Alicia Ault

WASHINGTON – Most Americans think that health insurance should pay for emergency department visits for conditions believed by the patient to be urgent, according to a new survey commissioned by the American College of Emergency Physicians.

Some 85% of the survey respondents who had a regular physician said that when they had used the emergency department, they did so because they could not have waited to see that regular provider.

The survey, conducted by Harris Interactive, was commissioned as a counterbalance to increasing efforts by state Medicaid programs to curb ED visits, said Dr. David Seaberg, ACEP President.

Washington state was the first to seek limits on so-called nonemergent use of the ED by its Medicaid enrollees. Denial of coverage was going to be based on a list of 500 diagnoses the state had determined to be nonemergent. That policy has since been suspended.

But California, Illinois, Iowa, New Hampshire, and Tennessee have also been looking at restrictive policies. Dr. Seaberg said that his home state of Tennessee has been charging a screening fee only to Medicaid patients who end up having a nonemergent diagnosis. Emergency physicians are in discussions with the state to change that policy, he said at the ACEP Leadership and Advocacy Conference.

"We’re trying to protect the federal ‘prudent layperson’ standard," he said, referring to the federal law that requires health plans to cover ED visits if the patient believes he or she has a medical emergency.

In the survey of 1,026 adults conducted in mid-April, two-thirds agreed that health insurance should pay for an ED visit even if the condition is later diagnosed as nonserious or non–life threatening. Some 86% of those who had insurance said they thought ED visits should be covered when it applied to them personally.

Many of those surveyed said they had gone to the ED because they could not get in to see their regular provider or because they believed they could not wait. A total of 24% of those with private insurance and 35% of those with Medicare or Medicaid said they had tried to get an appointment before going to the ED but that either their physician told them to go to the hospital, the office was closed, or their physician could not see them soon enough.

When asked what they would do if emergency care was not covered, many of those surveyed said they’d be less likely to go to the emergency department. Of the 18- to 34-year olds, 83% said they’d be somewhat less likely to seek care in the ED; the percentage who would stay away declined with age, with only 63% of those aged 55 or older saying they’d be somewhat less likely to seek care in the ED.

The numbers are concerning, said Dr. Seaberg. If patients do not seek care, they may end up even sicker, which would be more costly to the health care system, he said.

Americans also seemed to lack knowledge about the true costs of ED care. According to ACEP, emergency department care accounts for less than 2% of total health care costs in the United States. Only 4% of survey respondents said that ED care accounts for less than 5% of health costs. Most vastly overestimated the cost of care, with 40% of respondents saying it was 26%-50% of health care costs and another quarter pegging the figure at 51%-75% of costs.

Even though emergency care is a small portion of the nation’s total health bill, emergency medicine still needs to work at reducing costs, Dr. Seaberg said. "We understand we need to [have a] value-based purchasing mindset, and we need to try to decrease our costs," he said, but added that it should be through methods other than limiting visits.

ACEP is also asking patients to sign an online petition calling on insurers and other payers, including Medicaid, to protect access to ED care. The petition is meant to show payers that the public feels that emergency care is important, Dr. Seaberg said.

WASHINGTON – Most Americans think that health insurance should pay for emergency department visits for conditions believed by the patient to be urgent, according to a new survey commissioned by the American College of Emergency Physicians.

Some 85% of the survey respondents who had a regular physician said that when they had used the emergency department, they did so because they could not have waited to see that regular provider.

The survey, conducted by Harris Interactive, was commissioned as a counterbalance to increasing efforts by state Medicaid programs to curb ED visits, said Dr. David Seaberg, ACEP President.

Washington state was the first to seek limits on so-called nonemergent use of the ED by its Medicaid enrollees. Denial of coverage was going to be based on a list of 500 diagnoses the state had determined to be nonemergent. That policy has since been suspended.

But California, Illinois, Iowa, New Hampshire, and Tennessee have also been looking at restrictive policies. Dr. Seaberg said that his home state of Tennessee has been charging a screening fee only to Medicaid patients who end up having a nonemergent diagnosis. Emergency physicians are in discussions with the state to change that policy, he said at the ACEP Leadership and Advocacy Conference.

"We’re trying to protect the federal ‘prudent layperson’ standard," he said, referring to the federal law that requires health plans to cover ED visits if the patient believes he or she has a medical emergency.

In the survey of 1,026 adults conducted in mid-April, two-thirds agreed that health insurance should pay for an ED visit even if the condition is later diagnosed as nonserious or non–life threatening. Some 86% of those who had insurance said they thought ED visits should be covered when it applied to them personally.

Many of those surveyed said they had gone to the ED because they could not get in to see their regular provider or because they believed they could not wait. A total of 24% of those with private insurance and 35% of those with Medicare or Medicaid said they had tried to get an appointment before going to the ED but that either their physician told them to go to the hospital, the office was closed, or their physician could not see them soon enough.

When asked what they would do if emergency care was not covered, many of those surveyed said they’d be less likely to go to the emergency department. Of the 18- to 34-year olds, 83% said they’d be somewhat less likely to seek care in the ED; the percentage who would stay away declined with age, with only 63% of those aged 55 or older saying they’d be somewhat less likely to seek care in the ED.

The numbers are concerning, said Dr. Seaberg. If patients do not seek care, they may end up even sicker, which would be more costly to the health care system, he said.

Americans also seemed to lack knowledge about the true costs of ED care. According to ACEP, emergency department care accounts for less than 2% of total health care costs in the United States. Only 4% of survey respondents said that ED care accounts for less than 5% of health costs. Most vastly overestimated the cost of care, with 40% of respondents saying it was 26%-50% of health care costs and another quarter pegging the figure at 51%-75% of costs.

Even though emergency care is a small portion of the nation’s total health bill, emergency medicine still needs to work at reducing costs, Dr. Seaberg said. "We understand we need to [have a] value-based purchasing mindset, and we need to try to decrease our costs," he said, but added that it should be through methods other than limiting visits.

ACEP is also asking patients to sign an online petition calling on insurers and other payers, including Medicaid, to protect access to ED care. The petition is meant to show payers that the public feels that emergency care is important, Dr. Seaberg said.

WASHINGTON – Most Americans think that health insurance should pay for emergency department visits for conditions believed by the patient to be urgent, according to a new survey commissioned by the American College of Emergency Physicians.

Some 85% of the survey respondents who had a regular physician said that when they had used the emergency department, they did so because they could not have waited to see that regular provider.

The survey, conducted by Harris Interactive, was commissioned as a counterbalance to increasing efforts by state Medicaid programs to curb ED visits, said Dr. David Seaberg, ACEP President.

Washington state was the first to seek limits on so-called nonemergent use of the ED by its Medicaid enrollees. Denial of coverage was going to be based on a list of 500 diagnoses the state had determined to be nonemergent. That policy has since been suspended.

But California, Illinois, Iowa, New Hampshire, and Tennessee have also been looking at restrictive policies. Dr. Seaberg said that his home state of Tennessee has been charging a screening fee only to Medicaid patients who end up having a nonemergent diagnosis. Emergency physicians are in discussions with the state to change that policy, he said at the ACEP Leadership and Advocacy Conference.

"We’re trying to protect the federal ‘prudent layperson’ standard," he said, referring to the federal law that requires health plans to cover ED visits if the patient believes he or she has a medical emergency.

In the survey of 1,026 adults conducted in mid-April, two-thirds agreed that health insurance should pay for an ED visit even if the condition is later diagnosed as nonserious or non–life threatening. Some 86% of those who had insurance said they thought ED visits should be covered when it applied to them personally.

Many of those surveyed said they had gone to the ED because they could not get in to see their regular provider or because they believed they could not wait. A total of 24% of those with private insurance and 35% of those with Medicare or Medicaid said they had tried to get an appointment before going to the ED but that either their physician told them to go to the hospital, the office was closed, or their physician could not see them soon enough.

When asked what they would do if emergency care was not covered, many of those surveyed said they’d be less likely to go to the emergency department. Of the 18- to 34-year olds, 83% said they’d be somewhat less likely to seek care in the ED; the percentage who would stay away declined with age, with only 63% of those aged 55 or older saying they’d be somewhat less likely to seek care in the ED.

The numbers are concerning, said Dr. Seaberg. If patients do not seek care, they may end up even sicker, which would be more costly to the health care system, he said.

Americans also seemed to lack knowledge about the true costs of ED care. According to ACEP, emergency department care accounts for less than 2% of total health care costs in the United States. Only 4% of survey respondents said that ED care accounts for less than 5% of health costs. Most vastly overestimated the cost of care, with 40% of respondents saying it was 26%-50% of health care costs and another quarter pegging the figure at 51%-75% of costs.

Even though emergency care is a small portion of the nation’s total health bill, emergency medicine still needs to work at reducing costs, Dr. Seaberg said. "We understand we need to [have a] value-based purchasing mindset, and we need to try to decrease our costs," he said, but added that it should be through methods other than limiting visits.

ACEP is also asking patients to sign an online petition calling on insurers and other payers, including Medicaid, to protect access to ED care. The petition is meant to show payers that the public feels that emergency care is important, Dr. Seaberg said.

At the request of the Food and Drug Administration, U.S. Marshals seized an unapproved topical corticosteroid gel marketed by Crescendo Therapeutics.

The move was not entirely unexpected, as the FDA warned Crescendo in November 2011 that marketing of the drug, HybriSil (methylprednisolone acetate 1% in silicone gel), was illegal because it had never been approved and was being misbranded.

After the November warning, Crescendo responded to the FDA that it intended to file an investigational new drug (IND) application, according to the company president and CEO, Eric Glader. It made that filing in January 2012.

However, the FDA made a return inspection of Crescendo in late January and determined the company still was distributing the product for noninvestigational purposes. In early May, the FDA ordered Crescendo to discontinue manufacturing, and the company agreed.

The seizure was undertaken to ensure no more product would reach the market. The FDA said it has not received any reports of adverse reactions associated with HybriSil.

Mr. Glader said in an interview with Skin & Allergy News that Crescendo has begun clinical trials and intends to work with the agency to secure approval of a prescription HybriSil, and eventually, an over-the-counter version.

At the request of the Food and Drug Administration, U.S. Marshals seized an unapproved topical corticosteroid gel marketed by Crescendo Therapeutics.

The move was not entirely unexpected, as the FDA warned Crescendo in November 2011 that marketing of the drug, HybriSil (methylprednisolone acetate 1% in silicone gel), was illegal because it had never been approved and was being misbranded.

After the November warning, Crescendo responded to the FDA that it intended to file an investigational new drug (IND) application, according to the company president and CEO, Eric Glader. It made that filing in January 2012.

However, the FDA made a return inspection of Crescendo in late January and determined the company still was distributing the product for noninvestigational purposes. In early May, the FDA ordered Crescendo to discontinue manufacturing, and the company agreed.

The seizure was undertaken to ensure no more product would reach the market. The FDA said it has not received any reports of adverse reactions associated with HybriSil.

Mr. Glader said in an interview with Skin & Allergy News that Crescendo has begun clinical trials and intends to work with the agency to secure approval of a prescription HybriSil, and eventually, an over-the-counter version.

At the request of the Food and Drug Administration, U.S. Marshals seized an unapproved topical corticosteroid gel marketed by Crescendo Therapeutics.

The move was not entirely unexpected, as the FDA warned Crescendo in November 2011 that marketing of the drug, HybriSil (methylprednisolone acetate 1% in silicone gel), was illegal because it had never been approved and was being misbranded.

After the November warning, Crescendo responded to the FDA that it intended to file an investigational new drug (IND) application, according to the company president and CEO, Eric Glader. It made that filing in January 2012.

However, the FDA made a return inspection of Crescendo in late January and determined the company still was distributing the product for noninvestigational purposes. In early May, the FDA ordered Crescendo to discontinue manufacturing, and the company agreed.

The seizure was undertaken to ensure no more product would reach the market. The FDA said it has not received any reports of adverse reactions associated with HybriSil.

Mr. Glader said in an interview with Skin & Allergy News that Crescendo has begun clinical trials and intends to work with the agency to secure approval of a prescription HybriSil, and eventually, an over-the-counter version.

NEW ORLEANS – When the Institute of Medicine released updated recommendations on calcium and vitamin D intake in late 2010, the report became the backbone for clinical guidance. But since then, they have been hotly debated among those who say that the recommendations were too weak, and others who say that it has been inappropriately used to herald vitamin D as the next wonder substance, with little scientific evidence backing that claim.

