Alicia Ault

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what's known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system also could help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said patients should not have to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Overall, 85% of errors are due to systems issues; only 15% are competency-related, so solutions should focus on systems design, Dr. O'Leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides—the top category—and surgical misadventures, the number two category, Dr. O'Leary said. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

Several states have looked at or adopted “I'm sorry” statutes to address malpractice. Under the 2003 law, physicians can apologize, admit fault, and explain the cause of an error without it being held against them in court. The law has reduced the number of cases going to trial in Colorado.

So far, 2,835 of the 6,000 physicians covered by the COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a legislative consultant to the company. Participating physicians have had at least 3,200 discussions with patients, and in about 2,000 cases, the discussion was all that was needed to close the case, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, Mr. Dikeou said. Of 116 cases that went to court, 54 cases were closed without payment and without attorney involvement. Six cases were closed with payment, 40 are still open, and 16 have gone to trial.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what's known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system also could help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said patients should not have to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Overall, 85% of errors are due to systems issues; only 15% are competency-related, so solutions should focus on systems design, Dr. O'Leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides—the top category—and surgical misadventures, the number two category, Dr. O'Leary said. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

Several states have looked at or adopted “I'm sorry” statutes to address malpractice. Under the 2003 law, physicians can apologize, admit fault, and explain the cause of an error without it being held against them in court. The law has reduced the number of cases going to trial in Colorado.

So far, 2,835 of the 6,000 physicians covered by the COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a legislative consultant to the company. Participating physicians have had at least 3,200 discussions with patients, and in about 2,000 cases, the discussion was all that was needed to close the case, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, Mr. Dikeou said. Of 116 cases that went to court, 54 cases were closed without payment and without attorney involvement. Six cases were closed with payment, 40 are still open, and 16 have gone to trial.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what's known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system also could help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said patients should not have to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Overall, 85% of errors are due to systems issues; only 15% are competency-related, so solutions should focus on systems design, Dr. O'Leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides—the top category—and surgical misadventures, the number two category, Dr. O'Leary said. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

Several states have looked at or adopted “I'm sorry” statutes to address malpractice. Under the 2003 law, physicians can apologize, admit fault, and explain the cause of an error without it being held against them in court. The law has reduced the number of cases going to trial in Colorado.

So far, 2,835 of the 6,000 physicians covered by the COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a legislative consultant to the company. Participating physicians have had at least 3,200 discussions with patients, and in about 2,000 cases, the discussion was all that was needed to close the case, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, Mr. Dikeou said. Of 116 cases that went to court, 54 cases were closed without payment and without attorney involvement. Six cases were closed with payment, 40 are still open, and 16 have gone to trial.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the "health court" concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was "avoidable" or "preventable" (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, and decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said that patients should not be required to start the claims process, as is proposed. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Overall, 85% of errors are due to systems issues; only 15% are competency related, so solutions should focus on systems design, Dr. O'Leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides—the top category—and surgical misadventures, the number two category, Dr. O'Leary said.

Several states have looked at or adopted "I'm sorry" statutes to address malpractice. Under the 2003 law, physicians can apologize, admit fault, and explain the cause of an error without it being held against them in court. The law has reduced the number of cases going to trial in Colorado.

So far, 2,835 of the 6,000 physicians covered by COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a consultant to the company. Participating physicians have had at least 3,200 discussions with patients, and in about 2,000 cases, the discussion was all that was needed to close the case, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, Mr. Dikeou said. Of 116 cases that went to court, 54 were closed without payment and without attorney involvement.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the "health court" concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was "avoidable" or "preventable" (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, and decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said that patients should not be required to start the claims process, as is proposed. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Overall, 85% of errors are due to systems issues; only 15% are competency related, so solutions should focus on systems design, Dr. O'Leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides—the top category—and surgical misadventures, the number two category, Dr. O'Leary said.

Several states have looked at or adopted "I'm sorry" statutes to address malpractice. Under the 2003 law, physicians can apologize, admit fault, and explain the cause of an error without it being held against them in court. The law has reduced the number of cases going to trial in Colorado.

So far, 2,835 of the 6,000 physicians covered by COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a consultant to the company. Participating physicians have had at least 3,200 discussions with patients, and in about 2,000 cases, the discussion was all that was needed to close the case, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, Mr. Dikeou said. Of 116 cases that went to court, 54 were closed without payment and without attorney involvement.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the "health court" concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was "avoidable" or "preventable" (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, and decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said that patients should not be required to start the claims process, as is proposed. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Overall, 85% of errors are due to systems issues; only 15% are competency related, so solutions should focus on systems design, Dr. O'Leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides—the top category—and surgical misadventures, the number two category, Dr. O'Leary said.

Several states have looked at or adopted "I'm sorry" statutes to address malpractice. Under the 2003 law, physicians can apologize, admit fault, and explain the cause of an error without it being held against them in court. The law has reduced the number of cases going to trial in Colorado.

So far, 2,835 of the 6,000 physicians covered by COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a consultant to the company. Participating physicians have had at least 3,200 discussions with patients, and in about 2,000 cases, the discussion was all that was needed to close the case, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, Mr. Dikeou said. Of 116 cases that went to court, 54 were closed without payment and without attorney involvement.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), who has been one of Dr. von Eschenbach's most vocal critics. As chairman of the Finance Committee, he and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. "I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch," the senator said.

