Government and Regulations

There is no doubt we are getting healthcare reform, and in the end, Democrats will declare victory for the first meaningful progress since the 1960s, when Medicare and Medicaid were passed. Of course, in the interim, we have had legislation facilitating the development of HMOs under President Nixon and a senior pharmacy benefit under President George W. Bush, but many presidents have flailed at taking a crack at making major changes.

Republicans will declare victory, too, for stopping many bad ideas and trying to hold the line on costs. And everyone will complain about all the things that are not in the bill President Obama will sign this year.

And everyone will be right.

One Out of Three

To oversimplify things, all of the talk about healthcare reform has focused on three main areas:

• Increasing access for the uninsured and underinsured;
• Reigning in healthcare costs; and
• Designing a new system that rewards performance and safety.

At best, all we are getting is a down payment on access—and it will come with a substantial cost.

But what we are more likely beginning is an unraveling of business as usual and a reshuffling of the deck—and some key stakeholders won’t like the cards they will be dealt. The best way to think of what is happening in 2010 is that this is the first step toward having the healthcare system we will have in 2020.

Civic Obligation

It is a national embarrassment for the U.S. to be the only developed country that has not come up with a solution that offers most of its citizens access to healthcare. As a culture, we have decided that every child deserves a free education, that all families should have access to fire and police protection, and that we all should have access to due process and “an attorney who will be appointed to you if you cannot afford one.”

But right now in our country, about 47 million people live sicker and die quicker because of a healthcare system that doesn’t include them. A more sorry aspect is the “underinsured,” the constantly employed person with “good” insurance who is unfortunate enough to be diagnosed with cancer only to find out that their $1 million lifetime benefit runs out in year two or three. Those families face the tough choices between bankruptcy and foreclosure, or allowing Mom or Dad to give up another year or two or three of life. Is this the America we are living in?

Reform, Part I

To get this partial loaf of healthcare reform, Obama and Congressional leaders had to be creative. What has torpedoed previous efforts has been the vast power and reach of large, well-funded stakeholders who see any change as a threat and take a “what’s in it for me” approach. These industries have not been shy about using power and money to influence Congress and the White House, and even more insidiously have gone “direct” with advertisements and commentators who use “Harry and Louise” tactics to frighten an underinformed public about this complex process.

But this time, Obama promised the doctors, the insurance industry, the pharmaceutical companies, the hospitals, the device-makers, and just about anybody who would listen that “they” would not be hurt by these reforms. In fact, in the access discussion for many of these stakeholders, the initial result would be 47 million more customers paying for healthcare products and services. Is it any wonder that the price tag must go up, and by trillions of dollars?

It is the price of admission, at least to get the ball rolling. Now we all are in the box. With a price tag approaching $3 trillion a year, and an aging population and a taxpaying workforce shrinking relative to those they must support with entitlements (think Medicare and Social Security), the die is cast for “Healthcare Reform: The Sequel.”

Trust me—the next round of change will be more cataclysmic. In the aggregate, physicians will make less than the nearly $500 billion we make now. Sure, the primary-care physicians (PCPs) and lower-paid specialties might not be hit (and could even move up), but some physicians will see a marked change in their compensation.

Hospitals will need to adapt as well. They must become more efficient. We saw this in California, Washington, Oregon, Massachusetts, and elsewhere, as capitation and managed care ratcheted down on the old “cost-plus” payment method and moved the industry to reward value and efficiency. Those who are efficient and effective will do very well. Those who have lived by just doing more and more without demonstrating their performance or achieving standards will suffer and be dissatisfied.

More Reforms Possible

The future of the insurance industry will be very different as well, maybe because of government’s more intrusive role (think Medicare for most people) or by evolving to a model like Germany’s, where 200 nonprofit insurance companies compete for business. We will demand that insurance companies return $0.95 on the dollar for patient care, not $0.75 or less, as is common practice today.

Device-makers and Big Pharma might start to see a glimpse into the future as comparative-effectiveness research looks at the value of new, expensive technology and advances in treatments. As medications become “included” in the standard benefits bundle, just like physician fees and hospitalizations, we will see a relentless push downward on pricing. Drugs will become just one more line item to be budgeted for, especially if MedPAC and Congress are involved. We will get what we can afford, not everything that is possible or available.

Because this is 21st-century America, under the cacophony of Glenn Beck and Keith Olbermann and Rush Limbaugh and Rachel Maddow, the potential losers will be loud. They will trumpet any fact or pseudo-fact to alarm the populace. Phrases like “government takeover” and “you will lose the great healthcare you have,” and “death squads” and “illegal immigrants” and “back to 19th-century healthcare,” will bounce around the 24-hour news cycle. They will make real, positive change difficult.

But the beauty of what we are passing now, in 2010, is that the train is leaving the station. We are burning the boats. The healthcare system shakeup officially is under way. There is no turning back.

HM was not borne of a new law or mandate. We are an innovation of a system that must change and evolve. And while HM is not all it eventually will be, there are hints of what we can become. For a new healthcare system that offers greater access and is grounded in documented performance and efficiency, HM will be a solution for hospitals with hospitalist groups.

A lot of uncertainty remains out there, and the next decade promises to be even more turbulent, but hospitalists are as well positioned as any stakeholder in healthcare.

We are ready to be an active, contributing, and solution-oriented profession that will add value to our patients and our healthcare communities.

Stay tuned. TH

Dr. Wellikson is CEO of SHM.

There is no doubt we are getting healthcare reform, and in the end, Democrats will declare victory for the first meaningful progress since the 1960s, when Medicare and Medicaid were passed. Of course, in the interim, we have had legislation facilitating the development of HMOs under President Nixon and a senior pharmacy benefit under President George W. Bush, but many presidents have flailed at taking a crack at making major changes.

Republicans will declare victory, too, for stopping many bad ideas and trying to hold the line on costs. And everyone will complain about all the things that are not in the bill President Obama will sign this year.

And everyone will be right.

One Out of Three

To oversimplify things, all of the talk about healthcare reform has focused on three main areas:

• Increasing access for the uninsured and underinsured;
• Reigning in healthcare costs; and
• Designing a new system that rewards performance and safety.

At best, all we are getting is a down payment on access—and it will come with a substantial cost.

But what we are more likely beginning is an unraveling of business as usual and a reshuffling of the deck—and some key stakeholders won’t like the cards they will be dealt. The best way to think of what is happening in 2010 is that this is the first step toward having the healthcare system we will have in 2020.

Civic Obligation

It is a national embarrassment for the U.S. to be the only developed country that has not come up with a solution that offers most of its citizens access to healthcare. As a culture, we have decided that every child deserves a free education, that all families should have access to fire and police protection, and that we all should have access to due process and “an attorney who will be appointed to you if you cannot afford one.”

But right now in our country, about 47 million people live sicker and die quicker because of a healthcare system that doesn’t include them. A more sorry aspect is the “underinsured,” the constantly employed person with “good” insurance who is unfortunate enough to be diagnosed with cancer only to find out that their $1 million lifetime benefit runs out in year two or three. Those families face the tough choices between bankruptcy and foreclosure, or allowing Mom or Dad to give up another year or two or three of life. Is this the America we are living in?

