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FDA approves peramivir, first IV flu antiviral
Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*
It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.
“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.
“The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health care professionals and patients to have a choice based on an individual patient’s needs,” he added.
Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.
“Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.
Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.
The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.
*Correction, 12/23/2014: An earlier version of this story misstated the date Peramivir was approved.
Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*
It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.
“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.
“The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health care professionals and patients to have a choice based on an individual patient’s needs,” he added.
Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.
“Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.
Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.
The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.
*Correction, 12/23/2014: An earlier version of this story misstated the date Peramivir was approved.
Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*
It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.
“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.
“The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health care professionals and patients to have a choice based on an individual patient’s needs,” he added.
Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.
“Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.
Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.
The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.
*Correction, 12/23/2014: An earlier version of this story misstated the date Peramivir was approved.
Experimental drug for vascular leak syndrome used to treat Ebola
A doctor who contracted Ebola at a field hospital in Sierra Leone made a complete recovery due in part to a 3-day treatment course with an experimental drug called FX06, a fibrin-derived peptide used to slow vascular leakage.
The patient, a 38-year old physician from Uganda, was flown into University Hospital Frankfurt, Germany. Within 72 hours of admission he developed signs of vascular leakage and severe multiorgan failure, The patient then began the experimental treatment in the hospital’s intensive care isolation unit. In addition to being administered FX06, the patient was placed on a ventilator and received renal replacement therapy until virologic remission, Dr. Timo Wolf of the hospital and associates wrote in the Lancet (2014 Dec. 19 [doi:10.1016/S0140-6736(14)62384-9]).
FX06 has never been used to treat a patient with Ebola virus disease, although it was shown to reduce hemorrhaging from dengue virus in mice. Use of the experimental drug was approved by the hospital ethical board due to the patient’s deteriorating health, and it was used until the patient’s own immune response could effectively control the infection.
The patient was released to his family after viral remission and a 30-day isolation period.
“The efficacy of FX06 should soon be assessed in clinical trials or at least by standardized collection of data from patients with Ebola virus disease who received it in a compassionate use setting,” the investigators wrote.
The investigators reported that they had no conflicts of interest.
A doctor who contracted Ebola at a field hospital in Sierra Leone made a complete recovery due in part to a 3-day treatment course with an experimental drug called FX06, a fibrin-derived peptide used to slow vascular leakage.
The patient, a 38-year old physician from Uganda, was flown into University Hospital Frankfurt, Germany. Within 72 hours of admission he developed signs of vascular leakage and severe multiorgan failure, The patient then began the experimental treatment in the hospital’s intensive care isolation unit. In addition to being administered FX06, the patient was placed on a ventilator and received renal replacement therapy until virologic remission, Dr. Timo Wolf of the hospital and associates wrote in the Lancet (2014 Dec. 19 [doi:10.1016/S0140-6736(14)62384-9]).
FX06 has never been used to treat a patient with Ebola virus disease, although it was shown to reduce hemorrhaging from dengue virus in mice. Use of the experimental drug was approved by the hospital ethical board due to the patient’s deteriorating health, and it was used until the patient’s own immune response could effectively control the infection.
The patient was released to his family after viral remission and a 30-day isolation period.
“The efficacy of FX06 should soon be assessed in clinical trials or at least by standardized collection of data from patients with Ebola virus disease who received it in a compassionate use setting,” the investigators wrote.
The investigators reported that they had no conflicts of interest.
A doctor who contracted Ebola at a field hospital in Sierra Leone made a complete recovery due in part to a 3-day treatment course with an experimental drug called FX06, a fibrin-derived peptide used to slow vascular leakage.
The patient, a 38-year old physician from Uganda, was flown into University Hospital Frankfurt, Germany. Within 72 hours of admission he developed signs of vascular leakage and severe multiorgan failure, The patient then began the experimental treatment in the hospital’s intensive care isolation unit. In addition to being administered FX06, the patient was placed on a ventilator and received renal replacement therapy until virologic remission, Dr. Timo Wolf of the hospital and associates wrote in the Lancet (2014 Dec. 19 [doi:10.1016/S0140-6736(14)62384-9]).
FX06 has never been used to treat a patient with Ebola virus disease, although it was shown to reduce hemorrhaging from dengue virus in mice. Use of the experimental drug was approved by the hospital ethical board due to the patient’s deteriorating health, and it was used until the patient’s own immune response could effectively control the infection.
The patient was released to his family after viral remission and a 30-day isolation period.
“The efficacy of FX06 should soon be assessed in clinical trials or at least by standardized collection of data from patients with Ebola virus disease who received it in a compassionate use setting,” the investigators wrote.
The investigators reported that they had no conflicts of interest.
FROM THE LANCET
VA and Walgreens Pair up to Offer Free Flu Shots
Veterans can now get their seasonal flu shot at a neighborhood Walgreens. In a first-of-its-kind program, the VA is partnering with Walgreens to provide greater access to vaccinations. Through the VA Retail Immunization Care Coordination Program, VA is funding about 75,000 no-cost flu vaccinations for veterans enrolled in the VA health care system, available through more than 8,000 Walgreens nationwide. The free flu shots are available until funding expires.
Pharmacists will use eHealth Exchange, through its Walgreens Cloud Electronic Health Records platform, to securely share immunization records with the VA. As soon as the pharmacist has given the vaccination, the immunization record is transmitted to VA clinicians within 24 hours and becomes part of the patient’s record. The patient will be able to view the information on his or her My HealtheVet Blue Button download.
