Frances Correa

A plan to finally replace Medicare’s much-maligned sustainable growth rate (SGR) payment formula could be unveiled by this summer, federal lawmakers said at a committee hearing. “Here’s the bottom line: If we get to December and we’re doing an extension, that’s a failure on our part,” Rep. Michael Burgess (R–Tex) said at the hearing. “We need a permanent solution that’s predictable, updatable, and reasonable for this year—and nothing else will do.”

“Whatever virtues the SGR had when it was created 14 years ago..., it’s clear that they have vanished,” added Rep. Henry A. Waxman (D–Calif). He noted that in the past 2 years, Congress has had to pass legislation six times, blocking fee cuts of up to 21% or more.

About 30 medical associations, including the American Society of Clinical Oncology (ASCO), responded to the House subcommittee’s request for suggestions and proposals in developing a new system. On May 5, 2011, House subcommittee members met with a five-person panel of experts from medical associations and health policy organizations to consider alternatives to the current SGR formula, which some participants labeled as anything but sustainable.

One size won’t fit all

Although the details of ASCO’s plan and others vary, they also show a consensus on several fronts: repealing the SGR, moving away from the traditional fee-for-services payment model, and providing a 4- to 5-year transition period during which providers can experiment with a variety of payment systems.

In a letter accompanying the ASCO recommendations, the president, Dr. George Sledge, and CEO, Dr. Allen Lichter, stressed that SGR reforms in general should be linked to existing “robust” systems that promote evidence-based medicine. For oncology in particular, that effort should leverage the Quality Oncology Practice Initiative (QOPI), a comprehensive, field-tested program that more than one-quarter of outpatient oncology practices in the United States already participate in. More than 80% of oncology care is provided in that setting.

“The current SGR system has created an uncertain and unstable environment—a situation that threatens the viability of practices and access to care for thousands of cancer patients,” they concluded.

In its recommendations, ASCO asserted that evidence-based medicine is “both warranted and necessary” because:

• Medicare beneficiaries account for more than half of all new cancer diagnoses in the United States, and treatment and prevention of the disease comprise almost 10% of costs under fee-for-service Medicare;
• The care is complex, treatment can span many specialties, and treatment strategies change rapidly to keep pace with scientific advances; and
• These complexities would not be adequately addressed if a multispecialty system (such as the Physician Quality Reporting System) were to be applied in the oncology setting.
The recommendations also detailed why the QOPI should be incorporated as the primary quality measurement program: 25%-30% of a range of practices—urban, rural, community, and academic—participate in it; it is free; some private insurers have adopted incentives for participation in the program; the performance measures are field-tested and up-to-date; and participation promotes high-quality, high-value care and can help identify and address discrepancies in oncology care.

Moreover, QOPI “protects the best interests of patients, reduces exposure to unnecessary treatments and tests, minimizes the use of suboptimal treatment options, promotes the coordination of care, and protects the Medicare program from costs associated with poor-quality care,” ASCO asserted in the recommendation.

Members of the expert panel also stressed the importance of avoiding a “one-size-fits-all” solution. “We should [be mindful] that what will work in one part of the country will not work in another part of the country, and that’s why we have continued to talk about a variety of options,” said Dr. Cecil Wilson, president of the American Medical Association (AMA). “There is a temptation to feel that we ought to figure out one rule ...that solves it all.”

Dr. Wilson pointed to the provisions in the Affordable Care Act that allow for a variety of models of accountable care organizations, embodying the concept of options in the medical system. In that spirit, he said that the AMA has formed a physician leadership group to evaluate the effectiveness of alternative payment methods.

Dr. Roland A. Goertz, president of the American Academy of Family Physicians (AAFP), noted in written testimony to the committee that “the evidence shows that to achieve the savings Congress is looking for, and to improve the quality of health care delivered to millions of patients in the country, reform must include investment in primary care.”

To strengthen primary care’s role in Medicare, the AAFP backs payment reforms that would boost primary care reimbursement and support the concept of the patient-centered medical home (PCMH). The AAFP’s proposal would create a blended reimbursement system for primary care delivered within a PCMH: fee-for-service payments and pay for performance, plus care management fees for PCMH-related activities that do not involve direct patient care.

To prepare for that new payment system, the AAFP has proposed a 5-year transition period with mandated pay increases for primary care physicians, an increase in the Primary Care Incentive Care payment from 10% to 20%, and a rule that Medicaid payments to primary care physicians will always be at least equal to Medicare payments.

Dr. David Hoyt, executive director of the American College of Surgeons, said the College is analyzing the use of bundled payments for surgery. Dr. M. Todd Williamson, of the Coalition of State Medical and National Specialty Societies, introduced the option of private contracting, in which patients would be free to apply their benefits to a doctor of their choice, who would be free to opt out on a per-patient basis.

“Private contracting is a key principle of American freedom and liberty,” Dr. Williamson said. “[It] will help the federal government achieve fiscal stability while fulfilling its promise to Medicare beneficiaries.”

Harold Miller, executive director of the Center for Healthcare Quality and Payment Reform, suggested an episode-of-care payment plan through which hospitals and physicians jointly charge one price for all services included in a hospitalization. The model would also include a warranty stating that any infections or complications would be treated at no additional cost. Also, a physician practice would receive one payment for all patient needs associated with chronic diseases or other conditions.

Rep. Burgess, who is also a physician, said organizations should focus on ways to address patients with chronic conditions, adding that 80% of Medicare funding is spent by 20% of beneficiaries with chronic illnesses.

Is the IPAB the new SGR?

Rep. Fred Upton (R–Mich) raised concerns about the Independent Payment Advisory Board (IPAB), created by the Affordable Care Act. The Board sets expenditure targets on which it bases spending cuts. In 2018, targets will be based on the gross domestic product. “Sounds a lot like the SGR, which we’re trying to get rid of,” Mr. Upton said. “Since hospitals are exempt from IPAB cuts through the rest of the decade, it seems that the IPAB has the potential to undermine any serious efforts at physician payment reform.”

