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Alzheimer’s a winner in federal spending bill
*Article updated 12/18/14
The massive $1.1 trillion spending bill that was approved by Congress before it left for an extended recess included several provisions aimed at bolstering Alzheimer’s disease research.
The bill, signed into law by President Obama on Dec. 16, fully incorporated the Alzheimer’s Accountability Act. That bipartisan proposal requires the director of the National Institutes of Health to submit an annual budget to Congress until 2025, spelling out the amount of money needed to meet each milestone of the National Plan to Address Alzheimer’s Disease.
The Alzheimer’s Accountability Act (H.R. 4351/S. 2192) was introduced in April.
“The Alzheimer’s Association urged the introduction and passage of this Act so that Congress understands what science will bring us to the day when there will be survivors of Alzheimer’s, just as there now are for the other major diseases in our country,” said Harry Johns, president and CEO of the Alzheimer’s Association, in a statement after the spending bill’s passage.
“It facilitates a dialog between the people doing the research and the people doing the appropriations,” said Dr. Daniel C. Potts, associate clinical professor at the University of Alabama, Tuscaloosa, and a member of the American Academy of Neurology’s Government Relations Committee.
The Association said that the Accountability Act creates “a mechanism that will utilize rigorous scientific judgment, rather than shifting political interests and unforeseen events, to guide Congressional funding allocations.”
The federal spending bill, which keeps the government funded through Sept. 30, 2015, also includes a $25 million increase for Alzheimer’s research, according to the Alzheimer’s Association. The group noted that this year’s increase comes after a $122 million increase in fiscal 2014. Altogether, federal funding for Alzheimer’s research stands at $591 million.
But that is not enough, the association said. “According to leading experts, we must dramatically increase research funding to accomplish the primary goal of the National Alzheimer’s Plan to prevent and effectively treat Alzheimer’s by 2025,” Mr. Johns said.
“We’re woefully, woefully underfunding Alzheimer’s disease compared with other leading causes of morbidity and mortality in this country,” Dr. Potts agreed. But he said that the additional funding this year – and a bipartisan agreement to focus more on scientific, rather than political, priorities are a step in the right direction.
Alzheimer’s is a “sociocultural atom bomb,” said Dr. Potts, adding, “I think people are beginning to realize this.”
On Twitter @aliciaault
*Article updated 12/18/14
The massive $1.1 trillion spending bill that was approved by Congress before it left for an extended recess included several provisions aimed at bolstering Alzheimer’s disease research.
The bill, signed into law by President Obama on Dec. 16, fully incorporated the Alzheimer’s Accountability Act. That bipartisan proposal requires the director of the National Institutes of Health to submit an annual budget to Congress until 2025, spelling out the amount of money needed to meet each milestone of the National Plan to Address Alzheimer’s Disease.
The Alzheimer’s Accountability Act (H.R. 4351/S. 2192) was introduced in April.
“The Alzheimer’s Association urged the introduction and passage of this Act so that Congress understands what science will bring us to the day when there will be survivors of Alzheimer’s, just as there now are for the other major diseases in our country,” said Harry Johns, president and CEO of the Alzheimer’s Association, in a statement after the spending bill’s passage.
“It facilitates a dialog between the people doing the research and the people doing the appropriations,” said Dr. Daniel C. Potts, associate clinical professor at the University of Alabama, Tuscaloosa, and a member of the American Academy of Neurology’s Government Relations Committee.
The Association said that the Accountability Act creates “a mechanism that will utilize rigorous scientific judgment, rather than shifting political interests and unforeseen events, to guide Congressional funding allocations.”
The federal spending bill, which keeps the government funded through Sept. 30, 2015, also includes a $25 million increase for Alzheimer’s research, according to the Alzheimer’s Association. The group noted that this year’s increase comes after a $122 million increase in fiscal 2014. Altogether, federal funding for Alzheimer’s research stands at $591 million.
But that is not enough, the association said. “According to leading experts, we must dramatically increase research funding to accomplish the primary goal of the National Alzheimer’s Plan to prevent and effectively treat Alzheimer’s by 2025,” Mr. Johns said.