The VA-Walgreens partnership grew out of a successful pilot program in Florida, which VA decided to expand nationwide. Walgreens is the first partner, but others are expected.
“The VA-Walgreens partnership gives veterans greater choice in time and location for getting their flu shots without having to complete any other VA forms,” said Interim Under Secretary for Health Dr. Carolyn Clancy in an October 2, 2014, VA press release.
The partnership, said Secretary of Veterans Affairs Robert A. McDonald, “is a great example of how government and the private sector can work together to effectively and efficiently provide veterans the care and benefits that they’ve earned.”
Veterans need only to let the Walgreens pharmacist know that they are enrolled in the VA health system and present their VA ID card. Vaccinations are available daily during all pharmacy hours with no appointment necessary (subject to availability). Age, state, and health-related restrictions may apply.
VA medical centers and clinics will continue to provide free flu shots during any scheduled VA appointment or at one of the walk-in flu stations. After the funding is depleted, there may be a cost for the flu shot for veterans who are enrolled in the VA health system and who do not have insurance coverage, according to the VA. For more information visit http://www.ehealth.va.gov/Immunization.asp.
Veterans can now get their seasonal flu shot at a neighborhood Walgreens. In a first-of-its-kind program, the VA is partnering with Walgreens to provide greater access to vaccinations. Through the VA Retail Immunization Care Coordination Program, VA is funding about 75,000 no-cost flu vaccinations for veterans enrolled in the VA health care system, available through more than 8,000 Walgreens nationwide. The free flu shots are available until funding expires.
Pharmacists will use eHealth Exchange, through its Walgreens Cloud Electronic Health Records platform, to securely share immunization records with the VA. As soon as the pharmacist has given the vaccination, the immunization record is transmitted to VA clinicians within 24 hours and becomes part of the patient’s record. The patient will be able to view the information on his or her My HealtheVet Blue Button download.
The VA-Walgreens partnership grew out of a successful pilot program in Florida, which VA decided to expand nationwide. Walgreens is the first partner, but others are expected.
“The VA-Walgreens partnership gives veterans greater choice in time and location for getting their flu shots without having to complete any other VA forms,” said Interim Under Secretary for Health Dr. Carolyn Clancy in an October 2, 2014, VA press release.
The partnership, said Secretary of Veterans Affairs Robert A. McDonald, “is a great example of how government and the private sector can work together to effectively and efficiently provide veterans the care and benefits that they’ve earned.”
Veterans need only to let the Walgreens pharmacist know that they are enrolled in the VA health system and present their VA ID card. Vaccinations are available daily during all pharmacy hours with no appointment necessary (subject to availability). Age, state, and health-related restrictions may apply.
VA medical centers and clinics will continue to provide free flu shots during any scheduled VA appointment or at one of the walk-in flu stations. After the funding is depleted, there may be a cost for the flu shot for veterans who are enrolled in the VA health system and who do not have insurance coverage, according to the VA. For more information visit http://www.ehealth.va.gov/Immunization.asp.
Veterans can now get their seasonal flu shot at a neighborhood Walgreens. In a first-of-its-kind program, the VA is partnering with Walgreens to provide greater access to vaccinations. Through the VA Retail Immunization Care Coordination Program, VA is funding about 75,000 no-cost flu vaccinations for veterans enrolled in the VA health care system, available through more than 8,000 Walgreens nationwide. The free flu shots are available until funding expires.
Pharmacists will use eHealth Exchange, through its Walgreens Cloud Electronic Health Records platform, to securely share immunization records with the VA. As soon as the pharmacist has given the vaccination, the immunization record is transmitted to VA clinicians within 24 hours and becomes part of the patient’s record. The patient will be able to view the information on his or her My HealtheVet Blue Button download.
The VA-Walgreens partnership grew out of a successful pilot program in Florida, which VA decided to expand nationwide. Walgreens is the first partner, but others are expected.
“The VA-Walgreens partnership gives veterans greater choice in time and location for getting their flu shots without having to complete any other VA forms,” said Interim Under Secretary for Health Dr. Carolyn Clancy in an October 2, 2014, VA press release.
The partnership, said Secretary of Veterans Affairs Robert A. McDonald, “is a great example of how government and the private sector can work together to effectively and efficiently provide veterans the care and benefits that they’ve earned.”
Veterans need only to let the Walgreens pharmacist know that they are enrolled in the VA health system and present their VA ID card. Vaccinations are available daily during all pharmacy hours with no appointment necessary (subject to availability). Age, state, and health-related restrictions may apply.
VA medical centers and clinics will continue to provide free flu shots during any scheduled VA appointment or at one of the walk-in flu stations. After the funding is depleted, there may be a cost for the flu shot for veterans who are enrolled in the VA health system and who do not have insurance coverage, according to the VA. For more information visit http://www.ehealth.va.gov/Immunization.asp.
Feds call for more transparency in reporting clinical trial results
A proposal is being floated to make clinical trial results posted to ClinicalTrials.gov more transparent, complete, and timely, regardless of whether the trial is related to an approved product.
The Department of Health & Human Services posted a proposed rule for public inspection on Nov. 19 that would expand the reporting requirements for ClinicalTrials.gov to include results on all clinical trials that are required to register on the trials database, not just results for drugs and devices that are approved, licensed, or cleared for use. It also expands data elements that are accessible and proposes more frequent updating for certain data.