Some panelists agreed. “It’s not impossible that [the IPAB] could serve a function,” Dr. Wilson said, “but as presently constituted, we see it [as] basically another target for physicians to meet, potential double jeopardy, with an SGR as well as the pronouncements from this body.”

The panelists also asserted their belief that whatever plan chosen should be physician led, with financial support of the government. “It would be very helpful if physicians could get better financial support in their own payment system to enable them to lead all of those efforts,” said Dr. Mark B. McClellan, director of the Engelberg Center for Health Care Reform and former administrator of the Centers for Medicare and Medicaid Services. “Right now, with fee-for-service staying the way it is, they’re staying behind.” Dr. McClellan added that physicians can be the best sources for innovative and cost-saving mechanisms.

A plan to finally replace Medicare’s much-maligned sustainable growth rate (SGR) payment formula could be unveiled by this summer, federal lawmakers said at a committee hearing. “Here’s the bottom line: If we get to December and we’re doing an extension, that’s a failure on our part,” Rep. Michael Burgess (R–Tex) said at the hearing. “We need a permanent solution that’s predictable, updatable, and reasonable for this year—and nothing else will do.”

“Whatever virtues the SGR had when it was created 14 years ago..., it’s clear that they have vanished,” added Rep. Henry A. Waxman (D–Calif). He noted that in the past 2 years, Congress has had to pass legislation six times, blocking fee cuts of up to 21% or more.

About 30 medical associations, including the American Society of Clinical Oncology (ASCO), responded to the House subcommittee’s request for suggestions and proposals in developing a new system. On May 5, 2011, House subcommittee members met with a five-person panel of experts from medical associations and health policy organizations to consider alternatives to the current SGR formula, which some participants labeled as anything but sustainable.

One size won’t fit all

Although the details of ASCO’s plan and others vary, they also show a consensus on several fronts: repealing the SGR, moving away from the traditional fee-for-services payment model, and providing a 4- to 5-year transition period during which providers can experiment with a variety of payment systems.

In a letter accompanying the ASCO recommendations, the president, Dr. George Sledge, and CEO, Dr. Allen Lichter, stressed that SGR reforms in general should be linked to existing “robust” systems that promote evidence-based medicine. For oncology in particular, that effort should leverage the Quality Oncology Practice Initiative (QOPI), a comprehensive, field-tested program that more than one-quarter of outpatient oncology practices in the United States already participate in. More than 80% of oncology care is provided in that setting.

“The current SGR system has created an uncertain and unstable environment—a situation that threatens the viability of practices and access to care for thousands of cancer patients,” they concluded.

In its recommendations, ASCO asserted that evidence-based medicine is “both warranted and necessary” because:

• Medicare beneficiaries account for more than half of all new cancer diagnoses in the United States, and treatment and prevention of the disease comprise almost 10% of costs under fee-for-service Medicare;
• The care is complex, treatment can span many specialties, and treatment strategies change rapidly to keep pace with scientific advances; and
• These complexities would not be adequately addressed if a multispecialty system (such as the Physician Quality Reporting System) were to be applied in the oncology setting.
The recommendations also detailed why the QOPI should be incorporated as the primary quality measurement program: 25%-30% of a range of practices—urban, rural, community, and academic—participate in it; it is free; some private insurers have adopted incentives for participation in the program; the performance measures are field-tested and up-to-date; and participation promotes high-quality, high-value care and can help identify and address discrepancies in oncology care.

Moreover, QOPI “protects the best interests of patients, reduces exposure to unnecessary treatments and tests, minimizes the use of suboptimal treatment options, promotes the coordination of care, and protects the Medicare program from costs associated with poor-quality care,” ASCO asserted in the recommendation.

Members of the expert panel also stressed the importance of avoiding a “one-size-fits-all” solution. “We should [be mindful] that what will work in one part of the country will not work in another part of the country, and that’s why we have continued to talk about a variety of options,” said Dr. Cecil Wilson, president of the American Medical Association (AMA). “There is a temptation to feel that we ought to figure out one rule ...that solves it all.”

Dr. Wilson pointed to the provisions in the Affordable Care Act that allow for a variety of models of accountable care organizations, embodying the concept of options in the medical system. In that spirit, he said that the AMA has formed a physician leadership group to evaluate the effectiveness of alternative payment methods.

Dr. Roland A. Goertz, president of the American Academy of Family Physicians (AAFP), noted in written testimony to the committee that “the evidence shows that to achieve the savings Congress is looking for, and to improve the quality of health care delivered to millions of patients in the country, reform must include investment in primary care.”

To strengthen primary care’s role in Medicare, the AAFP backs payment reforms that would boost primary care reimbursement and support the concept of the patient-centered medical home (PCMH). The AAFP’s proposal would create a blended reimbursement system for primary care delivered within a PCMH: fee-for-service payments and pay for performance, plus care management fees for PCMH-related activities that do not involve direct patient care.

To prepare for that new payment system, the AAFP has proposed a 5-year transition period with mandated pay increases for primary care physicians, an increase in the Primary Care Incentive Care payment from 10% to 20%, and a rule that Medicaid payments to primary care physicians will always be at least equal to Medicare payments.

Dr. David Hoyt, executive director of the American College of Surgeons, said the College is analyzing the use of bundled payments for surgery. Dr. M. Todd Williamson, of the Coalition of State Medical and National Specialty Societies, introduced the option of private contracting, in which patients would be free to apply their benefits to a doctor of their choice, who would be free to opt out on a per-patient basis.

“Private contracting is a key principle of American freedom and liberty,” Dr. Williamson said. “[It] will help the federal government achieve fiscal stability while fulfilling its promise to Medicare beneficiaries.”

Harold Miller, executive director of the Center for Healthcare Quality and Payment Reform, suggested an episode-of-care payment plan through which hospitals and physicians jointly charge one price for all services included in a hospitalization. The model would also include a warranty stating that any infections or complications would be treated at no additional cost. Also, a physician practice would receive one payment for all patient needs associated with chronic diseases or other conditions.

