Congress leaves SGR, Medicaid parity, ICD-10 undone

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The year is ending on a sour note for physicians, as Congress is recessing without addressing the Medicare Sustainable Growth Rate formula or acting on a number of other doctors’ priorities.

Congress did not extend a pay increase for primary care physicians who serve Medicaid recipients, nor did it delay the implementation of the ICD-10 code set nor enact any legislative solutions to help physicians better grapple with meaningful use of health information technology.

Alicia Ault/Frontline Medical News

Physicians held out hope until the closing days of the 113th Congress, as legislators battled over what would be put into a massive spending bill that was needed to keep the government in operation beyond Dec. 11. That $1.1 trillion bill was approved by the House just before the government was to run out of money, and by the Senate two days later.

Physicians were not able to point out much that was positive in either the spending bill or the 2014 legislative session.

“We’ve had a Congress that’s just been much more interested in fighting with each other than with constructing meaningful legislation,” Dr. R. Mack Harrell, president of the American Association of Clinical Endocrinologists, said in an interview. “For physicians that means we’re stuck with an SGR system that everyone agrees is just not good for health care and not good for patients.”

Dr. R. Mack Harrell

Many physician groups said that the failure to repeal the SGR was their biggest disappointment.

“We were cautiously optimistic that this seventeeth year of trying to repeal the SGR might have been the successful one,” Dr. Patrick T. O’Gara, president of the American College of Cardiology, said in an interview. He said that the sticking point seemed to be that “there was no politically viable way to pay for it.”

American College of Physicians President Dr. David A. Fleming noted in a statement that finding the money had hung up what otherwise was huge progress: a bill that members of the House and Senate, Republicans and Democrats had put together, and that ultimately passed the House.

Dr. Patrick T. O'Gara

The current SGR patch expires Mar. 31, 2015, giving physicians little time to convince a new Congress of the merits of replacing the formula.

Noting that there is about 37 days between when the new Congress begins in January and when a 21% pay cut goes into effect in April, American Medical Association President Robert M. Wah, said in an interview, “We’re already really up against the end of the current patch.”

Even so, physician groups say that they’ll try to start where they left off – with the bill that had gained such widespread support 2014. “We fully expect that this bill will be considered by the new 114th Congress next year, and we will redouble our efforts to get Congress to act upon it before the current patch expires on March 31,” Dr. Fleming said in the statement.

Dr. Robert Wah

Dr. O’Gara said that the ACC would take a pragmatic approach. “It would likely not be successful to mount a campaign to repeal it between January and March.”

Dr. Robert Wergin, president of the American Academy of Family Physicians, said that having a framework that already exists – and that was supported by most physicians – should help get the ball rolling more quickly in 2015.

The AAFP and other primary care physicians were also disappointed that the Medicaid pay parity provision – which puts reimbursement on par with Medicare for primary care services – was not extended. Dr. Wergin said going back to Medicaid pay rates amounts to essentially a 41% cut.

In a recent report, the Urban Institute estimated that fees increased an average 73% and that the federal government had spent an estimated $5.6 billion on the pay bump by June 2014. The institute said it’s not entirely clear whether the increase in fees has led to more access, or to an easing of pressures on physician practices. And it’s not clear how many states might choose to continue the program without federal help. According to a Kaiser Family Foundation survey published in late October, 15 states said they will continue a pay raise in 2015; 24 states said they would not, and 12 states were undecided.

Many physicians were also disappointed that legislators did not find a way to further delay ICD-10, which is scheduled to go into effect Oct. 1, 2015. Prospects for a delay next year seem slimmer now that two key House Republicans -- Rep. Fred Upton (R-Mich.) and Rep. Pete Sessions (R-Tex.) have said they won’t consider a delay. But, they said, in a joint statement, they also are willing to help physicians and others meet the deadline, and make sure that everything goes smoothly.

 

 

ICD-10 “is an important milestone in the future of health care technologies, and it is essential that we understand the state of preparedness at CMS,” they said.

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The year is ending on a sour note for physicians, as Congress is recessing without addressing the Medicare Sustainable Growth Rate formula or acting on a number of other doctors’ priorities.

Congress did not extend a pay increase for primary care physicians who serve Medicaid recipients, nor did it delay the implementation of the ICD-10 code set nor enact any legislative solutions to help physicians better grapple with meaningful use of health information technology.

Alicia Ault/Frontline Medical News

Physicians held out hope until the closing days of the 113th Congress, as legislators battled over what would be put into a massive spending bill that was needed to keep the government in operation beyond Dec. 11. That $1.1 trillion bill was approved by the House just before the government was to run out of money, and by the Senate two days later.

Physicians were not able to point out much that was positive in either the spending bill or the 2014 legislative session.

“We’ve had a Congress that’s just been much more interested in fighting with each other than with constructing meaningful legislation,” Dr. R. Mack Harrell, president of the American Association of Clinical Endocrinologists, said in an interview. “For physicians that means we’re stuck with an SGR system that everyone agrees is just not good for health care and not good for patients.”

Dr. R. Mack Harrell

Many physician groups said that the failure to repeal the SGR was their biggest disappointment.

“We were cautiously optimistic that this seventeeth year of trying to repeal the SGR might have been the successful one,” Dr. Patrick T. O’Gara, president of the American College of Cardiology, said in an interview. He said that the sticking point seemed to be that “there was no politically viable way to pay for it.”

American College of Physicians President Dr. David A. Fleming noted in a statement that finding the money had hung up what otherwise was huge progress: a bill that members of the House and Senate, Republicans and Democrats had put together, and that ultimately passed the House.

Dr. Patrick T. O'Gara

The current SGR patch expires Mar. 31, 2015, giving physicians little time to convince a new Congress of the merits of replacing the formula.

Noting that there is about 37 days between when the new Congress begins in January and when a 21% pay cut goes into effect in April, American Medical Association President Robert M. Wah, said in an interview, “We’re already really up against the end of the current patch.”

Even so, physician groups say that they’ll try to start where they left off – with the bill that had gained such widespread support 2014. “We fully expect that this bill will be considered by the new 114th Congress next year, and we will redouble our efforts to get Congress to act upon it before the current patch expires on March 31,” Dr. Fleming said in the statement.

Dr. Robert Wah

Dr. O’Gara said that the ACC would take a pragmatic approach. “It would likely not be successful to mount a campaign to repeal it between January and March.”

Dr. Robert Wergin, president of the American Academy of Family Physicians, said that having a framework that already exists – and that was supported by most physicians – should help get the ball rolling more quickly in 2015.

The AAFP and other primary care physicians were also disappointed that the Medicaid pay parity provision – which puts reimbursement on par with Medicare for primary care services – was not extended. Dr. Wergin said going back to Medicaid pay rates amounts to essentially a 41% cut.

In a recent report, the Urban Institute estimated that fees increased an average 73% and that the federal government had spent an estimated $5.6 billion on the pay bump by June 2014. The institute said it’s not entirely clear whether the increase in fees has led to more access, or to an easing of pressures on physician practices. And it’s not clear how many states might choose to continue the program without federal help. According to a Kaiser Family Foundation survey published in late October, 15 states said they will continue a pay raise in 2015; 24 states said they would not, and 12 states were undecided.

Many physicians were also disappointed that legislators did not find a way to further delay ICD-10, which is scheduled to go into effect Oct. 1, 2015. Prospects for a delay next year seem slimmer now that two key House Republicans -- Rep. Fred Upton (R-Mich.) and Rep. Pete Sessions (R-Tex.) have said they won’t consider a delay. But, they said, in a joint statement, they also are willing to help physicians and others meet the deadline, and make sure that everything goes smoothly.

 

 

ICD-10 “is an important milestone in the future of health care technologies, and it is essential that we understand the state of preparedness at CMS,” they said.

The year is ending on a sour note for physicians, as Congress is recessing without addressing the Medicare Sustainable Growth Rate formula or acting on a number of other doctors’ priorities.