Other than phase I studies of drugs and biologics and small feasibility studies of devices, trials involving drugs and devices regulated by the Food and Drug Administration would be subject to the reporting requirement under this proposal, irrespective of who is funding the study.
A separate proposal by the National Institutes of Health would apply the expanded reporting proposal to all trials funded by NIH, regardless of whether those trials would otherwise not be required to report to ClinicalTrials.gov under requirements set in the FDA Amendments Act of 2007.
“The scientific community has a disappointing track record for dissemination of clinical trial results,” NIH Deputy Director for Science, Outreach and Policy Kathy Hudson, Ph.D., and Director Dr. Francis Collins wrote in a viewpoint published in JAMA (2014 Nov. 19 [doi:10.1001/jama.2014.10716]) .
The NIH officials noted that a “recent analysis of 400 clinical studies revealed that 30% had not shared results through publication or through results reporting in ClinicalTrials.gov within 4 years of completion. This is a serious issue and the proposed rule underscores the intent of NIH to take strong action to promote timely dissemination of clinical trial results.”
Comments on the proposed rule are due within 90 days of its publication in the Federal Register on Nov. 21. The response date for comments on the NIH draft policy on reporting requirements for NIH-funded studies is Feb. 19, 2015.
A proposal is being floated to make clinical trial results posted to ClinicalTrials.gov more transparent, complete, and timely, regardless of whether the trial is related to an approved product.
The Department of Health & Human Services posted a proposed rule for public inspection on Nov. 19 that would expand the reporting requirements for ClinicalTrials.gov to include results on all clinical trials that are required to register on the trials database, not just results for drugs and devices that are approved, licensed, or cleared for use. It also expands data elements that are accessible and proposes more frequent updating for certain data.
Other than phase I studies of drugs and biologics and small feasibility studies of devices, trials involving drugs and devices regulated by the Food and Drug Administration would be subject to the reporting requirement under this proposal, irrespective of who is funding the study.
A separate proposal by the National Institutes of Health would apply the expanded reporting proposal to all trials funded by NIH, regardless of whether those trials would otherwise not be required to report to ClinicalTrials.gov under requirements set in the FDA Amendments Act of 2007.
“The scientific community has a disappointing track record for dissemination of clinical trial results,” NIH Deputy Director for Science, Outreach and Policy Kathy Hudson, Ph.D., and Director Dr. Francis Collins wrote in a viewpoint published in JAMA (2014 Nov. 19 [doi:10.1001/jama.2014.10716]) .
The NIH officials noted that a “recent analysis of 400 clinical studies revealed that 30% had not shared results through publication or through results reporting in ClinicalTrials.gov within 4 years of completion. This is a serious issue and the proposed rule underscores the intent of NIH to take strong action to promote timely dissemination of clinical trial results.”
Comments on the proposed rule are due within 90 days of its publication in the Federal Register on Nov. 21. The response date for comments on the NIH draft policy on reporting requirements for NIH-funded studies is Feb. 19, 2015.
A proposal is being floated to make clinical trial results posted to ClinicalTrials.gov more transparent, complete, and timely, regardless of whether the trial is related to an approved product.
The Department of Health & Human Services posted a proposed rule for public inspection on Nov. 19 that would expand the reporting requirements for ClinicalTrials.gov to include results on all clinical trials that are required to register on the trials database, not just results for drugs and devices that are approved, licensed, or cleared for use. It also expands data elements that are accessible and proposes more frequent updating for certain data.
Other than phase I studies of drugs and biologics and small feasibility studies of devices, trials involving drugs and devices regulated by the Food and Drug Administration would be subject to the reporting requirement under this proposal, irrespective of who is funding the study.
A separate proposal by the National Institutes of Health would apply the expanded reporting proposal to all trials funded by NIH, regardless of whether those trials would otherwise not be required to report to ClinicalTrials.gov under requirements set in the FDA Amendments Act of 2007.
“The scientific community has a disappointing track record for dissemination of clinical trial results,” NIH Deputy Director for Science, Outreach and Policy Kathy Hudson, Ph.D., and Director Dr. Francis Collins wrote in a viewpoint published in JAMA (2014 Nov. 19 [doi:10.1001/jama.2014.10716]) .
The NIH officials noted that a “recent analysis of 400 clinical studies revealed that 30% had not shared results through publication or through results reporting in ClinicalTrials.gov within 4 years of completion. This is a serious issue and the proposed rule underscores the intent of NIH to take strong action to promote timely dissemination of clinical trial results.”
Comments on the proposed rule are due within 90 days of its publication in the Federal Register on Nov. 21. The response date for comments on the NIH draft policy on reporting requirements for NIH-funded studies is Feb. 19, 2015.
Rapid syphilis test cleared for use in medical offices, hospitals
A screening test for syphilis that can produce results in 12 minutes has been granted a waiver, allowing it “to be used in a greater variety of health care settings,” including physician’s offices, the Food and Drug Administration announced on Dec. 15.
The Syphilis Health Check test, which uses a finger stick blood sample, was granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA) to allow it to be used outside of traditional laboratory settings. The approval was based on data “demonstrating the test’s ease of use and accuracy,” according to the statement. Other settings in which it can now be used include emergency departments, maternity wards, health department clinics, and community-based organizations and testing sites.
Health care workers without special training will be allowed to perform the test, the FDA said.
