Alicia Ault

The Food and Drug Administration has approved a new agent for the urgent reversal of vitamin K antagonist anticoagulation in adults with acute major bleeding.

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

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

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

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

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

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

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

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

aault@frontlinemedcom.com

The Food and Drug Administration has approved a new agent for the urgent reversal of vitamin K antagonist anticoagulation in adults with acute major bleeding.

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

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

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

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

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

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

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

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

aault@frontlinemedcom.com

The Food and Drug Administration has approved a new agent for the urgent reversal of vitamin K antagonist anticoagulation in adults with acute major bleeding.

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

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

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

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

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

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

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

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

aault@frontlinemedcom.com

The Internal Revenue Service has issued the final regulation on collecting a 10% tax on tanning salon receipts as called for by the Affordable Care Act.

The tax first went into effect in July 2010 under temporary regulations while the IRS collected comments on the proposal. Updated regulations were issued and opened for comments in 2012.

Tanning salons have widely complained about the tax, which they said would help drive many of them out of business.

It’s not clear whether that has come to pass, Dr. Jack Resneck Jr., a member of the American Academy of Dermatology board of directors, said in a statement.

"It’s too early to assess the full impact of the tanning tax, but we know it has provided countless opportunities to raise awareness about the dangers of indoor tanning," said Dr. Resneck, vice-chair of clinical dermatology at the University of California, San Francisco.

In 2011, the Indoor Tanning Association was able to rally Republicans in the House and Senate to sponsor a bill to repeal the tax. The campaign did not gain much ground.

"Efforts by the tanning industry to fight this important public health measure have only furthered our efforts to communicate through the media about the overwhelming evidence on the risks of indoor UV tanning," Dr. Resneck said.

"Combined with the FDA’s recent proposal to reclassify tanning beds, as well as efforts in numerous states to restrict minors’ access to indoor tanning, I am optimistic that we are witnessing a real turning point in public awareness and sentiment," he added.

The final rule exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax, as was proposed in 2010.

Phototherapy performed by, and on the premises of, a licensed medical professional also is exempted.

aault@frontlinemedcom.com On Twitter @aliciaault

The Internal Revenue Service has issued the final regulation on collecting a 10% tax on tanning salon receipts as called for by the Affordable Care Act.

The tax first went into effect in July 2010 under temporary regulations while the IRS collected comments on the proposal. Updated regulations were issued and opened for comments in 2012.

Tanning salons have widely complained about the tax, which they said would help drive many of them out of business.

It’s not clear whether that has come to pass, Dr. Jack Resneck Jr., a member of the American Academy of Dermatology board of directors, said in a statement.

"It’s too early to assess the full impact of the tanning tax, but we know it has provided countless opportunities to raise awareness about the dangers of indoor tanning," said Dr. Resneck, vice-chair of clinical dermatology at the University of California, San Francisco.

In 2011, the Indoor Tanning Association was able to rally Republicans in the House and Senate to sponsor a bill to repeal the tax. The campaign did not gain much ground.

"Efforts by the tanning industry to fight this important public health measure have only furthered our efforts to communicate through the media about the overwhelming evidence on the risks of indoor UV tanning," Dr. Resneck said.

"Combined with the FDA’s recent proposal to reclassify tanning beds, as well as efforts in numerous states to restrict minors’ access to indoor tanning, I am optimistic that we are witnessing a real turning point in public awareness and sentiment," he added.

The final rule exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax, as was proposed in 2010.

Phototherapy performed by, and on the premises of, a licensed medical professional also is exempted.

aault@frontlinemedcom.com On Twitter @aliciaault

The Internal Revenue Service has issued the final regulation on collecting a 10% tax on tanning salon receipts as called for by the Affordable Care Act.

The tax first went into effect in July 2010 under temporary regulations while the IRS collected comments on the proposal. Updated regulations were issued and opened for comments in 2012.

Tanning salons have widely complained about the tax, which they said would help drive many of them out of business.

It’s not clear whether that has come to pass, Dr. Jack Resneck Jr., a member of the American Academy of Dermatology board of directors, said in a statement.

"It’s too early to assess the full impact of the tanning tax, but we know it has provided countless opportunities to raise awareness about the dangers of indoor tanning," said Dr. Resneck, vice-chair of clinical dermatology at the University of California, San Francisco.

In 2011, the Indoor Tanning Association was able to rally Republicans in the House and Senate to sponsor a bill to repeal the tax. The campaign did not gain much ground.

"Efforts by the tanning industry to fight this important public health measure have only furthered our efforts to communicate through the media about the overwhelming evidence on the risks of indoor UV tanning," Dr. Resneck said.

"Combined with the FDA’s recent proposal to reclassify tanning beds, as well as efforts in numerous states to restrict minors’ access to indoor tanning, I am optimistic that we are witnessing a real turning point in public awareness and sentiment," he added.

The final rule exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax, as was proposed in 2010.

Phototherapy performed by, and on the premises of, a licensed medical professional also is exempted.

aault@frontlinemedcom.com On Twitter @aliciaault

WASHINGTON – The government wants you to analyze its data and come up with solutions to health system problems.

At Health Datapalooza IV, an annual conference dedicated to health data transparency, the Health and Human Services Department released vast amounts of data on electronic health record use and vendors, top outpatient procedures, and county-level data on Medicare expenditures and chronic conditions.

Alicia Ault/IMNG Medical Media

"A more data driven and transparent health care marketplace can help consumers and their families make important decisions about their care," HHS Secretary Kathleen Sebelius said in a statement. "The administration is committed to making the health system more transparent and harnessing data to empower consumers."

When it comes to electronic health records (EHR), the HHS Office of the National Coordinator for Health Information Technology (ONC) made public a huge database of information on 146,000 physicians who have sought help on how to become meaningful users of EHRs from the ONC’s 62 Regional Extension Centers.

The extension centers were established largely to help primary care physicians, especially those who work in underserved communities, Mat Kendall, director of the ONC Office of Provider Adoption Support, said in an interview. There are about 310,000 primary care physicians in the United States; a little less than half are working with an extension center, he said.

The database includes a unique identification for each provider or practice, and lists practice type, specialty, the stage of meaningful use, EHR vendor, and whether the practice has had issues that vendor.

If the data were aggregated, physicians might be able to see how many of their colleagues have experienced similar challenges with a particular EHR or vendor. Or, physicians could tell how many of their peers had reached meaningful use via a particular EHR, said Mr. Kendall.

"Ultimately what we’re trying to do is facilitate a way for people linking together," he said.

Sharing the data on those 146,000 physicians’ experience could help more physicians get to meaningful use, Mr. Kendall said. "We’ve really been working hard to analyze the data ourselves to identify opportunities for improvement, as well as challenges," he said. Now, others will be able to sift through it and look for weak and strong points, he said.

Overall, as of the end of April, more than 291,000 physicians and other eligible professionals had received incentive payments from the Medicare and Medicaid EHR Incentive Programs. Physicians can earn up to $44,000 in bonus payments from Medicare by being meaningful users of EHRs, and up to $63,750 over 6 years from Medicaid.

Also at the meeting, HHS officials announced they were releasing data on hospital charges for 30 outpatient procedures, including clinic visits, echocardiograms, and endoscopies, following the release in May of charge data on the 100 most common inpatient procedures performed on Medicare patients.

"I know that those of you in this room can help us figure out ways to make that data come alive, for policy makers, for researchers, and consumers," said Ms. Sebelius.

Finally, the agency made public a database on Medicare spending and use and chronic conditions in beneficiaries, down to the county level. In a statement, HHS officials said that these databases will help researchers, data innovators, and the public better understand Medicare spending and service use.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – The government wants you to analyze its data and come up with solutions to health system problems.

At Health Datapalooza IV, an annual conference dedicated to health data transparency, the Health and Human Services Department released vast amounts of data on electronic health record use and vendors, top outpatient procedures, and county-level data on Medicare expenditures and chronic conditions.

Alicia Ault/IMNG Medical Media

"A more data driven and transparent health care marketplace can help consumers and their families make important decisions about their care," HHS Secretary Kathleen Sebelius said in a statement. "The administration is committed to making the health system more transparent and harnessing data to empower consumers."

