Alicia Ault

Tourette syndrome may get a higher profile in Congress now that a congressional caucus has been formed to highlight the condition.

The Congressional Caucus on Tourette Syndrome was formed by Rep. Steve Cohen (D-Tenn.) and Rep. Peter King (R-N.Y.). Caucuses – and there are hundreds – are established as sorts of internal lobbying organizations by members of the House.

"The bipartisan Congressional Caucus on Tourette Syndrome is long overdue and will increase awareness on this often misunderstood neurological disorder and promote legislation to help those who are suffering from it," Rep. Cohen said in a statement.

Rep. King, who noted that he was a recipient of the Tourette Syndrome Association’s 2013 Public Policy Award, said in the same statement, "I look forward to working with my colleagues on the Congressional Caucus on Tourette Syndrome to recognize, educate and address the needs of the children and adults that endure the stigma, isolation and psychological impact of this disorder."

According to the National Institute of Neurological Disorders and Stroke, Tourette syndrome, named for the French neurologist who first described it in 1885, is a neurologic disorder characterized by repetitive, stereotyped, involuntary movements and vocalizations. These are popularly called tics.

The Tourette Syndrome Association says that it is often misdiagnosed and inadequately treated, and estimates that 200,000 Americans have the condition. TSA President Judit Ungar said in a statement that the new caucus should be helpful, noting that "congressional support has proven to be instrumental in accelerating progress in other disorders, such as cancer, autism, and Parkinson’s disease."

The goals of the caucus include increasing knowledge and awareness of Tourette syndrome and its impact on patients and educating members of Congress on current and future research for Tourette syndrome and also about related disorders, including attention-deficit/hyperactivity disorder and obsessive-compulsive disorder.

Currently, additional caucus members include Elijah Cummings (D-Md.), Ted Deutch (D-Fla.), Keith Ellison (D-Minn.), Steve Israel (D-N.Y.), Zoe Lofgren (D-Calif.), Carolyn McCarthy (D-N.Y.), Joseph Pitts (R-Pa.), Albio Sires (D-N.J.), Ed Whitfield (R-Ky.), John Yarmouth (D-Ky.), and Bill Young (R-Fla.).

aault@frontlinemedcom.com

On Twitter @aliciaault

Tourette syndrome may get a higher profile in Congress now that a congressional caucus has been formed to highlight the condition.

The Congressional Caucus on Tourette Syndrome was formed by Rep. Steve Cohen (D-Tenn.) and Rep. Peter King (R-N.Y.). Caucuses – and there are hundreds – are established as sorts of internal lobbying organizations by members of the House.

"The bipartisan Congressional Caucus on Tourette Syndrome is long overdue and will increase awareness on this often misunderstood neurological disorder and promote legislation to help those who are suffering from it," Rep. Cohen said in a statement.

Rep. King, who noted that he was a recipient of the Tourette Syndrome Association’s 2013 Public Policy Award, said in the same statement, "I look forward to working with my colleagues on the Congressional Caucus on Tourette Syndrome to recognize, educate and address the needs of the children and adults that endure the stigma, isolation and psychological impact of this disorder."

According to the National Institute of Neurological Disorders and Stroke, Tourette syndrome, named for the French neurologist who first described it in 1885, is a neurologic disorder characterized by repetitive, stereotyped, involuntary movements and vocalizations. These are popularly called tics.

The Tourette Syndrome Association says that it is often misdiagnosed and inadequately treated, and estimates that 200,000 Americans have the condition. TSA President Judit Ungar said in a statement that the new caucus should be helpful, noting that "congressional support has proven to be instrumental in accelerating progress in other disorders, such as cancer, autism, and Parkinson’s disease."

The goals of the caucus include increasing knowledge and awareness of Tourette syndrome and its impact on patients and educating members of Congress on current and future research for Tourette syndrome and also about related disorders, including attention-deficit/hyperactivity disorder and obsessive-compulsive disorder.

Currently, additional caucus members include Elijah Cummings (D-Md.), Ted Deutch (D-Fla.), Keith Ellison (D-Minn.), Steve Israel (D-N.Y.), Zoe Lofgren (D-Calif.), Carolyn McCarthy (D-N.Y.), Joseph Pitts (R-Pa.), Albio Sires (D-N.J.), Ed Whitfield (R-Ky.), John Yarmouth (D-Ky.), and Bill Young (R-Fla.).

aault@frontlinemedcom.com

On Twitter @aliciaault

Tourette syndrome may get a higher profile in Congress now that a congressional caucus has been formed to highlight the condition.

The Congressional Caucus on Tourette Syndrome was formed by Rep. Steve Cohen (D-Tenn.) and Rep. Peter King (R-N.Y.). Caucuses – and there are hundreds – are established as sorts of internal lobbying organizations by members of the House.

"The bipartisan Congressional Caucus on Tourette Syndrome is long overdue and will increase awareness on this often misunderstood neurological disorder and promote legislation to help those who are suffering from it," Rep. Cohen said in a statement.

Rep. King, who noted that he was a recipient of the Tourette Syndrome Association’s 2013 Public Policy Award, said in the same statement, "I look forward to working with my colleagues on the Congressional Caucus on Tourette Syndrome to recognize, educate and address the needs of the children and adults that endure the stigma, isolation and psychological impact of this disorder."

According to the National Institute of Neurological Disorders and Stroke, Tourette syndrome, named for the French neurologist who first described it in 1885, is a neurologic disorder characterized by repetitive, stereotyped, involuntary movements and vocalizations. These are popularly called tics.

The Tourette Syndrome Association says that it is often misdiagnosed and inadequately treated, and estimates that 200,000 Americans have the condition. TSA President Judit Ungar said in a statement that the new caucus should be helpful, noting that "congressional support has proven to be instrumental in accelerating progress in other disorders, such as cancer, autism, and Parkinson’s disease."

The goals of the caucus include increasing knowledge and awareness of Tourette syndrome and its impact on patients and educating members of Congress on current and future research for Tourette syndrome and also about related disorders, including attention-deficit/hyperactivity disorder and obsessive-compulsive disorder.

Currently, additional caucus members include Elijah Cummings (D-Md.), Ted Deutch (D-Fla.), Keith Ellison (D-Minn.), Steve Israel (D-N.Y.), Zoe Lofgren (D-Calif.), Carolyn McCarthy (D-N.Y.), Joseph Pitts (R-Pa.), Albio Sires (D-N.J.), Ed Whitfield (R-Ky.), John Yarmouth (D-Ky.), and Bill Young (R-Fla.).

aault@frontlinemedcom.com

On Twitter @aliciaault

Got a better way to deliver and pay for health care? If so, the feds have a billion dollars worth of grants you can apply for.

The $1 billion is the second round of Health Care Innovation Awards from the Center for Medicare and Medicaid Innovation (CMMI), a division of the Centers for Medicare and Medicaid Services.

"We’re seeking out innovative practices that have a high likelihood of delivering better care and lower costs on a national scale," Kathleen Sebelius, Health and Human Services secretary, said in a press briefing.

The first round of awards "welcomed a wide range of proposals," but this year’s awards focus "very directly on identifying and testing new payment models to support the service delivery models funded by this initiative," Dr. Richard Gilfillan, CMMI director, said during the briefing.

CMMI is seeking proposals in four specific areas:

• Models that are designed to rapidly reduce outpatient and/or post–acute care costs under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP). Such models might address diagnostic services, outpatient radiology, physician-administered drugs, home-based services, and postacute care, Dr. Gilfillan said.

• Models that improve care for specific populations, such as high-cost pediatric populations, children in foster care, and children at high risk for dental disease, as well as patients with Alzheimer’s disease, HIV/AIDS, or serious mental illness.

• Models that transform financial and clinical models for specialists who treat patients with complex medical needs.

• Models that improve population health – either geographically (health of a community), clinically (health of those with specific diseases), or socioeconomically – through prevention, wellness, and comprehensive care beyond the clinic.

Awardees have 3 years to demonstrate their projects. In this second round, they must have the payment model operational at some point during that period, Dr. Gilfillan said.

The CMMI has the authority to expand any program nationally if it looks like it is producing savings.

Republican members of Congress have been seeking progress reports on the first round of innovation grants, but Dr. Gilfillan said it was too early to say whether any of the models were saving money, or how much they might be saving.

To apply for a grant, submit a letter of intent by June 28. An application must follow and will be accepted from June 14 until Aug. 15. All applications must include "design of a payment model that is consistent with the new service delivery model that they propose," according to the CMS. Awards will be announced in January 2014.

More information can be found at the CMMI web page.

aault@frontlinemedcom.com

On Twitter @aliciaault

Got a better way to deliver and pay for health care? If so, the feds have a billion dollars worth of grants you can apply for.

The $1 billion is the second round of Health Care Innovation Awards from the Center for Medicare and Medicaid Innovation (CMMI), a division of the Centers for Medicare and Medicaid Services.

"We’re seeking out innovative practices that have a high likelihood of delivering better care and lower costs on a national scale," Kathleen Sebelius, Health and Human Services secretary, said in a press briefing.