When the test was initially approved in 2011, it was categorized as “moderate and high complexity” under CLIA. The current waiver was granted based on data submitted by the manufacturer. Over 4 months, the test was used in 417 people at sites that have CLIA waivers, which included physician offices. The people performing the test were not trained, and the results were highly accurate.
If the test is positive, another blood sample should be obtained during the same visit and sent to a lab for serologic testing, and patients should be further evaluated before a final diagnosis is made, the FDA advised.
“The broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection,” 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 the statement.
About 55,000 people in the United States become infected with syphilis every year, and 75% of the primary and secondary syphilis cases in 2012 were among men who have sex with men, according to estimates from the Centers for Disease Control and Prevention.
The test is manufactured by a French company, VEDA LAB, for Diagnostics Direct, LLC, which is based in the United States.
A screening test for syphilis that can produce results in 12 minutes has been granted a waiver, allowing it “to be used in a greater variety of health care settings,” including physician’s offices, the Food and Drug Administration announced on Dec. 15.
The Syphilis Health Check test, which uses a finger stick blood sample, was granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA) to allow it to be used outside of traditional laboratory settings. The approval was based on data “demonstrating the test’s ease of use and accuracy,” according to the statement. Other settings in which it can now be used include emergency departments, maternity wards, health department clinics, and community-based organizations and testing sites.
Health care workers without special training will be allowed to perform the test, the FDA said.
When the test was initially approved in 2011, it was categorized as “moderate and high complexity” under CLIA. The current waiver was granted based on data submitted by the manufacturer. Over 4 months, the test was used in 417 people at sites that have CLIA waivers, which included physician offices. The people performing the test were not trained, and the results were highly accurate.
If the test is positive, another blood sample should be obtained during the same visit and sent to a lab for serologic testing, and patients should be further evaluated before a final diagnosis is made, the FDA advised.
“The broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection,” 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 the statement.
About 55,000 people in the United States become infected with syphilis every year, and 75% of the primary and secondary syphilis cases in 2012 were among men who have sex with men, according to estimates from the Centers for Disease Control and Prevention.
The test is manufactured by a French company, VEDA LAB, for Diagnostics Direct, LLC, which is based in the United States.
A screening test for syphilis that can produce results in 12 minutes has been granted a waiver, allowing it “to be used in a greater variety of health care settings,” including physician’s offices, the Food and Drug Administration announced on Dec. 15.
The Syphilis Health Check test, which uses a finger stick blood sample, was granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA) to allow it to be used outside of traditional laboratory settings. The approval was based on data “demonstrating the test’s ease of use and accuracy,” according to the statement. Other settings in which it can now be used include emergency departments, maternity wards, health department clinics, and community-based organizations and testing sites.
Health care workers without special training will be allowed to perform the test, the FDA said.
When the test was initially approved in 2011, it was categorized as “moderate and high complexity” under CLIA. The current waiver was granted based on data submitted by the manufacturer. Over 4 months, the test was used in 417 people at sites that have CLIA waivers, which included physician offices. The people performing the test were not trained, and the results were highly accurate.
If the test is positive, another blood sample should be obtained during the same visit and sent to a lab for serologic testing, and patients should be further evaluated before a final diagnosis is made, the FDA advised.
“The broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection,” 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 the statement.
About 55,000 people in the United States become infected with syphilis every year, and 75% of the primary and secondary syphilis cases in 2012 were among men who have sex with men, according to estimates from the Centers for Disease Control and Prevention.
The test is manufactured by a French company, VEDA LAB, for Diagnostics Direct, LLC, which is based in the United States.
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.
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
HHS Funds Programs That Combat Chronic Diseases
Every year, chronic diseases cause 7 of every 10 deaths among Americans and account for > 80% of the $2.7 trillion the U.S. government spends annually on health care, according to the HHS. That’s why HHS is awarding 193 grants at nearly $212 million to support programs aimed at preventing chronic diseases. Funded in part by the Affordable Care Act (ACA) and administered by the CDC, these grants are going to states, large and small cities and counties, tribes and tribal organizations, and national and community organizations.
The grants are organized according to programs that address death and disability due to tobacco use, obesity, diabetes, heart disease, and stroke. All 6 programs address ≥ 1 of the leading risk factors for chronic disease: tobacco use, poor nutrition, and physical inactivity. Some also address key health system improvements and community supports to help Americans manage chronic conditions, such as high blood pressure and prediabetes.
Some of the funding, almost $40 million, will go to Partnerships to Improve Community Health (PICH), the newest generation in CDC’s community health initiatives that target chronic disease. The PICH initiative uses “evidence- and practice-based strategies to create or strengthen healthy environments that make it easier for people to make healthy choices,” according to the CDC.
Another program, REACH (Racial and Ethnic Approaches to Community Health), will receive about $35 million to support tribal and other organizations in public health strategies to reduce tobacco use and exposure, improve nutrition, and increase physical activity.
A new initiative, A Comprehensive Approach to Good Health and Wellness in Indian Country, will receive $11.3 million for its holistic approach to population health and wellness, which uses community-chosen and culturally adapted public health interventions to, for instance, increase support for breastfeeding and increase health literacy.
Commenting on the grants, HHS Secretary Sylvia M. Burwell said they represent “important progress in our work to transition from a health care system focused on treating the sick to one that also helps keep people well throughout their lives.”
