Mary Ellen Schneider

Being younger, being male, or having an elevated C-reactive protein level are just a few of the factors that are likely to predict whether patients with ankylosing spondylitis will improve when taking tumor necrosis factor inhibitors for the first time, according to new data.

Dr. Karen M. Fagerli of the Diakonh-jemmet Hospital in Oslo, and her associates identified several independent predictors of major improvement in ASDAS (Ankylosing Spondylitis Disease Activity Score) in patients with ankylosing spondylitis (AS) after 3 months of taking a TNF inhibitor.

The independent predictors are younger age, male sex, C-reactive protein (CRP) level greater than 10 mg/L, HLA-B27 positivity, and a higher baseline patient global assessment score.

The results confirm findings from previous studies that both age and elevated CRP are predictors of success with TNF inhibitors. They could be used in selecting patients most likely to respond to treatment, especially in countries with limited access to TNF inhibitors.

Clinicians should exercise caution in applying the other predictors found in the study to a clinical setting, Dr. Fagerli stressed in an interview.

Other studies have not found gender to be a significant predictor, and few other studies have shown HLA-B27 positivity to be a predictive factor.

“The independent predictors identified in this model give information about which patients are most likely to show a good clinical response on a group level, but may have limited value for use on the individual patient level,” Dr. Fagerli said.

The researchers extracted data from the Norwegian DMARD (NOR-DMARD) register, a repository of data on adult patients with inflammatory arthropathies who are starting a new disease-modifying antirheumatic drug treatment. The patients are consecutively included from across five rheumatology departments in Norway.

The current analysis included 171 AS patients who were being treated with their first TNF inhibitor. The mean age of the patients in the sample was 42 years, more than 73% were male, and the average disease duration was 10 years. Nearly a third of the patients in the study achieved ASDAS major improvement on a TNF inhibitor at 3 months.

The researchers plan to repeat these analyses with an updated data set that includes more patients, Dr. Fagerli said.

She also noted that the results will need to be validated in other cohorts, particularly the findings related to gender, patient global assessment, and HLA-B27.

In general, more research is needed into new and more accurate predictors of response to TNF inhibitors in AS and other rheumatic diseases, Dr. Fagerli said. Pharmacogenetic studies have the potential to identify these predictors, and further research to find new soluble biomarkers as markers of response will also be important. In addition, the role of MRI in diagnosis, predicting response, and monitoring treatment will be an important field in the years to come.

Dr. Fagerli said she had no financial disclosures.

'The independent predictors identified … may have limited value for use on the individual patient level.'

Source DR. FAGERLI

Being younger, being male, or having an elevated C-reactive protein level are just a few of the factors that are likely to predict whether patients with ankylosing spondylitis will improve when taking tumor necrosis factor inhibitors for the first time, according to new data.

Dr. Karen M. Fagerli of the Diakonh-jemmet Hospital in Oslo, and her associates identified several independent predictors of major improvement in ASDAS (Ankylosing Spondylitis Disease Activity Score) in patients with ankylosing spondylitis (AS) after 3 months of taking a TNF inhibitor.

The independent predictors are younger age, male sex, C-reactive protein (CRP) level greater than 10 mg/L, HLA-B27 positivity, and a higher baseline patient global assessment score.

The results confirm findings from previous studies that both age and elevated CRP are predictors of success with TNF inhibitors. They could be used in selecting patients most likely to respond to treatment, especially in countries with limited access to TNF inhibitors.

Clinicians should exercise caution in applying the other predictors found in the study to a clinical setting, Dr. Fagerli stressed in an interview.

Other studies have not found gender to be a significant predictor, and few other studies have shown HLA-B27 positivity to be a predictive factor.

“The independent predictors identified in this model give information about which patients are most likely to show a good clinical response on a group level, but may have limited value for use on the individual patient level,” Dr. Fagerli said.

The researchers extracted data from the Norwegian DMARD (NOR-DMARD) register, a repository of data on adult patients with inflammatory arthropathies who are starting a new disease-modifying antirheumatic drug treatment. The patients are consecutively included from across five rheumatology departments in Norway.

The current analysis included 171 AS patients who were being treated with their first TNF inhibitor. The mean age of the patients in the sample was 42 years, more than 73% were male, and the average disease duration was 10 years. Nearly a third of the patients in the study achieved ASDAS major improvement on a TNF inhibitor at 3 months.

The researchers plan to repeat these analyses with an updated data set that includes more patients, Dr. Fagerli said.

She also noted that the results will need to be validated in other cohorts, particularly the findings related to gender, patient global assessment, and HLA-B27.

In general, more research is needed into new and more accurate predictors of response to TNF inhibitors in AS and other rheumatic diseases, Dr. Fagerli said. Pharmacogenetic studies have the potential to identify these predictors, and further research to find new soluble biomarkers as markers of response will also be important. In addition, the role of MRI in diagnosis, predicting response, and monitoring treatment will be an important field in the years to come.

Dr. Fagerli said she had no financial disclosures.

'The independent predictors identified … may have limited value for use on the individual patient level.'

Source DR. FAGERLI

Being younger, being male, or having an elevated C-reactive protein level are just a few of the factors that are likely to predict whether patients with ankylosing spondylitis will improve when taking tumor necrosis factor inhibitors for the first time, according to new data.

Dr. Karen M. Fagerli of the Diakonh-jemmet Hospital in Oslo, and her associates identified several independent predictors of major improvement in ASDAS (Ankylosing Spondylitis Disease Activity Score) in patients with ankylosing spondylitis (AS) after 3 months of taking a TNF inhibitor.

The independent predictors are younger age, male sex, C-reactive protein (CRP) level greater than 10 mg/L, HLA-B27 positivity, and a higher baseline patient global assessment score.

The results confirm findings from previous studies that both age and elevated CRP are predictors of success with TNF inhibitors. They could be used in selecting patients most likely to respond to treatment, especially in countries with limited access to TNF inhibitors.

Clinicians should exercise caution in applying the other predictors found in the study to a clinical setting, Dr. Fagerli stressed in an interview.

Other studies have not found gender to be a significant predictor, and few other studies have shown HLA-B27 positivity to be a predictive factor.

“The independent predictors identified in this model give information about which patients are most likely to show a good clinical response on a group level, but may have limited value for use on the individual patient level,” Dr. Fagerli said.

The researchers extracted data from the Norwegian DMARD (NOR-DMARD) register, a repository of data on adult patients with inflammatory arthropathies who are starting a new disease-modifying antirheumatic drug treatment. The patients are consecutively included from across five rheumatology departments in Norway.

The current analysis included 171 AS patients who were being treated with their first TNF inhibitor. The mean age of the patients in the sample was 42 years, more than 73% were male, and the average disease duration was 10 years. Nearly a third of the patients in the study achieved ASDAS major improvement on a TNF inhibitor at 3 months.

The researchers plan to repeat these analyses with an updated data set that includes more patients, Dr. Fagerli said.

She also noted that the results will need to be validated in other cohorts, particularly the findings related to gender, patient global assessment, and HLA-B27.

In general, more research is needed into new and more accurate predictors of response to TNF inhibitors in AS and other rheumatic diseases, Dr. Fagerli said. Pharmacogenetic studies have the potential to identify these predictors, and further research to find new soluble biomarkers as markers of response will also be important. In addition, the role of MRI in diagnosis, predicting response, and monitoring treatment will be an important field in the years to come.

Dr. Fagerli said she had no financial disclosures.

'The independent predictors identified … may have limited value for use on the individual patient level.'

Source DR. FAGERLI

The patient-centered medical home, which has been promoted by primary care organizations for decades, is finally getting some attention under the Affordable Care Act.

The concept, which calls for greater coordination of care and a team-based approach, is one of several care delivery improvement ideas being tested under the new health law.

This summer, government officials are accepting applications from federally qualified health centers to be part of a 3-year demonstration project. The project, which will run from September 2011 through August 2014, is designed to figure out what resources health centers need to become successful medical homes that improve care and reduce costs.

Under the Federally Qualified Health Center Advanced Primary Care Practice demonstration project, the federal government will pay health centers a monthly care management fee for each eligible Medicare beneficiary who receives primary care services, on top of their regular Medicare payments. In exchange, health centers must pursue Level 3 patient-centered medical home recognition through the National Committee for Quality Assurance. The project is being run jointly by the Centers for Medicare and Medicaid Services and the Health Resources Services Administration. CMS and HRSA will spend $42 million over 3 years to fund up to 500 health centers under the project.

Dr. Roland A. Goertz, the president of the American Academy of Family Physicians, explained how this project could shape future payment policy for primary care physicians.

Dr. Goertz: The five most important ingredients are a true team approach to care; clinical information systems such as e-prescribing, electronic medical records, registries for common chronic illnesses, and electronic patient access via a patient portal; training for all members of the care team in “patient self-management support” and between visit follow-up; care coordination for patients needing care outside of the medical home; and integration with community resources and the medical neighborhood.

RN: Under the project, health centers will receive a care management payment of $6 per patient per month. Is this enough?

Dr. Goertz: Federally Qualified Health Centers that participate will be paid care management fees only for the Medicare beneficiaries attributed to them. As grantees, the clinic sites will also receive free technical assistance and training resources and funds to cover survey costs.

Health centers will need to make a determination if they are ready for the transformation and whether the care management fees will cover their increased costs.

The fees will not be enough to leverage change if the Federally Qualified Health Center serves only a small number of Medicare patients.

DR. GOERTZ is a family physician in Waco, Tex., and the president of the AAFP.

Whether the fee of $6 per patient per month is enough to leverage change depends on how many patients are served.

Source DR. GOERTZ

The patient-centered medical home, which has been promoted by primary care organizations for decades, is finally getting some attention under the Affordable Care Act.

The concept, which calls for greater coordination of care and a team-based approach, is one of several care delivery improvement ideas being tested under the new health law.

This summer, government officials are accepting applications from federally qualified health centers to be part of a 3-year demonstration project. The project, which will run from September 2011 through August 2014, is designed to figure out what resources health centers need to become successful medical homes that improve care and reduce costs.

Under the Federally Qualified Health Center Advanced Primary Care Practice demonstration project, the federal government will pay health centers a monthly care management fee for each eligible Medicare beneficiary who receives primary care services, on top of their regular Medicare payments. In exchange, health centers must pursue Level 3 patient-centered medical home recognition through the National Committee for Quality Assurance. The project is being run jointly by the Centers for Medicare and Medicaid Services and the Health Resources Services Administration. CMS and HRSA will spend $42 million over 3 years to fund up to 500 health centers under the project.

Dr. Roland A. Goertz, the president of the American Academy of Family Physicians, explained how this project could shape future payment policy for primary care physicians.

Dr. Goertz: The five most important ingredients are a true team approach to care; clinical information systems such as e-prescribing, electronic medical records, registries for common chronic illnesses, and electronic patient access via a patient portal; training for all members of the care team in “patient self-management support” and between visit follow-up; care coordination for patients needing care outside of the medical home; and integration with community resources and the medical neighborhood.

RN: Under the project, health centers will receive a care management payment of $6 per patient per month. Is this enough?

Dr. Goertz: Federally Qualified Health Centers that participate will be paid care management fees only for the Medicare beneficiaries attributed to them. As grantees, the clinic sites will also receive free technical assistance and training resources and funds to cover survey costs.

Health centers will need to make a determination if they are ready for the transformation and whether the care management fees will cover their increased costs.

The fees will not be enough to leverage change if the Federally Qualified Health Center serves only a small number of Medicare patients.

DR. GOERTZ is a family physician in Waco, Tex., and the president of the AAFP.

Whether the fee of $6 per patient per month is enough to leverage change depends on how many patients are served.