When it comes to electronic health records (EHR), the HHS Office of the National Coordinator for Health Information Technology (ONC) made public a huge database of information on 146,000 physicians who have sought help on how to become meaningful users of EHRs from the ONC’s 62 Regional Extension Centers.

The extension centers were established largely to help primary care physicians, especially those who work in underserved communities, Mat Kendall, director of the ONC Office of Provider Adoption Support, said in an interview. There are about 310,000 primary care physicians in the United States; a little less than half are working with an extension center, he said.

The database includes a unique identification for each provider or practice, and lists practice type, specialty, the stage of meaningful use, EHR vendor, and whether the practice has had issues that vendor.

If the data were aggregated, physicians might be able to see how many of their colleagues have experienced similar challenges with a particular EHR or vendor. Or, physicians could tell how many of their peers had reached meaningful use via a particular EHR, said Mr. Kendall.

"Ultimately what we’re trying to do is facilitate a way for people linking together," he said.

Sharing the data on those 146,000 physicians’ experience could help more physicians get to meaningful use, Mr. Kendall said. "We’ve really been working hard to analyze the data ourselves to identify opportunities for improvement, as well as challenges," he said. Now, others will be able to sift through it and look for weak and strong points, he said.

Overall, as of the end of April, more than 291,000 physicians and other eligible professionals had received incentive payments from the Medicare and Medicaid EHR Incentive Programs. Physicians can earn up to $44,000 in bonus payments from Medicare by being meaningful users of EHRs, and up to $63,750 over 6 years from Medicaid.

Also at the meeting, HHS officials announced they were releasing data on hospital charges for 30 outpatient procedures, including clinic visits, echocardiograms, and endoscopies, following the release in May of charge data on the 100 most common inpatient procedures performed on Medicare patients.

"I know that those of you in this room can help us figure out ways to make that data come alive, for policy makers, for researchers, and consumers," said Ms. Sebelius.

Finally, the agency made public a database on Medicare spending and use and chronic conditions in beneficiaries, down to the county level. In a statement, HHS officials said that these databases will help researchers, data innovators, and the public better understand Medicare spending and service use.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – The government wants you to analyze its data and come up with solutions to health system problems.

At Health Datapalooza IV, an annual conference dedicated to health data transparency, the Health and Human Services Department released vast amounts of data on electronic health record use and vendors, top outpatient procedures, and county-level data on Medicare expenditures and chronic conditions.

Alicia Ault/IMNG Medical Media

"A more data driven and transparent health care marketplace can help consumers and their families make important decisions about their care," HHS Secretary Kathleen Sebelius said in a statement. "The administration is committed to making the health system more transparent and harnessing data to empower consumers."

When it comes to electronic health records (EHR), the HHS Office of the National Coordinator for Health Information Technology (ONC) made public a huge database of information on 146,000 physicians who have sought help on how to become meaningful users of EHRs from the ONC’s 62 Regional Extension Centers.

The extension centers were established largely to help primary care physicians, especially those who work in underserved communities, Mat Kendall, director of the ONC Office of Provider Adoption Support, said in an interview. There are about 310,000 primary care physicians in the United States; a little less than half are working with an extension center, he said.

The database includes a unique identification for each provider or practice, and lists practice type, specialty, the stage of meaningful use, EHR vendor, and whether the practice has had issues that vendor.

If the data were aggregated, physicians might be able to see how many of their colleagues have experienced similar challenges with a particular EHR or vendor. Or, physicians could tell how many of their peers had reached meaningful use via a particular EHR, said Mr. Kendall.

"Ultimately what we’re trying to do is facilitate a way for people linking together," he said.

Sharing the data on those 146,000 physicians’ experience could help more physicians get to meaningful use, Mr. Kendall said. "We’ve really been working hard to analyze the data ourselves to identify opportunities for improvement, as well as challenges," he said. Now, others will be able to sift through it and look for weak and strong points, he said.

Overall, as of the end of April, more than 291,000 physicians and other eligible professionals had received incentive payments from the Medicare and Medicaid EHR Incentive Programs. Physicians can earn up to $44,000 in bonus payments from Medicare by being meaningful users of EHRs, and up to $63,750 over 6 years from Medicaid.

Also at the meeting, HHS officials announced they were releasing data on hospital charges for 30 outpatient procedures, including clinic visits, echocardiograms, and endoscopies, following the release in May of charge data on the 100 most common inpatient procedures performed on Medicare patients.

"I know that those of you in this room can help us figure out ways to make that data come alive, for policy makers, for researchers, and consumers," said Ms. Sebelius.

Finally, the agency made public a database on Medicare spending and use and chronic conditions in beneficiaries, down to the county level. In a statement, HHS officials said that these databases will help researchers, data innovators, and the public better understand Medicare spending and service use.

aault@frontlinemedcom.com

On Twitter @aliciaault

Republicans on the House Energy and Commerce Committee have released a draft bill that would eliminate the Medicare Sustainable Growth Rate formula that they say has a good chance of being enacted.

Physician groups have been involved in the crafting of the draft, which was first circulated in early February.

Alicia Ault/IMNG Medical Media

"This discussion draft carries on the trend of soliciting more provider feedback than at any point in history on this issue," Rep. Michael Burgess (R-Tex.) said in a statement. "We are taking an important next step with this release by showing providers that we are committed to repealing the SGR and maintaining the option of fee-for-service for providers, while improving the Medicare program."

Rep. Burgess, who is an ob.gyn., and also vice chairman of the Energy and Commerce Health Subcommittee, said that he and his colleagues looked forward to hearing more from physicians.

The draft legislation would repeal the SGR and replace it with a fee-for-service system that would put more emphasis on rewarding quality. Physicians would have a guiding hand in developing quality measures in conjunction with the secretary of Health and Human Services. They would also be given the ability to opt out of fee-for-service and practice instead under new delivery models like accountable care organizations or patient-centered medical homes.

"We are working to restore certainty, fiscal sanity, and we will responsibly pay for these reforms," said Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce committee, in a statement. "We will continue working closely with Ways and Means Committee Chairman [Dave] Camp [R-Mich.] as well as maintain our ongoing dialogue with committee Democrats as we work toward long-term solutions in the effort to improve quality of care."

Physician groups were cautious about the proposal at press time. In a statement, Dr. Jeremy Lazarus, president of the American Medical Association, said, "The Energy and Commerce Committee’s framework is another step in the important process of eliminating the SGR and moving toward new ways of delivering and paying for care that reward quality and reduce costs."

He said that the AMA "look[ed] forward to continuing to work to see that progress is made this year."

The American Academy of Family Physicians supports the proposal’s goal of establishing "a period of stable and predictable payment increases," and incentives to improve quality of care, said Dr. Jeffrey Cain, AAFP president, in an interview.

But by largely focusing on the fee-for-service payment system, the committee is overlooking the bigger picture of how physician payment affects health care costs and quality, he said. The AAFP would like to see an increase in pay for primary care because "investing in primary care would improve our country’s health care by increasing quality and decreasing overall costs by reducing unnecessary medical utilization," said Dr. Cain.

In early February, the American College of Physicians and several other groups lent their support to an SGR replacement bill that has elements similar to the Energy and Commerce draft. The bill, the Medicare Physician Payment Innovation Act (H.R. 574), was introduced by Reps. Allyson Schwartz (D-Penn.) and Joe Heck (R-Nev.).

In early May, Rep. Schwartz commended the Energy and Commerce bill, noting that it shared principles in common with H.R. 574. The bill also showed "that there is common ground on a framework for fixing the Medicare reimbursement system," said Rep. Schwartz in a statement.

The Energy and Commerce Committee said that comments on its draft legislation would be accepted until June 10, at SGRComments@mail.house.gov.

aault@frontlinemedcom.com

On Twitter @aliciaault

Republicans on the House Energy and Commerce Committee have released a draft bill that would eliminate the Medicare Sustainable Growth Rate formula that they say has a good chance of being enacted.

Physician groups have been involved in the crafting of the draft, which was first circulated in early February.