“We’re woefully, woefully underfunding Alzheimer’s disease compared with other leading causes of morbidity and mortality in this country,” Dr. Potts agreed. But he said that the additional funding this year – and a bipartisan agreement to focus more on scientific, rather than political, priorities are a step in the right direction.
Alzheimer’s is a “sociocultural atom bomb,” said Dr. Potts, adding, “I think people are beginning to realize this.”
On Twitter @aliciaault
*Article updated 12/18/14
The massive $1.1 trillion spending bill that was approved by Congress before it left for an extended recess included several provisions aimed at bolstering Alzheimer’s disease research.
The bill, signed into law by President Obama on Dec. 16, fully incorporated the Alzheimer’s Accountability Act. That bipartisan proposal requires the director of the National Institutes of Health to submit an annual budget to Congress until 2025, spelling out the amount of money needed to meet each milestone of the National Plan to Address Alzheimer’s Disease.
The Alzheimer’s Accountability Act (H.R. 4351/S. 2192) was introduced in April.
“The Alzheimer’s Association urged the introduction and passage of this Act so that Congress understands what science will bring us to the day when there will be survivors of Alzheimer’s, just as there now are for the other major diseases in our country,” said Harry Johns, president and CEO of the Alzheimer’s Association, in a statement after the spending bill’s passage.
“It facilitates a dialog between the people doing the research and the people doing the appropriations,” said Dr. Daniel C. Potts, associate clinical professor at the University of Alabama, Tuscaloosa, and a member of the American Academy of Neurology’s Government Relations Committee.
The Association said that the Accountability Act creates “a mechanism that will utilize rigorous scientific judgment, rather than shifting political interests and unforeseen events, to guide Congressional funding allocations.”
The federal spending bill, which keeps the government funded through Sept. 30, 2015, also includes a $25 million increase for Alzheimer’s research, according to the Alzheimer’s Association. The group noted that this year’s increase comes after a $122 million increase in fiscal 2014. Altogether, federal funding for Alzheimer’s research stands at $591 million.
But that is not enough, the association said. “According to leading experts, we must dramatically increase research funding to accomplish the primary goal of the National Alzheimer’s Plan to prevent and effectively treat Alzheimer’s by 2025,” Mr. Johns said.
“We’re woefully, woefully underfunding Alzheimer’s disease compared with other leading causes of morbidity and mortality in this country,” Dr. Potts agreed. But he said that the additional funding this year – and a bipartisan agreement to focus more on scientific, rather than political, priorities are a step in the right direction.
Alzheimer’s is a “sociocultural atom bomb,” said Dr. Potts, adding, “I think people are beginning to realize this.”
On Twitter @aliciaault
Senate confirms Murthy as Surgeon General
Boston hospitalist Dr. Vivek Murthy was confirmed Dec. 15 as the 19th U.S. Surgeon General, by a 51-43 vote of the U.S. Senate.
“Being ‘America’s doctor’ requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients,” Dr. Burke Kealey, president of the Society of Hospital Medicine, said in a statement. “Like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country.”
“As a practicing physician, Dr. Murthy brings extensive clinical expertise caring for patients and training hundreds of medical residents,” Dr. Robert L. Wergin, president of the American Academy of Family Physicians, said in a statement. “Dr. Murthy demonstrates a clear and thoughtful understanding of how important it is to transform our health care system from one focused on sick care to one based on wellness, good health practices, and early intervention.”
Dr. Murthy was nominated by President Obama in November 2013 and got fairly light treatment at a Senate confirmation hearing in February 2014. But Republican senators refused to entertain a confirmation vote for a variety of reasons, with Dr. Murthy’s advocacy on gun violence being cited most often. They also objected to his activist role in the passage of the Affordable Care Act while president of Doctors for America and his campaigning for Mr. Obama in the 2008 presidential election.
“The majority of his career has not been spent as a doctor treating patients, but as an activist,” said Sen. John Barrasso (R-Wyo.) in a speech before the confirmation vote.
But Sen. Dick Durbin (D-Ill.) called Dr. Murthy an outstanding physician and a public health expert, and noted that he had received the backing of some 100 health-related organizations earlier this year, including the American College of Physicians, the AAFP, the American Academy of Pediatrics, the American Cancer Society, the American Hospital Association, the American Diabetes Association, and many others.