Congress did not extend a pay increase for primary care physicians who serve Medicaid recipients, nor did it delay the implementation of the ICD-10 code set nor enact any legislative solutions to help physicians better grapple with meaningful use of health information technology.

Alicia Ault/Frontline Medical News

Physicians held out hope until the closing days of the 113th Congress, as legislators battled over what would be put into a massive spending bill that was needed to keep the government in operation beyond Dec. 11. That $1.1 trillion bill was approved by the House just before the government was to run out of money, and by the Senate two days later.

Physicians were not able to point out much that was positive in either the spending bill or the 2014 legislative session.

“We’ve had a Congress that’s just been much more interested in fighting with each other than with constructing meaningful legislation,” Dr. R. Mack Harrell, president of the American Association of Clinical Endocrinologists, said in an interview. “For physicians that means we’re stuck with an SGR system that everyone agrees is just not good for health care and not good for patients.”

Dr. R. Mack Harrell

Many physician groups said that the failure to repeal the SGR was their biggest disappointment.

“We were cautiously optimistic that this seventeeth year of trying to repeal the SGR might have been the successful one,” Dr. Patrick T. O’Gara, president of the American College of Cardiology, said in an interview. He said that the sticking point seemed to be that “there was no politically viable way to pay for it.”

American College of Physicians President Dr. David A. Fleming noted in a statement that finding the money had hung up what otherwise was huge progress: a bill that members of the House and Senate, Republicans and Democrats had put together, and that ultimately passed the House.

Dr. Patrick T. O'Gara

The current SGR patch expires Mar. 31, 2015, giving physicians little time to convince a new Congress of the merits of replacing the formula.

Noting that there is about 37 days between when the new Congress begins in January and when a 21% pay cut goes into effect in April, American Medical Association President Robert M. Wah, said in an interview, “We’re already really up against the end of the current patch.”

Even so, physician groups say that they’ll try to start where they left off – with the bill that had gained such widespread support 2014. “We fully expect that this bill will be considered by the new 114th Congress next year, and we will redouble our efforts to get Congress to act upon it before the current patch expires on March 31,” Dr. Fleming said in the statement.

Dr. Robert Wah

Dr. O’Gara said that the ACC would take a pragmatic approach. “It would likely not be successful to mount a campaign to repeal it between January and March.”

Dr. Robert Wergin, president of the American Academy of Family Physicians, said that having a framework that already exists – and that was supported by most physicians – should help get the ball rolling more quickly in 2015.

The AAFP and other primary care physicians were also disappointed that the Medicaid pay parity provision – which puts reimbursement on par with Medicare for primary care services – was not extended. Dr. Wergin said going back to Medicaid pay rates amounts to essentially a 41% cut.

In a recent report, the Urban Institute estimated that fees increased an average 73% and that the federal government had spent an estimated $5.6 billion on the pay bump by June 2014. The institute said it’s not entirely clear whether the increase in fees has led to more access, or to an easing of pressures on physician practices. And it’s not clear how many states might choose to continue the program without federal help. According to a Kaiser Family Foundation survey published in late October, 15 states said they will continue a pay raise in 2015; 24 states said they would not, and 12 states were undecided.

Many physicians were also disappointed that legislators did not find a way to further delay ICD-10, which is scheduled to go into effect Oct. 1, 2015. Prospects for a delay next year seem slimmer now that two key House Republicans -- Rep. Fred Upton (R-Mich.) and Rep. Pete Sessions (R-Tex.) have said they won’t consider a delay. But, they said, in a joint statement, they also are willing to help physicians and others meet the deadline, and make sure that everything goes smoothly.

 

 

ICD-10 “is an important milestone in the future of health care technologies, and it is essential that we understand the state of preparedness at CMS,” they said.

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FDA Warns of Potentially Fatal Skin Reaction With Ziprasidone

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FDA Warns of Potentially Fatal Skin Reaction With Ziprasidone

The Food and Drug Administration is warning that the atypical antipsychotic ziprasidone (Geodon) may be associated with a rare but potentially fatal skin reaction.

The agency issued the communication on Dec. 11, saying that it had reviewed six worldwide cases of the condition, known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that were associated with ziprasidone use. All six cases were reported through the FDA Adverse Event Reporting System. Symptoms began within 11-30 days after ziprasidone therapy was started. In three cases, symptoms recurred – and began more quickly – with discontinuation and reinitiation.

There were no deaths, but DRESS is potentially fatal, with a mortality rate of up to 10%, the FDA noted in a safety announcement. DRESS consists of at least three of the following symptoms: cutaneous reaction, eosinophilia, fever, and lymphadenopathy; and at least one systemic complication, such as hepatitis, nephritis, pneumonitis, myocarditis, pericarditis, and pancreatitis.

The pathogenesis of the condition is unclear, the agency said, but it added that a combination of genetic and immunologic factors are thought to be at play. The FDA said the six cases it reviewed seem to be associated with ziprasidone use because of the signs and symptoms, the temporal relationship between initiation and onset of symptoms, and the cases of positive rechallenge.

There is no specific treatment for DRESS, said the agency, adding that early recognition, quick discontinuation of the offending agent, and supportive care are all crucial to managing the condition.

The FDA said that patients should not stop taking ziprasidone or change the dose without talking with their physician, but noted that those who have a fever with a rash and/or swollen lymph glands should seek urgent medical care.

Clinicians should immediately stop treatment if DRESS is suspected. Adverse reactions involving ziprasidone should be reported to the FDA’s MedWatch program.

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The Food and Drug Administration is warning that the atypical antipsychotic ziprasidone (Geodon) may be associated with a rare but potentially fatal skin reaction.

The agency issued the communication on Dec. 11, saying that it had reviewed six worldwide cases of the condition, known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that were associated with ziprasidone use. All six cases were reported through the FDA Adverse Event Reporting System. Symptoms began within 11-30 days after ziprasidone therapy was started. In three cases, symptoms recurred – and began more quickly – with discontinuation and reinitiation.

There were no deaths, but DRESS is potentially fatal, with a mortality rate of up to 10%, the FDA noted in a safety announcement. DRESS consists of at least three of the following symptoms: cutaneous reaction, eosinophilia, fever, and lymphadenopathy; and at least one systemic complication, such as hepatitis, nephritis, pneumonitis, myocarditis, pericarditis, and pancreatitis.

The pathogenesis of the condition is unclear, the agency said, but it added that a combination of genetic and immunologic factors are thought to be at play. The FDA said the six cases it reviewed seem to be associated with ziprasidone use because of the signs and symptoms, the temporal relationship between initiation and onset of symptoms, and the cases of positive rechallenge.

There is no specific treatment for DRESS, said the agency, adding that early recognition, quick discontinuation of the offending agent, and supportive care are all crucial to managing the condition.

The FDA said that patients should not stop taking ziprasidone or change the dose without talking with their physician, but noted that those who have a fever with a rash and/or swollen lymph glands should seek urgent medical care.

Clinicians should immediately stop treatment if DRESS is suspected. Adverse reactions involving ziprasidone should be reported to the FDA’s MedWatch program.

The Food and Drug Administration is warning that the atypical antipsychotic ziprasidone (Geodon) may be associated with a rare but potentially fatal skin reaction.

The agency issued the communication on Dec. 11, saying that it had reviewed six worldwide cases of the condition, known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that were associated with ziprasidone use. All six cases were reported through the FDA Adverse Event Reporting System. Symptoms began within 11-30 days after ziprasidone therapy was started. In three cases, symptoms recurred – and began more quickly – with discontinuation and reinitiation.

There were no deaths, but DRESS is potentially fatal, with a mortality rate of up to 10%, the FDA noted in a safety announcement. DRESS consists of at least three of the following symptoms: cutaneous reaction, eosinophilia, fever, and lymphadenopathy; and at least one systemic complication, such as hepatitis, nephritis, pneumonitis, myocarditis, pericarditis, and pancreatitis.