Alicia Ault/IMNG Medical Media

"This discussion draft carries on the trend of soliciting more provider feedback than at any point in history on this issue," Rep. Michael Burgess (R-Tex.) said in a statement. "We are taking an important next step with this release by showing providers that we are committed to repealing the SGR and maintaining the option of fee-for-service for providers, while improving the Medicare program."

Rep. Burgess, who is an ob.gyn., and also vice chairman of the Energy and Commerce Health Subcommittee, said that he and his colleagues looked forward to hearing more from physicians.

The draft legislation would repeal the SGR and replace it with a fee-for-service system that would put more emphasis on rewarding quality. Physicians would have a guiding hand in developing quality measures in conjunction with the secretary of Health and Human Services. They would also be given the ability to opt out of fee-for-service and practice instead under new delivery models like accountable care organizations or patient-centered medical homes.

"We are working to restore certainty, fiscal sanity, and we will responsibly pay for these reforms," said Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce committee, in a statement. "We will continue working closely with Ways and Means Committee Chairman [Dave] Camp [R-Mich.] as well as maintain our ongoing dialogue with committee Democrats as we work toward long-term solutions in the effort to improve quality of care."

Physician groups were cautious about the proposal at press time. In a statement, Dr. Jeremy Lazarus, president of the American Medical Association, said, "The Energy and Commerce Committee’s framework is another step in the important process of eliminating the SGR and moving toward new ways of delivering and paying for care that reward quality and reduce costs."

He said that the AMA "look[ed] forward to continuing to work to see that progress is made this year."

The American Academy of Family Physicians supports the proposal’s goal of establishing "a period of stable and predictable payment increases," and incentives to improve quality of care, said Dr. Jeffrey Cain, AAFP president, in an interview.

But by largely focusing on the fee-for-service payment system, the committee is overlooking the bigger picture of how physician payment affects health care costs and quality, he said. The AAFP would like to see an increase in pay for primary care because "investing in primary care would improve our country’s health care by increasing quality and decreasing overall costs by reducing unnecessary medical utilization," said Dr. Cain.

In early February, the American College of Physicians and several other groups lent their support to an SGR replacement bill that has elements similar to the Energy and Commerce draft. The bill, the Medicare Physician Payment Innovation Act (H.R. 574), was introduced by Reps. Allyson Schwartz (D-Penn.) and Joe Heck (R-Nev.).

In early May, Rep. Schwartz commended the Energy and Commerce bill, noting that it shared principles in common with H.R. 574. The bill also showed "that there is common ground on a framework for fixing the Medicare reimbursement system," said Rep. Schwartz in a statement.

The Energy and Commerce Committee said that comments on its draft legislation would be accepted until June 10, at SGRComments@mail.house.gov.

aault@frontlinemedcom.com

On Twitter @aliciaault

Republicans on the House Energy and Commerce Committee have released a draft bill that would eliminate the Medicare Sustainable Growth Rate formula that they say has a good chance of being enacted.

Physician groups have been involved in the crafting of the draft, which was first circulated in early February.

Alicia Ault/IMNG Medical Media

"This discussion draft carries on the trend of soliciting more provider feedback than at any point in history on this issue," Rep. Michael Burgess (R-Tex.) said in a statement. "We are taking an important next step with this release by showing providers that we are committed to repealing the SGR and maintaining the option of fee-for-service for providers, while improving the Medicare program."

Rep. Burgess, who is an ob.gyn., and also vice chairman of the Energy and Commerce Health Subcommittee, said that he and his colleagues looked forward to hearing more from physicians.

The draft legislation would repeal the SGR and replace it with a fee-for-service system that would put more emphasis on rewarding quality. Physicians would have a guiding hand in developing quality measures in conjunction with the secretary of Health and Human Services. They would also be given the ability to opt out of fee-for-service and practice instead under new delivery models like accountable care organizations or patient-centered medical homes.

"We are working to restore certainty, fiscal sanity, and we will responsibly pay for these reforms," said Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce committee, in a statement. "We will continue working closely with Ways and Means Committee Chairman [Dave] Camp [R-Mich.] as well as maintain our ongoing dialogue with committee Democrats as we work toward long-term solutions in the effort to improve quality of care."

Physician groups were cautious about the proposal at press time. In a statement, Dr. Jeremy Lazarus, president of the American Medical Association, said, "The Energy and Commerce Committee’s framework is another step in the important process of eliminating the SGR and moving toward new ways of delivering and paying for care that reward quality and reduce costs."

He said that the AMA "look[ed] forward to continuing to work to see that progress is made this year."

The American Academy of Family Physicians supports the proposal’s goal of establishing "a period of stable and predictable payment increases," and incentives to improve quality of care, said Dr. Jeffrey Cain, AAFP president, in an interview.

But by largely focusing on the fee-for-service payment system, the committee is overlooking the bigger picture of how physician payment affects health care costs and quality, he said. The AAFP would like to see an increase in pay for primary care because "investing in primary care would improve our country’s health care by increasing quality and decreasing overall costs by reducing unnecessary medical utilization," said Dr. Cain.

In early February, the American College of Physicians and several other groups lent their support to an SGR replacement bill that has elements similar to the Energy and Commerce draft. The bill, the Medicare Physician Payment Innovation Act (H.R. 574), was introduced by Reps. Allyson Schwartz (D-Penn.) and Joe Heck (R-Nev.).

In early May, Rep. Schwartz commended the Energy and Commerce bill, noting that it shared principles in common with H.R. 574. The bill also showed "that there is common ground on a framework for fixing the Medicare reimbursement system," said Rep. Schwartz in a statement.

The Energy and Commerce Committee said that comments on its draft legislation would be accepted until June 10, at SGRComments@mail.house.gov.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Stand by for some unexpected and potentially nasty surprises when the health insurance exchanges start up in 2014.

The exchanges will start enrolling patients this fall and begin sending information to patients and physicians this summer. Health insurers will begin sending new contracts to physicians around then too.

But there’s information available now that should send shivers up physicians’ spines, Elizabeth McNeil, vice president of the center for federal government relations at the California Medical Association, said at the annual meeting of the American College of Physicians.

A little-noticed provision of the Affordable Care Act gives exchange participants a 90-day grace period to pay their premiums. This was designed to provide a cushion for people who might not be used to paying health insurance premiums. Insurers have to pay all claims incurred by the patient in the first month, but in the second month, if the patient is still delinquent, all claims can be held as pending. By the third month, if the patient still has not paid, the insurer can terminate him or her.

The physician then has to collect payment for all outstanding claims from the patient. "This is going to put you at a lot of risk," Ms. McNeil said. "You’re going to have to be very vigilant with the exchange patients in watching what’s going on."

Many patients who’ll get coverage through the health insurance exchanges will also have much larger out-of-pocket costs than they are used to paying, Ms. McNeil said. In California, the CMA estimates an individual could face as much as $6,400 in uncovered expenses, and a family, up to $12,800.

Physicians also will need to pay attention to the contracts they sign with health insurers participating in the exchanges. The exchange could bring a large number of new patients to the practice and physicians need to think about how many additional patients they can actually accommodate, she said.

Another thing to keep in mind: Does the contract have an all-payer clause that requires your practice to accept exchange patients? When negotiating rates, be aware that many patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have been uninsured or underinsured, Ms. McNeil advised. Their care could be more complex and time consuming, so doctors will want to be sure that reimbursement rates are adequate to cover this care.

Lawrence Kosinski, M.D., MBA, AGAF, chair of the AGA Institute Practice Management and Economics Committee, said: "The health insurance exchanges created in the ACA will have very significant financial consequences for our practices. It’s time for all of us to become knowledgeable of their ramifications."

On Twitter @aliciaault

SAN FRANCISCO – Stand by for some unexpected and potentially nasty surprises when the health insurance exchanges start up in 2014.

The exchanges will start enrolling patients this fall and begin sending information to patients and physicians this summer. Health insurers will begin sending new contracts to physicians around then too.

But there’s information available now that should send shivers up physicians’ spines, Elizabeth McNeil, vice president of the center for federal government relations at the California Medical Association, said at the annual meeting of the American College of Physicians.

