Government and Regulations

The federal government publicly released the first data about drug and device industry payments to physicians and hospitals, part of a push toward greater transparency that was mandated under the Affordable Care Act.

On Sept. 30, the Centers for Medicare & Medicaid Services published 4.4 million records of payments to about 546,000 individual physicians and nearly 1,360 teaching hospitals. In total, the records represent $3.5 billion in financial transactions between industry and health care providers.

The Open Payments program, known previously as the Sunshine Act, requires medical device manufacturers and pharmaceutical companies to report payments and transfers of value to physicians and teaching hospitals, including consulting fees, research grants, travel reimbursements, ownership interests, and other gifts.

The data released on Sept. 30 cover only payments made from August through December 2013. Data on payments made in 2014 are slated to be published in June 2015.

“We are taking a big step forward in shining the light on these financial arrangements between physicians and the health care industry,” said Dr. Shantanu Agrawal, director of the CMS Center for Program Integrity. “Using [these] new data, it is now possible to conduct a wide range of analyses of payments made by drug and device manufacturers that were never possible before.”

But the program has been plagued by delays and technical problems. CMS had to extend multiple times the 45-day “review and dispute” period, during which physicians could check the accuracy of data reported about them. It took the agency days to correct technical problems that had caused data to be intermingled, matching the wrong records to physicians with similar names.

Of the 4.4 million records released on Sept. 30, about 40% had to be deidentified either because of data inconsistencies that kept CMS from being able to match them to an individual physician or teaching hospital, or because the data were not available for review for the full 45-day period. CMS expects the data to be fully identified in 2015 once the manufacturers submit corrected information.

Another 199,000 records that were reported to the agency were not published at all, according to CMS. The vast majority of those records were unpublished at the request of the industry, since they related to ongoing research of unapproved treatments. About 9,000 records were not published because they are under active dispute, according to Dr. Agrawal.

While physicians and the industry have been generally supportive of CMS’s move toward greater openness about payments, there has been plenty of criticism of the implementation of the Open Payments program. The American Medical Association has said repeatedly that physicians have not had enough time to review the accuracy of the payments and that CMS is not providing adequate context about what the payments actually say about physician-industry relationships.

“Publicly reporting industry payments to individual physicians can imply, wrongly, that such payments are always inappropriate,” the AMA wrote in a guide for reporters covering the release of Open Payments data. “Some may be, but to be able to make an informed judgment, it is vital to be able to set the financial information in context. Just because a physician has a relationship with industry does not automatically mean that his or her professional judgment has been influenced inappropriately.”

The AMA also said that the process of registering and later reviewing payments was confusing and overly cumbersome for physicians. Only about 26,000 physicians and 400 teaching hospitals registered in the Open Payments system to review their data, according to CMS.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

The federal government publicly released the first data about drug and device industry payments to physicians and hospitals, part of a push toward greater transparency that was mandated under the Affordable Care Act.

On Sept. 30, the Centers for Medicare & Medicaid Services published 4.4 million records of payments to about 546,000 individual physicians and nearly 1,360 teaching hospitals. In total, the records represent $3.5 billion in financial transactions between industry and health care providers.

The Open Payments program, known previously as the Sunshine Act, requires medical device manufacturers and pharmaceutical companies to report payments and transfers of value to physicians and teaching hospitals, including consulting fees, research grants, travel reimbursements, ownership interests, and other gifts.

The data released on Sept. 30 cover only payments made from August through December 2013. Data on payments made in 2014 are slated to be published in June 2015.

“We are taking a big step forward in shining the light on these financial arrangements between physicians and the health care industry,” said Dr. Shantanu Agrawal, director of the CMS Center for Program Integrity. “Using [these] new data, it is now possible to conduct a wide range of analyses of payments made by drug and device manufacturers that were never possible before.”

But the program has been plagued by delays and technical problems. CMS had to extend multiple times the 45-day “review and dispute” period, during which physicians could check the accuracy of data reported about them. It took the agency days to correct technical problems that had caused data to be intermingled, matching the wrong records to physicians with similar names.

Of the 4.4 million records released on Sept. 30, about 40% had to be deidentified either because of data inconsistencies that kept CMS from being able to match them to an individual physician or teaching hospital, or because the data were not available for review for the full 45-day period. CMS expects the data to be fully identified in 2015 once the manufacturers submit corrected information.

Another 199,000 records that were reported to the agency were not published at all, according to CMS. The vast majority of those records were unpublished at the request of the industry, since they related to ongoing research of unapproved treatments. About 9,000 records were not published because they are under active dispute, according to Dr. Agrawal.

While physicians and the industry have been generally supportive of CMS’s move toward greater openness about payments, there has been plenty of criticism of the implementation of the Open Payments program. The American Medical Association has said repeatedly that physicians have not had enough time to review the accuracy of the payments and that CMS is not providing adequate context about what the payments actually say about physician-industry relationships.

“Publicly reporting industry payments to individual physicians can imply, wrongly, that such payments are always inappropriate,” the AMA wrote in a guide for reporters covering the release of Open Payments data. “Some may be, but to be able to make an informed judgment, it is vital to be able to set the financial information in context. Just because a physician has a relationship with industry does not automatically mean that his or her professional judgment has been influenced inappropriately.”

The AMA also said that the process of registering and later reviewing payments was confusing and overly cumbersome for physicians. Only about 26,000 physicians and 400 teaching hospitals registered in the Open Payments system to review their data, according to CMS.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

The federal government publicly released the first data about drug and device industry payments to physicians and hospitals, part of a push toward greater transparency that was mandated under the Affordable Care Act.

On Sept. 30, the Centers for Medicare & Medicaid Services published 4.4 million records of payments to about 546,000 individual physicians and nearly 1,360 teaching hospitals. In total, the records represent $3.5 billion in financial transactions between industry and health care providers.

The Open Payments program, known previously as the Sunshine Act, requires medical device manufacturers and pharmaceutical companies to report payments and transfers of value to physicians and teaching hospitals, including consulting fees, research grants, travel reimbursements, ownership interests, and other gifts.

The data released on Sept. 30 cover only payments made from August through December 2013. Data on payments made in 2014 are slated to be published in June 2015.