The pathogenesis of the condition is unclear, the agency said, but it added that a combination of genetic and immunologic factors are thought to be at play. The FDA said the six cases it reviewed seem to be associated with ziprasidone use because of the signs and symptoms, the temporal relationship between initiation and onset of symptoms, and the cases of positive rechallenge.

There is no specific treatment for DRESS, said the agency, adding that early recognition, quick discontinuation of the offending agent, and supportive care are all crucial to managing the condition.

The FDA said that patients should not stop taking ziprasidone or change the dose without talking with their physician, but noted that those who have a fever with a rash and/or swollen lymph glands should seek urgent medical care.

Clinicians should immediately stop treatment if DRESS is suspected. Adverse reactions involving ziprasidone should be reported to the FDA’s MedWatch program.

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FDA warns of potentially fatal skin reaction with ziprasidone

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FDA warns of potentially fatal skin reaction with ziprasidone

The Food and Drug Administration is warning that the atypical antipsychotic ziprasidone (Geodon) may be associated with a rare but potentially fatal skin reaction.

The agency issued the communication on Dec. 11, saying that it had reviewed six worldwide cases of the condition, known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that were associated with ziprasidone use. All six cases were reported through the FDA Adverse Event Reporting System. Symptoms began within 11-30 days after ziprasidone therapy was started. In three cases, symptoms recurred – and began more quickly – with discontinuation and reinitiation.

There were no deaths, but DRESS is potentially fatal, with a mortality rate of up to 10%, the FDA noted in a safety announcement. DRESS consists of at least three of the following symptoms: cutaneous reaction, eosinophilia, fever, and lymphadenopathy; and at least one systemic complication, such as hepatitis, nephritis, pneumonitis, myocarditis, pericarditis, and pancreatitis.

The pathogenesis of the condition is unclear, the agency said, but it added that a combination of genetic and immunologic factors are thought to be at play. The FDA said the six cases it reviewed seem to be associated with ziprasidone use because of the signs and symptoms, the temporal relationship between initiation and onset of symptoms, and the cases of positive rechallenge.

There is no specific treatment for DRESS, said the agency, adding that early recognition, quick discontinuation of the offending agent, and supportive care are all crucial to managing the condition.

The FDA said that patients should not stop taking ziprasidone or change the dose without talking with their physician, but noted that those who have a fever with a rash and/or swollen lymph glands should seek urgent medical care.

Clinicians should immediately stop treatment if DRESS is suspected. Adverse reactions involving ziprasidone should be reported to the FDA’s MedWatch program.

[email protected]

On Twitter @aliciaault

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The Food and Drug Administration is warning that the atypical antipsychotic ziprasidone (Geodon) may be associated with a rare but potentially fatal skin reaction.

The agency issued the communication on Dec. 11, saying that it had reviewed six worldwide cases of the condition, known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that were associated with ziprasidone use. All six cases were reported through the FDA Adverse Event Reporting System. Symptoms began within 11-30 days after ziprasidone therapy was started. In three cases, symptoms recurred – and began more quickly – with discontinuation and reinitiation.

There were no deaths, but DRESS is potentially fatal, with a mortality rate of up to 10%, the FDA noted in a safety announcement. DRESS consists of at least three of the following symptoms: cutaneous reaction, eosinophilia, fever, and lymphadenopathy; and at least one systemic complication, such as hepatitis, nephritis, pneumonitis, myocarditis, pericarditis, and pancreatitis.

The pathogenesis of the condition is unclear, the agency said, but it added that a combination of genetic and immunologic factors are thought to be at play. The FDA said the six cases it reviewed seem to be associated with ziprasidone use because of the signs and symptoms, the temporal relationship between initiation and onset of symptoms, and the cases of positive rechallenge.

There is no specific treatment for DRESS, said the agency, adding that early recognition, quick discontinuation of the offending agent, and supportive care are all crucial to managing the condition.

The FDA said that patients should not stop taking ziprasidone or change the dose without talking with their physician, but noted that those who have a fever with a rash and/or swollen lymph glands should seek urgent medical care.

Clinicians should immediately stop treatment if DRESS is suspected. Adverse reactions involving ziprasidone should be reported to the FDA’s MedWatch program.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration is warning that the atypical antipsychotic ziprasidone (Geodon) may be associated with a rare but potentially fatal skin reaction.

The agency issued the communication on Dec. 11, saying that it had reviewed six worldwide cases of the condition, known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that were associated with ziprasidone use. All six cases were reported through the FDA Adverse Event Reporting System. Symptoms began within 11-30 days after ziprasidone therapy was started. In three cases, symptoms recurred – and began more quickly – with discontinuation and reinitiation.

There were no deaths, but DRESS is potentially fatal, with a mortality rate of up to 10%, the FDA noted in a safety announcement. DRESS consists of at least three of the following symptoms: cutaneous reaction, eosinophilia, fever, and lymphadenopathy; and at least one systemic complication, such as hepatitis, nephritis, pneumonitis, myocarditis, pericarditis, and pancreatitis.

The pathogenesis of the condition is unclear, the agency said, but it added that a combination of genetic and immunologic factors are thought to be at play. The FDA said the six cases it reviewed seem to be associated with ziprasidone use because of the signs and symptoms, the temporal relationship between initiation and onset of symptoms, and the cases of positive rechallenge.

There is no specific treatment for DRESS, said the agency, adding that early recognition, quick discontinuation of the offending agent, and supportive care are all crucial to managing the condition.

The FDA said that patients should not stop taking ziprasidone or change the dose without talking with their physician, but noted that those who have a fever with a rash and/or swollen lymph glands should seek urgent medical care.

Clinicians should immediately stop treatment if DRESS is suspected. Adverse reactions involving ziprasidone should be reported to the FDA’s MedWatch program.

[email protected]

On Twitter @aliciaault

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EHRs: Incentives spurred adoption

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Financial incentives and potential penalties were the major influencers on most physicians’ decision to adopt electronic health records, according to a new report from the Office of the National Coordinator for Health IT.

Almost two-thirds (62%) of physicians cited the incentives/penalties established by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 as the major influence for adoption of EHRs.

©Brian Jackson/iStockphoto.com

“We have seen a significant increase in the adoption and use of health IT systems among providers and the new data show the importance of incentives in building an interoperable health IT system,” Dr. Karen DeSalvo, Acting Assistant Secretary of Health and National Coordinator for Health IT, said in a statement.

Two other big factors for adoption, according to the report: Thirty-nine percent said because it was a requirement for board certification, and 37% said because trusted colleagues were using EHRs.

The vast majority of physicians (81%) said they currently were using an EHR or planned to adopt one. Doctors in large or multispecialty practices had the highest rates of adoption and the lowest numbers of those who said they would never have an EHR.

Solo practice physicians (44%) and surgical specialists (32%) were those most likely to have not adopted an EHR and to have no plans to do so.

The biggest reasons for not having an EHR were a lack of money, time, or staff, along with privacy concerns.

Of physicians who were not currently using EHRs, 51% said that incentive payments or financial penalties would be a major driver for adoption, 46% said technical assistance with adoption would be a motivator, and 44% said that having EHRs as a requirement for board certification would fuel adoption.

“It’s no surprise that incentives have helped drive adoption of health information technology,” said Dr. Robert Wergin, president of the American Academy of Family Physicians.

Dr. Wergin noted that physicians can’t pass on infrastructure costs to patients, so “incentives to help defray the cost of that infrastructure helped make health information technology adoption possible.”

The report is based on the 2011-2013 Physician Workflow Survey, a component of the National Ambulatory Medical Care Survey, conducted by the Centers for Disease Control and Prevention.

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On Twitter @aliciaault

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Financial incentives and potential penalties were the major influencers on most physicians’ decision to adopt electronic health records, according to a new report from the Office of the National Coordinator for Health IT.

Almost two-thirds (62%) of physicians cited the incentives/penalties established by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 as the major influence for adoption of EHRs.