The IOM guidelines "fail the smell test," said Dr. Neil Binkley, a geriatrician and research scientist at the University of Wisconsin–Madison. The recommended intake for a 1-year-old (600 IU/day) is the same as for a 70-year-old. That would make the recommended dietary allowance for vitamin D one of the few RDAs that do not adjust for age, he said at the annual meeting of the American College of Physicians.

©Joss/Fotolia.com

In addition, the recommendations were formulated from a public health standpoint. That makes them less useful for determining the best recommended dietary allowance for an individual patient. Knowing an individual’s particular risk factors and variables in his or her life are crucial for determining an appropriate intake, he said.

Vitamin D deficiency is likely a growing issue, not just in the United States, but worldwide. Vitamin D is not commonly found in food, but is easily synthesized from sunlight. Centuries ago, humans wore less clothing and did not wear sunscreen. Now, of course, avoidance of sun exposure is common practice and has likely contributed to lower serum vitamin D levels in modern humans, he said.

For instance, a recent study showed that two traditional sub-Saharan tribes – the Maasai and the Hadzabe – who wear little clothing, do not use sunscreen, and have darkly pigmented skin (putting them at greater risk for vitamin D deficiency) – had a mean serum 25-hydroxyvitamin D concentration of 46 ng/mL (or 115 nmol/L), according to a study (Br. J. Nutr. 2012 Jan. 23 [doi:10.1017/S0007114511007161]).

This serum concentration is much greater than the IOM’s target of "sufficient" levels (defined as greater than 30 nmol/L). Levels between 20 and 30 nmol/L are considered insufficient, and less than 12 is considered deficient. According to these IOM figures, some 80% of whites have sufficient levels, whereas 71% of African Americans and 46% of Mexican Americans have low levels of serum vitamin D. Dr. Binkley said that he considers the IOM cut-offs to be conservative, but even according to those numbers, as much as a third of the U.S. population may be deficient.

Guidelines subsequently issued by the Endocrine Society called for higher RDAs than that recommended by the IOM, underscoring the lack of consensus around what constitutes a sufficient vitamin D intake, said Dr. Binkley.

There’s also lack of consensus around who should be screened for serum vitamin D levels. The Endocrine Society has called for screening of those "at risk," but then categorizes so many people as being at risk that it’s essentially equivalent to total population screening, said Dr. Binkley. He supports screening, in particular of older adults with a history of falls, and of others with a history of nontraumatic fractures. But he does not advocate total population screening.

What should physicians do? First, recognize that not all patients are the same and that a serum concentration of 20 ng/L may not be sufficient for every individual. Also, just urging sun exposure may not be enough for some patients, either. Multiple studies in the literature have shown that serum concentrations can vary widely among individuals, even when they have had equivalent levels of sun exposure, said Dr. Binkley.

Lab tests for serum vitamin D levels have improved over the years, but they are far from perfect.

So what are adequate levels? According to several studies in sun-exposed individuals, 20 ng/mL seems low and levels in the mid-30s seem reasonable, said Dr. Binkley. "I think we need to be above 30," he said, noting that, for many patients, that means a daily intake of 1,000-2,000 IU of vitamin D daily.

That advice jibes with a statement the American Association of Clinical Endocrinologists issued shortly after the IOM report. AACE recommended that an optimal range for most patients should be 30-50 ng/mL. To achieve that, it would be necessary to take 1,000-2,000 IU of vitamin D daily. The group also said that physicians should use the IOM recommendations "in conjunction with clinical judgment to determine the proper vitamin D requirement for any given patient."

The evidence seems to support that higher serum levels (greater than 30 ng/mL) are associated with reduced fracture and fall risk, but that at super-high levels, vitamin D actually increases falls and fractures, said Dr. Binkley. It’s not clear why that is. In the study, women were given a megadose of 500,000 IU of vitamin D once a year; findings suggested that a big blast of the vitamin is not helpful, he said (JAMA 2010:303:1815-22).

The data show that for each additional 1,000 IU daily, the serum level goes up by about 6 ng/mL. Increases will be greater for patients who start with lower serum levels. To determine what’s optimal, it’s probably necessary to measure serum levels periodically, Dr. Binkley said.

If you write a prescription, you’re likely to get the less optimal form of vitamin D, that is, vitamin D₂. Humans make vitamin D₃ when they are exposed to sunlight, but only D₂ is available in prescription form. Dr. Binkley said that he prefers patients to take D₃, which is available over the counter. But if he’s going for a big repletion – say a typical 50,000 IU dose – he has to use the D₂ form.

It is possible to have vitamin D intoxication. Most studies have never documented anyone with serum levels greater than 70 ng/mL. Patients who have levels above 70 are probably getting too much vitamin D, he said.

Equally intoxicating is the hype surrounding vitamin D, which recently has been touted as a veritable fountain of youth. Almost every tissue in the body has a vitamin D receptor and it is produced locally by many tissues. But the evidence does not support the notion that low levels are responsible for a laundry list of diseases, Dr. Binkley said. It is plausible that low vitamin D contributes to impaired immune function, diabetes, vascular disease, and a higher risk for bone loss and fractures, among other conditions. Sufficient vitamin D may also reduce cancer risk.

But so far, too many studies show association, and not causation. "We need to stay tuned," said Dr. Binkley, noting that there need to be more randomized, prospective studies and no more meta-analyses.

The IOM report "is too weak," but trying to get patients to serum vitamin D levels greater than 40 ng/mL is not responsible, Dr. Binkley stressed.

Dr. Binkley has consulting arrangements with Eli Lilly and Merck, and grants from those companies as well as Amgen and Tarsa, but none relate to vitamin D.

NEW ORLEANS – When the Institute of Medicine released updated recommendations on calcium and vitamin D intake in late 2010, the report became the backbone for clinical guidance. But since then, they have been hotly debated among those who say that the recommendations were too weak, and others who say that it has been inappropriately used to herald vitamin D as the next wonder substance, with little scientific evidence backing that claim.

The IOM guidelines "fail the smell test," said Dr. Neil Binkley, a geriatrician and research scientist at the University of Wisconsin–Madison. The recommended intake for a 1-year-old (600 IU/day) is the same as for a 70-year-old. That would make the recommended dietary allowance for vitamin D one of the few RDAs that do not adjust for age, he said at the annual meeting of the American College of Physicians.

©Joss/Fotolia.com

In addition, the recommendations were formulated from a public health standpoint. That makes them less useful for determining the best recommended dietary allowance for an individual patient. Knowing an individual’s particular risk factors and variables in his or her life are crucial for determining an appropriate intake, he said.

Vitamin D deficiency is likely a growing issue, not just in the United States, but worldwide. Vitamin D is not commonly found in food, but is easily synthesized from sunlight. Centuries ago, humans wore less clothing and did not wear sunscreen. Now, of course, avoidance of sun exposure is common practice and has likely contributed to lower serum vitamin D levels in modern humans, he said.

For instance, a recent study showed that two traditional sub-Saharan tribes – the Maasai and the Hadzabe – who wear little clothing, do not use sunscreen, and have darkly pigmented skin (putting them at greater risk for vitamin D deficiency) – had a mean serum 25-hydroxyvitamin D concentration of 46 ng/mL (or 115 nmol/L), according to a study (Br. J. Nutr. 2012 Jan. 23 [doi:10.1017/S0007114511007161]).

This serum concentration is much greater than the IOM’s target of "sufficient" levels (defined as greater than 30 nmol/L). Levels between 20 and 30 nmol/L are considered insufficient, and less than 12 is considered deficient. According to these IOM figures, some 80% of whites have sufficient levels, whereas 71% of African Americans and 46% of Mexican Americans have low levels of serum vitamin D. Dr. Binkley said that he considers the IOM cut-offs to be conservative, but even according to those numbers, as much as a third of the U.S. population may be deficient.

Guidelines subsequently issued by the Endocrine Society called for higher RDAs than that recommended by the IOM, underscoring the lack of consensus around what constitutes a sufficient vitamin D intake, said Dr. Binkley.

There’s also lack of consensus around who should be screened for serum vitamin D levels. The Endocrine Society has called for screening of those "at risk," but then categorizes so many people as being at risk that it’s essentially equivalent to total population screening, said Dr. Binkley. He supports screening, in particular of older adults with a history of falls, and of others with a history of nontraumatic fractures. But he does not advocate total population screening.

What should physicians do? First, recognize that not all patients are the same and that a serum concentration of 20 ng/L may not be sufficient for every individual. Also, just urging sun exposure may not be enough for some patients, either. Multiple studies in the literature have shown that serum concentrations can vary widely among individuals, even when they have had equivalent levels of sun exposure, said Dr. Binkley.

Lab tests for serum vitamin D levels have improved over the years, but they are far from perfect.

So what are adequate levels? According to several studies in sun-exposed individuals, 20 ng/mL seems low and levels in the mid-30s seem reasonable, said Dr. Binkley. "I think we need to be above 30," he said, noting that, for many patients, that means a daily intake of 1,000-2,000 IU of vitamin D daily.

That advice jibes with a statement the American Association of Clinical Endocrinologists issued shortly after the IOM report. AACE recommended that an optimal range for most patients should be 30-50 ng/mL. To achieve that, it would be necessary to take 1,000-2,000 IU of vitamin D daily. The group also said that physicians should use the IOM recommendations "in conjunction with clinical judgment to determine the proper vitamin D requirement for any given patient."

The evidence seems to support that higher serum levels (greater than 30 ng/mL) are associated with reduced fracture and fall risk, but that at super-high levels, vitamin D actually increases falls and fractures, said Dr. Binkley. It’s not clear why that is. In the study, women were given a megadose of 500,000 IU of vitamin D once a year; findings suggested that a big blast of the vitamin is not helpful, he said (JAMA 2010:303:1815-22).

The data show that for each additional 1,000 IU daily, the serum level goes up by about 6 ng/mL. Increases will be greater for patients who start with lower serum levels. To determine what’s optimal, it’s probably necessary to measure serum levels periodically, Dr. Binkley said.

If you write a prescription, you’re likely to get the less optimal form of vitamin D, that is, vitamin D₂. Humans make vitamin D₃ when they are exposed to sunlight, but only D₂ is available in prescription form. Dr. Binkley said that he prefers patients to take D₃, which is available over the counter. But if he’s going for a big repletion – say a typical 50,000 IU dose – he has to use the D₂ form.

It is possible to have vitamin D intoxication. Most studies have never documented anyone with serum levels greater than 70 ng/mL. Patients who have levels above 70 are probably getting too much vitamin D, he said.

Equally intoxicating is the hype surrounding vitamin D, which recently has been touted as a veritable fountain of youth. Almost every tissue in the body has a vitamin D receptor and it is produced locally by many tissues. But the evidence does not support the notion that low levels are responsible for a laundry list of diseases, Dr. Binkley said. It is plausible that low vitamin D contributes to impaired immune function, diabetes, vascular disease, and a higher risk for bone loss and fractures, among other conditions. Sufficient vitamin D may also reduce cancer risk.

But so far, too many studies show association, and not causation. "We need to stay tuned," said Dr. Binkley, noting that there need to be more randomized, prospective studies and no more meta-analyses.

The IOM report "is too weak," but trying to get patients to serum vitamin D levels greater than 40 ng/mL is not responsible, Dr. Binkley stressed.

Dr. Binkley has consulting arrangements with Eli Lilly and Merck, and grants from those companies as well as Amgen and Tarsa, but none relate to vitamin D.

NEW ORLEANS – When the Institute of Medicine released updated recommendations on calcium and vitamin D intake in late 2010, the report became the backbone for clinical guidance. But since then, they have been hotly debated among those who say that the recommendations were too weak, and others who say that it has been inappropriately used to herald vitamin D as the next wonder substance, with little scientific evidence backing that claim.

The IOM guidelines "fail the smell test," said Dr. Neil Binkley, a geriatrician and research scientist at the University of Wisconsin–Madison. The recommended intake for a 1-year-old (600 IU/day) is the same as for a 70-year-old. That would make the recommended dietary allowance for vitamin D one of the few RDAs that do not adjust for age, he said at the annual meeting of the American College of Physicians.

©Joss/Fotolia.com

In addition, the recommendations were formulated from a public health standpoint. That makes them less useful for determining the best recommended dietary allowance for an individual patient. Knowing an individual’s particular risk factors and variables in his or her life are crucial for determining an appropriate intake, he said.