“We are taking a big step forward in shining the light on these financial arrangements between physicians and the health care industry,” said Dr. Shantanu Agrawal, director of the CMS Center for Program Integrity. “Using [these] new data, it is now possible to conduct a wide range of analyses of payments made by drug and device manufacturers that were never possible before.”

But the program has been plagued by delays and technical problems. CMS had to extend multiple times the 45-day “review and dispute” period, during which physicians could check the accuracy of data reported about them. It took the agency days to correct technical problems that had caused data to be intermingled, matching the wrong records to physicians with similar names.

Of the 4.4 million records released on Sept. 30, about 40% had to be deidentified either because of data inconsistencies that kept CMS from being able to match them to an individual physician or teaching hospital, or because the data were not available for review for the full 45-day period. CMS expects the data to be fully identified in 2015 once the manufacturers submit corrected information.

Another 199,000 records that were reported to the agency were not published at all, according to CMS. The vast majority of those records were unpublished at the request of the industry, since they related to ongoing research of unapproved treatments. About 9,000 records were not published because they are under active dispute, according to Dr. Agrawal.

While physicians and the industry have been generally supportive of CMS’s move toward greater openness about payments, there has been plenty of criticism of the implementation of the Open Payments program. The American Medical Association has said repeatedly that physicians have not had enough time to review the accuracy of the payments and that CMS is not providing adequate context about what the payments actually say about physician-industry relationships.

“Publicly reporting industry payments to individual physicians can imply, wrongly, that such payments are always inappropriate,” the AMA wrote in a guide for reporters covering the release of Open Payments data. “Some may be, but to be able to make an informed judgment, it is vital to be able to set the financial information in context. Just because a physician has a relationship with industry does not automatically mean that his or her professional judgment has been influenced inappropriately.”

The AMA also said that the process of registering and later reviewing payments was confusing and overly cumbersome for physicians. Only about 26,000 physicians and 400 teaching hospitals registered in the Open Payments system to review their data, according to CMS.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

Acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter have been noted in several children who tested positive for enterovirus D68 infections, which have been spreading rapidly across the nation.

Federal health officials are urging that cases be reported to state and local health departments. The Centers for Disease Control and Prevention issued the alert on Sept. 26th in response to an ongoing investigation in Colorado involving a cluster of nine children who have been hospitalized with acute neurologic illness. A 10th case was added to the cluster on Monday, Sept. 29, according to the Colorado Department of Public Health & Environment.

Four of the children have tested positive for the virus and test results are pending in two other cases. Most cases had a febrile respiratory illness in the 2 weeks before they developed neurologic symptoms.

EV-D68, which has been historically rare, is a non–polio enterovirus causing mild to severe respiratory illness. Since initial reports in mid-August, more than 440 cases of EV-D68 have been confirmed in 40 states and the District of Columbia. The numbers are likely to increase as states process the backlog of specimens, according to the CDC. “As the scale of this year’s EV-D68 outbreak is much larger in comparison to the past, we will likely see rare complications of this infection, such as paralysis,” Dr. Jana Shaw, an infectious disease specialist at Upstate Golisano Children’s Hospital in Syracuse, N.Y., wrote in an e-mail. “In our experience, many patients with respiratory illness had uneventful hospitalizations and completely recovered. Hence, the frequency of paralysis with EV-D68 remains to be seen.”

The Colorado pediatric cases were identified between Aug. 9 and Sept. 17 this year among children aged 1-18 years old, with a median age of 10 years. All were hospitalized. Eight of the nine children are up to date with their polio vaccinations.

Most patients presented with acute focal limb weakness and their MRIs showed nonenhancing lesions that were largely restricted to the gray matter and spanned more than the level of the spinal cord in most cases. Some patients also had acute cranial nerve dysfunction with correlating nonenhancing brainstem lesions on MRI. There were no cases of altered mental status or seizure, nor any cortical, subcortical, basal ganglia, or thalamic lesions on MRI, according to the CDC report.

CDC is prioritizing testing of specimens from children with severe respiratory illness, according to its website.

Nearly half of the specimens tested for EV-D68 at the CDC have tested positive and about one-third have tested positive for an enterovirus or rhinovirus other than EV-D68, according to the agency.

“Not much is known about the spectrum and the severity of the disease [EV-D68] can cause,” Dr. Shaw said. “Recent reports of polio-like illness among children alert us to include EV-D68 virus in a differential diagnosis when evaluating a pediatric patient with acute focal limb weakness and prior respiratory illness. The current nationwide outbreak of EV-D68 gives us an opportunity to learn more about this virus, its epidemiology, and the etiology of recent polio-like illness reported in Colorado.”

In a recent commentary in JAMA Pediatrics, Dr. Shaw wrote that “rapid detection and media collaboration are crucial in limiting the effect of an outbreak in a community.”

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

Acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter have been noted in several children who tested positive for enterovirus D68 infections, which have been spreading rapidly across the nation.

Federal health officials are urging that cases be reported to state and local health departments. The Centers for Disease Control and Prevention issued the alert on Sept. 26th in response to an ongoing investigation in Colorado involving a cluster of nine children who have been hospitalized with acute neurologic illness. A 10th case was added to the cluster on Monday, Sept. 29, according to the Colorado Department of Public Health & Environment.

Four of the children have tested positive for the virus and test results are pending in two other cases. Most cases had a febrile respiratory illness in the 2 weeks before they developed neurologic symptoms.

EV-D68, which has been historically rare, is a non–polio enterovirus causing mild to severe respiratory illness. Since initial reports in mid-August, more than 440 cases of EV-D68 have been confirmed in 40 states and the District of Columbia. The numbers are likely to increase as states process the backlog of specimens, according to the CDC. “As the scale of this year’s EV-D68 outbreak is much larger in comparison to the past, we will likely see rare complications of this infection, such as paralysis,” Dr. Jana Shaw, an infectious disease specialist at Upstate Golisano Children’s Hospital in Syracuse, N.Y., wrote in an e-mail. “In our experience, many patients with respiratory illness had uneventful hospitalizations and completely recovered. Hence, the frequency of paralysis with EV-D68 remains to be seen.”

