Alicia Ault

BETHESDA, MD. – Surgery is curative in half of patients with refractory temporal lobe epilepsy, yet it is still highly underused – in part because of misperceptions about the risks and benefits, according to Dr. Edward F. Chang.

Dr. Chang, assistant professor of neurological surgery and physiology at the University of California, San Francisco, said that numerous studies have shown that 60%-70% of patients are free of seizures 1 year after surgery and that at least half have seizure freedom over the long term. Also, there are "well-documented quality of life improvements," he said at the meeting sponsored by the National Institute of Neurological Disorders and Stroke.

Sixty percent of people with epilepsy have focal seizures, and the temporal lobe form is the most common type of epilepsy that is characterized by focal seizures, according to NINDS. The Epilepsy Foundation estimates that there are at least 200,000 new cases of epilepsy (any type) in the United States each year.

Based on the totality of the evidence, in 2003 the American Academy of Neurology, the American Epilepsy Society, and the American Association of Neurological Surgeons jointly published a guideline statement (Neurology 2003;60:538-47), urging referral of refractory patients for surgery.

But physicians are still not heeding that guidance, said Dr. Chang. His own survey of clinicians (Neurology 2012;78:1200-6) showed that there had been no increase in surgery in a 5-year period after the joint recommendation. Dr. Chang characterized that as "very depressing in terms of how we are using evidence," especially since there has been an increasing burden of epilepsy. In some cases, patients have lived with epilepsy for 20-30 years before being referred for surgery, he said.

Surgery is safe and effective and the side effects are predictable, he noted, adding that the number needed to treat for one patient with refractory temporal lobe epilepsy to become free of disabling seizures is only two – a number that parallels the use of antibiotics for pneumonia.

"We are below the standard of care," Dr. Chang said. Clinicians and patients shy away from surgery because "of the idea that brain surgery is too dangerous," he said. And physicians don’t understand the data. Drug and device makers also are "spending millions of dollars a year telling patients there are other options," he said, but if "we address this basic utilization problem we’d see an immediate and substantial reduction ... in the burden of epilepsy worldwide."

There have been several advances in surgical technique in the last few years that might make neurologists and patients – who might be spooked by looking at photos and videos of temporal lobe surgery on the Internet – more comfortable. For instance, there are transcortical approaches, which use a small incision to go through the white matter to the hippocampus. With the subtemporal approach, "you don’t have to go through any lateral cortex at all," he noted.

"Even for relatively large lesions that are quite deep in the brain we can actually do these minimally invasive approaches by just going underneath the lateral temporal cortex and selectively removing the hippocampus," Dr. Chang said.

On the horizon, there are nonsurgical minimally invasive techniques under development that have the potential to yield outcomes similar to surgery, he added. NINDS is funding a pivotal trial of stereotactic radiosurgery. The device selectively delivers radiation to the hippocampus and mesial lobe and spares the lateral temporal areas en route. Overall, it is fairly safe, but some patients have severe swelling as long as a year after the procedure and most have no effect for at least a year.

Another approach under study is using MRI to guide laser thermoablation. "A lot of us are quite excited about this," Dr. Chang said. The MRI allows the clinician to accurately place the laser and study how much the tissue is heated, which can help researchers determine whether there is damage and if it might be irreversible.

Finally, there is MRI-guided focused ultrasound, which uses the same principles as radiosurgery to target structures deep in the brain, he said. The procedure is currently in phase III trials for essential tremor.

There is, however, "a lot of irrational exuberance with these technologies," he pointed out.

It is not clear how to validate them, especially since clinicians are currently struggling with how to validate different surgical approaches. A big issue for the surgery trials is that it is difficult to recruit patients. Many have said that they don’t want to participate because they don’t want to be randomized.

Researchers also are trying to better understand epileptogenesis and how to reduce procedural side effects, including how to predict effects on cognitive function. To get there, "we need to understand more about how human cognition works," Dr. Chang said. Brain-mapping studies are showing that most aspects of cognition are not centered in one specific, focused area.

"Just like we’re thinking now that seizures are part of a distributed network, we also need to understand comorbidities and morbidity from surgical approaches in the same kind of framework," he said.

Until surgery is better used and studied, it is unlikely that neurology can move forward to truly understand the safety and effectiveness of the minimally invasive approaches, Dr. Chang said.

Dr. Chang has received grants from the National Institutes of Health and the Esther A. and Joseph Klingenstein Fund.

aault@frontlinemedcom.com

On Twitter @aliciaault

BETHESDA, MD. – Surgery is curative in half of patients with refractory temporal lobe epilepsy, yet it is still highly underused – in part because of misperceptions about the risks and benefits, according to Dr. Edward F. Chang.

Dr. Chang, assistant professor of neurological surgery and physiology at the University of California, San Francisco, said that numerous studies have shown that 60%-70% of patients are free of seizures 1 year after surgery and that at least half have seizure freedom over the long term. Also, there are "well-documented quality of life improvements," he said at the meeting sponsored by the National Institute of Neurological Disorders and Stroke.

Sixty percent of people with epilepsy have focal seizures, and the temporal lobe form is the most common type of epilepsy that is characterized by focal seizures, according to NINDS. The Epilepsy Foundation estimates that there are at least 200,000 new cases of epilepsy (any type) in the United States each year.

Based on the totality of the evidence, in 2003 the American Academy of Neurology, the American Epilepsy Society, and the American Association of Neurological Surgeons jointly published a guideline statement (Neurology 2003;60:538-47), urging referral of refractory patients for surgery.

But physicians are still not heeding that guidance, said Dr. Chang. His own survey of clinicians (Neurology 2012;78:1200-6) showed that there had been no increase in surgery in a 5-year period after the joint recommendation. Dr. Chang characterized that as "very depressing in terms of how we are using evidence," especially since there has been an increasing burden of epilepsy. In some cases, patients have lived with epilepsy for 20-30 years before being referred for surgery, he said.

Surgery is safe and effective and the side effects are predictable, he noted, adding that the number needed to treat for one patient with refractory temporal lobe epilepsy to become free of disabling seizures is only two – a number that parallels the use of antibiotics for pneumonia.

"We are below the standard of care," Dr. Chang said. Clinicians and patients shy away from surgery because "of the idea that brain surgery is too dangerous," he said. And physicians don’t understand the data. Drug and device makers also are "spending millions of dollars a year telling patients there are other options," he said, but if "we address this basic utilization problem we’d see an immediate and substantial reduction ... in the burden of epilepsy worldwide."

There have been several advances in surgical technique in the last few years that might make neurologists and patients – who might be spooked by looking at photos and videos of temporal lobe surgery on the Internet – more comfortable. For instance, there are transcortical approaches, which use a small incision to go through the white matter to the hippocampus. With the subtemporal approach, "you don’t have to go through any lateral cortex at all," he noted.

"Even for relatively large lesions that are quite deep in the brain we can actually do these minimally invasive approaches by just going underneath the lateral temporal cortex and selectively removing the hippocampus," Dr. Chang said.

On the horizon, there are nonsurgical minimally invasive techniques under development that have the potential to yield outcomes similar to surgery, he added. NINDS is funding a pivotal trial of stereotactic radiosurgery. The device selectively delivers radiation to the hippocampus and mesial lobe and spares the lateral temporal areas en route. Overall, it is fairly safe, but some patients have severe swelling as long as a year after the procedure and most have no effect for at least a year.

Another approach under study is using MRI to guide laser thermoablation. "A lot of us are quite excited about this," Dr. Chang said. The MRI allows the clinician to accurately place the laser and study how much the tissue is heated, which can help researchers determine whether there is damage and if it might be irreversible.

Finally, there is MRI-guided focused ultrasound, which uses the same principles as radiosurgery to target structures deep in the brain, he said. The procedure is currently in phase III trials for essential tremor.

There is, however, "a lot of irrational exuberance with these technologies," he pointed out.

It is not clear how to validate them, especially since clinicians are currently struggling with how to validate different surgical approaches. A big issue for the surgery trials is that it is difficult to recruit patients. Many have said that they don’t want to participate because they don’t want to be randomized.

Researchers also are trying to better understand epileptogenesis and how to reduce procedural side effects, including how to predict effects on cognitive function. To get there, "we need to understand more about how human cognition works," Dr. Chang said. Brain-mapping studies are showing that most aspects of cognition are not centered in one specific, focused area.

"Just like we’re thinking now that seizures are part of a distributed network, we also need to understand comorbidities and morbidity from surgical approaches in the same kind of framework," he said.

Until surgery is better used and studied, it is unlikely that neurology can move forward to truly understand the safety and effectiveness of the minimally invasive approaches, Dr. Chang said.

Dr. Chang has received grants from the National Institutes of Health and the Esther A. and Joseph Klingenstein Fund.

aault@frontlinemedcom.com

On Twitter @aliciaault

BETHESDA, MD. – Surgery is curative in half of patients with refractory temporal lobe epilepsy, yet it is still highly underused – in part because of misperceptions about the risks and benefits, according to Dr. Edward F. Chang.

Dr. Chang, assistant professor of neurological surgery and physiology at the University of California, San Francisco, said that numerous studies have shown that 60%-70% of patients are free of seizures 1 year after surgery and that at least half have seizure freedom over the long term. Also, there are "well-documented quality of life improvements," he said at the meeting sponsored by the National Institute of Neurological Disorders and Stroke.

Sixty percent of people with epilepsy have focal seizures, and the temporal lobe form is the most common type of epilepsy that is characterized by focal seizures, according to NINDS. The Epilepsy Foundation estimates that there are at least 200,000 new cases of epilepsy (any type) in the United States each year.

Based on the totality of the evidence, in 2003 the American Academy of Neurology, the American Epilepsy Society, and the American Association of Neurological Surgeons jointly published a guideline statement (Neurology 2003;60:538-47), urging referral of refractory patients for surgery.

But physicians are still not heeding that guidance, said Dr. Chang. His own survey of clinicians (Neurology 2012;78:1200-6) showed that there had been no increase in surgery in a 5-year period after the joint recommendation. Dr. Chang characterized that as "very depressing in terms of how we are using evidence," especially since there has been an increasing burden of epilepsy. In some cases, patients have lived with epilepsy for 20-30 years before being referred for surgery, he said.

Surgery is safe and effective and the side effects are predictable, he noted, adding that the number needed to treat for one patient with refractory temporal lobe epilepsy to become free of disabling seizures is only two – a number that parallels the use of antibiotics for pneumonia.

"We are below the standard of care," Dr. Chang said. Clinicians and patients shy away from surgery because "of the idea that brain surgery is too dangerous," he said. And physicians don’t understand the data. Drug and device makers also are "spending millions of dollars a year telling patients there are other options," he said, but if "we address this basic utilization problem we’d see an immediate and substantial reduction ... in the burden of epilepsy worldwide."

There have been several advances in surgical technique in the last few years that might make neurologists and patients – who might be spooked by looking at photos and videos of temporal lobe surgery on the Internet – more comfortable. For instance, there are transcortical approaches, which use a small incision to go through the white matter to the hippocampus. With the subtemporal approach, "you don’t have to go through any lateral cortex at all," he noted.