Every year, chronic diseases cause 7 of every 10 deaths among Americans and account for > 80% of the $2.7 trillion the U.S. government spends annually on health care, according to the HHS. That’s why HHS is awarding 193 grants at nearly $212 million to support programs aimed at preventing chronic diseases. Funded in part by the Affordable Care Act (ACA) and administered by the CDC, these grants are going to states, large and small cities and counties, tribes and tribal organizations, and national and community organizations.
The grants are organized according to programs that address death and disability due to tobacco use, obesity, diabetes, heart disease, and stroke. All 6 programs address ≥ 1 of the leading risk factors for chronic disease: tobacco use, poor nutrition, and physical inactivity. Some also address key health system improvements and community supports to help Americans manage chronic conditions, such as high blood pressure and prediabetes.
Some of the funding, almost $40 million, will go to Partnerships to Improve Community Health (PICH), the newest generation in CDC’s community health initiatives that target chronic disease. The PICH initiative uses “evidence- and practice-based strategies to create or strengthen healthy environments that make it easier for people to make healthy choices,” according to the CDC.
Another program, REACH (Racial and Ethnic Approaches to Community Health), will receive about $35 million to support tribal and other organizations in public health strategies to reduce tobacco use and exposure, improve nutrition, and increase physical activity.
A new initiative, A Comprehensive Approach to Good Health and Wellness in Indian Country, will receive $11.3 million for its holistic approach to population health and wellness, which uses community-chosen and culturally adapted public health interventions to, for instance, increase support for breastfeeding and increase health literacy.
Commenting on the grants, HHS Secretary Sylvia M. Burwell said they represent “important progress in our work to transition from a health care system focused on treating the sick to one that also helps keep people well throughout their lives.”
Every year, chronic diseases cause 7 of every 10 deaths among Americans and account for > 80% of the $2.7 trillion the U.S. government spends annually on health care, according to the HHS. That’s why HHS is awarding 193 grants at nearly $212 million to support programs aimed at preventing chronic diseases. Funded in part by the Affordable Care Act (ACA) and administered by the CDC, these grants are going to states, large and small cities and counties, tribes and tribal organizations, and national and community organizations.
The grants are organized according to programs that address death and disability due to tobacco use, obesity, diabetes, heart disease, and stroke. All 6 programs address ≥ 1 of the leading risk factors for chronic disease: tobacco use, poor nutrition, and physical inactivity. Some also address key health system improvements and community supports to help Americans manage chronic conditions, such as high blood pressure and prediabetes.
Some of the funding, almost $40 million, will go to Partnerships to Improve Community Health (PICH), the newest generation in CDC’s community health initiatives that target chronic disease. The PICH initiative uses “evidence- and practice-based strategies to create or strengthen healthy environments that make it easier for people to make healthy choices,” according to the CDC.
Another program, REACH (Racial and Ethnic Approaches to Community Health), will receive about $35 million to support tribal and other organizations in public health strategies to reduce tobacco use and exposure, improve nutrition, and increase physical activity.
A new initiative, A Comprehensive Approach to Good Health and Wellness in Indian Country, will receive $11.3 million for its holistic approach to population health and wellness, which uses community-chosen and culturally adapted public health interventions to, for instance, increase support for breastfeeding and increase health literacy.
Commenting on the grants, HHS Secretary Sylvia M. Burwell said they represent “important progress in our work to transition from a health care system focused on treating the sick to one that also helps keep people well throughout their lives.”
VA Updates Disability Claims Application Process
VA is updating its process for filing claims and initiating appeals by introducing a standard form. By using standardized forms, VA can more quickly and accurately identify the nature of the claim or appeal and what benefits the veteran is seeking. The new forms “eliminate applicant guesswork,” according to a September 24, 2014, VA press release, “which often leads to delays in decisions and ultimately delays in receiving benefits.”
The new process will allow VA to move on to next steps in evidence-gathering and decision-making, which will not only make it easier for applicants, but also help save processing time and costs.
Previously, a veteran or survivor could submit claims or appeals on any piece of paper, which caused delays due to missing information. That process also is inconsistent with “most, if not all,” other government and nongovernment application processes, such as applying for a driver’s license or filing for an income tax refund. “We worked extensively with our partners in the veterans’ community to streamline the way we process claims,” said Under Secretary for Benefits Allison A. Hickey. For instance, she notes that the updated process now includes a new Intent to File a Claim process, allowing the veteran or survivor up to 1 year to compile the necessary documentation or evidence to support the claim while preserving an effective date of claim.
“We must do everything we can to make it as fast and easy as possible for veterans and their survivors to file for and receive an accurate decision on their claim,” said Secretary of Veterans Affairs Robert A. McDonald. Applicants will know at the outset what is needed, which removes subjective interpretation from the process, he adds. “We want to eliminate any barriers that make it difficult for our veterans or survivors to receive benefits to which they are entitled.”
The new regulations will go into effect in March 2015.
VA is updating its process for filing claims and initiating appeals by introducing a standard form. By using standardized forms, VA can more quickly and accurately identify the nature of the claim or appeal and what benefits the veteran is seeking. The new forms “eliminate applicant guesswork,” according to a September 24, 2014, VA press release, “which often leads to delays in decisions and ultimately delays in receiving benefits.”
The new process will allow VA to move on to next steps in evidence-gathering and decision-making, which will not only make it easier for applicants, but also help save processing time and costs.