The Colorado pediatric cases were identified between Aug. 9 and Sept. 17 this year among children aged 1-18 years old, with a median age of 10 years. All were hospitalized. Eight of the nine children are up to date with their polio vaccinations.

Most patients presented with acute focal limb weakness and their MRIs showed nonenhancing lesions that were largely restricted to the gray matter and spanned more than the level of the spinal cord in most cases. Some patients also had acute cranial nerve dysfunction with correlating nonenhancing brainstem lesions on MRI. There were no cases of altered mental status or seizure, nor any cortical, subcortical, basal ganglia, or thalamic lesions on MRI, according to the CDC report.

CDC is prioritizing testing of specimens from children with severe respiratory illness, according to its website.

Nearly half of the specimens tested for EV-D68 at the CDC have tested positive and about one-third have tested positive for an enterovirus or rhinovirus other than EV-D68, according to the agency.

“Not much is known about the spectrum and the severity of the disease [EV-D68] can cause,” Dr. Shaw said. “Recent reports of polio-like illness among children alert us to include EV-D68 virus in a differential diagnosis when evaluating a pediatric patient with acute focal limb weakness and prior respiratory illness. The current nationwide outbreak of EV-D68 gives us an opportunity to learn more about this virus, its epidemiology, and the etiology of recent polio-like illness reported in Colorado.”

In a recent commentary in JAMA Pediatrics, Dr. Shaw wrote that “rapid detection and media collaboration are crucial in limiting the effect of an outbreak in a community.”

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

Acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter have been noted in several children who tested positive for enterovirus D68 infections, which have been spreading rapidly across the nation.

Federal health officials are urging that cases be reported to state and local health departments. The Centers for Disease Control and Prevention issued the alert on Sept. 26th in response to an ongoing investigation in Colorado involving a cluster of nine children who have been hospitalized with acute neurologic illness. A 10th case was added to the cluster on Monday, Sept. 29, according to the Colorado Department of Public Health & Environment.

Four of the children have tested positive for the virus and test results are pending in two other cases. Most cases had a febrile respiratory illness in the 2 weeks before they developed neurologic symptoms.

EV-D68, which has been historically rare, is a non–polio enterovirus causing mild to severe respiratory illness. Since initial reports in mid-August, more than 440 cases of EV-D68 have been confirmed in 40 states and the District of Columbia. The numbers are likely to increase as states process the backlog of specimens, according to the CDC. “As the scale of this year’s EV-D68 outbreak is much larger in comparison to the past, we will likely see rare complications of this infection, such as paralysis,” Dr. Jana Shaw, an infectious disease specialist at Upstate Golisano Children’s Hospital in Syracuse, N.Y., wrote in an e-mail. “In our experience, many patients with respiratory illness had uneventful hospitalizations and completely recovered. Hence, the frequency of paralysis with EV-D68 remains to be seen.”

The Colorado pediatric cases were identified between Aug. 9 and Sept. 17 this year among children aged 1-18 years old, with a median age of 10 years. All were hospitalized. Eight of the nine children are up to date with their polio vaccinations.

Most patients presented with acute focal limb weakness and their MRIs showed nonenhancing lesions that were largely restricted to the gray matter and spanned more than the level of the spinal cord in most cases. Some patients also had acute cranial nerve dysfunction with correlating nonenhancing brainstem lesions on MRI. There were no cases of altered mental status or seizure, nor any cortical, subcortical, basal ganglia, or thalamic lesions on MRI, according to the CDC report.

CDC is prioritizing testing of specimens from children with severe respiratory illness, according to its website.

Nearly half of the specimens tested for EV-D68 at the CDC have tested positive and about one-third have tested positive for an enterovirus or rhinovirus other than EV-D68, according to the agency.

“Not much is known about the spectrum and the severity of the disease [EV-D68] can cause,” Dr. Shaw said. “Recent reports of polio-like illness among children alert us to include EV-D68 virus in a differential diagnosis when evaluating a pediatric patient with acute focal limb weakness and prior respiratory illness. The current nationwide outbreak of EV-D68 gives us an opportunity to learn more about this virus, its epidemiology, and the etiology of recent polio-like illness reported in Colorado.”

In a recent commentary in JAMA Pediatrics, Dr. Shaw wrote that “rapid detection and media collaboration are crucial in limiting the effect of an outbreak in a community.”

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

Affordable Care Act (ACA) funding is kicking accessible health care into gear in more than one way. The HHS announced an investment of $83.4 million to train more than 550 new residents (2014-2015 academic year) in 60 Teaching Health Centers and $100 million for building an estimated 150 new health center sites in 2015.

The Teaching Health Center (THC) program was created by the ACA to expand residency training in community-based settings, including urban, rural, and tribal. Residents are trained in family medicine, internal medicine, pediatrics, obstetrics and gynecology, psychiatry, geriatrics, and general dentistry. The ACA funding will boost the number of states with THCs from 21 to 24 and increase the number of residents trained in the previous academic year by more than 200.

The THC program not only provides training, but also “galvanizes communities,” said Health Resources and Service Administration (HRSA) Administrator Mary K. Wakefield, PhD, RN, in a July 7, 2014, HHS press release. “It brings hospitals, academic centers, health centers, and community organizations together to provide top-notch medical education and services in areas of the country that need them most.”

The funding for new health centers will add to the > 550 health center sites that have opened in the past 3 years due to the ACA. According to a July 8, 2014, HHS press release, nearly 1,300 health centers operate more than 9,200 service delivery sites that provide care to more than 21 million patients in every state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin.

The centers also conduct outreach and enrollment activities to link individuals to affordable coverage. According to Dr. Wakefield, since last fall, health centers have provided enrollment assistance to more than 4.7 million people across the country.

To learn more about the HRSA THC program, visit http://bphc.hrsa.gov/about.

Affordable Care Act (ACA) funding is kicking accessible health care into gear in more than one way. The HHS announced an investment of $83.4 million to train more than 550 new residents (2014-2015 academic year) in 60 Teaching Health Centers and $100 million for building an estimated 150 new health center sites in 2015.