Reform, Part I

To get this partial loaf of healthcare reform, Obama and Congressional leaders had to be creative. What has torpedoed previous efforts has been the vast power and reach of large, well-funded stakeholders who see any change as a threat and take a “what’s in it for me” approach. These industries have not been shy about using power and money to influence Congress and the White House, and even more insidiously have gone “direct” with advertisements and commentators who use “Harry and Louise” tactics to frighten an underinformed public about this complex process.

But this time, Obama promised the doctors, the insurance industry, the pharmaceutical companies, the hospitals, the device-makers, and just about anybody who would listen that “they” would not be hurt by these reforms. In fact, in the access discussion for many of these stakeholders, the initial result would be 47 million more customers paying for healthcare products and services. Is it any wonder that the price tag must go up, and by trillions of dollars?

It is the price of admission, at least to get the ball rolling. Now we all are in the box. With a price tag approaching $3 trillion a year, and an aging population and a taxpaying workforce shrinking relative to those they must support with entitlements (think Medicare and Social Security), the die is cast for “Healthcare Reform: The Sequel.”

Trust me—the next round of change will be more cataclysmic. In the aggregate, physicians will make less than the nearly $500 billion we make now. Sure, the primary-care physicians (PCPs) and lower-paid specialties might not be hit (and could even move up), but some physicians will see a marked change in their compensation.

Hospitals will need to adapt as well. They must become more efficient. We saw this in California, Washington, Oregon, Massachusetts, and elsewhere, as capitation and managed care ratcheted down on the old “cost-plus” payment method and moved the industry to reward value and efficiency. Those who are efficient and effective will do very well. Those who have lived by just doing more and more without demonstrating their performance or achieving standards will suffer and be dissatisfied.

More Reforms Possible

The future of the insurance industry will be very different as well, maybe because of government’s more intrusive role (think Medicare for most people) or by evolving to a model like Germany’s, where 200 nonprofit insurance companies compete for business. We will demand that insurance companies return $0.95 on the dollar for patient care, not $0.75 or less, as is common practice today.

Device-makers and Big Pharma might start to see a glimpse into the future as comparative-effectiveness research looks at the value of new, expensive technology and advances in treatments. As medications become “included” in the standard benefits bundle, just like physician fees and hospitalizations, we will see a relentless push downward on pricing. Drugs will become just one more line item to be budgeted for, especially if MedPAC and Congress are involved. We will get what we can afford, not everything that is possible or available.

Because this is 21st-century America, under the cacophony of Glenn Beck and Keith Olbermann and Rush Limbaugh and Rachel Maddow, the potential losers will be loud. They will trumpet any fact or pseudo-fact to alarm the populace. Phrases like “government takeover” and “you will lose the great healthcare you have,” and “death squads” and “illegal immigrants” and “back to 19th-century healthcare,” will bounce around the 24-hour news cycle. They will make real, positive change difficult.

But the beauty of what we are passing now, in 2010, is that the train is leaving the station. We are burning the boats. The healthcare system shakeup officially is under way. There is no turning back.

HM was not borne of a new law or mandate. We are an innovation of a system that must change and evolve. And while HM is not all it eventually will be, there are hints of what we can become. For a new healthcare system that offers greater access and is grounded in documented performance and efficiency, HM will be a solution for hospitals with hospitalist groups.

A lot of uncertainty remains out there, and the next decade promises to be even more turbulent, but hospitalists are as well positioned as any stakeholder in healthcare.

We are ready to be an active, contributing, and solution-oriented profession that will add value to our patients and our healthcare communities.

Stay tuned. TH

Dr. Wellikson is CEO of SHM.

There is no doubt we are getting healthcare reform, and in the end, Democrats will declare victory for the first meaningful progress since the 1960s, when Medicare and Medicaid were passed. Of course, in the interim, we have had legislation facilitating the development of HMOs under President Nixon and a senior pharmacy benefit under President George W. Bush, but many presidents have flailed at taking a crack at making major changes.

Republicans will declare victory, too, for stopping many bad ideas and trying to hold the line on costs. And everyone will complain about all the things that are not in the bill President Obama will sign this year.

And everyone will be right.

One Out of Three

To oversimplify things, all of the talk about healthcare reform has focused on three main areas:

• Increasing access for the uninsured and underinsured;
• Reigning in healthcare costs; and
• Designing a new system that rewards performance and safety.

At best, all we are getting is a down payment on access—and it will come with a substantial cost.

But what we are more likely beginning is an unraveling of business as usual and a reshuffling of the deck—and some key stakeholders won’t like the cards they will be dealt. The best way to think of what is happening in 2010 is that this is the first step toward having the healthcare system we will have in 2020.

Civic Obligation

It is a national embarrassment for the U.S. to be the only developed country that has not come up with a solution that offers most of its citizens access to healthcare. As a culture, we have decided that every child deserves a free education, that all families should have access to fire and police protection, and that we all should have access to due process and “an attorney who will be appointed to you if you cannot afford one.”

But right now in our country, about 47 million people live sicker and die quicker because of a healthcare system that doesn’t include them. A more sorry aspect is the “underinsured,” the constantly employed person with “good” insurance who is unfortunate enough to be diagnosed with cancer only to find out that their $1 million lifetime benefit runs out in year two or three. Those families face the tough choices between bankruptcy and foreclosure, or allowing Mom or Dad to give up another year or two or three of life. Is this the America we are living in?

Reform, Part I

To get this partial loaf of healthcare reform, Obama and Congressional leaders had to be creative. What has torpedoed previous efforts has been the vast power and reach of large, well-funded stakeholders who see any change as a threat and take a “what’s in it for me” approach. These industries have not been shy about using power and money to influence Congress and the White House, and even more insidiously have gone “direct” with advertisements and commentators who use “Harry and Louise” tactics to frighten an underinformed public about this complex process.

But this time, Obama promised the doctors, the insurance industry, the pharmaceutical companies, the hospitals, the device-makers, and just about anybody who would listen that “they” would not be hurt by these reforms. In fact, in the access discussion for many of these stakeholders, the initial result would be 47 million more customers paying for healthcare products and services. Is it any wonder that the price tag must go up, and by trillions of dollars?

It is the price of admission, at least to get the ball rolling. Now we all are in the box. With a price tag approaching $3 trillion a year, and an aging population and a taxpaying workforce shrinking relative to those they must support with entitlements (think Medicare and Social Security), the die is cast for “Healthcare Reform: The Sequel.”

Trust me—the next round of change will be more cataclysmic. In the aggregate, physicians will make less than the nearly $500 billion we make now. Sure, the primary-care physicians (PCPs) and lower-paid specialties might not be hit (and could even move up), but some physicians will see a marked change in their compensation.

Hospitals will need to adapt as well. They must become more efficient. We saw this in California, Washington, Oregon, Massachusetts, and elsewhere, as capitation and managed care ratcheted down on the old “cost-plus” payment method and moved the industry to reward value and efficiency. Those who are efficient and effective will do very well. Those who have lived by just doing more and more without demonstrating their performance or achieving standards will suffer and be dissatisfied.