"Even for relatively large lesions that are quite deep in the brain we can actually do these minimally invasive approaches by just going underneath the lateral temporal cortex and selectively removing the hippocampus," Dr. Chang said.

On the horizon, there are nonsurgical minimally invasive techniques under development that have the potential to yield outcomes similar to surgery, he added. NINDS is funding a pivotal trial of stereotactic radiosurgery. The device selectively delivers radiation to the hippocampus and mesial lobe and spares the lateral temporal areas en route. Overall, it is fairly safe, but some patients have severe swelling as long as a year after the procedure and most have no effect for at least a year.

Another approach under study is using MRI to guide laser thermoablation. "A lot of us are quite excited about this," Dr. Chang said. The MRI allows the clinician to accurately place the laser and study how much the tissue is heated, which can help researchers determine whether there is damage and if it might be irreversible.

Finally, there is MRI-guided focused ultrasound, which uses the same principles as radiosurgery to target structures deep in the brain, he said. The procedure is currently in phase III trials for essential tremor.

There is, however, "a lot of irrational exuberance with these technologies," he pointed out.

It is not clear how to validate them, especially since clinicians are currently struggling with how to validate different surgical approaches. A big issue for the surgery trials is that it is difficult to recruit patients. Many have said that they don’t want to participate because they don’t want to be randomized.

Researchers also are trying to better understand epileptogenesis and how to reduce procedural side effects, including how to predict effects on cognitive function. To get there, "we need to understand more about how human cognition works," Dr. Chang said. Brain-mapping studies are showing that most aspects of cognition are not centered in one specific, focused area.

"Just like we’re thinking now that seizures are part of a distributed network, we also need to understand comorbidities and morbidity from surgical approaches in the same kind of framework," he said.

Until surgery is better used and studied, it is unlikely that neurology can move forward to truly understand the safety and effectiveness of the minimally invasive approaches, Dr. Chang said.

Dr. Chang has received grants from the National Institutes of Health and the Esther A. and Joseph Klingenstein Fund.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – The American College of Physicians plans to issue an exhaustive, evidence-based review of firearms policy and gun violence later this year.

The current policies are "a little dated," so "we’re going through an evidence-based review on firearms policy and gun violence [to] come up with more contemporary recommendations," said Dr. David L. Bronson, immediate past president of the ACP.

"We are aware that firearms are part of the American culture, and this can be a divisive issue for this country and for some of our members," said Dr. Bronson at the annual meeting of the ACP. He said that’s one reason why the college will take an evidence-based approach to formulating its new recommendations.

The college plans to issue a series of policy recommendations for state, local, and federal agencies, and for the medical and public health communities, noted Bob Doherty, ACP’s senior vice president for governmental affairs and public policy.

To get those recommendations, the ACP will analyze peer-reviewed literature on the causes and effects of firearm injuries and death, and on the effectiveness of various policy interventions to reduce preventable injuries and deaths, said Mr. Doherty.

It will be a multifaceted statement, "looking not only at laws on access to firearms and ammunition, but also public health interventions, mental health, substance abuse, culture, video games that simulate gun violence, and other contributing factors – as well as the role of physicians in asking patients about firearms and counseling them on how to reduce the risks," he said.

The ACP last reviewed evidence on gun violence in 1996.

Even as the ACP reformulates its policy recommendations, a bill aimed at preventing gun violence failed to pass the Senate April 17. The Safe Communities, Safe Schools Act of 2013 (S. 649) was introduced March 21 by Sen. Harry Reid (D-Nev.) and was supported by the ACP. The college wrote to Sen. Reid April 5 stating that it backed the bill’s provisions to improve the National Instant Criminal Background Check System (NICS), require a background check for every firearm sale, and to levy stricter penalties for "straw man" purchases of guns.

The bill did not, however, include a ban on assault weapons or high-capacity magazines, which the ACP would like to see, said Mr. Doherty.

Even if the Senate tries again to pass gun violence legislation, the House has not yet indicated whether it would take up any such bill that the Senate might pass. In any case, a gun violence bill would face a tougher road in the House, Mr. Doherty said. First, it would have to go through the House Judiciary Committee, "which is very conservative," he said. To pass the full House, a proposal would need the support of almost all Democrats and at least a few Republicans, he said.

"We are going to just keep pushing it and hope we prevail," said Mr. Doherty.

Dr. Bronson noted that opponents of proposals to rein in firearms may also find ways to reassert their rights and desires in legislation unrelated to gun violence. "You have to keep your eye on the ball," he said, adding, "they have a relentless lobby."

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – The American College of Physicians plans to issue an exhaustive, evidence-based review of firearms policy and gun violence later this year.

The current policies are "a little dated," so "we’re going through an evidence-based review on firearms policy and gun violence [to] come up with more contemporary recommendations," said Dr. David L. Bronson, immediate past president of the ACP.

"We are aware that firearms are part of the American culture, and this can be a divisive issue for this country and for some of our members," said Dr. Bronson at the annual meeting of the ACP. He said that’s one reason why the college will take an evidence-based approach to formulating its new recommendations.

The college plans to issue a series of policy recommendations for state, local, and federal agencies, and for the medical and public health communities, noted Bob Doherty, ACP’s senior vice president for governmental affairs and public policy.

To get those recommendations, the ACP will analyze peer-reviewed literature on the causes and effects of firearm injuries and death, and on the effectiveness of various policy interventions to reduce preventable injuries and deaths, said Mr. Doherty.

It will be a multifaceted statement, "looking not only at laws on access to firearms and ammunition, but also public health interventions, mental health, substance abuse, culture, video games that simulate gun violence, and other contributing factors – as well as the role of physicians in asking patients about firearms and counseling them on how to reduce the risks," he said.

The ACP last reviewed evidence on gun violence in 1996.

Even as the ACP reformulates its policy recommendations, a bill aimed at preventing gun violence failed to pass the Senate April 17. The Safe Communities, Safe Schools Act of 2013 (S. 649) was introduced March 21 by Sen. Harry Reid (D-Nev.) and was supported by the ACP. The college wrote to Sen. Reid April 5 stating that it backed the bill’s provisions to improve the National Instant Criminal Background Check System (NICS), require a background check for every firearm sale, and to levy stricter penalties for "straw man" purchases of guns.

The bill did not, however, include a ban on assault weapons or high-capacity magazines, which the ACP would like to see, said Mr. Doherty.

Even if the Senate tries again to pass gun violence legislation, the House has not yet indicated whether it would take up any such bill that the Senate might pass. In any case, a gun violence bill would face a tougher road in the House, Mr. Doherty said. First, it would have to go through the House Judiciary Committee, "which is very conservative," he said. To pass the full House, a proposal would need the support of almost all Democrats and at least a few Republicans, he said.

"We are going to just keep pushing it and hope we prevail," said Mr. Doherty.

Dr. Bronson noted that opponents of proposals to rein in firearms may also find ways to reassert their rights and desires in legislation unrelated to gun violence. "You have to keep your eye on the ball," he said, adding, "they have a relentless lobby."

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – The American College of Physicians plans to issue an exhaustive, evidence-based review of firearms policy and gun violence later this year.

The current policies are "a little dated," so "we’re going through an evidence-based review on firearms policy and gun violence [to] come up with more contemporary recommendations," said Dr. David L. Bronson, immediate past president of the ACP.

"We are aware that firearms are part of the American culture, and this can be a divisive issue for this country and for some of our members," said Dr. Bronson at the annual meeting of the ACP. He said that’s one reason why the college will take an evidence-based approach to formulating its new recommendations.

The college plans to issue a series of policy recommendations for state, local, and federal agencies, and for the medical and public health communities, noted Bob Doherty, ACP’s senior vice president for governmental affairs and public policy.

To get those recommendations, the ACP will analyze peer-reviewed literature on the causes and effects of firearm injuries and death, and on the effectiveness of various policy interventions to reduce preventable injuries and deaths, said Mr. Doherty.

It will be a multifaceted statement, "looking not only at laws on access to firearms and ammunition, but also public health interventions, mental health, substance abuse, culture, video games that simulate gun violence, and other contributing factors – as well as the role of physicians in asking patients about firearms and counseling them on how to reduce the risks," he said.

The ACP last reviewed evidence on gun violence in 1996.

Even as the ACP reformulates its policy recommendations, a bill aimed at preventing gun violence failed to pass the Senate April 17. The Safe Communities, Safe Schools Act of 2013 (S. 649) was introduced March 21 by Sen. Harry Reid (D-Nev.) and was supported by the ACP. The college wrote to Sen. Reid April 5 stating that it backed the bill’s provisions to improve the National Instant Criminal Background Check System (NICS), require a background check for every firearm sale, and to levy stricter penalties for "straw man" purchases of guns.

The bill did not, however, include a ban on assault weapons or high-capacity magazines, which the ACP would like to see, said Mr. Doherty.

Even if the Senate tries again to pass gun violence legislation, the House has not yet indicated whether it would take up any such bill that the Senate might pass. In any case, a gun violence bill would face a tougher road in the House, Mr. Doherty said. First, it would have to go through the House Judiciary Committee, "which is very conservative," he said. To pass the full House, a proposal would need the support of almost all Democrats and at least a few Republicans, he said.

"We are going to just keep pushing it and hope we prevail," said Mr. Doherty.

Dr. Bronson noted that opponents of proposals to rein in firearms may also find ways to reassert their rights and desires in legislation unrelated to gun violence. "You have to keep your eye on the ball," he said, adding, "they have a relentless lobby."

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 as soon as this summer. Health insurers will begin sending new contracts to physicians at around the same time.

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."

Ms. McNeil added in an interview later, "Why would a doctor sign up if they are going to be completely at risk and have to collect from the patient for the care?"

The CMA is seeking a change in the federal regulation on the grace period, which was included in the overall health insurance regulations issued in November 2012.

So far, none of the California insurers who have issued materials about their health insurance exchange plans have mentioned the grace period, Ms. McNeil said. She added that 33 health plans have said they were interested in participating in the California exchange, which is called Covered California.

Many patients who get insurance 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 that 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 close attention to the contracts they sign with health insurers that are 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? Can the practice opt in or out of a network? Many plans in California still have not determined their premiums or benefits for the exchange policies, which means they also have not set their reimbursement rates, Ms. McNeil said.

When negotiating rates, be aware that many of the patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have previously 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.

"There are a lot of issues here. You’re going to have to watch your practice and the big picture," she said.

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 as soon as this summer. Health insurers will begin sending new contracts to physicians at around the same time.

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."

Ms. McNeil added in an interview later, "Why would a doctor sign up if they are going to be completely at risk and have to collect from the patient for the care?"

The CMA is seeking a change in the federal regulation on the grace period, which was included in the overall health insurance regulations issued in November 2012.

So far, none of the California insurers who have issued materials about their health insurance exchange plans have mentioned the grace period, Ms. McNeil said. She added that 33 health plans have said they were interested in participating in the California exchange, which is called Covered California.

Many patients who get insurance 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 that 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 close attention to the contracts they sign with health insurers that are 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? Can the practice opt in or out of a network? Many plans in California still have not determined their premiums or benefits for the exchange policies, which means they also have not set their reimbursement rates, Ms. McNeil said.