Vitamin D deficiency is likely a growing issue, not just in the United States, but worldwide. Vitamin D is not commonly found in food, but is easily synthesized from sunlight. Centuries ago, humans wore less clothing and did not wear sunscreen. Now, of course, avoidance of sun exposure is common practice and has likely contributed to lower serum vitamin D levels in modern humans, he said.

For instance, a recent study showed that two traditional sub-Saharan tribes – the Maasai and the Hadzabe – who wear little clothing, do not use sunscreen, and have darkly pigmented skin (putting them at greater risk for vitamin D deficiency) – had a mean serum 25-hydroxyvitamin D concentration of 46 ng/mL (or 115 nmol/L), according to a study (Br. J. Nutr. 2012 Jan. 23 [doi:10.1017/S0007114511007161]).

This serum concentration is much greater than the IOM’s target of "sufficient" levels (defined as greater than 30 nmol/L). Levels between 20 and 30 nmol/L are considered insufficient, and less than 12 is considered deficient. According to these IOM figures, some 80% of whites have sufficient levels, whereas 71% of African Americans and 46% of Mexican Americans have low levels of serum vitamin D. Dr. Binkley said that he considers the IOM cut-offs to be conservative, but even according to those numbers, as much as a third of the U.S. population may be deficient.

Guidelines subsequently issued by the Endocrine Society called for higher RDAs than that recommended by the IOM, underscoring the lack of consensus around what constitutes a sufficient vitamin D intake, said Dr. Binkley.

There’s also lack of consensus around who should be screened for serum vitamin D levels. The Endocrine Society has called for screening of those "at risk," but then categorizes so many people as being at risk that it’s essentially equivalent to total population screening, said Dr. Binkley. He supports screening, in particular of older adults with a history of falls, and of others with a history of nontraumatic fractures. But he does not advocate total population screening.

What should physicians do? First, recognize that not all patients are the same and that a serum concentration of 20 ng/L may not be sufficient for every individual. Also, just urging sun exposure may not be enough for some patients, either. Multiple studies in the literature have shown that serum concentrations can vary widely among individuals, even when they have had equivalent levels of sun exposure, said Dr. Binkley.

Lab tests for serum vitamin D levels have improved over the years, but they are far from perfect.

So what are adequate levels? According to several studies in sun-exposed individuals, 20 ng/mL seems low and levels in the mid-30s seem reasonable, said Dr. Binkley. "I think we need to be above 30," he said, noting that, for many patients, that means a daily intake of 1,000-2,000 IU of vitamin D daily.

That advice jibes with a statement the American Association of Clinical Endocrinologists issued shortly after the IOM report. AACE recommended that an optimal range for most patients should be 30-50 ng/mL. To achieve that, it would be necessary to take 1,000-2,000 IU of vitamin D daily. The group also said that physicians should use the IOM recommendations "in conjunction with clinical judgment to determine the proper vitamin D requirement for any given patient."

The evidence seems to support that higher serum levels (greater than 30 ng/mL) are associated with reduced fracture and fall risk, but that at super-high levels, vitamin D actually increases falls and fractures, said Dr. Binkley. It’s not clear why that is. In the study, women were given a megadose of 500,000 IU of vitamin D once a year; findings suggested that a big blast of the vitamin is not helpful, he said (JAMA 2010:303:1815-22).

The data show that for each additional 1,000 IU daily, the serum level goes up by about 6 ng/mL. Increases will be greater for patients who start with lower serum levels. To determine what’s optimal, it’s probably necessary to measure serum levels periodically, Dr. Binkley said.

If you write a prescription, you’re likely to get the less optimal form of vitamin D, that is, vitamin D₂. Humans make vitamin D₃ when they are exposed to sunlight, but only D₂ is available in prescription form. Dr. Binkley said that he prefers patients to take D₃, which is available over the counter. But if he’s going for a big repletion – say a typical 50,000 IU dose – he has to use the D₂ form.

It is possible to have vitamin D intoxication. Most studies have never documented anyone with serum levels greater than 70 ng/mL. Patients who have levels above 70 are probably getting too much vitamin D, he said.

Equally intoxicating is the hype surrounding vitamin D, which recently has been touted as a veritable fountain of youth. Almost every tissue in the body has a vitamin D receptor and it is produced locally by many tissues. But the evidence does not support the notion that low levels are responsible for a laundry list of diseases, Dr. Binkley said. It is plausible that low vitamin D contributes to impaired immune function, diabetes, vascular disease, and a higher risk for bone loss and fractures, among other conditions. Sufficient vitamin D may also reduce cancer risk.

But so far, too many studies show association, and not causation. "We need to stay tuned," said Dr. Binkley, noting that there need to be more randomized, prospective studies and no more meta-analyses.

The IOM report "is too weak," but trying to get patients to serum vitamin D levels greater than 40 ng/mL is not responsible, Dr. Binkley stressed.

Dr. Binkley has consulting arrangements with Eli Lilly and Merck, and grants from those companies as well as Amgen and Tarsa, but none relate to vitamin D.

The American College of Radiology’s Imaging Network and the Eastern Cooperative Oncology Group have completed their merger, which was first announced in March 2011.

As of May 17, the two groups will be known as the ECOG-ACRIN Cancer Research Group. The merger became official when they completed and approved a constitution that fully integrates the governance, administrative, and scientific components of both groups.

The new ECOG-ACRIN group comprises nearly 650 institutions and 6,000 individuals from a variety of disciplines.

The Eastern Cooperative Oncology Group was one of the first clinical trial cooperative groups sponsored by the National Cancer Institute. Now, it claims to be one of the largest cancer research organizations in the United States.

The American College of Radiology’s Imaging Network has a network of investigators from 100 academic and community-based facilities in the United States and overseas.

The merger is part of an ongoing process to streamline and consolidate the NCI cooperative groups. The overhaul was spurred by a 2010 Institute of Medicine report that found the NCI clinical trials enterprise had become unwieldy. Cooperative groups also were finding themselves increasingly in the position of competing for the same limited amount of resources for cancer research.

In a joint statement issued upon completion of the merger, ECOG-ACRIN cochairs Dr. Robert L. Comis of Drexel University and Dr. Mitchell L. Schnall of the University of Pennsylvania, both in Philadelphia, said that the new group "establishes for the public and private sectors one organizational structure capable of studying the entire cancer care pathway – prevention and screening, surveillance, early detection, staging, diagnosis, treatment, follow-up, and survivorship."

The two groups also believe that they will be stronger together than they would have been individually, said the joint statement. "For example, our core pathology and imaging scientists, and their associated laboratories and extensive IT infrastructures, make it entirely possible for the Group to integrate large data sets required for biomarker-driven science," the statement said.

Dr. Comis is also chairman of the Coalition of Cancer Cooperative Groups.

When the merger was announced in 2011, the two groups said that the new entity would focus on three main areas: early detection and diagnosis; biomarker-driven phase II and phase III therapeutic studies; and "genetic, molecular, and imaging marker research to predict and monitor treatment response."

The newly merged group said that it expects to start enrolling patients in joint clinical trials soon.

The American College of Radiology’s Imaging Network and the Eastern Cooperative Oncology Group have completed their merger, which was first announced in March 2011.

As of May 17, the two groups will be known as the ECOG-ACRIN Cancer Research Group. The merger became official when they completed and approved a constitution that fully integrates the governance, administrative, and scientific components of both groups.

The new ECOG-ACRIN group comprises nearly 650 institutions and 6,000 individuals from a variety of disciplines.

The Eastern Cooperative Oncology Group was one of the first clinical trial cooperative groups sponsored by the National Cancer Institute. Now, it claims to be one of the largest cancer research organizations in the United States.

The American College of Radiology’s Imaging Network has a network of investigators from 100 academic and community-based facilities in the United States and overseas.

The merger is part of an ongoing process to streamline and consolidate the NCI cooperative groups. The overhaul was spurred by a 2010 Institute of Medicine report that found the NCI clinical trials enterprise had become unwieldy. Cooperative groups also were finding themselves increasingly in the position of competing for the same limited amount of resources for cancer research.

In a joint statement issued upon completion of the merger, ECOG-ACRIN cochairs Dr. Robert L. Comis of Drexel University and Dr. Mitchell L. Schnall of the University of Pennsylvania, both in Philadelphia, said that the new group "establishes for the public and private sectors one organizational structure capable of studying the entire cancer care pathway – prevention and screening, surveillance, early detection, staging, diagnosis, treatment, follow-up, and survivorship."

The two groups also believe that they will be stronger together than they would have been individually, said the joint statement. "For example, our core pathology and imaging scientists, and their associated laboratories and extensive IT infrastructures, make it entirely possible for the Group to integrate large data sets required for biomarker-driven science," the statement said.

Dr. Comis is also chairman of the Coalition of Cancer Cooperative Groups.

When the merger was announced in 2011, the two groups said that the new entity would focus on three main areas: early detection and diagnosis; biomarker-driven phase II and phase III therapeutic studies; and "genetic, molecular, and imaging marker research to predict and monitor treatment response."

The newly merged group said that it expects to start enrolling patients in joint clinical trials soon.

The American College of Radiology’s Imaging Network and the Eastern Cooperative Oncology Group have completed their merger, which was first announced in March 2011.

As of May 17, the two groups will be known as the ECOG-ACRIN Cancer Research Group. The merger became official when they completed and approved a constitution that fully integrates the governance, administrative, and scientific components of both groups.

The new ECOG-ACRIN group comprises nearly 650 institutions and 6,000 individuals from a variety of disciplines.

The Eastern Cooperative Oncology Group was one of the first clinical trial cooperative groups sponsored by the National Cancer Institute. Now, it claims to be one of the largest cancer research organizations in the United States.

The American College of Radiology’s Imaging Network has a network of investigators from 100 academic and community-based facilities in the United States and overseas.

The merger is part of an ongoing process to streamline and consolidate the NCI cooperative groups. The overhaul was spurred by a 2010 Institute of Medicine report that found the NCI clinical trials enterprise had become unwieldy. Cooperative groups also were finding themselves increasingly in the position of competing for the same limited amount of resources for cancer research.

In a joint statement issued upon completion of the merger, ECOG-ACRIN cochairs Dr. Robert L. Comis of Drexel University and Dr. Mitchell L. Schnall of the University of Pennsylvania, both in Philadelphia, said that the new group "establishes for the public and private sectors one organizational structure capable of studying the entire cancer care pathway – prevention and screening, surveillance, early detection, staging, diagnosis, treatment, follow-up, and survivorship."

The two groups also believe that they will be stronger together than they would have been individually, said the joint statement. "For example, our core pathology and imaging scientists, and their associated laboratories and extensive IT infrastructures, make it entirely possible for the Group to integrate large data sets required for biomarker-driven science," the statement said.

Dr. Comis is also chairman of the Coalition of Cancer Cooperative Groups.

When the merger was announced in 2011, the two groups said that the new entity would focus on three main areas: early detection and diagnosis; biomarker-driven phase II and phase III therapeutic studies; and "genetic, molecular, and imaging marker research to predict and monitor treatment response."

The newly merged group said that it expects to start enrolling patients in joint clinical trials soon.

NEW ORLEANS – How long does it take before the cumulative effect of repeated blows to the head result in significant cognitive changes? Preliminary results from a longitudinal study of boxers and mixed martial arts fighters suggest that it takes maybe a dozen years – but that anatomical changes begin showing up in half that time.

The results so far in 109 fighters suggest that "if you wait for people to get symptomatic, the disease has possibly progressed a fair amount," said Dr. Charles Bernick, lead investigator of the study and associate medical director of the Cleveland Clinic’s Lou Ruvo Center for Brain Health in Las Vegas.

Photo credit: Piotr Sikora/iStockphoto.com

Clinicians may need to be assessing fighters sooner for potential damage, he said at the annual meeting of the American Academy of Neurology. Although it is not yet known, perhaps rest periods or even stopping fighting altogether might halt the neurodegenerative process.

Dr. Bernick and his colleagues at the center aim to enroll 600 people in the Professional Fighters Brain Health Study by the time funding runs out 4 years from now. Because it is longitudinal, it has a running enrollment. Those already enrolled will be continually followed.

"The real payoff will be following these guys over time and looking at the trajectories," Dr. Bernick said in an interview. The investigators are conducting volumetric brain MRI and computerized cognitive testing. Participants also are tested for mood disorders and impulsivity, and they also undergo speech analysis as well, said Dr. Bernick.