More Reforms Possible

The future of the insurance industry will be very different as well, maybe because of government’s more intrusive role (think Medicare for most people) or by evolving to a model like Germany’s, where 200 nonprofit insurance companies compete for business. We will demand that insurance companies return $0.95 on the dollar for patient care, not $0.75 or less, as is common practice today.

Device-makers and Big Pharma might start to see a glimpse into the future as comparative-effectiveness research looks at the value of new, expensive technology and advances in treatments. As medications become “included” in the standard benefits bundle, just like physician fees and hospitalizations, we will see a relentless push downward on pricing. Drugs will become just one more line item to be budgeted for, especially if MedPAC and Congress are involved. We will get what we can afford, not everything that is possible or available.

Because this is 21st-century America, under the cacophony of Glenn Beck and Keith Olbermann and Rush Limbaugh and Rachel Maddow, the potential losers will be loud. They will trumpet any fact or pseudo-fact to alarm the populace. Phrases like “government takeover” and “you will lose the great healthcare you have,” and “death squads” and “illegal immigrants” and “back to 19th-century healthcare,” will bounce around the 24-hour news cycle. They will make real, positive change difficult.

But the beauty of what we are passing now, in 2010, is that the train is leaving the station. We are burning the boats. The healthcare system shakeup officially is under way. There is no turning back.

HM was not borne of a new law or mandate. We are an innovation of a system that must change and evolve. And while HM is not all it eventually will be, there are hints of what we can become. For a new healthcare system that offers greater access and is grounded in documented performance and efficiency, HM will be a solution for hospitals with hospitalist groups.

A lot of uncertainty remains out there, and the next decade promises to be even more turbulent, but hospitalists are as well positioned as any stakeholder in healthcare.

We are ready to be an active, contributing, and solution-oriented profession that will add value to our patients and our healthcare communities.

Stay tuned. TH

Dr. Wellikson is CEO of SHM.

No one can call 2009 a dull year for healthcare policy. And 2010 already is shaping up as another humdinger, with several issues bubbling to the surface. One of the biggest comes courtesy of the Dartmouth Atlas of Health Care (www.dartmouthatlas.org), as politicians, analysts, researchers, and physicians grapple over how to resolve the contentious issue of geographical disparities in healthcare spending.

One of the main bodies of evidence driving the debate, the interactive Dartmouth map, depicts a color-coded nation in which wide swaths of the Midwest and West are colored with a pale green hue, which represents a significantly reduced amount of Medicare reimbursements. Meanwhile, states such as New York, New Jersey, Massachusetts, Florida, Texas, and Louisiana are marked by a darker shade of green—representing the nation’s most expensive per capita reimbursement rates.

Tucked within 2009’s massive Affordable Health Care for America Act passed by the House is a provision calling for a study of “geographic variation in healthcare spending and promoting high-value healthcare,” which is aiming for a more evenly colored landscape.

More than 50 legislators, hailing primarily from the Midwest and Pacific Northwest and calling themselves the Quality Care Coalition, pushed through the wording as a condition for supporting the larger healthcare reform bill. One measure would direct the nonpartisan Institute of Medicine (IOM) to check the accuracy of the geographic adjustment factors that underlie existing Medicare reimbursements and suggest necessary revisions. The second would call upon the IOM “to conduct a study on geographic variation and growth in volume and intensity of services in per capita healthcare spending among the Medicare, Medicaid, privately insured, and uninsured populations.”

Recommendations to Secretary of Health and Human Services Kathleen Sebelius as a result of that study would go into effect unless the House and Senate passed a joint resolution of disapproval with a two-thirds vote.

Reimbursement Battles

The implicit message is that some states, cities, and health providers have been shortchanged in their reimbursements—a complaint that flows into the larger meme that the country’s dysfunctional payment system rewards quantity, not quality. Officials at the Mayo Clinic in Rochester, Minn., have suggested in media accounts that the current Medicare formula cost the clinic $840 million in lost reimbursements in 2008 alone.

Rep. Jay Inslee (D-Washington), whose district lies northwest of Seattle, served as one of the lead negotiators on the issue. According to Inslee spokesman Robert Kellar, the geographical disparity in healthcare spending has been a perennial concern for the Washington delegation due to reimbursement rates that lag by as much as 50%, depending on the procedure. “Hospitals haven’t been able to keep or attract the personnel that they could have because of this issue,” Kellar says. In Washington state, per capita Medicare reimbursements in 2006 hovered about $1,200 below the national average, though 15 other states, led by Hawaii, received even less.

Despite the specter of a skirmish between urban and rural states and hospitals, however, the Dartmouth Atlas suggests that many disparities are more geographically nuanced. In 2006, for example, the Miami hospital referral region received more than $16,300 in Medicare reimbursements per enrollee, while nearby Fort Lauderdale received $9,800 and Atlanta less than $7,400. By comparison, New York netted $12,100, Seattle received $7,200, Rochester, Minn., received $6,700, and Honolulu was reimbursed only $5,300.

Representatives of higher-spending areas have complained that the atlas doesn’t tell the whole story—that steep living costs, poorer populations seeking medical care, and infrastructure necessary for teaching institutions can drive up Medicare expenses. As part of a compromise negotiated with the Quality Care Coalition, the examination of per capita spending will not include expenses related to graduate medical education, disproportionate share hospital (DSH) payments, and health information technology.

In attempting to get at the source of remaining cost disparities, however, the IOM has been charged with considering such factors as a local population’s relative health and socioeconomic status (race, ethnicity, gender, age, income, and education). The study will scrutinize healthcare providers’ organizational models, practice patterns, healthcare outcomes, quality benchmarks, and doctors’ discretion in making treatment decisions, among other criteria.

Differences of Opinion

Dylan Roby, an assistant professor at the UCLA Center for Health Policy Research, says the general expectation among healthcare analysts is that significant differences will remain even with additional sophisticated modeling techniques. “The main hypothesis by most people in the field is that it’s differences in practice patterns that are really driving this, not differences in need or differences in disease burden,” he says.

But what about outcomes? A recent study of heart failure patients at six California hospitals seemed to throw cold water on the notion that higher resource use doesn’t equate with better results with patients.1 The study found more treatment did lead to higher odds of survival.

Roby thinks the study’s results lay the framework for looking at hospital-to-hospital differences in how providers deliver care and allocate resources, but he cautions that they shouldn’t be overanalyzed. All six of the California hospitals in the study are linked to universities and have ample access to resources, he points out.

HM at the Forefront

As for hospitalists, Roby hopes they will be increasingly called upon as focal points for improving efficiencies within provider networks. He concedes that plenty of challenges remain: An institution’s internal politics, for instance, could stymie even the most efficient and proactive physician. Even so, Roby is hopeful that an independent study could at least spur a dialogue about best practices. “I think what the study could potentially do, rather than just act as a way to penalize hospitals that might not be efficient with care, is really offer the ability for us to look at the characteristics of hospitals, in terms of how the care is delivered,” he says.

Ideally, the ability to learn would be followed by the impetus to change. But as analysts have noted, a panel’s recommendations on how to improve healthcare delivery don’t always neatly translate into federal policy.