Rep. Burgess, who is also a physician, said organizations should focus on ways to address patients with chronic conditions, adding that 80% of Medicare funding is spent by 20% of beneficiaries with chronic illnesses.

Is the IPAB the new SGR?

Rep. Fred Upton (R–Mich) raised concerns about the Independent Payment Advisory Board (IPAB), created by the Affordable Care Act. The Board sets expenditure targets on which it bases spending cuts. In 2018, targets will be based on the gross domestic product. “Sounds a lot like the SGR, which we’re trying to get rid of,” Mr. Upton said. “Since hospitals are exempt from IPAB cuts through the rest of the decade, it seems that the IPAB has the potential to undermine any serious efforts at physician payment reform.”

Some panelists agreed. “It’s not impossible that [the IPAB] could serve a function,” Dr. Wilson said, “but as presently constituted, we see it [as] basically another target for physicians to meet, potential double jeopardy, with an SGR as well as the pronouncements from this body.”

The panelists also asserted their belief that whatever plan chosen should be physician led, with financial support of the government. “It would be very helpful if physicians could get better financial support in their own payment system to enable them to lead all of those efforts,” said Dr. Mark B. McClellan, director of the Engelberg Center for Health Care Reform and former administrator of the Centers for Medicare and Medicaid Services. “Right now, with fee-for-service staying the way it is, they’re staying behind.” Dr. McClellan added that physicians can be the best sources for innovative and cost-saving mechanisms.

A plan to finally replace Medicare’s much-maligned sustainable growth rate (SGR) payment formula could be unveiled by this summer, federal lawmakers said at a committee hearing. “Here’s the bottom line: If we get to December and we’re doing an extension, that’s a failure on our part,” Rep. Michael Burgess (R–Tex) said at the hearing. “We need a permanent solution that’s predictable, updatable, and reasonable for this year—and nothing else will do.”

“Whatever virtues the SGR had when it was created 14 years ago..., it’s clear that they have vanished,” added Rep. Henry A. Waxman (D–Calif). He noted that in the past 2 years, Congress has had to pass legislation six times, blocking fee cuts of up to 21% or more.

About 30 medical associations, including the American Society of Clinical Oncology (ASCO), responded to the House subcommittee’s request for suggestions and proposals in developing a new system. On May 5, 2011, House subcommittee members met with a five-person panel of experts from medical associations and health policy organizations to consider alternatives to the current SGR formula, which some participants labeled as anything but sustainable.

One size won’t fit all

Although the details of ASCO’s plan and others vary, they also show a consensus on several fronts: repealing the SGR, moving away from the traditional fee-for-services payment model, and providing a 4- to 5-year transition period during which providers can experiment with a variety of payment systems.

In a letter accompanying the ASCO recommendations, the president, Dr. George Sledge, and CEO, Dr. Allen Lichter, stressed that SGR reforms in general should be linked to existing “robust” systems that promote evidence-based medicine. For oncology in particular, that effort should leverage the Quality Oncology Practice Initiative (QOPI), a comprehensive, field-tested program that more than one-quarter of outpatient oncology practices in the United States already participate in. More than 80% of oncology care is provided in that setting.

“The current SGR system has created an uncertain and unstable environment—a situation that threatens the viability of practices and access to care for thousands of cancer patients,” they concluded.

In its recommendations, ASCO asserted that evidence-based medicine is “both warranted and necessary” because:

• Medicare beneficiaries account for more than half of all new cancer diagnoses in the United States, and treatment and prevention of the disease comprise almost 10% of costs under fee-for-service Medicare;
• The care is complex, treatment can span many specialties, and treatment strategies change rapidly to keep pace with scientific advances; and
• These complexities would not be adequately addressed if a multispecialty system (such as the Physician Quality Reporting System) were to be applied in the oncology setting.
The recommendations also detailed why the QOPI should be incorporated as the primary quality measurement program: 25%-30% of a range of practices—urban, rural, community, and academic—participate in it; it is free; some private insurers have adopted incentives for participation in the program; the performance measures are field-tested and up-to-date; and participation promotes high-quality, high-value care and can help identify and address discrepancies in oncology care.

Moreover, QOPI “protects the best interests of patients, reduces exposure to unnecessary treatments and tests, minimizes the use of suboptimal treatment options, promotes the coordination of care, and protects the Medicare program from costs associated with poor-quality care,” ASCO asserted in the recommendation.

Members of the expert panel also stressed the importance of avoiding a “one-size-fits-all” solution. “We should [be mindful] that what will work in one part of the country will not work in another part of the country, and that’s why we have continued to talk about a variety of options,” said Dr. Cecil Wilson, president of the American Medical Association (AMA). “There is a temptation to feel that we ought to figure out one rule ...that solves it all.”

Dr. Wilson pointed to the provisions in the Affordable Care Act that allow for a variety of models of accountable care organizations, embodying the concept of options in the medical system. In that spirit, he said that the AMA has formed a physician leadership group to evaluate the effectiveness of alternative payment methods.

Dr. Roland A. Goertz, president of the American Academy of Family Physicians (AAFP), noted in written testimony to the committee that “the evidence shows that to achieve the savings Congress is looking for, and to improve the quality of health care delivered to millions of patients in the country, reform must include investment in primary care.”

To strengthen primary care’s role in Medicare, the AAFP backs payment reforms that would boost primary care reimbursement and support the concept of the patient-centered medical home (PCMH). The AAFP’s proposal would create a blended reimbursement system for primary care delivered within a PCMH: fee-for-service payments and pay for performance, plus care management fees for PCMH-related activities that do not involve direct patient care.

To prepare for that new payment system, the AAFP has proposed a 5-year transition period with mandated pay increases for primary care physicians, an increase in the Primary Care Incentive Care payment from 10% to 20%, and a rule that Medicaid payments to primary care physicians will always be at least equal to Medicare payments.