When negotiating rates, be aware that many of the patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have previously 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.

"There are a lot of issues here. You’re going to have to watch your practice and the big picture," she said.

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 as soon as this summer. Health insurers will begin sending new contracts to physicians at around the same time.

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."

Ms. McNeil added in an interview later, "Why would a doctor sign up if they are going to be completely at risk and have to collect from the patient for the care?"

The CMA is seeking a change in the federal regulation on the grace period, which was included in the overall health insurance regulations issued in November 2012.

So far, none of the California insurers who have issued materials about their health insurance exchange plans have mentioned the grace period, Ms. McNeil said. She added that 33 health plans have said they were interested in participating in the California exchange, which is called Covered California.

Many patients who get insurance 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 that 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 close attention to the contracts they sign with health insurers that are 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? Can the practice opt in or out of a network? Many plans in California still have not determined their premiums or benefits for the exchange policies, which means they also have not set their reimbursement rates, Ms. McNeil said.

When negotiating rates, be aware that many of the patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have previously 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.

"There are a lot of issues here. You’re going to have to watch your practice and the big picture," she said.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Tempted to "friend" a patient on your personal Facebook page? That’s probably not a good idea, according to new guidelines issued by the American College of Physicians and the Federation of State Medical Boards.

The ACP and federation guidelines outline many benefits from use of e-mail and social media, including improving access to care, but "the boundaries between professional and social spheres can blur online," said Dr. Humayun J. Chaudhry, president and chief executive officer of the Federation of State Medical Boards (FSMB) and an author of the guidelines. "Physicians should keep the spheres separate and comport themselves professionally online."

Alicia Ault/IMNG Medical Media

Opportunities for misadventure abound with online communications and texting, Dr. Chaudhry said at the annual meeting of the American College of Physicians. Confidentiality can be breached, as can the patient-physician relationship; the communications can be taken out of context or be spread widely beyond the original conversation.

And disciplinary actions are likely to increase. In a recent study of state medical boards, 92% reported that they had dealt with at least one case of unprofessional online behavior that led to punishment, including license revocation (Ann. Intern. Med. 2013;158:124-30).

The ACP and FSMB guidelines, published online Apr. 11 in the Annals of Internal Medicine, are meant "to serve as a wake-up call to physicians, to make them aware of some of the dangers that are out there," he said. Aside from not "friending" patients, the guidelines also recommend the following to physicians:

• Don’t use text messaging for medical interactions, even with established patients, except with caution and the patient’s consent.

• Only use e-mail within the context of an established relationship with a patient, and with that patient’s consent.

• Establish a professional online profile so that it appears at the top of a web-based search, above any physician rating site.

• Discourage e-mail or on-line communications with individuals who are not patients, instead referring them to make an appointment or visit an appropriate health provider.

• Manage their digital image, including refraining from posting about personal social activities that might not reflect positively or providing less-than-measured comments on Twitter, blogs, or in response to online articles.

E-mail presents several dangers, said Dr. David A. Fleming, a member of the ACP Board of Regents and chairman of the ACP Ethics, Professionalism, and Human Rights Committee. The new guidelines urge e-mail communications only with established patients who have a relationship with the physician and understand that the communication might not be secure, he said, adding that information sent via e-mail also can be discoverable for legal purposes.

Alicia Ault/IMNG Medical Media

An e-mail from a patient in a crisis situation presents a different present challenge. "As soon as we respond in any way, then the relationship forms and we have a fiduciary responsibility to, first of all, know our limits, but also the extent to which an intervention is needed," Dr. Fleming said. If the crisis warrants intervention, then the physician is obligated to help the patient.

Social media can be a great way to encourage patients to get vaccinated or exercise or watch their weight, but postings on Twitter or Facebook can still be fraught with peril, Dr. Fleming and Dr. Chaudhry said. Physicians need to be clear when they are expressing their personal opinion or representing a professional organization, for instance.

Both physicians said that the ACP and the FSMB are not advocating censorship.

"We’re not telling people what to say, what not to say, we’re just asking them to think before you press send," said Dr. Chaudhry.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Tempted to "friend" a patient on your personal Facebook page? That’s probably not a good idea, according to new guidelines issued by the American College of Physicians and the Federation of State Medical Boards.

The ACP and federation guidelines outline many benefits from use of e-mail and social media, including improving access to care, but "the boundaries between professional and social spheres can blur online," said Dr. Humayun J. Chaudhry, president and chief executive officer of the Federation of State Medical Boards (FSMB) and an author of the guidelines. "Physicians should keep the spheres separate and comport themselves professionally online."

Alicia Ault/IMNG Medical Media

Opportunities for misadventure abound with online communications and texting, Dr. Chaudhry said at the annual meeting of the American College of Physicians. Confidentiality can be breached, as can the patient-physician relationship; the communications can be taken out of context or be spread widely beyond the original conversation.

And disciplinary actions are likely to increase. In a recent study of state medical boards, 92% reported that they had dealt with at least one case of unprofessional online behavior that led to punishment, including license revocation (Ann. Intern. Med. 2013;158:124-30).

The ACP and FSMB guidelines, published online Apr. 11 in the Annals of Internal Medicine, are meant "to serve as a wake-up call to physicians, to make them aware of some of the dangers that are out there," he said. Aside from not "friending" patients, the guidelines also recommend the following to physicians:

• Don’t use text messaging for medical interactions, even with established patients, except with caution and the patient’s consent.

• Only use e-mail within the context of an established relationship with a patient, and with that patient’s consent.

• Establish a professional online profile so that it appears at the top of a web-based search, above any physician rating site.

• Discourage e-mail or on-line communications with individuals who are not patients, instead referring them to make an appointment or visit an appropriate health provider.

• Manage their digital image, including refraining from posting about personal social activities that might not reflect positively or providing less-than-measured comments on Twitter, blogs, or in response to online articles.

E-mail presents several dangers, said Dr. David A. Fleming, a member of the ACP Board of Regents and chairman of the ACP Ethics, Professionalism, and Human Rights Committee. The new guidelines urge e-mail communications only with established patients who have a relationship with the physician and understand that the communication might not be secure, he said, adding that information sent via e-mail also can be discoverable for legal purposes.

Alicia Ault/IMNG Medical Media

An e-mail from a patient in a crisis situation presents a different present challenge. "As soon as we respond in any way, then the relationship forms and we have a fiduciary responsibility to, first of all, know our limits, but also the extent to which an intervention is needed," Dr. Fleming said. If the crisis warrants intervention, then the physician is obligated to help the patient.

Social media can be a great way to encourage patients to get vaccinated or exercise or watch their weight, but postings on Twitter or Facebook can still be fraught with peril, Dr. Fleming and Dr. Chaudhry said. Physicians need to be clear when they are expressing their personal opinion or representing a professional organization, for instance.

Both physicians said that the ACP and the FSMB are not advocating censorship.

"We’re not telling people what to say, what not to say, we’re just asking them to think before you press send," said Dr. Chaudhry.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Tempted to "friend" a patient on your personal Facebook page? That’s probably not a good idea, according to new guidelines issued by the American College of Physicians and the Federation of State Medical Boards.

The ACP and federation guidelines outline many benefits from use of e-mail and social media, including improving access to care, but "the boundaries between professional and social spheres can blur online," said Dr. Humayun J. Chaudhry, president and chief executive officer of the Federation of State Medical Boards (FSMB) and an author of the guidelines. "Physicians should keep the spheres separate and comport themselves professionally online."

Alicia Ault/IMNG Medical Media

Opportunities for misadventure abound with online communications and texting, Dr. Chaudhry said at the annual meeting of the American College of Physicians. Confidentiality can be breached, as can the patient-physician relationship; the communications can be taken out of context or be spread widely beyond the original conversation.

And disciplinary actions are likely to increase. In a recent study of state medical boards, 92% reported that they had dealt with at least one case of unprofessional online behavior that led to punishment, including license revocation (Ann. Intern. Med. 2013;158:124-30).

The ACP and FSMB guidelines, published online Apr. 11 in the Annals of Internal Medicine, are meant "to serve as a wake-up call to physicians, to make them aware of some of the dangers that are out there," he said. Aside from not "friending" patients, the guidelines also recommend the following to physicians:

• Don’t use text messaging for medical interactions, even with established patients, except with caution and the patient’s consent.

• Only use e-mail within the context of an established relationship with a patient, and with that patient’s consent.

• Establish a professional online profile so that it appears at the top of a web-based search, above any physician rating site.

• Discourage e-mail or on-line communications with individuals who are not patients, instead referring them to make an appointment or visit an appropriate health provider.

• Manage their digital image, including refraining from posting about personal social activities that might not reflect positively or providing less-than-measured comments on Twitter, blogs, or in response to online articles.

E-mail presents several dangers, said Dr. David A. Fleming, a member of the ACP Board of Regents and chairman of the ACP Ethics, Professionalism, and Human Rights Committee. The new guidelines urge e-mail communications only with established patients who have a relationship with the physician and understand that the communication might not be secure, he said, adding that information sent via e-mail also can be discoverable for legal purposes.

Alicia Ault/IMNG Medical Media

An e-mail from a patient in a crisis situation presents a different present challenge. "As soon as we respond in any way, then the relationship forms and we have a fiduciary responsibility to, first of all, know our limits, but also the extent to which an intervention is needed," Dr. Fleming said. If the crisis warrants intervention, then the physician is obligated to help the patient.

Social media can be a great way to encourage patients to get vaccinated or exercise or watch their weight, but postings on Twitter or Facebook can still be fraught with peril, Dr. Fleming and Dr. Chaudhry said. Physicians need to be clear when they are expressing their personal opinion or representing a professional organization, for instance.

Both physicians said that the ACP and the FSMB are not advocating censorship.

"We’re not telling people what to say, what not to say, we’re just asking them to think before you press send," said Dr. Chaudhry.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – A new policy statement aims to help cancer patients to quit using tobacco and encourage more physicians to consider tobacco use as a measure in trials and as a key vital sign.

"Today, we call on the oncology community in this statement to assess and document tobacco use by, and to provide cessation support to all cancer patients," Dr. Roy S. Herbst said at a press briefing April 9 at the annual meeting of the American Association for Cancer Research.

Dr. Herbst is a member of the AACR Tobacco and Cancer Subcommittee that wrote the statement, and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven in Conn.

The report’s two main recommendations:

• Patients with cancer, participants in cancer trials, and patients being screened for cancer and who use tobacco or who have recently quit, should be given evidence-based tobacco-cessation assistance, ideally within an oncology practice.

• Tobacco use should be comprehensively and repeatedly documented in all cancer patients – both in practices and in trials – so as to gauge the effect of tobacco on treatment, disease progression, comorbidities, and survival.

Addressing tobacco use is urgent because up to a third of all cancer-related deaths and 87% of lung cancer deaths are because of tobacco use, Dr. Herbst said. Tobacco use plays a role in 18 different cancers. Prevention is the goal, but it’s also important to urge people who have cancer – or who have survived it – to stop using tobacco, he said.