FDA Warns on Topical Anesthetics

FDA is warning that topical anesthetics being compounded by five manufacturers may contain high-potency lidocaine, tetracaine, benzocaine, and prilocaine. Patients may experience seizure, irregular heartbeat, and even death when exposed to the agents for long periods or over broad skin areas. Small children and patients with heart disease or severe liver disease are most at risk, said the FDA. Because the drugs are compounded, they are not reviewed by the FDA for safety or effectiveness. However, the five companies—Triangle Compounding Pharmacy, Custom Scripts Pharmacy, Hal's Compounding Pharmacy, University Pharmacy, and New England Compounding Center—are acting like drug makers, because they are compounding standardized versions of FDA-approved and commercially available anesthetics for general distribution, rather than formulating them to meet individuals' needs, said the agency. Two deaths have been connected to anesthetics compounded by Triangle and University, said the FDA. It said its warning should serve as a caution to other companies compounding standardized anesthetic creams. The topical anesthetics are often used as a numbing agent before laser hair removal, tattooing, and skin treatments.

Public NPI Directory Possible

The Centers for Medicare and Medicaid Services is considering publishing a directory of physicians who have National Provider Identifiers. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated that all providers who submit claims or conduct other transactions subject to the law must have an NPI by May 23, 2007. However, the law did not allow for a directory of NPI providers to be published. Physicians have said that such a directory helps facilitate referrals. Medicare's Practicing Physicians Advisory Council has endorsed the idea of publishing a directory. At a PPAC meeting in December, Dr. William Rogers, director of the Physicians Regulatory Issues Team at CMS, said that the agency agreed and that it would pursue development of an online directory for physicians and their office staff.

Poll: No Off-Label Use

About half of Americans said physicians should not be allowed to prescribe pharmaceuticals for unapproved uses, according to a recent

WSJ.com/Harris

Medicare Advantage Costs More

If the incoming Democrat Congress is looking for funding to expand the Medicare drug benefit, Medicare Advantage may be a ripe target, according to an analysis from the Commonwealth Fund. Researchers at the Commonwealth Fund estimate that in 2005 the federal government paid private Medicare managed care plans, known as Medicare Advantage plans, an average of $922 more per enrollee than comparable beneficiaries would cost under the traditional fee-for-service program, for a total of $5.2 billion. "Medicare should carefully examine whether extra payments to Medicare Advantage plans are the best use of dollars," Commonwealth Fund President Karen Davis said in a statement.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), who has been one of Dr. von Eschenbach's most vocal critics. As chairman of the Finance Committee, he and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. "I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch," the senator said.

FDA Warns on Topical Anesthetics

FDA is warning that topical anesthetics being compounded by five manufacturers may contain high-potency lidocaine, tetracaine, benzocaine, and prilocaine. Patients may experience seizure, irregular heartbeat, and even death when exposed to the agents for long periods or over broad skin areas. Small children and patients with heart disease or severe liver disease are most at risk, said the FDA. Because the drugs are compounded, they are not reviewed by the FDA for safety or effectiveness. However, the five companies—Triangle Compounding Pharmacy, Custom Scripts Pharmacy, Hal's Compounding Pharmacy, University Pharmacy, and New England Compounding Center—are acting like drug makers, because they are compounding standardized versions of FDA-approved and commercially available anesthetics for general distribution, rather than formulating them to meet individuals' needs, said the agency. Two deaths have been connected to anesthetics compounded by Triangle and University, said the FDA. It said its warning should serve as a caution to other companies compounding standardized anesthetic creams. The topical anesthetics are often used as a numbing agent before laser hair removal, tattooing, and skin treatments.

Public NPI Directory Possible

The Centers for Medicare and Medicaid Services is considering publishing a directory of physicians who have National Provider Identifiers. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated that all providers who submit claims or conduct other transactions subject to the law must have an NPI by May 23, 2007. However, the law did not allow for a directory of NPI providers to be published. Physicians have said that such a directory helps facilitate referrals. Medicare's Practicing Physicians Advisory Council has endorsed the idea of publishing a directory. At a PPAC meeting in December, Dr. William Rogers, director of the Physicians Regulatory Issues Team at CMS, said that the agency agreed and that it would pursue development of an online directory for physicians and their office staff.

Poll: No Off-Label Use

About half of Americans said physicians should not be allowed to prescribe pharmaceuticals for unapproved uses, according to a recent

WSJ.com/Harris

Medicare Advantage Costs More

If the incoming Democrat Congress is looking for funding to expand the Medicare drug benefit, Medicare Advantage may be a ripe target, according to an analysis from the Commonwealth Fund. Researchers at the Commonwealth Fund estimate that in 2005 the federal government paid private Medicare managed care plans, known as Medicare Advantage plans, an average of $922 more per enrollee than comparable beneficiaries would cost under the traditional fee-for-service program, for a total of $5.2 billion. "Medicare should carefully examine whether extra payments to Medicare Advantage plans are the best use of dollars," Commonwealth Fund President Karen Davis said in a statement.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), who has been one of Dr. von Eschenbach's most vocal critics. As chairman of the Finance Committee, he and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. "I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch," the senator said.

FDA Warns on Topical Anesthetics

FDA is warning that topical anesthetics being compounded by five manufacturers may contain high-potency lidocaine, tetracaine, benzocaine, and prilocaine. Patients may experience seizure, irregular heartbeat, and even death when exposed to the agents for long periods or over broad skin areas. Small children and patients with heart disease or severe liver disease are most at risk, said the FDA. Because the drugs are compounded, they are not reviewed by the FDA for safety or effectiveness. However, the five companies—Triangle Compounding Pharmacy, Custom Scripts Pharmacy, Hal's Compounding Pharmacy, University Pharmacy, and New England Compounding Center—are acting like drug makers, because they are compounding standardized versions of FDA-approved and commercially available anesthetics for general distribution, rather than formulating them to meet individuals' needs, said the agency. Two deaths have been connected to anesthetics compounded by Triangle and University, said the FDA. It said its warning should serve as a caution to other companies compounding standardized anesthetic creams. The topical anesthetics are often used as a numbing agent before laser hair removal, tattooing, and skin treatments.