Dr. David Hoyt, executive director of the American College of Surgeons, said the College is analyzing the use of bundled payments for surgery. Dr. M. Todd Williamson, of the Coalition of State Medical and National Specialty Societies, introduced the option of private contracting, in which patients would be free to apply their benefits to a doctor of their choice, who would be free to opt out on a per-patient basis.

“Private contracting is a key principle of American freedom and liberty,” Dr. Williamson said. “[It] will help the federal government achieve fiscal stability while fulfilling its promise to Medicare beneficiaries.”

Harold Miller, executive director of the Center for Healthcare Quality and Payment Reform, suggested an episode-of-care payment plan through which hospitals and physicians jointly charge one price for all services included in a hospitalization. The model would also include a warranty stating that any infections or complications would be treated at no additional cost. Also, a physician practice would receive one payment for all patient needs associated with chronic diseases or other conditions.

Rep. Burgess, who is also a physician, said organizations should focus on ways to address patients with chronic conditions, adding that 80% of Medicare funding is spent by 20% of beneficiaries with chronic illnesses.

Is the IPAB the new SGR?

Rep. Fred Upton (R–Mich) raised concerns about the Independent Payment Advisory Board (IPAB), created by the Affordable Care Act. The Board sets expenditure targets on which it bases spending cuts. In 2018, targets will be based on the gross domestic product. “Sounds a lot like the SGR, which we’re trying to get rid of,” Mr. Upton said. “Since hospitals are exempt from IPAB cuts through the rest of the decade, it seems that the IPAB has the potential to undermine any serious efforts at physician payment reform.”

Some panelists agreed. “It’s not impossible that [the IPAB] could serve a function,” Dr. Wilson said, “but as presently constituted, we see it [as] basically another target for physicians to meet, potential double jeopardy, with an SGR as well as the pronouncements from this body.”

The panelists also asserted their belief that whatever plan chosen should be physician led, with financial support of the government. “It would be very helpful if physicians could get better financial support in their own payment system to enable them to lead all of those efforts,” said Dr. Mark B. McClellan, director of the Engelberg Center for Health Care Reform and former administrator of the Centers for Medicare and Medicaid Services. “Right now, with fee-for-service staying the way it is, they’re staying behind.” Dr. McClellan added that physicians can be the best sources for innovative and cost-saving mechanisms.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA's Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program's necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration's plan, known as Epidemic: Responding to America's Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA's Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program's necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration's plan, known as Epidemic: Responding to America's Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA's Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program's necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration's plan, known as Epidemic: Responding to America's Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians who prescribe extended-release opioid prescription drugs may be required to undergo training before obtaining or renewing their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians who prescribe extended-release opioid prescription drugs may be required to undergo training before obtaining or renewing their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians who prescribe extended-release opioid prescription drugs may be required to undergo training before obtaining or renewing their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

WASHINGTON – Physicians may require training on how to prescribe extended-release opioid prescription drugs in order to obtain or renew their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.

The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.

"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.

Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.

She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.

Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.

Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.

"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.

The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.

As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.

Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.

To accomplish the goals of the health reform act, accountable care organizations will have to engage and inform their patients, and commit to serve their communities – besides their underlying mission to take financial responsibility for the quality of care for Medicare patients, according to a paper released April 14 by the Commonwealth Fund.

In response to the recently released, proposed regulations for accountable care organizations (ACOs) from the Centers for Medicare and Medicaid Services, Mark Zezza, Ph.D., and Stuart Guterman of the Commonwealth Fund outlined 10 recommendations for Medicare officials to consider as they finalize the regulations before the end of this year.

ACOs should be part of a shared savings system that incorporates "creativity and flexibility" in rewarding participating organizations for improving care, the authors stressed. They also recommended that Medicare’s payment models for ACOs should accommodate a variety of organizational structures.

"The notion that there would be one kind of [ACO] model, or even a few kinds of models" doesn't hold for existing integrated health systems that are likely to transition easily into ACOs, Mr. Guterman said in a press conference.

The CMS has estimated that 75-150 organizations will form ACOs and that each will face first-year costs of approximately $1.7 million to do so. Despite the potential of rewards from Medicare for patient-care savings while improving quality, some physician organizations have expressed reservations about ACOs.

The answer to that concern is teamwork. "The more payers that are involved, the more patients, the more the costs get spread" in an ACO and the "less onerous" the process becomes, Mr. Guterman said. He and Dr. Zezza also recommended that the CMS cover some start-up fees for ACOs, which Mr. Guterman said should apply especially to providers who offer care to low-income citizens.

When asked whether enough physician groups will buy into the ACO model, Karen Davis, Ph.D., president of the Commonwealth Fund, said she is not concerned. According to Dr. Davis, the 36,000 medical practices that have met the meaningful-use standards for electronic medical records suggest the number of physicians who are interested in ACOs.

If similar numbers of physicians sign up, ACOs "will be regarded as a success," Dr. Davis said. However, she added that meeting ACO standards will take time for some medical practices.

"Those that are not there today should start working towards it today," Dr. Davis said.

To accomplish the goals of the health reform act, accountable care organizations will have to engage and inform their patients, and commit to serve their communities – besides their underlying mission to take financial responsibility for the quality of care for Medicare patients, according to a paper released April 14 by the Commonwealth Fund.

In response to the recently released, proposed regulations for accountable care organizations (ACOs) from the Centers for Medicare and Medicaid Services, Mark Zezza, Ph.D., and Stuart Guterman of the Commonwealth Fund outlined 10 recommendations for Medicare officials to consider as they finalize the regulations before the end of this year.

ACOs should be part of a shared savings system that incorporates "creativity and flexibility" in rewarding participating organizations for improving care, the authors stressed. They also recommended that Medicare’s payment models for ACOs should accommodate a variety of organizational structures.

"The notion that there would be one kind of [ACO] model, or even a few kinds of models" doesn't hold for existing integrated health systems that are likely to transition easily into ACOs, Mr. Guterman said in a press conference.

The CMS has estimated that 75-150 organizations will form ACOs and that each will face first-year costs of approximately $1.7 million to do so. Despite the potential of rewards from Medicare for patient-care savings while improving quality, some physician organizations have expressed reservations about ACOs.