Sen. Mark Kirk (Ill.) was the only Republican to vote to confirm Dr. Murthy, while three Democrats voted against him: Sen. Joe Donnelly (Ind.), Sen. Heidi Heitkamp (N.D.), and Sen. Joe Manchin (W.Va.). There were 6 abstentions.
The ACP reiterated its support for Dr. Murthy, citing a Feburary letter to two Senate committee chairmen in which college leaders called Dr. Murthy “a strong advocate for the provision of health insurance coverage to all Americans and ... a proven leader who can build coalitions among diverse individuals to ensure better health for our communities.”
The ACP statement also highlighted Dr. Murthy’s extensive public health experience, including serving on the U.S. Presidential Advisory Council on Prevention, Health Promotion, and Integrative and Public Health; cofounding VISIONS Worldwide in 1995, a nonprofit organization focused on HIV/AIDS education in India and the U.S.; and cofounding TrialNetworks, aimed at optimizing the quality and efficiency of clinical trials.
The nation has been without a confirmed surgeon general since Dr. Regina M. Benjamin retired in 2013.
On Twitter @aliciaault
Boston hospitalist Dr. Vivek Murthy was confirmed Dec. 15 as the 19th U.S. Surgeon General, by a 51-43 vote of the U.S. Senate.
“Being ‘America’s doctor’ requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients,” Dr. Burke Kealey, president of the Society of Hospital Medicine, said in a statement. “Like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country.”
“As a practicing physician, Dr. Murthy brings extensive clinical expertise caring for patients and training hundreds of medical residents,” Dr. Robert L. Wergin, president of the American Academy of Family Physicians, said in a statement. “Dr. Murthy demonstrates a clear and thoughtful understanding of how important it is to transform our health care system from one focused on sick care to one based on wellness, good health practices, and early intervention.”
Dr. Murthy was nominated by President Obama in November 2013 and got fairly light treatment at a Senate confirmation hearing in February 2014. But Republican senators refused to entertain a confirmation vote for a variety of reasons, with Dr. Murthy’s advocacy on gun violence being cited most often. They also objected to his activist role in the passage of the Affordable Care Act while president of Doctors for America and his campaigning for Mr. Obama in the 2008 presidential election.
“The majority of his career has not been spent as a doctor treating patients, but as an activist,” said Sen. John Barrasso (R-Wyo.) in a speech before the confirmation vote.
But Sen. Dick Durbin (D-Ill.) called Dr. Murthy an outstanding physician and a public health expert, and noted that he had received the backing of some 100 health-related organizations earlier this year, including the American College of Physicians, the AAFP, the American Academy of Pediatrics, the American Cancer Society, the American Hospital Association, the American Diabetes Association, and many others.
Sen. Mark Kirk (Ill.) was the only Republican to vote to confirm Dr. Murthy, while three Democrats voted against him: Sen. Joe Donnelly (Ind.), Sen. Heidi Heitkamp (N.D.), and Sen. Joe Manchin (W.Va.). There were 6 abstentions.
The ACP reiterated its support for Dr. Murthy, citing a Feburary letter to two Senate committee chairmen in which college leaders called Dr. Murthy “a strong advocate for the provision of health insurance coverage to all Americans and ... a proven leader who can build coalitions among diverse individuals to ensure better health for our communities.”
The ACP statement also highlighted Dr. Murthy’s extensive public health experience, including serving on the U.S. Presidential Advisory Council on Prevention, Health Promotion, and Integrative and Public Health; cofounding VISIONS Worldwide in 1995, a nonprofit organization focused on HIV/AIDS education in India and the U.S.; and cofounding TrialNetworks, aimed at optimizing the quality and efficiency of clinical trials.
The nation has been without a confirmed surgeon general since Dr. Regina M. Benjamin retired in 2013.
On Twitter @aliciaault
Boston hospitalist Dr. Vivek Murthy was confirmed Dec. 15 as the 19th U.S. Surgeon General, by a 51-43 vote of the U.S. Senate.
“Being ‘America’s doctor’ requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients,” Dr. Burke Kealey, president of the Society of Hospital Medicine, said in a statement. “Like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country.”