Source DR. GOERTZ

The patient-centered medical home, which has been promoted by primary care organizations for decades, is finally getting some attention under the Affordable Care Act.

The concept, which calls for greater coordination of care and a team-based approach, is one of several care delivery improvement ideas being tested under the new health law.

This summer, government officials are accepting applications from federally qualified health centers to be part of a 3-year demonstration project. The project, which will run from September 2011 through August 2014, is designed to figure out what resources health centers need to become successful medical homes that improve care and reduce costs.

Under the Federally Qualified Health Center Advanced Primary Care Practice demonstration project, the federal government will pay health centers a monthly care management fee for each eligible Medicare beneficiary who receives primary care services, on top of their regular Medicare payments. In exchange, health centers must pursue Level 3 patient-centered medical home recognition through the National Committee for Quality Assurance. The project is being run jointly by the Centers for Medicare and Medicaid Services and the Health Resources Services Administration. CMS and HRSA will spend $42 million over 3 years to fund up to 500 health centers under the project.

Dr. Roland A. Goertz, the president of the American Academy of Family Physicians, explained how this project could shape future payment policy for primary care physicians.

Dr. Goertz: The five most important ingredients are a true team approach to care; clinical information systems such as e-prescribing, electronic medical records, registries for common chronic illnesses, and electronic patient access via a patient portal; training for all members of the care team in “patient self-management support” and between visit follow-up; care coordination for patients needing care outside of the medical home; and integration with community resources and the medical neighborhood.

RN: Under the project, health centers will receive a care management payment of $6 per patient per month. Is this enough?

Dr. Goertz: Federally Qualified Health Centers that participate will be paid care management fees only for the Medicare beneficiaries attributed to them. As grantees, the clinic sites will also receive free technical assistance and training resources and funds to cover survey costs.

Health centers will need to make a determination if they are ready for the transformation and whether the care management fees will cover their increased costs.

The fees will not be enough to leverage change if the Federally Qualified Health Center serves only a small number of Medicare patients.

DR. GOERTZ is a family physician in Waco, Tex., and the president of the AAFP.

Whether the fee of $6 per patient per month is enough to leverage change depends on how many patients are served.

Source DR. GOERTZ

A look at Washington state's Medicaid program could provide clues for how to control costs as states prepare for the massive 2014 expansion of Medicaid under the Affordable Care Act.

Washington has provided widespread access to outpatient services and prescription drugs while keeping down spending on inpatient care, according to an analysis published in Health Affairs (2011;30:1316-24 [doi: 10.1377/hlthaff.2011.0106]).

The per-beneficiary cost for inpatient stays was 35% below the national average in Washington, while outpatient visits and prescriptions were each 15% above the national average, wrote Todd P. Gilmer, Ph.D., and Richard G. Kronick, Ph.D., who were both at the University of California, San Diego, when the article was written. Dr. Kronick is now deputy assistant secretary for health policy at the Department of Health and Human Services.

Dr. Gilmer and Dr. Kronick analyzed Medicaid claims data for 2001-2005 to see how the volume and the price of services affected the variation in spending across the states. They limited their analysis to claims for Medicaid-only, disabled beneficiaries receiving cash assistance.

“Several states are using their Medicaid resources in a way that's helping to reduce the need for more expensive hospital care,” Dr. Gilmer said in a statement. “This suggests that there is a great deal of room for innovation in Medicaid. By increasing access to primary care and experimenting with team-based delivery models and low-cost providers, states may be able to improve quality while reducing Medicaid spending.”

Medicaid programs in Connecticut, Massachusetts, New Hampshire, and Vermont spent more than most on prescription costs and outpatient visits, but had a lower-than-average number of hospital days. The inpatient and outpatient spending offset each other, the researchers wrote, resulting in average overall spending just below the mean among all states.

A large primary care workforce was linked with reduced hospital stays for some chronic conditions, the researchers found. Paying more for outpatient visits was also linked to reduced hospital admissions, according to the study. Similarly, paying more for hospital stays was associated with more admissions.

The authors received funding from the Robert Wood Johnson Foundation's Changes in Health Care Financing and Organization initiative.

A look at Washington state's Medicaid program could provide clues for how to control costs as states prepare for the massive 2014 expansion of Medicaid under the Affordable Care Act.

Washington has provided widespread access to outpatient services and prescription drugs while keeping down spending on inpatient care, according to an analysis published in Health Affairs (2011;30:1316-24 [doi: 10.1377/hlthaff.2011.0106]).

The per-beneficiary cost for inpatient stays was 35% below the national average in Washington, while outpatient visits and prescriptions were each 15% above the national average, wrote Todd P. Gilmer, Ph.D., and Richard G. Kronick, Ph.D., who were both at the University of California, San Diego, when the article was written. Dr. Kronick is now deputy assistant secretary for health policy at the Department of Health and Human Services.

Dr. Gilmer and Dr. Kronick analyzed Medicaid claims data for 2001-2005 to see how the volume and the price of services affected the variation in spending across the states. They limited their analysis to claims for Medicaid-only, disabled beneficiaries receiving cash assistance.

“Several states are using their Medicaid resources in a way that's helping to reduce the need for more expensive hospital care,” Dr. Gilmer said in a statement. “This suggests that there is a great deal of room for innovation in Medicaid. By increasing access to primary care and experimenting with team-based delivery models and low-cost providers, states may be able to improve quality while reducing Medicaid spending.”

Medicaid programs in Connecticut, Massachusetts, New Hampshire, and Vermont spent more than most on prescription costs and outpatient visits, but had a lower-than-average number of hospital days. The inpatient and outpatient spending offset each other, the researchers wrote, resulting in average overall spending just below the mean among all states.

A large primary care workforce was linked with reduced hospital stays for some chronic conditions, the researchers found. Paying more for outpatient visits was also linked to reduced hospital admissions, according to the study. Similarly, paying more for hospital stays was associated with more admissions.

The authors received funding from the Robert Wood Johnson Foundation's Changes in Health Care Financing and Organization initiative.

A look at Washington state's Medicaid program could provide clues for how to control costs as states prepare for the massive 2014 expansion of Medicaid under the Affordable Care Act.

Washington has provided widespread access to outpatient services and prescription drugs while keeping down spending on inpatient care, according to an analysis published in Health Affairs (2011;30:1316-24 [doi: 10.1377/hlthaff.2011.0106]).

The per-beneficiary cost for inpatient stays was 35% below the national average in Washington, while outpatient visits and prescriptions were each 15% above the national average, wrote Todd P. Gilmer, Ph.D., and Richard G. Kronick, Ph.D., who were both at the University of California, San Diego, when the article was written. Dr. Kronick is now deputy assistant secretary for health policy at the Department of Health and Human Services.

Dr. Gilmer and Dr. Kronick analyzed Medicaid claims data for 2001-2005 to see how the volume and the price of services affected the variation in spending across the states. They limited their analysis to claims for Medicaid-only, disabled beneficiaries receiving cash assistance.

“Several states are using their Medicaid resources in a way that's helping to reduce the need for more expensive hospital care,” Dr. Gilmer said in a statement. “This suggests that there is a great deal of room for innovation in Medicaid. By increasing access to primary care and experimenting with team-based delivery models and low-cost providers, states may be able to improve quality while reducing Medicaid spending.”

Medicaid programs in Connecticut, Massachusetts, New Hampshire, and Vermont spent more than most on prescription costs and outpatient visits, but had a lower-than-average number of hospital days. The inpatient and outpatient spending offset each other, the researchers wrote, resulting in average overall spending just below the mean among all states.

A large primary care workforce was linked with reduced hospital stays for some chronic conditions, the researchers found. Paying more for outpatient visits was also linked to reduced hospital admissions, according to the study. Similarly, paying more for hospital stays was associated with more admissions.

The authors received funding from the Robert Wood Johnson Foundation's Changes in Health Care Financing and Organization initiative.

The patient-centered medical home, which has been promoted by primary care organizations for decades, is finally getting some attention under the Affordable Care Act.

The concept, which calls for greater coordination of care and a team-based approach, is one of several care delivery improvement ideas being tested under the new health law.

This summer, government officials are accepting applications from federally qualified health centers to be part of a 3-year demonstration project. The project, which will run from September 2011 through August 2014, is designed to figure out what resources health centers need to become successful medical homes that improve care and reduce costs.

Under the Federally Qualified Health Center Advanced Primary Care Practice demonstration project, the federal government will pay health centers a monthly care management fee for each eligible Medicare beneficiary that receives primary care services, on top of their regular Medicare payments. In exchange, health centers must pursue Level 3 patient-centered medical home recognition through the National Committee for Quality Assurance. The project is being run jointly by the Centers for Medicare and Medicaid Services and the Health Resources Services Administration.

CMS and HRSA will spend $42 million over 3 years to fund up to 500 health centers under the project.

Dr. Roland A. Goertz, the president of the American Academy of Family Physicians, explained how this project could shape future payment policy for primary care physicians.

Dr. Goertz: The five most important ingredients are a true team approach to care; clinical information systems such as e-prescribing, electronic medical records, registries for common chronic illnesses, and electronic patient access via a patient portal; training for all members of the care team in “patient self-management support” and between visit follow-up; care coordination for patients needing care outside of the medical home; and integration with community resources and the medical neighborhood.

CN: Under the project, health centers will receive a care management payment of $6 per patient per month. Is this enough?

Dr. Goertz: Federally Qualified Health Centers that participate in the demonstration project will be paid care management fees only for the Medicare beneficiaries attributed to them. As grantees, the clinic sites will also receive free technical assistance and training resources and funds to cover survey costs.

Health centers will need to make a determination if they are ready for the transformation and whether the care management fees will cover their increased costs.

The fees will not be enough to leverage change if the Federally Qualified Health Center serves only a small number of Medicare patients.

CN: How important is the adoption of electronic health records to the success of the medical home?

Dr. Goertz: The goal is to have computerized support for important clinical functions and integration so that physicians have the information they need to make the best decisions about diagnosis and management.

Electronic medical records with functions to help with prescribing, registries, e-mail, education, and home monitoring will soon be the standard of care. Whatever other changes a practice is making, they should continue the momentum needed to get to fully integrated electronic medical records at some point in the future.

Two keys to improved care will be appropriate data collection and use of that data. Electronic tools are very effective in these efforts.

CN: If this demonstration is successful, what will it mean for Medicare payments for medical home services in the future?

Dr. Goertz: This demonstration will show important additional proof of the value of the patient-centered medical home.

A successful demonstration will show improved care while maintaining or reducing costs, which should result in resources flowing to primary care practices to more appropriately pay them for providing patients the best care possible.

DR. GOERTZ is a family physician in Waco, Tex., and the president of the AAFP.

For more information on the initiative, go to www.cms.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS1230016

A successful demonstration will show improved care while maintaining or reducing costs.

Source Dr. goertz

The patient-centered medical home, which has been promoted by primary care organizations for decades, is finally getting some attention under the Affordable Care Act.

The concept, which calls for greater coordination of care and a team-based approach, is one of several care delivery improvement ideas being tested under the new health law.

This summer, government officials are accepting applications from federally qualified health centers to be part of a 3-year demonstration project. The project, which will run from September 2011 through August 2014, is designed to figure out what resources health centers need to become successful medical homes that improve care and reduce costs.

Under the Federally Qualified Health Center Advanced Primary Care Practice demonstration project, the federal government will pay health centers a monthly care management fee for each eligible Medicare beneficiary that receives primary care services, on top of their regular Medicare payments. In exchange, health centers must pursue Level 3 patient-centered medical home recognition through the National Committee for Quality Assurance. The project is being run jointly by the Centers for Medicare and Medicaid Services and the Health Resources Services Administration.