Public NPI Directory Possible

The Centers for Medicare and Medicaid Services is considering publishing a directory of physicians who have National Provider Identifiers. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated that all providers who submit claims or conduct other transactions subject to the law must have an NPI by May 23, 2007. However, the law did not allow for a directory of NPI providers to be published. Physicians have said that such a directory helps facilitate referrals. Medicare's Practicing Physicians Advisory Council has endorsed the idea of publishing a directory. At a PPAC meeting in December, Dr. William Rogers, director of the Physicians Regulatory Issues Team at CMS, said that the agency agreed and that it would pursue development of an online directory for physicians and their office staff.

Poll: No Off-Label Use

About half of Americans said physicians should not be allowed to prescribe pharmaceuticals for unapproved uses, according to a recent

WSJ.com/Harris

Medicare Advantage Costs More

If the incoming Democrat Congress is looking for funding to expand the Medicare drug benefit, Medicare Advantage may be a ripe target, according to an analysis from the Commonwealth Fund. Researchers at the Commonwealth Fund estimate that in 2005 the federal government paid private Medicare managed care plans, known as Medicare Advantage plans, an average of $922 more per enrollee than comparable beneficiaries would cost under the traditional fee-for-service program, for a total of $5.2 billion. "Medicare should carefully examine whether extra payments to Medicare Advantage plans are the best use of dollars," Commonwealth Fund President Karen Davis said in a statement.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what is known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said that patients should not be required to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Overall, 85% of errors are due to systems issues; only 15% are competency-related, so solutions should focus on systems design, Dr. O'leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides, which is the top category, and surgical misadventures, the number two category, Dr. O'Leary said. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

Several states have looked at or adopted “I'm sorry” statutes to address malpractice. Under the 2003 law, physicians can apologize, admit fault, and explain the cause of an error without it being held against them in court. The law has reduced the number of cases going to trial in Colorado.

So far, 2,835 of the 6,000 physicians covered by the COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a legislative consultant to the company. Participating physicians have had at least 3,200 discussions with patients, and in about 2,000 cases, the discussion was all that was needed to close the case, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, Mr. Dikeou said. Of 116 cases that went to court, 54 cases were closed without payment and without attorney involvement. Six cases were closed with payment, 40 are still open, and 16 have gone to trial.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what is known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said that patients should not be required to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Overall, 85% of errors are due to systems issues; only 15% are competency-related, so solutions should focus on systems design, Dr. O'leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides, which is the top category, and surgical misadventures, the number two category, Dr. O'Leary said. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

Several states have looked at or adopted “I'm sorry” statutes to address malpractice. Under the 2003 law, physicians can apologize, admit fault, and explain the cause of an error without it being held against them in court. The law has reduced the number of cases going to trial in Colorado.

So far, 2,835 of the 6,000 physicians covered by the COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a legislative consultant to the company. Participating physicians have had at least 3,200 discussions with patients, and in about 2,000 cases, the discussion was all that was needed to close the case, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, Mr. Dikeou said. Of 116 cases that went to court, 54 cases were closed without payment and without attorney involvement. Six cases were closed with payment, 40 are still open, and 16 have gone to trial.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what is known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said that patients should not be required to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Overall, 85% of errors are due to systems issues; only 15% are competency-related, so solutions should focus on systems design, Dr. O'leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides, which is the top category, and surgical misadventures, the number two category, Dr. O'Leary said. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

Several states have looked at or adopted “I'm sorry” statutes to address malpractice. Under the 2003 law, physicians can apologize, admit fault, and explain the cause of an error without it being held against them in court. The law has reduced the number of cases going to trial in Colorado.

So far, 2,835 of the 6,000 physicians covered by the COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a legislative consultant to the company. Participating physicians have had at least 3,200 discussions with patients, and in about 2,000 cases, the discussion was all that was needed to close the case, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, Mr. Dikeou said. Of 116 cases that went to court, 54 cases were closed without payment and without attorney involvement. Six cases were closed with payment, 40 are still open, and 16 have gone to trial.

WASHINGTON — Patients who read at or below the 6th-grade level had a low level of comprehension of instructions on the labels of five commonly used medications, according to a study led by Terry Davis, Ph.D., of the Louisiana State University.

Even though labels seem short and to the point, “many patients need more specific, concrete information,” including instructions on exactly what time of day to take a medication, Ms. Davis said in presenting the findings at a conference on health literacy sponsored by the American College of Physicians.

Along with colleagues at Northwestern University, the University of North Carolina, Western Michigan Area Health Education Center, and Emory University, she queried 395 patients at three clinics that primarily serve the indigent about their understanding of labels for the following drugs: amoxicillin for pediatric use, trimethoprim, guaifenesin, felodipine, and furosemide.

The study was published online at the Annals of Internal Medicine Web site (www.annals.org/cgi/content/full/0000605-200612190-00144v1

The goal was to determine whether primary care patients could read and correctly state how to take medicines after reading the labels on actual pill bottles, Ms. Davis said. The researchers hypothesized that patients with low literacy were more likely to misunderstand instructions. They also believed that the increasing number of medications taken by Americans is leading to growing confusion and medication errors.

Participants spoke English as a primary language and were not hearing or vision impaired. Half were African American and half were white. The mean age was 45 years, and 29% had a less than high school education. Literacy was assessed with the Rapid Estimate of Adult Literacy in Medicine (REALM) test. Of the 395 patients, 19% (75) were deemed to have low literacy, reading at or below a 6th grade level, and 29% (114) had marginal literacy, reading at the 7th- to 8th-grade level.

All patients were asked how they would take the medicine. A “correct” answer was given if they included all aspects of the label instruction, including dosage, timing, and duration. Overall, 47% (185) of patients misunderstood at least one of the instructions. For marginal literacy patients, 51% (201) misunderstood one or more instructions, and for low literacy patients, 63% (249) misunderstood.

The majority—91%, or 359 patients—understood the felodipine instructions, which were, “Take one tablet by mouth once each day.” The lowest level of comprehension was for trimethoprim, which had a label instructing to “take one tablet by mouth twice daily for seven days.”