The answer to that concern is teamwork. "The more payers that are involved, the more patients, the more the costs get spread" in an ACO and the "less onerous" the process becomes, Mr. Guterman said. He and Dr. Zezza also recommended that the CMS cover some start-up fees for ACOs, which Mr. Guterman said should apply especially to providers who offer care to low-income citizens.

When asked whether enough physician groups will buy into the ACO model, Karen Davis, Ph.D., president of the Commonwealth Fund, said she is not concerned. According to Dr. Davis, the 36,000 medical practices that have met the meaningful-use standards for electronic medical records suggest the number of physicians who are interested in ACOs.

If similar numbers of physicians sign up, ACOs "will be regarded as a success," Dr. Davis said. However, she added that meeting ACO standards will take time for some medical practices.

"Those that are not there today should start working towards it today," Dr. Davis said.

To accomplish the goals of the health reform act, accountable care organizations will have to engage and inform their patients, and commit to serve their communities – besides their underlying mission to take financial responsibility for the quality of care for Medicare patients, according to a paper released April 14 by the Commonwealth Fund.

In response to the recently released, proposed regulations for accountable care organizations (ACOs) from the Centers for Medicare and Medicaid Services, Mark Zezza, Ph.D., and Stuart Guterman of the Commonwealth Fund outlined 10 recommendations for Medicare officials to consider as they finalize the regulations before the end of this year.

ACOs should be part of a shared savings system that incorporates "creativity and flexibility" in rewarding participating organizations for improving care, the authors stressed. They also recommended that Medicare’s payment models for ACOs should accommodate a variety of organizational structures.

"The notion that there would be one kind of [ACO] model, or even a few kinds of models" doesn't hold for existing integrated health systems that are likely to transition easily into ACOs, Mr. Guterman said in a press conference.

The CMS has estimated that 75-150 organizations will form ACOs and that each will face first-year costs of approximately $1.7 million to do so. Despite the potential of rewards from Medicare for patient-care savings while improving quality, some physician organizations have expressed reservations about ACOs.

The answer to that concern is teamwork. "The more payers that are involved, the more patients, the more the costs get spread" in an ACO and the "less onerous" the process becomes, Mr. Guterman said. He and Dr. Zezza also recommended that the CMS cover some start-up fees for ACOs, which Mr. Guterman said should apply especially to providers who offer care to low-income citizens.

When asked whether enough physician groups will buy into the ACO model, Karen Davis, Ph.D., president of the Commonwealth Fund, said she is not concerned. According to Dr. Davis, the 36,000 medical practices that have met the meaningful-use standards for electronic medical records suggest the number of physicians who are interested in ACOs.

If similar numbers of physicians sign up, ACOs "will be regarded as a success," Dr. Davis said. However, she added that meeting ACO standards will take time for some medical practices.

"Those that are not there today should start working towards it today," Dr. Davis said.

Despite efforts to improve the quality of care in the Department of Veterans Affairs health system, racial disparities remain for certain conditions, according to a study published in the April issue of Health Affairs .

Clinical outcomes for glucose control, low-density lipoprotein control, and blood pressure showed the greatest degree of disparity between black and white veterans. Researchers based their findings on quality data from the VA’s External Peer Review Program from 2000 to 2009. The study examined disparities following a major reorganization of the VA health system and a push for quality improvement in the late 1990s.

The results highlight the need for the VA to routinely track clinical outcomes for vulnerable groups, Dr. Amal Trivedi, the study’s lead author, said in an interview.

"Even in a system that’s achieved really significant quality gains, there are still disparities that need to be addressed," said Dr. Trivedi, a research investigator at the Providence VA Medical Center and an assistant professor of community health at Brown University in Providence, R.I.

One of the most surprising findings, according to the researchers, was that the disparities weren’t a result of black veterans receiving care at lower-quality facilities. Instead, the greatest differences in care were noted when black and white veterans were treated in the same hospital.

In the study, researchers measured performance indicators for 1,126,254 veterans (955,047 white; 171,207 black). Researchers also compared clinical outcomes to process-of-care indicators such as screening measures (Health Aff. 2011;30:707-15). Patients were separated on the basis of sex, age, census region, and socioeconomic status.

Black veterans, on average, were younger, less educated, of low socioeconomic status, and from the Southern region. With the exception of mammography, performance rates notably improved for both racial groups. However, clinical outcomes for black veterans lagged behind those for white veterans in a few areas. For example, on measures of cardiovascular care, there was an 8.3% difference between outcomes for white veterans and black veterans on LDL control. Under the diabetes care measures, there was a 5.8% difference in HbA_1c control and a 6.8% difference in LDL control between blacks and whites. Under the hypertension measure, there was a 5.8% difference in blood pressure control.

These findings are consistent with the results of previous studies showing racial disparities in glucose, blood pressure, and cholesterol control, according to Dr. Trivedi. These findings are a cry for consistency of care and standardized treatment protocols, the researchers said.

The study results were limited to VA services only. The researchers did not assess possible disparities among other ethnicities or examine the impact of other possible contributing factors, such as lifestyle modifications or comorbid medical conditions.

The research was funded in part by the Department of Veterans Affairs and the Robert Wood Johnson Foundation.

Despite efforts to improve the quality of care in the Department of Veterans Affairs health system, racial disparities remain for certain conditions, according to a study published in the April issue of Health Affairs .

Clinical outcomes for glucose control, low-density lipoprotein control, and blood pressure showed the greatest degree of disparity between black and white veterans. Researchers based their findings on quality data from the VA’s External Peer Review Program from 2000 to 2009. The study examined disparities following a major reorganization of the VA health system and a push for quality improvement in the late 1990s.

The results highlight the need for the VA to routinely track clinical outcomes for vulnerable groups, Dr. Amal Trivedi, the study’s lead author, said in an interview.

"Even in a system that’s achieved really significant quality gains, there are still disparities that need to be addressed," said Dr. Trivedi, a research investigator at the Providence VA Medical Center and an assistant professor of community health at Brown University in Providence, R.I.