Consider November’s uproar over mammogram recommendations. When the 16-member U.S. Preventive Services Task Force recommended that women wait until age 50 for routine mammograms instead of starting the screening process at 40, in large part to prevent overtreatment, the fallout was fast and furious. Sebelius quickly signaled in a strongly worded statement that federal policy wasn’t about to change, despite the evidence-based conclusions of a panel convened by her department’s Agency for Healthcare Research and Quality. A group of Republican legislators decried the recommendation as evidence of bureaucrats intruding on healthcare decisions, and even Rep. Debbie Wasserman Schulz (D-Florida), herself a breast-cancer survivor, called the panel’s recommendations “disturbing” and considered Congressional hearings.

The take-home message is readily transferrable to hospitalists: The perception that patients might receive less care can spark public upheaval and force policy makers to beat a hasty retreat away from evidence-based medicine.

Despite the best intentions, a federal panel’s recommendations over resolving geographical disparities in spending could unleash far more drama. Inevitably, such a study will identify both winners and losers, the latter of whom might not accept reduced payments willingly or quietly. TH

Bryn Nelson is a freelance writer based in Seattle.

Reference

1. Ellis SG, Miller D, Keys TF. Comparing physician-specific two-year patient outcomes after coronary angiography. J Am Coll Cardiol. 1999;33:1278-1285.

No one can call 2009 a dull year for healthcare policy. And 2010 already is shaping up as another humdinger, with several issues bubbling to the surface. One of the biggest comes courtesy of the Dartmouth Atlas of Health Care (www.dartmouthatlas.org), as politicians, analysts, researchers, and physicians grapple over how to resolve the contentious issue of geographical disparities in healthcare spending.

One of the main bodies of evidence driving the debate, the interactive Dartmouth map, depicts a color-coded nation in which wide swaths of the Midwest and West are colored with a pale green hue, which represents a significantly reduced amount of Medicare reimbursements. Meanwhile, states such as New York, New Jersey, Massachusetts, Florida, Texas, and Louisiana are marked by a darker shade of green—representing the nation’s most expensive per capita reimbursement rates.

Tucked within 2009’s massive Affordable Health Care for America Act passed by the House is a provision calling for a study of “geographic variation in healthcare spending and promoting high-value healthcare,” which is aiming for a more evenly colored landscape.

More than 50 legislators, hailing primarily from the Midwest and Pacific Northwest and calling themselves the Quality Care Coalition, pushed through the wording as a condition for supporting the larger healthcare reform bill. One measure would direct the nonpartisan Institute of Medicine (IOM) to check the accuracy of the geographic adjustment factors that underlie existing Medicare reimbursements and suggest necessary revisions. The second would call upon the IOM “to conduct a study on geographic variation and growth in volume and intensity of services in per capita healthcare spending among the Medicare, Medicaid, privately insured, and uninsured populations.”

Recommendations to Secretary of Health and Human Services Kathleen Sebelius as a result of that study would go into effect unless the House and Senate passed a joint resolution of disapproval with a two-thirds vote.

Reimbursement Battles

The implicit message is that some states, cities, and health providers have been shortchanged in their reimbursements—a complaint that flows into the larger meme that the country’s dysfunctional payment system rewards quantity, not quality. Officials at the Mayo Clinic in Rochester, Minn., have suggested in media accounts that the current Medicare formula cost the clinic $840 million in lost reimbursements in 2008 alone.

Rep. Jay Inslee (D-Washington), whose district lies northwest of Seattle, served as one of the lead negotiators on the issue. According to Inslee spokesman Robert Kellar, the geographical disparity in healthcare spending has been a perennial concern for the Washington delegation due to reimbursement rates that lag by as much as 50%, depending on the procedure. “Hospitals haven’t been able to keep or attract the personnel that they could have because of this issue,” Kellar says. In Washington state, per capita Medicare reimbursements in 2006 hovered about $1,200 below the national average, though 15 other states, led by Hawaii, received even less.

Despite the specter of a skirmish between urban and rural states and hospitals, however, the Dartmouth Atlas suggests that many disparities are more geographically nuanced. In 2006, for example, the Miami hospital referral region received more than $16,300 in Medicare reimbursements per enrollee, while nearby Fort Lauderdale received $9,800 and Atlanta less than $7,400. By comparison, New York netted $12,100, Seattle received $7,200, Rochester, Minn., received $6,700, and Honolulu was reimbursed only $5,300.

Representatives of higher-spending areas have complained that the atlas doesn’t tell the whole story—that steep living costs, poorer populations seeking medical care, and infrastructure necessary for teaching institutions can drive up Medicare expenses. As part of a compromise negotiated with the Quality Care Coalition, the examination of per capita spending will not include expenses related to graduate medical education, disproportionate share hospital (DSH) payments, and health information technology.

In attempting to get at the source of remaining cost disparities, however, the IOM has been charged with considering such factors as a local population’s relative health and socioeconomic status (race, ethnicity, gender, age, income, and education). The study will scrutinize healthcare providers’ organizational models, practice patterns, healthcare outcomes, quality benchmarks, and doctors’ discretion in making treatment decisions, among other criteria.

Differences of Opinion

Dylan Roby, an assistant professor at the UCLA Center for Health Policy Research, says the general expectation among healthcare analysts is that significant differences will remain even with additional sophisticated modeling techniques. “The main hypothesis by most people in the field is that it’s differences in practice patterns that are really driving this, not differences in need or differences in disease burden,” he says.

But what about outcomes? A recent study of heart failure patients at six California hospitals seemed to throw cold water on the notion that higher resource use doesn’t equate with better results with patients.1 The study found more treatment did lead to higher odds of survival.

Roby thinks the study’s results lay the framework for looking at hospital-to-hospital differences in how providers deliver care and allocate resources, but he cautions that they shouldn’t be overanalyzed. All six of the California hospitals in the study are linked to universities and have ample access to resources, he points out.

HM at the Forefront

As for hospitalists, Roby hopes they will be increasingly called upon as focal points for improving efficiencies within provider networks. He concedes that plenty of challenges remain: An institution’s internal politics, for instance, could stymie even the most efficient and proactive physician. Even so, Roby is hopeful that an independent study could at least spur a dialogue about best practices. “I think what the study could potentially do, rather than just act as a way to penalize hospitals that might not be efficient with care, is really offer the ability for us to look at the characteristics of hospitals, in terms of how the care is delivered,” he says.

Ideally, the ability to learn would be followed by the impetus to change. But as analysts have noted, a panel’s recommendations on how to improve healthcare delivery don’t always neatly translate into federal policy.

Consider November’s uproar over mammogram recommendations. When the 16-member U.S. Preventive Services Task Force recommended that women wait until age 50 for routine mammograms instead of starting the screening process at 40, in large part to prevent overtreatment, the fallout was fast and furious. Sebelius quickly signaled in a strongly worded statement that federal policy wasn’t about to change, despite the evidence-based conclusions of a panel convened by her department’s Agency for Healthcare Research and Quality. A group of Republican legislators decried the recommendation as evidence of bureaucrats intruding on healthcare decisions, and even Rep. Debbie Wasserman Schulz (D-Florida), herself a breast-cancer survivor, called the panel’s recommendations “disturbing” and considered Congressional hearings.