The first round of awards "welcomed a wide range of proposals," but this year’s awards focus "very directly on identifying and testing new payment models to support the service delivery models funded by this initiative," Dr. Richard Gilfillan, CMMI director, said during the briefing.

CMMI is seeking proposals in four specific areas:

• Models that are designed to rapidly reduce outpatient and/or post–acute care costs under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP). Such models might address diagnostic services, outpatient radiology, physician-administered drugs, home-based services, and postacute care, Dr. Gilfillan said.

• Models that improve care for specific populations, such as high-cost pediatric populations, children in foster care, and children at high risk for dental disease, as well as patients with Alzheimer’s disease, HIV/AIDS, or serious mental illness.

• Models that transform financial and clinical models for specialists who treat patients with complex medical needs.

• Models that improve population health – either geographically (health of a community), clinically (health of those with specific diseases), or socioeconomically – through prevention, wellness, and comprehensive care beyond the clinic.

Awardees have 3 years to demonstrate their projects. In this second round, they must have the payment model operational at some point during that period, Dr. Gilfillan said.

The CMMI has the authority to expand any program nationally if it looks like it is producing savings.

Republican members of Congress have been seeking progress reports on the first round of innovation grants, but Dr. Gilfillan said it was too early to say whether any of the models were saving money, or how much they might be saving.

To apply for a grant, submit a letter of intent by June 28. An application must follow and will be accepted from June 14 until Aug. 15. All applications must include "design of a payment model that is consistent with the new service delivery model that they propose," according to the CMS. Awards will be announced in January 2014.

More information can be found at the CMMI web page.

aault@frontlinemedcom.com

On Twitter @aliciaault

Got a better way to deliver and pay for health care? If so, the feds have a billion dollars worth of grants you can apply for.

The $1 billion is the second round of Health Care Innovation Awards from the Center for Medicare and Medicaid Innovation (CMMI), a division of the Centers for Medicare and Medicaid Services.

"We’re seeking out innovative practices that have a high likelihood of delivering better care and lower costs on a national scale," Kathleen Sebelius, Health and Human Services secretary, said in a press briefing.

The first round of awards "welcomed a wide range of proposals," but this year’s awards focus "very directly on identifying and testing new payment models to support the service delivery models funded by this initiative," Dr. Richard Gilfillan, CMMI director, said during the briefing.

CMMI is seeking proposals in four specific areas:

• Models that are designed to rapidly reduce outpatient and/or post–acute care costs under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP). Such models might address diagnostic services, outpatient radiology, physician-administered drugs, home-based services, and postacute care, Dr. Gilfillan said.

• Models that improve care for specific populations, such as high-cost pediatric populations, children in foster care, and children at high risk for dental disease, as well as patients with Alzheimer’s disease, HIV/AIDS, or serious mental illness.

• Models that transform financial and clinical models for specialists who treat patients with complex medical needs.

• Models that improve population health – either geographically (health of a community), clinically (health of those with specific diseases), or socioeconomically – through prevention, wellness, and comprehensive care beyond the clinic.

Awardees have 3 years to demonstrate their projects. In this second round, they must have the payment model operational at some point during that period, Dr. Gilfillan said.

The CMMI has the authority to expand any program nationally if it looks like it is producing savings.

Republican members of Congress have been seeking progress reports on the first round of innovation grants, but Dr. Gilfillan said it was too early to say whether any of the models were saving money, or how much they might be saving.

To apply for a grant, submit a letter of intent by June 28. An application must follow and will be accepted from June 14 until Aug. 15. All applications must include "design of a payment model that is consistent with the new service delivery model that they propose," according to the CMS. Awards will be announced in January 2014.

More information can be found at the CMMI web page.

aault@frontlinemedcom.com

On Twitter @aliciaault

For the first time in 7 years, the Centers for Medicare and Medicaid Services has a Senate-confirmed administrator, now that Marilyn Tavenner has received that body’s stamp of approval.

Ms. Tavenner was confirmed on May 15 by a 91-7 vote (two senators did not vote). The Republican senators opposing her confirmation were Mike Crapo of Idaho, Ted Cruz of Texas, Ron Johnson of Wisconsin, Mike Lee of Utah, Mitch McConnell of Kentucky, Rand Paul of Kentucky, and James Risch of Idaho.

Ms. Tavenner has been serving as acting administrator since December 2011, when Dr. Don Berwick stepped down.

"Marilyn brings with her a breadth of experience and expertise from virtually all angles of health care policy and delivery, having served as a hospital CEO, a state health official, and a registered nurse," Kathleen Sebelius, Health and Human Services Secretary, said in a statement. "Marilyn will serve in a critical role at CMS as we work to improve the health care for hundreds of millions of Americans."

Ms. Tavenner has said that she wants the agency to evolve into something a bit different under her leadership. In a written response to questions during her confirmation process, she said that she will have three primary aims.

First "we need to operate CMS as a business and act like business partners," she wrote. That includes "an ‘open-door policy’ to work together and listen to the concerns of all the groups we work with and work for: beneficiaries, taxpayers, providers, hospitals, members of Congress, states, advocacy groups, insurance companies and our own employees and contractors."

The second aim is implementing the ACA and the third is to use new tools to reduce health costs and improve delivery.

"These tools include new payment strategies connected to performance, new models of care, and enhanced tools to combat fraud," she wrote.

Ms. Tavenner has generally been well regarded among physicians and other health care providers, and they applauded her confirmation.

"The American Medical Association is very pleased that the Senate has confirmed Marilyn Tavenner as administrator of CMS," Dr. Jeremy Lazarus, president of the AMA, said in a statement. "As acting administrator, she has demonstrated her ability to be a capable and effective leader. We look forward to continuing to work with the administrator to strengthen the Medicare system to improve health outcomes for patients and the practice environment for physicians."

The American Society of Clinical Oncology also issued a statement of support, noting that the agency was at a critical point.

"CMS faces many challenges in the coming months that will impact oncologists and their patients," Dr. Sandra Swain, ASCO president, said in a statement. "ASCO encourages Administrator Tavenner to continue working closely with the cancer community specifically as it works to develop a system to qualify registry programs, such as the Quality Oncology Practice Initiative (QOPI), for reporting under the Physician Quality Reporting System (PQRS)," she said.

Prior to joining the federal government, Ms. Tavenner worked extensively for the Hospital Corporation of America and served as the company’s group president of outpatient services just prior to leaving in 2005. She is a registered nurse and received both her nursing degree and master’s of health administration from Virginia Commonwealth University.

aault@frontlinemedcom.com

On Twitter @aliciaault

For the first time in 7 years, the Centers for Medicare and Medicaid Services has a Senate-confirmed administrator, now that Marilyn Tavenner has received that body’s stamp of approval.

Ms. Tavenner was confirmed on May 15 by a 91-7 vote (two senators did not vote). The Republican senators opposing her confirmation were Mike Crapo of Idaho, Ted Cruz of Texas, Ron Johnson of Wisconsin, Mike Lee of Utah, Mitch McConnell of Kentucky, Rand Paul of Kentucky, and James Risch of Idaho.

Ms. Tavenner has been serving as acting administrator since December 2011, when Dr. Don Berwick stepped down.

"Marilyn brings with her a breadth of experience and expertise from virtually all angles of health care policy and delivery, having served as a hospital CEO, a state health official, and a registered nurse," Kathleen Sebelius, Health and Human Services Secretary, said in a statement. "Marilyn will serve in a critical role at CMS as we work to improve the health care for hundreds of millions of Americans."

Ms. Tavenner has said that she wants the agency to evolve into something a bit different under her leadership. In a written response to questions during her confirmation process, she said that she will have three primary aims.

First "we need to operate CMS as a business and act like business partners," she wrote. That includes "an ‘open-door policy’ to work together and listen to the concerns of all the groups we work with and work for: beneficiaries, taxpayers, providers, hospitals, members of Congress, states, advocacy groups, insurance companies and our own employees and contractors."

The second aim is implementing the ACA and the third is to use new tools to reduce health costs and improve delivery.

"These tools include new payment strategies connected to performance, new models of care, and enhanced tools to combat fraud," she wrote.

Ms. Tavenner has generally been well regarded among physicians and other health care providers, and they applauded her confirmation.

"The American Medical Association is very pleased that the Senate has confirmed Marilyn Tavenner as administrator of CMS," Dr. Jeremy Lazarus, president of the AMA, said in a statement. "As acting administrator, she has demonstrated her ability to be a capable and effective leader. We look forward to continuing to work with the administrator to strengthen the Medicare system to improve health outcomes for patients and the practice environment for physicians."

The American Society of Clinical Oncology also issued a statement of support, noting that the agency was at a critical point.

"CMS faces many challenges in the coming months that will impact oncologists and their patients," Dr. Sandra Swain, ASCO president, said in a statement. "ASCO encourages Administrator Tavenner to continue working closely with the cancer community specifically as it works to develop a system to qualify registry programs, such as the Quality Oncology Practice Initiative (QOPI), for reporting under the Physician Quality Reporting System (PQRS)," she said.