A little-noticed provision of the Affordable Care Act gives exchange participants a 90-day grace period to pay their premiums. This was designed to provide a cushion for people who might not be used to paying health insurance premiums. Insurers have to pay all claims incurred by the patient in the first month, but in the second month, if the patient is still delinquent, all claims can be held as pending. By the third month, if the patient still has not paid, the insurer can terminate him or her.

The physician then has to collect payment for all outstanding claims from the patient. "This is going to put you at a lot of risk," Ms. McNeil said. "You’re going to have to be very vigilant with the exchange patients in watching what’s going on."

Many patients who’ll get coverage through the health insurance exchanges will also have much larger out-of-pocket costs than they are used to paying, Ms. McNeil said. In California, the CMA estimates an individual could face as much as $6,400 in uncovered expenses, and a family, up to $12,800.

Physicians also will need to pay attention to the contracts they sign with health insurers participating in the exchanges. The exchange could bring a large number of new patients to the practice and physicians need to think about how many additional patients they can actually accommodate, she said.

Another thing to keep in mind: Does the contract have an all-payer clause that requires your practice to accept exchange patients? When negotiating rates, be aware that many patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have been uninsured or underinsured, Ms. McNeil advised. Their care could be more complex and time consuming, so doctors will want to be sure that reimbursement rates are adequate to cover this care.

Lawrence Kosinski, M.D., MBA, AGAF, chair of the AGA Institute Practice Management and Economics Committee, said: "The health insurance exchanges created in the ACA will have very significant financial consequences for our practices. It’s time for all of us to become knowledgeable of their ramifications."

On Twitter @aliciaault

SAN FRANCISCO – Stand by for some unexpected and potentially nasty surprises when the health insurance exchanges start up in 2014.

The exchanges will start enrolling patients this fall and begin sending information to patients and physicians this summer. Health insurers will begin sending new contracts to physicians around then too.

But there’s information available now that should send shivers up physicians’ spines, Elizabeth McNeil, vice president of the center for federal government relations at the California Medical Association, said at the annual meeting of the American College of Physicians.

A little-noticed provision of the Affordable Care Act gives exchange participants a 90-day grace period to pay their premiums. This was designed to provide a cushion for people who might not be used to paying health insurance premiums. Insurers have to pay all claims incurred by the patient in the first month, but in the second month, if the patient is still delinquent, all claims can be held as pending. By the third month, if the patient still has not paid, the insurer can terminate him or her.

The physician then has to collect payment for all outstanding claims from the patient. "This is going to put you at a lot of risk," Ms. McNeil said. "You’re going to have to be very vigilant with the exchange patients in watching what’s going on."

Many patients who’ll get coverage through the health insurance exchanges will also have much larger out-of-pocket costs than they are used to paying, Ms. McNeil said. In California, the CMA estimates an individual could face as much as $6,400 in uncovered expenses, and a family, up to $12,800.

Physicians also will need to pay attention to the contracts they sign with health insurers participating in the exchanges. The exchange could bring a large number of new patients to the practice and physicians need to think about how many additional patients they can actually accommodate, she said.

Another thing to keep in mind: Does the contract have an all-payer clause that requires your practice to accept exchange patients? When negotiating rates, be aware that many patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have been uninsured or underinsured, Ms. McNeil advised. Their care could be more complex and time consuming, so doctors will want to be sure that reimbursement rates are adequate to cover this care.

Lawrence Kosinski, M.D., MBA, AGAF, chair of the AGA Institute Practice Management and Economics Committee, said: "The health insurance exchanges created in the ACA will have very significant financial consequences for our practices. It’s time for all of us to become knowledgeable of their ramifications."

On Twitter @aliciaault

The European Commission has approved the use of rivaroxaban in combination with antiplatelet therapy to help prevent atherothrombotic events after acute coronary syndrome.

The drug was approved at a dose of 2.5 milligrams twice daily in adults with elevated cardiac biomarkers.

The approval was expected, as the European Medicines Agency Committee for Medicinal Products for Human Use recommended rivaroxaban for the indication on March 21. Rivaroxaban is marketed outside the United States by Bayer HealthCare and in the United States by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, as Xarelto.

The approval for secondary prevention was based on results from the ATLAS ACS 2-TIMI 51 (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With/Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome) study of more than 15,500 patients. In the trial, rivaroxaban 2.5 mg twice daily added to standard antiplatelet therapy – low-dose aspirin with or without a thienopyridine (clopidogrel or ticlopidine) – significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction, or stroke in patients after a recent ACS compared to those who received standard antiplatelet therapy alone, according to Bayer.

Based on that trial, the 2012 European Society of Cardiology guidelines recommended that treatment with rivaroxaban be considered for patients with ST-segment elevation myocardial infarction (STEMI) who are at low bleeding risk and on antiplatelet therapy with aspirin and clopidogrel, the company said.

In a statement issued by Bayer, Dr. C. Michael Gibson, Chairman of the PERFUSE Study Group at Harvard Medical School and the Principal Investigator in the ATLAS ACS studies, said that ACS patients are at risk for secondary events because thrombin levels remain elevated long afterwards. "In the ATLAS ACS 2-TIMI 51 study, we’ve shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation, providing more complete long-term protection, including significant reduction in mortality risk," said Dr. Gibson.

Janssen awaits Food and Drug Administration approval for secondary prevention for patients with ACS. The company first sought approval in 2011. A year later, the FDA requested more data. In May 2012, an FDA advisory panel voted against approval of the indication. In March this year, the FDA again said there were outstanding issues that needed to be addressed.

The drug was first approved in 2011 for prophylaxis of deep vein thrombosis or pulmonary embolism in patients undergoing hip or knee replacement surgery. It now has five additional approvals in the United States, including the treatment of DVT or PE and for reducing the recurrence of DVT and PE after initial treatment. Rivaroxaban is approved in 120 countries.

aault@frontlinemedcom.com

On Twitter @aliciaault

The European Commission has approved the use of rivaroxaban in combination with antiplatelet therapy to help prevent atherothrombotic events after acute coronary syndrome.

The drug was approved at a dose of 2.5 milligrams twice daily in adults with elevated cardiac biomarkers.

The approval was expected, as the European Medicines Agency Committee for Medicinal Products for Human Use recommended rivaroxaban for the indication on March 21. Rivaroxaban is marketed outside the United States by Bayer HealthCare and in the United States by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, as Xarelto.

The approval for secondary prevention was based on results from the ATLAS ACS 2-TIMI 51 (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With/Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome) study of more than 15,500 patients. In the trial, rivaroxaban 2.5 mg twice daily added to standard antiplatelet therapy – low-dose aspirin with or without a thienopyridine (clopidogrel or ticlopidine) – significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction, or stroke in patients after a recent ACS compared to those who received standard antiplatelet therapy alone, according to Bayer.

Based on that trial, the 2012 European Society of Cardiology guidelines recommended that treatment with rivaroxaban be considered for patients with ST-segment elevation myocardial infarction (STEMI) who are at low bleeding risk and on antiplatelet therapy with aspirin and clopidogrel, the company said.

In a statement issued by Bayer, Dr. C. Michael Gibson, Chairman of the PERFUSE Study Group at Harvard Medical School and the Principal Investigator in the ATLAS ACS studies, said that ACS patients are at risk for secondary events because thrombin levels remain elevated long afterwards. "In the ATLAS ACS 2-TIMI 51 study, we’ve shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation, providing more complete long-term protection, including significant reduction in mortality risk," said Dr. Gibson.

Janssen awaits Food and Drug Administration approval for secondary prevention for patients with ACS. The company first sought approval in 2011. A year later, the FDA requested more data. In May 2012, an FDA advisory panel voted against approval of the indication. In March this year, the FDA again said there were outstanding issues that needed to be addressed.

The drug was first approved in 2011 for prophylaxis of deep vein thrombosis or pulmonary embolism in patients undergoing hip or knee replacement surgery. It now has five additional approvals in the United States, including the treatment of DVT or PE and for reducing the recurrence of DVT and PE after initial treatment. Rivaroxaban is approved in 120 countries.

aault@frontlinemedcom.com

On Twitter @aliciaault

The European Commission has approved the use of rivaroxaban in combination with antiplatelet therapy to help prevent atherothrombotic events after acute coronary syndrome.