Patients who use tobacco have worse outcomes and more difficult treatment. According to the policy statement, tobacco use decreases the effectiveness of chemotherapies and interferes with drug metabolism. The data also shows that it decreases survival in cancer of the lung, head and neck, breast, prostate, colon, esophagus, cervix, bladder, and ovaries and in leukemia.

Evidence-based tobacco cessation models developed by the U.S. Public Health Service are endorsed by the AACR, the American Society of Clinical Oncology, and others, and yet few clinicians offer cessation services.

The AACR committee also reported that only 38% of National Cancer Institute–designated Cancer Centers record smoking as a vital sign and less than half have dedicated tobacco cessation personnel. And, in a survey by the International Association for the Study of Lung Cancer, only about 40% of lung cancer specialists said they discussed medication or offered cessation support to patients.

Tobacco assessment in cancer patients may be underperformed in part because of physician and patient perceptions that it’s too late to have an impact, Dr. Herbst said. "There is the feeling that someone’s smoking, they already have cancer, why worry about it."

There is also the issue of payment.

Smoking cessation generally has been not covered in the past, although Medicare covers up to eight visits a year for counseling. The Affordable Care Act requires coverage of tobacco cessation by all insurers starting in 2014.

"It’s true that reimbursement in the past was very poor," said Benjamin A. Toll, Ph.D., a psychiatrist and program director of the smoking cessation service at Smilow Cancer Hospital at Yale-New Haven. "It’s still not particularly high, but it’s getting better," he said, at the briefing.

Clinicians and researchers also have not been diligent about assessing tobacco use in trials. A survey of 155 NCI Cooperative Group Trials showed that only 29% of trials assessed tobacco use at enrollment; far fewer recorded smoking status during the trial. Less than 5% followed up subsequently on tobacco use status during or after the trial.

None of the studies evaluated nicotine dependence or the patient’s interest in quitting.

"It really is incredible that so many of these NCI trials are done and these data are not recorded," said Dr. Herbst.

"Assessing Tobacco Use in Cancer Patients and Facilitating Cessation" is the third statement on tobacco use by the AACR, published online in Clinical Cancer Research (2013;19:1-8).

The statement was Dr. Herbst reported that he received consulting fees from Biothera, Diatech, and Quintiles. Mr. Toll reported that he received support from Pfizer, for medicine only.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – A new policy statement aims to help cancer patients to quit using tobacco and encourage more physicians to consider tobacco use as a measure in trials and as a key vital sign.

"Today, we call on the oncology community in this statement to assess and document tobacco use by, and to provide cessation support to all cancer patients," Dr. Roy S. Herbst said at a press briefing April 9 at the annual meeting of the American Association for Cancer Research.

Dr. Herbst is a member of the AACR Tobacco and Cancer Subcommittee that wrote the statement, and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven in Conn.

The report’s two main recommendations:

• Patients with cancer, participants in cancer trials, and patients being screened for cancer and who use tobacco or who have recently quit, should be given evidence-based tobacco-cessation assistance, ideally within an oncology practice.

• Tobacco use should be comprehensively and repeatedly documented in all cancer patients – both in practices and in trials – so as to gauge the effect of tobacco on treatment, disease progression, comorbidities, and survival.

Addressing tobacco use is urgent because up to a third of all cancer-related deaths and 87% of lung cancer deaths are because of tobacco use, Dr. Herbst said. Tobacco use plays a role in 18 different cancers. Prevention is the goal, but it’s also important to urge people who have cancer – or who have survived it – to stop using tobacco, he said.

Patients who use tobacco have worse outcomes and more difficult treatment. According to the policy statement, tobacco use decreases the effectiveness of chemotherapies and interferes with drug metabolism. The data also shows that it decreases survival in cancer of the lung, head and neck, breast, prostate, colon, esophagus, cervix, bladder, and ovaries and in leukemia.

Evidence-based tobacco cessation models developed by the U.S. Public Health Service are endorsed by the AACR, the American Society of Clinical Oncology, and others, and yet few clinicians offer cessation services.

The AACR committee also reported that only 38% of National Cancer Institute–designated Cancer Centers record smoking as a vital sign and less than half have dedicated tobacco cessation personnel. And, in a survey by the International Association for the Study of Lung Cancer, only about 40% of lung cancer specialists said they discussed medication or offered cessation support to patients.

Tobacco assessment in cancer patients may be underperformed in part because of physician and patient perceptions that it’s too late to have an impact, Dr. Herbst said. "There is the feeling that someone’s smoking, they already have cancer, why worry about it."

There is also the issue of payment.

Smoking cessation generally has been not covered in the past, although Medicare covers up to eight visits a year for counseling. The Affordable Care Act requires coverage of tobacco cessation by all insurers starting in 2014.

"It’s true that reimbursement in the past was very poor," said Benjamin A. Toll, Ph.D., a psychiatrist and program director of the smoking cessation service at Smilow Cancer Hospital at Yale-New Haven. "It’s still not particularly high, but it’s getting better," he said, at the briefing.

Clinicians and researchers also have not been diligent about assessing tobacco use in trials. A survey of 155 NCI Cooperative Group Trials showed that only 29% of trials assessed tobacco use at enrollment; far fewer recorded smoking status during the trial. Less than 5% followed up subsequently on tobacco use status during or after the trial.

None of the studies evaluated nicotine dependence or the patient’s interest in quitting.

"It really is incredible that so many of these NCI trials are done and these data are not recorded," said Dr. Herbst.

"Assessing Tobacco Use in Cancer Patients and Facilitating Cessation" is the third statement on tobacco use by the AACR, published online in Clinical Cancer Research (2013;19:1-8).

The statement was Dr. Herbst reported that he received consulting fees from Biothera, Diatech, and Quintiles. Mr. Toll reported that he received support from Pfizer, for medicine only.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – A new policy statement aims to help cancer patients to quit using tobacco and encourage more physicians to consider tobacco use as a measure in trials and as a key vital sign.

"Today, we call on the oncology community in this statement to assess and document tobacco use by, and to provide cessation support to all cancer patients," Dr. Roy S. Herbst said at a press briefing April 9 at the annual meeting of the American Association for Cancer Research.

Dr. Herbst is a member of the AACR Tobacco and Cancer Subcommittee that wrote the statement, and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven in Conn.

The report’s two main recommendations:

• Patients with cancer, participants in cancer trials, and patients being screened for cancer and who use tobacco or who have recently quit, should be given evidence-based tobacco-cessation assistance, ideally within an oncology practice.

• Tobacco use should be comprehensively and repeatedly documented in all cancer patients – both in practices and in trials – so as to gauge the effect of tobacco on treatment, disease progression, comorbidities, and survival.

Addressing tobacco use is urgent because up to a third of all cancer-related deaths and 87% of lung cancer deaths are because of tobacco use, Dr. Herbst said. Tobacco use plays a role in 18 different cancers. Prevention is the goal, but it’s also important to urge people who have cancer – or who have survived it – to stop using tobacco, he said.

Patients who use tobacco have worse outcomes and more difficult treatment. According to the policy statement, tobacco use decreases the effectiveness of chemotherapies and interferes with drug metabolism. The data also shows that it decreases survival in cancer of the lung, head and neck, breast, prostate, colon, esophagus, cervix, bladder, and ovaries and in leukemia.

Evidence-based tobacco cessation models developed by the U.S. Public Health Service are endorsed by the AACR, the American Society of Clinical Oncology, and others, and yet few clinicians offer cessation services.

The AACR committee also reported that only 38% of National Cancer Institute–designated Cancer Centers record smoking as a vital sign and less than half have dedicated tobacco cessation personnel. And, in a survey by the International Association for the Study of Lung Cancer, only about 40% of lung cancer specialists said they discussed medication or offered cessation support to patients.

Tobacco assessment in cancer patients may be underperformed in part because of physician and patient perceptions that it’s too late to have an impact, Dr. Herbst said. "There is the feeling that someone’s smoking, they already have cancer, why worry about it."

There is also the issue of payment.

Smoking cessation generally has been not covered in the past, although Medicare covers up to eight visits a year for counseling. The Affordable Care Act requires coverage of tobacco cessation by all insurers starting in 2014.

"It’s true that reimbursement in the past was very poor," said Benjamin A. Toll, Ph.D., a psychiatrist and program director of the smoking cessation service at Smilow Cancer Hospital at Yale-New Haven. "It’s still not particularly high, but it’s getting better," he said, at the briefing.

Clinicians and researchers also have not been diligent about assessing tobacco use in trials. A survey of 155 NCI Cooperative Group Trials showed that only 29% of trials assessed tobacco use at enrollment; far fewer recorded smoking status during the trial. Less than 5% followed up subsequently on tobacco use status during or after the trial.

None of the studies evaluated nicotine dependence or the patient’s interest in quitting.

"It really is incredible that so many of these NCI trials are done and these data are not recorded," said Dr. Herbst.

"Assessing Tobacco Use in Cancer Patients and Facilitating Cessation" is the third statement on tobacco use by the AACR, published online in Clinical Cancer Research (2013;19:1-8).

The statement was Dr. Herbst reported that he received consulting fees from Biothera, Diatech, and Quintiles. Mr. Toll reported that he received support from Pfizer, for medicine only.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – Flat funding over the last decade combined with inflation has effectively cut 20% out of the research budget for the National Institutes of Health – and now another 5% is gone thanks to the federal budget sequester.

Cancer researchers, practicing oncologists, advocates, and congressional supporters took a break from the annual meeting of the American Association for Cancer Research to protest the long and lingering decline in funding. They were joined at the Rally for Medical Research by representatives from at least 200 partner organizations involved in research, patient care, or advocacy for diabetes, heart disease, stroke, Alzheimer’s disease, and AIDS, among other conditions.

Even President Obama chimed in via a message read by Dr. Margaret Foti, AACR chief executive officer.

"By investing in the best ideas and supporting the work of our scientists, we will improve health and change lives in ways we could have never imagined," read Dr. Foti from the president’s remarks.

In her own remarks, Dr. Foti said that just showing up was important to the greater goal. "By participating in today’s rally, you are taking a very important step to ensure that America will continue to lead the world in medical research," she said.

The rally focused on the cuts to funding for the 27 institutes and centers at the National Institutes of Health. The NIH is currently funded at $30.6 billion, which makes it biggest supporter of medical research in the world, according to rally organizers. But, they said, NIH appropriations have been flat since 2003. Factoring in biomedical inflation, the agency has effectively lost approximately $6 billion, or 20% of its purchasing power over that same time period. Sequestration threatens another 5%, or $5 billion cut.

Rep. Rosa DeLauro (D-Conn.), an ovarian cancer survivor, said at the rally that biomedical research helps grow the economy. "Every dollar that goes to the NIH results in $2 of business activity," she said, calling on rally participants to visit their congressional delegations and urge them to take money from other programs to balance the budget.

Rep. Chris Van Hollen (D-Md.), is whose district NIH is headquartered, said that continued cuts to biomedical funding could deter young people from pursuing careers in science.

"We should not be retreating on medical research, we should be redoubling our efforts," said Rep. Van Hollen, who serves as ranking member on the House Budget Committee.