The researchers obtain fighting history, including years of fighting and fights per year, from self-reports and published records. The study will also examine biomarkers, genetic profiles, and serum proteins that might be markers of damage, he said.

In the preliminary analysis, the investigators divided the fighters into three groups based on median years of fighting: less than 6 years, 6-12 years, and greater than 12 years. The relationship between exposure variables, brain volumetrics, and cognitive results were examined by correlational analysis.

The 32 fighters who fought 6 years or more had lower hippocampal and thalamic volumes. But cognitive changes – measured in lower scores on memory tests and processing speed – were found only in the 39 fighters who had fought more than 12 years. The relationships remained even after adjusting for the effect of age.

The ongoing study is funded by the Lincy Foundation. Dr. Bernick reported having no financial disclosures.

NEW ORLEANS – How long does it take before the cumulative effect of repeated blows to the head result in significant cognitive changes? Preliminary results from a longitudinal study of boxers and mixed martial arts fighters suggest that it takes maybe a dozen years – but that anatomical changes begin showing up in half that time.

The results so far in 109 fighters suggest that "if you wait for people to get symptomatic, the disease has possibly progressed a fair amount," said Dr. Charles Bernick, lead investigator of the study and associate medical director of the Cleveland Clinic’s Lou Ruvo Center for Brain Health in Las Vegas.

Photo credit: Piotr Sikora/iStockphoto.com

Clinicians may need to be assessing fighters sooner for potential damage, he said at the annual meeting of the American Academy of Neurology. Although it is not yet known, perhaps rest periods or even stopping fighting altogether might halt the neurodegenerative process.

Dr. Bernick and his colleagues at the center aim to enroll 600 people in the Professional Fighters Brain Health Study by the time funding runs out 4 years from now. Because it is longitudinal, it has a running enrollment. Those already enrolled will be continually followed.

"The real payoff will be following these guys over time and looking at the trajectories," Dr. Bernick said in an interview. The investigators are conducting volumetric brain MRI and computerized cognitive testing. Participants also are tested for mood disorders and impulsivity, and they also undergo speech analysis as well, said Dr. Bernick.

The researchers obtain fighting history, including years of fighting and fights per year, from self-reports and published records. The study will also examine biomarkers, genetic profiles, and serum proteins that might be markers of damage, he said.

In the preliminary analysis, the investigators divided the fighters into three groups based on median years of fighting: less than 6 years, 6-12 years, and greater than 12 years. The relationship between exposure variables, brain volumetrics, and cognitive results were examined by correlational analysis.

The 32 fighters who fought 6 years or more had lower hippocampal and thalamic volumes. But cognitive changes – measured in lower scores on memory tests and processing speed – were found only in the 39 fighters who had fought more than 12 years. The relationships remained even after adjusting for the effect of age.

The ongoing study is funded by the Lincy Foundation. Dr. Bernick reported having no financial disclosures.

NEW ORLEANS – How long does it take before the cumulative effect of repeated blows to the head result in significant cognitive changes? Preliminary results from a longitudinal study of boxers and mixed martial arts fighters suggest that it takes maybe a dozen years – but that anatomical changes begin showing up in half that time.

The results so far in 109 fighters suggest that "if you wait for people to get symptomatic, the disease has possibly progressed a fair amount," said Dr. Charles Bernick, lead investigator of the study and associate medical director of the Cleveland Clinic’s Lou Ruvo Center for Brain Health in Las Vegas.

Photo credit: Piotr Sikora/iStockphoto.com

Clinicians may need to be assessing fighters sooner for potential damage, he said at the annual meeting of the American Academy of Neurology. Although it is not yet known, perhaps rest periods or even stopping fighting altogether might halt the neurodegenerative process.

Dr. Bernick and his colleagues at the center aim to enroll 600 people in the Professional Fighters Brain Health Study by the time funding runs out 4 years from now. Because it is longitudinal, it has a running enrollment. Those already enrolled will be continually followed.

"The real payoff will be following these guys over time and looking at the trajectories," Dr. Bernick said in an interview. The investigators are conducting volumetric brain MRI and computerized cognitive testing. Participants also are tested for mood disorders and impulsivity, and they also undergo speech analysis as well, said Dr. Bernick.

The researchers obtain fighting history, including years of fighting and fights per year, from self-reports and published records. The study will also examine biomarkers, genetic profiles, and serum proteins that might be markers of damage, he said.

In the preliminary analysis, the investigators divided the fighters into three groups based on median years of fighting: less than 6 years, 6-12 years, and greater than 12 years. The relationship between exposure variables, brain volumetrics, and cognitive results were examined by correlational analysis.

The 32 fighters who fought 6 years or more had lower hippocampal and thalamic volumes. But cognitive changes – measured in lower scores on memory tests and processing speed – were found only in the 39 fighters who had fought more than 12 years. The relationships remained even after adjusting for the effect of age.

The ongoing study is funded by the Lincy Foundation. Dr. Bernick reported having no financial disclosures.

The Environmental Working Group has issued its annual ranking of sunscreens, and reported that of more than 1,800 it reviewed, about 25% pass muster. That’s up from 20% in 2011 and 8% in 2010.

According to the group, children’s sunscreens contain the most effective and safest ingredients. Sixty percent of the 180 products marketed for children have ingredients such as minerals, which are considered effective, compared with only 40% of those for the general public. Also, kids’ sunscreens are less likely to contain oxybenzone – which the EWG said is an endocrine-disrupter – or chemicals that might cause allergic reactions.

The group recommends that consumers choose products with zinc oxide, titanium dioxide, or 3% avobenzone and that they avoid oxybenzone and vitamin A (retinyl palmitate). Sunscreen sprays and powders are not as effective as creams or lotions, according to the group. And it found that many manufacturers are selling products with escalating SPF values. More than one in seven have SPF values higher than 50, compared with only one in eight in 2009, according to EWG’s analysis.

In a statement from the EWG, Sen. Jack Reed (D-RI) said the FDA needs to move more quickly on instituting sunscreen standards, but in the meantime, "it is good to know Environmental Working Group is providing consumers with the facts about the effectiveness of sunscreen products that are currently on shelves."

The American Academy of Dermatology refuted much of the EWG claim in a statement, noting that there is no evidence that oxybenzone affects hormones, nor is oxybenzone or vitamin A dangerous in sunscreens, said AAD President Daniel M. Siegel. The AAD continues to back use of a water-resistant, broad-spectrum sunscreen that protects against UVA and UVB, with an SPF 30 or higher, in conjunction with limiting sun exposure and wearing sun-protective clothing.

The Environmental Working Group has issued its annual ranking of sunscreens, and reported that of more than 1,800 it reviewed, about 25% pass muster. That’s up from 20% in 2011 and 8% in 2010.

According to the group, children’s sunscreens contain the most effective and safest ingredients. Sixty percent of the 180 products marketed for children have ingredients such as minerals, which are considered effective, compared with only 40% of those for the general public. Also, kids’ sunscreens are less likely to contain oxybenzone – which the EWG said is an endocrine-disrupter – or chemicals that might cause allergic reactions.

The group recommends that consumers choose products with zinc oxide, titanium dioxide, or 3% avobenzone and that they avoid oxybenzone and vitamin A (retinyl palmitate). Sunscreen sprays and powders are not as effective as creams or lotions, according to the group. And it found that many manufacturers are selling products with escalating SPF values. More than one in seven have SPF values higher than 50, compared with only one in eight in 2009, according to EWG’s analysis.

In a statement from the EWG, Sen. Jack Reed (D-RI) said the FDA needs to move more quickly on instituting sunscreen standards, but in the meantime, "it is good to know Environmental Working Group is providing consumers with the facts about the effectiveness of sunscreen products that are currently on shelves."

The American Academy of Dermatology refuted much of the EWG claim in a statement, noting that there is no evidence that oxybenzone affects hormones, nor is oxybenzone or vitamin A dangerous in sunscreens, said AAD President Daniel M. Siegel. The AAD continues to back use of a water-resistant, broad-spectrum sunscreen that protects against UVA and UVB, with an SPF 30 or higher, in conjunction with limiting sun exposure and wearing sun-protective clothing.

The Environmental Working Group has issued its annual ranking of sunscreens, and reported that of more than 1,800 it reviewed, about 25% pass muster. That’s up from 20% in 2011 and 8% in 2010.

According to the group, children’s sunscreens contain the most effective and safest ingredients. Sixty percent of the 180 products marketed for children have ingredients such as minerals, which are considered effective, compared with only 40% of those for the general public. Also, kids’ sunscreens are less likely to contain oxybenzone – which the EWG said is an endocrine-disrupter – or chemicals that might cause allergic reactions.

The group recommends that consumers choose products with zinc oxide, titanium dioxide, or 3% avobenzone and that they avoid oxybenzone and vitamin A (retinyl palmitate). Sunscreen sprays and powders are not as effective as creams or lotions, according to the group. And it found that many manufacturers are selling products with escalating SPF values. More than one in seven have SPF values higher than 50, compared with only one in eight in 2009, according to EWG’s analysis.

In a statement from the EWG, Sen. Jack Reed (D-RI) said the FDA needs to move more quickly on instituting sunscreen standards, but in the meantime, "it is good to know Environmental Working Group is providing consumers with the facts about the effectiveness of sunscreen products that are currently on shelves."

The American Academy of Dermatology refuted much of the EWG claim in a statement, noting that there is no evidence that oxybenzone affects hormones, nor is oxybenzone or vitamin A dangerous in sunscreens, said AAD President Daniel M. Siegel. The AAD continues to back use of a water-resistant, broad-spectrum sunscreen that protects against UVA and UVB, with an SPF 30 or higher, in conjunction with limiting sun exposure and wearing sun-protective clothing.

The risk of developing progressive multifocal leukoencephalopathy from natalizumab therapy appears to be greater than previously thought, being greatest in multiple sclerosis patients with certain risk factors, according to an updated analysis.

The analysis provides an algorithm that might help clinicians hone in on which patients are least or most likely to develop PML, and give them support in discussing risks and benefits, said Dr. Gary Bloomgren and his coauthors, all of whom work for Biogen Idec, which makes natalizumab (Tysabri).

Courtesy Biogen Idec

The algorithm took into account anti-JC virus antibody status; whether there was prior use of immunosuppressants; and duration of treatment. Positive anti-JC status, prior immunosuppressant use and longer treatment all have been previously identified as PML risk factors. But there has not been a physician-friendly way to stratify risk.

PML is an opportunistic brain infection caused by the JC virus. Previous estimates had put the incidence at about 1 case per 1,000. In April 2011, the Food and Drug Administration reported that 102 cases of PML had been reported among 82,732 patients treated with natalizumab worldwide.

But now that risk is 2.1 per 1,000, given that there have been 212 confirmed cases of PML among the 99,571 patients worldwide who have been treated with natalizumab, Dr. Bloomgren and his colleagues reported May 16 in the New England Journal of Medicine.

The incidence of PML rises to as much as 11.1 per 1,000 in multiple sclerosis patients who are positive for anti-JC virus antibodies, who have taken immunosuppressants before starting natalizumab, and who have taken the drug for 25-48 months.

Although this is a longer period of follow-up than has been reported previously, there were not enough data to calculate the risk beyond 4 years of treatment.

In January of this year, the FDA warned that anti–JC virus–positive status was associated with an increased risk, in addition to the other known risk factors for PML. The agency also estimated the incidence of PML for patients with those risk factors at 11.1 per 1,000.

Dr. Bloomgren and his associates based their calculations on data from Biogen Idec’s safety database, from clinical trials such as the Tysabri Global Observational Program in Safety study (TYGRIS-U.S. and TYGRIS–Rest of World) and from AFFIRM and STRATIFY-1. Data from an independent Swedish registry of patients with multiple sclerosis were also used (N. Engl. J. Med. 2012;366:1870-80).

The algorithm can help stratify risk and assist physicians in deciding whether to use natalizumab, the authors said. Avoiding PML is of great importance. The Biogen Idec researchers said that of the 212 confirmed PML cases, 46 of the patients had died, and that 23 of the 58 survivors for whom data was available had severe disability.