Prior to joining the federal government, Ms. Tavenner worked extensively for the Hospital Corporation of America and served as the company’s group president of outpatient services just prior to leaving in 2005. She is a registered nurse and received both her nursing degree and master’s of health administration from Virginia Commonwealth University.

aault@frontlinemedcom.com

On Twitter @aliciaault

For the first time in 7 years, the Centers for Medicare and Medicaid Services has a Senate-confirmed administrator, now that Marilyn Tavenner has received that body’s stamp of approval.

Ms. Tavenner was confirmed on May 15 by a 91-7 vote (two senators did not vote). The Republican senators opposing her confirmation were Mike Crapo of Idaho, Ted Cruz of Texas, Ron Johnson of Wisconsin, Mike Lee of Utah, Mitch McConnell of Kentucky, Rand Paul of Kentucky, and James Risch of Idaho.

Ms. Tavenner has been serving as acting administrator since December 2011, when Dr. Don Berwick stepped down.

"Marilyn brings with her a breadth of experience and expertise from virtually all angles of health care policy and delivery, having served as a hospital CEO, a state health official, and a registered nurse," Kathleen Sebelius, Health and Human Services Secretary, said in a statement. "Marilyn will serve in a critical role at CMS as we work to improve the health care for hundreds of millions of Americans."

Ms. Tavenner has said that she wants the agency to evolve into something a bit different under her leadership. In a written response to questions during her confirmation process, she said that she will have three primary aims.

First "we need to operate CMS as a business and act like business partners," she wrote. That includes "an ‘open-door policy’ to work together and listen to the concerns of all the groups we work with and work for: beneficiaries, taxpayers, providers, hospitals, members of Congress, states, advocacy groups, insurance companies and our own employees and contractors."

The second aim is implementing the ACA and the third is to use new tools to reduce health costs and improve delivery.

"These tools include new payment strategies connected to performance, new models of care, and enhanced tools to combat fraud," she wrote.

Ms. Tavenner has generally been well regarded among physicians and other health care providers, and they applauded her confirmation.

"The American Medical Association is very pleased that the Senate has confirmed Marilyn Tavenner as administrator of CMS," Dr. Jeremy Lazarus, president of the AMA, said in a statement. "As acting administrator, she has demonstrated her ability to be a capable and effective leader. We look forward to continuing to work with the administrator to strengthen the Medicare system to improve health outcomes for patients and the practice environment for physicians."

The American Society of Clinical Oncology also issued a statement of support, noting that the agency was at a critical point.

"CMS faces many challenges in the coming months that will impact oncologists and their patients," Dr. Sandra Swain, ASCO president, said in a statement. "ASCO encourages Administrator Tavenner to continue working closely with the cancer community specifically as it works to develop a system to qualify registry programs, such as the Quality Oncology Practice Initiative (QOPI), for reporting under the Physician Quality Reporting System (PQRS)," she said.

Prior to joining the federal government, Ms. Tavenner worked extensively for the Hospital Corporation of America and served as the company’s group president of outpatient services just prior to leaving in 2005. She is a registered nurse and received both her nursing degree and master’s of health administration from Virginia Commonwealth University.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration has approved the first companion diagnostic test to detect epidermal growth factor receptor gene mutations.

The cobas epidermal growth factor receptor (EGFR) mutation test will be used to determine whether non–small cell lung cancer (NSCLC) patients with the mutation are eligible for treatment with erlotinib (Tarceva). That already-marketed small-molecule tyrosine kinase inhibitor received expanded approval as a first-line drug in metastatic NSCLC.

"Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a statement.

According to test maker Roche Molecular Systems, the cobas EGFR Mutation Test is "a real-time PCR [polymerase chain reaction] test for the qualitative detection and identification of mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from FFPET [formalin-fixed paraffin-embedded] human NSCLC tumor tissue." The test can be conducted in 8 hours.

About 85% of the 228,000 cases of lung cancer in the U.S. are NSCLCs, according to the National Cancer Institute.

Both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) have recommended EGFR testing for patients considering tyrosine kinase inhibitors as first-line therapy in metastatic or recurring NSCLC.

ASCO issued a provisional clinical opinion on the subject in May 2011, and the NCCN updated clinical management guidelines earlier that year to include a category 1 recommendation that EGFR testing should be undertaken after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma.

Both groups based their endorsements on studies demonstrating that mutations in two regions of the EGFR gene appear to predict tumor response to chemotherapy in general and to tyrosine kinase inhibitors specifically.

On average, NSCLC patients who had the two EGFR mutations detected by the cobas EGFR Mutation Test and who took erlotinib lived 10.4 months before their disease progressed, compared with 5.4 months for those who received a standard two-drug chemotherapy regimen.

Erlotinib was first approved in November 2004 for treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. It has received two other approvals before the current one, including for maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

The drug is comarketed by Genentech, a member of the Roche Group and OSI Pharmaceuticals.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration has approved the first companion diagnostic test to detect epidermal growth factor receptor gene mutations.

The cobas epidermal growth factor receptor (EGFR) mutation test will be used to determine whether non–small cell lung cancer (NSCLC) patients with the mutation are eligible for treatment with erlotinib (Tarceva). That already-marketed small-molecule tyrosine kinase inhibitor received expanded approval as a first-line drug in metastatic NSCLC.

"Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a statement.

According to test maker Roche Molecular Systems, the cobas EGFR Mutation Test is "a real-time PCR [polymerase chain reaction] test for the qualitative detection and identification of mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from FFPET [formalin-fixed paraffin-embedded] human NSCLC tumor tissue." The test can be conducted in 8 hours.

About 85% of the 228,000 cases of lung cancer in the U.S. are NSCLCs, according to the National Cancer Institute.

Both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) have recommended EGFR testing for patients considering tyrosine kinase inhibitors as first-line therapy in metastatic or recurring NSCLC.

ASCO issued a provisional clinical opinion on the subject in May 2011, and the NCCN updated clinical management guidelines earlier that year to include a category 1 recommendation that EGFR testing should be undertaken after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma.

Both groups based their endorsements on studies demonstrating that mutations in two regions of the EGFR gene appear to predict tumor response to chemotherapy in general and to tyrosine kinase inhibitors specifically.

On average, NSCLC patients who had the two EGFR mutations detected by the cobas EGFR Mutation Test and who took erlotinib lived 10.4 months before their disease progressed, compared with 5.4 months for those who received a standard two-drug chemotherapy regimen.

Erlotinib was first approved in November 2004 for treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. It has received two other approvals before the current one, including for maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

The drug is comarketed by Genentech, a member of the Roche Group and OSI Pharmaceuticals.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration has approved the first companion diagnostic test to detect epidermal growth factor receptor gene mutations.

The cobas epidermal growth factor receptor (EGFR) mutation test will be used to determine whether non–small cell lung cancer (NSCLC) patients with the mutation are eligible for treatment with erlotinib (Tarceva). That already-marketed small-molecule tyrosine kinase inhibitor received expanded approval as a first-line drug in metastatic NSCLC.

"Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a statement.

According to test maker Roche Molecular Systems, the cobas EGFR Mutation Test is "a real-time PCR [polymerase chain reaction] test for the qualitative detection and identification of mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from FFPET [formalin-fixed paraffin-embedded] human NSCLC tumor tissue." The test can be conducted in 8 hours.

About 85% of the 228,000 cases of lung cancer in the U.S. are NSCLCs, according to the National Cancer Institute.

Both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) have recommended EGFR testing for patients considering tyrosine kinase inhibitors as first-line therapy in metastatic or recurring NSCLC.

ASCO issued a provisional clinical opinion on the subject in May 2011, and the NCCN updated clinical management guidelines earlier that year to include a category 1 recommendation that EGFR testing should be undertaken after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma.

Both groups based their endorsements on studies demonstrating that mutations in two regions of the EGFR gene appear to predict tumor response to chemotherapy in general and to tyrosine kinase inhibitors specifically.

On average, NSCLC patients who had the two EGFR mutations detected by the cobas EGFR Mutation Test and who took erlotinib lived 10.4 months before their disease progressed, compared with 5.4 months for those who received a standard two-drug chemotherapy regimen.

Erlotinib was first approved in November 2004 for treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. It has received two other approvals before the current one, including for maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

The drug is comarketed by Genentech, a member of the Roche Group and OSI Pharmaceuticals.

aault@frontlinemedcom.com

On Twitter @aliciaault

Sequestration is causing oncology practices to change how they do business and care for patients, two new surveys show.

The sequester’s 2% Medicare cut began on April 1.

Some 80% of the 500 members surveyed by the American Society of Clinical Oncology said that sequestration has affected their practice. Three-quarters said that they were having trouble paying for chemotherapy drugs.

Half said they were able to continue caring only for Medicare patients who had supplemental insurance. Fourteen percent said they were not seeing Medicare patients at all. Half said that they were sending Medicare patients to outpatient infusion offices, instead of infusing them in their offices.

"It’s encouraging to see that oncologists are currently doing whatever they can to ensure that their patients receive the critical treatment they need under these funding cuts," Dr. Sandra M. Swain, ASCO president, said in a statement. "But patient care is clearly being disrupted in some cases, and practices are under great stress. These early findings may just be the tip of the iceberg."