The take-home message is readily transferrable to hospitalists: The perception that patients might receive less care can spark public upheaval and force policy makers to beat a hasty retreat away from evidence-based medicine.

Despite the best intentions, a federal panel’s recommendations over resolving geographical disparities in spending could unleash far more drama. Inevitably, such a study will identify both winners and losers, the latter of whom might not accept reduced payments willingly or quietly. TH

Bryn Nelson is a freelance writer based in Seattle.

Reference

1. Ellis SG, Miller D, Keys TF. Comparing physician-specific two-year patient outcomes after coronary angiography. J Am Coll Cardiol. 1999;33:1278-1285.

No one can call 2009 a dull year for healthcare policy. And 2010 already is shaping up as another humdinger, with several issues bubbling to the surface. One of the biggest comes courtesy of the Dartmouth Atlas of Health Care (www.dartmouthatlas.org), as politicians, analysts, researchers, and physicians grapple over how to resolve the contentious issue of geographical disparities in healthcare spending.

One of the main bodies of evidence driving the debate, the interactive Dartmouth map, depicts a color-coded nation in which wide swaths of the Midwest and West are colored with a pale green hue, which represents a significantly reduced amount of Medicare reimbursements. Meanwhile, states such as New York, New Jersey, Massachusetts, Florida, Texas, and Louisiana are marked by a darker shade of green—representing the nation’s most expensive per capita reimbursement rates.

Tucked within 2009’s massive Affordable Health Care for America Act passed by the House is a provision calling for a study of “geographic variation in healthcare spending and promoting high-value healthcare,” which is aiming for a more evenly colored landscape.

More than 50 legislators, hailing primarily from the Midwest and Pacific Northwest and calling themselves the Quality Care Coalition, pushed through the wording as a condition for supporting the larger healthcare reform bill. One measure would direct the nonpartisan Institute of Medicine (IOM) to check the accuracy of the geographic adjustment factors that underlie existing Medicare reimbursements and suggest necessary revisions. The second would call upon the IOM “to conduct a study on geographic variation and growth in volume and intensity of services in per capita healthcare spending among the Medicare, Medicaid, privately insured, and uninsured populations.”

Recommendations to Secretary of Health and Human Services Kathleen Sebelius as a result of that study would go into effect unless the House and Senate passed a joint resolution of disapproval with a two-thirds vote.

Reimbursement Battles

The implicit message is that some states, cities, and health providers have been shortchanged in their reimbursements—a complaint that flows into the larger meme that the country’s dysfunctional payment system rewards quantity, not quality. Officials at the Mayo Clinic in Rochester, Minn., have suggested in media accounts that the current Medicare formula cost the clinic $840 million in lost reimbursements in 2008 alone.

Rep. Jay Inslee (D-Washington), whose district lies northwest of Seattle, served as one of the lead negotiators on the issue. According to Inslee spokesman Robert Kellar, the geographical disparity in healthcare spending has been a perennial concern for the Washington delegation due to reimbursement rates that lag by as much as 50%, depending on the procedure. “Hospitals haven’t been able to keep or attract the personnel that they could have because of this issue,” Kellar says. In Washington state, per capita Medicare reimbursements in 2006 hovered about $1,200 below the national average, though 15 other states, led by Hawaii, received even less.

Despite the specter of a skirmish between urban and rural states and hospitals, however, the Dartmouth Atlas suggests that many disparities are more geographically nuanced. In 2006, for example, the Miami hospital referral region received more than $16,300 in Medicare reimbursements per enrollee, while nearby Fort Lauderdale received $9,800 and Atlanta less than $7,400. By comparison, New York netted $12,100, Seattle received $7,200, Rochester, Minn., received $6,700, and Honolulu was reimbursed only $5,300.

Representatives of higher-spending areas have complained that the atlas doesn’t tell the whole story—that steep living costs, poorer populations seeking medical care, and infrastructure necessary for teaching institutions can drive up Medicare expenses. As part of a compromise negotiated with the Quality Care Coalition, the examination of per capita spending will not include expenses related to graduate medical education, disproportionate share hospital (DSH) payments, and health information technology.

In attempting to get at the source of remaining cost disparities, however, the IOM has been charged with considering such factors as a local population’s relative health and socioeconomic status (race, ethnicity, gender, age, income, and education). The study will scrutinize healthcare providers’ organizational models, practice patterns, healthcare outcomes, quality benchmarks, and doctors’ discretion in making treatment decisions, among other criteria.

Differences of Opinion

Dylan Roby, an assistant professor at the UCLA Center for Health Policy Research, says the general expectation among healthcare analysts is that significant differences will remain even with additional sophisticated modeling techniques. “The main hypothesis by most people in the field is that it’s differences in practice patterns that are really driving this, not differences in need or differences in disease burden,” he says.

But what about outcomes? A recent study of heart failure patients at six California hospitals seemed to throw cold water on the notion that higher resource use doesn’t equate with better results with patients.1 The study found more treatment did lead to higher odds of survival.

Roby thinks the study’s results lay the framework for looking at hospital-to-hospital differences in how providers deliver care and allocate resources, but he cautions that they shouldn’t be overanalyzed. All six of the California hospitals in the study are linked to universities and have ample access to resources, he points out.

HM at the Forefront

As for hospitalists, Roby hopes they will be increasingly called upon as focal points for improving efficiencies within provider networks. He concedes that plenty of challenges remain: An institution’s internal politics, for instance, could stymie even the most efficient and proactive physician. Even so, Roby is hopeful that an independent study could at least spur a dialogue about best practices. “I think what the study could potentially do, rather than just act as a way to penalize hospitals that might not be efficient with care, is really offer the ability for us to look at the characteristics of hospitals, in terms of how the care is delivered,” he says.

Ideally, the ability to learn would be followed by the impetus to change. But as analysts have noted, a panel’s recommendations on how to improve healthcare delivery don’t always neatly translate into federal policy.

Consider November’s uproar over mammogram recommendations. When the 16-member U.S. Preventive Services Task Force recommended that women wait until age 50 for routine mammograms instead of starting the screening process at 40, in large part to prevent overtreatment, the fallout was fast and furious. Sebelius quickly signaled in a strongly worded statement that federal policy wasn’t about to change, despite the evidence-based conclusions of a panel convened by her department’s Agency for Healthcare Research and Quality. A group of Republican legislators decried the recommendation as evidence of bureaucrats intruding on healthcare decisions, and even Rep. Debbie Wasserman Schulz (D-Florida), herself a breast-cancer survivor, called the panel’s recommendations “disturbing” and considered Congressional hearings.

The take-home message is readily transferrable to hospitalists: The perception that patients might receive less care can spark public upheaval and force policy makers to beat a hasty retreat away from evidence-based medicine.

Despite the best intentions, a federal panel’s recommendations over resolving geographical disparities in spending could unleash far more drama. Inevitably, such a study will identify both winners and losers, the latter of whom might not accept reduced payments willingly or quietly. TH

Bryn Nelson is a freelance writer based in Seattle.