©Brian Jackson/iStockphoto.com

“We have seen a significant increase in the adoption and use of health IT systems among providers and the new data show the importance of incentives in building an interoperable health IT system,” Dr. Karen DeSalvo, Acting Assistant Secretary of Health and National Coordinator for Health IT, said in a statement.

Two other big factors for adoption, according to the report: Thirty-nine percent said because it was a requirement for board certification, and 37% said because trusted colleagues were using EHRs.

The vast majority of physicians (81%) said they currently were using an EHR or planned to adopt one. Doctors in large or multispecialty practices had the highest rates of adoption and the lowest numbers of those who said they would never have an EHR.

Solo practice physicians (44%) and surgical specialists (32%) were those most likely to have not adopted an EHR and to have no plans to do so.

The biggest reasons for not having an EHR were a lack of money, time, or staff, along with privacy concerns.

Of physicians who were not currently using EHRs, 51% said that incentive payments or financial penalties would be a major driver for adoption, 46% said technical assistance with adoption would be a motivator, and 44% said that having EHRs as a requirement for board certification would fuel adoption.

“It’s no surprise that incentives have helped drive adoption of health information technology,” said Dr. Robert Wergin, president of the American Academy of Family Physicians.

Dr. Wergin noted that physicians can’t pass on infrastructure costs to patients, so “incentives to help defray the cost of that infrastructure helped make health information technology adoption possible.”

The report is based on the 2011-2013 Physician Workflow Survey, a component of the National Ambulatory Medical Care Survey, conducted by the Centers for Disease Control and Prevention.

[email protected]

On Twitter @aliciaault

Financial incentives and potential penalties were the major influencers on most physicians’ decision to adopt electronic health records, according to a new report from the Office of the National Coordinator for Health IT.

Almost two-thirds (62%) of physicians cited the incentives/penalties established by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 as the major influence for adoption of EHRs.

©Brian Jackson/iStockphoto.com

“We have seen a significant increase in the adoption and use of health IT systems among providers and the new data show the importance of incentives in building an interoperable health IT system,” Dr. Karen DeSalvo, Acting Assistant Secretary of Health and National Coordinator for Health IT, said in a statement.

Two other big factors for adoption, according to the report: Thirty-nine percent said because it was a requirement for board certification, and 37% said because trusted colleagues were using EHRs.

The vast majority of physicians (81%) said they currently were using an EHR or planned to adopt one. Doctors in large or multispecialty practices had the highest rates of adoption and the lowest numbers of those who said they would never have an EHR.

Solo practice physicians (44%) and surgical specialists (32%) were those most likely to have not adopted an EHR and to have no plans to do so.

The biggest reasons for not having an EHR were a lack of money, time, or staff, along with privacy concerns.

Of physicians who were not currently using EHRs, 51% said that incentive payments or financial penalties would be a major driver for adoption, 46% said technical assistance with adoption would be a motivator, and 44% said that having EHRs as a requirement for board certification would fuel adoption.

“It’s no surprise that incentives have helped drive adoption of health information technology,” said Dr. Robert Wergin, president of the American Academy of Family Physicians.

Dr. Wergin noted that physicians can’t pass on infrastructure costs to patients, so “incentives to help defray the cost of that infrastructure helped make health information technology adoption possible.”

The report is based on the 2011-2013 Physician Workflow Survey, a component of the National Ambulatory Medical Care Survey, conducted by the Centers for Disease Control and Prevention.

[email protected]

On Twitter @aliciaault

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FDA expands ruxolitinib approval to include polycythemia vera

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FDA expands ruxolitinib approval to include polycythemia vera

Ruxolitinib has been approved for the treatment of polycythemia vera in patients who have an inadequate response to hydroxyurea or are unable to tolerate that drug.

The Food and Drug Administration approved the drug, a Janus-associated kinase (JAK) inhibitor marketed as Jakafi, on Dec. 4. Ruxolitinib received a priority, expedited review at the agency.

“The approval of Jakafi for polycythemia vera underscores the importance of developing drugs matched to our increasing knowledge of the mechanisms of diseases,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Ruxolitinib “represents an important advance for patients with uncontrolled PV,” said Dr. Srdan Verstovsek, a professor in the leukemia department at the University of Texas MD Anderson Cancer Center, Houston, in a statement issued by ruxolitinib maker Incyte Corp. “For the first time, we are able to provide these patients a treatment that has been shown to provide effective and consistent control of their blood counts and reduce spleen volume.”

Polycythemia vera, a chronic disease, causes a hyperproliferation of red blood cells. Patients may also experience an increase in white blood cells and platelets, and splenomegaly, and are at higher risk for heart attack and stroke.

“The trial used to evaluate Jakafi confirmed clinically meaningful reductions in spleen size and the need for phlebotomies to control the disease,” said Dr. Pazdur.

Dr. Richard Pazdur

Ruxolitinib was first approved in 2011 for myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis, and post–essential thrombocythemia myelofibrosis.

The new indication is for polycythemia vera patients who do not respond to or cannot tolerate hydroxyurea.

The drug’s safety and effectiveness were evaluated in a study of 222 patients who received either ruxolitinib or the best available therapy, and who had the disease for at least 24 weeks, had an inadequate response to or could not tolerate hydroxyurea, had undergone a phlebotomy procedure and exhibited an enlarged spleen.

Of patients receiving ruxolitinib, 21% experienced a reduction in the need for a phlebotomy and a reduction in spleen volume by the end of the 32-week study, compared with 1% of participants who received best available therapy.

The most common side effects were anemia and thrombocytopenia, dizziness, constipation, and shingles.

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On Twitter @aliciaault

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Ruxolitinib has been approved for the treatment of polycythemia vera in patients who have an inadequate response to hydroxyurea or are unable to tolerate that drug.

The Food and Drug Administration approved the drug, a Janus-associated kinase (JAK) inhibitor marketed as Jakafi, on Dec. 4. Ruxolitinib received a priority, expedited review at the agency.

“The approval of Jakafi for polycythemia vera underscores the importance of developing drugs matched to our increasing knowledge of the mechanisms of diseases,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Ruxolitinib “represents an important advance for patients with uncontrolled PV,” said Dr. Srdan Verstovsek, a professor in the leukemia department at the University of Texas MD Anderson Cancer Center, Houston, in a statement issued by ruxolitinib maker Incyte Corp. “For the first time, we are able to provide these patients a treatment that has been shown to provide effective and consistent control of their blood counts and reduce spleen volume.”

Polycythemia vera, a chronic disease, causes a hyperproliferation of red blood cells. Patients may also experience an increase in white blood cells and platelets, and splenomegaly, and are at higher risk for heart attack and stroke.

“The trial used to evaluate Jakafi confirmed clinically meaningful reductions in spleen size and the need for phlebotomies to control the disease,” said Dr. Pazdur.

Dr. Richard Pazdur

Ruxolitinib was first approved in 2011 for myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis, and post–essential thrombocythemia myelofibrosis.

The new indication is for polycythemia vera patients who do not respond to or cannot tolerate hydroxyurea.

The drug’s safety and effectiveness were evaluated in a study of 222 patients who received either ruxolitinib or the best available therapy, and who had the disease for at least 24 weeks, had an inadequate response to or could not tolerate hydroxyurea, had undergone a phlebotomy procedure and exhibited an enlarged spleen.

Of patients receiving ruxolitinib, 21% experienced a reduction in the need for a phlebotomy and a reduction in spleen volume by the end of the 32-week study, compared with 1% of participants who received best available therapy.

The most common side effects were anemia and thrombocytopenia, dizziness, constipation, and shingles.

[email protected]

On Twitter @aliciaault

Ruxolitinib has been approved for the treatment of polycythemia vera in patients who have an inadequate response to hydroxyurea or are unable to tolerate that drug.

The Food and Drug Administration approved the drug, a Janus-associated kinase (JAK) inhibitor marketed as Jakafi, on Dec. 4. Ruxolitinib received a priority, expedited review at the agency.