The drug was approved at a dose of 2.5 milligrams twice daily in adults with elevated cardiac biomarkers.

The approval was expected, as the European Medicines Agency Committee for Medicinal Products for Human Use recommended rivaroxaban for the indication on March 21. Rivaroxaban is marketed outside the United States by Bayer HealthCare and in the United States by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, as Xarelto.

The approval for secondary prevention was based on results from the ATLAS ACS 2-TIMI 51 (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With/Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome) study of more than 15,500 patients. In the trial, rivaroxaban 2.5 mg twice daily added to standard antiplatelet therapy – low-dose aspirin with or without a thienopyridine (clopidogrel or ticlopidine) – significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction, or stroke in patients after a recent ACS compared to those who received standard antiplatelet therapy alone, according to Bayer.

Based on that trial, the 2012 European Society of Cardiology guidelines recommended that treatment with rivaroxaban be considered for patients with ST-segment elevation myocardial infarction (STEMI) who are at low bleeding risk and on antiplatelet therapy with aspirin and clopidogrel, the company said.

In a statement issued by Bayer, Dr. C. Michael Gibson, Chairman of the PERFUSE Study Group at Harvard Medical School and the Principal Investigator in the ATLAS ACS studies, said that ACS patients are at risk for secondary events because thrombin levels remain elevated long afterwards. "In the ATLAS ACS 2-TIMI 51 study, we’ve shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation, providing more complete long-term protection, including significant reduction in mortality risk," said Dr. Gibson.

Janssen awaits Food and Drug Administration approval for secondary prevention for patients with ACS. The company first sought approval in 2011. A year later, the FDA requested more data. In May 2012, an FDA advisory panel voted against approval of the indication. In March this year, the FDA again said there were outstanding issues that needed to be addressed.

The drug was first approved in 2011 for prophylaxis of deep vein thrombosis or pulmonary embolism in patients undergoing hip or knee replacement surgery. It now has five additional approvals in the United States, including the treatment of DVT or PE and for reducing the recurrence of DVT and PE after initial treatment. Rivaroxaban is approved in 120 countries.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – Doctors need to step up their efforts to counsel patients on smoking cessation.

That was the message from officials at the Centers for Disease Control and Prevention and primary care physicians group at a press briefing May 22.

"Every doctor can help their patients quit, and every doctor should do everything possible to help their patients quit," Dr. Tom Frieden, CDC director, said at a press conference. "Even spending 3-5 minutes on personalized, clear advice will double the likelihood that they will quit for good."

He added that talking about smoking – or about quitting – is still not a part of routine doctor visits.

Alicia Ault/IMNG Medical Media

"That extra moment can make all the difference and help them quit," agreed Surgeon General Regina Benjamin, who also spoke at the briefing.

The CDC estimates that 43 million American adults smoke, and that smoking kills about 440,000 of them each year.

Representatives of the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, and the American Medical Association, joined Dr. Frieden in urging their members and other physicians to do more.

"It’s very important for all of the medical associations to be speaking with one voice," Dr. Charles Cutler, chair of the ACP Board of Regents, said in an interview. "When we’re all saying the same thing, the message for doctors throughout America becomes more resonant."

Advertisements that are part of the CDC’s current "Tips From Former Smokers" campaignwill be tagged with a new line from May 27 through June 2. During that time, ads will say "You can quit. Talk with your doctor for help."

So far, the Tips campaign, which features individuals disfigured from a lifetime of smoking, has generated 200,000 excess calls to the 1-800-QUIT-NOW line managed by the CDC, Dr. Frieden said. The campaign is funded at about $50 million a year with money from the Public Health and Prevention Fund, which was established by the Affordable Care Act.

Alicia Ault/IMNG Medical Media

AAFP president Jeffrey Cain said that physicians are crucial allies for patients who are trying to quit. He noted that the AAFP has several tools to help physicians counsel and care for smokers, including the "Ask and Act Practice Toolkit," and a treating tobacco dependence practice manual. "You have to make it so that tobacco is a vital sign when a patient comes in," said Dr. Cain.

The Tips campaign gives patients a critical way to start conversations about smoking, said Dr. Patrice Harris of the AMA Board of Trustees. "Physicians should talk to every patient who smokes about quitting at every office visit," she said. The AMA’s Healthier Life Steps program helps direct physicians toward resources they can share with patients, she said.

The AAP joined the effort because so many children are exposed to second-hand smoke and because very often, the smoking habit begins in adolescence, said AAP President Thomas K. McInerny. He said that many pediatricians had been remiss in either asking patients or parents about smoking, or encouraging them to quit.

"Pediatricians must intervene during a clinical encounter, yet, unfortunately, many don’t do so," he said.

ACOG president Jeanne A. Conry said that the Tips campaign would help her colleagues improve women’s health and support healthier pregnancies – but only if ob.gyns. make it a part of every visit. "If we are able to discuss tobacco use and well-woman health care with every woman at every time, we will make a difference," she said.

In an editorial published simultaneously in JAMA, Dr. Tim McAfee of the CDC Office on Smoking and Health further underlined and explained the resources available to physicians for smoking cessation counseling (2013;1-2 [doi:10.1001/jama.2013.5975]).

Alicia Ault/IMNG Medical Media

"Physicians have made major strides over the past 2 decades in helping smokers quit, but still fall short of making cessation treatment a routine part of standard care," he wrote. "By making it easier to discuss smoking, the ‘talk with your doctor’ initiative can help bring the nation a step closer to achieving the goal of substantially reducing smoking and smoking-related disease and death."

For smoking cessation counseling information and tools, visit the CDC’s Tips website.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – Doctors need to step up their efforts to counsel patients on smoking cessation.

That was the message from officials at the Centers for Disease Control and Prevention and primary care physicians group at a press briefing May 22.

"Every doctor can help their patients quit, and every doctor should do everything possible to help their patients quit," Dr. Tom Frieden, CDC director, said at a press conference. "Even spending 3-5 minutes on personalized, clear advice will double the likelihood that they will quit for good."

He added that talking about smoking – or about quitting – is still not a part of routine doctor visits.

Alicia Ault/IMNG Medical Media

"That extra moment can make all the difference and help them quit," agreed Surgeon General Regina Benjamin, who also spoke at the briefing.

The CDC estimates that 43 million American adults smoke, and that smoking kills about 440,000 of them each year.

Representatives of the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, and the American Medical Association, joined Dr. Frieden in urging their members and other physicians to do more.

"It’s very important for all of the medical associations to be speaking with one voice," Dr. Charles Cutler, chair of the ACP Board of Regents, said in an interview. "When we’re all saying the same thing, the message for doctors throughout America becomes more resonant."

Advertisements that are part of the CDC’s current "Tips From Former Smokers" campaignwill be tagged with a new line from May 27 through June 2. During that time, ads will say "You can quit. Talk with your doctor for help."

So far, the Tips campaign, which features individuals disfigured from a lifetime of smoking, has generated 200,000 excess calls to the 1-800-QUIT-NOW line managed by the CDC, Dr. Frieden said. The campaign is funded at about $50 million a year with money from the Public Health and Prevention Fund, which was established by the Affordable Care Act.

Alicia Ault/IMNG Medical Media

AAFP president Jeffrey Cain said that physicians are crucial allies for patients who are trying to quit. He noted that the AAFP has several tools to help physicians counsel and care for smokers, including the "Ask and Act Practice Toolkit," and a treating tobacco dependence practice manual. "You have to make it so that tobacco is a vital sign when a patient comes in," said Dr. Cain.

The Tips campaign gives patients a critical way to start conversations about smoking, said Dr. Patrice Harris of the AMA Board of Trustees. "Physicians should talk to every patient who smokes about quitting at every office visit," she said. The AMA’s Healthier Life Steps program helps direct physicians toward resources they can share with patients, she said.