The Teaching Health Center (THC) program was created by the ACA to expand residency training in community-based settings, including urban, rural, and tribal. Residents are trained in family medicine, internal medicine, pediatrics, obstetrics and gynecology, psychiatry, geriatrics, and general dentistry. The ACA funding will boost the number of states with THCs from 21 to 24 and increase the number of residents trained in the previous academic year by more than 200.

The THC program not only provides training, but also “galvanizes communities,” said Health Resources and Service Administration (HRSA) Administrator Mary K. Wakefield, PhD, RN, in a July 7, 2014, HHS press release. “It brings hospitals, academic centers, health centers, and community organizations together to provide top-notch medical education and services in areas of the country that need them most.”

The funding for new health centers will add to the > 550 health center sites that have opened in the past 3 years due to the ACA. According to a July 8, 2014, HHS press release, nearly 1,300 health centers operate more than 9,200 service delivery sites that provide care to more than 21 million patients in every state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin.

The centers also conduct outreach and enrollment activities to link individuals to affordable coverage. According to Dr. Wakefield, since last fall, health centers have provided enrollment assistance to more than 4.7 million people across the country.

To learn more about the HRSA THC program, visit http://bphc.hrsa.gov/about.

Affordable Care Act (ACA) funding is kicking accessible health care into gear in more than one way. The HHS announced an investment of $83.4 million to train more than 550 new residents (2014-2015 academic year) in 60 Teaching Health Centers and $100 million for building an estimated 150 new health center sites in 2015.

The Teaching Health Center (THC) program was created by the ACA to expand residency training in community-based settings, including urban, rural, and tribal. Residents are trained in family medicine, internal medicine, pediatrics, obstetrics and gynecology, psychiatry, geriatrics, and general dentistry. The ACA funding will boost the number of states with THCs from 21 to 24 and increase the number of residents trained in the previous academic year by more than 200.

The THC program not only provides training, but also “galvanizes communities,” said Health Resources and Service Administration (HRSA) Administrator Mary K. Wakefield, PhD, RN, in a July 7, 2014, HHS press release. “It brings hospitals, academic centers, health centers, and community organizations together to provide top-notch medical education and services in areas of the country that need them most.”

The funding for new health centers will add to the > 550 health center sites that have opened in the past 3 years due to the ACA. According to a July 8, 2014, HHS press release, nearly 1,300 health centers operate more than 9,200 service delivery sites that provide care to more than 21 million patients in every state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin.

The centers also conduct outreach and enrollment activities to link individuals to affordable coverage. According to Dr. Wakefield, since last fall, health centers have provided enrollment assistance to more than 4.7 million people across the country.

To learn more about the HRSA THC program, visit http://bphc.hrsa.gov/about.

WASHINGTON – The best way to fight the flu is to “get a flu shot this year and every year,” said Dr. Thomas Frieden.

Last year was a bad year, especially for adults aged 18-64 years, who had their highest rate of flu-related hospitalizations since the 2009 pandemic, Dr. Frieden, director of the Centers for Disease Control and Prevention, Atlanta, said at a recent press conference sponsored by the National Foundation for Infectious Diseases.

©CDC

Approximately 150 million doses of flu vaccine are expected to be available this season, and there should be plenty to go around, he emphasized.

The CDC has a three-pronged message for patients and health care providers: Get vaccinated, stay home if you are sick, and take medications if they are prescribed.

Overall vaccination coverage of the U.S. population aged 6 months and older was 46% in 2013-2014, which was a slight increase from the previous year. The upward trend is encouraging, Dr. Frieden said, especially the 65% of adults aged 65 and older and 70% of children aged 6 months to 5 years who received flu vaccination last year, but there is certainly room for improvement.

Fortunately, there are more flu vaccine options, and places to get them, than ever before, said Dr. William Schaffner, professor and chairman of the department of preventive medicine at Vanderbilt University, Nashville, past president of the NFID. Choices include the traditional intramuscular shot, an intradermal version with a smaller needle, nasal spray, an egg-free vaccine, and a high-dose vaccine especially for adults aged 65 and older, he said.

This year, for the first time, the CDC recommends the nasal spray as the preferred flu vaccination method for children aged 2-8 years if they have no contraindications, said Dr. Paul A. Offit, chief of the division of infectious diseases and director of the vaccine education center of the Children’s Hospital of Philadelphia. Parents, however, should not postpone vaccinating their children with a different vaccine if the spray is not available, since all are effective, he said.

Although flu vaccination rates in children are up, coverage of pregnant women held steady, said Dr. Laura E. Riley, medical director of labor and delivery in the obstetrics service of Massachusetts General Hospital, Boston.

Vaccination coverage among pregnant women during the 2013-2014 flu season was 52%, only a slight increase from 51% the previous year. Coverage rates varied by age: 46% for pregnant women aged 18-24 years, 57% for those aged 24-34 years, and 53% for those aged 35-49 years.

Numerous studies have shown that the flu shot is safe during all trimesters, although the nasal spray is not recommended for pregnant women, Dr. Riley noted. Employ each doctor visit as an opportunity to offer and recommend flu vaccination. “A strong recommendation” from a health care provider has been significantly associated with increased vaccination across all demographic groups of pregnant women, she said.

Health care personnel seem to be getting the message about flu vaccination, said Dr. Schaffner. Overall, 75% of health care personnel received a flu vaccine last year, including 92% of physicians and 90% of nurses.

He exhorted health care workers to keep the trend going and to get vaccinated for their patients’ health, as well as their own.

“Immunization of health care personnel is, first and foremost, a patient safety issue,” he said.

Complete data on vaccination coverage in health care workers and patient populations were published in the CDC’s Morbidity and Mortality Weekly Report on Sept. 19 (MMWR 2014;63:805-11). Data on flu vaccine coverage in the U.S. population are available online.

hsplete@frontlinemedcom.com

WASHINGTON – The best way to fight the flu is to “get a flu shot this year and every year,” said Dr. Thomas Frieden.

Last year was a bad year, especially for adults aged 18-64 years, who had their highest rate of flu-related hospitalizations since the 2009 pandemic, Dr. Frieden, director of the Centers for Disease Control and Prevention, Atlanta, said at a recent press conference sponsored by the National Foundation for Infectious Diseases.

©CDC

Approximately 150 million doses of flu vaccine are expected to be available this season, and there should be plenty to go around, he emphasized.