ASCO is concerned that many patients might be more than just inconvenienced. "Cancer patients are very sick, often elderly, and may struggle with great fatigue and discomfort," Dr. Swain said. "Having to travel just an additional 10 miles and be treated in a larger system can be a traumatic experience."

Oncology research may also suffer under sequestration – a quarter of survey respondents said they were no longer participating in clinical trials.

The ASCO survey was conducted April 23 to May 1. Forty-four percent of respondents practice in the suburbs, 41% in the city, and 16% in rural areas. Practices ranged in size from 1 to 48 full-time medical oncologists.

In a different survey, members of the Community Oncology Alliance indicated that they are struggling under sequestration. About 70% of respondents said they had already made changes to their practices.

"We are now seeing the cascading effects of sequestration," Dr. Mark Thompson, COA president and an oncologist at the Zangmeister Center, Columbus, Ohio, said in a statement. "Many practices are now sending their Medicare patients to hospitals for chemotherapy while others are laying off staff," he said. "Practices are so financially threatened that discussions of merging with a hospital – despite the increase in cost of care to the patients and the system – are being reopened."

Almost half of those surveyed said they were treating only Medicare patients who had supplemental insurance. A third said they were laying off staff or reducing hours. Fifteen percent reported sending Medicare patients elsewhere for treatment and a third said that they were not treating any Medicare patients if the cost of a single drug exceeded the Medicare payment for that drug. Twenty-one percent indicated that they were in talks to be acquired by a hospital or to forge some other kind of agreement to align with other professionals.

More than half of 326 primarily office-based respondents said patients had complained to them about costs, inconvenience, and travel burdens. A third reported that the facility where they referred patients had indicated that they could not handle the additional influx.

The COA estimated that the sequester reduction for chemotherapy drugs was actually increasing cost to the federal government. Sending patients to the hospital for infusions costs Medicare an estimated $592 million, according to the COA, while the sequester saves about $150 in cancer care and drugs.

"The net impact of the sequester cut just to cancer drugs is an increase in federal spending of $442 million to $600 million annualized," the group stated in its survey.

Both the COA and ASCO are urging repeal of sequestration. The oncology community also is backing The Cancer Patient Protection Act of 2013 (H.R. 1416), introduced by Rep. Renee Ellmers (R-NC) in April. The bill would specifically repeal the 2% cut for oncology drugs and restore any payments that were lost due to the sequestration. It has 64 cosponsors, but no hearings have been scheduled on the legislation.

aault@frontlinemedcom.com

On Twitter @aliciaault

Sequestration is causing oncology practices to change how they do business and care for patients, two new surveys show.

The sequester’s 2% Medicare cut began on April 1.

Some 80% of the 500 members surveyed by the American Society of Clinical Oncology said that sequestration has affected their practice. Three-quarters said that they were having trouble paying for chemotherapy drugs.

Half said they were able to continue caring only for Medicare patients who had supplemental insurance. Fourteen percent said they were not seeing Medicare patients at all. Half said that they were sending Medicare patients to outpatient infusion offices, instead of infusing them in their offices.

"It’s encouraging to see that oncologists are currently doing whatever they can to ensure that their patients receive the critical treatment they need under these funding cuts," Dr. Sandra M. Swain, ASCO president, said in a statement. "But patient care is clearly being disrupted in some cases, and practices are under great stress. These early findings may just be the tip of the iceberg."

ASCO is concerned that many patients might be more than just inconvenienced. "Cancer patients are very sick, often elderly, and may struggle with great fatigue and discomfort," Dr. Swain said. "Having to travel just an additional 10 miles and be treated in a larger system can be a traumatic experience."

Oncology research may also suffer under sequestration – a quarter of survey respondents said they were no longer participating in clinical trials.

The ASCO survey was conducted April 23 to May 1. Forty-four percent of respondents practice in the suburbs, 41% in the city, and 16% in rural areas. Practices ranged in size from 1 to 48 full-time medical oncologists.

In a different survey, members of the Community Oncology Alliance indicated that they are struggling under sequestration. About 70% of respondents said they had already made changes to their practices.

"We are now seeing the cascading effects of sequestration," Dr. Mark Thompson, COA president and an oncologist at the Zangmeister Center, Columbus, Ohio, said in a statement. "Many practices are now sending their Medicare patients to hospitals for chemotherapy while others are laying off staff," he said. "Practices are so financially threatened that discussions of merging with a hospital – despite the increase in cost of care to the patients and the system – are being reopened."

Almost half of those surveyed said they were treating only Medicare patients who had supplemental insurance. A third said they were laying off staff or reducing hours. Fifteen percent reported sending Medicare patients elsewhere for treatment and a third said that they were not treating any Medicare patients if the cost of a single drug exceeded the Medicare payment for that drug. Twenty-one percent indicated that they were in talks to be acquired by a hospital or to forge some other kind of agreement to align with other professionals.

More than half of 326 primarily office-based respondents said patients had complained to them about costs, inconvenience, and travel burdens. A third reported that the facility where they referred patients had indicated that they could not handle the additional influx.

The COA estimated that the sequester reduction for chemotherapy drugs was actually increasing cost to the federal government. Sending patients to the hospital for infusions costs Medicare an estimated $592 million, according to the COA, while the sequester saves about $150 in cancer care and drugs.

"The net impact of the sequester cut just to cancer drugs is an increase in federal spending of $442 million to $600 million annualized," the group stated in its survey.

Both the COA and ASCO are urging repeal of sequestration. The oncology community also is backing The Cancer Patient Protection Act of 2013 (H.R. 1416), introduced by Rep. Renee Ellmers (R-NC) in April. The bill would specifically repeal the 2% cut for oncology drugs and restore any payments that were lost due to the sequestration. It has 64 cosponsors, but no hearings have been scheduled on the legislation.

aault@frontlinemedcom.com

On Twitter @aliciaault

Sequestration is causing oncology practices to change how they do business and care for patients, two new surveys show.

The sequester’s 2% Medicare cut began on April 1.

Some 80% of the 500 members surveyed by the American Society of Clinical Oncology said that sequestration has affected their practice. Three-quarters said that they were having trouble paying for chemotherapy drugs.

Half said they were able to continue caring only for Medicare patients who had supplemental insurance. Fourteen percent said they were not seeing Medicare patients at all. Half said that they were sending Medicare patients to outpatient infusion offices, instead of infusing them in their offices.

"It’s encouraging to see that oncologists are currently doing whatever they can to ensure that their patients receive the critical treatment they need under these funding cuts," Dr. Sandra M. Swain, ASCO president, said in a statement. "But patient care is clearly being disrupted in some cases, and practices are under great stress. These early findings may just be the tip of the iceberg."

ASCO is concerned that many patients might be more than just inconvenienced. "Cancer patients are very sick, often elderly, and may struggle with great fatigue and discomfort," Dr. Swain said. "Having to travel just an additional 10 miles and be treated in a larger system can be a traumatic experience."

Oncology research may also suffer under sequestration – a quarter of survey respondents said they were no longer participating in clinical trials.

The ASCO survey was conducted April 23 to May 1. Forty-four percent of respondents practice in the suburbs, 41% in the city, and 16% in rural areas. Practices ranged in size from 1 to 48 full-time medical oncologists.

In a different survey, members of the Community Oncology Alliance indicated that they are struggling under sequestration. About 70% of respondents said they had already made changes to their practices.

"We are now seeing the cascading effects of sequestration," Dr. Mark Thompson, COA president and an oncologist at the Zangmeister Center, Columbus, Ohio, said in a statement. "Many practices are now sending their Medicare patients to hospitals for chemotherapy while others are laying off staff," he said. "Practices are so financially threatened that discussions of merging with a hospital – despite the increase in cost of care to the patients and the system – are being reopened."

Almost half of those surveyed said they were treating only Medicare patients who had supplemental insurance. A third said they were laying off staff or reducing hours. Fifteen percent reported sending Medicare patients elsewhere for treatment and a third said that they were not treating any Medicare patients if the cost of a single drug exceeded the Medicare payment for that drug. Twenty-one percent indicated that they were in talks to be acquired by a hospital or to forge some other kind of agreement to align with other professionals.

More than half of 326 primarily office-based respondents said patients had complained to them about costs, inconvenience, and travel burdens. A third reported that the facility where they referred patients had indicated that they could not handle the additional influx.

The COA estimated that the sequester reduction for chemotherapy drugs was actually increasing cost to the federal government. Sending patients to the hospital for infusions costs Medicare an estimated $592 million, according to the COA, while the sequester saves about $150 in cancer care and drugs.

"The net impact of the sequester cut just to cancer drugs is an increase in federal spending of $442 million to $600 million annualized," the group stated in its survey.

Both the COA and ASCO are urging repeal of sequestration. The oncology community also is backing The Cancer Patient Protection Act of 2013 (H.R. 1416), introduced by Rep. Renee Ellmers (R-NC) in April. The bill would specifically repeal the 2% cut for oncology drugs and restore any payments that were lost due to the sequestration. It has 64 cosponsors, but no hearings have been scheduled on the legislation.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Maintaining balance and enthusiasm – at home and at your practice – can seem to be an impossible challenge. And yet, without it – in every aspect of your life – you will be a less-capable physician, a less-engaged and happy spouse or friend, a less satisfied person, and not on top of your game.