Rep. Van Hollen said he hoped the rally would bring a sharper focus to the impact of the sequester. "The more public attention we draw to this issue, the better chance we’ll have at replacing the sequester," he said in an interview. "This is one area that has consequences for people of every political persuasion."

The sequester cuts are being felt already, according to Candace Johnson, Ph.D., deputy director of the Roswell Park Cancer Institute, Buffalo, N.Y. The institute could lose at least $8 million from its overall budget of $550 million, but the cuts will fall disproportionately on the research programs, Dr. Johnson said in an interview. And there’s continued uncertainty with the sequester – it is possible that some grants will be cut even more than anticipated. "We’re in the dark here," she said.

Cutting research will also have an effect on clinical care, Dr. Johnson said. "When you cut basic science, you cut that road to better and more innovative clinical care. If you don’t have basic science, you don’t have cancer centers doing basic discovery, then you don’t have a phase I program."

Dr. Sandra Swain, president of the American Society of Clinical Oncology, said that sustained and predictable funding increases were crucial to progress. And she noted, there’s no substitute for federal funds. "While private industry is a strong partner in cancer research, public funding is essential to pursue the types of research in which industry may have no interest," she said, in a statement. "This is particularly true for rare diseases, combinations of different companies’ products, therapies with multiple treatment modalities (such as surgery, radiation, and chemotherapy), and direct comparisons of company products," Dr. Swain said.

ASCO also sounded a note of caution about the budget for the Food and Drug Administration, which is also cut under sequestration. ASCO "is concerned that sequestration will cause slower approval of new and potentially life-saving drugs, difficulty in meeting challenges in monitoring of food and drug safety, and an inability to keep up with advancing science and technology," Dr. Swain said.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – Flat funding over the last decade combined with inflation has effectively cut 20% out of the research budget for the National Institutes of Health – and now another 5% is gone thanks to the federal budget sequester.

Cancer researchers, practicing oncologists, advocates, and congressional supporters took a break from the annual meeting of the American Association for Cancer Research to protest the long and lingering decline in funding. They were joined at the Rally for Medical Research by representatives from at least 200 partner organizations involved in research, patient care, or advocacy for diabetes, heart disease, stroke, Alzheimer’s disease, and AIDS, among other conditions.

Even President Obama chimed in via a message read by Dr. Margaret Foti, AACR chief executive officer.

"By investing in the best ideas and supporting the work of our scientists, we will improve health and change lives in ways we could have never imagined," read Dr. Foti from the president’s remarks.

In her own remarks, Dr. Foti said that just showing up was important to the greater goal. "By participating in today’s rally, you are taking a very important step to ensure that America will continue to lead the world in medical research," she said.

The rally focused on the cuts to funding for the 27 institutes and centers at the National Institutes of Health. The NIH is currently funded at $30.6 billion, which makes it biggest supporter of medical research in the world, according to rally organizers. But, they said, NIH appropriations have been flat since 2003. Factoring in biomedical inflation, the agency has effectively lost approximately $6 billion, or 20% of its purchasing power over that same time period. Sequestration threatens another 5%, or $5 billion cut.

Rep. Rosa DeLauro (D-Conn.), an ovarian cancer survivor, said at the rally that biomedical research helps grow the economy. "Every dollar that goes to the NIH results in $2 of business activity," she said, calling on rally participants to visit their congressional delegations and urge them to take money from other programs to balance the budget.

Rep. Chris Van Hollen (D-Md.), is whose district NIH is headquartered, said that continued cuts to biomedical funding could deter young people from pursuing careers in science.

"We should not be retreating on medical research, we should be redoubling our efforts," said Rep. Van Hollen, who serves as ranking member on the House Budget Committee.

Rep. Van Hollen said he hoped the rally would bring a sharper focus to the impact of the sequester. "The more public attention we draw to this issue, the better chance we’ll have at replacing the sequester," he said in an interview. "This is one area that has consequences for people of every political persuasion."

The sequester cuts are being felt already, according to Candace Johnson, Ph.D., deputy director of the Roswell Park Cancer Institute, Buffalo, N.Y. The institute could lose at least $8 million from its overall budget of $550 million, but the cuts will fall disproportionately on the research programs, Dr. Johnson said in an interview. And there’s continued uncertainty with the sequester – it is possible that some grants will be cut even more than anticipated. "We’re in the dark here," she said.

Cutting research will also have an effect on clinical care, Dr. Johnson said. "When you cut basic science, you cut that road to better and more innovative clinical care. If you don’t have basic science, you don’t have cancer centers doing basic discovery, then you don’t have a phase I program."

Dr. Sandra Swain, president of the American Society of Clinical Oncology, said that sustained and predictable funding increases were crucial to progress. And she noted, there’s no substitute for federal funds. "While private industry is a strong partner in cancer research, public funding is essential to pursue the types of research in which industry may have no interest," she said, in a statement. "This is particularly true for rare diseases, combinations of different companies’ products, therapies with multiple treatment modalities (such as surgery, radiation, and chemotherapy), and direct comparisons of company products," Dr. Swain said.

ASCO also sounded a note of caution about the budget for the Food and Drug Administration, which is also cut under sequestration. ASCO "is concerned that sequestration will cause slower approval of new and potentially life-saving drugs, difficulty in meeting challenges in monitoring of food and drug safety, and an inability to keep up with advancing science and technology," Dr. Swain said.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – Flat funding over the last decade combined with inflation has effectively cut 20% out of the research budget for the National Institutes of Health – and now another 5% is gone thanks to the federal budget sequester.

Cancer researchers, practicing oncologists, advocates, and congressional supporters took a break from the annual meeting of the American Association for Cancer Research to protest the long and lingering decline in funding. They were joined at the Rally for Medical Research by representatives from at least 200 partner organizations involved in research, patient care, or advocacy for diabetes, heart disease, stroke, Alzheimer’s disease, and AIDS, among other conditions.

Even President Obama chimed in via a message read by Dr. Margaret Foti, AACR chief executive officer.

"By investing in the best ideas and supporting the work of our scientists, we will improve health and change lives in ways we could have never imagined," read Dr. Foti from the president’s remarks.

In her own remarks, Dr. Foti said that just showing up was important to the greater goal. "By participating in today’s rally, you are taking a very important step to ensure that America will continue to lead the world in medical research," she said.

The rally focused on the cuts to funding for the 27 institutes and centers at the National Institutes of Health. The NIH is currently funded at $30.6 billion, which makes it biggest supporter of medical research in the world, according to rally organizers. But, they said, NIH appropriations have been flat since 2003. Factoring in biomedical inflation, the agency has effectively lost approximately $6 billion, or 20% of its purchasing power over that same time period. Sequestration threatens another 5%, or $5 billion cut.

Rep. Rosa DeLauro (D-Conn.), an ovarian cancer survivor, said at the rally that biomedical research helps grow the economy. "Every dollar that goes to the NIH results in $2 of business activity," she said, calling on rally participants to visit their congressional delegations and urge them to take money from other programs to balance the budget.

Rep. Chris Van Hollen (D-Md.), is whose district NIH is headquartered, said that continued cuts to biomedical funding could deter young people from pursuing careers in science.

"We should not be retreating on medical research, we should be redoubling our efforts," said Rep. Van Hollen, who serves as ranking member on the House Budget Committee.

Rep. Van Hollen said he hoped the rally would bring a sharper focus to the impact of the sequester. "The more public attention we draw to this issue, the better chance we’ll have at replacing the sequester," he said in an interview. "This is one area that has consequences for people of every political persuasion."

The sequester cuts are being felt already, according to Candace Johnson, Ph.D., deputy director of the Roswell Park Cancer Institute, Buffalo, N.Y. The institute could lose at least $8 million from its overall budget of $550 million, but the cuts will fall disproportionately on the research programs, Dr. Johnson said in an interview. And there’s continued uncertainty with the sequester – it is possible that some grants will be cut even more than anticipated. "We’re in the dark here," she said.

Cutting research will also have an effect on clinical care, Dr. Johnson said. "When you cut basic science, you cut that road to better and more innovative clinical care. If you don’t have basic science, you don’t have cancer centers doing basic discovery, then you don’t have a phase I program."

Dr. Sandra Swain, president of the American Society of Clinical Oncology, said that sustained and predictable funding increases were crucial to progress. And she noted, there’s no substitute for federal funds. "While private industry is a strong partner in cancer research, public funding is essential to pursue the types of research in which industry may have no interest," she said, in a statement. "This is particularly true for rare diseases, combinations of different companies’ products, therapies with multiple treatment modalities (such as surgery, radiation, and chemotherapy), and direct comparisons of company products," Dr. Swain said.

ASCO also sounded a note of caution about the budget for the Food and Drug Administration, which is also cut under sequestration. ASCO "is concerned that sequestration will cause slower approval of new and potentially life-saving drugs, difficulty in meeting challenges in monitoring of food and drug safety, and an inability to keep up with advancing science and technology," Dr. Swain said.

aault@frontlinemedcom.com

On Twitter @aliciaault

Several organizations representing gay, lesbian, and transgender people have filed an administrative challenge seeking to overturn Medicare’s 32-year-old prohibition on coverage of sex reassignment surgery.

"This administrative challenge is being considered and working its way through the proper administrative channels," a spokesman for the Centers for Medicare and Medicaid Services said.

The American Civil Liberties Union, Gay & Lesbian Advocates & Defenders, the National Center for Lesbian Rights, and civil rights attorney Mary Lou Boelcke filed the challenge on March 26 on behalf of Denee Mallon, "a transgender woman whose doctors have recommended surgery to alleviate her severe gender dysphoria," according to a statement.

"Medicare’s categorical exclusion of this care lacks any scientific basis," said NCLR legal director Shannon Minter, in the statement. "Study after study has shown that these surgeries are the only effective treatment for many patients suffering from severe gender dysphoria."

Joshua Block, a staff attorney with the ACLU Lesbian Gay Bisexual Transgender Project, noted that "the American Medical Association, the Endocrine Society, and the American Psychological Society all support these treatments for transgender patients." He added, "These procedures have been performed for decades and are proven to be safe and effective."

The AMA House of Delegates adopted a resolution in 2008 advocating private and public health insurance coverage for treatment of gender identity disorder, as recommended by a physician. The American Psychological Association’s Council of Representatives adopted a policy statement the same year that, among other things, advocated adequate mental and physical health care for transgender and gender variant individuals. The Endocrine Society approved guidelines for transgender care in 2009.

In 2012, the American Psychiatric Association’s Assembly approved a new policy backing public and private insurance coverage of gender transition treatment, and opposing exclusions for medically necessary treatment for transgender and gender variant people.

Kenneth Zucker, Ph.D., chair of the DSM-5 Workgroup on Sexual and Gender Identity Disorders, said in an interview that "there’s considerable evidence that hormonal therapy and sex reassignment surgery is often the treatment of choice for adults with gender dysphoria who are carefully assessed." Dr. Zucker, psychologist in chief at the Centre for Addiction and Mental Health in Toronto, called that "beyond debate." The DSM-5, which is to be published in mid-May, will include gender dysphoria as a diagnosis.

But Dr. Zucker said that a diagnosis does not dictate the best practice or treatment for any individual patient. He added that gender dysphoria had existed as a diagnosis since the DSM-III was published in 1980; however, it previously was known by other terms.