“The approval of Jakafi for polycythemia vera underscores the importance of developing drugs matched to our increasing knowledge of the mechanisms of diseases,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Ruxolitinib “represents an important advance for patients with uncontrolled PV,” said Dr. Srdan Verstovsek, a professor in the leukemia department at the University of Texas MD Anderson Cancer Center, Houston, in a statement issued by ruxolitinib maker Incyte Corp. “For the first time, we are able to provide these patients a treatment that has been shown to provide effective and consistent control of their blood counts and reduce spleen volume.”

Polycythemia vera, a chronic disease, causes a hyperproliferation of red blood cells. Patients may also experience an increase in white blood cells and platelets, and splenomegaly, and are at higher risk for heart attack and stroke.

“The trial used to evaluate Jakafi confirmed clinically meaningful reductions in spleen size and the need for phlebotomies to control the disease,” said Dr. Pazdur.

Dr. Richard Pazdur

Ruxolitinib was first approved in 2011 for myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis, and post–essential thrombocythemia myelofibrosis.

The new indication is for polycythemia vera patients who do not respond to or cannot tolerate hydroxyurea.

The drug’s safety and effectiveness were evaluated in a study of 222 patients who received either ruxolitinib or the best available therapy, and who had the disease for at least 24 weeks, had an inadequate response to or could not tolerate hydroxyurea, had undergone a phlebotomy procedure and exhibited an enlarged spleen.

Of patients receiving ruxolitinib, 21% experienced a reduction in the need for a phlebotomy and a reduction in spleen volume by the end of the 32-week study, compared with 1% of participants who received best available therapy.

The most common side effects were anemia and thrombocytopenia, dizziness, constipation, and shingles.

[email protected]

On Twitter @aliciaault

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HHS: Early Data Shows 9% Drop in HACs

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HHS: Early Data Shows 9% Drop in HACs

BALTIMORE – Incidence of hospital-acquired conditions dropped 9% in 2013, preliminary federal data show.

The new report from the Agency for Health Care Research and Quality estimates that the incidence of hospital-acquired conditions (HAC) was 17% lower in 2013 than in 2010, when the Center for Medicare & Medicaid Services began more closely tracking readmissions from HACs.

The improvement seems to indicate continued progress in the effort to prevent conditions such as catheter-related infections, pressure ulcers, and drug-related adverse events, Health and Human Services Secretary Sylvia Burwell said at the CMS Healthcare Quality Conference.

“Between 2010 and 2013, we reduced hospital-acquired conditions by 1.3 million events – with much of this progress coming over the last year,” Ms. Burwell said. Her agency estimates the reduced number of adverse events and preventable conditions translates to $12 billion in savings.

Next page: Biggest impact >>

 

 

Much of the reduction came in 2013 – when there were 800,000 fewer incidents and 35,000 fewer patients died in hospitals, leading to $8 billion in savings, according to HHS.

“This is historic,” Dr. Patrick Conway, CMS deputy administrator for innovation and quality and chief medical officer said at the meeting.

The incidence of hospital-acquired infections has declined from 145 per 1,000 discharges in 2010, to 132 in 2012, to 121 in the latest data.

The biggest impact has been from a decline in pressure ulcers (21% decline) and in adverse drug events (44% decline), according to the report. The 3-year drop in pressure ulcers led to an estimated $5 billion in savings, while the decline in drug events saved the health care system almost $3 billion These two conditions also accounted for the greatest number of deaths averted over the 3 years, at 20,272 and 11,540 respectively.

“HHS will work with partners across the country to continue to build on this progress,” Secretary Burwell said.

The new report updates data for 2012 that was released in May.

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BALTIMORE – Incidence of hospital-acquired conditions dropped 9% in 2013, preliminary federal data show.

The new report from the Agency for Health Care Research and Quality estimates that the incidence of hospital-acquired conditions (HAC) was 17% lower in 2013 than in 2010, when the Center for Medicare & Medicaid Services began more closely tracking readmissions from HACs.

The improvement seems to indicate continued progress in the effort to prevent conditions such as catheter-related infections, pressure ulcers, and drug-related adverse events, Health and Human Services Secretary Sylvia Burwell said at the CMS Healthcare Quality Conference.

“Between 2010 and 2013, we reduced hospital-acquired conditions by 1.3 million events – with much of this progress coming over the last year,” Ms. Burwell said. Her agency estimates the reduced number of adverse events and preventable conditions translates to $12 billion in savings.

Next page: Biggest impact >>

 

 

Much of the reduction came in 2013 – when there were 800,000 fewer incidents and 35,000 fewer patients died in hospitals, leading to $8 billion in savings, according to HHS.

“This is historic,” Dr. Patrick Conway, CMS deputy administrator for innovation and quality and chief medical officer said at the meeting.

The incidence of hospital-acquired infections has declined from 145 per 1,000 discharges in 2010, to 132 in 2012, to 121 in the latest data.

The biggest impact has been from a decline in pressure ulcers (21% decline) and in adverse drug events (44% decline), according to the report. The 3-year drop in pressure ulcers led to an estimated $5 billion in savings, while the decline in drug events saved the health care system almost $3 billion These two conditions also accounted for the greatest number of deaths averted over the 3 years, at 20,272 and 11,540 respectively.

“HHS will work with partners across the country to continue to build on this progress,” Secretary Burwell said.

The new report updates data for 2012 that was released in May.

BALTIMORE – Incidence of hospital-acquired conditions dropped 9% in 2013, preliminary federal data show.

The new report from the Agency for Health Care Research and Quality estimates that the incidence of hospital-acquired conditions (HAC) was 17% lower in 2013 than in 2010, when the Center for Medicare & Medicaid Services began more closely tracking readmissions from HACs.

The improvement seems to indicate continued progress in the effort to prevent conditions such as catheter-related infections, pressure ulcers, and drug-related adverse events, Health and Human Services Secretary Sylvia Burwell said at the CMS Healthcare Quality Conference.

“Between 2010 and 2013, we reduced hospital-acquired conditions by 1.3 million events – with much of this progress coming over the last year,” Ms. Burwell said. Her agency estimates the reduced number of adverse events and preventable conditions translates to $12 billion in savings.

Next page: Biggest impact >>

 

 

Much of the reduction came in 2013 – when there were 800,000 fewer incidents and 35,000 fewer patients died in hospitals, leading to $8 billion in savings, according to HHS.

“This is historic,” Dr. Patrick Conway, CMS deputy administrator for innovation and quality and chief medical officer said at the meeting.

The incidence of hospital-acquired infections has declined from 145 per 1,000 discharges in 2010, to 132 in 2012, to 121 in the latest data.

The biggest impact has been from a decline in pressure ulcers (21% decline) and in adverse drug events (44% decline), according to the report. The 3-year drop in pressure ulcers led to an estimated $5 billion in savings, while the decline in drug events saved the health care system almost $3 billion These two conditions also accounted for the greatest number of deaths averted over the 3 years, at 20,272 and 11,540 respectively.

“HHS will work with partners across the country to continue to build on this progress,” Secretary Burwell said.

The new report updates data for 2012 that was released in May.

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HHS: Early data shows 9% drop in HACs

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HHS: Early data shows 9% drop in HACs

BALTIMORE – Incidence of hospital-acquired conditions dropped 9% in 2013, preliminary federal data show.

The new report from the Agency for Health Care Research and Quality estimates that the incidence of hospital-acquired conditions (HAC) was 17% lower in 2013 than in 2010, when the Center for Medicare & Medicaid Services began more closely tracking readmissions from HACs.

The improvement seems to indicate continued progress in the effort to prevent conditions such as catheter-related infections, pressure ulcers, and drug-related adverse events, Health and Human Services Secretary Sylvia Burwell said at the CMS Healthcare Quality Conference.

“Between 2010 and 2013, we reduced hospital-acquired conditions by 1.3 million events – with much of this progress coming over the last year,” Ms. Burwell said. Her agency estimates the reduced number of adverse events and preventable conditions translates to $12 billion in savings.

Much of the reduction came in 2013 – when there were 800,000 fewer incidents and 35,000 fewer patients died in hospitals, leading to $8 billion in savings, according to HHS.