Higher literacy patients routinely understood instructions better than those with lower literacy, Ms. Davis said. The adjusted odds ratio of misunderstanding for low literacy was 2.32, and for marginal literacy, 1.94. Most misunderstandings had to do with dosage. For instance, patients commonly believed they should give children a tablespoon instead of a teaspoon of amoxicillin.

Patients who took more medications were also more likely to misunderstand labels, with the adjusted relative risk rising from 2.29 for 1–2 medications to 2.98 for 5 or more medications.

In a substudy, patients were tested on their understanding of the instruction, “Take two tablets by mouth twice daily,” on a bottle of guaifenesin. Overall, 84% were able to correctly state the instruction, but fewer patients knew how many pills to take. Among those with adequate literacy, 80% counted out the correct number of pills. That ability decreased with declining literacy: 63% of marginal literacy patients and 35% of those with low literacy could correctly count pills. Ms. Davis and her colleagues said that although this may have reflected patients' numeracy skills more than reading skills, numeracy is an aspect of literacy.

Study limitations included the fact that the authors only examined understanding of the primary label. They did not assess patients' actual compliance or drug-taking behavior, whether medication errors occurred, or if any of the patients had experience with any of the five medications.

In an editorial accompanying Ms. Davis' study (www.annals.org/cgi/content/full/0000605-200612190-00145v1

But that “does not weaken the conclusion that many patients do not comprehend prescription labels and cannot act on their instructions,” added Dr. Schillinger, of the University of California, San Francisco.

WASHINGTON — Patients who read at or below the 6th-grade level had a low level of comprehension of instructions on the labels of five commonly used medications, according to a study led by Terry Davis, Ph.D., of the Louisiana State University.

Even though labels seem short and to the point, “many patients need more specific, concrete information,” including instructions on exactly what time of day to take a medication, Ms. Davis said in presenting the findings at a conference on health literacy sponsored by the American College of Physicians.

Along with colleagues at Northwestern University, the University of North Carolina, Western Michigan Area Health Education Center, and Emory University, she queried 395 patients at three clinics that primarily serve the indigent about their understanding of labels for the following drugs: amoxicillin for pediatric use, trimethoprim, guaifenesin, felodipine, and furosemide.

The study was published online at the Annals of Internal Medicine Web site (www.annals.org/cgi/content/full/0000605-200612190-00144v1

The goal was to determine whether primary care patients could read and correctly state how to take medicines after reading the labels on actual pill bottles, Ms. Davis said. The researchers hypothesized that patients with low literacy were more likely to misunderstand instructions. They also believed that the increasing number of medications taken by Americans is leading to growing confusion and medication errors.

Participants spoke English as a primary language and were not hearing or vision impaired. Half were African American and half were white. The mean age was 45 years, and 29% had a less than high school education. Literacy was assessed with the Rapid Estimate of Adult Literacy in Medicine (REALM) test. Of the 395 patients, 19% (75) were deemed to have low literacy, reading at or below a 6th grade level, and 29% (114) had marginal literacy, reading at the 7th- to 8th-grade level.

All patients were asked how they would take the medicine. A “correct” answer was given if they included all aspects of the label instruction, including dosage, timing, and duration. Overall, 47% (185) of patients misunderstood at least one of the instructions. For marginal literacy patients, 51% (201) misunderstood one or more instructions, and for low literacy patients, 63% (249) misunderstood.

The majority—91%, or 359 patients—understood the felodipine instructions, which were, “Take one tablet by mouth once each day.” The lowest level of comprehension was for trimethoprim, which had a label instructing to “take one tablet by mouth twice daily for seven days.”

Higher literacy patients routinely understood instructions better than those with lower literacy, Ms. Davis said. The adjusted odds ratio of misunderstanding for low literacy was 2.32, and for marginal literacy, 1.94. Most misunderstandings had to do with dosage. For instance, patients commonly believed they should give children a tablespoon instead of a teaspoon of amoxicillin.

Patients who took more medications were also more likely to misunderstand labels, with the adjusted relative risk rising from 2.29 for 1–2 medications to 2.98 for 5 or more medications.

In a substudy, patients were tested on their understanding of the instruction, “Take two tablets by mouth twice daily,” on a bottle of guaifenesin. Overall, 84% were able to correctly state the instruction, but fewer patients knew how many pills to take. Among those with adequate literacy, 80% counted out the correct number of pills. That ability decreased with declining literacy: 63% of marginal literacy patients and 35% of those with low literacy could correctly count pills. Ms. Davis and her colleagues said that although this may have reflected patients' numeracy skills more than reading skills, numeracy is an aspect of literacy.

Study limitations included the fact that the authors only examined understanding of the primary label. They did not assess patients' actual compliance or drug-taking behavior, whether medication errors occurred, or if any of the patients had experience with any of the five medications.

In an editorial accompanying Ms. Davis' study (www.annals.org/cgi/content/full/0000605-200612190-00145v1

But that “does not weaken the conclusion that many patients do not comprehend prescription labels and cannot act on their instructions,” added Dr. Schillinger, of the University of California, San Francisco.

WASHINGTON — Patients who read at or below the 6th-grade level had a low level of comprehension of instructions on the labels of five commonly used medications, according to a study led by Terry Davis, Ph.D., of the Louisiana State University.

Even though labels seem short and to the point, “many patients need more specific, concrete information,” including instructions on exactly what time of day to take a medication, Ms. Davis said in presenting the findings at a conference on health literacy sponsored by the American College of Physicians.

Along with colleagues at Northwestern University, the University of North Carolina, Western Michigan Area Health Education Center, and Emory University, she queried 395 patients at three clinics that primarily serve the indigent about their understanding of labels for the following drugs: amoxicillin for pediatric use, trimethoprim, guaifenesin, felodipine, and furosemide.