The CDC has a three-pronged message for patients and health care providers: Get vaccinated, stay home if you are sick, and take medications if they are prescribed.

Overall vaccination coverage of the U.S. population aged 6 months and older was 46% in 2013-2014, which was a slight increase from the previous year. The upward trend is encouraging, Dr. Frieden said, especially the 65% of adults aged 65 and older and 70% of children aged 6 months to 5 years who received flu vaccination last year, but there is certainly room for improvement.

Fortunately, there are more flu vaccine options, and places to get them, than ever before, said Dr. William Schaffner, professor and chairman of the department of preventive medicine at Vanderbilt University, Nashville, past president of the NFID. Choices include the traditional intramuscular shot, an intradermal version with a smaller needle, nasal spray, an egg-free vaccine, and a high-dose vaccine especially for adults aged 65 and older, he said.

This year, for the first time, the CDC recommends the nasal spray as the preferred flu vaccination method for children aged 2-8 years if they have no contraindications, said Dr. Paul A. Offit, chief of the division of infectious diseases and director of the vaccine education center of the Children’s Hospital of Philadelphia. Parents, however, should not postpone vaccinating their children with a different vaccine if the spray is not available, since all are effective, he said.

Although flu vaccination rates in children are up, coverage of pregnant women held steady, said Dr. Laura E. Riley, medical director of labor and delivery in the obstetrics service of Massachusetts General Hospital, Boston.

Vaccination coverage among pregnant women during the 2013-2014 flu season was 52%, only a slight increase from 51% the previous year. Coverage rates varied by age: 46% for pregnant women aged 18-24 years, 57% for those aged 24-34 years, and 53% for those aged 35-49 years.

Numerous studies have shown that the flu shot is safe during all trimesters, although the nasal spray is not recommended for pregnant women, Dr. Riley noted. Employ each doctor visit as an opportunity to offer and recommend flu vaccination. “A strong recommendation” from a health care provider has been significantly associated with increased vaccination across all demographic groups of pregnant women, she said.

Health care personnel seem to be getting the message about flu vaccination, said Dr. Schaffner. Overall, 75% of health care personnel received a flu vaccine last year, including 92% of physicians and 90% of nurses.

He exhorted health care workers to keep the trend going and to get vaccinated for their patients’ health, as well as their own.

“Immunization of health care personnel is, first and foremost, a patient safety issue,” he said.

Complete data on vaccination coverage in health care workers and patient populations were published in the CDC’s Morbidity and Mortality Weekly Report on Sept. 19 (MMWR 2014;63:805-11). Data on flu vaccine coverage in the U.S. population are available online.

hsplete@frontlinemedcom.com

WASHINGTON – The best way to fight the flu is to “get a flu shot this year and every year,” said Dr. Thomas Frieden.

Last year was a bad year, especially for adults aged 18-64 years, who had their highest rate of flu-related hospitalizations since the 2009 pandemic, Dr. Frieden, director of the Centers for Disease Control and Prevention, Atlanta, said at a recent press conference sponsored by the National Foundation for Infectious Diseases.

©CDC

Approximately 150 million doses of flu vaccine are expected to be available this season, and there should be plenty to go around, he emphasized.

The CDC has a three-pronged message for patients and health care providers: Get vaccinated, stay home if you are sick, and take medications if they are prescribed.

Overall vaccination coverage of the U.S. population aged 6 months and older was 46% in 2013-2014, which was a slight increase from the previous year. The upward trend is encouraging, Dr. Frieden said, especially the 65% of adults aged 65 and older and 70% of children aged 6 months to 5 years who received flu vaccination last year, but there is certainly room for improvement.

Fortunately, there are more flu vaccine options, and places to get them, than ever before, said Dr. William Schaffner, professor and chairman of the department of preventive medicine at Vanderbilt University, Nashville, past president of the NFID. Choices include the traditional intramuscular shot, an intradermal version with a smaller needle, nasal spray, an egg-free vaccine, and a high-dose vaccine especially for adults aged 65 and older, he said.

This year, for the first time, the CDC recommends the nasal spray as the preferred flu vaccination method for children aged 2-8 years if they have no contraindications, said Dr. Paul A. Offit, chief of the division of infectious diseases and director of the vaccine education center of the Children’s Hospital of Philadelphia. Parents, however, should not postpone vaccinating their children with a different vaccine if the spray is not available, since all are effective, he said.

Although flu vaccination rates in children are up, coverage of pregnant women held steady, said Dr. Laura E. Riley, medical director of labor and delivery in the obstetrics service of Massachusetts General Hospital, Boston.

Vaccination coverage among pregnant women during the 2013-2014 flu season was 52%, only a slight increase from 51% the previous year. Coverage rates varied by age: 46% for pregnant women aged 18-24 years, 57% for those aged 24-34 years, and 53% for those aged 35-49 years.

Numerous studies have shown that the flu shot is safe during all trimesters, although the nasal spray is not recommended for pregnant women, Dr. Riley noted. Employ each doctor visit as an opportunity to offer and recommend flu vaccination. “A strong recommendation” from a health care provider has been significantly associated with increased vaccination across all demographic groups of pregnant women, she said.

Health care personnel seem to be getting the message about flu vaccination, said Dr. Schaffner. Overall, 75% of health care personnel received a flu vaccine last year, including 92% of physicians and 90% of nurses.

He exhorted health care workers to keep the trend going and to get vaccinated for their patients’ health, as well as their own.

“Immunization of health care personnel is, first and foremost, a patient safety issue,” he said.

Complete data on vaccination coverage in health care workers and patient populations were published in the CDC’s Morbidity and Mortality Weekly Report on Sept. 19 (MMWR 2014;63:805-11). Data on flu vaccine coverage in the U.S. population are available online.

hsplete@frontlinemedcom.com

A quick, large-scale response to an Ebola outbreak can contain it and actually bend the curve to limit new cases, according to a new modeling tool released by the Centers for Disease Control and Prevention.

Announced Sept. 23, the tool, EbolaResponse, allows for estimations of projected cases based on various response scenarios. Use of the tool can demonstrate how interventions can help slow and ultimately stop an Ebola epidemic.