They noted that their risk estimates were limited by several factors, including the assumption that anti–JC-positive status was clearly associated with development of PML. This assumption was based on the fact that all 54 patients identified in the postmarketing setting had been anti–JC-positive before their PML diagnosis. But blood samples were not available for all patients with PML, and the anti-JC virus assay – which is now commercially available – has a small, but perceptible false negative rate.

In a commentary accompanying the study, Dr. Allan H. Ropper said that MS patients who test negative for anti-JC antibodies ostensibly can be reassured that it is safe to take natalizumab. But he noted that there are "basic limitations to serologic tests for JC virus, since there is no standard by which to judge the absence of the virus" (N. Engl. J. Med. 2012;366:1938-9).

Also, the seroprevalance of the virus increases with age, and patients can undergo seroconversion at any time, said Dr. Ropper, a neurologist at Brigham and Women’s Hospital, Boston. He urged retesting for any patients undergoing natalizumab therapy.

While it is not entirely clear why natalizumab is associated with PML, it appears that it may reactivate the JC virus and that it might possibly cause the emergence of a mutation in the virus that leads to the emergency of PML.

Dr. Ropper disclosed no financial conflicts, but reported that he is the associate editor of the New England Journal of Medicine.

Registry to Track PML Scheduled for Fall

With the incidence of progressive multifocal leukoencephalopathy on the rise, the National Institute of Neurological Disorders and Stroke plans to have a registry for the condition up and running by this fall.

The purpose of the registry is to acquire clinical information and biologic material for cases from all over the world, so that researchers can tease out the incidence, prevalence, and potential contributing factors, Eugene O. Major, Ph.D, chief of the laboratory of molecular medicine and neuroscience at the NINDS, said at the annual meeting of the American Academy of Neurology in New Orleans.

The research may also give rise to diagnostics and therapies for the condition, which has up to 50% mortality in the first few months after diagnosis, according to the NINDS.

PML is caused by the reactivation of infection with the JC virus.It is rare, and is most often seen in HIV-infected individuals, but is also seen in people who are undergoing chronic immunosuppression, as with certain cancers. But the disease has also been on the rise in multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus due to biologic therapies that appear to reactivate the JC virus. The NINDS estimates that 5% of HIV patients develop PML.

Much of the data in the registry will be collected through a network of cooperating clinical centers. But the registry, which will be web-based, will have several access points for reporting clinicians and a portal for the public as well, Dr. Major said. The public-facing side of the site will connect patients to the NINDS, its lab site, clinicaltrials.gov, and advocacy groups.

Neurologists and other clinicians will enter cases using a form that will give patients a random identifier. There will be space for narratives and for attaching MRI scans and lab results.

There will also be diagnostic criteria posted, which are currently under review by the AAN, Dr. Major said.

The aim is to conduct a pilot study using five academic medical centers and then have the registry publicly available in the fall, he said.

The risk of developing progressive multifocal leukoencephalopathy from natalizumab therapy appears to be greater than previously thought, being greatest in multiple sclerosis patients with certain risk factors, according to an updated analysis.

The analysis provides an algorithm that might help clinicians hone in on which patients are least or most likely to develop PML, and give them support in discussing risks and benefits, said Dr. Gary Bloomgren and his coauthors, all of whom work for Biogen Idec, which makes natalizumab (Tysabri).

Courtesy Biogen Idec

The algorithm took into account anti-JC virus antibody status; whether there was prior use of immunosuppressants; and duration of treatment. Positive anti-JC status, prior immunosuppressant use and longer treatment all have been previously identified as PML risk factors. But there has not been a physician-friendly way to stratify risk.

PML is an opportunistic brain infection caused by the JC virus. Previous estimates had put the incidence at about 1 case per 1,000. In April 2011, the Food and Drug Administration reported that 102 cases of PML had been reported among 82,732 patients treated with natalizumab worldwide.

But now that risk is 2.1 per 1,000, given that there have been 212 confirmed cases of PML among the 99,571 patients worldwide who have been treated with natalizumab, Dr. Bloomgren and his colleagues reported May 16 in the New England Journal of Medicine.

The incidence of PML rises to as much as 11.1 per 1,000 in multiple sclerosis patients who are positive for anti-JC virus antibodies, who have taken immunosuppressants before starting natalizumab, and who have taken the drug for 25-48 months.

Although this is a longer period of follow-up than has been reported previously, there were not enough data to calculate the risk beyond 4 years of treatment.

In January of this year, the FDA warned that anti–JC virus–positive status was associated with an increased risk, in addition to the other known risk factors for PML. The agency also estimated the incidence of PML for patients with those risk factors at 11.1 per 1,000.

Dr. Bloomgren and his associates based their calculations on data from Biogen Idec’s safety database, from clinical trials such as the Tysabri Global Observational Program in Safety study (TYGRIS-U.S. and TYGRIS–Rest of World) and from AFFIRM and STRATIFY-1. Data from an independent Swedish registry of patients with multiple sclerosis were also used (N. Engl. J. Med. 2012;366:1870-80).

The algorithm can help stratify risk and assist physicians in deciding whether to use natalizumab, the authors said. Avoiding PML is of great importance. The Biogen Idec researchers said that of the 212 confirmed PML cases, 46 of the patients had died, and that 23 of the 58 survivors for whom data was available had severe disability.

They noted that their risk estimates were limited by several factors, including the assumption that anti–JC-positive status was clearly associated with development of PML. This assumption was based on the fact that all 54 patients identified in the postmarketing setting had been anti–JC-positive before their PML diagnosis. But blood samples were not available for all patients with PML, and the anti-JC virus assay – which is now commercially available – has a small, but perceptible false negative rate.

In a commentary accompanying the study, Dr. Allan H. Ropper said that MS patients who test negative for anti-JC antibodies ostensibly can be reassured that it is safe to take natalizumab. But he noted that there are "basic limitations to serologic tests for JC virus, since there is no standard by which to judge the absence of the virus" (N. Engl. J. Med. 2012;366:1938-9).

Also, the seroprevalance of the virus increases with age, and patients can undergo seroconversion at any time, said Dr. Ropper, a neurologist at Brigham and Women’s Hospital, Boston. He urged retesting for any patients undergoing natalizumab therapy.

While it is not entirely clear why natalizumab is associated with PML, it appears that it may reactivate the JC virus and that it might possibly cause the emergence of a mutation in the virus that leads to the emergency of PML.

Dr. Ropper disclosed no financial conflicts, but reported that he is the associate editor of the New England Journal of Medicine.

Registry to Track PML Scheduled for Fall

With the incidence of progressive multifocal leukoencephalopathy on the rise, the National Institute of Neurological Disorders and Stroke plans to have a registry for the condition up and running by this fall.

The purpose of the registry is to acquire clinical information and biologic material for cases from all over the world, so that researchers can tease out the incidence, prevalence, and potential contributing factors, Eugene O. Major, Ph.D, chief of the laboratory of molecular medicine and neuroscience at the NINDS, said at the annual meeting of the American Academy of Neurology in New Orleans.

The research may also give rise to diagnostics and therapies for the condition, which has up to 50% mortality in the first few months after diagnosis, according to the NINDS.

PML is caused by the reactivation of infection with the JC virus.It is rare, and is most often seen in HIV-infected individuals, but is also seen in people who are undergoing chronic immunosuppression, as with certain cancers. But the disease has also been on the rise in multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus due to biologic therapies that appear to reactivate the JC virus. The NINDS estimates that 5% of HIV patients develop PML.

Much of the data in the registry will be collected through a network of cooperating clinical centers. But the registry, which will be web-based, will have several access points for reporting clinicians and a portal for the public as well, Dr. Major said. The public-facing side of the site will connect patients to the NINDS, its lab site, clinicaltrials.gov, and advocacy groups.

Neurologists and other clinicians will enter cases using a form that will give patients a random identifier. There will be space for narratives and for attaching MRI scans and lab results.

There will also be diagnostic criteria posted, which are currently under review by the AAN, Dr. Major said.

The aim is to conduct a pilot study using five academic medical centers and then have the registry publicly available in the fall, he said.

The risk of developing progressive multifocal leukoencephalopathy from natalizumab therapy appears to be greater than previously thought, being greatest in multiple sclerosis patients with certain risk factors, according to an updated analysis.

The analysis provides an algorithm that might help clinicians hone in on which patients are least or most likely to develop PML, and give them support in discussing risks and benefits, said Dr. Gary Bloomgren and his coauthors, all of whom work for Biogen Idec, which makes natalizumab (Tysabri).

Courtesy Biogen Idec

The algorithm took into account anti-JC virus antibody status; whether there was prior use of immunosuppressants; and duration of treatment. Positive anti-JC status, prior immunosuppressant use and longer treatment all have been previously identified as PML risk factors. But there has not been a physician-friendly way to stratify risk.

PML is an opportunistic brain infection caused by the JC virus. Previous estimates had put the incidence at about 1 case per 1,000. In April 2011, the Food and Drug Administration reported that 102 cases of PML had been reported among 82,732 patients treated with natalizumab worldwide.

But now that risk is 2.1 per 1,000, given that there have been 212 confirmed cases of PML among the 99,571 patients worldwide who have been treated with natalizumab, Dr. Bloomgren and his colleagues reported May 16 in the New England Journal of Medicine.

The incidence of PML rises to as much as 11.1 per 1,000 in multiple sclerosis patients who are positive for anti-JC virus antibodies, who have taken immunosuppressants before starting natalizumab, and who have taken the drug for 25-48 months.

Although this is a longer period of follow-up than has been reported previously, there were not enough data to calculate the risk beyond 4 years of treatment.

In January of this year, the FDA warned that anti–JC virus–positive status was associated with an increased risk, in addition to the other known risk factors for PML. The agency also estimated the incidence of PML for patients with those risk factors at 11.1 per 1,000.

Dr. Bloomgren and his associates based their calculations on data from Biogen Idec’s safety database, from clinical trials such as the Tysabri Global Observational Program in Safety study (TYGRIS-U.S. and TYGRIS–Rest of World) and from AFFIRM and STRATIFY-1. Data from an independent Swedish registry of patients with multiple sclerosis were also used (N. Engl. J. Med. 2012;366:1870-80).

The algorithm can help stratify risk and assist physicians in deciding whether to use natalizumab, the authors said. Avoiding PML is of great importance. The Biogen Idec researchers said that of the 212 confirmed PML cases, 46 of the patients had died, and that 23 of the 58 survivors for whom data was available had severe disability.

They noted that their risk estimates were limited by several factors, including the assumption that anti–JC-positive status was clearly associated with development of PML. This assumption was based on the fact that all 54 patients identified in the postmarketing setting had been anti–JC-positive before their PML diagnosis. But blood samples were not available for all patients with PML, and the anti-JC virus assay – which is now commercially available – has a small, but perceptible false negative rate.

In a commentary accompanying the study, Dr. Allan H. Ropper said that MS patients who test negative for anti-JC antibodies ostensibly can be reassured that it is safe to take natalizumab. But he noted that there are "basic limitations to serologic tests for JC virus, since there is no standard by which to judge the absence of the virus" (N. Engl. J. Med. 2012;366:1938-9).

Also, the seroprevalance of the virus increases with age, and patients can undergo seroconversion at any time, said Dr. Ropper, a neurologist at Brigham and Women’s Hospital, Boston. He urged retesting for any patients undergoing natalizumab therapy.

While it is not entirely clear why natalizumab is associated with PML, it appears that it may reactivate the JC virus and that it might possibly cause the emergence of a mutation in the virus that leads to the emergency of PML.

Dr. Ropper disclosed no financial conflicts, but reported that he is the associate editor of the New England Journal of Medicine.

Registry to Track PML Scheduled for Fall

With the incidence of progressive multifocal leukoencephalopathy on the rise, the National Institute of Neurological Disorders and Stroke plans to have a registry for the condition up and running by this fall.

The purpose of the registry is to acquire clinical information and biologic material for cases from all over the world, so that researchers can tease out the incidence, prevalence, and potential contributing factors, Eugene O. Major, Ph.D, chief of the laboratory of molecular medicine and neuroscience at the NINDS, said at the annual meeting of the American Academy of Neurology in New Orleans.

The research may also give rise to diagnostics and therapies for the condition, which has up to 50% mortality in the first few months after diagnosis, according to the NINDS.

PML is caused by the reactivation of infection with the JC virus.It is rare, and is most often seen in HIV-infected individuals, but is also seen in people who are undergoing chronic immunosuppression, as with certain cancers. But the disease has also been on the rise in multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus due to biologic therapies that appear to reactivate the JC virus. The NINDS estimates that 5% of HIV patients develop PML.