Previously, a veteran or survivor could submit claims or appeals on any piece of paper, which caused delays due to missing information. That process also is inconsistent with “most, if not all,” other government and nongovernment application processes, such as applying for a driver’s license or filing for an income tax refund. “We worked extensively with our partners in the veterans’ community to streamline the way we process claims,” said Under Secretary for Benefits Allison A. Hickey. For instance, she notes that the updated process now includes a new Intent to File a Claim process, allowing the veteran or survivor up to 1 year to compile the necessary documentation or evidence to support the claim while preserving an effective date of claim.
“We must do everything we can to make it as fast and easy as possible for veterans and their survivors to file for and receive an accurate decision on their claim,” said Secretary of Veterans Affairs Robert A. McDonald. Applicants will know at the outset what is needed, which removes subjective interpretation from the process, he adds. “We want to eliminate any barriers that make it difficult for our veterans or survivors to receive benefits to which they are entitled.”
The new regulations will go into effect in March 2015.
VA is updating its process for filing claims and initiating appeals by introducing a standard form. By using standardized forms, VA can more quickly and accurately identify the nature of the claim or appeal and what benefits the veteran is seeking. The new forms “eliminate applicant guesswork,” according to a September 24, 2014, VA press release, “which often leads to delays in decisions and ultimately delays in receiving benefits.”
The new process will allow VA to move on to next steps in evidence-gathering and decision-making, which will not only make it easier for applicants, but also help save processing time and costs.
Previously, a veteran or survivor could submit claims or appeals on any piece of paper, which caused delays due to missing information. That process also is inconsistent with “most, if not all,” other government and nongovernment application processes, such as applying for a driver’s license or filing for an income tax refund. “We worked extensively with our partners in the veterans’ community to streamline the way we process claims,” said Under Secretary for Benefits Allison A. Hickey. For instance, she notes that the updated process now includes a new Intent to File a Claim process, allowing the veteran or survivor up to 1 year to compile the necessary documentation or evidence to support the claim while preserving an effective date of claim.
“We must do everything we can to make it as fast and easy as possible for veterans and their survivors to file for and receive an accurate decision on their claim,” said Secretary of Veterans Affairs Robert A. McDonald. Applicants will know at the outset what is needed, which removes subjective interpretation from the process, he adds. “We want to eliminate any barriers that make it difficult for our veterans or survivors to receive benefits to which they are entitled.”
The new regulations will go into effect in March 2015.
CDC predicts bad flu season, stresses vaccination, antiviral treatment
The 2014-2015 flu season may be particularly severe, and the 2014-2015 vaccine will provide important, but limited protection, according to a health advisory from the Centers for Disease Control and Prevention that is based on early analyses of reported disease cases.
The advisory also stresses the importance of antiviral treatment in those with confirmed or suspected influenza, particularly those at risk of developing complications, including young children, adults aged 65 years and older, pregnant women, and those with chronic health conditions, such as asthma, diabetes, or heart, lung, or kidney disease.
Influenza A viruses, mainly H3N2, predominate thus far during the 2014-2015 flu season, comprising more than 91% of the specimens collected and analyzed, and only about half of those have been antigenically similar to H3N2 components included in the 2014-2015 vaccine, according to the advisory.
This doesn’t bode well for the effectiveness of the vaccine, which is particularly troubling given that H3N2-predominate seasons historically have been associated with up to twice the rate of overall and age-specific flu-related hospitalizations and deaths, CDC director Dr. Thomas R. Frieden explained during a press briefing.
Still, vaccination remains the best line of defense against infection, he said.
The vaccine will protect against circulating strains that have not undergone significant antigenic drift, including the influenza B viruses, which have comprised about 9% of those collected to date. In addition, the vaccine has been found to provide some protection against the antigenically drifted H3N2 viruses, he said.
“We continue to recommend flu vaccine as the single best way to protect yourself against the flu,” he said.
Dr. Frieden also stressed the importance of antiviral use.
“Antivirals aren’t a substitute for vaccinations … but they are an important second line of defense for treating the flu, and this year, treatment with antiviral drugs is especially important, particularly for people who are at high risk for serious flu complications or for people who are very sick with flu,” he said.
These agents are greatly underprescribed, with fewer than one in six severely ill patients receiving antiviral treatment, he noted.
“It’s very important that we do better for people who are severely ill or who could become severely ill with influenza,” he said, adding that antiviral use is even more important during seasons such as this one when the circulating viruses are different from the vaccine viruses.
The two neuraminidase inhibitor antiviral medications currently approved for treating influenza – oseltamivir and zanamivir – shorten the duration of fever and illness symptoms by about a day and can reduce the risk of severe outcomes, he said.
Treatment should be provided withing 2 days of symptoms onset when possible, but it may also provide benefit to hospitalized patients even if taken later in the course of illness.
“We strongly recommend that if doctors suspect the flu in someone who may be severely ill from the flu, they don’t wait for the results of a flu test before starting antivirals,” he said.
“There is no way to predict with certainly what will happen. We have four different strains of flu circulating. The B strain, the H1 strain, the well-matched H3 strain, and the poorly matched H3 strain. Only time will tell which of them, if any, will predominate for the coming weeks and months of this year’s flu season,” he said.
However, already this season there have been five pediatric deaths from influenza, including three in patients with H3N2 disease, and one in a patient with influenza type B.