The AAP joined the effort because so many children are exposed to second-hand smoke and because very often, the smoking habit begins in adolescence, said AAP President Thomas K. McInerny. He said that many pediatricians had been remiss in either asking patients or parents about smoking, or encouraging them to quit.

"Pediatricians must intervene during a clinical encounter, yet, unfortunately, many don’t do so," he said.

ACOG president Jeanne A. Conry said that the Tips campaign would help her colleagues improve women’s health and support healthier pregnancies – but only if ob.gyns. make it a part of every visit. "If we are able to discuss tobacco use and well-woman health care with every woman at every time, we will make a difference," she said.

In an editorial published simultaneously in JAMA, Dr. Tim McAfee of the CDC Office on Smoking and Health further underlined and explained the resources available to physicians for smoking cessation counseling (2013;1-2 [doi:10.1001/jama.2013.5975]).

Alicia Ault/IMNG Medical Media

"Physicians have made major strides over the past 2 decades in helping smokers quit, but still fall short of making cessation treatment a routine part of standard care," he wrote. "By making it easier to discuss smoking, the ‘talk with your doctor’ initiative can help bring the nation a step closer to achieving the goal of substantially reducing smoking and smoking-related disease and death."

For smoking cessation counseling information and tools, visit the CDC’s Tips website.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – Doctors need to step up their efforts to counsel patients on smoking cessation.

That was the message from officials at the Centers for Disease Control and Prevention and primary care physicians group at a press briefing May 22.

"Every doctor can help their patients quit, and every doctor should do everything possible to help their patients quit," Dr. Tom Frieden, CDC director, said at a press conference. "Even spending 3-5 minutes on personalized, clear advice will double the likelihood that they will quit for good."

He added that talking about smoking – or about quitting – is still not a part of routine doctor visits.

Alicia Ault/IMNG Medical Media

"That extra moment can make all the difference and help them quit," agreed Surgeon General Regina Benjamin, who also spoke at the briefing.

The CDC estimates that 43 million American adults smoke, and that smoking kills about 440,000 of them each year.

Representatives of the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, and the American Medical Association, joined Dr. Frieden in urging their members and other physicians to do more.

"It’s very important for all of the medical associations to be speaking with one voice," Dr. Charles Cutler, chair of the ACP Board of Regents, said in an interview. "When we’re all saying the same thing, the message for doctors throughout America becomes more resonant."

Advertisements that are part of the CDC’s current "Tips From Former Smokers" campaignwill be tagged with a new line from May 27 through June 2. During that time, ads will say "You can quit. Talk with your doctor for help."

So far, the Tips campaign, which features individuals disfigured from a lifetime of smoking, has generated 200,000 excess calls to the 1-800-QUIT-NOW line managed by the CDC, Dr. Frieden said. The campaign is funded at about $50 million a year with money from the Public Health and Prevention Fund, which was established by the Affordable Care Act.

Alicia Ault/IMNG Medical Media

AAFP president Jeffrey Cain said that physicians are crucial allies for patients who are trying to quit. He noted that the AAFP has several tools to help physicians counsel and care for smokers, including the "Ask and Act Practice Toolkit," and a treating tobacco dependence practice manual. "You have to make it so that tobacco is a vital sign when a patient comes in," said Dr. Cain.

The Tips campaign gives patients a critical way to start conversations about smoking, said Dr. Patrice Harris of the AMA Board of Trustees. "Physicians should talk to every patient who smokes about quitting at every office visit," she said. The AMA’s Healthier Life Steps program helps direct physicians toward resources they can share with patients, she said.

The AAP joined the effort because so many children are exposed to second-hand smoke and because very often, the smoking habit begins in adolescence, said AAP President Thomas K. McInerny. He said that many pediatricians had been remiss in either asking patients or parents about smoking, or encouraging them to quit.

"Pediatricians must intervene during a clinical encounter, yet, unfortunately, many don’t do so," he said.

ACOG president Jeanne A. Conry said that the Tips campaign would help her colleagues improve women’s health and support healthier pregnancies – but only if ob.gyns. make it a part of every visit. "If we are able to discuss tobacco use and well-woman health care with every woman at every time, we will make a difference," she said.

In an editorial published simultaneously in JAMA, Dr. Tim McAfee of the CDC Office on Smoking and Health further underlined and explained the resources available to physicians for smoking cessation counseling (2013;1-2 [doi:10.1001/jama.2013.5975]).

Alicia Ault/IMNG Medical Media

"Physicians have made major strides over the past 2 decades in helping smokers quit, but still fall short of making cessation treatment a routine part of standard care," he wrote. "By making it easier to discuss smoking, the ‘talk with your doctor’ initiative can help bring the nation a step closer to achieving the goal of substantially reducing smoking and smoking-related disease and death."

For smoking cessation counseling information and tools, visit the CDC’s Tips website.

aault@frontlinemedcom.com

On Twitter @aliciaault

How do you advise your patients about sunscreen? Some fodder for discussion (or possibly more confusion) comes from the Environmental Working Group, which has released its annual list of which sunscreens it deems both safe and effective – according to its criteria.

The Environmental Working Group (EWG), a nonprofit environmental health research and advocacy organization based in Washington, has issued the list for the past 7 years, just before Memorial Day weekend – the date most Americans view as the official start of summer.

This year, the EWG said that only 25% of the 1,400 sunscreens, lotions, lip products, and makeups that claim sun protection properties met its standards.

Courtesy of the U.S. Food and Drug Administration

"The vast majority of sunscreens available to the consumer aren’t as good as most people think they are, but there are a handful of products that rise above the rest," Sonya Lunder, senior research analyst at EWG and lead author of the report, said in a statement. "The best advice for concerned consumers is to use sun-protective clothing, stay in the shade to reduce intense sun exposure, and schedule regular skin examinations by a doctor," she said.

The EWG’s pronouncements are not without controversy. The group claimed in its press release that part of the reason that melanoma has been on the rise may be caused by "the decades of deceptive marketing claims by sunscreen manufacturers."

But your patients need not panic if their favorite sunscreen didn’t make the EWG list, according to the American Academy of Dermatology. The AAD’s position on sunscreens is practical: "The best type of sunscreen is the one you will use again and again," said Dr. Henry W. Lim, chairman of the dermatology department at Henry Ford Hospital in Detroit, in a general AAD statement on sunscreen issued on May 20.

"Just be sure to choose one that offers broad-spectrum protection, has an SPF of 30 or greater, and is water resistant," said Dr. Lim.

However, the AAD emphasized in the statement that seeking shade and wearing protective clothing are also important actions to avoid excessive sun exposure and reduce the risk of skin cancer.

The Food and Drug Administration does regulate sunscreens, having issued a final rule governing much about the products in June 2011. Most of the regulations went into effect in June 2012, but products did not start appearing with the new labels until January.

Manufacturers cannot claim that their products are waterproof or sweatproof. Products can be labeled broad spectrum if they prove to the agency that they protect against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA) and have a sun protection factor of 15 or higher.

The EWG also says that the FDA should stop manufacturers from selling products with an SPF of 50 or higher, saying they lead consumers to spend more time in the sun than is advisable. This year, the agency will examine whether those products provide any better protection than an SPF 50 sunscreen. The agency proposed in June 2011 that sunscreens with an SPF greater than 50 be labeled "SPF 50–plus," but nothing further has been issued.

According to the EWG, its analysis of 750 beach and sport sunscreens found that the new FDA rules have not led to sunscreens that are better than those sold in the years before the ruling. It gave only 184 of them its thumbs up. Similarly, for other products that claimed to have sun protection, the EWG only recommended 22 moisturizers, 18 lip balms, and 16 kinds of makeup.

The EWG also said that consumers should not use spray sunscreens.

The AAD agreed that sprays may not be as effective because the individual might not use enough to cover all sun-exposed areas of the body.

The EWG also said that Americans should not use products that contain retinyl palmitate or oxybenzone. The group claims that retinyl palmitate is carcinogenic, and that oxybenzone is an endocrine disrupter. About half of the beach and sport sunscreens in the EWG 2013 list contain oxybenzone, the group said.