Much of the data in the registry will be collected through a network of cooperating clinical centers. But the registry, which will be web-based, will have several access points for reporting clinicians and a portal for the public as well, Dr. Major said. The public-facing side of the site will connect patients to the NINDS, its lab site, clinicaltrials.gov, and advocacy groups.

Neurologists and other clinicians will enter cases using a form that will give patients a random identifier. There will be space for narratives and for attaching MRI scans and lab results.

There will also be diagnostic criteria posted, which are currently under review by the AAN, Dr. Major said.

The aim is to conduct a pilot study using five academic medical centers and then have the registry publicly available in the fall, he said.

The Food and Drug Administration announced in May that it was giving sunscreen manufacturers 6 additional months to comply with the final ruling on product labeling and effectiveness testing.

That final rule was published in June 2011; soon after, the Personal Care Products Council (PCPC) and the Consumer Healthcare Products Association (CHPA) sought a 6-month delay in the deadline, saying that manufacturers needed more time.

The agency agreed and has pushed back compliance dates. Now, products that have sales of less than $25,000 will have until Dec. 17, 2013, to comply; all other products must comply by Dec. 17, 2012. However, the agency is encouraging manufacturers to "introduce individual products bearing the new labeling as it becomes available, even in advance of the revised compliance date."

The American Academy of Dermatology also urged sunscreen makers to comply sooner, rather than later, but said in a statement that the extension "allows manufacturers the necessary time to test their products for broad-spectrum protection and properly label them."

The Environmental Working Group, which publishes a database of sunscreen effectiveness, chided the FDA, saying in a statement that it "has caved to industry pressure every step of the way," of getting the rules finalized – a 30-year process. The group estimates that 90% of sunscreens are already in compliance with what it calls the FDA’s "low-bar regulations on efficacy and safety."

The Food and Drug Administration announced in May that it was giving sunscreen manufacturers 6 additional months to comply with the final ruling on product labeling and effectiveness testing.

That final rule was published in June 2011; soon after, the Personal Care Products Council (PCPC) and the Consumer Healthcare Products Association (CHPA) sought a 6-month delay in the deadline, saying that manufacturers needed more time.

The agency agreed and has pushed back compliance dates. Now, products that have sales of less than $25,000 will have until Dec. 17, 2013, to comply; all other products must comply by Dec. 17, 2012. However, the agency is encouraging manufacturers to "introduce individual products bearing the new labeling as it becomes available, even in advance of the revised compliance date."

The American Academy of Dermatology also urged sunscreen makers to comply sooner, rather than later, but said in a statement that the extension "allows manufacturers the necessary time to test their products for broad-spectrum protection and properly label them."

The Environmental Working Group, which publishes a database of sunscreen effectiveness, chided the FDA, saying in a statement that it "has caved to industry pressure every step of the way," of getting the rules finalized – a 30-year process. The group estimates that 90% of sunscreens are already in compliance with what it calls the FDA’s "low-bar regulations on efficacy and safety."

The Food and Drug Administration announced in May that it was giving sunscreen manufacturers 6 additional months to comply with the final ruling on product labeling and effectiveness testing.

That final rule was published in June 2011; soon after, the Personal Care Products Council (PCPC) and the Consumer Healthcare Products Association (CHPA) sought a 6-month delay in the deadline, saying that manufacturers needed more time.

The agency agreed and has pushed back compliance dates. Now, products that have sales of less than $25,000 will have until Dec. 17, 2013, to comply; all other products must comply by Dec. 17, 2012. However, the agency is encouraging manufacturers to "introduce individual products bearing the new labeling as it becomes available, even in advance of the revised compliance date."

The American Academy of Dermatology also urged sunscreen makers to comply sooner, rather than later, but said in a statement that the extension "allows manufacturers the necessary time to test their products for broad-spectrum protection and properly label them."

The Environmental Working Group, which publishes a database of sunscreen effectiveness, chided the FDA, saying in a statement that it "has caved to industry pressure every step of the way," of getting the rules finalized – a 30-year process. The group estimates that 90% of sunscreens are already in compliance with what it calls the FDA’s "low-bar regulations on efficacy and safety."

NEW ORLEANS – Like many other specialties – particularly cognitive specialties – neurology is under pressure to figure out how best to survive in an environment in which expenses are rising, but income is declining. So what are some strategies for staying in practice, choosing what type of practice is best, ensuring a steady income stream, and staying sane?

At the recent annual meeting of the American Academy of Neurology, several neurologists offered their personal take on preserving the pleasures of practice while maintaining revenues.

Dr. Laurence J. Kinsella, codirector of neurology for SSM Neurosciences Institute, St. Louis, noted that although median income for neurologists had risen fairly steadily since the mid-1990s, a neurologist’s value was very much dependent on what area of the country he or she practices in, whether it is urban or rural, and whether the practice is academic or private, or interventionist or cognitive.*

Choosing where to practice and the best type of practice is dependent on which options offer the best proximity to family or accommodation of a spouse’s needs, as well as the most professional growth, leadership potential, and collegiality, among other factors, said Dr. Kinsella, who is also vice chair of the AAN’s government affairs committee.

In the assessment of a group practice, for instance, be aware that survey data and published research have shown that the average turnover is 7% per year, and 60% of those who leave do so in the first 5 years. The biggest reasons for leaving include practice issues; compensation and location issues; and spousal concerns. Some questions to raise are whether the senior partners are advocates for equity for all partners, and whether the path to partnership is clearly stated, Dr. Kinsella said.

Before signing a contract with any group, it’s worthwhile to consult with an attorney who specializes in health care, he said. Keep in mind that everything is negotiable. Some key components to explore include salary and bonus; productivity scale; call schedule; pension and profit sharing; termination; and malpractice, health, and disability insurance.

"The most important thing is, you have to pay attention and be limber and adjust your models as things change."

Whether you take the academic, private, solo, or group path, the reimbursement challenges will be the same. The elimination of the Medicare consult codes in 2010 have led to a 6%-20% reduction in reimbursement, according to AAN survey data, Dr. Kinsella said.

There is a tool to assess the impact on a practice at www.mitsi.org/. One way to make up for lost revenue is to take a closer look at evaluation and management (E&M) codes, he added. At least 60% of neurologists’ billing is for E&M services. AAN provides templates for determining efficient and appropriate use of E&M codes. Dr. Kinsella said he advocated for the use of prolonged service codes such as 99354 (31-74 minutes) and 99355 (for each additional 30 minutes). "I’d encourage you to get comfortable with these. They are very good to use," he said.

Most neurologists also bill at level 4, then level 5 and level 3 for E&M, and they should be billing primarily level 5, Dr. Kinsella said. A level 5 consult requires more than just a single diagnosis.

Some 40% of neurology practice now comes from neurophysiology, such as sleep studies and electromyography/nerve conduction studies. These procedures pay better than E&M and thus are worth adding into a practice, he said.

Some other revenue-generating ideas include taking on a hospital directorship, such as stroke director; participating in clinical trials; giving botulinum toxin injections and nerve blocks for rotator cuff injuries, for instance; doing skin biopsies for small fiber neuropathy; and doing chart reviews for legal cases and interpretation of images.

Consider also moonlighting as a neurohospitalist. Dr. Kinsella’s practice offered 24/7 coverage to a hospital that suddenly lost a group of neurologists, which worked out well.

"The key is to leverage your scarcity," Dr. Kinsella said, noting that neurologists are in sparse supply and that many hospitals need coverage for call, stroke centers, and telemedicine.

Another avenue is to offer coverage for rural health clinics. Medicare has been assisting rural hospitals and clinics to recruit neurologists. With higher reimbursement in place to help these centers, working for a rural clinic can "cover your windshield cost" to make the drive and take the time away from practice, he said.

His suggestions for keeping practice fun? Get a clinical appointment to teach residents. Or have a different area of practice every day.

Dr. Elaine C. Jones, a colleague of Dr. Kinsella’s on the AAN government affairs committee, has taken a somewhat contrary path to getting satisfaction out of her practice by moving from an academic setting to set up her own solo practice.

She began practicing in the late 1990s at a large multispecialty group based at an academic hospital in Providence, R.I. By 2001, she was chief of neurology, but she felt as if the responsibility was not matched by an equal level of decision-making power. She decided that by going solo she could cut out the middleman on issues concerning staffing decisions, expenses, program development, and office renovations.

She consulted with other physicians in private practice, read up on various publications from the American Medical Association, and relied on her boyfriend, who had banking experience and a law degree, all of which helped her to decide which business model to use. She hired attorneys to help file the necessary paperwork to set up the practice. The hardest decision was naming the practice; she decided on Southern New England Neurology, with an eye on expanding in the future.

In 2005, Dr. Jones opened the practice in Bristol, R.I., renting space in a primary care practice building. Reaching this point had taken $40,000 in personal savings, $50,000 from a home-equity credit line, and a $30,000 equipment loan. Within 6 months, she had covered her costs, and within 18 months she had paid off the loan and was paying down the equity line.

An important initial investment was an electronic health record system, Dr. Jones said.

She began by working just 4 days a week, which gave her time for personal pursuits. But 3 years in, she had outgrown the space and the increased patient volume was taxing her existing staff. Dr. Jones was afraid to leave the bosom of the primary care group and its built-in referrals, but it had no additional room, so she decided to buy a property. She purchased a duplex and invested in extensive renovations, which took about a year to complete.

She has found private practice to be very rewarding because it gives her control over her scheduling, hours, and staffing, and no one is standing behind her pushing for an increase in productivity. But it requires a lot of focus on managing expenses.

In 2010 and 2011, Dr. Jones had a decline in reimbursement, but her patient volume was increasing. There are only so many patients she can see on her own, so she looked for ways to cut expenses and increase income. Accounting, for instance, had gone up to 20% of her expenses. She dismissed her bookkeeper and now does her own books. The health plan cost had increased by 8%, so when the policy came up for renewal, she found state incentives for small businesses, which allowed her to reduce that expense.

Initially, she had an experienced nurse practitioner on staff who helped maintain or increase patient volume. But her salary was more than she could bring in independently, so Dr. Jones decided to let her go.

She’s found ways to bring in new revenue – for instance, by offering botulinum toxin injections for chronic migraines and punch skin biopsies. Dr. Jones said that participating in Medicare’s incentive programs for meaningful use and electronic prescribing have also boosted revenue. "It’s a lot of work, and it changes how you do things, but it is a revenue stream," she said.

With demand outstripping supply, neurologists will continue to be in demand, but the Affordable Care Act and other pressures will still make it hard to practice, Dr. Jones said. She’s considering taking on some coverage with some local hospitals, but added that she’s "not thrilled with working harder" or on more nights and weekends, although she is not ruling out this option.

Nor is she ruling out selling her practice and getting out of medicine all together.

"The most important thing is, you have to pay attention and be limber and adjust your models as things change," said Dr. Jones. But, she acknowledged, "I don’t know if I’ll still be in neurology in 5 years."

Dr. Kinsella disclosed that he owns stock in Rural Healthcare Logistics and is a subcontractor for Premier Service Network. Dr. Jones had no disclosures.

*Correction, 7/13/2012: An earlier version of this story misstated Dr. Kinsella's professional position.

NEW ORLEANS – Like many other specialties – particularly cognitive specialties – neurology is under pressure to figure out how best to survive in an environment in which expenses are rising, but income is declining. So what are some strategies for staying in practice, choosing what type of practice is best, ensuring a steady income stream, and staying sane?

At the recent annual meeting of the American Academy of Neurology, several neurologists offered their personal take on preserving the pleasures of practice while maintaining revenues.

Dr. Laurence J. Kinsella, codirector of neurology for SSM Neurosciences Institute, St. Louis, noted that although median income for neurologists had risen fairly steadily since the mid-1990s, a neurologist’s value was very much dependent on what area of the country he or she practices in, whether it is urban or rural, and whether the practice is academic or private, or interventionist or cognitive.*

Choosing where to practice and the best type of practice is dependent on which options offer the best proximity to family or accommodation of a spouse’s needs, as well as the most professional growth, leadership potential, and collegiality, among other factors, said Dr. Kinsella, who is also vice chair of the AAN’s government affairs committee.