“We’ve also heard of outbreaks in schools and in nursing homes,” Dr. Frieden said, adding that “getting a vaccine, even if it doesn’t provide as good protection as we would hope, would be more important than ever, and remains the single most effective way to protect yourself against the flu.”
Physicians should continue to vaccinate patients, he said, noting that nearly 150 million doses have been distributed by manufacturers, and that the supply is expected to meet the demand. The supply of antiviral medications is also expected to be adequate.
Patients should also be advised to stay home when they are sick to avoid spreading influenza, and to seek treatment promptly for flu symptoms, including fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, and fatigue, he said.
 |
| Dr. Daniel R. Ouellette |
Dr. Daniel R. Ouellette, FCCP, comments: "Every time I take the vaccine, I get the flu. Besides, it doesn't work this year. I heard it on the news."
Sheila, a woman in her 50s with asthma, responded to my advice to be inoculated with the influenza vaccine this fall with this refrain. Refrain indeed, because my patients sing this song on a daily basis. Simply telling them that I know that the vaccine doesn't cause the flu isn't effective. Responding with an anecdote about patients who have been under my care in the ICU, who were previously healthy, and who died of influenza, works better. Following this with the statement that 'I make sure that I get vaccinated every year' seems to work the best.
And yet, there is some truth to the statement above. The CDC has informed us that not all strains of influenza will be covered by this year's version of the vaccine. Despite this, our patients will have increased protection by getting vaccinated, and we must be advocates for this measure. However, we also must be vigilant this year so that we may identify influenza cases early, and start antiviral treatment when appropriate, to limit the effects of this disease.
Dr. Ouellette is with the Pulmonary Disease Service at Henry Ford Hospital in Detroit, MI.
|
| Dr. Daniel R. Ouellette |
Dr. Daniel R. Ouellette, FCCP, comments: "Every time I take the vaccine, I get the flu. Besides, it doesn't work this year. I heard it on the news."
Sheila, a woman in her 50s with asthma, responded to my advice to be inoculated with the influenza vaccine this fall with this refrain. Refrain indeed, because my patients sing this song on a daily basis. Simply telling them that I know that the vaccine doesn't cause the flu isn't effective. Responding with an anecdote about patients who have been under my care in the ICU, who were previously healthy, and who died of influenza, works better. Following this with the statement that 'I make sure that I get vaccinated every year' seems to work the best.
And yet, there is some truth to the statement above. The CDC has informed us that not all strains of influenza will be covered by this year's version of the vaccine. Despite this, our patients will have increased protection by getting vaccinated, and we must be advocates for this measure. However, we also must be vigilant this year so that we may identify influenza cases early, and start antiviral treatment when appropriate, to limit the effects of this disease.
Dr. Ouellette is with the Pulmonary Disease Service at Henry Ford Hospital in Detroit, MI.
|
| Dr. Daniel R. Ouellette |
Dr. Daniel R. Ouellette, FCCP, comments: "Every time I take the vaccine, I get the flu. Besides, it doesn't work this year. I heard it on the news."
Sheila, a woman in her 50s with asthma, responded to my advice to be inoculated with the influenza vaccine this fall with this refrain. Refrain indeed, because my patients sing this song on a daily basis. Simply telling them that I know that the vaccine doesn't cause the flu isn't effective. Responding with an anecdote about patients who have been under my care in the ICU, who were previously healthy, and who died of influenza, works better. Following this with the statement that 'I make sure that I get vaccinated every year' seems to work the best.
And yet, there is some truth to the statement above. The CDC has informed us that not all strains of influenza will be covered by this year's version of the vaccine. Despite this, our patients will have increased protection by getting vaccinated, and we must be advocates for this measure. However, we also must be vigilant this year so that we may identify influenza cases early, and start antiviral treatment when appropriate, to limit the effects of this disease.
Dr. Ouellette is with the Pulmonary Disease Service at Henry Ford Hospital in Detroit, MI.
The 2014-2015 flu season may be particularly severe, and the 2014-2015 vaccine will provide important, but limited protection, according to a health advisory from the Centers for Disease Control and Prevention that is based on early analyses of reported disease cases.
The advisory also stresses the importance of antiviral treatment in those with confirmed or suspected influenza, particularly those at risk of developing complications, including young children, adults aged 65 years and older, pregnant women, and those with chronic health conditions, such as asthma, diabetes, or heart, lung, or kidney disease.
Influenza A viruses, mainly H3N2, predominate thus far during the 2014-2015 flu season, comprising more than 91% of the specimens collected and analyzed, and only about half of those have been antigenically similar to H3N2 components included in the 2014-2015 vaccine, according to the advisory.
This doesn’t bode well for the effectiveness of the vaccine, which is particularly troubling given that H3N2-predominate seasons historically have been associated with up to twice the rate of overall and age-specific flu-related hospitalizations and deaths, CDC director Dr. Thomas R. Frieden explained during a press briefing.
Still, vaccination remains the best line of defense against infection, he said.
The vaccine will protect against circulating strains that have not undergone significant antigenic drift, including the influenza B viruses, which have comprised about 9% of those collected to date. In addition, the vaccine has been found to provide some protection against the antigenically drifted H3N2 viruses, he said.
“We continue to recommend flu vaccine as the single best way to protect yourself against the flu,” he said.
Dr. Frieden also stressed the importance of antiviral use.