Reference

1. Ellis SG, Miller D, Keys TF. Comparing physician-specific two-year patient outcomes after coronary angiography. J Am Coll Cardiol. 1999;33:1278-1285.

New Generics

• Tamsulosin (generic Flomax) capsules should be available March 2, 20101

New Drugs, Indications, Dosage Forms, and Approvals

• C1 Esterase inhibitor [human] (Berinert) has been approved by the Food and Drug Administration (FDA) to treat acute abdominal attacks and facial edema associated with hereditary angioedema (HAE) in adolescents and adults. It is derived from human plasma and regulates clotting and inflammatory reactions. HAE, a genetic disorder affecting 6,000 to 10,000 Americans, is caused by a deficit of C1-INH.2
• Colesevelam HCl tablets (Welchol) have been approved by the FDA as an adjunct to diet and exercise for reducing LDL-C levels in boys and postmenarchal girls ages 10 to 17, with heterozygous familial hypercholesterolemia as monotherapy, or in combination with a statin after failing an adequate trial of diet therapy.3
• Colesevelam HCl (Welchol) has been approved by the FDA as an oral solution providing an alternate dosage form to the large oral tablets currently available.3
• Oxycodone HCl has been recommended for FDA approval. When this new formulation is dissolved in water, it forms a gel, which makes it difficult to abuse. If approved, the new formulation will keep the OxyContin name and will be available in seven dosages. The older product will be phased out and only the newer product will be available.4
• Peginterferon alpha-2b injection (PegIntron) has been recommended for FDA approval for the treatment of patients with stage-III malignant melanoma. Peginterferon alpha-2b currently is approved for treating hepatitis C in combination with ribavirin. It is a once-weekly, subcutaneous injection.5
• Ustekinumab (Stelara) has been approved by the FDA for treating moderate to severe plaque psoriasis by disabling two interleukin (IL) cytokines, IL-12 and IL-23.6 It is a monoclonal antibody administered via subcutaneous injection. Recommended dosing is a baseline injection followed by another injection at week four, followed by subsequent injections every 12 weeks.7 Serious infections have been reported in clinical trials. Therefore, the company has developed a Risk Evaluation and Mitigation Strategy (REMS), as well as targeted healthcare provider education and a patient guide. The product label also contains cautions related to potential immunosuppression, as well as information on avoiding live vaccines while being treated with the agent.

Pipeline

• Cladribine, originally approved by the FDA in an intravenous formulation in the 1990s to treat hairy cell leukemia, has been reformulated as an oral product to manage patients with multiple sclerosis.8 Merck has submitted oral cladribine as a disease-modifying therapy for multiple sclerosis. If approved, it will be the first oral disease modifying agent for treating multiple sclerosis patients.9
• Dapagliflozin, a new mechanism renal sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been shown to reduce fasting plasma glucose and significantly reduce HbA1c levels in patients with Type 2 diabetes mellitus, compared with patients treated with a metformin and placebo combination.10,11 Additionally, about 25% of patients treated with dapagliflozin (vs. 6% of the placebo-metformin-treated patients) had at least a 5% decrease in body weight. Diastolic blood pressure and uric acid level also decreased but not significantly. Serious adverse events were similar between the two treated groups.
• Fingolimod, an oral, disease-modifying agent to treat multiple sclerosis, is the first in a new class of agents known as sphingosine 1-phosphate receptor modulators (S1P-R). A recent two-year study showed it significantly reduced both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.12,13 More information will be available on this agent.
• Naproxcinod is a cyclo-oxygenase-inhibiting nitric oxide donator (CINOD) anti-inflammatory agent.14 The proposed indication is for the relief of the signs and symptoms of osteoarthritis, predominantly for pain management.

Safety Information

• Promethazine injection has undergone a label change to include a boxed warning. The warning is to emphasize the risk of serious tissue injury when promethazine is incorrectly administered.15 The preferred route is deep intramuscular injection; if administered in or near a vein, severe tissue injury might occur. The FDA previously informed healthcare professionals about the risks of incorrectly administered promethazine in December 2006 and again in February 2008. Post-marketing adverse events reported from 1969 to 2009 have identified cases of gangrene requiring amputation associated with administration of injectable promethazine.
• Since its original FDA approval in October 2006, sitagliptin, the first oral dipeptidyl peptidase-4 (DPP-4) inhibitor, is undergoing a safety label change.16 There have been 88 post-marketing cases reported of acute pancreatitis, including two cases of necrotizing or hemorrhagic pancreatitis reported between Oct. 16, 2006, and Feb. 9, 2009.17 The updated labeling discusses more information on the pancreatitis cases reported, and recommends that healthcare professionals carefully monitor patients for the development of pancreatitis, either upon beginning therapy or around dose increases. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Japan’s Astellas settles with Impax on prostate drug. Reuters Web site. Available at: http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUST28251320091007. Accessed Oct. 13, 2009.
2. FDA approves Berinert. Drugs.com Web site. Available at: http://www.drugs.com/newdrugs/csl-behring-announces-fda-approval-berinert-first-only-therapy-approved-acute-abdominal-facial-1681.html. Accessed Oct. 13, 2009.
3. Welchol package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf. Accessed Oct. 13, 2009.
4. Walker E. FDA Panel recommends approval of new oxycodone formulation. Medpage Today Web site. Available at: http://www.medpagetoday.com/Neurology/PainManagement/16132?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.
5. Todoruk M. FDA panel supports approval of Schering-Plough’s PegIntron for patients with melanoma. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=8E68078692384C8A8249EA4A4C036635&logRowId=330581. Accessed Oct. 13, 2009.
6. Gever J, Agus ZS. FDA approves biologic drug for psoriasis. Medpage Today Web site. Available at: http://www.medpagetoday.com/InfectiousDisease/PublicHealth/16147?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.
7. Stelara package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf. Accessed Oct. 13, 2009.
8. Leustatin package label. FDA Web site. Available at: http://www.cancerconsultants.com/druginserts/Cladribine.pdf. Accessed Oct. 13, 2009.
9. Todoruk M. Merck KGaA files cladribine for FDA approval. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=08CF20114B2A4F1DA8FD33AAC7240AB8&logRowId=329839. Accessed Oct. 2, 2009.
10. Dennis M. AstraZeneca, Bristol-Myers Squibb’s dapagliflozin meets endpoints in Phase III study. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=3B158484CA7A47B99CEA373CB2ABFFA2&logRowId=330336. Accessed Oct. 13, 2009.
11. Gever J, Zaleznik DF, Caputo D. EASD: Phase III data look good for novel diabetes drug. Medpage Today Web site. Available at: http://www.medpagetoday.com/MeetingCoverage/EASD/16270. Accessed Oct. 11, 2009.
12. Dennis M. Novartis: Phase III study shows oral MS drug fingolimod reduces relapses, disability progression. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=EDBA0E3366E2477DB714674E9C19821D&logRowId=329838. Accessed Oct. 13, 2009.
13. Multiple sclerosis therapy FTY720 reduces relapses and disability progression. The Multiple Sclerosis Resource Centre Web site. Available at: http://www.msrc.co.uk/printable.cfm?pageid=1309. Accessed Oct. 13, 2009.
14. NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA. NicOx Web site. Available at: http://www.nicox.com/upload/PR_NDA_submission-250909__EN.pdf. Accessed Oct. 13, 2009.
15. Riley K. FDA requires boxed warning for promethazine hydrochloride injection. FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182498.htm. Accessed Oct. 13, 2009.
16. ­Januvia package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf. Accessed Oct. 13, 2009.
17. Information for healthcare professionals—acute pancreatitis and sitagliptin (marketed as Januvia and Janumet). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm183764.htm. Accessed Sept. 26, 2009.