That’s according to Dr. Linda Clever, an internist who is president of Renew, a project of the Institute for Health & Healing at California Pacific Medical Center in San Francisco.

"It turns out that if we’re bored, if we’re sad, if we’re frightened, it leads to a loss of creativity, a loss of enthusiasm and engagement, and resilience and effectiveness, not just at work, but at home," Dr. Clever told attendees at the annual meeting of the American College of Physicians.

She was not discussing burnout, but something different. "If you’re rushing through the day just to get through the day, that’s an incipient sign of not being engaged," she said, calling that "a danger signal."

The key is to use your values as your foundation. "What gets you to happiness is living your values."

Dr. Clever said that people who are balanced, and at the top of their game:

• Have strong relationships.

• Have a religious or spiritual life of some sort, which might just be having a constant sense of wonder at the world.

• Take care of themselves.

• Like their work.

• Have the basic conviction that they can play the hand that’s dealt them. That is, the ways things are might not be the preferred way, but life is manageable.

During her presentation at the meeting, Dr. Clever led attendees through a variation on the workshops she gives at Renew. The program helps people identify and define their personal values, and offers ways to live out those values even while managing complex responsibilities and priorities. She asked attendees for their definition of success. Among the terms she collected: balance, happiness, peace, wellness, making a difference, money, and positive feedback. Control was also mentioned.

Dr. Clever said that control is a common term among physicians. Doctors "like to control things," she said. It’s not surprising, as they really have to be obsessive-compulsive, said Dr. Clever. "Who else is going to get a second creatinine? Who else is going to take a picture of that lesion and follow it for 3 days? Who else is going to draw a circle around that erythema and look at it again in 2 hours?" she asked.

But that creates what she called a "soft underbelly." The desire for control is a vulnerability because "when we aren’t perfect, it’s very hard on us, and it’s very disturbing," said Dr. Clever.

There are some things that physicians can control. The most important thing is to live your values. Values are what someone believes is good or bad, right or wrong, and what gives meaning, fuel, and joy. Once you know your values, then you can define success, and know how you will spend your time," she said.

When physician attendees were asked to share some of their values, they mentioned honesty, integrity, humor, empathy, compassion, self-sacrifice, tolerance, service, humility, charity, sustainability, spirituality, and respect for self and others. Values should be written down, discussed out loud and shared with loved ones, advised Dr. Clever.

Physicians, like anyone striving for balance, can also control their attitudes and how they respond and cope when faced with adversity. In that vein, she said, many people have been inspired by "Man's Search for Meaning," (Boston: Beacon Press, 2006) a memoir by psychiatrist Viktor Frankl, who spent several years in Nazi concentration camps.

"Frankl wrote that the last human freedom is the freedom to choose your attitude in a given set of circumstances," said Dr. Clever. She said that physicians could adopt this philosophy and talk to their patients, or to their teenagers, about this concept. "You can choose to be a victim and you can choose to be a winner."

If you’re feeling overwhelmed, get help, advised Dr. Clever, adding, "That’s what money is for." Consider a gardener or a housekeeper or even a life coach. And, if things aren’t going well, don’t just complain. Also, give up what Dr. Clever calls "BMW": bitching, moaning, and whining.

Learn new tricks, she advised, especially if the old way isn’t working. "We have to get more comfortable with change."

"One new trick is to learn how to say ‘no,’ " Dr. Clever said. Physicians like to please and "it turns out if we’re doing too much, we can’t do anything well."

One tip for saying no gracefully is to employ what she called the "no sandwich." On the top, you thank the person for asking you. In the middle is the "no," and on the bottom, you thank the person again and say that you are honored to have been asked.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Maintaining balance and enthusiasm – at home and at your practice – can seem to be an impossible challenge. And yet, without it – in every aspect of your life – you will be a less-capable physician, a less-engaged and happy spouse or friend, a less satisfied person, and not on top of your game.

That’s according to Dr. Linda Clever, an internist who is president of Renew, a project of the Institute for Health & Healing at California Pacific Medical Center in San Francisco.

"It turns out that if we’re bored, if we’re sad, if we’re frightened, it leads to a loss of creativity, a loss of enthusiasm and engagement, and resilience and effectiveness, not just at work, but at home," Dr. Clever told attendees at the annual meeting of the American College of Physicians.

She was not discussing burnout, but something different. "If you’re rushing through the day just to get through the day, that’s an incipient sign of not being engaged," she said, calling that "a danger signal."

The key is to use your values as your foundation. "What gets you to happiness is living your values."

Dr. Clever said that people who are balanced, and at the top of their game:

• Have strong relationships.

• Have a religious or spiritual life of some sort, which might just be having a constant sense of wonder at the world.

• Take care of themselves.

• Like their work.

• Have the basic conviction that they can play the hand that’s dealt them. That is, the ways things are might not be the preferred way, but life is manageable.

During her presentation at the meeting, Dr. Clever led attendees through a variation on the workshops she gives at Renew. The program helps people identify and define their personal values, and offers ways to live out those values even while managing complex responsibilities and priorities. She asked attendees for their definition of success. Among the terms she collected: balance, happiness, peace, wellness, making a difference, money, and positive feedback. Control was also mentioned.

Dr. Clever said that control is a common term among physicians. Doctors "like to control things," she said. It’s not surprising, as they really have to be obsessive-compulsive, said Dr. Clever. "Who else is going to get a second creatinine? Who else is going to take a picture of that lesion and follow it for 3 days? Who else is going to draw a circle around that erythema and look at it again in 2 hours?" she asked.

But that creates what she called a "soft underbelly." The desire for control is a vulnerability because "when we aren’t perfect, it’s very hard on us, and it’s very disturbing," said Dr. Clever.

There are some things that physicians can control. The most important thing is to live your values. Values are what someone believes is good or bad, right or wrong, and what gives meaning, fuel, and joy. Once you know your values, then you can define success, and know how you will spend your time," she said.

When physician attendees were asked to share some of their values, they mentioned honesty, integrity, humor, empathy, compassion, self-sacrifice, tolerance, service, humility, charity, sustainability, spirituality, and respect for self and others. Values should be written down, discussed out loud and shared with loved ones, advised Dr. Clever.

Physicians, like anyone striving for balance, can also control their attitudes and how they respond and cope when faced with adversity. In that vein, she said, many people have been inspired by "Man's Search for Meaning," (Boston: Beacon Press, 2006) a memoir by psychiatrist Viktor Frankl, who spent several years in Nazi concentration camps.

"Frankl wrote that the last human freedom is the freedom to choose your attitude in a given set of circumstances," said Dr. Clever. She said that physicians could adopt this philosophy and talk to their patients, or to their teenagers, about this concept. "You can choose to be a victim and you can choose to be a winner."

If you’re feeling overwhelmed, get help, advised Dr. Clever, adding, "That’s what money is for." Consider a gardener or a housekeeper or even a life coach. And, if things aren’t going well, don’t just complain. Also, give up what Dr. Clever calls "BMW": bitching, moaning, and whining.

Learn new tricks, she advised, especially if the old way isn’t working. "We have to get more comfortable with change."

"One new trick is to learn how to say ‘no,’ " Dr. Clever said. Physicians like to please and "it turns out if we’re doing too much, we can’t do anything well."

One tip for saying no gracefully is to employ what she called the "no sandwich." On the top, you thank the person for asking you. In the middle is the "no," and on the bottom, you thank the person again and say that you are honored to have been asked.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Maintaining balance and enthusiasm – at home and at your practice – can seem to be an impossible challenge. And yet, without it – in every aspect of your life – you will be a less-capable physician, a less-engaged and happy spouse or friend, a less satisfied person, and not on top of your game.

That’s according to Dr. Linda Clever, an internist who is president of Renew, a project of the Institute for Health & Healing at California Pacific Medical Center in San Francisco.

"It turns out that if we’re bored, if we’re sad, if we’re frightened, it leads to a loss of creativity, a loss of enthusiasm and engagement, and resilience and effectiveness, not just at work, but at home," Dr. Clever told attendees at the annual meeting of the American College of Physicians.

She was not discussing burnout, but something different. "If you’re rushing through the day just to get through the day, that’s an incipient sign of not being engaged," she said, calling that "a danger signal."

The key is to use your values as your foundation. "What gets you to happiness is living your values."

Dr. Clever said that people who are balanced, and at the top of their game:

• Have strong relationships.

• Have a religious or spiritual life of some sort, which might just be having a constant sense of wonder at the world.

• Take care of themselves.

• Like their work.

• Have the basic conviction that they can play the hand that’s dealt them. That is, the ways things are might not be the preferred way, but life is manageable.

During her presentation at the meeting, Dr. Clever led attendees through a variation on the workshops she gives at Renew. The program helps people identify and define their personal values, and offers ways to live out those values even while managing complex responsibilities and priorities. She asked attendees for their definition of success. Among the terms she collected: balance, happiness, peace, wellness, making a difference, money, and positive feedback. Control was also mentioned.