CMS and HRSA will spend $42 million over 3 years to fund up to 500 health centers under the project.

Dr. Roland A. Goertz, the president of the American Academy of Family Physicians, explained how this project could shape future payment policy for primary care physicians.

Dr. Goertz: The five most important ingredients are a true team approach to care; clinical information systems such as e-prescribing, electronic medical records, registries for common chronic illnesses, and electronic patient access via a patient portal; training for all members of the care team in “patient self-management support” and between visit follow-up; care coordination for patients needing care outside of the medical home; and integration with community resources and the medical neighborhood.

CN: Under the project, health centers will receive a care management payment of $6 per patient per month. Is this enough?

Dr. Goertz: Federally Qualified Health Centers that participate in the demonstration project will be paid care management fees only for the Medicare beneficiaries attributed to them. As grantees, the clinic sites will also receive free technical assistance and training resources and funds to cover survey costs.

Health centers will need to make a determination if they are ready for the transformation and whether the care management fees will cover their increased costs.

The fees will not be enough to leverage change if the Federally Qualified Health Center serves only a small number of Medicare patients.

CN: How important is the adoption of electronic health records to the success of the medical home?

Dr. Goertz: The goal is to have computerized support for important clinical functions and integration so that physicians have the information they need to make the best decisions about diagnosis and management.

Electronic medical records with functions to help with prescribing, registries, e-mail, education, and home monitoring will soon be the standard of care. Whatever other changes a practice is making, they should continue the momentum needed to get to fully integrated electronic medical records at some point in the future.

Two keys to improved care will be appropriate data collection and use of that data. Electronic tools are very effective in these efforts.

CN: If this demonstration is successful, what will it mean for Medicare payments for medical home services in the future?

Dr. Goertz: This demonstration will show important additional proof of the value of the patient-centered medical home.

A successful demonstration will show improved care while maintaining or reducing costs, which should result in resources flowing to primary care practices to more appropriately pay them for providing patients the best care possible.

DR. GOERTZ is a family physician in Waco, Tex., and the president of the AAFP.

For more information on the initiative, go to www.cms.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS1230016

A successful demonstration will show improved care while maintaining or reducing costs.

Source Dr. goertz

The patient-centered medical home, which has been promoted by primary care organizations for decades, is finally getting some attention under the Affordable Care Act.

The concept, which calls for greater coordination of care and a team-based approach, is one of several care delivery improvement ideas being tested under the new health law.

This summer, government officials are accepting applications from federally qualified health centers to be part of a 3-year demonstration project. The project, which will run from September 2011 through August 2014, is designed to figure out what resources health centers need to become successful medical homes that improve care and reduce costs.

Under the Federally Qualified Health Center Advanced Primary Care Practice demonstration project, the federal government will pay health centers a monthly care management fee for each eligible Medicare beneficiary that receives primary care services, on top of their regular Medicare payments. In exchange, health centers must pursue Level 3 patient-centered medical home recognition through the National Committee for Quality Assurance. The project is being run jointly by the Centers for Medicare and Medicaid Services and the Health Resources Services Administration.

CMS and HRSA will spend $42 million over 3 years to fund up to 500 health centers under the project.

Dr. Roland A. Goertz, the president of the American Academy of Family Physicians, explained how this project could shape future payment policy for primary care physicians.

Dr. Goertz: The five most important ingredients are a true team approach to care; clinical information systems such as e-prescribing, electronic medical records, registries for common chronic illnesses, and electronic patient access via a patient portal; training for all members of the care team in “patient self-management support” and between visit follow-up; care coordination for patients needing care outside of the medical home; and integration with community resources and the medical neighborhood.

CN: Under the project, health centers will receive a care management payment of $6 per patient per month. Is this enough?

Dr. Goertz: Federally Qualified Health Centers that participate in the demonstration project will be paid care management fees only for the Medicare beneficiaries attributed to them. As grantees, the clinic sites will also receive free technical assistance and training resources and funds to cover survey costs.

Health centers will need to make a determination if they are ready for the transformation and whether the care management fees will cover their increased costs.

The fees will not be enough to leverage change if the Federally Qualified Health Center serves only a small number of Medicare patients.

CN: How important is the adoption of electronic health records to the success of the medical home?

Dr. Goertz: The goal is to have computerized support for important clinical functions and integration so that physicians have the information they need to make the best decisions about diagnosis and management.

Electronic medical records with functions to help with prescribing, registries, e-mail, education, and home monitoring will soon be the standard of care. Whatever other changes a practice is making, they should continue the momentum needed to get to fully integrated electronic medical records at some point in the future.

Two keys to improved care will be appropriate data collection and use of that data. Electronic tools are very effective in these efforts.

CN: If this demonstration is successful, what will it mean for Medicare payments for medical home services in the future?

Dr. Goertz: This demonstration will show important additional proof of the value of the patient-centered medical home.

A successful demonstration will show improved care while maintaining or reducing costs, which should result in resources flowing to primary care practices to more appropriately pay them for providing patients the best care possible.

DR. GOERTZ is a family physician in Waco, Tex., and the president of the AAFP.

For more information on the initiative, go to www.cms.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS1230016

A successful demonstration will show improved care while maintaining or reducing costs.

Source Dr. goertz

Legislation to raise the debt ceiling and cut the deficit, signed by the president, leaves physicians in limbo regarding their Medicare and Medicaid payments next year and in the future.

Right now, Medicaid has been left relatively unharmed by the debt ceiling agreement, said Dr. O. Marion Burton, president of the American Academy of Pediatrics. But that could change as the deficit control process moves forward.

The new law of the land, the Budget Control Act of 2011, establishes the Joint Select Committee on Deficit Reduction, also known as the super committee. That panel is free to consider cuts in Medicare and Medicaid. The 12-member panel will be made up of legislators from both parties and both houses of Congress.

The law requires the joint committee to draft legislation cutting another $1.2 trillion to $1.5 trillion in federal spending over 10 years. The committee has broad authority to consider spending cuts, taxes, and other changes across both discretionary and mandatory government programs. Funding for Affordable Care Act programs is also on the table.

Party leaders have until Aug. 16 to choose the members of the joint committee.

At press time, it was not clear who would serve on the committee. However, Republican leaders had indicated that they would not appoint anyone who would favor raising taxes, whereas Democratic leaders had noted that they would appoint committee members who would protect Medicare, Medicaid, and Social Security.

Before the joint committee can forward its recommendations to the full Congress, those recommendations must be approved by a majority vote.

“There's a lot of concern that the committee will be deadlocked,” said Edwin Park, vice president for health policy at the Center on Budget and Policy Priorities.

The joint committee must vote on recommendations by Nov. 23, and lawmakers must vote on the joint committee's bill by Dec. 23.

To keep the legislation from getting bogged down in the Senate, the Budget Control Act requires that the joint committee's bill be given a fast-track, up-or-down vote requiring a simple majority to pass each chamber.

Should the joint committee's bill fail, or if the committee deadlocks, the Budget Control Act calls for automatic cuts across the federal government totaling $1.2 trillion over 10 years.

Medicaid benefits would be exempt from those automatic cuts, but any cuts to federal aid to cash-strapped states could result in reductions in provider pay under the program. Given the large number of children covered by Medicaid, that would make it very hard for pediatricians to cope, Dr. Burton said.

“If Medicaid rates deteriorate, and there's evidence around the country that's already happening, then we'll certainly be increasingly unable to afford to take care of these children in our offices,” Dr. Burton said.

Coupled with those potential Medicaid fee cuts would be reductions of up to 2% in Medicare physician payments each year beginning in 2013, if automatic cuts went into effect.

Dr. Burton said that he is also concerned about the immediate federal spending cuts enacted under the Budget Control Act. The new law puts in place about $1 trillion in spending cuts over the next decade from the discretionary side of the federal budget. Although these immediate cuts do not directly affect physicians, they could impact programs of great importance to children, Dr. Burton said.

Lawmakers will make specific decisions about which programs get cut down the road, but with the budget reduced by about $1 trillion over 10 years, many programs could be on the chopping block. Dr. Burton said the AAP is very concerned that family planning funding, the Head Start program, and the maternal and child health block grant program will be at risk.

“All of these things support children in the socioeconomic strata that most [need] these services,” he said. “We're really concerned that they are almost immediately on the table for reductions. We pediatricians rely on those programs everyday in our practices to be able to help these children and families. If we don't have those resources in our communities all across America, I believe that children will be harmed.”

These immediate cuts will also impact graduate medical education: Medical students who take out subsidized graduate student loans on or after July 1, 2012, will have to start paying the interest on those loans earlier.

The other major uncertainty facing physicians in the deficit reduction process is what will happen with the 29.5% cut to Medicare physician fees scheduled for Jan. 1, 2012. This massive payment cut is called for under the Sustainable Growth Rate (SGR) formula, the formula used to set Medicare payments to physicians.

Physicians' groups, led by the American Medical Association, lobbied Congress to include a permanent fix to the SGR in the deficit reduction package. They argued that while fixing the SGR carries a $300 billion price tag, getting the job done now would save the government money down the road. Instead, lawmakers left the SGR out of the package completely.

“I don't know anyone who can continue very well with a 30% reduction in payment for a significant segment of their business,” said Dr. Roland Goertz, president of the American Academy of Family Physicians. “It just makes it very, very tough.”

Physicians won't stop practicing medicine, Dr. Goertz said, but they may move into another community with fewer Medicare patients or join a group that sees fewer Medicare patients. “Altruism is great, and all of our members have a dedication to patient care, but they also have to understand what their families need.”

Shawn Martin, director of government relations for the American Osteopathic Association, said he expects that Congress will do something to provide short-term relief to physicians on the SGR cut.

Legislation to raise the debt ceiling and cut the deficit, signed by the president, leaves physicians in limbo regarding their Medicare and Medicaid payments next year and in the future.

Right now, Medicaid has been left relatively unharmed by the debt ceiling agreement, said Dr. O. Marion Burton, president of the American Academy of Pediatrics. But that could change as the deficit control process moves forward.

The new law of the land, the Budget Control Act of 2011, establishes the Joint Select Committee on Deficit Reduction, also known as the super committee. That panel is free to consider cuts in Medicare and Medicaid. The 12-member panel will be made up of legislators from both parties and both houses of Congress.

The law requires the joint committee to draft legislation cutting another $1.2 trillion to $1.5 trillion in federal spending over 10 years. The committee has broad authority to consider spending cuts, taxes, and other changes across both discretionary and mandatory government programs. Funding for Affordable Care Act programs is also on the table.

Party leaders have until Aug. 16 to choose the members of the joint committee.

At press time, it was not clear who would serve on the committee. However, Republican leaders had indicated that they would not appoint anyone who would favor raising taxes, whereas Democratic leaders had noted that they would appoint committee members who would protect Medicare, Medicaid, and Social Security.

Before the joint committee can forward its recommendations to the full Congress, those recommendations must be approved by a majority vote.

“There's a lot of concern that the committee will be deadlocked,” said Edwin Park, vice president for health policy at the Center on Budget and Policy Priorities.

The joint committee must vote on recommendations by Nov. 23, and lawmakers must vote on the joint committee's bill by Dec. 23.

To keep the legislation from getting bogged down in the Senate, the Budget Control Act requires that the joint committee's bill be given a fast-track, up-or-down vote requiring a simple majority to pass each chamber.

Should the joint committee's bill fail, or if the committee deadlocks, the Budget Control Act calls for automatic cuts across the federal government totaling $1.2 trillion over 10 years.