New Generics

• Tamsulosin (generic Flomax) capsules should be available March 2, 20101

New Drugs, Indications, Dosage Forms, and Approvals

• C1 Esterase inhibitor [human] (Berinert) has been approved by the Food and Drug Administration (FDA) to treat acute abdominal attacks and facial edema associated with hereditary angioedema (HAE) in adolescents and adults. It is derived from human plasma and regulates clotting and inflammatory reactions. HAE, a genetic disorder affecting 6,000 to 10,000 Americans, is caused by a deficit of C1-INH.2
• Colesevelam HCl tablets (Welchol) have been approved by the FDA as an adjunct to diet and exercise for reducing LDL-C levels in boys and postmenarchal girls ages 10 to 17, with heterozygous familial hypercholesterolemia as monotherapy, or in combination with a statin after failing an adequate trial of diet therapy.3
• Colesevelam HCl (Welchol) has been approved by the FDA as an oral solution providing an alternate dosage form to the large oral tablets currently available.3
• Oxycodone HCl has been recommended for FDA approval. When this new formulation is dissolved in water, it forms a gel, which makes it difficult to abuse. If approved, the new formulation will keep the OxyContin name and will be available in seven dosages. The older product will be phased out and only the newer product will be available.4
• Peginterferon alpha-2b injection (PegIntron) has been recommended for FDA approval for the treatment of patients with stage-III malignant melanoma. Peginterferon alpha-2b currently is approved for treating hepatitis C in combination with ribavirin. It is a once-weekly, subcutaneous injection.5
• Ustekinumab (Stelara) has been approved by the FDA for treating moderate to severe plaque psoriasis by disabling two interleukin (IL) cytokines, IL-12 and IL-23.6 It is a monoclonal antibody administered via subcutaneous injection. Recommended dosing is a baseline injection followed by another injection at week four, followed by subsequent injections every 12 weeks.7 Serious infections have been reported in clinical trials. Therefore, the company has developed a Risk Evaluation and Mitigation Strategy (REMS), as well as targeted healthcare provider education and a patient guide. The product label also contains cautions related to potential immunosuppression, as well as information on avoiding live vaccines while being treated with the agent.

Pipeline

• Cladribine, originally approved by the FDA in an intravenous formulation in the 1990s to treat hairy cell leukemia, has been reformulated as an oral product to manage patients with multiple sclerosis.8 Merck has submitted oral cladribine as a disease-modifying therapy for multiple sclerosis. If approved, it will be the first oral disease modifying agent for treating multiple sclerosis patients.9
• Dapagliflozin, a new mechanism renal sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been shown to reduce fasting plasma glucose and significantly reduce HbA1c levels in patients with Type 2 diabetes mellitus, compared with patients treated with a metformin and placebo combination.10,11 Additionally, about 25% of patients treated with dapagliflozin (vs. 6% of the placebo-metformin-treated patients) had at least a 5% decrease in body weight. Diastolic blood pressure and uric acid level also decreased but not significantly. Serious adverse events were similar between the two treated groups.
• Fingolimod, an oral, disease-modifying agent to treat multiple sclerosis, is the first in a new class of agents known as sphingosine 1-phosphate receptor modulators (S1P-R). A recent two-year study showed it significantly reduced both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.12,13 More information will be available on this agent.
• Naproxcinod is a cyclo-oxygenase-inhibiting nitric oxide donator (CINOD) anti-inflammatory agent.14 The proposed indication is for the relief of the signs and symptoms of osteoarthritis, predominantly for pain management.

Safety Information

• Promethazine injection has undergone a label change to include a boxed warning. The warning is to emphasize the risk of serious tissue injury when promethazine is incorrectly administered.15 The preferred route is deep intramuscular injection; if administered in or near a vein, severe tissue injury might occur. The FDA previously informed healthcare professionals about the risks of incorrectly administered promethazine in December 2006 and again in February 2008. Post-marketing adverse events reported from 1969 to 2009 have identified cases of gangrene requiring amputation associated with administration of injectable promethazine.
• Since its original FDA approval in October 2006, sitagliptin, the first oral dipeptidyl peptidase-4 (DPP-4) inhibitor, is undergoing a safety label change.16 There have been 88 post-marketing cases reported of acute pancreatitis, including two cases of necrotizing or hemorrhagic pancreatitis reported between Oct. 16, 2006, and Feb. 9, 2009.17 The updated labeling discusses more information on the pancreatitis cases reported, and recommends that healthcare professionals carefully monitor patients for the development of pancreatitis, either upon beginning therapy or around dose increases. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Japan’s Astellas settles with Impax on prostate drug. Reuters Web site. Available at: http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUST28251320091007. Accessed Oct. 13, 2009.
2. FDA approves Berinert. Drugs.com Web site. Available at: http://www.drugs.com/newdrugs/csl-behring-announces-fda-approval-berinert-first-only-therapy-approved-acute-abdominal-facial-1681.html. Accessed Oct. 13, 2009.
3. Welchol package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf. Accessed Oct. 13, 2009.
4. Walker E. FDA Panel recommends approval of new oxycodone formulation. Medpage Today Web site. Available at: http://www.medpagetoday.com/Neurology/PainManagement/16132?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.
5. Todoruk M. FDA panel supports approval of Schering-Plough’s PegIntron for patients with melanoma. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=8E68078692384C8A8249EA4A4C036635&logRowId=330581. Accessed Oct. 13, 2009.
6. Gever J, Agus ZS. FDA approves biologic drug for psoriasis. Medpage Today Web site. Available at: http://www.medpagetoday.com/InfectiousDisease/PublicHealth/16147?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.
7. Stelara package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf. Accessed Oct. 13, 2009.
8. Leustatin package label. FDA Web site. Available at: http://www.cancerconsultants.com/druginserts/Cladribine.pdf. Accessed Oct. 13, 2009.
9. Todoruk M. Merck KGaA files cladribine for FDA approval. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=08CF20114B2A4F1DA8FD33AAC7240AB8&logRowId=329839. Accessed Oct. 2, 2009.
10. Dennis M. AstraZeneca, Bristol-Myers Squibb’s dapagliflozin meets endpoints in Phase III study. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=3B158484CA7A47B99CEA373CB2ABFFA2&logRowId=330336. Accessed Oct. 13, 2009.
11. Gever J, Zaleznik DF, Caputo D. EASD: Phase III data look good for novel diabetes drug. Medpage Today Web site. Available at: http://www.medpagetoday.com/MeetingCoverage/EASD/16270. Accessed Oct. 11, 2009.
12. Dennis M. Novartis: Phase III study shows oral MS drug fingolimod reduces relapses, disability progression. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=EDBA0E3366E2477DB714674E9C19821D&logRowId=329838. Accessed Oct. 13, 2009.
13. Multiple sclerosis therapy FTY720 reduces relapses and disability progression. The Multiple Sclerosis Resource Centre Web site. Available at: http://www.msrc.co.uk/printable.cfm?pageid=1309. Accessed Oct. 13, 2009.
14. NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA. NicOx Web site. Available at: http://www.nicox.com/upload/PR_NDA_submission-250909__EN.pdf. Accessed Oct. 13, 2009.
15. Riley K. FDA requires boxed warning for promethazine hydrochloride injection. FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182498.htm. Accessed Oct. 13, 2009.
16. ­Januvia package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf. Accessed Oct. 13, 2009.
17. Information for healthcare professionals—acute pancreatitis and sitagliptin (marketed as Januvia and Janumet). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm183764.htm. Accessed Sept. 26, 2009.

