when coupled with other reforms, can help reduce health spending in certain settings, according to a report from the Congressional Budget Office. However, the adoption of health IT alone will not produce significant savings, the report concludes. “Office-based physicians in particular may see no benefit if they purchase [an electronic health record]—and may even suffer financial harm,” the CBO report said. Recent studies by the RAND Corporation and the Center for Information Technology Leadership estimate savings from health IT at around $80 billion annually. However, the CBO takes issue with those estimates because the savings figures are derived by assuming a number of changes to the health care system. The CBO report also outlines possible policy options for the federal government to encourage the adoption of health IT by physicians and hospitals. CBO analysts found that a subsidy to providers could increase adoption but would be costly to the government. On the other hand, a mandate for adoption or a penalty for lack of adoption would also be effective but costly for providers. The full report is available online at

www.cbo.gov

Group Calls for Obesity Action

The advocacy group Campaign to End Obesity, in concert with the American College of Gastroenterology, the American Heart Association, the American Diabetes Association, and others, has issued a call to action outlining what it said Congress must do to address the obesity epidemic. “It is time for the government to take a more comprehensive policy approach to the problem—to look holistically at factors that influence obesity and to look for ways to support people in preventing, managing and treating the disease,” the report said. The call to action said that there is much more that lawmakers can do about improving school nutrition and physical activity standards, and that Congress also should consider reimbursement for providers who manage and treat obesity.

Consumer Reports to Grade Hospitals

Consumer Reports has begun grading hospitals and plans to eventually add ratings for other health care providers. The ratings, which include nearly 3,000 hospitals, are available at

www.consumerreportshealth.org

ACOG Down on Home Genetic Tests

At-home genetic testing should be discouraged because of the potential for patients to misinterpret the test or get an inaccurate result, the American College of Obstetricians and Gynecologists' Committee on Genetics and Committee on Ethics said in a recent policy statement. Genetic testing should be performed only after a consultation with a qualified health care professional and a referral to a genetic counselor or medical geneticist may be necessary in the case of complex testing, according to the policy. “Appropriate pretest and posttest counseling should be provided, including a discussion of the risks, benefits, and limitations of the testing,” ACOG advised.

MDs Don't Recruit Research Subjects

Nearly 95% of Americans in a recent survey said that their physician has never spoken to them about participating in a medical research study. The survey results, released by the Society for Women's Health Research, also found that less than 10% of respondents had ever participated in such a study. Further, women were less likely than men to know that research opportunities were available. About 73% of women were aware of research opportunities, compared with 83% of men who were surveyed. Women were also more likely to say that they were too old or too sick to participate in research, according to the study. For example, 7.2% of women said that their age made them hesitant to participate in clinical research, compared with 2.4% of men. “Women 65 and older are among the fastest growing segments of our population, and we have very little health research data on them,” Sherry Marts, Ph.D., vice president of scientific affairs for the society, said in a statement. “This lack of information is an area of great need and growing concern.” The telephone survey included responses from 2,028 U.S. adults.

Women Favor Medical Home

More than half of American women in a recent survey said they had difficulty navigating the health care system. The survey, commissioned by the American Academy of Family Physicians, found that women aged 18-34 years had the most trouble obtaining health care services, with 74% saying it was at least somewhat difficult. But most women support the concept of the patient-centered medical home. More than two-thirds of women surveyed said that being able to obtain same-day appointments for acute illnesses was important to them. And 62% said that having one physician to coordinate all their care was important. “A system that is difficult to navigate and relies on patients to deliver tests and communicate diagnoses leads to fragmented care, duplication of tests, and sometimes unnecessary procedures—all of which steadily drive up the cost of health care for the nation as a whole,” Dr. James King, AAFP president, said in a statement. The online survey of 1,270 adult women was conducted by Harris Interactive.

Doubt Cast on Health IT Savings

Health information technology, when coupled with other reforms, can help reduce health spending in certain settings, according to a report from the Congressional Budget Office. However, the adoption of health IT alone will not produce significant savings, the report concludes. “Office-based physicians in particular may see no benefit if they purchase [an electronic health record]—and may even suffer financial harm,” the CBO report said. Recent studies by the RAND Corporation and the Center for Information Technology Leadership estimate savings from health IT at around $80 billion annually. However, the CBO takes issue with those estimates because the savings figures are derived by assuming a number of changes to the health care system. The CBO report also outlines possible policy options for the federal government to encourage the adoption of health IT by physicians and hospitals. CBO analysts found that a subsidy to providers could increase adoption but would be costly to the government. On the other hand, a mandate for adoption or a penalty for lack of adoption would also be effective but costly for providers. The full report is available online at

www.cbo.gov

Group Calls for Obesity Action

The advocacy group Campaign to End Obesity, in concert with the American College of Gastroenterology, the American Heart Association, the American Diabetes Association, and others, has issued a call to action outlining what it said Congress must do to address the obesity epidemic. “It is time for the government to take a more comprehensive policy approach to the problem—to look holistically at factors that influence obesity and to look for ways to support people in preventing, managing and treating the disease,” the report said. The call to action said that there is much more that lawmakers can do about improving school nutrition and physical activity standards, and that Congress also should consider reimbursement for providers who manage and treat obesity.