Dr. Clever said that control is a common term among physicians. Doctors "like to control things," she said. It’s not surprising, as they really have to be obsessive-compulsive, said Dr. Clever. "Who else is going to get a second creatinine? Who else is going to take a picture of that lesion and follow it for 3 days? Who else is going to draw a circle around that erythema and look at it again in 2 hours?" she asked.

But that creates what she called a "soft underbelly." The desire for control is a vulnerability because "when we aren’t perfect, it’s very hard on us, and it’s very disturbing," said Dr. Clever.

There are some things that physicians can control. The most important thing is to live your values. Values are what someone believes is good or bad, right or wrong, and what gives meaning, fuel, and joy. Once you know your values, then you can define success, and know how you will spend your time," she said.

When physician attendees were asked to share some of their values, they mentioned honesty, integrity, humor, empathy, compassion, self-sacrifice, tolerance, service, humility, charity, sustainability, spirituality, and respect for self and others. Values should be written down, discussed out loud and shared with loved ones, advised Dr. Clever.

Physicians, like anyone striving for balance, can also control their attitudes and how they respond and cope when faced with adversity. In that vein, she said, many people have been inspired by "Man's Search for Meaning," (Boston: Beacon Press, 2006) a memoir by psychiatrist Viktor Frankl, who spent several years in Nazi concentration camps.

"Frankl wrote that the last human freedom is the freedom to choose your attitude in a given set of circumstances," said Dr. Clever. She said that physicians could adopt this philosophy and talk to their patients, or to their teenagers, about this concept. "You can choose to be a victim and you can choose to be a winner."

If you’re feeling overwhelmed, get help, advised Dr. Clever, adding, "That’s what money is for." Consider a gardener or a housekeeper or even a life coach. And, if things aren’t going well, don’t just complain. Also, give up what Dr. Clever calls "BMW": bitching, moaning, and whining.

Learn new tricks, she advised, especially if the old way isn’t working. "We have to get more comfortable with change."

"One new trick is to learn how to say ‘no,’ " Dr. Clever said. Physicians like to please and "it turns out if we’re doing too much, we can’t do anything well."

One tip for saying no gracefully is to employ what she called the "no sandwich." On the top, you thank the person for asking you. In the middle is the "no," and on the bottom, you thank the person again and say that you are honored to have been asked.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration has approved a new agent – Kcentra (Prothrombin Complex Concentrate, Human) – for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding.

Kcentra, manufactured by CSL Behring of *King of Prussia, Pa., is a nonactivated 4-factor prothrombin complex concentrate (PCC). It contains the coagulation factors that are low in warfarin-treated patients: factors II (prothrombin), VII, IX, and X. The product also contains antithrombotic proteins C and S. Fresh frozen plasma is the only FDA-approved product for reversing warfarin-induced acute bleeding. Like plasma, Kcentra is used with administration of vitamin K to reverse the anticoagulation effect and stop bleeding. Unlike plasma, Kcentra can be given quickly because it does not require thawing or determination of blood type.

"The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. "Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation."

The American College of Chest Physicians endorsed use of PCC for rapid reversal of VKA-associated bleeding in its 2012 consensus guidelines on anticoagulant therapy (CHEST 2012;141(Suppl):e152S-e184S).

"Kcentra has been shown to restore the decreased vitamin K–dependent clotting factors significantly faster than plasma in patients on warfarin," Dr. Ravi Sarode, the coordinating investigator for the pivotal Kcentra trial and director of transfusion medicine and hemostasis reference laboratory at the University of Texas Southwestern Medical Center, said in a statement issued by CSL Behring.

According to the company, 3-4 million people in the United States each year receive warfarin to prevent clots after a stroke, heart attack, heart valve surgery, or deep vein thrombosis/pulmonary embolism, or for atrial fibrillation. Severe bleeding is possible, however, because of the warfarin-induced clotting factor deficiency. CSL Behring said that some 29,000 emergency department visits annually are for warfarin-associated bleeding.

The FDA said that Kcentra will carry a boxed warning on the risk of blood clots. Patients should be monitored for signs and symptoms of thromboembolic events. "Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance," said the FDA. The warning further states that Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months, and as such might not be suitable in patients who had any of those events in the 3 months before starting therapy.

Kcentra, made from pooled plasma of healthy donors, is processed to minimize risk of transmitting viral and other diseases, the agency said. It is marketed as Beriplex or Confidex in 25 countries.

Dr. Sarode received compensation as coordinating principal investigator of the study.

aault@frontlinemedcom.com

On Twitter @aliciaault

*Clarification (5/2/13): A previous version of this story said that the manufacturer of Kcentra, CSL Behring, was based in Marburg, Germany. Kcentra will be manufactured in the Marburg facility. 

The Food and Drug Administration has approved a new agent – Kcentra (Prothrombin Complex Concentrate, Human) – for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding.

Kcentra, manufactured by CSL Behring of *King of Prussia, Pa., is a nonactivated 4-factor prothrombin complex concentrate (PCC). It contains the coagulation factors that are low in warfarin-treated patients: factors II (prothrombin), VII, IX, and X. The product also contains antithrombotic proteins C and S. Fresh frozen plasma is the only FDA-approved product for reversing warfarin-induced acute bleeding. Like plasma, Kcentra is used with administration of vitamin K to reverse the anticoagulation effect and stop bleeding. Unlike plasma, Kcentra can be given quickly because it does not require thawing or determination of blood type.

"The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. "Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation."

The American College of Chest Physicians endorsed use of PCC for rapid reversal of VKA-associated bleeding in its 2012 consensus guidelines on anticoagulant therapy (CHEST 2012;141(Suppl):e152S-e184S).

"Kcentra has been shown to restore the decreased vitamin K–dependent clotting factors significantly faster than plasma in patients on warfarin," Dr. Ravi Sarode, the coordinating investigator for the pivotal Kcentra trial and director of transfusion medicine and hemostasis reference laboratory at the University of Texas Southwestern Medical Center, said in a statement issued by CSL Behring.

According to the company, 3-4 million people in the United States each year receive warfarin to prevent clots after a stroke, heart attack, heart valve surgery, or deep vein thrombosis/pulmonary embolism, or for atrial fibrillation. Severe bleeding is possible, however, because of the warfarin-induced clotting factor deficiency. CSL Behring said that some 29,000 emergency department visits annually are for warfarin-associated bleeding.

The FDA said that Kcentra will carry a boxed warning on the risk of blood clots. Patients should be monitored for signs and symptoms of thromboembolic events. "Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance," said the FDA. The warning further states that Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months, and as such might not be suitable in patients who had any of those events in the 3 months before starting therapy.

Kcentra, made from pooled plasma of healthy donors, is processed to minimize risk of transmitting viral and other diseases, the agency said. It is marketed as Beriplex or Confidex in 25 countries.

Dr. Sarode received compensation as coordinating principal investigator of the study.

aault@frontlinemedcom.com

On Twitter @aliciaault

*Clarification (5/2/13): A previous version of this story said that the manufacturer of Kcentra, CSL Behring, was based in Marburg, Germany. Kcentra will be manufactured in the Marburg facility. 

The Food and Drug Administration has approved a new agent – Kcentra (Prothrombin Complex Concentrate, Human) – for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding.

Kcentra, manufactured by CSL Behring of *King of Prussia, Pa., is a nonactivated 4-factor prothrombin complex concentrate (PCC). It contains the coagulation factors that are low in warfarin-treated patients: factors II (prothrombin), VII, IX, and X. The product also contains antithrombotic proteins C and S. Fresh frozen plasma is the only FDA-approved product for reversing warfarin-induced acute bleeding. Like plasma, Kcentra is used with administration of vitamin K to reverse the anticoagulation effect and stop bleeding. Unlike plasma, Kcentra can be given quickly because it does not require thawing or determination of blood type.

"The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. "Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation."

The American College of Chest Physicians endorsed use of PCC for rapid reversal of VKA-associated bleeding in its 2012 consensus guidelines on anticoagulant therapy (CHEST 2012;141(Suppl):e152S-e184S).

"Kcentra has been shown to restore the decreased vitamin K–dependent clotting factors significantly faster than plasma in patients on warfarin," Dr. Ravi Sarode, the coordinating investigator for the pivotal Kcentra trial and director of transfusion medicine and hemostasis reference laboratory at the University of Texas Southwestern Medical Center, said in a statement issued by CSL Behring.

According to the company, 3-4 million people in the United States each year receive warfarin to prevent clots after a stroke, heart attack, heart valve surgery, or deep vein thrombosis/pulmonary embolism, or for atrial fibrillation. Severe bleeding is possible, however, because of the warfarin-induced clotting factor deficiency. CSL Behring said that some 29,000 emergency department visits annually are for warfarin-associated bleeding.

The FDA said that Kcentra will carry a boxed warning on the risk of blood clots. Patients should be monitored for signs and symptoms of thromboembolic events. "Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance," said the FDA. The warning further states that Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months, and as such might not be suitable in patients who had any of those events in the 3 months before starting therapy.