Dr. Patrick Conway

“This is historic,” Dr. Patrick Conway, CMS deputy administrator for innovation and quality and chief medical officer said at the meeting.

The incidence of hospital-acquired infections has declined from 145 per 1,000 discharges in 2010, to 132 in 2012, to 121 in the latest data.

The biggest impact has been from a decline in pressure ulcers (21% decline) and in adverse drug events (44% decline), according to the report. The 3-year drop in pressure ulcers led to an estimated $5 billion in savings, while the decline in drug events saved the health care system almost $3 billion These two conditions also accounted for the greatest number of deaths averted over the 3 years, at 20,272 and 11,540 respectively.

“HHS will work with partners across the country to continue to build on this progress,” Secretary Burwell said.

The new report updates data for 2012 that was released in May.

[email protected]

On Twitter @aliciaault

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BALTIMORE – Incidence of hospital-acquired conditions dropped 9% in 2013, preliminary federal data show.

The new report from the Agency for Health Care Research and Quality estimates that the incidence of hospital-acquired conditions (HAC) was 17% lower in 2013 than in 2010, when the Center for Medicare & Medicaid Services began more closely tracking readmissions from HACs.

The improvement seems to indicate continued progress in the effort to prevent conditions such as catheter-related infections, pressure ulcers, and drug-related adverse events, Health and Human Services Secretary Sylvia Burwell said at the CMS Healthcare Quality Conference.

“Between 2010 and 2013, we reduced hospital-acquired conditions by 1.3 million events – with much of this progress coming over the last year,” Ms. Burwell said. Her agency estimates the reduced number of adverse events and preventable conditions translates to $12 billion in savings.

Much of the reduction came in 2013 – when there were 800,000 fewer incidents and 35,000 fewer patients died in hospitals, leading to $8 billion in savings, according to HHS.

Dr. Patrick Conway

“This is historic,” Dr. Patrick Conway, CMS deputy administrator for innovation and quality and chief medical officer said at the meeting.

The incidence of hospital-acquired infections has declined from 145 per 1,000 discharges in 2010, to 132 in 2012, to 121 in the latest data.

The biggest impact has been from a decline in pressure ulcers (21% decline) and in adverse drug events (44% decline), according to the report. The 3-year drop in pressure ulcers led to an estimated $5 billion in savings, while the decline in drug events saved the health care system almost $3 billion These two conditions also accounted for the greatest number of deaths averted over the 3 years, at 20,272 and 11,540 respectively.

“HHS will work with partners across the country to continue to build on this progress,” Secretary Burwell said.

The new report updates data for 2012 that was released in May.

[email protected]

On Twitter @aliciaault

BALTIMORE – Incidence of hospital-acquired conditions dropped 9% in 2013, preliminary federal data show.

The new report from the Agency for Health Care Research and Quality estimates that the incidence of hospital-acquired conditions (HAC) was 17% lower in 2013 than in 2010, when the Center for Medicare & Medicaid Services began more closely tracking readmissions from HACs.

The improvement seems to indicate continued progress in the effort to prevent conditions such as catheter-related infections, pressure ulcers, and drug-related adverse events, Health and Human Services Secretary Sylvia Burwell said at the CMS Healthcare Quality Conference.

“Between 2010 and 2013, we reduced hospital-acquired conditions by 1.3 million events – with much of this progress coming over the last year,” Ms. Burwell said. Her agency estimates the reduced number of adverse events and preventable conditions translates to $12 billion in savings.

Much of the reduction came in 2013 – when there were 800,000 fewer incidents and 35,000 fewer patients died in hospitals, leading to $8 billion in savings, according to HHS.

Dr. Patrick Conway

“This is historic,” Dr. Patrick Conway, CMS deputy administrator for innovation and quality and chief medical officer said at the meeting.

The incidence of hospital-acquired infections has declined from 145 per 1,000 discharges in 2010, to 132 in 2012, to 121 in the latest data.

The biggest impact has been from a decline in pressure ulcers (21% decline) and in adverse drug events (44% decline), according to the report. The 3-year drop in pressure ulcers led to an estimated $5 billion in savings, while the decline in drug events saved the health care system almost $3 billion These two conditions also accounted for the greatest number of deaths averted over the 3 years, at 20,272 and 11,540 respectively.

“HHS will work with partners across the country to continue to build on this progress,” Secretary Burwell said.

The new report updates data for 2012 that was released in May.

[email protected]

On Twitter @aliciaault

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FDA approves blinatumomab for Philadelphia-negative ALL

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FDA approves blinatumomab for Philadelphia-negative ALL

The Food and Drug Administration has approved blinatumomab (Blincyto) for Philadelphia chromosome–negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The approval on Dec. 3 came almost 5 months early. Blinatumomab maker Amgen applied for accelerated approval with the agency in early October, and a decision was due by May 19, 2015, according to the company.

“Recognizing the potential of this novel therapy, the FDA worked proactively with the sponsor under our breakthrough therapy designation program to facilitate the approval of this novel agent,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The National Cancer Institute estimates that 6,020 Americans will be diagnosed with ALL and 1,440 will die from the disease in 2014.

The drug is the first bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct approved by the FDA and is also the first single-agent immunotherapy to be approved for the treatment of patients with Philadelphia chromosome–negative relapsed or refractory B-cell precursor ALL, said Amgen.

The FDA based the approval on results of Amgen’s MT103-211 trial, a phase II, multicenter, single-arm, open-label study. Of the 185 patients evaluated in the trial, 42% (77 of 185) achieved complete remission or complete remission with partial hematologic recovery within two cycles of treatment. Blinatumomab was given by continuous infusion for 4 weeks of a 6-week cycle. Up to two cycles were used for induction and three cycles for consolidation.

The response was durable (with a median of 6.7 months; range, 0.46-16.5 months).

The FDA evaluated safety in 212 patients. The most common adverse reactions were pyrexia (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%), and constipation (20%).

Neurologic toxicities – including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders – were common, occurring in almost half of patients, and were a frequent reason for interruption of therapy.

There is a boxed warning on neurologic toxicities and cytokine-release syndrome, which was reported in 11% of the patients. The FDA also is requiring a Risk Evaluation and Mitigation Strategy for blinatumomab, which consists of a communication plan to inform health care providers about the serious risks and the potential for preparation and administration errors.

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On Twitter @aliciaault

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The Food and Drug Administration has approved blinatumomab (Blincyto) for Philadelphia chromosome–negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The approval on Dec. 3 came almost 5 months early. Blinatumomab maker Amgen applied for accelerated approval with the agency in early October, and a decision was due by May 19, 2015, according to the company.

“Recognizing the potential of this novel therapy, the FDA worked proactively with the sponsor under our breakthrough therapy designation program to facilitate the approval of this novel agent,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The National Cancer Institute estimates that 6,020 Americans will be diagnosed with ALL and 1,440 will die from the disease in 2014.

The drug is the first bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct approved by the FDA and is also the first single-agent immunotherapy to be approved for the treatment of patients with Philadelphia chromosome–negative relapsed or refractory B-cell precursor ALL, said Amgen.

The FDA based the approval on results of Amgen’s MT103-211 trial, a phase II, multicenter, single-arm, open-label study. Of the 185 patients evaluated in the trial, 42% (77 of 185) achieved complete remission or complete remission with partial hematologic recovery within two cycles of treatment. Blinatumomab was given by continuous infusion for 4 weeks of a 6-week cycle. Up to two cycles were used for induction and three cycles for consolidation.

The response was durable (with a median of 6.7 months; range, 0.46-16.5 months).

The FDA evaluated safety in 212 patients. The most common adverse reactions were pyrexia (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%), and constipation (20%).

Neurologic toxicities – including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders – were common, occurring in almost half of patients, and were a frequent reason for interruption of therapy.