“The EbolaResponse modeling tool is intended to help local governments and international responders generate short-term estimates of the Ebola situation in countries, districts, and villages,” the CDC said in a fact sheet on the new tool.

Speaking during a same-day press conference call, CDC Director Thomas R. Frieden said that the model shows something other models out there do not – that a surge in response “can break the back of the epidemic. … [I]f you get enough people effectively isolated, the epidemic can be stopped and, related to that, when you reach a high enough number [with isolation and treatment] … the number of cases plummets rapidly, almost as rapidly as the exponential rise we are seeing now.”

Dr. Frieden also noted the model’s cautionary tale: “For each month of delay, there is a big increase in the number of cases, and it gets much more difficult to control the epidemic.”

The CDC, in its latest Morbidity and Mortality Weekly Report, used the tool to estimate, based on various scenarios, the number of cases in Liberia and Sierra Leone, which offered a range of scenarios and put the number of cases at between 550,000 and 1.4 million by Jan. 20, 2015, but Dr. Frieden stressed that the number was generated a few weeks ago and is not based on the latest information that would bring those numbers down. The tool is available as a free download from the agency.

gtwatchtman@frontlinemedcom.com

A quick, large-scale response to an Ebola outbreak can contain it and actually bend the curve to limit new cases, according to a new modeling tool released by the Centers for Disease Control and Prevention.

Announced Sept. 23, the tool, EbolaResponse, allows for estimations of projected cases based on various response scenarios. Use of the tool can demonstrate how interventions can help slow and ultimately stop an Ebola epidemic.

“The EbolaResponse modeling tool is intended to help local governments and international responders generate short-term estimates of the Ebola situation in countries, districts, and villages,” the CDC said in a fact sheet on the new tool.

Speaking during a same-day press conference call, CDC Director Thomas R. Frieden said that the model shows something other models out there do not – that a surge in response “can break the back of the epidemic. … [I]f you get enough people effectively isolated, the epidemic can be stopped and, related to that, when you reach a high enough number [with isolation and treatment] … the number of cases plummets rapidly, almost as rapidly as the exponential rise we are seeing now.”

Dr. Frieden also noted the model’s cautionary tale: “For each month of delay, there is a big increase in the number of cases, and it gets much more difficult to control the epidemic.”

The CDC, in its latest Morbidity and Mortality Weekly Report, used the tool to estimate, based on various scenarios, the number of cases in Liberia and Sierra Leone, which offered a range of scenarios and put the number of cases at between 550,000 and 1.4 million by Jan. 20, 2015, but Dr. Frieden stressed that the number was generated a few weeks ago and is not based on the latest information that would bring those numbers down. The tool is available as a free download from the agency.

gtwatchtman@frontlinemedcom.com

A quick, large-scale response to an Ebola outbreak can contain it and actually bend the curve to limit new cases, according to a new modeling tool released by the Centers for Disease Control and Prevention.

Announced Sept. 23, the tool, EbolaResponse, allows for estimations of projected cases based on various response scenarios. Use of the tool can demonstrate how interventions can help slow and ultimately stop an Ebola epidemic.

“The EbolaResponse modeling tool is intended to help local governments and international responders generate short-term estimates of the Ebola situation in countries, districts, and villages,” the CDC said in a fact sheet on the new tool.

Speaking during a same-day press conference call, CDC Director Thomas R. Frieden said that the model shows something other models out there do not – that a surge in response “can break the back of the epidemic. … [I]f you get enough people effectively isolated, the epidemic can be stopped and, related to that, when you reach a high enough number [with isolation and treatment] … the number of cases plummets rapidly, almost as rapidly as the exponential rise we are seeing now.”

Dr. Frieden also noted the model’s cautionary tale: “For each month of delay, there is a big increase in the number of cases, and it gets much more difficult to control the epidemic.”

The CDC, in its latest Morbidity and Mortality Weekly Report, used the tool to estimate, based on various scenarios, the number of cases in Liberia and Sierra Leone, which offered a range of scenarios and put the number of cases at between 550,000 and 1.4 million by Jan. 20, 2015, but Dr. Frieden stressed that the number was generated a few weeks ago and is not based on the latest information that would bring those numbers down. The tool is available as a free download from the agency.

gtwatchtman@frontlinemedcom.com

Naloxegol, an orally administered peripherally acting mu-opioid receptor antagonist, has been approved by the Food and Drug Administration as a treatment for opioid-induced constipation in adults with chronic noncancer pain, the agency announced on Sept. 17.

The drug will be marketed by AstraZeneca Pharmaceuticals as Movantik and is expected to be available during the first half of 2015, according to a company statement. A company petition for the drug to be descheduled is under review at the US Drug Enforcement Administration. Because the drug is structurally related to noroxymorphone, naloxegol is considered a schedule II drug, but the FDA-approved labeling states that it has “no risk of abuse or dependency,” the company statement said.

Approval of the drug, which is taken once a day in a tablet formulation, was based on two 12-week studies of 1,352 patients who had taken opioids for noncancer related pain for at least 4 weeks and had opioid-induced constipation, according to a FDA statement. The two studies, KODIAC-04 and KODIAC-05, were published in June (N. Engl. J. Med. 2014;370:2387-96).

Patients with noncancer-related pain and opioid-induced constipation were randomized to receive one of two doses of naloxegol or placebo, once a day for 12 weeks. The 12-week endpoint was at least three spontaneous bowel movements per week and an increase of at least one spontaneous bowel movement per week from baseline for at least 9 of the 12 weeks and for at least 3 of the final 4 weeks of the study. In one study, 44% of those on the 25-mg dose and 41% of those on the lower dose met this endpoint, vs. 29% of those on placebo. In the second study, 40% of those on the higher dose and 35% of those on the lower dose met this endpoint, vs. 29% of those on placebo.

Abdominal pain, diarrhea, headache, and flatulence were among the common side effects of the drug, according to the FDA.

The manufacturer is required to conduct a postmarketing study to evaluate the possible cardiovascular risks of the drug in patients, according to the agency.

Naloxegol is under review by the European Medicines Agency in Europe, according to the company.

emechcatie@frontlinemedcom.com

Naloxegol, an orally administered peripherally acting mu-opioid receptor antagonist, has been approved by the Food and Drug Administration as a treatment for opioid-induced constipation in adults with chronic noncancer pain, the agency announced on Sept. 17.