Kcentra, made from pooled plasma of healthy donors, is processed to minimize risk of transmitting viral and other diseases, the agency said. It is marketed as Beriplex or Confidex in 25 countries.

Dr. Sarode received compensation as coordinating principal investigator of the study.

aault@frontlinemedcom.com

On Twitter @aliciaault

*Clarification (5/2/13): A previous version of this story said that the manufacturer of Kcentra, CSL Behring, was based in Marburg, Germany. Kcentra will be manufactured in the Marburg facility. 

WASHINGTON – The American Medical Association says that it is going to spend millions of dollars over the next 5 years to help physicians and patients do a better job of preventing and managing cardiovascular disease and diabetes.

AMA President Jeremy Lazarus announced the initiative at the National Minority Quality Forum’s Health Disparities Leadership Summit here, in part, because the two conditions disproportionately affect minorities. They have a significant impact on American life. Dr. Lazarus noted that 100 million Americans have prediabetes or diabetes – that’s one-third of the U.S. population. One of every three deaths is caused by cardiovascular disease. The cost of treating diabetes and CVD runs at least $500 billion a year, said Dr. Lazarus.

"The AMA will dedicate resources, expertise and reach to reduce the significant patient suffering and cost burdens associated with these diseases," said Dr. Lazarus.

Initially, the program will focus on helping physicians and patients focus on three risk factors for CVD and diabetes: hypertension, blood glucose, and lipids. The AMA plans to spend $6 million on the initiative in the first year alone, said Dr. Lazarus, in an interview.

The AMA will continue to evaluate the program as it goes along, possibly tweaking the goals, and eventually adding other conditions, said Dr. Lazarus. And, for physicians who participate, there may be another benefit: financial rewards for putting patients on the path to better health. Dr. Lazarus noted that many accountable care organizations and insurers were providing incentives for preventing and managing chronic conditions. "The health care system is moving in this direction," he said.

In hypertension, the AMA seeks to meet or exceed the goal of the Dept. of Health and Human Services’ Million Hearts campaign. That program aims to bring 10 million more Americans under control by 2017. To do that, the AMA has enlisted the Armstrong Institute for Patient Safety and Quality at the Johns Hopkins School of Medicine. The Armstrong Institute, directed by Dr. Peter J. Pronovost, is best known for creating a program to reduce central line-associated bloodstream infections in intensive care units.

The Institute will be sending people out to meet with physicians to figure out what factors in their patient population contributes to high blood pressure, said Dr. Lazarus, in the interview. That information, in conjunction with evidence-based interventions, will be used to help physicians determine how to best help their patients. "We think [physicians] will welcome the opportunity to work with the Armstrong Institute," Dr. Lazarus said.

For diabetes, the AMA is working with the YMCA to increase referrals to the evidence-based prevention program offered by the organization. The AMA wants to have 10,000 additional participants in the program by July 2015.

"Connecting physician practices to the YMCA’s Diabetes Prevention Program will ensure that those at greatest risk have the opportunity to prevent or delay diabetes," said Jonathan Lever, vice president of health innovation and strategy, YMCA of the USA, in a statement. "This novel collaboration between medical practices and community-based programs could prove to be a model for promoting health and wellness."

At the disparities meeting, Dr. Cedric Bright, director of special programs at the University of North Carolina, Chapel Hill, said that YMCA’s are not always in communities of color, and he suggested that the AMA also work with Boys and Girls Clubs. Dr. Lazarus agreed, and said, "We’re going to be looking for all kinds of partners to get the information out."

Dr. Rodney Hood, president of the Multicultural Primary Care Medical Group, an independent practice association in San Diego said he congratulated the AMA for starting the initiative. "Dr. Lazarus, I think this is a big deal," said Dr. Hood.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – The American Medical Association says that it is going to spend millions of dollars over the next 5 years to help physicians and patients do a better job of preventing and managing cardiovascular disease and diabetes.

AMA President Jeremy Lazarus announced the initiative at the National Minority Quality Forum’s Health Disparities Leadership Summit here, in part, because the two conditions disproportionately affect minorities. They have a significant impact on American life. Dr. Lazarus noted that 100 million Americans have prediabetes or diabetes – that’s one-third of the U.S. population. One of every three deaths is caused by cardiovascular disease. The cost of treating diabetes and CVD runs at least $500 billion a year, said Dr. Lazarus.

"The AMA will dedicate resources, expertise and reach to reduce the significant patient suffering and cost burdens associated with these diseases," said Dr. Lazarus.

Initially, the program will focus on helping physicians and patients focus on three risk factors for CVD and diabetes: hypertension, blood glucose, and lipids. The AMA plans to spend $6 million on the initiative in the first year alone, said Dr. Lazarus, in an interview.

The AMA will continue to evaluate the program as it goes along, possibly tweaking the goals, and eventually adding other conditions, said Dr. Lazarus. And, for physicians who participate, there may be another benefit: financial rewards for putting patients on the path to better health. Dr. Lazarus noted that many accountable care organizations and insurers were providing incentives for preventing and managing chronic conditions. "The health care system is moving in this direction," he said.

In hypertension, the AMA seeks to meet or exceed the goal of the Dept. of Health and Human Services’ Million Hearts campaign. That program aims to bring 10 million more Americans under control by 2017. To do that, the AMA has enlisted the Armstrong Institute for Patient Safety and Quality at the Johns Hopkins School of Medicine. The Armstrong Institute, directed by Dr. Peter J. Pronovost, is best known for creating a program to reduce central line-associated bloodstream infections in intensive care units.

The Institute will be sending people out to meet with physicians to figure out what factors in their patient population contributes to high blood pressure, said Dr. Lazarus, in the interview. That information, in conjunction with evidence-based interventions, will be used to help physicians determine how to best help their patients. "We think [physicians] will welcome the opportunity to work with the Armstrong Institute," Dr. Lazarus said.

For diabetes, the AMA is working with the YMCA to increase referrals to the evidence-based prevention program offered by the organization. The AMA wants to have 10,000 additional participants in the program by July 2015.

"Connecting physician practices to the YMCA’s Diabetes Prevention Program will ensure that those at greatest risk have the opportunity to prevent or delay diabetes," said Jonathan Lever, vice president of health innovation and strategy, YMCA of the USA, in a statement. "This novel collaboration between medical practices and community-based programs could prove to be a model for promoting health and wellness."

At the disparities meeting, Dr. Cedric Bright, director of special programs at the University of North Carolina, Chapel Hill, said that YMCA’s are not always in communities of color, and he suggested that the AMA also work with Boys and Girls Clubs. Dr. Lazarus agreed, and said, "We’re going to be looking for all kinds of partners to get the information out."

Dr. Rodney Hood, president of the Multicultural Primary Care Medical Group, an independent practice association in San Diego said he congratulated the AMA for starting the initiative. "Dr. Lazarus, I think this is a big deal," said Dr. Hood.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – The American Medical Association says that it is going to spend millions of dollars over the next 5 years to help physicians and patients do a better job of preventing and managing cardiovascular disease and diabetes.

AMA President Jeremy Lazarus announced the initiative at the National Minority Quality Forum’s Health Disparities Leadership Summit here, in part, because the two conditions disproportionately affect minorities. They have a significant impact on American life. Dr. Lazarus noted that 100 million Americans have prediabetes or diabetes – that’s one-third of the U.S. population. One of every three deaths is caused by cardiovascular disease. The cost of treating diabetes and CVD runs at least $500 billion a year, said Dr. Lazarus.

"The AMA will dedicate resources, expertise and reach to reduce the significant patient suffering and cost burdens associated with these diseases," said Dr. Lazarus.

Initially, the program will focus on helping physicians and patients focus on three risk factors for CVD and diabetes: hypertension, blood glucose, and lipids. The AMA plans to spend $6 million on the initiative in the first year alone, said Dr. Lazarus, in an interview.

The AMA will continue to evaluate the program as it goes along, possibly tweaking the goals, and eventually adding other conditions, said Dr. Lazarus. And, for physicians who participate, there may be another benefit: financial rewards for putting patients on the path to better health. Dr. Lazarus noted that many accountable care organizations and insurers were providing incentives for preventing and managing chronic conditions. "The health care system is moving in this direction," he said.

In hypertension, the AMA seeks to meet or exceed the goal of the Dept. of Health and Human Services’ Million Hearts campaign. That program aims to bring 10 million more Americans under control by 2017. To do that, the AMA has enlisted the Armstrong Institute for Patient Safety and Quality at the Johns Hopkins School of Medicine. The Armstrong Institute, directed by Dr. Peter J. Pronovost, is best known for creating a program to reduce central line-associated bloodstream infections in intensive care units.

The Institute will be sending people out to meet with physicians to figure out what factors in their patient population contributes to high blood pressure, said Dr. Lazarus, in the interview. That information, in conjunction with evidence-based interventions, will be used to help physicians determine how to best help their patients. "We think [physicians] will welcome the opportunity to work with the Armstrong Institute," Dr. Lazarus said.

For diabetes, the AMA is working with the YMCA to increase referrals to the evidence-based prevention program offered by the organization. The AMA wants to have 10,000 additional participants in the program by July 2015.