One of the most surprising findings, according to the researchers, was that the disparities weren’t a result of black veterans receiving care at lower-quality facilities. Instead, the greatest differences in care were noted when black and white veterans were treated in the same hospital.

In the study, researchers measured performance indicators for 1,126,254 veterans (955,047 white; 171,207 black). Researchers also compared clinical outcomes to process-of-care indicators such as screening measures (Health Aff. 2011;30:707-15). Patients were separated on the basis of sex, age, census region, and socioeconomic status.

Black veterans, on average, were younger, less educated, of low socioeconomic status, and from the Southern region. With the exception of mammography, performance rates notably improved for both racial groups. However, clinical outcomes for black veterans lagged behind those for white veterans in a few areas. For example, on measures of cardiovascular care, there was an 8.3% difference between outcomes for white veterans and black veterans on LDL control. Under the diabetes care measures, there was a 5.8% difference in HbA_1c control and a 6.8% difference in LDL control between blacks and whites. Under the hypertension measure, there was a 5.8% difference in blood pressure control.

These findings are consistent with the results of previous studies showing racial disparities in glucose, blood pressure, and cholesterol control, according to Dr. Trivedi. These findings are a cry for consistency of care and standardized treatment protocols, the researchers said.

The study results were limited to VA services only. The researchers did not assess possible disparities among other ethnicities or examine the impact of other possible contributing factors, such as lifestyle modifications or comorbid medical conditions.

The research was funded in part by the Department of Veterans Affairs and the Robert Wood Johnson Foundation.

Despite efforts to improve the quality of care in the Department of Veterans Affairs health system, racial disparities remain for certain conditions, according to a study published in the April issue of Health Affairs .

Clinical outcomes for glucose control, low-density lipoprotein control, and blood pressure showed the greatest degree of disparity between black and white veterans. Researchers based their findings on quality data from the VA’s External Peer Review Program from 2000 to 2009. The study examined disparities following a major reorganization of the VA health system and a push for quality improvement in the late 1990s.

The results highlight the need for the VA to routinely track clinical outcomes for vulnerable groups, Dr. Amal Trivedi, the study’s lead author, said in an interview.

"Even in a system that’s achieved really significant quality gains, there are still disparities that need to be addressed," said Dr. Trivedi, a research investigator at the Providence VA Medical Center and an assistant professor of community health at Brown University in Providence, R.I.

One of the most surprising findings, according to the researchers, was that the disparities weren’t a result of black veterans receiving care at lower-quality facilities. Instead, the greatest differences in care were noted when black and white veterans were treated in the same hospital.

In the study, researchers measured performance indicators for 1,126,254 veterans (955,047 white; 171,207 black). Researchers also compared clinical outcomes to process-of-care indicators such as screening measures (Health Aff. 2011;30:707-15). Patients were separated on the basis of sex, age, census region, and socioeconomic status.

Black veterans, on average, were younger, less educated, of low socioeconomic status, and from the Southern region. With the exception of mammography, performance rates notably improved for both racial groups. However, clinical outcomes for black veterans lagged behind those for white veterans in a few areas. For example, on measures of cardiovascular care, there was an 8.3% difference between outcomes for white veterans and black veterans on LDL control. Under the diabetes care measures, there was a 5.8% difference in HbA_1c control and a 6.8% difference in LDL control between blacks and whites. Under the hypertension measure, there was a 5.8% difference in blood pressure control.

These findings are consistent with the results of previous studies showing racial disparities in glucose, blood pressure, and cholesterol control, according to Dr. Trivedi. These findings are a cry for consistency of care and standardized treatment protocols, the researchers said.

The study results were limited to VA services only. The researchers did not assess possible disparities among other ethnicities or examine the impact of other possible contributing factors, such as lifestyle modifications or comorbid medical conditions.

The research was funded in part by the Department of Veterans Affairs and the Robert Wood Johnson Foundation.

Despite efforts to improve the quality of care in the Department of Veterans Affairs health system, racial disparities remain for certain conditions, according to a study published in the April issue of Health Affairs .

Clinical outcomes for glucose control, low-density lipoprotein control, and blood pressure showed the greatest degree of disparity between black and white veterans. Researchers based their findings on quality data from the VA’s External Peer Review Program from 2000 to 2009. The study examined disparities following a major reorganization of the VA health system and a push for quality improvement in the late 1990s.

The results highlight the need for the VA to routinely track clinical outcomes for vulnerable groups, Dr. Amal Trivedi, the study’s lead author, said in an interview.

"Even in a system that’s achieved really significant quality gains, there are still disparities that need to be addressed," said Dr. Trivedi, a research investigator at the Providence VA Medical Center and an assistant professor of community health at Brown University in Providence, R.I.

One of the most surprising findings, according to the researchers, was that the disparities weren’t a result of black veterans receiving care at lower-quality facilities. Instead, the greatest differences in care were noted when black and white veterans were treated in the same hospital.

In the study, researchers measured performance indicators for 1,126,254 veterans (955,047 white; 171,207 black). Researchers also compared clinical outcomes to process-of-care indicators such as screening measures (Health Aff. 2011;30:707-15). Patients were separated on the basis of sex, age, census region, and socioeconomic status.

Black veterans, on average, were younger, less educated, of low socioeconomic status, and from the Southern region. With the exception of mammography, performance rates notably improved for both racial groups. However, clinical outcomes for black veterans lagged behind those for white veterans in a few areas. For example, on measures of cardiovascular care, there was an 8.3% difference between outcomes for white veterans and black veterans on LDL control. Under the diabetes care measures, there was a 5.8% difference in HbA_1c control and a 6.8% difference in LDL control between blacks and whites. Under the hypertension measure, there was a 5.8% difference in blood pressure control.

These findings are consistent with the results of previous studies showing racial disparities in glucose, blood pressure, and cholesterol control, according to Dr. Trivedi. These findings are a cry for consistency of care and standardized treatment protocols, the researchers said.