“As a practicing physician, Dr. Murthy brings extensive clinical expertise caring for patients and training hundreds of medical residents,” Dr. Robert L. Wergin, president of the American Academy of Family Physicians, said in a statement. “Dr. Murthy demonstrates a clear and thoughtful understanding of how important it is to transform our health care system from one focused on sick care to one based on wellness, good health practices, and early intervention.”
Dr. Murthy was nominated by President Obama in November 2013 and got fairly light treatment at a Senate confirmation hearing in February 2014. But Republican senators refused to entertain a confirmation vote for a variety of reasons, with Dr. Murthy’s advocacy on gun violence being cited most often. They also objected to his activist role in the passage of the Affordable Care Act while president of Doctors for America and his campaigning for Mr. Obama in the 2008 presidential election.
“The majority of his career has not been spent as a doctor treating patients, but as an activist,” said Sen. John Barrasso (R-Wyo.) in a speech before the confirmation vote.
But Sen. Dick Durbin (D-Ill.) called Dr. Murthy an outstanding physician and a public health expert, and noted that he had received the backing of some 100 health-related organizations earlier this year, including the American College of Physicians, the AAFP, the American Academy of Pediatrics, the American Cancer Society, the American Hospital Association, the American Diabetes Association, and many others.
Sen. Mark Kirk (Ill.) was the only Republican to vote to confirm Dr. Murthy, while three Democrats voted against him: Sen. Joe Donnelly (Ind.), Sen. Heidi Heitkamp (N.D.), and Sen. Joe Manchin (W.Va.). There were 6 abstentions.
The ACP reiterated its support for Dr. Murthy, citing a Feburary letter to two Senate committee chairmen in which college leaders called Dr. Murthy “a strong advocate for the provision of health insurance coverage to all Americans and ... a proven leader who can build coalitions among diverse individuals to ensure better health for our communities.”
The ACP statement also highlighted Dr. Murthy’s extensive public health experience, including serving on the U.S. Presidential Advisory Council on Prevention, Health Promotion, and Integrative and Public Health; cofounding VISIONS Worldwide in 1995, a nonprofit organization focused on HIV/AIDS education in India and the U.S.; and cofounding TrialNetworks, aimed at optimizing the quality and efficiency of clinical trials.
The nation has been without a confirmed surgeon general since Dr. Regina M. Benjamin retired in 2013.
On Twitter @aliciaault
FDA approves newborn screening test for SCID
The Food and Drug Administration has approved a screening test for severe combined immunodeficiency in newborns.
It is the first such screening test to receive FDA approval. A laboratory-developed screen has been used over the last several years.
The test approved by the FDA on Dec. 15 – the EnLite neonatal TREC kit – uses a few drops of blood taken from the newborn’s heel, which are then dried on filter paper. The kit determines whether T-cell receptor excision circles (TRECs) DNA is low or missing. According to the FDA, newborns with severe combined immunodeficiency (SCID) typically have zero or low amounts of TREC DNA. The EnLite is just a screen. Additional testing is required for a SCID diagnosis.
Severe combined immunodeficiency is extremely rare. The FDA said there are only 40-100 new cases identified in the United States each year. Babies with SCID usually develop life-threatening infections within a few months, but early detection and treatment can improve survival, the agency said.
In 2010, the secretary of the Department of Health and Human Services added SCID to the national Recommended Uniform Screening Panel for newborns.
According to the Immune Deficiency Foundation, 25 states, Washington, D.C., and the Navajo Nation currently screen for SCID, while 18 states and territories have said they will begin testing soon.
Some states require that their newborn screening program use an FDA-approved or FDA-cleared test, according to the FDA.
The newly approved test “will enable states to incorporate an FDA-reviewed SCID test into their standard newborn screening panels and allow earlier identification for affected individuals,” 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, said in a statement.
The FDA found that the EnLite test correctly identified 17 of 17 SCID cases in a study of 6,400 blood spot specimens from routine screening of newborns. The test also was able to adequately detect very low TREC DNA values that are associated with SCID, according to the agency.
The EnLite neonatal TREC kit is manufactured by Wallac Oy, a subsidiary of PerkinElmer. A PerkinElmer spokesman said the test is available immediately in the United States.
On Twitter @aliciaault
The Food and Drug Administration has approved a screening test for severe combined immunodeficiency in newborns.