Medicaid benefits would be exempt from those automatic cuts, but any cuts to federal aid to cash-strapped states could result in reductions in provider pay under the program. Given the large number of children covered by Medicaid, that would make it very hard for pediatricians to cope, Dr. Burton said.

“If Medicaid rates deteriorate, and there's evidence around the country that's already happening, then we'll certainly be increasingly unable to afford to take care of these children in our offices,” Dr. Burton said.

Coupled with those potential Medicaid fee cuts would be reductions of up to 2% in Medicare physician payments each year beginning in 2013, if automatic cuts went into effect.

Dr. Burton said that he is also concerned about the immediate federal spending cuts enacted under the Budget Control Act. The new law puts in place about $1 trillion in spending cuts over the next decade from the discretionary side of the federal budget. Although these immediate cuts do not directly affect physicians, they could impact programs of great importance to children, Dr. Burton said.

Lawmakers will make specific decisions about which programs get cut down the road, but with the budget reduced by about $1 trillion over 10 years, many programs could be on the chopping block. Dr. Burton said the AAP is very concerned that family planning funding, the Head Start program, and the maternal and child health block grant program will be at risk.

“All of these things support children in the socioeconomic strata that most [need] these services,” he said. “We're really concerned that they are almost immediately on the table for reductions. We pediatricians rely on those programs everyday in our practices to be able to help these children and families. If we don't have those resources in our communities all across America, I believe that children will be harmed.”

These immediate cuts will also impact graduate medical education: Medical students who take out subsidized graduate student loans on or after July 1, 2012, will have to start paying the interest on those loans earlier.

The other major uncertainty facing physicians in the deficit reduction process is what will happen with the 29.5% cut to Medicare physician fees scheduled for Jan. 1, 2012. This massive payment cut is called for under the Sustainable Growth Rate (SGR) formula, the formula used to set Medicare payments to physicians.

Physicians' groups, led by the American Medical Association, lobbied Congress to include a permanent fix to the SGR in the deficit reduction package. They argued that while fixing the SGR carries a $300 billion price tag, getting the job done now would save the government money down the road. Instead, lawmakers left the SGR out of the package completely.

“I don't know anyone who can continue very well with a 30% reduction in payment for a significant segment of their business,” said Dr. Roland Goertz, president of the American Academy of Family Physicians. “It just makes it very, very tough.”

Physicians won't stop practicing medicine, Dr. Goertz said, but they may move into another community with fewer Medicare patients or join a group that sees fewer Medicare patients. “Altruism is great, and all of our members have a dedication to patient care, but they also have to understand what their families need.”

Shawn Martin, director of government relations for the American Osteopathic Association, said he expects that Congress will do something to provide short-term relief to physicians on the SGR cut.

Legislation to raise the debt ceiling and cut the deficit, signed by the president, leaves physicians in limbo regarding their Medicare and Medicaid payments next year and in the future.

Right now, Medicaid has been left relatively unharmed by the debt ceiling agreement, said Dr. O. Marion Burton, president of the American Academy of Pediatrics. But that could change as the deficit control process moves forward.

The new law of the land, the Budget Control Act of 2011, establishes the Joint Select Committee on Deficit Reduction, also known as the super committee. That panel is free to consider cuts in Medicare and Medicaid. The 12-member panel will be made up of legislators from both parties and both houses of Congress.

The law requires the joint committee to draft legislation cutting another $1.2 trillion to $1.5 trillion in federal spending over 10 years. The committee has broad authority to consider spending cuts, taxes, and other changes across both discretionary and mandatory government programs. Funding for Affordable Care Act programs is also on the table.

Party leaders have until Aug. 16 to choose the members of the joint committee.

At press time, it was not clear who would serve on the committee. However, Republican leaders had indicated that they would not appoint anyone who would favor raising taxes, whereas Democratic leaders had noted that they would appoint committee members who would protect Medicare, Medicaid, and Social Security.

Before the joint committee can forward its recommendations to the full Congress, those recommendations must be approved by a majority vote.

“There's a lot of concern that the committee will be deadlocked,” said Edwin Park, vice president for health policy at the Center on Budget and Policy Priorities.

The joint committee must vote on recommendations by Nov. 23, and lawmakers must vote on the joint committee's bill by Dec. 23.

To keep the legislation from getting bogged down in the Senate, the Budget Control Act requires that the joint committee's bill be given a fast-track, up-or-down vote requiring a simple majority to pass each chamber.

Should the joint committee's bill fail, or if the committee deadlocks, the Budget Control Act calls for automatic cuts across the federal government totaling $1.2 trillion over 10 years.

Medicaid benefits would be exempt from those automatic cuts, but any cuts to federal aid to cash-strapped states could result in reductions in provider pay under the program. Given the large number of children covered by Medicaid, that would make it very hard for pediatricians to cope, Dr. Burton said.

“If Medicaid rates deteriorate, and there's evidence around the country that's already happening, then we'll certainly be increasingly unable to afford to take care of these children in our offices,” Dr. Burton said.

Coupled with those potential Medicaid fee cuts would be reductions of up to 2% in Medicare physician payments each year beginning in 2013, if automatic cuts went into effect.

Dr. Burton said that he is also concerned about the immediate federal spending cuts enacted under the Budget Control Act. The new law puts in place about $1 trillion in spending cuts over the next decade from the discretionary side of the federal budget. Although these immediate cuts do not directly affect physicians, they could impact programs of great importance to children, Dr. Burton said.

Lawmakers will make specific decisions about which programs get cut down the road, but with the budget reduced by about $1 trillion over 10 years, many programs could be on the chopping block. Dr. Burton said the AAP is very concerned that family planning funding, the Head Start program, and the maternal and child health block grant program will be at risk.

“All of these things support children in the socioeconomic strata that most [need] these services,” he said. “We're really concerned that they are almost immediately on the table for reductions. We pediatricians rely on those programs everyday in our practices to be able to help these children and families. If we don't have those resources in our communities all across America, I believe that children will be harmed.”

These immediate cuts will also impact graduate medical education: Medical students who take out subsidized graduate student loans on or after July 1, 2012, will have to start paying the interest on those loans earlier.

The other major uncertainty facing physicians in the deficit reduction process is what will happen with the 29.5% cut to Medicare physician fees scheduled for Jan. 1, 2012. This massive payment cut is called for under the Sustainable Growth Rate (SGR) formula, the formula used to set Medicare payments to physicians.

Physicians' groups, led by the American Medical Association, lobbied Congress to include a permanent fix to the SGR in the deficit reduction package. They argued that while fixing the SGR carries a $300 billion price tag, getting the job done now would save the government money down the road. Instead, lawmakers left the SGR out of the package completely.

“I don't know anyone who can continue very well with a 30% reduction in payment for a significant segment of their business,” said Dr. Roland Goertz, president of the American Academy of Family Physicians. “It just makes it very, very tough.”

Physicians won't stop practicing medicine, Dr. Goertz said, but they may move into another community with fewer Medicare patients or join a group that sees fewer Medicare patients. “Altruism is great, and all of our members have a dedication to patient care, but they also have to understand what their families need.”

Shawn Martin, director of government relations for the American Osteopathic Association, said he expects that Congress will do something to provide short-term relief to physicians on the SGR cut.

The Food and Drug Administration’s process for clearing moderate-risk medical devices for marketing does not ensure safety and effectiveness and should be replaced, according to a report from the Institute of Medicine.

In the report, released July 29, an IOM expert panel urged the FDA not to bother tinkering with the existing 510(k) process, but instead to work with Congress to create a new system for the premarket evaluation of certain medical devices. The new process should focus on determining safety and effectiveness before products hit the market, rather than basing premarket clearance on equivalence to an existing product, the panel recommended.

Under the 35-year-old 510(k) process, moderate-risk class II medical devices do not have to go through the FDA’s rigorous premarket approval process, which requires manufacturers to submit the results of safety and efficacy testing. Instead, the 510(k) process allows device manufacturers to show that their product is "substantially equivalent" to a comparable product already on the market.

But the substantial equivalence test falls short, the IOM panel said, because the majority of the devices that are used for comparison were on the market before 1976 and were never reviewed for safety or effectiveness by the FDA. The IOM pointed out that the lack of review does not mean those devices, or their equivalent follow-on devices, are not safe. But the 510(k) process itself does not allow the FDA to vouch for the safety and effectiveness of a device, they wrote.

"We recognize that we are suggesting a paradigm shift that is likely to be disquieting to a variety of constituencies," Dr. David R. Challoner, the IOM panel chair and vice president emeritis for health affairs at the University of Florida, Gainesville, said during a press briefing to release the report. "I can assure you that our committee, after careful deliberation, is firmly together on the recommendations."

At this point, the FDA has no plans to replace the 510(k) program. In a statement, FDA officials said the process should not be eliminated but they will consider other proposals to improve their device review programs. Since commissioning the IOM report in 2009, the FDA has crafted its own action plan for improving the 510(k) process and its other device review programs.

"Many of the IOM findings parallel changes that are already underway at the FDA to improve how we regulate devices," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. "These actions, plus a sufficiently funded device review program, will contribute to a stronger program."

The agency is planning a meeting to give the public a chance to weigh in on the IOM report and is opening a public docket to allow people to submit their comments in writing.

The medical device industry has already dismissed the IOM’s recommendations. "The report’s conclusions do not deserve serious consideration from the Congress or the Administration," Stephen J. Ubl, president and CEO of Advanced Medical Technology Association (AdvaMed), said in a statement. "It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven, and unspecified new legal structure. This would be a disservice to patients and the public health."

The current process has a number of problems, from escalating review time to inconsistency in clearance decisions, according to AdvaMed. However, the FDA’s action plan, if properly implemented, could address many of these issues, the group said.

The IOM panel did not attempt to construct a new regulatory framework for the FDA, but panel members did offer some advice. In the 280-page report, the panel wrote that the improved process should be clear, fair, and predictable. It should also be able to ensure safety and effectiveness throughout the life of a product. And it should be based on science and a device’s level of risk.

One option for a new process would be to use a modified version of the FDA’s "de novo" process for devices that have no substantial equivalent and are deemed to be of low or moderate risk. That process reduces the amount of information device manufacturers must supply. But in those cases, devices are evaluated individually for safety and effectiveness, and are not compared to products already on the market. If the FDA used this approach, it would still have plenty of work to do to fix problems with the de novo process, which the IOM called "time consuming" and "difficult to navigate."

Any solution will need to include robust postmarket surveillance, the IOM panel wrote.

The IOM panel also called on the FDA to take action on 26 device types that are classified as "high risk," but eligible to be cleared for the market under the 510(k) process. The FDA should either reclassify these devices into a lower-risk category or require them to go through the more rigorous premarket approval process, the IOM panel said. The FDA is already looking at this problem and plans to complete its review and reclassification of these device types by the end of 2012.

The FDA asked the IOM to review its 510(k) clearance process in September 2009. In recent years, there have been reports of problems with a number of devices cleared through the process. At the same time, the device industry has complained the process is too burdensome and slows the pace of medical innovation. The IOM panel was charged with determining whether the 510(k) process protects patients and promotes innovation and what changes could improve the process.

Even before the report was released, the IOM panel and its process were under fire from critics. In June, the Washington Legal Foundation called on the FDA to disregard any advice from the IOM on the 510(k) pathway. The group filed a citizen petition arguing that the IOM panel was not "fairly balanced" because it did not include individuals with experience in areas of importance to the committee’s charge, such as product developers who are familiar with the FDA clearance process or patients who would benefit from the medical devices. Achieving balance on the committee is critical, even if it means appointing individuals with conflicts of interest, the group wrote. The IOM said the 12 members of the 510(k) expert panel had a range of relevant expertise related to the development and regulation of medical devices, postmarket surveillance, health sciences policy, consumer protection, and FDA processes.