The study was published online at the Annals of Internal Medicine Web site (www.annals.org/cgi/content/full/0000605-200612190-00144v1

The goal was to determine whether primary care patients could read and correctly state how to take medicines after reading the labels on actual pill bottles, Ms. Davis said. The researchers hypothesized that patients with low literacy were more likely to misunderstand instructions. They also believed that the increasing number of medications taken by Americans is leading to growing confusion and medication errors.

Participants spoke English as a primary language and were not hearing or vision impaired. Half were African American and half were white. The mean age was 45 years, and 29% had a less than high school education. Literacy was assessed with the Rapid Estimate of Adult Literacy in Medicine (REALM) test. Of the 395 patients, 19% (75) were deemed to have low literacy, reading at or below a 6th grade level, and 29% (114) had marginal literacy, reading at the 7th- to 8th-grade level.

All patients were asked how they would take the medicine. A “correct” answer was given if they included all aspects of the label instruction, including dosage, timing, and duration. Overall, 47% (185) of patients misunderstood at least one of the instructions. For marginal literacy patients, 51% (201) misunderstood one or more instructions, and for low literacy patients, 63% (249) misunderstood.

The majority—91%, or 359 patients—understood the felodipine instructions, which were, “Take one tablet by mouth once each day.” The lowest level of comprehension was for trimethoprim, which had a label instructing to “take one tablet by mouth twice daily for seven days.”

Higher literacy patients routinely understood instructions better than those with lower literacy, Ms. Davis said. The adjusted odds ratio of misunderstanding for low literacy was 2.32, and for marginal literacy, 1.94. Most misunderstandings had to do with dosage. For instance, patients commonly believed they should give children a tablespoon instead of a teaspoon of amoxicillin.

Patients who took more medications were also more likely to misunderstand labels, with the adjusted relative risk rising from 2.29 for 1–2 medications to 2.98 for 5 or more medications.

In a substudy, patients were tested on their understanding of the instruction, “Take two tablets by mouth twice daily,” on a bottle of guaifenesin. Overall, 84% were able to correctly state the instruction, but fewer patients knew how many pills to take. Among those with adequate literacy, 80% counted out the correct number of pills. That ability decreased with declining literacy: 63% of marginal literacy patients and 35% of those with low literacy could correctly count pills. Ms. Davis and her colleagues said that although this may have reflected patients' numeracy skills more than reading skills, numeracy is an aspect of literacy.

Study limitations included the fact that the authors only examined understanding of the primary label. They did not assess patients' actual compliance or drug-taking behavior, whether medication errors occurred, or if any of the patients had experience with any of the five medications.

In an editorial accompanying Ms. Davis' study (www.annals.org/cgi/content/full/0000605-200612190-00145v1

But that “does not weaken the conclusion that many patients do not comprehend prescription labels and cannot act on their instructions,” added Dr. Schillinger, of the University of California, San Francisco.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), one of Dr. von Eschenbach's most vocal critics. As Finance Committee chairman, Sen. Grassley and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. “I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch,” the senator said.

AMA Joins Washington Lawsuit

The American Medical Association has joined six Washington state physicians and the Washington State Medical Association in a lawsuit against Regence BlueShield asserting that the insurer used faulty internal quality data in excluding nearly 500 physicians from a new network that Regence is developing. “This lawsuit has repercussions far beyond Washington state as more health insurers impose financial disincentives which threaten to disrupt patients' long-standing relationships with physicians they know and trust,” AMA Past President Edward J. Hill commented in a statement. The lawsuit, filed Sept. 21, stems from Regence's decision to create a “select network” of physicians who deliver “high quality, efficient care” to serve mainly Boeing Co. engineers. The lawsuit contends that the methodology Regence used to calculate performance failed to consider the population of patients seen by the physicians, used small samples and inaccurate records, and included patients who should have been excluded “because of their personal medical histories.”

Med School Enrollment on Rise

The Association of American Medical Colleges reports that U.S. medical school enrollment for 2006 increased by just over 2% to 17,370. Some schools posted even greater gains, among them: Florida State University (36% increase), Brown University (25%), Boston University (15%), Saint Louis University (15%), Pennsylvania State University (13%), Wayne State University (11%), West Virginia University (11%), Drexel University (10%), and the University of Alabama, Birmingham (10%). There was an almost 5% increase in applicants in 2006, to 39,109. There were almost equal numbers of male and female applicants (19,812 and 19,297, respectively) and enrollees—8,924 men and 8,446 women. There was a 9% increase in the number of accepted black applicants and an 8% increase in the number of black enrollees. “With the looming doctor shortage, these results are good news indeed, and we hope this encouraging trend continues,” said Dr. Darrell G. Kirch, AAMC president.

Health IT Have-Nots

The adoption gap in health information technology continues to widen, with physicians in smaller practices being left behind, according to a report from the Center for Studying Health System Change (HSC). Compared with 2000 and 2001, in 2004 and 2005 physicians in all types of practices increased their use of health IT for accessing patient notes, generating patient reminders, exchanging clinical data, accessing guidelines, and writing prescriptions. However, practices with 1 or 2 physicians increased their use of health IT for writing prescriptions by 5%, compared with 28% among practices with more than 50 physicians. The gaps are likely because of the greater financial and administrative resources of larger practices and economies of scale. Large practices also may have an advantage in adoption because they have more active physician leaders who are promoting IT and quality improvement, according to the report. The data in the report are from the HSC Community Tracking Study Physician survey, a nationally representative telephone survey of physicians who are involved in direct patient care in the United States. “Larger practices appear to be gaining critical mass in adopting IT for patient care, but the smallest practices, which account for more than half of all practicing physicians, appear to be at risk of being left behind,” Joy M. Grossman, senior health researcher at HSC, said in a statement. The report is available online at

www.hschange.org/CONTENT/891

Omnicare Settles Drug Overcharges

Covington, Ky.-based Omnicare, which provides pharmacy services to nursing homes, has agreed to pay the federal government and 43 states $49.5 million to settle claims that the company overcharged Medicaid. The suit was filed by two whistle-blowers, who alleged that from 2000 to 2005, Omnicare was switching patients from cheaper to more costly versions of three drugs—ranitidine, fluoxetine, and buspirone—to inflate profits. In most cases, the company was substituting capsules for tablets or vice versa. Physicians either weren't aware of the switches or were falsely told that the substitution would cost less. The settlement was filed in U.S. District Court for the Northern District of Illinois in Chicago; Omnicare admitted no wrongdoing.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), one of Dr. von Eschenbach's most vocal critics. As Finance Committee chairman, Sen. Grassley and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. “I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch,” the senator said.