There is a boxed warning on neurologic toxicities and cytokine-release syndrome, which was reported in 11% of the patients. The FDA also is requiring a Risk Evaluation and Mitigation Strategy for blinatumomab, which consists of a communication plan to inform health care providers about the serious risks and the potential for preparation and administration errors.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved blinatumomab (Blincyto) for Philadelphia chromosome–negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The approval on Dec. 3 came almost 5 months early. Blinatumomab maker Amgen applied for accelerated approval with the agency in early October, and a decision was due by May 19, 2015, according to the company.

“Recognizing the potential of this novel therapy, the FDA worked proactively with the sponsor under our breakthrough therapy designation program to facilitate the approval of this novel agent,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The National Cancer Institute estimates that 6,020 Americans will be diagnosed with ALL and 1,440 will die from the disease in 2014.

The drug is the first bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct approved by the FDA and is also the first single-agent immunotherapy to be approved for the treatment of patients with Philadelphia chromosome–negative relapsed or refractory B-cell precursor ALL, said Amgen.

The FDA based the approval on results of Amgen’s MT103-211 trial, a phase II, multicenter, single-arm, open-label study. Of the 185 patients evaluated in the trial, 42% (77 of 185) achieved complete remission or complete remission with partial hematologic recovery within two cycles of treatment. Blinatumomab was given by continuous infusion for 4 weeks of a 6-week cycle. Up to two cycles were used for induction and three cycles for consolidation.

The response was durable (with a median of 6.7 months; range, 0.46-16.5 months).

The FDA evaluated safety in 212 patients. The most common adverse reactions were pyrexia (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%), and constipation (20%).

Neurologic toxicities – including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders – were common, occurring in almost half of patients, and were a frequent reason for interruption of therapy.

There is a boxed warning on neurologic toxicities and cytokine-release syndrome, which was reported in 11% of the patients. The FDA also is requiring a Risk Evaluation and Mitigation Strategy for blinatumomab, which consists of a communication plan to inform health care providers about the serious risks and the potential for preparation and administration errors.

[email protected]

On Twitter @aliciaault

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Spending on physician services shrunk again in 2013

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WASHINGTON– Health spending in 2013 grew at the slowest rate since the federal government began keeping track in 1960, in part because of lower spending by both Medicare and private health insurance plans, especially on physician services.

The lingering effects of the 2009 recession played a role, and the Affordable Care Act had a negligible impact, adding to spending in some categories, and reducing it in others, according to economists with the Centers for Medicare & Medicaid Services. Their findings were published Dec. 3 in the journal Health Affairs (doi:10.1377/hlthaff.2014.1107).

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Overall spending grew 3.6% in 2013, slower than the 4.1% it grew in 2012.

Overall spending grew 3.6% in 2013, slower than the 4.1% it grew in 2012, Micah Hartman of the Office of the Actuary at CMS, said in a briefing with reporters. The nation’s health bill totaled $2.9 trillion in 2013, or about 17% of the gross domestic product.

Medicare spent $586 billion in 2013, accounting for 20% of the nation’s health tab. Expenditures by that program rose only 3.4%, compared with 4% in 2012, in part because of clampdowns on spending for fee for service. Medicare, along with most payers, spent less on both hospital and physician services in 2013.

The program’s physician spending was restrained by a 2% across-the-board cut mandated by sequestration, and a 0% increase in the Sustainable Growth Rate formula. Prices for physician services also had little impact, rising by just 0.1%, Mr. Hartman said.

Use and intensity of physician and hospital services across the health care system had rebounded a bit in 2012 from their recession-related lows, but shrunk again in 2013, the CMS economists reported.

But Medicaid spending on physician services grew by10% in 2013, compared with just under 3% growth in 2012. That was because of the temporary increase in Medicaid reimbursement to primary care physicians that was established by the ACA. That pay bump expires on Dec. 31.

Medicaid spending, which makes up 15% of the nation’s health bill, hit $450 billion in 2013, a 6% increase from the previous year. That continued an upward trend, as did enrollment, which grew by almost 3%, compared with just under 2% the year before. Enrollment is expected to sharply spike in 2014, when the ACA is more fully in effect, said David Lassman of the CMS Office of the Actuary.

Private insurers still account for the largest portion of America’s health budget, paying a third of the tab. They, too, spent less on physician services in 2013. Spending was also reined in by lower premiums and ACA provisions that kept a lid on rate increases.

The CMS economists noted that private insurers have been successful in shifting more consumers into high-deductible health plans, which may in turn be having a dampening effect on their use of health care. “Consumers enrolled in high-deductible plans tend to use services at a lower rate than those enrolled in plans with lower or no cost sharing,” they wrote.

As to the effects of the ACA, the economists said that the law helped reduce spending through productivity adjustments to Medicare fee-for-service payments, reduced Medicare Advantage payments, and increased prescription drug rebates for Medicaid. But it also raised costs through Medicaid expansion, increased Medicaid payments for primary care, and subsidized prescription drugs under Medicare Part D.

“The key question is whether health spending growth will accelerate once economic conditions improve significantly,” Mr. Hartman said in a statement. “Historical evidence suggests it will.”

The report updates the economists’ spending projections for 2013, which were issued in September.

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WASHINGTON– Health spending in 2013 grew at the slowest rate since the federal government began keeping track in 1960, in part because of lower spending by both Medicare and private health insurance plans, especially on physician services.

The lingering effects of the 2009 recession played a role, and the Affordable Care Act had a negligible impact, adding to spending in some categories, and reducing it in others, according to economists with the Centers for Medicare & Medicaid Services. Their findings were published Dec. 3 in the journal Health Affairs (doi:10.1377/hlthaff.2014.1107).

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Overall spending grew 3.6% in 2013, slower than the 4.1% it grew in 2012.

Overall spending grew 3.6% in 2013, slower than the 4.1% it grew in 2012, Micah Hartman of the Office of the Actuary at CMS, said in a briefing with reporters. The nation’s health bill totaled $2.9 trillion in 2013, or about 17% of the gross domestic product.

Medicare spent $586 billion in 2013, accounting for 20% of the nation’s health tab. Expenditures by that program rose only 3.4%, compared with 4% in 2012, in part because of clampdowns on spending for fee for service. Medicare, along with most payers, spent less on both hospital and physician services in 2013.

The program’s physician spending was restrained by a 2% across-the-board cut mandated by sequestration, and a 0% increase in the Sustainable Growth Rate formula. Prices for physician services also had little impact, rising by just 0.1%, Mr. Hartman said.

Use and intensity of physician and hospital services across the health care system had rebounded a bit in 2012 from their recession-related lows, but shrunk again in 2013, the CMS economists reported.

But Medicaid spending on physician services grew by10% in 2013, compared with just under 3% growth in 2012. That was because of the temporary increase in Medicaid reimbursement to primary care physicians that was established by the ACA. That pay bump expires on Dec. 31.

Medicaid spending, which makes up 15% of the nation’s health bill, hit $450 billion in 2013, a 6% increase from the previous year. That continued an upward trend, as did enrollment, which grew by almost 3%, compared with just under 2% the year before. Enrollment is expected to sharply spike in 2014, when the ACA is more fully in effect, said David Lassman of the CMS Office of the Actuary.

Private insurers still account for the largest portion of America’s health budget, paying a third of the tab. They, too, spent less on physician services in 2013. Spending was also reined in by lower premiums and ACA provisions that kept a lid on rate increases.

The CMS economists noted that private insurers have been successful in shifting more consumers into high-deductible health plans, which may in turn be having a dampening effect on their use of health care. “Consumers enrolled in high-deductible plans tend to use services at a lower rate than those enrolled in plans with lower or no cost sharing,” they wrote.

As to the effects of the ACA, the economists said that the law helped reduce spending through productivity adjustments to Medicare fee-for-service payments, reduced Medicare Advantage payments, and increased prescription drug rebates for Medicaid. But it also raised costs through Medicaid expansion, increased Medicaid payments for primary care, and subsidized prescription drugs under Medicare Part D.