The Food and Drug Administration’s process for clearing moderate-risk medical devices for marketing does not ensure safety and effectiveness and should be replaced, according to a report from the Institute of Medicine.

In the report, released July 29, an IOM expert panel urged the FDA not to bother tinkering with the existing 510(k) process, but instead to work with Congress to create a new system for the premarket evaluation of certain medical devices. The new process should focus on determining safety and effectiveness before products hit the market, rather than basing premarket clearance on equivalence to an existing product, the panel recommended.

Under the 35-year-old 510(k) process, moderate-risk class II medical devices do not have to go through the FDA’s rigorous premarket approval process, which requires manufacturers to submit the results of safety and efficacy testing. Instead, the 510(k) process allows device manufacturers to show that their product is "substantially equivalent" to a comparable product already on the market.

But the substantial equivalence test falls short, the IOM panel said, because the majority of the devices that are used for comparison were on the market before 1976 and were never reviewed for safety or effectiveness by the FDA. The IOM pointed out that the lack of review does not mean those devices, or their equivalent follow-on devices, are not safe. But the 510(k) process itself does not allow the FDA to vouch for the safety and effectiveness of a device, they wrote.

"We recognize that we are suggesting a paradigm shift that is likely to be disquieting to a variety of constituencies," Dr. David R. Challoner, the IOM panel chair and vice president emeritis for health affairs at the University of Florida, Gainesville, said during a press briefing to release the report. "I can assure you that our committee, after careful deliberation, is firmly together on the recommendations."

At this point, the FDA has no plans to replace the 510(k) program. In a statement, FDA officials said the process should not be eliminated but they will consider other proposals to improve their device review programs. Since commissioning the IOM report in 2009, the FDA has crafted its own action plan for improving the 510(k) process and its other device review programs.

"Many of the IOM findings parallel changes that are already underway at the FDA to improve how we regulate devices," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. "These actions, plus a sufficiently funded device review program, will contribute to a stronger program."

The agency is planning a meeting to give the public a chance to weigh in on the IOM report and is opening a public docket to allow people to submit their comments in writing.

The medical device industry has already dismissed the IOM’s recommendations. "The report’s conclusions do not deserve serious consideration from the Congress or the Administration," Stephen J. Ubl, president and CEO of Advanced Medical Technology Association (AdvaMed), said in a statement. "It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven, and unspecified new legal structure. This would be a disservice to patients and the public health."

The current process has a number of problems, from escalating review time to inconsistency in clearance decisions, according to AdvaMed. However, the FDA’s action plan, if properly implemented, could address many of these issues, the group said.

The IOM panel did not attempt to construct a new regulatory framework for the FDA, but panel members did offer some advice. In the 280-page report, the panel wrote that the improved process should be clear, fair, and predictable. It should also be able to ensure safety and effectiveness throughout the life of a product. And it should be based on science and a device’s level of risk.

One option for a new process would be to use a modified version of the FDA’s "de novo" process for devices that have no substantial equivalent and are deemed to be of low or moderate risk. That process reduces the amount of information device manufacturers must supply. But in those cases, devices are evaluated individually for safety and effectiveness, and are not compared to products already on the market. If the FDA used this approach, it would still have plenty of work to do to fix problems with the de novo process, which the IOM called "time consuming" and "difficult to navigate."

Any solution will need to include robust postmarket surveillance, the IOM panel wrote.

The IOM panel also called on the FDA to take action on 26 device types that are classified as "high risk," but eligible to be cleared for the market under the 510(k) process. The FDA should either reclassify these devices into a lower-risk category or require them to go through the more rigorous premarket approval process, the IOM panel said. The FDA is already looking at this problem and plans to complete its review and reclassification of these device types by the end of 2012.

The FDA asked the IOM to review its 510(k) clearance process in September 2009. In recent years, there have been reports of problems with a number of devices cleared through the process. At the same time, the device industry has complained the process is too burdensome and slows the pace of medical innovation. The IOM panel was charged with determining whether the 510(k) process protects patients and promotes innovation and what changes could improve the process.

Even before the report was released, the IOM panel and its process were under fire from critics. In June, the Washington Legal Foundation called on the FDA to disregard any advice from the IOM on the 510(k) pathway. The group filed a citizen petition arguing that the IOM panel was not "fairly balanced" because it did not include individuals with experience in areas of importance to the committee’s charge, such as product developers who are familiar with the FDA clearance process or patients who would benefit from the medical devices. Achieving balance on the committee is critical, even if it means appointing individuals with conflicts of interest, the group wrote. The IOM said the 12 members of the 510(k) expert panel had a range of relevant expertise related to the development and regulation of medical devices, postmarket surveillance, health sciences policy, consumer protection, and FDA processes.

The Food and Drug Administration’s process for clearing moderate-risk medical devices for marketing does not ensure safety and effectiveness and should be replaced, according to a report from the Institute of Medicine.

In the report, released July 29, an IOM expert panel urged the FDA not to bother tinkering with the existing 510(k) process, but instead to work with Congress to create a new system for the premarket evaluation of certain medical devices. The new process should focus on determining safety and effectiveness before products hit the market, rather than basing premarket clearance on equivalence to an existing product, the panel recommended.

Under the 35-year-old 510(k) process, moderate-risk class II medical devices do not have to go through the FDA’s rigorous premarket approval process, which requires manufacturers to submit the results of safety and efficacy testing. Instead, the 510(k) process allows device manufacturers to show that their product is "substantially equivalent" to a comparable product already on the market.

But the substantial equivalence test falls short, the IOM panel said, because the majority of the devices that are used for comparison were on the market before 1976 and were never reviewed for safety or effectiveness by the FDA. The IOM pointed out that the lack of review does not mean those devices, or their equivalent follow-on devices, are not safe. But the 510(k) process itself does not allow the FDA to vouch for the safety and effectiveness of a device, they wrote.

"We recognize that we are suggesting a paradigm shift that is likely to be disquieting to a variety of constituencies," Dr. David R. Challoner, the IOM panel chair and vice president emeritis for health affairs at the University of Florida, Gainesville, said during a press briefing to release the report. "I can assure you that our committee, after careful deliberation, is firmly together on the recommendations."

At this point, the FDA has no plans to replace the 510(k) program. In a statement, FDA officials said the process should not be eliminated but they will consider other proposals to improve their device review programs. Since commissioning the IOM report in 2009, the FDA has crafted its own action plan for improving the 510(k) process and its other device review programs.

"Many of the IOM findings parallel changes that are already underway at the FDA to improve how we regulate devices," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. "These actions, plus a sufficiently funded device review program, will contribute to a stronger program."

The agency is planning a meeting to give the public a chance to weigh in on the IOM report and is opening a public docket to allow people to submit their comments in writing.

The medical device industry has already dismissed the IOM’s recommendations. "The report’s conclusions do not deserve serious consideration from the Congress or the Administration," Stephen J. Ubl, president and CEO of Advanced Medical Technology Association (AdvaMed), said in a statement. "It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven, and unspecified new legal structure. This would be a disservice to patients and the public health."

The current process has a number of problems, from escalating review time to inconsistency in clearance decisions, according to AdvaMed. However, the FDA’s action plan, if properly implemented, could address many of these issues, the group said.

The IOM panel did not attempt to construct a new regulatory framework for the FDA, but panel members did offer some advice. In the 280-page report, the panel wrote that the improved process should be clear, fair, and predictable. It should also be able to ensure safety and effectiveness throughout the life of a product. And it should be based on science and a device’s level of risk.

One option for a new process would be to use a modified version of the FDA’s "de novo" process for devices that have no substantial equivalent and are deemed to be of low or moderate risk. That process reduces the amount of information device manufacturers must supply. But in those cases, devices are evaluated individually for safety and effectiveness, and are not compared to products already on the market. If the FDA used this approach, it would still have plenty of work to do to fix problems with the de novo process, which the IOM called "time consuming" and "difficult to navigate."

Any solution will need to include robust postmarket surveillance, the IOM panel wrote.

The IOM panel also called on the FDA to take action on 26 device types that are classified as "high risk," but eligible to be cleared for the market under the 510(k) process. The FDA should either reclassify these devices into a lower-risk category or require them to go through the more rigorous premarket approval process, the IOM panel said. The FDA is already looking at this problem and plans to complete its review and reclassification of these device types by the end of 2012.

The FDA asked the IOM to review its 510(k) clearance process in September 2009. In recent years, there have been reports of problems with a number of devices cleared through the process. At the same time, the device industry has complained the process is too burdensome and slows the pace of medical innovation. The IOM panel was charged with determining whether the 510(k) process protects patients and promotes innovation and what changes could improve the process.

Even before the report was released, the IOM panel and its process were under fire from critics. In June, the Washington Legal Foundation called on the FDA to disregard any advice from the IOM on the 510(k) pathway. The group filed a citizen petition arguing that the IOM panel was not "fairly balanced" because it did not include individuals with experience in areas of importance to the committee’s charge, such as product developers who are familiar with the FDA clearance process or patients who would benefit from the medical devices. Achieving balance on the committee is critical, even if it means appointing individuals with conflicts of interest, the group wrote. The IOM said the 12 members of the 510(k) expert panel had a range of relevant expertise related to the development and regulation of medical devices, postmarket surveillance, health sciences policy, consumer protection, and FDA processes.

The federal government plans to overhaul the rules for conducting research with human subjects with the aim of bringing the regulations in line with the realities of research in the 21st century.

Officials at the Department of Health and Human Services published the advanced notice of proposed rule making on human subjects’ research in the Federal Register on July 26. The proposal seeks public comment on a series of possible changes, from relying on a single institutional review board for multi-center studies to simplifying informed consent forms. This is the first time the regulations on human subjects’ research, known as the Common Rule, have been updated since 1991.

(See what physicians, historians and patients are saying about informed consent, HeLa cells, and Henrietta Lacks.)

Photo credit: Wikimedia

While the Common Rule was a landmark development in the protection of research participants, those rules were developed during a "simpler time," Dr. Howard Koh, assistant secretary for health at HHS, said during a briefing with reporters on June 22. Twenty years later, human subjects’ research includes a variety of new areas such as genomics and behavioral and social science research, as well as studies utilizing the Internet and large-scale data networks.

"These changes in the research landscape have raised questions regarding the effectiveness of the current regulatory framework," he said.

With that in mind, HHS is proposing to offer greater protection to study participants in several ways, such as:

• Giving participants the right to say whether researchers can use their biospecimens in future research.

• Helping researchers to craft informed consent forms that are easier to understand.

• Making data security and information protections uniform across all studies that involve potentially identifiable patient information.

• Developing a more systematic approach to collecting adverse event data from ongoing studies.

Officials also aim to ease regulatory burdens for researchers in the following ways:

• Designing review requirements to match the risk posed to research subjects.

• Ensuring that any guidance issued by the federal government is consistent across departments.

• Allowing research at multiple sites to be overseen by a single institutional review board.

HHS also seeks to expand the reach of the regulation by extending it to all studies conducted by institutions that receive federal funding for human subjects’ research from a Common Rule agency.

The proposal is being well-received in the research community. Mary Woolley, president and CEO of Research!America, a not-for-profit organization that advocates for public and private funding of medical research, said the proposal would benefit both patients and researchers because it streamlines some of the process while adding patient protections.

"We’re going to speed the conduct of research and thus speed the day when we have more and more personalized medicine based on research that is going to save lives and save money," she said.