The AAD has refuted the EWG’s claims about retinyl palmitate and oxybenzone in the past.

aault@frontlinemedcom.com

On Twitter @aliciaault

How do you advise your patients about sunscreen? Some fodder for discussion (or possibly more confusion) comes from the Environmental Working Group, which has released its annual list of which sunscreens it deems both safe and effective – according to its criteria.

The Environmental Working Group (EWG), a nonprofit environmental health research and advocacy organization based in Washington, has issued the list for the past 7 years, just before Memorial Day weekend – the date most Americans view as the official start of summer.

This year, the EWG said that only 25% of the 1,400 sunscreens, lotions, lip products, and makeups that claim sun protection properties met its standards.

Courtesy of the U.S. Food and Drug Administration

"The vast majority of sunscreens available to the consumer aren’t as good as most people think they are, but there are a handful of products that rise above the rest," Sonya Lunder, senior research analyst at EWG and lead author of the report, said in a statement. "The best advice for concerned consumers is to use sun-protective clothing, stay in the shade to reduce intense sun exposure, and schedule regular skin examinations by a doctor," she said.

The EWG’s pronouncements are not without controversy. The group claimed in its press release that part of the reason that melanoma has been on the rise may be caused by "the decades of deceptive marketing claims by sunscreen manufacturers."

But your patients need not panic if their favorite sunscreen didn’t make the EWG list, according to the American Academy of Dermatology. The AAD’s position on sunscreens is practical: "The best type of sunscreen is the one you will use again and again," said Dr. Henry W. Lim, chairman of the dermatology department at Henry Ford Hospital in Detroit, in a general AAD statement on sunscreen issued on May 20.

"Just be sure to choose one that offers broad-spectrum protection, has an SPF of 30 or greater, and is water resistant," said Dr. Lim.

However, the AAD emphasized in the statement that seeking shade and wearing protective clothing are also important actions to avoid excessive sun exposure and reduce the risk of skin cancer.

The Food and Drug Administration does regulate sunscreens, having issued a final rule governing much about the products in June 2011. Most of the regulations went into effect in June 2012, but products did not start appearing with the new labels until January.

Manufacturers cannot claim that their products are waterproof or sweatproof. Products can be labeled broad spectrum if they prove to the agency that they protect against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA) and have a sun protection factor of 15 or higher.

The EWG also says that the FDA should stop manufacturers from selling products with an SPF of 50 or higher, saying they lead consumers to spend more time in the sun than is advisable. This year, the agency will examine whether those products provide any better protection than an SPF 50 sunscreen. The agency proposed in June 2011 that sunscreens with an SPF greater than 50 be labeled "SPF 50–plus," but nothing further has been issued.

According to the EWG, its analysis of 750 beach and sport sunscreens found that the new FDA rules have not led to sunscreens that are better than those sold in the years before the ruling. It gave only 184 of them its thumbs up. Similarly, for other products that claimed to have sun protection, the EWG only recommended 22 moisturizers, 18 lip balms, and 16 kinds of makeup.

The EWG also said that consumers should not use spray sunscreens.

The AAD agreed that sprays may not be as effective because the individual might not use enough to cover all sun-exposed areas of the body.

The EWG also said that Americans should not use products that contain retinyl palmitate or oxybenzone. The group claims that retinyl palmitate is carcinogenic, and that oxybenzone is an endocrine disrupter. About half of the beach and sport sunscreens in the EWG 2013 list contain oxybenzone, the group said.

The AAD has refuted the EWG’s claims about retinyl palmitate and oxybenzone in the past.

aault@frontlinemedcom.com

On Twitter @aliciaault

How do you advise your patients about sunscreen? Some fodder for discussion (or possibly more confusion) comes from the Environmental Working Group, which has released its annual list of which sunscreens it deems both safe and effective – according to its criteria.

The Environmental Working Group (EWG), a nonprofit environmental health research and advocacy organization based in Washington, has issued the list for the past 7 years, just before Memorial Day weekend – the date most Americans view as the official start of summer.

This year, the EWG said that only 25% of the 1,400 sunscreens, lotions, lip products, and makeups that claim sun protection properties met its standards.

Courtesy of the U.S. Food and Drug Administration

"The vast majority of sunscreens available to the consumer aren’t as good as most people think they are, but there are a handful of products that rise above the rest," Sonya Lunder, senior research analyst at EWG and lead author of the report, said in a statement. "The best advice for concerned consumers is to use sun-protective clothing, stay in the shade to reduce intense sun exposure, and schedule regular skin examinations by a doctor," she said.

The EWG’s pronouncements are not without controversy. The group claimed in its press release that part of the reason that melanoma has been on the rise may be caused by "the decades of deceptive marketing claims by sunscreen manufacturers."

But your patients need not panic if their favorite sunscreen didn’t make the EWG list, according to the American Academy of Dermatology. The AAD’s position on sunscreens is practical: "The best type of sunscreen is the one you will use again and again," said Dr. Henry W. Lim, chairman of the dermatology department at Henry Ford Hospital in Detroit, in a general AAD statement on sunscreen issued on May 20.

"Just be sure to choose one that offers broad-spectrum protection, has an SPF of 30 or greater, and is water resistant," said Dr. Lim.

However, the AAD emphasized in the statement that seeking shade and wearing protective clothing are also important actions to avoid excessive sun exposure and reduce the risk of skin cancer.

The Food and Drug Administration does regulate sunscreens, having issued a final rule governing much about the products in June 2011. Most of the regulations went into effect in June 2012, but products did not start appearing with the new labels until January.

Manufacturers cannot claim that their products are waterproof or sweatproof. Products can be labeled broad spectrum if they prove to the agency that they protect against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA) and have a sun protection factor of 15 or higher.

The EWG also says that the FDA should stop manufacturers from selling products with an SPF of 50 or higher, saying they lead consumers to spend more time in the sun than is advisable. This year, the agency will examine whether those products provide any better protection than an SPF 50 sunscreen. The agency proposed in June 2011 that sunscreens with an SPF greater than 50 be labeled "SPF 50–plus," but nothing further has been issued.

According to the EWG, its analysis of 750 beach and sport sunscreens found that the new FDA rules have not led to sunscreens that are better than those sold in the years before the ruling. It gave only 184 of them its thumbs up. Similarly, for other products that claimed to have sun protection, the EWG only recommended 22 moisturizers, 18 lip balms, and 16 kinds of makeup.

The EWG also said that consumers should not use spray sunscreens.

The AAD agreed that sprays may not be as effective because the individual might not use enough to cover all sun-exposed areas of the body.

The EWG also said that Americans should not use products that contain retinyl palmitate or oxybenzone. The group claims that retinyl palmitate is carcinogenic, and that oxybenzone is an endocrine disrupter. About half of the beach and sport sunscreens in the EWG 2013 list contain oxybenzone, the group said.

The AAD has refuted the EWG’s claims about retinyl palmitate and oxybenzone in the past.

aault@frontlinemedcom.com

On Twitter @aliciaault

Having a critical care specialist physically present in the intensive care unit overnight does not seem to improve a broad range of patient outcomes, according to research published May 20 in the New England Journal of Medicine (doi: 0.1056/NEMJoa1302854).

Dr. Meeta Prasad Kerlin and her colleagues at the University of Pennsylvania, Philadelphia, randomized admissions to a 24-bed medical ICU over a 1-year period; they offer several explanations as to why having a nighttime intensivist does not seem to make a difference. Their research was presented simultaneously at the annual meeting of the American Thoracic Society.

Photo Credit: Robert Press/Penn Medicine

First, if the ICU is well staffed during the day and has adopted systems of care, there might not be a lot of room for patient improvement. Second, bringing on a new physician in the evening – rather than keeping the same intensivist on call – might disrupt continuity of care for some patients, they said.

All ICU patients admitted to the hospital at the university were randomized to the intervention group or the control group. The intervention group received care from an intensivist (a board-eligible or board-certified critical care specialist) who was on staff from 7 p.m. to 7 a.m., or from residents who normally were assigned to the ICU.

The control group received care from residents, who were able to reach two daytime intensivists or two critical care fellows at night by phone. Generally, the nursing ratio was one per two patients.