Surgical and other medical treatment of gender dysphoria has lagged in the United States primarily because of a lack of insurance coverage, Dr. Zucker said.

"If Medicare endorses sex reassignment surgery as a treatment option for carefully evaluated patients and this was then taken up and supported by more private insurers, this would reduce barriers to care," he said.

"A decision by Medicare that this treatment is medically necessary and not experimental could impact other health coverage of this surgery," agreed Dr. Dan Karasic, clinical professor of psychiatry at the University of California, San Francisco. He said a Medicare policy change could benefit some, including those who are disabled by HIV or mental illness, and elderly patients with gender dysphoria. "The clear preponderance of the evidence and consensus of experts supports the medical necessity of surgical treatment for gender dysphoria," Dr. Karasic said in an interview.

Treatment for the gender dysphoria is covered in many countries with national health systems including the Netherlands, Belgium, and the United Kingdom, Dr. Zucker said.

Mr. Block of the ACLU notes that California, Oregon, the District of Columbia, and Colorado have issued regulations clarifying that private insurers cannot exclude transition-related health care from their coverage.

According to the Human Rights Campaign’s Corporate Equality Index, only 25% of Fortune 500 companies currently offer transgender inclusive health benefits. That is defined as equal health coverage for transgender individuals without exclusion for medically necessary care, without blanket exclusions, and based on the World Professional Association for Transgender Health Standards of Care.

The administrative challenge was filed with the departmental appeals board of the U.S. Health and Human Services department. Mr. Block of the ACLU said that the board will first weigh the evidence that was used to make the initial coverage decision in 1981. If it finds that the decision was not properly supported – or that developments have called into question the reasonableness of the decision – it will consider new evidence. The ACLU-led complaint included an expert declaration "that collects the contemporary evidence to show the national coverage decision lacks any scientific basis," Mr. Block said.

There appears to be no time limit on when the Appeals Board must make a decision, he said.

Coincidentally, the administration challenge was filed the same week that the CMS posted a notice that it would reopen its national coverage decision on sex reassignment surgery, which has been in place since 1981. The notice was subsequently removed.

"In light of the challenge, we are no longer reopening the national coverage determination for reconsideration," a CMS spokesman said.

Brian Moulton, legal director of the Human Rights Campaign, applauded the challenge.

"Regardless of the mechanism, we are pleased that CMS will be reviewing its outdated policy with regard to treatment related to gender transition and hope they will follow the mainstream medical opinion that public and private insurance programs should provide coverage for this medically necessary care," he said.

aault@frontlinemedcom.com

On Twitter @aliciaault

Several organizations representing gay, lesbian, and transgender people have filed an administrative challenge seeking to overturn Medicare’s 32-year-old prohibition on coverage of sex reassignment surgery.

"This administrative challenge is being considered and working its way through the proper administrative channels," a spokesman for the Centers for Medicare and Medicaid Services said.

The American Civil Liberties Union, Gay & Lesbian Advocates & Defenders, the National Center for Lesbian Rights, and civil rights attorney Mary Lou Boelcke filed the challenge on March 26 on behalf of Denee Mallon, "a transgender woman whose doctors have recommended surgery to alleviate her severe gender dysphoria," according to a statement.

"Medicare’s categorical exclusion of this care lacks any scientific basis," said NCLR legal director Shannon Minter, in the statement. "Study after study has shown that these surgeries are the only effective treatment for many patients suffering from severe gender dysphoria."

Joshua Block, a staff attorney with the ACLU Lesbian Gay Bisexual Transgender Project, noted that "the American Medical Association, the Endocrine Society, and the American Psychological Society all support these treatments for transgender patients." He added, "These procedures have been performed for decades and are proven to be safe and effective."

The AMA House of Delegates adopted a resolution in 2008 advocating private and public health insurance coverage for treatment of gender identity disorder, as recommended by a physician. The American Psychological Association’s Council of Representatives adopted a policy statement the same year that, among other things, advocated adequate mental and physical health care for transgender and gender variant individuals. The Endocrine Society approved guidelines for transgender care in 2009.

In 2012, the American Psychiatric Association’s Assembly approved a new policy backing public and private insurance coverage of gender transition treatment, and opposing exclusions for medically necessary treatment for transgender and gender variant people.

Kenneth Zucker, Ph.D., chair of the DSM-5 Workgroup on Sexual and Gender Identity Disorders, said in an interview that "there’s considerable evidence that hormonal therapy and sex reassignment surgery is often the treatment of choice for adults with gender dysphoria who are carefully assessed." Dr. Zucker, psychologist in chief at the Centre for Addiction and Mental Health in Toronto, called that "beyond debate." The DSM-5, which is to be published in mid-May, will include gender dysphoria as a diagnosis.

But Dr. Zucker said that a diagnosis does not dictate the best practice or treatment for any individual patient. He added that gender dysphoria had existed as a diagnosis since the DSM-III was published in 1980; however, it previously was known by other terms.

Surgical and other medical treatment of gender dysphoria has lagged in the United States primarily because of a lack of insurance coverage, Dr. Zucker said.

"If Medicare endorses sex reassignment surgery as a treatment option for carefully evaluated patients and this was then taken up and supported by more private insurers, this would reduce barriers to care," he said.

"A decision by Medicare that this treatment is medically necessary and not experimental could impact other health coverage of this surgery," agreed Dr. Dan Karasic, clinical professor of psychiatry at the University of California, San Francisco. He said a Medicare policy change could benefit some, including those who are disabled by HIV or mental illness, and elderly patients with gender dysphoria. "The clear preponderance of the evidence and consensus of experts supports the medical necessity of surgical treatment for gender dysphoria," Dr. Karasic said in an interview.

Treatment for the gender dysphoria is covered in many countries with national health systems including the Netherlands, Belgium, and the United Kingdom, Dr. Zucker said.

Mr. Block of the ACLU notes that California, Oregon, the District of Columbia, and Colorado have issued regulations clarifying that private insurers cannot exclude transition-related health care from their coverage.

According to the Human Rights Campaign’s Corporate Equality Index, only 25% of Fortune 500 companies currently offer transgender inclusive health benefits. That is defined as equal health coverage for transgender individuals without exclusion for medically necessary care, without blanket exclusions, and based on the World Professional Association for Transgender Health Standards of Care.

The administrative challenge was filed with the departmental appeals board of the U.S. Health and Human Services department. Mr. Block of the ACLU said that the board will first weigh the evidence that was used to make the initial coverage decision in 1981. If it finds that the decision was not properly supported – or that developments have called into question the reasonableness of the decision – it will consider new evidence. The ACLU-led complaint included an expert declaration "that collects the contemporary evidence to show the national coverage decision lacks any scientific basis," Mr. Block said.

There appears to be no time limit on when the Appeals Board must make a decision, he said.

Coincidentally, the administration challenge was filed the same week that the CMS posted a notice that it would reopen its national coverage decision on sex reassignment surgery, which has been in place since 1981. The notice was subsequently removed.

"In light of the challenge, we are no longer reopening the national coverage determination for reconsideration," a CMS spokesman said.

Brian Moulton, legal director of the Human Rights Campaign, applauded the challenge.

"Regardless of the mechanism, we are pleased that CMS will be reviewing its outdated policy with regard to treatment related to gender transition and hope they will follow the mainstream medical opinion that public and private insurance programs should provide coverage for this medically necessary care," he said.

aault@frontlinemedcom.com

On Twitter @aliciaault

Several organizations representing gay, lesbian, and transgender people have filed an administrative challenge seeking to overturn Medicare’s 32-year-old prohibition on coverage of sex reassignment surgery.

"This administrative challenge is being considered and working its way through the proper administrative channels," a spokesman for the Centers for Medicare and Medicaid Services said.

The American Civil Liberties Union, Gay & Lesbian Advocates & Defenders, the National Center for Lesbian Rights, and civil rights attorney Mary Lou Boelcke filed the challenge on March 26 on behalf of Denee Mallon, "a transgender woman whose doctors have recommended surgery to alleviate her severe gender dysphoria," according to a statement.

"Medicare’s categorical exclusion of this care lacks any scientific basis," said NCLR legal director Shannon Minter, in the statement. "Study after study has shown that these surgeries are the only effective treatment for many patients suffering from severe gender dysphoria."

Joshua Block, a staff attorney with the ACLU Lesbian Gay Bisexual Transgender Project, noted that "the American Medical Association, the Endocrine Society, and the American Psychological Society all support these treatments for transgender patients." He added, "These procedures have been performed for decades and are proven to be safe and effective."

The AMA House of Delegates adopted a resolution in 2008 advocating private and public health insurance coverage for treatment of gender identity disorder, as recommended by a physician. The American Psychological Association’s Council of Representatives adopted a policy statement the same year that, among other things, advocated adequate mental and physical health care for transgender and gender variant individuals. The Endocrine Society approved guidelines for transgender care in 2009.

In 2012, the American Psychiatric Association’s Assembly approved a new policy backing public and private insurance coverage of gender transition treatment, and opposing exclusions for medically necessary treatment for transgender and gender variant people.

Kenneth Zucker, Ph.D., chair of the DSM-5 Workgroup on Sexual and Gender Identity Disorders, said in an interview that "there’s considerable evidence that hormonal therapy and sex reassignment surgery is often the treatment of choice for adults with gender dysphoria who are carefully assessed." Dr. Zucker, psychologist in chief at the Centre for Addiction and Mental Health in Toronto, called that "beyond debate." The DSM-5, which is to be published in mid-May, will include gender dysphoria as a diagnosis.

But Dr. Zucker said that a diagnosis does not dictate the best practice or treatment for any individual patient. He added that gender dysphoria had existed as a diagnosis since the DSM-III was published in 1980; however, it previously was known by other terms.

Surgical and other medical treatment of gender dysphoria has lagged in the United States primarily because of a lack of insurance coverage, Dr. Zucker said.

"If Medicare endorses sex reassignment surgery as a treatment option for carefully evaluated patients and this was then taken up and supported by more private insurers, this would reduce barriers to care," he said.

"A decision by Medicare that this treatment is medically necessary and not experimental could impact other health coverage of this surgery," agreed Dr. Dan Karasic, clinical professor of psychiatry at the University of California, San Francisco. He said a Medicare policy change could benefit some, including those who are disabled by HIV or mental illness, and elderly patients with gender dysphoria. "The clear preponderance of the evidence and consensus of experts supports the medical necessity of surgical treatment for gender dysphoria," Dr. Karasic said in an interview.

Treatment for the gender dysphoria is covered in many countries with national health systems including the Netherlands, Belgium, and the United Kingdom, Dr. Zucker said.

Mr. Block of the ACLU notes that California, Oregon, the District of Columbia, and Colorado have issued regulations clarifying that private insurers cannot exclude transition-related health care from their coverage.

According to the Human Rights Campaign’s Corporate Equality Index, only 25% of Fortune 500 companies currently offer transgender inclusive health benefits. That is defined as equal health coverage for transgender individuals without exclusion for medically necessary care, without blanket exclusions, and based on the World Professional Association for Transgender Health Standards of Care.