The study results were limited to VA services only. The researchers did not assess possible disparities among other ethnicities or examine the impact of other possible contributing factors, such as lifestyle modifications or comorbid medical conditions.

The research was funded in part by the Department of Veterans Affairs and the Robert Wood Johnson Foundation.

Despite efforts to improve the quality of care in the Department of Veterans Affairs health system, racial disparities remain for certain conditions, according to a study published in the April issue of Health Affairs .

Clinical outcomes for glucose control, low-density lipoprotein control, and blood pressure showed the greatest degree of disparity between black and white veterans. Researchers based their findings on quality data from the VA’s External Peer Review Program from 2000 to 2009. The study examined disparities following a major reorganization of the VA health system and a push for quality improvement in the late 1990s.

The results highlight the need for the VA to routinely track clinical outcomes for vulnerable groups, Dr. Amal Trivedi, the study’s lead author, said in an interview.

"Even in a system that’s achieved really significant quality gains, there are still disparities that need to be addressed," said Dr. Trivedi, a research investigator at the Providence VA Medical Center and an assistant professor of community health at Brown University in Providence, R.I.

One of the most surprising findings, according to the researchers, was that the disparities weren’t a result of black veterans receiving care at lower-quality facilities. Instead, the greatest differences in care were noted when black and white veterans were treated in the same hospital.

In the study, researchers measured performance indicators for 1,126,254 veterans (955,047 white; 171,207 black). Researchers also compared clinical outcomes to process-of-care indicators such as screening measures (Health Aff. 2011;30:707-15). Patients were separated on the basis of sex, age, census region, and socioeconomic status.

Black veterans, on average, were younger, less educated, of low socioeconomic status, and from the Southern region. With the exception of mammography, performance rates notably improved for both racial groups. However, clinical outcomes for black veterans lagged behind those for white veterans in a few areas. For example, on measures of cardiovascular care, there was an 8.3% difference between outcomes for white veterans and black veterans on LDL control. Under the diabetes care measures, there was a 5.8% difference in HbA_1c control and a 6.8% difference in LDL control between blacks and whites. Under the hypertension measure, there was a 5.8% difference in blood pressure control.

These findings are consistent with the results of previous studies showing racial disparities in glucose, blood pressure, and cholesterol control, according to Dr. Trivedi. These findings are a cry for consistency of care and standardized treatment protocols, the researchers said.

The study results were limited to VA services only. The researchers did not assess possible disparities among other ethnicities or examine the impact of other possible contributing factors, such as lifestyle modifications or comorbid medical conditions.

The research was funded in part by the Department of Veterans Affairs and the Robert Wood Johnson Foundation.

Despite efforts to improve the quality of care in the Department of Veterans Affairs health system, racial disparities remain for certain conditions, according to a study published in the April issue of Health Affairs .

Clinical outcomes for glucose control, low-density lipoprotein control, and blood pressure showed the greatest degree of disparity between black and white veterans. Researchers based their findings on quality data from the VA’s External Peer Review Program from 2000 to 2009. The study examined disparities following a major reorganization of the VA health system and a push for quality improvement in the late 1990s.

The results highlight the need for the VA to routinely track clinical outcomes for vulnerable groups, Dr. Amal Trivedi, the study’s lead author, said in an interview.

"Even in a system that’s achieved really significant quality gains, there are still disparities that need to be addressed," said Dr. Trivedi, a research investigator at the Providence VA Medical Center and an assistant professor of community health at Brown University in Providence, R.I.

One of the most surprising findings, according to the researchers, was that the disparities weren’t a result of black veterans receiving care at lower-quality facilities. Instead, the greatest differences in care were noted when black and white veterans were treated in the same hospital.

In the study, researchers measured performance indicators for 1,126,254 veterans (955,047 white; 171,207 black). Researchers also compared clinical outcomes to process-of-care indicators such as screening measures (Health Aff. 2011;30:707-15). Patients were separated on the basis of sex, age, census region, and socioeconomic status.

Black veterans, on average, were younger, less educated, of low socioeconomic status, and from the Southern region. With the exception of mammography, performance rates notably improved for both racial groups. However, clinical outcomes for black veterans lagged behind those for white veterans in a few areas. For example, on measures of cardiovascular care, there was an 8.3% difference between outcomes for white veterans and black veterans on LDL control. Under the diabetes care measures, there was a 5.8% difference in HbA_1c control and a 6.8% difference in LDL control between blacks and whites. Under the hypertension measure, there was a 5.8% difference in blood pressure control.

These findings are consistent with the results of previous studies showing racial disparities in glucose, blood pressure, and cholesterol control, according to Dr. Trivedi. These findings are a cry for consistency of care and standardized treatment protocols, the researchers said.

The study results were limited to VA services only. The researchers did not assess possible disparities among other ethnicities or examine the impact of other possible contributing factors, such as lifestyle modifications or comorbid medical conditions.

The research was funded in part by the Department of Veterans Affairs and the Robert Wood Johnson Foundation.

Despite efforts to improve the quality of care in the Department of Veterans Affairs health system, racial disparities remain for certain conditions, according to a study published in the April issue of Health Affairs .

Clinical outcomes for glucose control, low-density lipoprotein control, and blood pressure showed the greatest degree of disparity between black and white veterans. Researchers based their findings on quality data from the VA’s External Peer Review Program from 2000 to 2009. The study examined disparities following a major reorganization of the VA health system and a push for quality improvement in the late 1990s.

The results highlight the need for the VA to routinely track clinical outcomes for vulnerable groups, Dr. Amal Trivedi, the study’s lead author, said in an interview.

"Even in a system that’s achieved really significant quality gains, there are still disparities that need to be addressed," said Dr. Trivedi, a research investigator at the Providence VA Medical Center and an assistant professor of community health at Brown University in Providence, R.I.

One of the most surprising findings, according to the researchers, was that the disparities weren’t a result of black veterans receiving care at lower-quality facilities. Instead, the greatest differences in care were noted when black and white veterans were treated in the same hospital.