AMA Joins Washington Lawsuit

The American Medical Association has joined six Washington state physicians and the Washington State Medical Association in a lawsuit against Regence BlueShield asserting that the insurer used faulty internal quality data in excluding nearly 500 physicians from a new network that Regence is developing. “This lawsuit has repercussions far beyond Washington state as more health insurers impose financial disincentives which threaten to disrupt patients' long-standing relationships with physicians they know and trust,” AMA Past President Edward J. Hill commented in a statement. The lawsuit, filed Sept. 21, stems from Regence's decision to create a “select network” of physicians who deliver “high quality, efficient care” to serve mainly Boeing Co. engineers. The lawsuit contends that the methodology Regence used to calculate performance failed to consider the population of patients seen by the physicians, used small samples and inaccurate records, and included patients who should have been excluded “because of their personal medical histories.”

Med School Enrollment on Rise

The Association of American Medical Colleges reports that U.S. medical school enrollment for 2006 increased by just over 2% to 17,370. Some schools posted even greater gains, among them: Florida State University (36% increase), Brown University (25%), Boston University (15%), Saint Louis University (15%), Pennsylvania State University (13%), Wayne State University (11%), West Virginia University (11%), Drexel University (10%), and the University of Alabama, Birmingham (10%). There was an almost 5% increase in applicants in 2006, to 39,109. There were almost equal numbers of male and female applicants (19,812 and 19,297, respectively) and enrollees—8,924 men and 8,446 women. There was a 9% increase in the number of accepted black applicants and an 8% increase in the number of black enrollees. “With the looming doctor shortage, these results are good news indeed, and we hope this encouraging trend continues,” said Dr. Darrell G. Kirch, AAMC president.

Health IT Have-Nots

The adoption gap in health information technology continues to widen, with physicians in smaller practices being left behind, according to a report from the Center for Studying Health System Change (HSC). Compared with 2000 and 2001, in 2004 and 2005 physicians in all types of practices increased their use of health IT for accessing patient notes, generating patient reminders, exchanging clinical data, accessing guidelines, and writing prescriptions. However, practices with 1 or 2 physicians increased their use of health IT for writing prescriptions by 5%, compared with 28% among practices with more than 50 physicians. The gaps are likely because of the greater financial and administrative resources of larger practices and economies of scale. Large practices also may have an advantage in adoption because they have more active physician leaders who are promoting IT and quality improvement, according to the report. The data in the report are from the HSC Community Tracking Study Physician survey, a nationally representative telephone survey of physicians who are involved in direct patient care in the United States. “Larger practices appear to be gaining critical mass in adopting IT for patient care, but the smallest practices, which account for more than half of all practicing physicians, appear to be at risk of being left behind,” Joy M. Grossman, senior health researcher at HSC, said in a statement. The report is available online at

www.hschange.org/CONTENT/891

Omnicare Settles Drug Overcharges

Covington, Ky.-based Omnicare, which provides pharmacy services to nursing homes, has agreed to pay the federal government and 43 states $49.5 million to settle claims that the company overcharged Medicaid. The suit was filed by two whistle-blowers, who alleged that from 2000 to 2005, Omnicare was switching patients from cheaper to more costly versions of three drugs—ranitidine, fluoxetine, and buspirone—to inflate profits. In most cases, the company was substituting capsules for tablets or vice versa. Physicians either weren't aware of the switches or were falsely told that the substitution would cost less. The settlement was filed in U.S. District Court for the Northern District of Illinois in Chicago; Omnicare admitted no wrongdoing.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), one of Dr. von Eschenbach's most vocal critics. As Finance Committee chairman, Sen. Grassley and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. “I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch,” the senator said.

AMA Joins Washington Lawsuit

The American Medical Association has joined six Washington state physicians and the Washington State Medical Association in a lawsuit against Regence BlueShield asserting that the insurer used faulty internal quality data in excluding nearly 500 physicians from a new network that Regence is developing. “This lawsuit has repercussions far beyond Washington state as more health insurers impose financial disincentives which threaten to disrupt patients' long-standing relationships with physicians they know and trust,” AMA Past President Edward J. Hill commented in a statement. The lawsuit, filed Sept. 21, stems from Regence's decision to create a “select network” of physicians who deliver “high quality, efficient care” to serve mainly Boeing Co. engineers. The lawsuit contends that the methodology Regence used to calculate performance failed to consider the population of patients seen by the physicians, used small samples and inaccurate records, and included patients who should have been excluded “because of their personal medical histories.”

Med School Enrollment on Rise

The Association of American Medical Colleges reports that U.S. medical school enrollment for 2006 increased by just over 2% to 17,370. Some schools posted even greater gains, among them: Florida State University (36% increase), Brown University (25%), Boston University (15%), Saint Louis University (15%), Pennsylvania State University (13%), Wayne State University (11%), West Virginia University (11%), Drexel University (10%), and the University of Alabama, Birmingham (10%). There was an almost 5% increase in applicants in 2006, to 39,109. There were almost equal numbers of male and female applicants (19,812 and 19,297, respectively) and enrollees—8,924 men and 8,446 women. There was a 9% increase in the number of accepted black applicants and an 8% increase in the number of black enrollees. “With the looming doctor shortage, these results are good news indeed, and we hope this encouraging trend continues,” said Dr. Darrell G. Kirch, AAMC president.