In the assessment of a group practice, for instance, be aware that survey data and published research have shown that the average turnover is 7% per year, and 60% of those who leave do so in the first 5 years. The biggest reasons for leaving include practice issues; compensation and location issues; and spousal concerns. Some questions to raise are whether the senior partners are advocates for equity for all partners, and whether the path to partnership is clearly stated, Dr. Kinsella said.

Before signing a contract with any group, it’s worthwhile to consult with an attorney who specializes in health care, he said. Keep in mind that everything is negotiable. Some key components to explore include salary and bonus; productivity scale; call schedule; pension and profit sharing; termination; and malpractice, health, and disability insurance.

"The most important thing is, you have to pay attention and be limber and adjust your models as things change."

Whether you take the academic, private, solo, or group path, the reimbursement challenges will be the same. The elimination of the Medicare consult codes in 2010 have led to a 6%-20% reduction in reimbursement, according to AAN survey data, Dr. Kinsella said.

There is a tool to assess the impact on a practice at www.mitsi.org/. One way to make up for lost revenue is to take a closer look at evaluation and management (E&M) codes, he added. At least 60% of neurologists’ billing is for E&M services. AAN provides templates for determining efficient and appropriate use of E&M codes. Dr. Kinsella said he advocated for the use of prolonged service codes such as 99354 (31-74 minutes) and 99355 (for each additional 30 minutes). "I’d encourage you to get comfortable with these. They are very good to use," he said.

Most neurologists also bill at level 4, then level 5 and level 3 for E&M, and they should be billing primarily level 5, Dr. Kinsella said. A level 5 consult requires more than just a single diagnosis.

Some 40% of neurology practice now comes from neurophysiology, such as sleep studies and electromyography/nerve conduction studies. These procedures pay better than E&M and thus are worth adding into a practice, he said.

Some other revenue-generating ideas include taking on a hospital directorship, such as stroke director; participating in clinical trials; giving botulinum toxin injections and nerve blocks for rotator cuff injuries, for instance; doing skin biopsies for small fiber neuropathy; and doing chart reviews for legal cases and interpretation of images.

Consider also moonlighting as a neurohospitalist. Dr. Kinsella’s practice offered 24/7 coverage to a hospital that suddenly lost a group of neurologists, which worked out well.

"The key is to leverage your scarcity," Dr. Kinsella said, noting that neurologists are in sparse supply and that many hospitals need coverage for call, stroke centers, and telemedicine.

Another avenue is to offer coverage for rural health clinics. Medicare has been assisting rural hospitals and clinics to recruit neurologists. With higher reimbursement in place to help these centers, working for a rural clinic can "cover your windshield cost" to make the drive and take the time away from practice, he said.

His suggestions for keeping practice fun? Get a clinical appointment to teach residents. Or have a different area of practice every day.

Dr. Elaine C. Jones, a colleague of Dr. Kinsella’s on the AAN government affairs committee, has taken a somewhat contrary path to getting satisfaction out of her practice by moving from an academic setting to set up her own solo practice.

She began practicing in the late 1990s at a large multispecialty group based at an academic hospital in Providence, R.I. By 2001, she was chief of neurology, but she felt as if the responsibility was not matched by an equal level of decision-making power. She decided that by going solo she could cut out the middleman on issues concerning staffing decisions, expenses, program development, and office renovations.

She consulted with other physicians in private practice, read up on various publications from the American Medical Association, and relied on her boyfriend, who had banking experience and a law degree, all of which helped her to decide which business model to use. She hired attorneys to help file the necessary paperwork to set up the practice. The hardest decision was naming the practice; she decided on Southern New England Neurology, with an eye on expanding in the future.

In 2005, Dr. Jones opened the practice in Bristol, R.I., renting space in a primary care practice building. Reaching this point had taken $40,000 in personal savings, $50,000 from a home-equity credit line, and a $30,000 equipment loan. Within 6 months, she had covered her costs, and within 18 months she had paid off the loan and was paying down the equity line.

An important initial investment was an electronic health record system, Dr. Jones said.

She began by working just 4 days a week, which gave her time for personal pursuits. But 3 years in, she had outgrown the space and the increased patient volume was taxing her existing staff. Dr. Jones was afraid to leave the bosom of the primary care group and its built-in referrals, but it had no additional room, so she decided to buy a property. She purchased a duplex and invested in extensive renovations, which took about a year to complete.

She has found private practice to be very rewarding because it gives her control over her scheduling, hours, and staffing, and no one is standing behind her pushing for an increase in productivity. But it requires a lot of focus on managing expenses.

In 2010 and 2011, Dr. Jones had a decline in reimbursement, but her patient volume was increasing. There are only so many patients she can see on her own, so she looked for ways to cut expenses and increase income. Accounting, for instance, had gone up to 20% of her expenses. She dismissed her bookkeeper and now does her own books. The health plan cost had increased by 8%, so when the policy came up for renewal, she found state incentives for small businesses, which allowed her to reduce that expense.

Initially, she had an experienced nurse practitioner on staff who helped maintain or increase patient volume. But her salary was more than she could bring in independently, so Dr. Jones decided to let her go.

She’s found ways to bring in new revenue – for instance, by offering botulinum toxin injections for chronic migraines and punch skin biopsies. Dr. Jones said that participating in Medicare’s incentive programs for meaningful use and electronic prescribing have also boosted revenue. "It’s a lot of work, and it changes how you do things, but it is a revenue stream," she said.

With demand outstripping supply, neurologists will continue to be in demand, but the Affordable Care Act and other pressures will still make it hard to practice, Dr. Jones said. She’s considering taking on some coverage with some local hospitals, but added that she’s "not thrilled with working harder" or on more nights and weekends, although she is not ruling out this option.

Nor is she ruling out selling her practice and getting out of medicine all together.

"The most important thing is, you have to pay attention and be limber and adjust your models as things change," said Dr. Jones. But, she acknowledged, "I don’t know if I’ll still be in neurology in 5 years."

Dr. Kinsella disclosed that he owns stock in Rural Healthcare Logistics and is a subcontractor for Premier Service Network. Dr. Jones had no disclosures.

*Correction, 7/13/2012: An earlier version of this story misstated Dr. Kinsella's professional position.

NEW ORLEANS – Like many other specialties – particularly cognitive specialties – neurology is under pressure to figure out how best to survive in an environment in which expenses are rising, but income is declining. So what are some strategies for staying in practice, choosing what type of practice is best, ensuring a steady income stream, and staying sane?

At the recent annual meeting of the American Academy of Neurology, several neurologists offered their personal take on preserving the pleasures of practice while maintaining revenues.

Dr. Laurence J. Kinsella, codirector of neurology for SSM Neurosciences Institute, St. Louis, noted that although median income for neurologists had risen fairly steadily since the mid-1990s, a neurologist’s value was very much dependent on what area of the country he or she practices in, whether it is urban or rural, and whether the practice is academic or private, or interventionist or cognitive.*

Choosing where to practice and the best type of practice is dependent on which options offer the best proximity to family or accommodation of a spouse’s needs, as well as the most professional growth, leadership potential, and collegiality, among other factors, said Dr. Kinsella, who is also vice chair of the AAN’s government affairs committee.

In the assessment of a group practice, for instance, be aware that survey data and published research have shown that the average turnover is 7% per year, and 60% of those who leave do so in the first 5 years. The biggest reasons for leaving include practice issues; compensation and location issues; and spousal concerns. Some questions to raise are whether the senior partners are advocates for equity for all partners, and whether the path to partnership is clearly stated, Dr. Kinsella said.

Before signing a contract with any group, it’s worthwhile to consult with an attorney who specializes in health care, he said. Keep in mind that everything is negotiable. Some key components to explore include salary and bonus; productivity scale; call schedule; pension and profit sharing; termination; and malpractice, health, and disability insurance.

"The most important thing is, you have to pay attention and be limber and adjust your models as things change."

Whether you take the academic, private, solo, or group path, the reimbursement challenges will be the same. The elimination of the Medicare consult codes in 2010 have led to a 6%-20% reduction in reimbursement, according to AAN survey data, Dr. Kinsella said.

There is a tool to assess the impact on a practice at www.mitsi.org/. One way to make up for lost revenue is to take a closer look at evaluation and management (E&M) codes, he added. At least 60% of neurologists’ billing is for E&M services. AAN provides templates for determining efficient and appropriate use of E&M codes. Dr. Kinsella said he advocated for the use of prolonged service codes such as 99354 (31-74 minutes) and 99355 (for each additional 30 minutes). "I’d encourage you to get comfortable with these. They are very good to use," he said.

Most neurologists also bill at level 4, then level 5 and level 3 for E&M, and they should be billing primarily level 5, Dr. Kinsella said. A level 5 consult requires more than just a single diagnosis.

Some 40% of neurology practice now comes from neurophysiology, such as sleep studies and electromyography/nerve conduction studies. These procedures pay better than E&M and thus are worth adding into a practice, he said.

Some other revenue-generating ideas include taking on a hospital directorship, such as stroke director; participating in clinical trials; giving botulinum toxin injections and nerve blocks for rotator cuff injuries, for instance; doing skin biopsies for small fiber neuropathy; and doing chart reviews for legal cases and interpretation of images.

Consider also moonlighting as a neurohospitalist. Dr. Kinsella’s practice offered 24/7 coverage to a hospital that suddenly lost a group of neurologists, which worked out well.

"The key is to leverage your scarcity," Dr. Kinsella said, noting that neurologists are in sparse supply and that many hospitals need coverage for call, stroke centers, and telemedicine.

Another avenue is to offer coverage for rural health clinics. Medicare has been assisting rural hospitals and clinics to recruit neurologists. With higher reimbursement in place to help these centers, working for a rural clinic can "cover your windshield cost" to make the drive and take the time away from practice, he said.

His suggestions for keeping practice fun? Get a clinical appointment to teach residents. Or have a different area of practice every day.

Dr. Elaine C. Jones, a colleague of Dr. Kinsella’s on the AAN government affairs committee, has taken a somewhat contrary path to getting satisfaction out of her practice by moving from an academic setting to set up her own solo practice.

She began practicing in the late 1990s at a large multispecialty group based at an academic hospital in Providence, R.I. By 2001, she was chief of neurology, but she felt as if the responsibility was not matched by an equal level of decision-making power. She decided that by going solo she could cut out the middleman on issues concerning staffing decisions, expenses, program development, and office renovations.

She consulted with other physicians in private practice, read up on various publications from the American Medical Association, and relied on her boyfriend, who had banking experience and a law degree, all of which helped her to decide which business model to use. She hired attorneys to help file the necessary paperwork to set up the practice. The hardest decision was naming the practice; she decided on Southern New England Neurology, with an eye on expanding in the future.

In 2005, Dr. Jones opened the practice in Bristol, R.I., renting space in a primary care practice building. Reaching this point had taken $40,000 in personal savings, $50,000 from a home-equity credit line, and a $30,000 equipment loan. Within 6 months, she had covered her costs, and within 18 months she had paid off the loan and was paying down the equity line.

An important initial investment was an electronic health record system, Dr. Jones said.

She began by working just 4 days a week, which gave her time for personal pursuits. But 3 years in, she had outgrown the space and the increased patient volume was taxing her existing staff. Dr. Jones was afraid to leave the bosom of the primary care group and its built-in referrals, but it had no additional room, so she decided to buy a property. She purchased a duplex and invested in extensive renovations, which took about a year to complete.

She has found private practice to be very rewarding because it gives her control over her scheduling, hours, and staffing, and no one is standing behind her pushing for an increase in productivity. But it requires a lot of focus on managing expenses.

In 2010 and 2011, Dr. Jones had a decline in reimbursement, but her patient volume was increasing. There are only so many patients she can see on her own, so she looked for ways to cut expenses and increase income. Accounting, for instance, had gone up to 20% of her expenses. She dismissed her bookkeeper and now does her own books. The health plan cost had increased by 8%, so when the policy came up for renewal, she found state incentives for small businesses, which allowed her to reduce that expense.

Initially, she had an experienced nurse practitioner on staff who helped maintain or increase patient volume. But her salary was more than she could bring in independently, so Dr. Jones decided to let her go.

She’s found ways to bring in new revenue – for instance, by offering botulinum toxin injections for chronic migraines and punch skin biopsies. Dr. Jones said that participating in Medicare’s incentive programs for meaningful use and electronic prescribing have also boosted revenue. "It’s a lot of work, and it changes how you do things, but it is a revenue stream," she said.