“The key question is whether health spending growth will accelerate once economic conditions improve significantly,” Mr. Hartman said in a statement. “Historical evidence suggests it will.”

The report updates the economists’ spending projections for 2013, which were issued in September.

[email protected]

On Twitter @aliciaault

WASHINGTON– Health spending in 2013 grew at the slowest rate since the federal government began keeping track in 1960, in part because of lower spending by both Medicare and private health insurance plans, especially on physician services.

The lingering effects of the 2009 recession played a role, and the Affordable Care Act had a negligible impact, adding to spending in some categories, and reducing it in others, according to economists with the Centers for Medicare & Medicaid Services. Their findings were published Dec. 3 in the journal Health Affairs (doi:10.1377/hlthaff.2014.1107).

thinkstockphotos.com
Overall spending grew 3.6% in 2013, slower than the 4.1% it grew in 2012.

Overall spending grew 3.6% in 2013, slower than the 4.1% it grew in 2012, Micah Hartman of the Office of the Actuary at CMS, said in a briefing with reporters. The nation’s health bill totaled $2.9 trillion in 2013, or about 17% of the gross domestic product.

Medicare spent $586 billion in 2013, accounting for 20% of the nation’s health tab. Expenditures by that program rose only 3.4%, compared with 4% in 2012, in part because of clampdowns on spending for fee for service. Medicare, along with most payers, spent less on both hospital and physician services in 2013.

The program’s physician spending was restrained by a 2% across-the-board cut mandated by sequestration, and a 0% increase in the Sustainable Growth Rate formula. Prices for physician services also had little impact, rising by just 0.1%, Mr. Hartman said.

Use and intensity of physician and hospital services across the health care system had rebounded a bit in 2012 from their recession-related lows, but shrunk again in 2013, the CMS economists reported.

But Medicaid spending on physician services grew by10% in 2013, compared with just under 3% growth in 2012. That was because of the temporary increase in Medicaid reimbursement to primary care physicians that was established by the ACA. That pay bump expires on Dec. 31.

Medicaid spending, which makes up 15% of the nation’s health bill, hit $450 billion in 2013, a 6% increase from the previous year. That continued an upward trend, as did enrollment, which grew by almost 3%, compared with just under 2% the year before. Enrollment is expected to sharply spike in 2014, when the ACA is more fully in effect, said David Lassman of the CMS Office of the Actuary.

Private insurers still account for the largest portion of America’s health budget, paying a third of the tab. They, too, spent less on physician services in 2013. Spending was also reined in by lower premiums and ACA provisions that kept a lid on rate increases.

The CMS economists noted that private insurers have been successful in shifting more consumers into high-deductible health plans, which may in turn be having a dampening effect on their use of health care. “Consumers enrolled in high-deductible plans tend to use services at a lower rate than those enrolled in plans with lower or no cost sharing,” they wrote.

As to the effects of the ACA, the economists said that the law helped reduce spending through productivity adjustments to Medicare fee-for-service payments, reduced Medicare Advantage payments, and increased prescription drug rebates for Medicaid. But it also raised costs through Medicaid expansion, increased Medicaid payments for primary care, and subsidized prescription drugs under Medicare Part D.

“The key question is whether health spending growth will accelerate once economic conditions improve significantly,” Mr. Hartman said in a statement. “Historical evidence suggests it will.”

The report updates the economists’ spending projections for 2013, which were issued in September.

[email protected]

On Twitter @aliciaault

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New Law Will Speed Sunscreen Ingredient Approval

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New Law Will Speed Sunscreen Ingredient Approval

President Obama has signed into law a bill that requires speedier review of sunscreen ingredients.

The Sunscreen Innovation Act garnered support from Democrats and Republicans in the House and Senate, and from manufacturers and dermatologists as well. The House and Senate reconciled their two proposals – S. 2141 and H.R. 4250 – in mid-November, and the final bill was signed by the president on Nov. 26.

The law sets strict timetables for Food and Drug Administration action. The bill was prompted by a huge backlog of ingredients that have been awaiting review at the agency.

According to the PASS Coalition, the last new over-the-counter sunscreen ingredient was approved in the 1990s. Manufacturers have sought approval for eight new ingredients since 2002, but none has been acted on, according to PASS, an advocacy group made up of manufacturers, physicians, and organizations including the American Cancer Society Cancer Action Network, the American College of Mohs Surgery, and the Melanoma International Foundation.

The approval by Congress of the new law “signals the urgent public health need to make more effective products available to consumers, as skin cancer rates continue to rise at an alarming pace,” American Academy of Dermatology President Brett M. Coldiron said in a statement issued in mid-November. “The AADA looks forward to working closely with the FDA to implement the new law, and will be providing comments on its implementation,” said Dr. Coldiron.

Rep. Ed Whitfield (R-Ky.), a coauthor of the original House bill, said that it had been too long since the approval of a new sunscreen ingredient. “With the president’s signature, Americans will finally be able to begin purchasing products that take advantage of improved research,” said Rep. Whitfield, in a statement.

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President Obama has signed into law a bill that requires speedier review of sunscreen ingredients.

The Sunscreen Innovation Act garnered support from Democrats and Republicans in the House and Senate, and from manufacturers and dermatologists as well. The House and Senate reconciled their two proposals – S. 2141 and H.R. 4250 – in mid-November, and the final bill was signed by the president on Nov. 26.

The law sets strict timetables for Food and Drug Administration action. The bill was prompted by a huge backlog of ingredients that have been awaiting review at the agency.

According to the PASS Coalition, the last new over-the-counter sunscreen ingredient was approved in the 1990s. Manufacturers have sought approval for eight new ingredients since 2002, but none has been acted on, according to PASS, an advocacy group made up of manufacturers, physicians, and organizations including the American Cancer Society Cancer Action Network, the American College of Mohs Surgery, and the Melanoma International Foundation.

The approval by Congress of the new law “signals the urgent public health need to make more effective products available to consumers, as skin cancer rates continue to rise at an alarming pace,” American Academy of Dermatology President Brett M. Coldiron said in a statement issued in mid-November. “The AADA looks forward to working closely with the FDA to implement the new law, and will be providing comments on its implementation,” said Dr. Coldiron.

Rep. Ed Whitfield (R-Ky.), a coauthor of the original House bill, said that it had been too long since the approval of a new sunscreen ingredient. “With the president’s signature, Americans will finally be able to begin purchasing products that take advantage of improved research,” said Rep. Whitfield, in a statement.

President Obama has signed into law a bill that requires speedier review of sunscreen ingredients.

The Sunscreen Innovation Act garnered support from Democrats and Republicans in the House and Senate, and from manufacturers and dermatologists as well. The House and Senate reconciled their two proposals – S. 2141 and H.R. 4250 – in mid-November, and the final bill was signed by the president on Nov. 26.

The law sets strict timetables for Food and Drug Administration action. The bill was prompted by a huge backlog of ingredients that have been awaiting review at the agency.

According to the PASS Coalition, the last new over-the-counter sunscreen ingredient was approved in the 1990s. Manufacturers have sought approval for eight new ingredients since 2002, but none has been acted on, according to PASS, an advocacy group made up of manufacturers, physicians, and organizations including the American Cancer Society Cancer Action Network, the American College of Mohs Surgery, and the Melanoma International Foundation.

The approval by Congress of the new law “signals the urgent public health need to make more effective products available to consumers, as skin cancer rates continue to rise at an alarming pace,” American Academy of Dermatology President Brett M. Coldiron said in a statement issued in mid-November. “The AADA looks forward to working closely with the FDA to implement the new law, and will be providing comments on its implementation,” said Dr. Coldiron.

Rep. Ed Whitfield (R-Ky.), a coauthor of the original House bill, said that it had been too long since the approval of a new sunscreen ingredient. “With the president’s signature, Americans will finally be able to begin purchasing products that take advantage of improved research,” said Rep. Whitfield, in a statement.

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New Law Will Speed Sunscreen Ingredient Approval
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New Law Will Speed Sunscreen Ingredient Approval
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