"Connecting physician practices to the YMCA’s Diabetes Prevention Program will ensure that those at greatest risk have the opportunity to prevent or delay diabetes," said Jonathan Lever, vice president of health innovation and strategy, YMCA of the USA, in a statement. "This novel collaboration between medical practices and community-based programs could prove to be a model for promoting health and wellness."

At the disparities meeting, Dr. Cedric Bright, director of special programs at the University of North Carolina, Chapel Hill, said that YMCA’s are not always in communities of color, and he suggested that the AMA also work with Boys and Girls Clubs. Dr. Lazarus agreed, and said, "We’re going to be looking for all kinds of partners to get the information out."

Dr. Rodney Hood, president of the Multicultural Primary Care Medical Group, an independent practice association in San Diego said he congratulated the AMA for starting the initiative. "Dr. Lazarus, I think this is a big deal," said Dr. Hood.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – Only about 11% of health plan payments to physicians and hospitals are tied to performance or efficiency – meaning that almost 90% of payments are still fee for service, according to a report released by Catalyst for Payment Reform.

The San Francisco–based nonprofit is a collaborative of employers and health plans that advocates the overhaul of the nation’s health care payment infrastructure by encouraging more value-based payment.

Alicia Ault/IMNG Medical Media

Using data provided by commercial health plans, the group determined that 11% of hospital payments, 6% of outpatient specialist payments, and 6% of primary care physician payments are "value oriented."

Of those payment arrangements, 57% involve provider risk such as bundled payment, capitation, and shared risk payment. The remaining 43% provide incentives, such as shared savings or pay for performance.

The main goal of Catalyst for Payment Reform (CPR) is to raise the volume of value-based commercial payments to health care providers to 20% by 2020. Coalition members said that they saw reason for both pessimism and optimism in the report’s findings.

"Obviously, these results are pretty disappointing," said Dr. Robert Galvin, chief executive officer of Equity Healthcare, which buys health care coverage for private equity companies. Even so, the report itself represents "the triumph of transparency," he said at the press briefing. "It is just simply good to know."

Susan Delbanco, executive director of CPR, noted that in 2010, 1%-3% of provider payments were tied to performance. Given the latest information, "it looks to me like we are on a fast track and that we may get there before 2020,"she said.

The group’s research also found that about 2% of health plan enrollees are enrolled in an accountable care organization or a patient-centered medical home.

Most health plan payments (about 75%) are still made to specialists, while 25% go to primary care physicians, according to their analysis. Non–fee-for-service payments are still not entirely rewarding or providing incentives to improve the quality of care. Only 35% of those value-based payments have quality of care as a factor.

Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services, said that the agency was "thrilled" with the report, noting that it showed that private payers were helping encourage a transformation in payment.

"We’re not discouraged – we think that change is happening, it’s underway," Dr. Gilfillan said at the press briefing.

The growing number of physicians participating in new payment models reflects a cultural shift, said Dr. Mark Smith, president and chief executive officer of the California HealthCare Foundation. "I think we have turned the corner on providers recognizing the feasibility, the desirability, and in fact, the inevitability of the kinds of payment reforms that you’ve heard about."

The California HealthCare Foundation and the Commonwealth Fund provided the funding for the National Scorecard on Payment Reform, and a sister effort, the National Compendium on Payment Reform.

The scorecard tabulated data that 57 health plans provided to the National Business Coalition on Health. Participation is voluntary, and not all 57 plans answered all questions posed. The plans represent 104 million people in the commercial group market, or about two-thirds of the total commercially insured population in the United States. Respondents were primarily large health plans, which means the results may not necessarily reflect the entire group market.

aault@frontlinemedcom.com

WASHINGTON – Only about 11% of health plan payments to physicians and hospitals are tied to performance or efficiency – meaning that almost 90% of payments are still fee for service, according to a report released by Catalyst for Payment Reform.

The San Francisco–based nonprofit is a collaborative of employers and health plans that advocates the overhaul of the nation’s health care payment infrastructure by encouraging more value-based payment.

Alicia Ault/IMNG Medical Media

Using data provided by commercial health plans, the group determined that 11% of hospital payments, 6% of outpatient specialist payments, and 6% of primary care physician payments are "value oriented."

Of those payment arrangements, 57% involve provider risk such as bundled payment, capitation, and shared risk payment. The remaining 43% provide incentives, such as shared savings or pay for performance.

The main goal of Catalyst for Payment Reform (CPR) is to raise the volume of value-based commercial payments to health care providers to 20% by 2020. Coalition members said that they saw reason for both pessimism and optimism in the report’s findings.

"Obviously, these results are pretty disappointing," said Dr. Robert Galvin, chief executive officer of Equity Healthcare, which buys health care coverage for private equity companies. Even so, the report itself represents "the triumph of transparency," he said at the press briefing. "It is just simply good to know."

Susan Delbanco, executive director of CPR, noted that in 2010, 1%-3% of provider payments were tied to performance. Given the latest information, "it looks to me like we are on a fast track and that we may get there before 2020,"she said.

The group’s research also found that about 2% of health plan enrollees are enrolled in an accountable care organization or a patient-centered medical home.

Most health plan payments (about 75%) are still made to specialists, while 25% go to primary care physicians, according to their analysis. Non–fee-for-service payments are still not entirely rewarding or providing incentives to improve the quality of care. Only 35% of those value-based payments have quality of care as a factor.

Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services, said that the agency was "thrilled" with the report, noting that it showed that private payers were helping encourage a transformation in payment.

"We’re not discouraged – we think that change is happening, it’s underway," Dr. Gilfillan said at the press briefing.

The growing number of physicians participating in new payment models reflects a cultural shift, said Dr. Mark Smith, president and chief executive officer of the California HealthCare Foundation. "I think we have turned the corner on providers recognizing the feasibility, the desirability, and in fact, the inevitability of the kinds of payment reforms that you’ve heard about."

The California HealthCare Foundation and the Commonwealth Fund provided the funding for the National Scorecard on Payment Reform, and a sister effort, the National Compendium on Payment Reform.

The scorecard tabulated data that 57 health plans provided to the National Business Coalition on Health. Participation is voluntary, and not all 57 plans answered all questions posed. The plans represent 104 million people in the commercial group market, or about two-thirds of the total commercially insured population in the United States. Respondents were primarily large health plans, which means the results may not necessarily reflect the entire group market.

aault@frontlinemedcom.com

WASHINGTON – Only about 11% of health plan payments to physicians and hospitals are tied to performance or efficiency – meaning that almost 90% of payments are still fee for service, according to a report released by Catalyst for Payment Reform.

The San Francisco–based nonprofit is a collaborative of employers and health plans that advocates the overhaul of the nation’s health care payment infrastructure by encouraging more value-based payment.

Alicia Ault/IMNG Medical Media

Using data provided by commercial health plans, the group determined that 11% of hospital payments, 6% of outpatient specialist payments, and 6% of primary care physician payments are "value oriented."

Of those payment arrangements, 57% involve provider risk such as bundled payment, capitation, and shared risk payment. The remaining 43% provide incentives, such as shared savings or pay for performance.

The main goal of Catalyst for Payment Reform (CPR) is to raise the volume of value-based commercial payments to health care providers to 20% by 2020. Coalition members said that they saw reason for both pessimism and optimism in the report’s findings.

"Obviously, these results are pretty disappointing," said Dr. Robert Galvin, chief executive officer of Equity Healthcare, which buys health care coverage for private equity companies. Even so, the report itself represents "the triumph of transparency," he said at the press briefing. "It is just simply good to know."

Susan Delbanco, executive director of CPR, noted that in 2010, 1%-3% of provider payments were tied to performance. Given the latest information, "it looks to me like we are on a fast track and that we may get there before 2020,"she said.

The group’s research also found that about 2% of health plan enrollees are enrolled in an accountable care organization or a patient-centered medical home.

Most health plan payments (about 75%) are still made to specialists, while 25% go to primary care physicians, according to their analysis. Non–fee-for-service payments are still not entirely rewarding or providing incentives to improve the quality of care. Only 35% of those value-based payments have quality of care as a factor.

Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services, said that the agency was "thrilled" with the report, noting that it showed that private payers were helping encourage a transformation in payment.

"We’re not discouraged – we think that change is happening, it’s underway," Dr. Gilfillan said at the press briefing.

The growing number of physicians participating in new payment models reflects a cultural shift, said Dr. Mark Smith, president and chief executive officer of the California HealthCare Foundation. "I think we have turned the corner on providers recognizing the feasibility, the desirability, and in fact, the inevitability of the kinds of payment reforms that you’ve heard about."

The California HealthCare Foundation and the Commonwealth Fund provided the funding for the National Scorecard on Payment Reform, and a sister effort, the National Compendium on Payment Reform.

The scorecard tabulated data that 57 health plans provided to the National Business Coalition on Health. Participation is voluntary, and not all 57 plans answered all questions posed. The plans represent 104 million people in the commercial group market, or about two-thirds of the total commercially insured population in the United States. Respondents were primarily large health plans, which means the results may not necessarily reflect the entire group market.

aault@frontlinemedcom.com