Consumer Reports to Grade Hospitals

Consumer Reports has begun grading hospitals and plans to eventually add ratings for other health care providers. The ratings, which include nearly 3,000 hospitals, are available at

www.consumerreportshealth.org

ACOG Down on Home Genetic Tests

At-home genetic testing should be discouraged because of the potential for patients to misinterpret the test or get an inaccurate result, the American College of Obstetricians and Gynecologists' Committee on Genetics and Committee on Ethics said in a recent policy statement. Genetic testing should be performed only after a consultation with a qualified health care professional and a referral to a genetic counselor or medical geneticist may be necessary in the case of complex testing, according to the policy. “Appropriate pretest and posttest counseling should be provided, including a discussion of the risks, benefits, and limitations of the testing,” ACOG advised.

MDs Don't Recruit Research Subjects

Nearly 95% of Americans in a recent survey said that their physician has never spoken to them about participating in a medical research study. The survey results, released by the Society for Women's Health Research, also found that less than 10% of respondents had ever participated in such a study. Further, women were less likely than men to know that research opportunities were available. About 73% of women were aware of research opportunities, compared with 83% of men who were surveyed. Women were also more likely to say that they were too old or too sick to participate in research, according to the study. For example, 7.2% of women said that their age made them hesitant to participate in clinical research, compared with 2.4% of men. “Women 65 and older are among the fastest growing segments of our population, and we have very little health research data on them,” Sherry Marts, Ph.D., vice president of scientific affairs for the society, said in a statement. “This lack of information is an area of great need and growing concern.” The telephone survey included responses from 2,028 U.S. adults.

Women Favor Medical Home

More than half of American women in a recent survey said they had difficulty navigating the health care system. The survey, commissioned by the American Academy of Family Physicians, found that women aged 18-34 years had the most trouble obtaining health care services, with 74% saying it was at least somewhat difficult. But most women support the concept of the patient-centered medical home. More than two-thirds of women surveyed said that being able to obtain same-day appointments for acute illnesses was important to them. And 62% said that having one physician to coordinate all their care was important. “A system that is difficult to navigate and relies on patients to deliver tests and communicate diagnoses leads to fragmented care, duplication of tests, and sometimes unnecessary procedures—all of which steadily drive up the cost of health care for the nation as a whole,” Dr. James King, AAFP president, said in a statement. The online survey of 1,270 adult women was conducted by Harris Interactive.

Doubt Cast on Health IT Savings

Health information technology, when coupled with other reforms, can help reduce health spending in certain settings, according to a report from the Congressional Budget Office. However, the adoption of health IT alone will not produce significant savings, the report concludes. “Office-based physicians in particular may see no benefit if they purchase [an electronic health record]—and may even suffer financial harm,” the CBO report said. Recent studies by the RAND Corporation and the Center for Information Technology Leadership estimate savings from health IT at around $80 billion annually. However, the CBO takes issue with those estimates because the savings figures are derived by assuming a number of changes to the health care system. The CBO report also outlines possible policy options for the federal government to encourage the adoption of health IT by physicians and hospitals. CBO analysts found that a subsidy to providers could increase adoption but would be costly to the government. On the other hand, a mandate for adoption or a penalty for lack of adoption would also be effective but costly for providers. The full report is available online at

www.cbo.gov

Group Calls for Obesity Action

The advocacy group Campaign to End Obesity, in concert with the American College of Gastroenterology, the American Heart Association, the American Diabetes Association, and others, has issued a call to action outlining what it said Congress must do to address the obesity epidemic. “It is time for the government to take a more comprehensive policy approach to the problem—to look holistically at factors that influence obesity and to look for ways to support people in preventing, managing and treating the disease,” the report said. The call to action said that there is much more that lawmakers can do about improving school nutrition and physical activity standards, and that Congress also should consider reimbursement for providers who manage and treat obesity.

Consumer Reports to Grade Hospitals

Consumer Reports has begun grading hospitals and plans to eventually add ratings for other health care providers. The ratings, which include nearly 3,000 hospitals, are available at

www.consumerreportshealth.org