Dr. Holly A. Taylor, Ph.D., a core faculty member of the Berman Institute of Bioethics at the Johns Hopkins University, Baltimore, praised the regulation’s focus on improving the informed consent process.

Dr. Taylor, who has conducted her own research on informed consent, said she agrees with HHS that, in many cases, the forms have become too long and complex for patients to understand. She urged the agency to work with investigators, who aren’t trained to write for a consumer audience, on rewriting the forms. It will be important for the government to tell investigators not just what to include in the form but how to do it, she said. "Given where we started, having a form like this was a really great idea. But there are ways now that it is sort of defeating its own purpose," she said.

Comments on the advance notice of proposed rule making will be accepted at www.regulations.gov until 5 p.m. ET on Sept. 26; instructions on how to do so can be found here.

The federal government plans to overhaul the rules for conducting research with human subjects with the aim of bringing the regulations in line with the realities of research in the 21st century.

Officials at the Department of Health and Human Services published the advanced notice of proposed rule making on human subjects’ research in the Federal Register on July 26. The proposal seeks public comment on a series of possible changes, from relying on a single institutional review board for multi-center studies to simplifying informed consent forms. This is the first time the regulations on human subjects’ research, known as the Common Rule, have been updated since 1991.

(See what physicians, historians and patients are saying about informed consent, HeLa cells, and Henrietta Lacks.)

Photo credit: Wikimedia

While the Common Rule was a landmark development in the protection of research participants, those rules were developed during a "simpler time," Dr. Howard Koh, assistant secretary for health at HHS, said during a briefing with reporters on June 22. Twenty years later, human subjects’ research includes a variety of new areas such as genomics and behavioral and social science research, as well as studies utilizing the Internet and large-scale data networks.

"These changes in the research landscape have raised questions regarding the effectiveness of the current regulatory framework," he said.

With that in mind, HHS is proposing to offer greater protection to study participants in several ways, such as:

• Giving participants the right to say whether researchers can use their biospecimens in future research.

• Helping researchers to craft informed consent forms that are easier to understand.

• Making data security and information protections uniform across all studies that involve potentially identifiable patient information.

• Developing a more systematic approach to collecting adverse event data from ongoing studies.

Officials also aim to ease regulatory burdens for researchers in the following ways:

• Designing review requirements to match the risk posed to research subjects.

• Ensuring that any guidance issued by the federal government is consistent across departments.

• Allowing research at multiple sites to be overseen by a single institutional review board.

HHS also seeks to expand the reach of the regulation by extending it to all studies conducted by institutions that receive federal funding for human subjects’ research from a Common Rule agency.

The proposal is being well-received in the research community. Mary Woolley, president and CEO of Research!America, a not-for-profit organization that advocates for public and private funding of medical research, said the proposal would benefit both patients and researchers because it streamlines some of the process while adding patient protections.

"We’re going to speed the conduct of research and thus speed the day when we have more and more personalized medicine based on research that is going to save lives and save money," she said.

Dr. Holly A. Taylor, Ph.D., a core faculty member of the Berman Institute of Bioethics at the Johns Hopkins University, Baltimore, praised the regulation’s focus on improving the informed consent process.

Dr. Taylor, who has conducted her own research on informed consent, said she agrees with HHS that, in many cases, the forms have become too long and complex for patients to understand. She urged the agency to work with investigators, who aren’t trained to write for a consumer audience, on rewriting the forms. It will be important for the government to tell investigators not just what to include in the form but how to do it, she said. "Given where we started, having a form like this was a really great idea. But there are ways now that it is sort of defeating its own purpose," she said.

Comments on the advance notice of proposed rule making will be accepted at www.regulations.gov until 5 p.m. ET on Sept. 26; instructions on how to do so can be found here.

The federal government plans to overhaul the rules for conducting research with human subjects with the aim of bringing the regulations in line with the realities of research in the 21st century.

Officials at the Department of Health and Human Services published the advanced notice of proposed rule making on human subjects’ research in the Federal Register on July 26. The proposal seeks public comment on a series of possible changes, from relying on a single institutional review board for multi-center studies to simplifying informed consent forms. This is the first time the regulations on human subjects’ research, known as the Common Rule, have been updated since 1991.

(See what physicians, historians and patients are saying about informed consent, HeLa cells, and Henrietta Lacks.)

Photo credit: Wikimedia

While the Common Rule was a landmark development in the protection of research participants, those rules were developed during a "simpler time," Dr. Howard Koh, assistant secretary for health at HHS, said during a briefing with reporters on June 22. Twenty years later, human subjects’ research includes a variety of new areas such as genomics and behavioral and social science research, as well as studies utilizing the Internet and large-scale data networks.

"These changes in the research landscape have raised questions regarding the effectiveness of the current regulatory framework," he said.

With that in mind, HHS is proposing to offer greater protection to study participants in several ways, such as:

• Giving participants the right to say whether researchers can use their biospecimens in future research.

• Helping researchers to craft informed consent forms that are easier to understand.

• Making data security and information protections uniform across all studies that involve potentially identifiable patient information.

• Developing a more systematic approach to collecting adverse event data from ongoing studies.

Officials also aim to ease regulatory burdens for researchers in the following ways:

• Designing review requirements to match the risk posed to research subjects.

• Ensuring that any guidance issued by the federal government is consistent across departments.

• Allowing research at multiple sites to be overseen by a single institutional review board.

HHS also seeks to expand the reach of the regulation by extending it to all studies conducted by institutions that receive federal funding for human subjects’ research from a Common Rule agency.

The proposal is being well-received in the research community. Mary Woolley, president and CEO of Research!America, a not-for-profit organization that advocates for public and private funding of medical research, said the proposal would benefit both patients and researchers because it streamlines some of the process while adding patient protections.

"We’re going to speed the conduct of research and thus speed the day when we have more and more personalized medicine based on research that is going to save lives and save money," she said.

Dr. Holly A. Taylor, Ph.D., a core faculty member of the Berman Institute of Bioethics at the Johns Hopkins University, Baltimore, praised the regulation’s focus on improving the informed consent process.

Dr. Taylor, who has conducted her own research on informed consent, said she agrees with HHS that, in many cases, the forms have become too long and complex for patients to understand. She urged the agency to work with investigators, who aren’t trained to write for a consumer audience, on rewriting the forms. It will be important for the government to tell investigators not just what to include in the form but how to do it, she said. "Given where we started, having a form like this was a really great idea. But there are ways now that it is sort of defeating its own purpose," she said.

Comments on the advance notice of proposed rule making will be accepted at www.regulations.gov until 5 p.m. ET on Sept. 26; instructions on how to do so can be found here.

The federal government plans to overhaul the rules for conducting research with human subjects with the aim of bringing the regulations in line with the realities of research in the 21st century.

Officials at the Department of Health and Human Services published the advanced notice of proposed rule making on human subjects’ research in the Federal Register on July 26. The proposal seeks public comment on a series of possible changes, from relying on a single institutional review board for multi-center studies to simplifying informed consent forms. This is the first time the regulations on human subjects’ research, known as the Common Rule, have been updated since 1991.

(See what physicians, historians and patients are saying about informed consent, HeLa cells, and Henrietta Lacks.)

Photo credit: Wikimedia

While the Common Rule was a landmark development in the protection of research participants, those rules were developed during a "simpler time," Dr. Howard Koh, assistant secretary for health at HHS, said during a briefing with reporters on June 22. Twenty years later, human subjects’ research includes a variety of new areas such as genomics and behavioral and social science research, as well as studies utilizing the Internet and large-scale data networks.

"These changes in the research landscape have raised questions regarding the effectiveness of the current regulatory framework," he said.

With that in mind, HHS is proposing to offer greater protection to study participants in several ways, such as:

• Giving participants the right to say whether researchers can use their biospecimens in future research.

• Helping researchers to craft informed consent forms that are easier to understand.

• Making data security and information protections uniform across all studies that involve potentially identifiable patient information.

• Developing a more systematic approach to collecting adverse event data from ongoing studies.

Officials also aim to ease regulatory burdens for researchers in the following ways:

• Designing review requirements to match the risk posed to research subjects.

• Ensuring that any guidance issued by the federal government is consistent across departments.

• Allowing research at multiple sites to be overseen by a single institutional review board.

HHS also seeks to expand the reach of the regulation by extending it to all studies conducted by institutions that receive federal funding for human subjects’ research from a Common Rule agency.

The proposal is being well-received in the research community. Mary Woolley, president and CEO of Research!America, a not-for-profit organization that advocates for public and private funding of medical research, said the proposal would benefit both patients and researchers because it streamlines some of the process while adding patient protections.

"We’re going to speed the conduct of research and thus speed the day when we have more and more personalized medicine based on research that is going to save lives and save money," she said.

Dr. Holly A. Taylor, Ph.D., a core faculty member of the Berman Institute of Bioethics at the Johns Hopkins University, Baltimore, praised the regulation’s focus on improving the informed consent process.

Dr. Taylor, who has conducted her own research on informed consent, said she agrees with HHS that, in many cases, the forms have become too long and complex for patients to understand. She urged the agency to work with investigators, who aren’t trained to write for a consumer audience, on rewriting the forms. It will be important for the government to tell investigators not just what to include in the form but how to do it, she said. "Given where we started, having a form like this was a really great idea. But there are ways now that it is sort of defeating its own purpose," she said.

Comments on the advance notice of proposed rule making will be accepted at www.regulations.gov until 5 p.m. ET on Sept. 26; instructions on how to do so can be found here.

The federal government plans to overhaul the rules for conducting research with human subjects with the aim of bringing the regulations in line with the realities of research in the 21st century.

Officials at the Department of Health and Human Services published the advanced notice of proposed rule making on human subjects’ research in the Federal Register on July 26. The proposal seeks public comment on a series of possible changes, from relying on a single institutional review board for multi-center studies to simplifying informed consent forms. This is the first time the regulations on human subjects’ research, known as the Common Rule, have been updated since 1991.

(See what physicians, historians and patients are saying about informed consent, HeLa cells, and Henrietta Lacks.)

Photo credit: Wikimedia

While the Common Rule was a landmark development in the protection of research participants, those rules were developed during a "simpler time," Dr. Howard Koh, assistant secretary for health at HHS, said during a briefing with reporters on June 22. Twenty years later, human subjects’ research includes a variety of new areas such as genomics and behavioral and social science research, as well as studies utilizing the Internet and large-scale data networks.

"These changes in the research landscape have raised questions regarding the effectiveness of the current regulatory framework," he said.

With that in mind, HHS is proposing to offer greater protection to study participants in several ways, such as:

• Giving participants the right to say whether researchers can use their biospecimens in future research.

• Helping researchers to craft informed consent forms that are easier to understand.

• Making data security and information protections uniform across all studies that involve potentially identifiable patient information.

• Developing a more systematic approach to collecting adverse event data from ongoing studies.

Officials also aim to ease regulatory burdens for researchers in the following ways:

• Designing review requirements to match the risk posed to research subjects.

• Ensuring that any guidance issued by the federal government is consistent across departments.

• Allowing research at multiple sites to be overseen by a single institutional review board.

HHS also seeks to expand the reach of the regulation by extending it to all studies conducted by institutions that receive federal funding for human subjects’ research from a Common Rule agency.

The proposal is being well-received in the research community. Mary Woolley, president and CEO of Research!America, a not-for-profit organization that advocates for public and private funding of medical research, said the proposal would benefit both patients and researchers because it streamlines some of the process while adding patient protections.

"We’re going to speed the conduct of research and thus speed the day when we have more and more personalized medicine based on research that is going to save lives and save money," she said.

Dr. Holly A. Taylor, Ph.D., a core faculty member of the Berman Institute of Bioethics at the Johns Hopkins University, Baltimore, praised the regulation’s focus on improving the informed consent process.