The administrative challenge was filed with the departmental appeals board of the U.S. Health and Human Services department. Mr. Block of the ACLU said that the board will first weigh the evidence that was used to make the initial coverage decision in 1981. If it finds that the decision was not properly supported – or that developments have called into question the reasonableness of the decision – it will consider new evidence. The ACLU-led complaint included an expert declaration "that collects the contemporary evidence to show the national coverage decision lacks any scientific basis," Mr. Block said.

There appears to be no time limit on when the Appeals Board must make a decision, he said.

Coincidentally, the administration challenge was filed the same week that the CMS posted a notice that it would reopen its national coverage decision on sex reassignment surgery, which has been in place since 1981. The notice was subsequently removed.

"In light of the challenge, we are no longer reopening the national coverage determination for reconsideration," a CMS spokesman said.

Brian Moulton, legal director of the Human Rights Campaign, applauded the challenge.

"Regardless of the mechanism, we are pleased that CMS will be reviewing its outdated policy with regard to treatment related to gender transition and hope they will follow the mainstream medical opinion that public and private insurance programs should provide coverage for this medically necessary care," he said.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration has approved canagliflozin, an oral, once-daily therapy for adult patients with type 2 diabetes.

The drug will be marketed by Janssen Pharmaceuticals as Invokana.

Canagliflozin is the first in a new class of medications known as selective sodium glucose cotransporter 2 (SGLT2) inhibitors; they act by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in people with diabetes who have elevated blood glucose levels, the FDA said in a statement announcing the approval. Canagliflozin was recommended for approval by an FDA advisory panel in a 10-5 vote in January.

For the approval, Janssen submitted the results of nine phase III international studies in almost 10,300 patients, comparing the drug with placebo or active controls, as monotherapy and as add-on therapy to other antihyperglycemic drugs.

The company also submitted the interim results of a cardiovascular outcomes study, required by the FDA for all new type 2 diabetes drugs. In the outcomes study, there were more cardiovascular events in the canagliflozin-treated patients in the first 30 days, but the risk dropped after that to below the threshold set by the FDA as acceptable.

Still, the agency is requiring five postmarketing studies including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two studies under the Pediatric Research Equity Act, which include a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

Canagliflozin’s most common side effects are vulvovaginal candidiasis and urinary tract infection. Use of the medication can also lead to orthostatic or postural hypotension; that side effect is most common in the first 3 months of therapy, according to the FDA.

The agency said that the drug should not be used in patients with type 1 diabetes, patients on dialysis, or in patients who have diabetic ketoacidosis, severe renal impairment, or end stage renal disease.

Several other SGLT2 inhibitors are in development, including ipragliflozin and empagliflozin. The FDA declined to approve dapagliflozin in 2012 because of safety concerns.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration has approved canagliflozin, an oral, once-daily therapy for adult patients with type 2 diabetes.

The drug will be marketed by Janssen Pharmaceuticals as Invokana.

Canagliflozin is the first in a new class of medications known as selective sodium glucose cotransporter 2 (SGLT2) inhibitors; they act by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in people with diabetes who have elevated blood glucose levels, the FDA said in a statement announcing the approval. Canagliflozin was recommended for approval by an FDA advisory panel in a 10-5 vote in January.

For the approval, Janssen submitted the results of nine phase III international studies in almost 10,300 patients, comparing the drug with placebo or active controls, as monotherapy and as add-on therapy to other antihyperglycemic drugs.

The company also submitted the interim results of a cardiovascular outcomes study, required by the FDA for all new type 2 diabetes drugs. In the outcomes study, there were more cardiovascular events in the canagliflozin-treated patients in the first 30 days, but the risk dropped after that to below the threshold set by the FDA as acceptable.

Still, the agency is requiring five postmarketing studies including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two studies under the Pediatric Research Equity Act, which include a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

Canagliflozin’s most common side effects are vulvovaginal candidiasis and urinary tract infection. Use of the medication can also lead to orthostatic or postural hypotension; that side effect is most common in the first 3 months of therapy, according to the FDA.

The agency said that the drug should not be used in patients with type 1 diabetes, patients on dialysis, or in patients who have diabetic ketoacidosis, severe renal impairment, or end stage renal disease.

Several other SGLT2 inhibitors are in development, including ipragliflozin and empagliflozin. The FDA declined to approve dapagliflozin in 2012 because of safety concerns.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration has approved canagliflozin, an oral, once-daily therapy for adult patients with type 2 diabetes.

The drug will be marketed by Janssen Pharmaceuticals as Invokana.

Canagliflozin is the first in a new class of medications known as selective sodium glucose cotransporter 2 (SGLT2) inhibitors; they act by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in people with diabetes who have elevated blood glucose levels, the FDA said in a statement announcing the approval. Canagliflozin was recommended for approval by an FDA advisory panel in a 10-5 vote in January.

For the approval, Janssen submitted the results of nine phase III international studies in almost 10,300 patients, comparing the drug with placebo or active controls, as monotherapy and as add-on therapy to other antihyperglycemic drugs.

The company also submitted the interim results of a cardiovascular outcomes study, required by the FDA for all new type 2 diabetes drugs. In the outcomes study, there were more cardiovascular events in the canagliflozin-treated patients in the first 30 days, but the risk dropped after that to below the threshold set by the FDA as acceptable.

Still, the agency is requiring five postmarketing studies including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two studies under the Pediatric Research Equity Act, which include a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

Canagliflozin’s most common side effects are vulvovaginal candidiasis and urinary tract infection. Use of the medication can also lead to orthostatic or postural hypotension; that side effect is most common in the first 3 months of therapy, according to the FDA.

The agency said that the drug should not be used in patients with type 1 diabetes, patients on dialysis, or in patients who have diabetic ketoacidosis, severe renal impairment, or end stage renal disease.

Several other SGLT2 inhibitors are in development, including ipragliflozin and empagliflozin. The FDA declined to approve dapagliflozin in 2012 because of safety concerns.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration has approved a new, twice-daily oral medication, dimethyl fumarate, for relapsing-remitting multiple sclerosis.

The drug, to be marketed as Tecfidera, is thought to defend the brain against oxidative stress, and experimental evidence has suggested that it may also act both as an anti-inflammatory and as a neuroprotective agent.

Tecfidera joins a host of already approved medications for MS. Two forms of interferon beta-1a (Avonex and Rebif) and two forms of interferon beta-1b (Betaseron and Extavia) have been approved for the relapsing-remitting form, as has glatiramer acetate (Copaxone), fingolimod (Gilenya), and teriflunomide (Aubagio). Natalizumab (Tysabri) is approved for relapsing-remitting MS, but with restrictions. Mitoxantrone (Novantrone) is approved for secondary progressive, progressive-relapsing, and worsening relapsing-remitting MS, according to the National MS Society. Dalfampridine (Ampyra) is approved to improve walking in individuals with MS.

"No drug provides a cure for multiple sclerosis, so it is important to have a variety of treatment options available for patients," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

According to the FDA, MS is among the most common causes of neurologic disability in young adults and occurs more frequently in women than men. Some 400,000 Americans are living with the condition, and the relapsing-remitting form is the most common. That is characterized by episodes of worsening function, followed by recovery periods. But recovery periods become less complete over time, leading to progressive decline in function and increased disability.

Dimethyl fumarate was approved based on results from two phase III trials that enrolled more than 2,600 patients: DEFINE and CONFIRM. DEFINE data were originally reported at the Fourth Cooperative Meeting on Multiple Sclerosis in 2011 and the CONFIRM data were reported at the Joint Congress of ECTRIMS/ACTRIMS in 2012.

According to Biogen Idec, which makes dimethyl fumarate, relapses were reduced by 49% in patients taking the drug in the DEFINE trial, and disability by 38%. Relapses declined by 34% in the CONFIRM study. In both trials, dimethyl fumarate significantly reduced lesions in the brain, when compared with placebo.

"In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in the early stages of MS or had more established disease," said Dr. Robert Fox, medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, in a Biogen statement. Dr. Fox was the lead investigator of the CONFIRM study, and is a paid adviser for Biogen Idec for projects not related to dimethyl fumarate. "This drug provides physicians with an important additional treatment option for their patients across the MS spectrum," Dr. Fox said.

The FDA said that dimethyl fumarate decreases lymphocyte counts, but that there was no evidence of an increase in infections in patients taking the drug in trials. The agency recommends monitoring lymphocyte counts before starting therapy, and annually thereafter. Flushing and gastrointestinal problems were the most common adverse reactions.

Biogen said the drug would be available in a matter of days. The recommended starting dose is 120 mg twice a day orally. After a week, the recommended dose increases to 240 mg twice daily.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration has approved a new, twice-daily oral medication, dimethyl fumarate, for relapsing-remitting multiple sclerosis.

The drug, to be marketed as Tecfidera, is thought to defend the brain against oxidative stress, and experimental evidence has suggested that it may also act both as an anti-inflammatory and as a neuroprotective agent.

Tecfidera joins a host of already approved medications for MS. Two forms of interferon beta-1a (Avonex and Rebif) and two forms of interferon beta-1b (Betaseron and Extavia) have been approved for the relapsing-remitting form, as has glatiramer acetate (Copaxone), fingolimod (Gilenya), and teriflunomide (Aubagio). Natalizumab (Tysabri) is approved for relapsing-remitting MS, but with restrictions. Mitoxantrone (Novantrone) is approved for secondary progressive, progressive-relapsing, and worsening relapsing-remitting MS, according to the National MS Society. Dalfampridine (Ampyra) is approved to improve walking in individuals with MS.

"No drug provides a cure for multiple sclerosis, so it is important to have a variety of treatment options available for patients," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

According to the FDA, MS is among the most common causes of neurologic disability in young adults and occurs more frequently in women than men. Some 400,000 Americans are living with the condition, and the relapsing-remitting form is the most common. That is characterized by episodes of worsening function, followed by recovery periods. But recovery periods become less complete over time, leading to progressive decline in function and increased disability.

Dimethyl fumarate was approved based on results from two phase III trials that enrolled more than 2,600 patients: DEFINE and CONFIRM. DEFINE data were originally reported at the Fourth Cooperative Meeting on Multiple Sclerosis in 2011 and the CONFIRM data were reported at the Joint Congress of ECTRIMS/ACTRIMS in 2012.

According to Biogen Idec, which makes dimethyl fumarate, relapses were reduced by 49% in patients taking the drug in the DEFINE trial, and disability by 38%. Relapses declined by 34% in the CONFIRM study. In both trials, dimethyl fumarate significantly reduced lesions in the brain, when compared with placebo.

"In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in the early stages of MS or had more established disease," said Dr. Robert Fox, medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, in a Biogen statement. Dr. Fox was the lead investigator of the CONFIRM study, and is a paid adviser for Biogen Idec for projects not related to dimethyl fumarate. "This drug provides physicians with an important additional treatment option for their patients across the MS spectrum," Dr. Fox said.

The FDA said that dimethyl fumarate decreases lymphocyte counts, but that there was no evidence of an increase in infections in patients taking the drug in trials. The agency recommends monitoring lymphocyte counts before starting therapy, and annually thereafter. Flushing and gastrointestinal problems were the most common adverse reactions.