New Generics

• Tamsulosin (generic Flomax) capsules should be available March 2, 20101

New Drugs, Indications, Dosage Forms, and Approvals

• C1 Esterase inhibitor [human] (Berinert) has been approved by the Food and Drug Administration (FDA) to treat acute abdominal attacks and facial edema associated with hereditary angioedema (HAE) in adolescents and adults. It is derived from human plasma and regulates clotting and inflammatory reactions. HAE, a genetic disorder affecting 6,000 to 10,000 Americans, is caused by a deficit of C1-INH.2
• Colesevelam HCl tablets (Welchol) have been approved by the FDA as an adjunct to diet and exercise for reducing LDL-C levels in boys and postmenarchal girls ages 10 to 17, with heterozygous familial hypercholesterolemia as monotherapy, or in combination with a statin after failing an adequate trial of diet therapy.3
• Colesevelam HCl (Welchol) has been approved by the FDA as an oral solution providing an alternate dosage form to the large oral tablets currently available.3
• Oxycodone HCl has been recommended for FDA approval. When this new formulation is dissolved in water, it forms a gel, which makes it difficult to abuse. If approved, the new formulation will keep the OxyContin name and will be available in seven dosages. The older product will be phased out and only the newer product will be available.4
• Peginterferon alpha-2b injection (PegIntron) has been recommended for FDA approval for the treatment of patients with stage-III malignant melanoma. Peginterferon alpha-2b currently is approved for treating hepatitis C in combination with ribavirin. It is a once-weekly, subcutaneous injection.5
• Ustekinumab (Stelara) has been approved by the FDA for treating moderate to severe plaque psoriasis by disabling two interleukin (IL) cytokines, IL-12 and IL-23.6 It is a monoclonal antibody administered via subcutaneous injection. Recommended dosing is a baseline injection followed by another injection at week four, followed by subsequent injections every 12 weeks.7 Serious infections have been reported in clinical trials. Therefore, the company has developed a Risk Evaluation and Mitigation Strategy (REMS), as well as targeted healthcare provider education and a patient guide. The product label also contains cautions related to potential immunosuppression, as well as information on avoiding live vaccines while being treated with the agent.

Pipeline

• Cladribine, originally approved by the FDA in an intravenous formulation in the 1990s to treat hairy cell leukemia, has been reformulated as an oral product to manage patients with multiple sclerosis.8 Merck has submitted oral cladribine as a disease-modifying therapy for multiple sclerosis. If approved, it will be the first oral disease modifying agent for treating multiple sclerosis patients.9
• Dapagliflozin, a new mechanism renal sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been shown to reduce fasting plasma glucose and significantly reduce HbA1c levels in patients with Type 2 diabetes mellitus, compared with patients treated with a metformin and placebo combination.10,11 Additionally, about 25% of patients treated with dapagliflozin (vs. 6% of the placebo-metformin-treated patients) had at least a 5% decrease in body weight. Diastolic blood pressure and uric acid level also decreased but not significantly. Serious adverse events were similar between the two treated groups.
• Fingolimod, an oral, disease-modifying agent to treat multiple sclerosis, is the first in a new class of agents known as sphingosine 1-phosphate receptor modulators (S1P-R). A recent two-year study showed it significantly reduced both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.12,13 More information will be available on this agent.
• Naproxcinod is a cyclo-oxygenase-inhibiting nitric oxide donator (CINOD) anti-inflammatory agent.14 The proposed indication is for the relief of the signs and symptoms of osteoarthritis, predominantly for pain management.

Safety Information

• Promethazine injection has undergone a label change to include a boxed warning. The warning is to emphasize the risk of serious tissue injury when promethazine is incorrectly administered.15 The preferred route is deep intramuscular injection; if administered in or near a vein, severe tissue injury might occur. The FDA previously informed healthcare professionals about the risks of incorrectly administered promethazine in December 2006 and again in February 2008. Post-marketing adverse events reported from 1969 to 2009 have identified cases of gangrene requiring amputation associated with administration of injectable promethazine.
• Since its original FDA approval in October 2006, sitagliptin, the first oral dipeptidyl peptidase-4 (DPP-4) inhibitor, is undergoing a safety label change.16 There have been 88 post-marketing cases reported of acute pancreatitis, including two cases of necrotizing or hemorrhagic pancreatitis reported between Oct. 16, 2006, and Feb. 9, 2009.17 The updated labeling discusses more information on the pancreatitis cases reported, and recommends that healthcare professionals carefully monitor patients for the development of pancreatitis, either upon beginning therapy or around dose increases. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Japan’s Astellas settles with Impax on prostate drug. Reuters Web site. Available at: http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUST28251320091007. Accessed Oct. 13, 2009.
2. FDA approves Berinert. Drugs.com Web site. Available at: http://www.drugs.com/newdrugs/csl-behring-announces-fda-approval-berinert-first-only-therapy-approved-acute-abdominal-facial-1681.html. Accessed Oct. 13, 2009.
3. Welchol package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf. Accessed Oct. 13, 2009.
4. Walker E. FDA Panel recommends approval of new oxycodone formulation. Medpage Today Web site. Available at: http://www.medpagetoday.com/Neurology/PainManagement/16132?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.
5. Todoruk M. FDA panel supports approval of Schering-Plough’s PegIntron for patients with melanoma. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=8E68078692384C8A8249EA4A4C036635&logRowId=330581. Accessed Oct. 13, 2009.
6. Gever J, Agus ZS. FDA approves biologic drug for psoriasis. Medpage Today Web site. Available at: http://www.medpagetoday.com/InfectiousDisease/PublicHealth/16147?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.
7. Stelara package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf. Accessed Oct. 13, 2009.
8. Leustatin package label. FDA Web site. Available at: http://www.cancerconsultants.com/druginserts/Cladribine.pdf. Accessed Oct. 13, 2009.
9. Todoruk M. Merck KGaA files cladribine for FDA approval. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=08CF20114B2A4F1DA8FD33AAC7240AB8&logRowId=329839. Accessed Oct. 2, 2009.
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