Health IT Have-Nots

The adoption gap in health information technology continues to widen, with physicians in smaller practices being left behind, according to a report from the Center for Studying Health System Change (HSC). Compared with 2000 and 2001, in 2004 and 2005 physicians in all types of practices increased their use of health IT for accessing patient notes, generating patient reminders, exchanging clinical data, accessing guidelines, and writing prescriptions. However, practices with 1 or 2 physicians increased their use of health IT for writing prescriptions by 5%, compared with 28% among practices with more than 50 physicians. The gaps are likely because of the greater financial and administrative resources of larger practices and economies of scale. Large practices also may have an advantage in adoption because they have more active physician leaders who are promoting IT and quality improvement, according to the report. The data in the report are from the HSC Community Tracking Study Physician survey, a nationally representative telephone survey of physicians who are involved in direct patient care in the United States. “Larger practices appear to be gaining critical mass in adopting IT for patient care, but the smallest practices, which account for more than half of all practicing physicians, appear to be at risk of being left behind,” Joy M. Grossman, senior health researcher at HSC, said in a statement. The report is available online at

www.hschange.org/CONTENT/891

Omnicare Settles Drug Overcharges

Covington, Ky.-based Omnicare, which provides pharmacy services to nursing homes, has agreed to pay the federal government and 43 states $49.5 million to settle claims that the company overcharged Medicaid. The suit was filed by two whistle-blowers, who alleged that from 2000 to 2005, Omnicare was switching patients from cheaper to more costly versions of three drugs—ranitidine, fluoxetine, and buspirone—to inflate profits. In most cases, the company was substituting capsules for tablets or vice versa. Physicians either weren't aware of the switches or were falsely told that the substitution would cost less. The settlement was filed in U.S. District Court for the Northern District of Illinois in Chicago; Omnicare admitted no wrongdoing.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), one of Dr. von Eschenbach's most vocal critics. As Finance Committee chairman, Sen. Grassley and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. “I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch,” the senator said.

AMA Joins Washington Lawsuit

The American Medical Association has joined six Washington state physicians and the Washington State Medical Association in a lawsuit against Regence BlueShield asserting that the insurer used faulty internal quality data in excluding nearly 500 physicians from a new network that Regence is developing. “This lawsuit has repercussions far beyond Washington state as more health insurers impose financial disincentives which threaten to disrupt patients' longstanding relationships with physicians they know and trust,” AMA Past President Edward J. Hill commented in a statement. The lawsuit, filed Sept. 21, stems from Regence's decision to create a “select network” of physicians who deliver “high quality, efficient care” to serve mainly Boeing Co. engineers. The lawsuit contends that the methodology Regence used to calculate performance failed to consider the population of patients seen by the physicians; used small samples and inaccurate records; and included patients who should have been excluded “because of their personal medical histories.”

Med School Enrollment on Rise

The Association of American Medical Colleges reports that U.S. medical school enrollment for 2006 increased by just over 2% to 17,370. Some schools posted even greater gains, among them: Florida State University (36% increase), Brown University (25%), Boston University (15%), Saint Louis University (15%), Pennsylvania State University (13%), Wayne State University (11%), West Virginia University (11%), Drexel University (10%), and the University of Alabama, Birmingham (10%). There was an almost 5% increase in applicants in 2006, to 39,109. There were almost equal numbers of male and female applicants (19,812 and 19,297, respectively) and enrollees—8,924 men and 8,446 women. There was a 9% increase in the number of accepted black applicants and an 8% increase in the number of black enrollees. “With the looming doctor shortage, these results are good news indeed, and we hope this encouraging trend continues,” said Dr. Darrell G. Kirch, AAMC president.

Health IT Have-Nots

The adoption gap in health information technology continues to widen, with physicians in smaller practices being left behind, according to a report from the Center for Studying Health System Change (HSC). Compared with 2000 and 2001, in 2004 and 2005 physicians in all types of practices increased their use of health IT for accessing patient notes, generating patient reminders, exchanging clinical data, accessing guidelines, and writing prescriptions. However, practices with 1 or 2 physicians increased their use of health IT for writing prescriptions by 5%, compared with 28% among practices with more than 50 physicians. The gaps are likely because of the greater financial and administrative resources of larger practices and economies of scale. Large practices also may have an advantage in adoption because they have more active physician leaders who are promoting IT and quality improvement, according to the report. The data in the report are from the HSC Community Tracking Study Physician survey, a nationally representative telephone survey of physicians who are involved in direct patient care in the United States. “Larger practices appear to be gaining critical mass in adopting IT for patient care, but the smallest practices, which account for more than half of all practicing physicians, appear to be at risk of being left behind,” Joy M. Grossman, senior health researcher at HSC, said in a statement. The report is available online at

www.hschange.org/CONTENT/891

Omnicare Settles Drug Overcharges

Covington, Ky.-based Omnicare, which provides pharmacy services to nursing homes, has agreed to pay the federal government and 43 states $49.5 million to settle claims that the company overcharged Medicaid. The suit was filed by two whistle-blowers, who alleged that from 2000 to 2005, Omnicare was switching patients from cheaper to more costly versions of three drugs—ranitidine, fluoxetine, and buspirone—to inflate profits. In most cases, the company was substituting capsules for tablets or vice versa. Physicians either weren't aware of the switches or were falsely told that the substitution would cost less. The settlement was filed in U.S. District Court for the Northern District of Illinois in Chicago; Omnicare admitted no wrongdoing.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), one of Dr. von Eschenbach's most vocal critics. As Finance Committee chairman, Sen. Grassley and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. “I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch,” the senator said.