In the study, researchers measured performance indicators for 1,126,254 veterans (955,047 white; 171,207 black). Researchers also compared clinical outcomes to process-of-care indicators such as screening measures (Health Aff. 2011;30:707-15). Patients were separated on the basis of sex, age, census region, and socioeconomic status.

Black veterans, on average, were younger, less educated, of low socioeconomic status, and from the Southern region. With the exception of mammography, performance rates notably improved for both racial groups. However, clinical outcomes for black veterans lagged behind those for white veterans in a few areas. For example, on measures of cardiovascular care, there was an 8.3% difference between outcomes for white veterans and black veterans on LDL control. Under the diabetes care measures, there was a 5.8% difference in HbA_1c control and a 6.8% difference in LDL control between blacks and whites. Under the hypertension measure, there was a 5.8% difference in blood pressure control.

These findings are consistent with the results of previous studies showing racial disparities in glucose, blood pressure, and cholesterol control, according to Dr. Trivedi. These findings are a cry for consistency of care and standardized treatment protocols, the researchers said.

The study results were limited to VA services only. The researchers did not assess possible disparities among other ethnicities or examine the impact of other possible contributing factors, such as lifestyle modifications or comorbid medical conditions.

The research was funded in part by the Department of Veterans Affairs and the Robert Wood Johnson Foundation.

Despite efforts to improve the quality of care in the Department of Veterans Affairs health system, racial disparities remain for certain conditions, according to a study published in the April issue of Health Affairs .

Clinical outcomes for glucose control, low-density lipoprotein control, and blood pressure showed the greatest degree of disparity between black and white veterans. Researchers based their findings on quality data from the VA’s External Peer Review Program from 2000 to 2009. The study examined disparities following a major reorganization of the VA health system and a push for quality improvement in the late 1990s.

The results highlight the need for the VA to routinely track clinical outcomes for vulnerable groups, Dr. Amal Trivedi, the study’s lead author, said in an interview.

"Even in a system that’s achieved really significant quality gains, there are still disparities that need to be addressed," said Dr. Trivedi, a research investigator at the Providence VA Medical Center and an assistant professor of community health at Brown University in Providence, R.I.

One of the most surprising findings, according to the researchers, was that the disparities weren’t a result of black veterans receiving care at lower-quality facilities. Instead, the greatest differences in care were noted when black and white veterans were treated in the same hospital.

In the study, researchers measured performance indicators for 1,126,254 veterans (955,047 white; 171,207 black). Researchers also compared clinical outcomes to process-of-care indicators such as screening measures (Health Aff. 2011;30:707-15). Patients were separated on the basis of sex, age, census region, and socioeconomic status.

Black veterans, on average, were younger, less educated, of low socioeconomic status, and from the Southern region. With the exception of mammography, performance rates notably improved for both racial groups. However, clinical outcomes for black veterans lagged behind those for white veterans in a few areas. For example, on measures of cardiovascular care, there was an 8.3% difference between outcomes for white veterans and black veterans on LDL control. Under the diabetes care measures, there was a 5.8% difference in HbA_1c control and a 6.8% difference in LDL control between blacks and whites. Under the hypertension measure, there was a 5.8% difference in blood pressure control.

These findings are consistent with the results of previous studies showing racial disparities in glucose, blood pressure, and cholesterol control, according to Dr. Trivedi. These findings are a cry for consistency of care and standardized treatment protocols, the researchers said.

The study results were limited to VA services only. The researchers did not assess possible disparities among other ethnicities or examine the impact of other possible contributing factors, such as lifestyle modifications or comorbid medical conditions.

The research was funded in part by the Department of Veterans Affairs and the Robert Wood Johnson Foundation.

Despite efforts to improve the quality of care in the Department of Veterans Affairs health system, racial disparities remain for certain conditions, according to a study published in the April issue of Health Affairs .

Clinical outcomes for glucose control, low-density lipoprotein control, and blood pressure showed the greatest degree of disparity between black and white veterans. Researchers based their findings on quality data from the VA’s External Peer Review Program from 2000 to 2009. The study examined disparities following a major reorganization of the VA health system and a push for quality improvement in the late 1990s.

The results highlight the need for the VA to routinely track clinical outcomes for vulnerable groups, Dr. Amal Trivedi, the study’s lead author, said in an interview.

"Even in a system that’s achieved really significant quality gains, there are still disparities that need to be addressed," said Dr. Trivedi, a research investigator at the Providence VA Medical Center and an assistant professor of community health at Brown University in Providence, R.I.

One of the most surprising findings, according to the researchers, was that the disparities weren’t a result of black veterans receiving care at lower-quality facilities. Instead, the greatest differences in care were noted when black and white veterans were treated in the same hospital.

In the study, researchers measured performance indicators for 1,126,254 veterans (955,047 white; 171,207 black). Researchers also compared clinical outcomes to process-of-care indicators such as screening measures (Health Aff. 2011;30:707-15). Patients were separated on the basis of sex, age, census region, and socioeconomic status.

Black veterans, on average, were younger, less educated, of low socioeconomic status, and from the Southern region. With the exception of mammography, performance rates notably improved for both racial groups. However, clinical outcomes for black veterans lagged behind those for white veterans in a few areas. For example, on measures of cardiovascular care, there was an 8.3% difference between outcomes for white veterans and black veterans on LDL control. Under the diabetes care measures, there was a 5.8% difference in HbA_1c control and a 6.8% difference in LDL control between blacks and whites. Under the hypertension measure, there was a 5.8% difference in blood pressure control.

These findings are consistent with the results of previous studies showing racial disparities in glucose, blood pressure, and cholesterol control, according to Dr. Trivedi. These findings are a cry for consistency of care and standardized treatment protocols, the researchers said.

The study results were limited to VA services only. The researchers did not assess possible disparities among other ethnicities or examine the impact of other possible contributing factors, such as lifestyle modifications or comorbid medical conditions.

The research was funded in part by the Department of Veterans Affairs and the Robert Wood Johnson Foundation.