The drug will be marketed by AstraZeneca Pharmaceuticals as Movantik and is expected to be available during the first half of 2015, according to a company statement. A company petition for the drug to be descheduled is under review at the US Drug Enforcement Administration. Because the drug is structurally related to noroxymorphone, naloxegol is considered a schedule II drug, but the FDA-approved labeling states that it has “no risk of abuse or dependency,” the company statement said.

Approval of the drug, which is taken once a day in a tablet formulation, was based on two 12-week studies of 1,352 patients who had taken opioids for noncancer related pain for at least 4 weeks and had opioid-induced constipation, according to a FDA statement. The two studies, KODIAC-04 and KODIAC-05, were published in June (N. Engl. J. Med. 2014;370:2387-96).

Patients with noncancer-related pain and opioid-induced constipation were randomized to receive one of two doses of naloxegol or placebo, once a day for 12 weeks. The 12-week endpoint was at least three spontaneous bowel movements per week and an increase of at least one spontaneous bowel movement per week from baseline for at least 9 of the 12 weeks and for at least 3 of the final 4 weeks of the study. In one study, 44% of those on the 25-mg dose and 41% of those on the lower dose met this endpoint, vs. 29% of those on placebo. In the second study, 40% of those on the higher dose and 35% of those on the lower dose met this endpoint, vs. 29% of those on placebo.

Abdominal pain, diarrhea, headache, and flatulence were among the common side effects of the drug, according to the FDA.

The manufacturer is required to conduct a postmarketing study to evaluate the possible cardiovascular risks of the drug in patients, according to the agency.

Naloxegol is under review by the European Medicines Agency in Europe, according to the company.

emechcatie@frontlinemedcom.com

Naloxegol, an orally administered peripherally acting mu-opioid receptor antagonist, has been approved by the Food and Drug Administration as a treatment for opioid-induced constipation in adults with chronic noncancer pain, the agency announced on Sept. 17.

The drug will be marketed by AstraZeneca Pharmaceuticals as Movantik and is expected to be available during the first half of 2015, according to a company statement. A company petition for the drug to be descheduled is under review at the US Drug Enforcement Administration. Because the drug is structurally related to noroxymorphone, naloxegol is considered a schedule II drug, but the FDA-approved labeling states that it has “no risk of abuse or dependency,” the company statement said.

Approval of the drug, which is taken once a day in a tablet formulation, was based on two 12-week studies of 1,352 patients who had taken opioids for noncancer related pain for at least 4 weeks and had opioid-induced constipation, according to a FDA statement. The two studies, KODIAC-04 and KODIAC-05, were published in June (N. Engl. J. Med. 2014;370:2387-96).

Patients with noncancer-related pain and opioid-induced constipation were randomized to receive one of two doses of naloxegol or placebo, once a day for 12 weeks. The 12-week endpoint was at least three spontaneous bowel movements per week and an increase of at least one spontaneous bowel movement per week from baseline for at least 9 of the 12 weeks and for at least 3 of the final 4 weeks of the study. In one study, 44% of those on the 25-mg dose and 41% of those on the lower dose met this endpoint, vs. 29% of those on placebo. In the second study, 40% of those on the higher dose and 35% of those on the lower dose met this endpoint, vs. 29% of those on placebo.

Abdominal pain, diarrhea, headache, and flatulence were among the common side effects of the drug, according to the FDA.

The manufacturer is required to conduct a postmarketing study to evaluate the possible cardiovascular risks of the drug in patients, according to the agency.

Naloxegol is under review by the European Medicines Agency in Europe, according to the company.

emechcatie@frontlinemedcom.com

The HHS announced a challenge to find the best practices for improving hypertension through health information technology (IT). The Electronic Health Records Innovations for Improving Hypertension Challenge, launched by the Office of the National Coordinator for Health IT, is asking health care professionals to submit the tools they use to improve patient care.

Many health care providers use clinical decision support tools such as standardized treatment approaches or protocols to control hypertension, said National Coordinator for Health IT Karen DeSalvo, MD, MPH, in a July 7, 2014, HHS press release. “This challenge helps us find the best examples of those efforts and scale them up.” Evidence-based treatment protocols provide a “playbook for providers to guide their selection of effective therapies for blood pressure control,” HHS said.

The challenge is part of the Million Hearts initiative led by CDC and the Centers for Medicare & Medicaid Services. Million Hearts brings together communities, health systems, nonprofit organizations, federal agencies, and private-sector partners, all with the goal of preventing 1 million heart attacks and strokes by 2017.

“We are excited that with this challenge we will be able to share the best practices that many physicians and their teams are using,” said Executive Director of Million Hearts Janet Wright, MD. “Our goal of preventing a million heart attacks and strokes in 5 years can happen by helping at least 10 million more hypertensive patients achieve safe and swift control.”

The deadline for submissions is October 6, 2014. Winners will be announced on October 28, 2014. For more information, visit http://challenge.sites.usa.gov/challenge/ehr-innovations-for-improving-hypertension-challenge.

The HHS announced a challenge to find the best practices for improving hypertension through health information technology (IT). The Electronic Health Records Innovations for Improving Hypertension Challenge, launched by the Office of the National Coordinator for Health IT, is asking health care professionals to submit the tools they use to improve patient care.

Many health care providers use clinical decision support tools such as standardized treatment approaches or protocols to control hypertension, said National Coordinator for Health IT Karen DeSalvo, MD, MPH, in a July 7, 2014, HHS press release. “This challenge helps us find the best examples of those efforts and scale them up.” Evidence-based treatment protocols provide a “playbook for providers to guide their selection of effective therapies for blood pressure control,” HHS said.

The challenge is part of the Million Hearts initiative led by CDC and the Centers for Medicare & Medicaid Services. Million Hearts brings together communities, health systems, nonprofit organizations, federal agencies, and private-sector partners, all with the goal of preventing 1 million heart attacks and strokes by 2017.

“We are excited that with this challenge we will be able to share the best practices that many physicians and their teams are using,” said Executive Director of Million Hearts Janet Wright, MD. “Our goal of preventing a million heart attacks and strokes in 5 years can happen by helping at least 10 million more hypertensive patients achieve safe and swift control.”