Dr. Taylor, who has conducted her own research on informed consent, said she agrees with HHS that, in many cases, the forms have become too long and complex for patients to understand. She urged the agency to work with investigators, who aren’t trained to write for a consumer audience, on rewriting the forms. It will be important for the government to tell investigators not just what to include in the form but how to do it, she said. "Given where we started, having a form like this was a really great idea. But there are ways now that it is sort of defeating its own purpose," she said.

Comments on the advance notice of proposed rule making will be accepted at www.regulations.gov until 5 p.m. ET on Sept. 26; instructions on how to do so can be found here.

The federal government plans to overhaul the rules for conducting research with human subjects with the aim of bringing the regulations in line with the realities of research in the 21st century.

Officials at the Department of Health and Human Services published the advanced notice of proposed rule making on human subjects’ research in the Federal Register on July 26. The proposal seeks public comment on a series of possible changes, from relying on a single institutional review board for multi-center studies to simplifying informed consent forms. This is the first time the regulations on human subjects’ research, known as the Common Rule, have been updated since 1991.

(See what physicians, historians and patients are saying about informed consent, HeLa cells, and Henrietta Lacks.)

Photo credit: Wikimedia

While the Common Rule was a landmark development in the protection of research participants, those rules were developed during a "simpler time," Dr. Howard Koh, assistant secretary for health at HHS, said during a briefing with reporters on June 22. Twenty years later, human subjects’ research includes a variety of new areas such as genomics and behavioral and social science research, as well as studies utilizing the Internet and large-scale data networks.

"These changes in the research landscape have raised questions regarding the effectiveness of the current regulatory framework," he said.

With that in mind, HHS is proposing to offer greater protection to study participants in several ways, such as:

• Giving participants the right to say whether researchers can use their biospecimens in future research.

• Helping researchers to craft informed consent forms that are easier to understand.

• Making data security and information protections uniform across all studies that involve potentially identifiable patient information.

• Developing a more systematic approach to collecting adverse event data from ongoing studies.

Officials also aim to ease regulatory burdens for researchers in the following ways:

• Designing review requirements to match the risk posed to research subjects.

• Ensuring that any guidance issued by the federal government is consistent across departments.

• Allowing research at multiple sites to be overseen by a single institutional review board.

HHS also seeks to expand the reach of the regulation by extending it to all studies conducted by institutions that receive federal funding for human subjects’ research from a Common Rule agency.

The proposal is being well-received in the research community. Mary Woolley, president and CEO of Research!America, a not-for-profit organization that advocates for public and private funding of medical research, said the proposal would benefit both patients and researchers because it streamlines some of the process while adding patient protections.

"We’re going to speed the conduct of research and thus speed the day when we have more and more personalized medicine based on research that is going to save lives and save money," she said.

Dr. Holly A. Taylor, Ph.D., a core faculty member of the Berman Institute of Bioethics at the Johns Hopkins University, Baltimore, praised the regulation’s focus on improving the informed consent process.

Dr. Taylor, who has conducted her own research on informed consent, said she agrees with HHS that, in many cases, the forms have become too long and complex for patients to understand. She urged the agency to work with investigators, who aren’t trained to write for a consumer audience, on rewriting the forms. It will be important for the government to tell investigators not just what to include in the form but how to do it, she said. "Given where we started, having a form like this was a really great idea. But there are ways now that it is sort of defeating its own purpose," she said.

Comments on the advance notice of proposed rule making will be accepted at www.regulations.gov until 5 p.m. ET on Sept. 26; instructions on how to do so can be found here.

The Community First Choice Option is among the lesser-known provisions of the Affordable Care Act. Formally known as Section 2401, this program offers states additional Medicaid funding to provide home- and community-based attendant services and other support to low-income disabled Americans, keeping them in the community and out of nursing homes.

Under the program, states can get a 6 percentage point increase in federal Medicaid matching payments to cover costs associated with providing community-based services such as assistance with activities of daily living and instrumental activities of daily living, as well as health-related tasks. States also would have the option of paying for transitions costs, such as the first month’s rent when a person moves from a nursing facility back to the community.

Eligibility and requirements associated with the program were outlined in a proposed rule in February; the program is scheduled to begin in October.

Kate Wilber, Ph.D., an expert on gerontology issues from the University of Southern California, explained how the program could help keep more disabled people in the community.

QUESTION: Who will be eligible for assistance under the Community First Choice Option?

DR. WILBER: Potential participants must live in a state that offers the program, qualify to receive medical assistance under their state’s Medicaid program, and have an income below 150% of the Federal Poverty Line. Individuals with higher incomes may participate if they are eligible for a nursing facility level of care that would be covered by the state Medicaid program. Right now, it is unclear how many states will choose to offer the program.

QUESTION: About 35 states already provide some type of personal care services through Medicaid. Is the increased federal payment likely to expand this much?

DR. WILBER: Close to half of the states have expressed interest in the program. The use of the increased federal match as an incentive is attractive. However, in contrast to waiver services with limited slots, this program is an entitlement, meaning it must be offered to everyone who is eligible. States that have concerns about offering a new entitlement in the current economic climate might take a "wait and see" attitude.

QUESTION: What impact will this have on nursing home care?

DR. WILBER: The resident mix in nursing homes has changed dramatically over the last decade or so, driven by several different factors that support expanded community options. In the 1999 Olmstead decision, the U.S. Supreme Court ruled that institutionalizing individuals who prefer to live in a community setting is discrimination, and that services should be provided in the most integrated and least restrictive setting. Over the last decade, the Centers for Medicare and Medicaid Services (CMS) have sought to reduce the Medicaid bias toward institutionalization by "rebalancing" funding toward more home and community-based service options. One initiative to promote rebalancing, known as "money follows the person," offers state incentives to transition long-stay residents out of facilities and into the community. States have also taken advantage of Medicaid waiver programs that permit individuals who are eligible for a nursing home level of care to use community-based services instead. The federal government has also funded demonstration programs to test the effectiveness of programs that offer consumer direction by providing cash benefits to purchase services. The Community First Option draws on and expands these options.

QUESTION: How can primary care physicians direct their disabled patients toward these programs?

DR. WILBER: Many primary care physicians are not familiar with long-term care services and supports, and the pathway from providing primary care to these services is not easy to find. Some physicians working in larger systems will have access to social workers who can assist with broader care planning for patients with complex conditions. Physicians are probably most familiar and most comfortable with skilled nursing facilities and home health care. Beyond that, there are a variety of programs with complex eligibility requirements, various levels of quality, and different funding sources. This is the system that the Institute of Medicine described as "a nightmare to navigate." Although the ACA attempts to address fragmentation, programs such as Community First will be shaped at the state level. Different states will have different approaches, with some choosing not to pursue the program at all. We will know more about what these programs will look like as states begin to develop their approaches.

QUESTION: The program requires a "person-centered planning process" and gives individuals the authority to hire, fire, and train their attendants. How does that improve the care provided?

DR. WILBER: Long-term care services and supports are "high touch," highly intrusive personal services that deal with many facets of a person’s life, often for many hours a day over a long period of time. For those receiving these services, it helps to have control over who provides them. Self-direction means care receivers have the authority to tailor their services according to their preferences, needs, cultural expectations, habits, and other lifestyle requirements. Evidence from self-directed care, such as the "Cash and Counseling" demonstrations have found that these services have good outcomes for the care recipient and caregivers, and are cost effective as well.

This column, "Implementing Health Reform," regularly appears in Internal Medicine News, an Elsevier publication. Kate Wilber, Ph.D., is the Mary Pickford Foundation Professor of Gerontology at the University of Southern California in Los Angeles.

The Community First Choice Option is among the lesser-known provisions of the Affordable Care Act. Formally known as Section 2401, this program offers states additional Medicaid funding to provide home- and community-based attendant services and other support to low-income disabled Americans, keeping them in the community and out of nursing homes.

Under the program, states can get a 6 percentage point increase in federal Medicaid matching payments to cover costs associated with providing community-based services such as assistance with activities of daily living and instrumental activities of daily living, as well as health-related tasks. States also would have the option of paying for transitions costs, such as the first month’s rent when a person moves from a nursing facility back to the community.

Eligibility and requirements associated with the program were outlined in a proposed rule in February; the program is scheduled to begin in October.

Kate Wilber, Ph.D., an expert on gerontology issues from the University of Southern California, explained how the program could help keep more disabled people in the community.

QUESTION: Who will be eligible for assistance under the Community First Choice Option?

DR. WILBER: Potential participants must live in a state that offers the program, qualify to receive medical assistance under their state’s Medicaid program, and have an income below 150% of the Federal Poverty Line. Individuals with higher incomes may participate if they are eligible for a nursing facility level of care that would be covered by the state Medicaid program. Right now, it is unclear how many states will choose to offer the program.

QUESTION: About 35 states already provide some type of personal care services through Medicaid. Is the increased federal payment likely to expand this much?

DR. WILBER: Close to half of the states have expressed interest in the program. The use of the increased federal match as an incentive is attractive. However, in contrast to waiver services with limited slots, this program is an entitlement, meaning it must be offered to everyone who is eligible. States that have concerns about offering a new entitlement in the current economic climate might take a "wait and see" attitude.

QUESTION: What impact will this have on nursing home care?

DR. WILBER: The resident mix in nursing homes has changed dramatically over the last decade or so, driven by several different factors that support expanded community options. In the 1999 Olmstead decision, the U.S. Supreme Court ruled that institutionalizing individuals who prefer to live in a community setting is discrimination, and that services should be provided in the most integrated and least restrictive setting. Over the last decade, the Centers for Medicare and Medicaid Services (CMS) have sought to reduce the Medicaid bias toward institutionalization by "rebalancing" funding toward more home and community-based service options. One initiative to promote rebalancing, known as "money follows the person," offers state incentives to transition long-stay residents out of facilities and into the community. States have also taken advantage of Medicaid waiver programs that permit individuals who are eligible for a nursing home level of care to use community-based services instead. The federal government has also funded demonstration programs to test the effectiveness of programs that offer consumer direction by providing cash benefits to purchase services. The Community First Option draws on and expands these options.

QUESTION: How can primary care physicians direct their disabled patients toward these programs?

DR. WILBER: Many primary care physicians are not familiar with long-term care services and supports, and the pathway from providing primary care to these services is not easy to find. Some physicians working in larger systems will have access to social workers who can assist with broader care planning for patients with complex conditions. Physicians are probably most familiar and most comfortable with skilled nursing facilities and home health care. Beyond that, there are a variety of programs with complex eligibility requirements, various levels of quality, and different funding sources. This is the system that the Institute of Medicine described as "a nightmare to navigate." Although the ACA attempts to address fragmentation, programs such as Community First will be shaped at the state level. Different states will have different approaches, with some choosing not to pursue the program at all. We will know more about what these programs will look like as states begin to develop their approaches.

QUESTION: The program requires a "person-centered planning process" and gives individuals the authority to hire, fire, and train their attendants. How does that improve the care provided?

DR. WILBER: Long-term care services and supports are "high touch," highly intrusive personal services that deal with many facets of a person’s life, often for many hours a day over a long period of time. For those receiving these services, it helps to have control over who provides them. Self-direction means care receivers have the authority to tailor their services according to their preferences, needs, cultural expectations, habits, and other lifestyle requirements. Evidence from self-directed care, such as the "Cash and Counseling" demonstrations have found that these services have good outcomes for the care recipient and caregivers, and are cost effective as well.

This column, "Implementing Health Reform," regularly appears in Internal Medicine News, an Elsevier publication. Kate Wilber, Ph.D., is the Mary Pickford Foundation Professor of Gerontology at the University of Southern California in Los Angeles.