The nighttime intensivists were daytime staff who volunteered to take on a nighttime assignment. During the study, they covered one night a week.

Overall, 820 patients were assigned to the intervention (4 were later excluded due to missing data), and 778 were in the control group (7 ended up with missing data). In total, 175 nights were assigned to the intervention; 95% (166) of those nights were staffed by an intensivist.

The median age of patients was 60 years, and about half were men. Almost half were admitted from the emergency department, while just over a third were transferred from the hospital’s general floor. The median APACHE (Acute Physiology and Chronic Health Evaluation) III score was 67.

Sixty-one percent (970) of all patients were admitted to the ICU at night (5 p.m. to 5 a.m.). Overall, 381 patients (24%) died in the hospital, with 293 (18%) of them dying in the ICU.

The authors found no effect on length of stay in the ICU (median, 52.7 hours) for those in the intervention group. They calculated a "rate ratio," which was the rate of instantaneous discharge from the ICU in the intervention group divided by the rate of instantaneous discharge from the ICU in the control group. For ICU length of stay, the ratio was 0.98 (P = .72); a ratio of more than 1 would mean that the intervention shortened the time to discharge.

They found similar ratios for hospital length of stay (median, 174 hours in the intervention group vs. 166 hours in the control group) and mortality. A patient’s APACHE III score made no difference in the outcomes; neither did resident experience and training .

In a subanalysis, the authors determined that ratios were unchanged for patients admitted at night.

Having so many patients admitted at night was a strength of the study, the authors said. "If nighttime intensivists were effective, it is likely they would be particularly effective in an ICU with such a large nighttime workload," they wrote.

The researchers noted that further research is important because currently one-third of U.S. academic medical centers employ nighttime intensivists. On the surface, nighttime ICU staffing seems compelling, said the authors. But it also may be "one of several expensive medical practices that have been adopted without a supportive evidence base."

aault@frontlinemedcom.com

On Twitter @aliciaault

Having a critical care specialist physically present in the intensive care unit overnight does not seem to improve a broad range of patient outcomes, according to research published May 20 in the New England Journal of Medicine (doi: 0.1056/NEMJoa1302854).

Dr. Meeta Prasad Kerlin and her colleagues at the University of Pennsylvania, Philadelphia, randomized admissions to a 24-bed medical ICU over a 1-year period; they offer several explanations as to why having a nighttime intensivist does not seem to make a difference. Their research was presented simultaneously at the annual meeting of the American Thoracic Society.

Photo Credit: Robert Press/Penn Medicine

First, if the ICU is well staffed during the day and has adopted systems of care, there might not be a lot of room for patient improvement. Second, bringing on a new physician in the evening – rather than keeping the same intensivist on call – might disrupt continuity of care for some patients, they said.

All ICU patients admitted to the hospital at the university were randomized to the intervention group or the control group. The intervention group received care from an intensivist (a board-eligible or board-certified critical care specialist) who was on staff from 7 p.m. to 7 a.m., or from residents who normally were assigned to the ICU.

The control group received care from residents, who were able to reach two daytime intensivists or two critical care fellows at night by phone. Generally, the nursing ratio was one per two patients.

The nighttime intensivists were daytime staff who volunteered to take on a nighttime assignment. During the study, they covered one night a week.

Overall, 820 patients were assigned to the intervention (4 were later excluded due to missing data), and 778 were in the control group (7 ended up with missing data). In total, 175 nights were assigned to the intervention; 95% (166) of those nights were staffed by an intensivist.

The median age of patients was 60 years, and about half were men. Almost half were admitted from the emergency department, while just over a third were transferred from the hospital’s general floor. The median APACHE (Acute Physiology and Chronic Health Evaluation) III score was 67.

Sixty-one percent (970) of all patients were admitted to the ICU at night (5 p.m. to 5 a.m.). Overall, 381 patients (24%) died in the hospital, with 293 (18%) of them dying in the ICU.

The authors found no effect on length of stay in the ICU (median, 52.7 hours) for those in the intervention group. They calculated a "rate ratio," which was the rate of instantaneous discharge from the ICU in the intervention group divided by the rate of instantaneous discharge from the ICU in the control group. For ICU length of stay, the ratio was 0.98 (P = .72); a ratio of more than 1 would mean that the intervention shortened the time to discharge.

They found similar ratios for hospital length of stay (median, 174 hours in the intervention group vs. 166 hours in the control group) and mortality. A patient’s APACHE III score made no difference in the outcomes; neither did resident experience and training .

In a subanalysis, the authors determined that ratios were unchanged for patients admitted at night.

Having so many patients admitted at night was a strength of the study, the authors said. "If nighttime intensivists were effective, it is likely they would be particularly effective in an ICU with such a large nighttime workload," they wrote.

The researchers noted that further research is important because currently one-third of U.S. academic medical centers employ nighttime intensivists. On the surface, nighttime ICU staffing seems compelling, said the authors. But it also may be "one of several expensive medical practices that have been adopted without a supportive evidence base."

aault@frontlinemedcom.com

On Twitter @aliciaault

Having a critical care specialist physically present in the intensive care unit overnight does not seem to improve a broad range of patient outcomes, according to research published May 20 in the New England Journal of Medicine (doi: 0.1056/NEMJoa1302854).

Dr. Meeta Prasad Kerlin and her colleagues at the University of Pennsylvania, Philadelphia, randomized admissions to a 24-bed medical ICU over a 1-year period; they offer several explanations as to why having a nighttime intensivist does not seem to make a difference. Their research was presented simultaneously at the annual meeting of the American Thoracic Society.

Photo Credit: Robert Press/Penn Medicine

First, if the ICU is well staffed during the day and has adopted systems of care, there might not be a lot of room for patient improvement. Second, bringing on a new physician in the evening – rather than keeping the same intensivist on call – might disrupt continuity of care for some patients, they said.

All ICU patients admitted to the hospital at the university were randomized to the intervention group or the control group. The intervention group received care from an intensivist (a board-eligible or board-certified critical care specialist) who was on staff from 7 p.m. to 7 a.m., or from residents who normally were assigned to the ICU.

The control group received care from residents, who were able to reach two daytime intensivists or two critical care fellows at night by phone. Generally, the nursing ratio was one per two patients.

The nighttime intensivists were daytime staff who volunteered to take on a nighttime assignment. During the study, they covered one night a week.

Overall, 820 patients were assigned to the intervention (4 were later excluded due to missing data), and 778 were in the control group (7 ended up with missing data). In total, 175 nights were assigned to the intervention; 95% (166) of those nights were staffed by an intensivist.

The median age of patients was 60 years, and about half were men. Almost half were admitted from the emergency department, while just over a third were transferred from the hospital’s general floor. The median APACHE (Acute Physiology and Chronic Health Evaluation) III score was 67.

Sixty-one percent (970) of all patients were admitted to the ICU at night (5 p.m. to 5 a.m.). Overall, 381 patients (24%) died in the hospital, with 293 (18%) of them dying in the ICU.

The authors found no effect on length of stay in the ICU (median, 52.7 hours) for those in the intervention group. They calculated a "rate ratio," which was the rate of instantaneous discharge from the ICU in the intervention group divided by the rate of instantaneous discharge from the ICU in the control group. For ICU length of stay, the ratio was 0.98 (P = .72); a ratio of more than 1 would mean that the intervention shortened the time to discharge.

They found similar ratios for hospital length of stay (median, 174 hours in the intervention group vs. 166 hours in the control group) and mortality. A patient’s APACHE III score made no difference in the outcomes; neither did resident experience and training .

In a subanalysis, the authors determined that ratios were unchanged for patients admitted at night.

Having so many patients admitted at night was a strength of the study, the authors said. "If nighttime intensivists were effective, it is likely they would be particularly effective in an ICU with such a large nighttime workload," they wrote.

The researchers noted that further research is important because currently one-third of U.S. academic medical centers employ nighttime intensivists. On the surface, nighttime ICU staffing seems compelling, said the authors. But it also may be "one of several expensive medical practices that have been adopted without a supportive evidence base."

aault@frontlinemedcom.com

On Twitter @aliciaault