“Antivirals aren’t a substitute for vaccinations … but they are an important second line of defense for treating the flu, and this year, treatment with antiviral drugs is especially important, particularly for people who are at high risk for serious flu complications or for people who are very sick with flu,” he said.
These agents are greatly underprescribed, with fewer than one in six severely ill patients receiving antiviral treatment, he noted.
“It’s very important that we do better for people who are severely ill or who could become severely ill with influenza,” he said, adding that antiviral use is even more important during seasons such as this one when the circulating viruses are different from the vaccine viruses.
The two neuraminidase inhibitor antiviral medications currently approved for treating influenza – oseltamivir and zanamivir – shorten the duration of fever and illness symptoms by about a day and can reduce the risk of severe outcomes, he said.
Treatment should be provided withing 2 days of symptoms onset when possible, but it may also provide benefit to hospitalized patients even if taken later in the course of illness.
“We strongly recommend that if doctors suspect the flu in someone who may be severely ill from the flu, they don’t wait for the results of a flu test before starting antivirals,” he said.
“There is no way to predict with certainly what will happen. We have four different strains of flu circulating. The B strain, the H1 strain, the well-matched H3 strain, and the poorly matched H3 strain. Only time will tell which of them, if any, will predominate for the coming weeks and months of this year’s flu season,” he said.
However, already this season there have been five pediatric deaths from influenza, including three in patients with H3N2 disease, and one in a patient with influenza type B.
“We’ve also heard of outbreaks in schools and in nursing homes,” Dr. Frieden said, adding that “getting a vaccine, even if it doesn’t provide as good protection as we would hope, would be more important than ever, and remains the single most effective way to protect yourself against the flu.”
Physicians should continue to vaccinate patients, he said, noting that nearly 150 million doses have been distributed by manufacturers, and that the supply is expected to meet the demand. The supply of antiviral medications is also expected to be adequate.
Patients should also be advised to stay home when they are sick to avoid spreading influenza, and to seek treatment promptly for flu symptoms, including fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, and fatigue, he said.
The 2014-2015 flu season may be particularly severe, and the 2014-2015 vaccine will provide important, but limited protection, according to a health advisory from the Centers for Disease Control and Prevention that is based on early analyses of reported disease cases.
The advisory also stresses the importance of antiviral treatment in those with confirmed or suspected influenza, particularly those at risk of developing complications, including young children, adults aged 65 years and older, pregnant women, and those with chronic health conditions, such as asthma, diabetes, or heart, lung, or kidney disease.
Influenza A viruses, mainly H3N2, predominate thus far during the 2014-2015 flu season, comprising more than 91% of the specimens collected and analyzed, and only about half of those have been antigenically similar to H3N2 components included in the 2014-2015 vaccine, according to the advisory.
This doesn’t bode well for the effectiveness of the vaccine, which is particularly troubling given that H3N2-predominate seasons historically have been associated with up to twice the rate of overall and age-specific flu-related hospitalizations and deaths, CDC director Dr. Thomas R. Frieden explained during a press briefing.
Still, vaccination remains the best line of defense against infection, he said.
The vaccine will protect against circulating strains that have not undergone significant antigenic drift, including the influenza B viruses, which have comprised about 9% of those collected to date. In addition, the vaccine has been found to provide some protection against the antigenically drifted H3N2 viruses, he said.
“We continue to recommend flu vaccine as the single best way to protect yourself against the flu,” he said.
Dr. Frieden also stressed the importance of antiviral use.
“Antivirals aren’t a substitute for vaccinations … but they are an important second line of defense for treating the flu, and this year, treatment with antiviral drugs is especially important, particularly for people who are at high risk for serious flu complications or for people who are very sick with flu,” he said.
These agents are greatly underprescribed, with fewer than one in six severely ill patients receiving antiviral treatment, he noted.
“It’s very important that we do better for people who are severely ill or who could become severely ill with influenza,” he said, adding that antiviral use is even more important during seasons such as this one when the circulating viruses are different from the vaccine viruses.
The two neuraminidase inhibitor antiviral medications currently approved for treating influenza – oseltamivir and zanamivir – shorten the duration of fever and illness symptoms by about a day and can reduce the risk of severe outcomes, he said.
Treatment should be provided withing 2 days of symptoms onset when possible, but it may also provide benefit to hospitalized patients even if taken later in the course of illness.
“We strongly recommend that if doctors suspect the flu in someone who may be severely ill from the flu, they don’t wait for the results of a flu test before starting antivirals,” he said.
“There is no way to predict with certainly what will happen. We have four different strains of flu circulating. The B strain, the H1 strain, the well-matched H3 strain, and the poorly matched H3 strain. Only time will tell which of them, if any, will predominate for the coming weeks and months of this year’s flu season,” he said.
However, already this season there have been five pediatric deaths from influenza, including three in patients with H3N2 disease, and one in a patient with influenza type B.
“We’ve also heard of outbreaks in schools and in nursing homes,” Dr. Frieden said, adding that “getting a vaccine, even if it doesn’t provide as good protection as we would hope, would be more important than ever, and remains the single most effective way to protect yourself against the flu.”
Physicians should continue to vaccinate patients, he said, noting that nearly 150 million doses have been distributed by manufacturers, and that the supply is expected to meet the demand. The supply of antiviral medications is also expected to be adequate.
Patients should also be advised to stay home when they are sick to avoid spreading influenza, and to seek treatment promptly for flu symptoms, including fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, and fatigue, he said.