It is the first such screening test to receive FDA approval. A laboratory-developed screen has been used over the last several years.
The test approved by the FDA on Dec. 15 – the EnLite neonatal TREC kit – uses a few drops of blood taken from the newborn’s heel, which are then dried on filter paper. The kit determines whether T-cell receptor excision circles (TRECs) DNA is low or missing. According to the FDA, newborns with severe combined immunodeficiency (SCID) typically have zero or low amounts of TREC DNA. The EnLite is just a screen. Additional testing is required for a SCID diagnosis.
Severe combined immunodeficiency is extremely rare. The FDA said there are only 40-100 new cases identified in the United States each year. Babies with SCID usually develop life-threatening infections within a few months, but early detection and treatment can improve survival, the agency said.
In 2010, the secretary of the Department of Health and Human Services added SCID to the national Recommended Uniform Screening Panel for newborns.
According to the Immune Deficiency Foundation, 25 states, Washington, D.C., and the Navajo Nation currently screen for SCID, while 18 states and territories have said they will begin testing soon.
Some states require that their newborn screening program use an FDA-approved or FDA-cleared test, according to the FDA.
The newly approved test “will enable states to incorporate an FDA-reviewed SCID test into their standard newborn screening panels and allow earlier identification for affected individuals,” 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, said in a statement.
The FDA found that the EnLite test correctly identified 17 of 17 SCID cases in a study of 6,400 blood spot specimens from routine screening of newborns. The test also was able to adequately detect very low TREC DNA values that are associated with SCID, according to the agency.
The EnLite neonatal TREC kit is manufactured by Wallac Oy, a subsidiary of PerkinElmer. A PerkinElmer spokesman said the test is available immediately in the United States.
On Twitter @aliciaault
The Food and Drug Administration has approved a screening test for severe combined immunodeficiency in newborns.
It is the first such screening test to receive FDA approval. A laboratory-developed screen has been used over the last several years.
The test approved by the FDA on Dec. 15 – the EnLite neonatal TREC kit – uses a few drops of blood taken from the newborn’s heel, which are then dried on filter paper. The kit determines whether T-cell receptor excision circles (TRECs) DNA is low or missing. According to the FDA, newborns with severe combined immunodeficiency (SCID) typically have zero or low amounts of TREC DNA. The EnLite is just a screen. Additional testing is required for a SCID diagnosis.
Severe combined immunodeficiency is extremely rare. The FDA said there are only 40-100 new cases identified in the United States each year. Babies with SCID usually develop life-threatening infections within a few months, but early detection and treatment can improve survival, the agency said.
In 2010, the secretary of the Department of Health and Human Services added SCID to the national Recommended Uniform Screening Panel for newborns.
According to the Immune Deficiency Foundation, 25 states, Washington, D.C., and the Navajo Nation currently screen for SCID, while 18 states and territories have said they will begin testing soon.
Some states require that their newborn screening program use an FDA-approved or FDA-cleared test, according to the FDA.
The newly approved test “will enable states to incorporate an FDA-reviewed SCID test into their standard newborn screening panels and allow earlier identification for affected individuals,” 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, said in a statement.
The FDA found that the EnLite test correctly identified 17 of 17 SCID cases in a study of 6,400 blood spot specimens from routine screening of newborns. The test also was able to adequately detect very low TREC DNA values that are associated with SCID, according to the agency.
The EnLite neonatal TREC kit is manufactured by Wallac Oy, a subsidiary of PerkinElmer. A PerkinElmer spokesman said the test is available immediately in the United States.
On Twitter @aliciaault
Congress leaves SGR, Medicaid parity, ICD-10 undone
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.
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.”
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.
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. 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.
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.”
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.
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. 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.
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.”
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.
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. 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.
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.
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.
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.
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.
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.
On Twitter @aliciaault
EHRs: Incentives spurred adoption
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.
“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.
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.
“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.
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.
“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.
On Twitter @aliciaault
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.
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.
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.
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.
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.
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.
On Twitter @aliciaault
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.
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.
AT QUALITYNET 2014
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.
“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.
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.
“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.
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.
“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.
On Twitter @aliciaault
AT QUALITYNET 2014