The Community First Choice Option is among the lesser-known provisions of the Affordable Care Act. Formally known as Section 2401, this program offers states additional Medicaid funding to provide home- and community-based attendant services and other support to low-income disabled Americans, keeping them in the community and out of nursing homes.

Under the program, states can get a 6 percentage point increase in federal Medicaid matching payments to cover costs associated with providing community-based services such as assistance with activities of daily living and instrumental activities of daily living, as well as health-related tasks. States also would have the option of paying for transitions costs, such as the first month’s rent when a person moves from a nursing facility back to the community.

Eligibility and requirements associated with the program were outlined in a proposed rule in February; the program is scheduled to begin in October.

Kate Wilber, Ph.D., an expert on gerontology issues from the University of Southern California, explained how the program could help keep more disabled people in the community.

QUESTION: Who will be eligible for assistance under the Community First Choice Option?

DR. WILBER: Potential participants must live in a state that offers the program, qualify to receive medical assistance under their state’s Medicaid program, and have an income below 150% of the Federal Poverty Line. Individuals with higher incomes may participate if they are eligible for a nursing facility level of care that would be covered by the state Medicaid program. Right now, it is unclear how many states will choose to offer the program.

QUESTION: About 35 states already provide some type of personal care services through Medicaid. Is the increased federal payment likely to expand this much?

DR. WILBER: Close to half of the states have expressed interest in the program. The use of the increased federal match as an incentive is attractive. However, in contrast to waiver services with limited slots, this program is an entitlement, meaning it must be offered to everyone who is eligible. States that have concerns about offering a new entitlement in the current economic climate might take a "wait and see" attitude.

QUESTION: What impact will this have on nursing home care?

DR. WILBER: The resident mix in nursing homes has changed dramatically over the last decade or so, driven by several different factors that support expanded community options. In the 1999 Olmstead decision, the U.S. Supreme Court ruled that institutionalizing individuals who prefer to live in a community setting is discrimination, and that services should be provided in the most integrated and least restrictive setting. Over the last decade, the Centers for Medicare and Medicaid Services (CMS) have sought to reduce the Medicaid bias toward institutionalization by "rebalancing" funding toward more home and community-based service options. One initiative to promote rebalancing, known as "money follows the person," offers state incentives to transition long-stay residents out of facilities and into the community. States have also taken advantage of Medicaid waiver programs that permit individuals who are eligible for a nursing home level of care to use community-based services instead. The federal government has also funded demonstration programs to test the effectiveness of programs that offer consumer direction by providing cash benefits to purchase services. The Community First Option draws on and expands these options.

QUESTION: How can primary care physicians direct their disabled patients toward these programs?

DR. WILBER: Many primary care physicians are not familiar with long-term care services and supports, and the pathway from providing primary care to these services is not easy to find. Some physicians working in larger systems will have access to social workers who can assist with broader care planning for patients with complex conditions. Physicians are probably most familiar and most comfortable with skilled nursing facilities and home health care. Beyond that, there are a variety of programs with complex eligibility requirements, various levels of quality, and different funding sources. This is the system that the Institute of Medicine described as "a nightmare to navigate." Although the ACA attempts to address fragmentation, programs such as Community First will be shaped at the state level. Different states will have different approaches, with some choosing not to pursue the program at all. We will know more about what these programs will look like as states begin to develop their approaches.

QUESTION: The program requires a "person-centered planning process" and gives individuals the authority to hire, fire, and train their attendants. How does that improve the care provided?

DR. WILBER: Long-term care services and supports are "high touch," highly intrusive personal services that deal with many facets of a person’s life, often for many hours a day over a long period of time. For those receiving these services, it helps to have control over who provides them. Self-direction means care receivers have the authority to tailor their services according to their preferences, needs, cultural expectations, habits, and other lifestyle requirements. Evidence from self-directed care, such as the "Cash and Counseling" demonstrations have found that these services have good outcomes for the care recipient and caregivers, and are cost effective as well.

This column, "Implementing Health Reform," regularly appears in Internal Medicine News, an Elsevier publication. Kate Wilber, Ph.D., is the Mary Pickford Foundation Professor of Gerontology at the University of Southern California in Los Angeles.

Starting in October 2012, about 1% of the payments that hospitals receive from Medicare will be calculated based on performance on clinical quality measures and patient satisfaction scores.

Details of the new initiative, known as the Hospital Inpatient Value-Based Purchasing program, were unveiled in a final rule released by the Centers for Medicare and Medicaid Services (CMS) this Spring.

The initiative was mandated by Congress under the Affordable Care Act.

Under the program, CMS will take 1% of the payments that would otherwise go to hospitals under Medicare’s Inpatient Prospective Payment System and put them in a fund to pay for care based on quality. In the first year, CMS estimates that about $850 million will be available through the fund. Medicare officials will score hospitals based on their performance on each of the measures compared with other hospitals and to how their performance has improved over time.

The new program is the first step in shifting payments toward quality and away from volume, aacording to Dr. Donald Berwick, a CMS administrator, who spoke during a press conference.

"This is one of those areas where improvement of quality and reduction in cost go hand-in-hand," Dr. Berwick said. "My feeling continues to be that the best way for us to arrive at sustainable costs for the health care system is precisely through the improvement of quality of care."

Under the program, payments will be based on performance on 12 clinical process-of-care measures and a survey of patient satisfaction. Process-of-care indicators include measures such as the percentage of patients with myocardial infarction who are given fibrinolytic medication within 30 minutes of arrival at the hospital.

To evaluate patient satisfaction, a random sample of discharged patients will be surveyed about their perceptions, including physician and nurse communication, hospital staff responsiveness, pain management, discharge instructions, and hospital cleanliness.

A complete list of the measures is available online at www.healthcare.gov/news/factsheets/valuebasedpurchasing04292011b.html.

The measures have been endorsed by such national panels as the National Quality Forum, and hospitals have already been reporting their performance on them through Medicare’s Hospital Compare website.

The measures are weighted so that 70% of the payment is based on the quality measures and 30% is based on patient evaluations.

Over time, CMS officials plan to add measures focused on patient outcomes, including prevention of hospital-acquired conditions. And measures will be phased out over time if hospitals achieve consistently high compliance scores, Dr. Berwick said.

The new value-based purchasing initiative is only one way that hospital payments will be tied to quality of care. Starting in 2013, Medicare will reduce payments to hospitals if they have excess 30-day readmissions for patients who suffer heart attacks, heart failure, and pneumonia.

And in 2015, hospitals could see their payments cut if they have high rates of certain hospital-acquired conditions.

The final rule on hospital value-based purchasing was published in the Federal Register in May and becomes final in July.

Starting in October 2012, about 1% of the payments that hospitals receive from Medicare will be calculated based on performance on clinical quality measures and patient satisfaction scores.

Details of the new initiative, known as the Hospital Inpatient Value-Based Purchasing program, were unveiled in a final rule released by the Centers for Medicare and Medicaid Services (CMS) this Spring.

The initiative was mandated by Congress under the Affordable Care Act.

Under the program, CMS will take 1% of the payments that would otherwise go to hospitals under Medicare’s Inpatient Prospective Payment System and put them in a fund to pay for care based on quality. In the first year, CMS estimates that about $850 million will be available through the fund. Medicare officials will score hospitals based on their performance on each of the measures compared with other hospitals and to how their performance has improved over time.

The new program is the first step in shifting payments toward quality and away from volume, aacording to Dr. Donald Berwick, a CMS administrator, who spoke during a press conference.

"This is one of those areas where improvement of quality and reduction in cost go hand-in-hand," Dr. Berwick said. "My feeling continues to be that the best way for us to arrive at sustainable costs for the health care system is precisely through the improvement of quality of care."

Under the program, payments will be based on performance on 12 clinical process-of-care measures and a survey of patient satisfaction. Process-of-care indicators include measures such as the percentage of patients with myocardial infarction who are given fibrinolytic medication within 30 minutes of arrival at the hospital.

To evaluate patient satisfaction, a random sample of discharged patients will be surveyed about their perceptions, including physician and nurse communication, hospital staff responsiveness, pain management, discharge instructions, and hospital cleanliness.

A complete list of the measures is available online at www.healthcare.gov/news/factsheets/valuebasedpurchasing04292011b.html.

The measures have been endorsed by such national panels as the National Quality Forum, and hospitals have already been reporting their performance on them through Medicare’s Hospital Compare website.

The measures are weighted so that 70% of the payment is based on the quality measures and 30% is based on patient evaluations.

Over time, CMS officials plan to add measures focused on patient outcomes, including prevention of hospital-acquired conditions. And measures will be phased out over time if hospitals achieve consistently high compliance scores, Dr. Berwick said.

The new value-based purchasing initiative is only one way that hospital payments will be tied to quality of care. Starting in 2013, Medicare will reduce payments to hospitals if they have excess 30-day readmissions for patients who suffer heart attacks, heart failure, and pneumonia.

And in 2015, hospitals could see their payments cut if they have high rates of certain hospital-acquired conditions.

The final rule on hospital value-based purchasing was published in the Federal Register in May and becomes final in July.

Starting in October 2012, about 1% of the payments that hospitals receive from Medicare will be calculated based on performance on clinical quality measures and patient satisfaction scores.

Details of the new initiative, known as the Hospital Inpatient Value-Based Purchasing program, were unveiled in a final rule released by the Centers for Medicare and Medicaid Services (CMS) this Spring.

The initiative was mandated by Congress under the Affordable Care Act.

Under the program, CMS will take 1% of the payments that would otherwise go to hospitals under Medicare’s Inpatient Prospective Payment System and put them in a fund to pay for care based on quality. In the first year, CMS estimates that about $850 million will be available through the fund. Medicare officials will score hospitals based on their performance on each of the measures compared with other hospitals and to how their performance has improved over time.

The new program is the first step in shifting payments toward quality and away from volume, aacording to Dr. Donald Berwick, a CMS administrator, who spoke during a press conference.

"This is one of those areas where improvement of quality and reduction in cost go hand-in-hand," Dr. Berwick said. "My feeling continues to be that the best way for us to arrive at sustainable costs for the health care system is precisely through the improvement of quality of care."

Under the program, payments will be based on performance on 12 clinical process-of-care measures and a survey of patient satisfaction. Process-of-care indicators include measures such as the percentage of patients with myocardial infarction who are given fibrinolytic medication within 30 minutes of arrival at the hospital.

To evaluate patient satisfaction, a random sample of discharged patients will be surveyed about their perceptions, including physician and nurse communication, hospital staff responsiveness, pain management, discharge instructions, and hospital cleanliness.

A complete list of the measures is available online at www.healthcare.gov/news/factsheets/valuebasedpurchasing04292011b.html.

The measures have been endorsed by such national panels as the National Quality Forum, and hospitals have already been reporting their performance on them through Medicare’s Hospital Compare website.

The measures are weighted so that 70% of the payment is based on the quality measures and 30% is based on patient evaluations.

Over time, CMS officials plan to add measures focused on patient outcomes, including prevention of hospital-acquired conditions. And measures will be phased out over time if hospitals achieve consistently high compliance scores, Dr. Berwick said.

The new value-based purchasing initiative is only one way that hospital payments will be tied to quality of care. Starting in 2013, Medicare will reduce payments to hospitals if they have excess 30-day readmissions for patients who suffer heart attacks, heart failure, and pneumonia.

And in 2015, hospitals could see their payments cut if they have high rates of certain hospital-acquired conditions.

The final rule on hospital value-based purchasing was published in the Federal Register in May and becomes final in July.