The deadline for submissions is October 6, 2014. Winners will be announced on October 28, 2014. For more information, visit http://challenge.sites.usa.gov/challenge/ehr-innovations-for-improving-hypertension-challenge.

The HHS announced a challenge to find the best practices for improving hypertension through health information technology (IT). The Electronic Health Records Innovations for Improving Hypertension Challenge, launched by the Office of the National Coordinator for Health IT, is asking health care professionals to submit the tools they use to improve patient care.

Many health care providers use clinical decision support tools such as standardized treatment approaches or protocols to control hypertension, said National Coordinator for Health IT Karen DeSalvo, MD, MPH, in a July 7, 2014, HHS press release. “This challenge helps us find the best examples of those efforts and scale them up.” Evidence-based treatment protocols provide a “playbook for providers to guide their selection of effective therapies for blood pressure control,” HHS said.

The challenge is part of the Million Hearts initiative led by CDC and the Centers for Medicare & Medicaid Services. Million Hearts brings together communities, health systems, nonprofit organizations, federal agencies, and private-sector partners, all with the goal of preventing 1 million heart attacks and strokes by 2017.

“We are excited that with this challenge we will be able to share the best practices that many physicians and their teams are using,” said Executive Director of Million Hearts Janet Wright, MD. “Our goal of preventing a million heart attacks and strokes in 5 years can happen by helping at least 10 million more hypertensive patients achieve safe and swift control.”

The deadline for submissions is October 6, 2014. Winners will be announced on October 28, 2014. For more information, visit http://challenge.sites.usa.gov/challenge/ehr-innovations-for-improving-hypertension-challenge.

The VA is renewing funding for transitional housing and support services to homeless veterans with special needs so they might “achieve residential stability, increase their skill levels and income, and gain greater self-determination.” The Homeless Providers Grant and Per Diem Program (GPD) Special Need Grants will allot $5 million to 25 organizations that provide services to veterans who are women, frail elderly, terminally ill, or chronically mentally ill, or who care for minor dependents.

The GPD offers funding grants annually. Only community agencies with supportive housing (up to 24 months) or service centers with case management, education, crisis intervention, counseling, and other services for specialized populations (such as homeless women veterans) are eligible for the funds. Grants can be used for acquisition, renovation, or construction of a building that will provide services for homeless veterans; per diem funding is paid to help organizations defray operational costs. Nonprofit organizations, state and local government agencies, and Indian Tribal governments are eligible to apply if 75% of their clients are veterans.

Although a 2013 survey counted 57,849 homeless veterans in the U.S., that number represents a 24% decline since January 2010, VA reports. In support of President Obama’s and VA’s goal of ending veteran homelessness in 2015, VA has also committed more than $1 billion in fiscal year 2014 to strengthen programs that prevent and treat the issues that can lead to homelessness.

“We will continue our work until no veteran has to sleep on the streets,” said then Acting Secretary of Veterans Affairs Sloan D. Gibson in a June 26, 2014, VA press release. “We have made significant progress toward our goal to end veterans’ homelessness. That progress would not have occurred without the important work of GPD Special Need grantees and other local partners.”

The VA is renewing funding for transitional housing and support services to homeless veterans with special needs so they might “achieve residential stability, increase their skill levels and income, and gain greater self-determination.” The Homeless Providers Grant and Per Diem Program (GPD) Special Need Grants will allot $5 million to 25 organizations that provide services to veterans who are women, frail elderly, terminally ill, or chronically mentally ill, or who care for minor dependents.

The GPD offers funding grants annually. Only community agencies with supportive housing (up to 24 months) or service centers with case management, education, crisis intervention, counseling, and other services for specialized populations (such as homeless women veterans) are eligible for the funds. Grants can be used for acquisition, renovation, or construction of a building that will provide services for homeless veterans; per diem funding is paid to help organizations defray operational costs. Nonprofit organizations, state and local government agencies, and Indian Tribal governments are eligible to apply if 75% of their clients are veterans.

Although a 2013 survey counted 57,849 homeless veterans in the U.S., that number represents a 24% decline since January 2010, VA reports. In support of President Obama’s and VA’s goal of ending veteran homelessness in 2015, VA has also committed more than $1 billion in fiscal year 2014 to strengthen programs that prevent and treat the issues that can lead to homelessness.

“We will continue our work until no veteran has to sleep on the streets,” said then Acting Secretary of Veterans Affairs Sloan D. Gibson in a June 26, 2014, VA press release. “We have made significant progress toward our goal to end veterans’ homelessness. That progress would not have occurred without the important work of GPD Special Need grantees and other local partners.”

The VA is renewing funding for transitional housing and support services to homeless veterans with special needs so they might “achieve residential stability, increase their skill levels and income, and gain greater self-determination.” The Homeless Providers Grant and Per Diem Program (GPD) Special Need Grants will allot $5 million to 25 organizations that provide services to veterans who are women, frail elderly, terminally ill, or chronically mentally ill, or who care for minor dependents.

The GPD offers funding grants annually. Only community agencies with supportive housing (up to 24 months) or service centers with case management, education, crisis intervention, counseling, and other services for specialized populations (such as homeless women veterans) are eligible for the funds. Grants can be used for acquisition, renovation, or construction of a building that will provide services for homeless veterans; per diem funding is paid to help organizations defray operational costs. Nonprofit organizations, state and local government agencies, and Indian Tribal governments are eligible to apply if 75% of their clients are veterans.

Although a 2013 survey counted 57,849 homeless veterans in the U.S., that number represents a 24% decline since January 2010, VA reports. In support of President Obama’s and VA’s goal of ending veteran homelessness in 2015, VA has also committed more than $1 billion in fiscal year 2014 to strengthen programs that prevent and treat the issues that can lead to homelessness.

“We will continue our work until no veteran has to sleep on the streets,” said then Acting Secretary of Veterans Affairs Sloan D. Gibson in a June 26, 2014, VA press release. “We have made significant progress toward our goal to end veterans’ homelessness. That progress would not have occurred without the important work of GPD Special Need grantees and other local partners.”