With demand outstripping supply, neurologists will continue to be in demand, but the Affordable Care Act and other pressures will still make it hard to practice, Dr. Jones said. She’s considering taking on some coverage with some local hospitals, but added that she’s "not thrilled with working harder" or on more nights and weekends, although she is not ruling out this option.

Nor is she ruling out selling her practice and getting out of medicine all together.

"The most important thing is, you have to pay attention and be limber and adjust your models as things change," said Dr. Jones. But, she acknowledged, "I don’t know if I’ll still be in neurology in 5 years."

Dr. Kinsella disclosed that he owns stock in Rural Healthcare Logistics and is a subcontractor for Premier Service Network. Dr. Jones had no disclosures.

*Correction, 7/13/2012: An earlier version of this story misstated Dr. Kinsella's professional position.

It’s time for cardiologists to pay more attention to patients’ needs and to advocate for patient-centered care with insurers and policy makers, according to a new health policy statement from the American College of Cardiology.

The statement outlines a new treatment paradigm of shared decision making with patients, and a systemic approach to care that, for the first time, urges creation of patient-centered medical homes led by cardiovascular specialists.

"In true patient-centered care, the focus is on the patient, not on the disease," Dr. Mary Norine Walsh, chair of the ACC’s patient-centered care committee, said in an interview. "Beyond knowing the technical aspects of the disease, we need to do a better job of understanding patients’ perception of their disease and their goals and life experience, so we can together chart a course for how we are going to manage the disease," said Dr. Walsh, medical director of the heart failure and cardiac transplantation programs at St. Vincent Indianapolis Hospital.

The bottom line is, physicians need to communicate better with patients, at a level that takes into account their health literacy, and patients need to be more actively engaged in their own care, according to the policy statement, which was published in the Journal of the American College of Cardiology (2012, May 14:doi:10.1016/j.jacc.2012.03.016).

"As clinicians, we have been taught for many years to give patients orders and expect things to happen," said Dr. Alfred A. Bove, professor emeritus, Temple University, Philadelphia, and vice chair of the patient-centered care committee, in a statement. "But when it comes to the day-to-day management of chronic conditions like heart disease, we have to empower patients to be actively involved in their own care. We won’t be effective unless we move toward a patient-centered approach. This initiative is intended to help us get there."

The statement is not designed to tell physicians how to manage their practices, said Dr. Walsh. It’s a call to payers and policy makers to help give physicians the tools they need to move to patient-centered care, she said. "The onus is not on the doctors here," said Dr. Walsh.

However, it does urge physicians to start thinking about educating patients in a variety of ways, including pamphlets, online programs, community events, and group education sessions. The statement estimates that 89 million American adults – one-third the population – are not literate enough, health-wise, to follow through on recommendations for tests and treatments and self-monitoring. Educational content should also be tailored to patients’ individual health situations and needs.

The next step should be to create easy-to-use decision aids for patients – so they are no longer passive recipients of recommendations for care – and self-management programs, including web portals, so that patients also engage in monitoring chronic conditions. Such portals are currently rare but will likely be required for physicians who want to qualify under stage 2 of the meaningful use criteria for Medicare’s electronic health record incentive program.

Dr. Walsh admitted that, even in her practice, she relies on outdated technology – giving patients a printed-out grid for monitoring their blood pressure – that is not ideal for engaging them in their own care. But for starters, she says, the ACC has a portal of sorts, the CardioSmart website, which offers patients some decision aids and information about various conditions and tests and treatments in lay-friendly language.

The ACC is also hoping to make inroads with the idea that cardiovascular specialists can lead medical homes, for certain patients. "We know that not every cardiologist will be a home for every patient," said Dr. Walsh. But for transplant patients, those with ventricular assist devices or congenital heart disease, the primary physician is a cardiologist or a surgeon, she said.

The specialist-led medical home will not operate to the exclusion of the traditional medical home; it will be one of many models, said Dr. Walsh.

The policy statement envisions a care team "to manage patients with advanced cardiac disease across the continuum of care from the stable outpatient environment to the level of intensive in-hospital care without changing care teams." Such a team would be directed by cardiologists with advanced training in cardiovascular disease management and include nurse practitioners, pharmacists, educators, and technologists with expertise in echocardiography, myocardial perfusion imaging, and other advanced imaging.

Overall, the policy statement "clearly puts a stake in the ground as far as what we as a professional society feel is important," said Dr. Walsh, who added that she expected that the statement will be used to educate physicians and payers and be taken to all of its discussions on Capitol Hill.

Dr. Walsh reported no relevant conflicts. Dr. Bove disclosed that he is a consultant for Health Station Networks. Most other authors and reviewers reported no relevant conflicts. Three who had potential conflicts were not permitted to draft text or vote on text or recommendations.

It’s time for cardiologists to pay more attention to patients’ needs and to advocate for patient-centered care with insurers and policy makers, according to a new health policy statement from the American College of Cardiology.

The statement outlines a new treatment paradigm of shared decision making with patients, and a systemic approach to care that, for the first time, urges creation of patient-centered medical homes led by cardiovascular specialists.

"In true patient-centered care, the focus is on the patient, not on the disease," Dr. Mary Norine Walsh, chair of the ACC’s patient-centered care committee, said in an interview. "Beyond knowing the technical aspects of the disease, we need to do a better job of understanding patients’ perception of their disease and their goals and life experience, so we can together chart a course for how we are going to manage the disease," said Dr. Walsh, medical director of the heart failure and cardiac transplantation programs at St. Vincent Indianapolis Hospital.

The bottom line is, physicians need to communicate better with patients, at a level that takes into account their health literacy, and patients need to be more actively engaged in their own care, according to the policy statement, which was published in the Journal of the American College of Cardiology (2012, May 14:doi:10.1016/j.jacc.2012.03.016).

"As clinicians, we have been taught for many years to give patients orders and expect things to happen," said Dr. Alfred A. Bove, professor emeritus, Temple University, Philadelphia, and vice chair of the patient-centered care committee, in a statement. "But when it comes to the day-to-day management of chronic conditions like heart disease, we have to empower patients to be actively involved in their own care. We won’t be effective unless we move toward a patient-centered approach. This initiative is intended to help us get there."

The statement is not designed to tell physicians how to manage their practices, said Dr. Walsh. It’s a call to payers and policy makers to help give physicians the tools they need to move to patient-centered care, she said. "The onus is not on the doctors here," said Dr. Walsh.

However, it does urge physicians to start thinking about educating patients in a variety of ways, including pamphlets, online programs, community events, and group education sessions. The statement estimates that 89 million American adults – one-third the population – are not literate enough, health-wise, to follow through on recommendations for tests and treatments and self-monitoring. Educational content should also be tailored to patients’ individual health situations and needs.

The next step should be to create easy-to-use decision aids for patients – so they are no longer passive recipients of recommendations for care – and self-management programs, including web portals, so that patients also engage in monitoring chronic conditions. Such portals are currently rare but will likely be required for physicians who want to qualify under stage 2 of the meaningful use criteria for Medicare’s electronic health record incentive program.

Dr. Walsh admitted that, even in her practice, she relies on outdated technology – giving patients a printed-out grid for monitoring their blood pressure – that is not ideal for engaging them in their own care. But for starters, she says, the ACC has a portal of sorts, the CardioSmart website, which offers patients some decision aids and information about various conditions and tests and treatments in lay-friendly language.

The ACC is also hoping to make inroads with the idea that cardiovascular specialists can lead medical homes, for certain patients. "We know that not every cardiologist will be a home for every patient," said Dr. Walsh. But for transplant patients, those with ventricular assist devices or congenital heart disease, the primary physician is a cardiologist or a surgeon, she said.

The specialist-led medical home will not operate to the exclusion of the traditional medical home; it will be one of many models, said Dr. Walsh.

The policy statement envisions a care team "to manage patients with advanced cardiac disease across the continuum of care from the stable outpatient environment to the level of intensive in-hospital care without changing care teams." Such a team would be directed by cardiologists with advanced training in cardiovascular disease management and include nurse practitioners, pharmacists, educators, and technologists with expertise in echocardiography, myocardial perfusion imaging, and other advanced imaging.

Overall, the policy statement "clearly puts a stake in the ground as far as what we as a professional society feel is important," said Dr. Walsh, who added that she expected that the statement will be used to educate physicians and payers and be taken to all of its discussions on Capitol Hill.

Dr. Walsh reported no relevant conflicts. Dr. Bove disclosed that he is a consultant for Health Station Networks. Most other authors and reviewers reported no relevant conflicts. Three who had potential conflicts were not permitted to draft text or vote on text or recommendations.

It’s time for cardiologists to pay more attention to patients’ needs and to advocate for patient-centered care with insurers and policy makers, according to a new health policy statement from the American College of Cardiology.

The statement outlines a new treatment paradigm of shared decision making with patients, and a systemic approach to care that, for the first time, urges creation of patient-centered medical homes led by cardiovascular specialists.

"In true patient-centered care, the focus is on the patient, not on the disease," Dr. Mary Norine Walsh, chair of the ACC’s patient-centered care committee, said in an interview. "Beyond knowing the technical aspects of the disease, we need to do a better job of understanding patients’ perception of their disease and their goals and life experience, so we can together chart a course for how we are going to manage the disease," said Dr. Walsh, medical director of the heart failure and cardiac transplantation programs at St. Vincent Indianapolis Hospital.

The bottom line is, physicians need to communicate better with patients, at a level that takes into account their health literacy, and patients need to be more actively engaged in their own care, according to the policy statement, which was published in the Journal of the American College of Cardiology (2012, May 14:doi:10.1016/j.jacc.2012.03.016).

"As clinicians, we have been taught for many years to give patients orders and expect things to happen," said Dr. Alfred A. Bove, professor emeritus, Temple University, Philadelphia, and vice chair of the patient-centered care committee, in a statement. "But when it comes to the day-to-day management of chronic conditions like heart disease, we have to empower patients to be actively involved in their own care. We won’t be effective unless we move toward a patient-centered approach. This initiative is intended to help us get there."

The statement is not designed to tell physicians how to manage their practices, said Dr. Walsh. It’s a call to payers and policy makers to help give physicians the tools they need to move to patient-centered care, she said. "The onus is not on the doctors here," said Dr. Walsh.

However, it does urge physicians to start thinking about educating patients in a variety of ways, including pamphlets, online programs, community events, and group education sessions. The statement estimates that 89 million American adults – one-third the population – are not literate enough, health-wise, to follow through on recommendations for tests and treatments and self-monitoring. Educational content should also be tailored to patients’ individual health situations and needs.

The next step should be to create easy-to-use decision aids for patients – so they are no longer passive recipients of recommendations for care – and self-management programs, including web portals, so that patients also engage in monitoring chronic conditions. Such portals are currently rare but will likely be required for physicians who want to qualify under stage 2 of the meaningful use criteria for Medicare’s electronic health record incentive program.

Dr. Walsh admitted that, even in her practice, she relies on outdated technology – giving patients a printed-out grid for monitoring their blood pressure – that is not ideal for engaging them in their own care. But for starters, she says, the ACC has a portal of sorts, the CardioSmart website, which offers patients some decision aids and information about various conditions and tests and treatments in lay-friendly language.

The ACC is also hoping to make inroads with the idea that cardiovascular specialists can lead medical homes, for certain patients. "We know that not every cardiologist will be a home for every patient," said Dr. Walsh. But for transplant patients, those with ventricular assist devices or congenital heart disease, the primary physician is a cardiologist or a surgeon, she said.

The specialist-led medical home will not operate to the exclusion of the traditional medical home; it will be one of many models, said Dr. Walsh.

The policy statement envisions a care team "to manage patients with advanced cardiac disease across the continuum of care from the stable outpatient environment to the level of intensive in-hospital care without changing care teams." Such a team would be directed by cardiologists with advanced training in cardiovascular disease management and include nurse practitioners, pharmacists, educators, and technologists with expertise in echocardiography, myocardial perfusion imaging, and other advanced imaging.

Overall, the policy statement "clearly puts a stake in the ground as far as what we as a professional society feel is important," said Dr. Walsh, who added that she expected that the statement will be used to educate physicians and payers and be taken to all of its discussions on Capitol Hill.

Dr. Walsh reported no relevant conflicts. Dr. Bove disclosed that he is a consultant for Health Station Networks. Most other authors and reviewers reported no relevant conflicts. Three who had potential conflicts were not permitted to draft text or vote on text or recommendations.