Biogen said the drug would be available in a matter of days. The recommended starting dose is 120 mg twice a day orally. After a week, the recommended dose increases to 240 mg twice daily.

aault@frontlinemedcom.com

On Twitter @aliciaault

The Food and Drug Administration has approved a new, twice-daily oral medication, dimethyl fumarate, for relapsing-remitting multiple sclerosis.

The drug, to be marketed as Tecfidera, is thought to defend the brain against oxidative stress, and experimental evidence has suggested that it may also act both as an anti-inflammatory and as a neuroprotective agent.

Tecfidera joins a host of already approved medications for MS. Two forms of interferon beta-1a (Avonex and Rebif) and two forms of interferon beta-1b (Betaseron and Extavia) have been approved for the relapsing-remitting form, as has glatiramer acetate (Copaxone), fingolimod (Gilenya), and teriflunomide (Aubagio). Natalizumab (Tysabri) is approved for relapsing-remitting MS, but with restrictions. Mitoxantrone (Novantrone) is approved for secondary progressive, progressive-relapsing, and worsening relapsing-remitting MS, according to the National MS Society. Dalfampridine (Ampyra) is approved to improve walking in individuals with MS.

"No drug provides a cure for multiple sclerosis, so it is important to have a variety of treatment options available for patients," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

According to the FDA, MS is among the most common causes of neurologic disability in young adults and occurs more frequently in women than men. Some 400,000 Americans are living with the condition, and the relapsing-remitting form is the most common. That is characterized by episodes of worsening function, followed by recovery periods. But recovery periods become less complete over time, leading to progressive decline in function and increased disability.

Dimethyl fumarate was approved based on results from two phase III trials that enrolled more than 2,600 patients: DEFINE and CONFIRM. DEFINE data were originally reported at the Fourth Cooperative Meeting on Multiple Sclerosis in 2011 and the CONFIRM data were reported at the Joint Congress of ECTRIMS/ACTRIMS in 2012.

According to Biogen Idec, which makes dimethyl fumarate, relapses were reduced by 49% in patients taking the drug in the DEFINE trial, and disability by 38%. Relapses declined by 34% in the CONFIRM study. In both trials, dimethyl fumarate significantly reduced lesions in the brain, when compared with placebo.

"In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in the early stages of MS or had more established disease," said Dr. Robert Fox, medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, in a Biogen statement. Dr. Fox was the lead investigator of the CONFIRM study, and is a paid adviser for Biogen Idec for projects not related to dimethyl fumarate. "This drug provides physicians with an important additional treatment option for their patients across the MS spectrum," Dr. Fox said.

The FDA said that dimethyl fumarate decreases lymphocyte counts, but that there was no evidence of an increase in infections in patients taking the drug in trials. The agency recommends monitoring lymphocyte counts before starting therapy, and annually thereafter. Flushing and gastrointestinal problems were the most common adverse reactions.

Biogen said the drug would be available in a matter of days. The recommended starting dose is 120 mg twice a day orally. After a week, the recommended dose increases to 240 mg twice daily.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – Only about 11% of health plan payments to physicians and hospitals are tied to performance or efficiency – meaning that almost 90% of payments are still fee for service, according to a report released March 26 by Catalyst for Payment Reform.

Alicia Ault/IMNG Medical Media

The San Francisco–based nonprofit is a collaborative of employers and health plans that advocates the overhaul of the nation’s health care payment infrastructure by encouraging more value-based payment.

Using data provided by commercial health plans, the group determined that 11% of hospital payments, 6% of outpatient specialist payments, and 6% of primary care physician payments are "value oriented."

Of those payment arrangements, 57% involve provider risk such as bundled payment, capitation, and shared risk payment. The remaining 43% provide incentives, such as shared savings or pay for performance.

The main goal of Catalyst for Payment Reform (CPR) is to raise the volume of value-based commercial payments to health care providers to 20% by 2020. Coalition members said that they saw reason for both pessimism and optimism in the report’s findings.

"Obviously, these results are pretty disappointing," said Dr. Robert Galvin, chief executive officer of Equity Healthcare, which buys health care coverage for private equity companies. Even so, the report itself represents "the triumph of transparency," he said at the press briefing. "It is just simply good to know."

Susan Delbanco, executive director of CPR, noted that in 2010, 1%-3% of provider payments were tied to performance. Given the latest information, "it looks to me like we are on a fast track and that we may get there before 2020,"she said.

The group's research also found that about 2% of health plan enrollees are enrolled in an accountable care organization or a patient-centered medical home.

Most health plan payments (about 75%) are still made to specialists, while 25% go to primary care physicians, according to their analysis. Non–fee-for-service payments are still not entirely rewarding or providing incentives to improve the quality of care. Only 35% of those value-based payments have quality of care as a factor.

Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services, said that the agency was "thrilled" with the report, noting that it showed that private payers were helping encourage a transformation in payment.

"We’re not discouraged – we think that change is happening, it’s underway," Dr. Gilfillan said at the press briefing.

The growing number of physicians participating in new payment models reflects a cultural shift, said Dr. Mark Smith, president and chief executive officer of the California HealthCare Foundation. "I think we have turned the corner on providers recognizing the feasibility, the desirability, and in fact, the inevitability of the kinds of payment reforms that you’ve heard about."

The California HealthCare Foundation and the Commonwealth Fund provided the funding for the National Scorecard on Payment Reform, and a sister effort, the National Compendium on Payment Reform.

The scorecard tabulated data that 57 health plans provided to the National Business Coalition on Health. Participation is voluntary, and not all 57 plans answered all questions posed. The plans represent 104 million people in the commercial group market, or about two-thirds of the total commercially insured population in the United States. Respondents were primarily large health plans, which means the results may not necessarily reflect the entire group market.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – Only about 11% of health plan payments to physicians and hospitals are tied to performance or efficiency – meaning that almost 90% of payments are still fee for service, according to a report released March 26 by Catalyst for Payment Reform.

Alicia Ault/IMNG Medical Media

The San Francisco–based nonprofit is a collaborative of employers and health plans that advocates the overhaul of the nation’s health care payment infrastructure by encouraging more value-based payment.

Using data provided by commercial health plans, the group determined that 11% of hospital payments, 6% of outpatient specialist payments, and 6% of primary care physician payments are "value oriented."

Of those payment arrangements, 57% involve provider risk such as bundled payment, capitation, and shared risk payment. The remaining 43% provide incentives, such as shared savings or pay for performance.

The main goal of Catalyst for Payment Reform (CPR) is to raise the volume of value-based commercial payments to health care providers to 20% by 2020. Coalition members said that they saw reason for both pessimism and optimism in the report’s findings.

"Obviously, these results are pretty disappointing," said Dr. Robert Galvin, chief executive officer of Equity Healthcare, which buys health care coverage for private equity companies. Even so, the report itself represents "the triumph of transparency," he said at the press briefing. "It is just simply good to know."

Susan Delbanco, executive director of CPR, noted that in 2010, 1%-3% of provider payments were tied to performance. Given the latest information, "it looks to me like we are on a fast track and that we may get there before 2020,"she said.

The group's research also found that about 2% of health plan enrollees are enrolled in an accountable care organization or a patient-centered medical home.

Most health plan payments (about 75%) are still made to specialists, while 25% go to primary care physicians, according to their analysis. Non–fee-for-service payments are still not entirely rewarding or providing incentives to improve the quality of care. Only 35% of those value-based payments have quality of care as a factor.

Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services, said that the agency was "thrilled" with the report, noting that it showed that private payers were helping encourage a transformation in payment.

"We’re not discouraged – we think that change is happening, it’s underway," Dr. Gilfillan said at the press briefing.

The growing number of physicians participating in new payment models reflects a cultural shift, said Dr. Mark Smith, president and chief executive officer of the California HealthCare Foundation. "I think we have turned the corner on providers recognizing the feasibility, the desirability, and in fact, the inevitability of the kinds of payment reforms that you’ve heard about."

The California HealthCare Foundation and the Commonwealth Fund provided the funding for the National Scorecard on Payment Reform, and a sister effort, the National Compendium on Payment Reform.

The scorecard tabulated data that 57 health plans provided to the National Business Coalition on Health. Participation is voluntary, and not all 57 plans answered all questions posed. The plans represent 104 million people in the commercial group market, or about two-thirds of the total commercially insured population in the United States. Respondents were primarily large health plans, which means the results may not necessarily reflect the entire group market.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – Only about 11% of health plan payments to physicians and hospitals are tied to performance or efficiency – meaning that almost 90% of payments are still fee for service, according to a report released March 26 by Catalyst for Payment Reform.

Alicia Ault/IMNG Medical Media

The San Francisco–based nonprofit is a collaborative of employers and health plans that advocates the overhaul of the nation’s health care payment infrastructure by encouraging more value-based payment.

Using data provided by commercial health plans, the group determined that 11% of hospital payments, 6% of outpatient specialist payments, and 6% of primary care physician payments are "value oriented."

Of those payment arrangements, 57% involve provider risk such as bundled payment, capitation, and shared risk payment. The remaining 43% provide incentives, such as shared savings or pay for performance.

The main goal of Catalyst for Payment Reform (CPR) is to raise the volume of value-based commercial payments to health care providers to 20% by 2020. Coalition members said that they saw reason for both pessimism and optimism in the report’s findings.

"Obviously, these results are pretty disappointing," said Dr. Robert Galvin, chief executive officer of Equity Healthcare, which buys health care coverage for private equity companies. Even so, the report itself represents "the triumph of transparency," he said at the press briefing. "It is just simply good to know."

Susan Delbanco, executive director of CPR, noted that in 2010, 1%-3% of provider payments were tied to performance. Given the latest information, "it looks to me like we are on a fast track and that we may get there before 2020,"she said.

The group's research also found that about 2% of health plan enrollees are enrolled in an accountable care organization or a patient-centered medical home.

Most health plan payments (about 75%) are still made to specialists, while 25% go to primary care physicians, according to their analysis. Non–fee-for-service payments are still not entirely rewarding or providing incentives to improve the quality of care. Only 35% of those value-based payments have quality of care as a factor.

Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services, said that the agency was "thrilled" with the report, noting that it showed that private payers were helping encourage a transformation in payment.

"We’re not discouraged – we think that change is happening, it’s underway," Dr. Gilfillan said at the press briefing.

The growing number of physicians participating in new payment models reflects a cultural shift, said Dr. Mark Smith, president and chief executive officer of the California HealthCare Foundation. "I think we have turned the corner on providers recognizing the feasibility, the desirability, and in fact, the inevitability of the kinds of payment reforms that you’ve heard about."

The California HealthCare Foundation and the Commonwealth Fund provided the funding for the National Scorecard on Payment Reform, and a sister effort, the National Compendium on Payment Reform.

The scorecard tabulated data that 57 health plans provided to the National Business Coalition on Health. Participation is voluntary, and not all 57 plans answered all questions posed. The plans represent 104 million people in the commercial group market, or about two-thirds of the total commercially insured population in the United States. Respondents were primarily large health plans, which means the results may not necessarily reflect the entire group market.

aault@frontlinemedcom.com

On Twitter @aliciaault