AMA Joins Washington Lawsuit

The American Medical Association has joined six Washington state physicians and the Washington State Medical Association in a lawsuit against Regence BlueShield asserting that the insurer used faulty internal quality data in excluding nearly 500 physicians from a new network that Regence is developing. “This lawsuit has repercussions far beyond Washington state as more health insurers impose financial disincentives which threaten to disrupt patients' longstanding relationships with physicians they know and trust,” AMA Past President Edward J. Hill commented in a statement. The lawsuit, filed Sept. 21, stems from Regence's decision to create a “select network” of physicians who deliver “high quality, efficient care” to serve mainly Boeing Co. engineers. The lawsuit contends that the methodology Regence used to calculate performance failed to consider the population of patients seen by the physicians; used small samples and inaccurate records; and included patients who should have been excluded “because of their personal medical histories.”

Med School Enrollment on Rise

The Association of American Medical Colleges reports that U.S. medical school enrollment for 2006 increased by just over 2% to 17,370. Some schools posted even greater gains, among them: Florida State University (36% increase), Brown University (25%), Boston University (15%), Saint Louis University (15%), Pennsylvania State University (13%), Wayne State University (11%), West Virginia University (11%), Drexel University (10%), and the University of Alabama, Birmingham (10%). There was an almost 5% increase in applicants in 2006, to 39,109. There were almost equal numbers of male and female applicants (19,812 and 19,297, respectively) and enrollees—8,924 men and 8,446 women. There was a 9% increase in the number of accepted black applicants and an 8% increase in the number of black enrollees. “With the looming doctor shortage, these results are good news indeed, and we hope this encouraging trend continues,” said Dr. Darrell G. Kirch, AAMC president.

Health IT Have-Nots

The adoption gap in health information technology continues to widen, with physicians in smaller practices being left behind, according to a report from the Center for Studying Health System Change (HSC). Compared with 2000 and 2001, in 2004 and 2005 physicians in all types of practices increased their use of health IT for accessing patient notes, generating patient reminders, exchanging clinical data, accessing guidelines, and writing prescriptions. However, practices with 1 or 2 physicians increased their use of health IT for writing prescriptions by 5%, compared with 28% among practices with more than 50 physicians. The gaps are likely because of the greater financial and administrative resources of larger practices and economies of scale. Large practices also may have an advantage in adoption because they have more active physician leaders who are promoting IT and quality improvement, according to the report. The data in the report are from the HSC Community Tracking Study Physician survey, a nationally representative telephone survey of physicians who are involved in direct patient care in the United States. “Larger practices appear to be gaining critical mass in adopting IT for patient care, but the smallest practices, which account for more than half of all practicing physicians, appear to be at risk of being left behind,” Joy M. Grossman, senior health researcher at HSC, said in a statement. The report is available online at

www.hschange.org/CONTENT/891

Omnicare Settles Drug Overcharges

Covington, Ky.-based Omnicare, which provides pharmacy services to nursing homes, has agreed to pay the federal government and 43 states $49.5 million to settle claims that the company overcharged Medicaid. The suit was filed by two whistle-blowers, who alleged that from 2000 to 2005, Omnicare was switching patients from cheaper to more costly versions of three drugs—ranitidine, fluoxetine, and buspirone—to inflate profits. In most cases, the company was substituting capsules for tablets or vice versa. Physicians either weren't aware of the switches or were falsely told that the substitution would cost less. The settlement was filed in U.S. District Court for the Northern District of Illinois in Chicago; Omnicare admitted no wrongdoing.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), one of Dr. von Eschenbach's most vocal critics. As Finance Committee chairman, Sen. Grassley and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. “I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch,” the senator said.

AMA Joins Washington Lawsuit

The American Medical Association has joined six Washington state physicians and the Washington State Medical Association in a lawsuit against Regence BlueShield asserting that the insurer used faulty internal quality data in excluding nearly 500 physicians from a new network that Regence is developing. “This lawsuit has repercussions far beyond Washington state as more health insurers impose financial disincentives which threaten to disrupt patients' longstanding relationships with physicians they know and trust,” AMA Past President Edward J. Hill commented in a statement. The lawsuit, filed Sept. 21, stems from Regence's decision to create a “select network” of physicians who deliver “high quality, efficient care” to serve mainly Boeing Co. engineers. The lawsuit contends that the methodology Regence used to calculate performance failed to consider the population of patients seen by the physicians; used small samples and inaccurate records; and included patients who should have been excluded “because of their personal medical histories.”

Med School Enrollment on Rise

The Association of American Medical Colleges reports that U.S. medical school enrollment for 2006 increased by just over 2% to 17,370. Some schools posted even greater gains, among them: Florida State University (36% increase), Brown University (25%), Boston University (15%), Saint Louis University (15%), Pennsylvania State University (13%), Wayne State University (11%), West Virginia University (11%), Drexel University (10%), and the University of Alabama, Birmingham (10%). There was an almost 5% increase in applicants in 2006, to 39,109. There were almost equal numbers of male and female applicants (19,812 and 19,297, respectively) and enrollees—8,924 men and 8,446 women. There was a 9% increase in the number of accepted black applicants and an 8% increase in the number of black enrollees. “With the looming doctor shortage, these results are good news indeed, and we hope this encouraging trend continues,” said Dr. Darrell G. Kirch, AAMC president.

Health IT Have-Nots

The adoption gap in health information technology continues to widen, with physicians in smaller practices being left behind, according to a report from the Center for Studying Health System Change (HSC). Compared with 2000 and 2001, in 2004 and 2005 physicians in all types of practices increased their use of health IT for accessing patient notes, generating patient reminders, exchanging clinical data, accessing guidelines, and writing prescriptions. However, practices with 1 or 2 physicians increased their use of health IT for writing prescriptions by 5%, compared with 28% among practices with more than 50 physicians. The gaps are likely because of the greater financial and administrative resources of larger practices and economies of scale. Large practices also may have an advantage in adoption because they have more active physician leaders who are promoting IT and quality improvement, according to the report. The data in the report are from the HSC Community Tracking Study Physician survey, a nationally representative telephone survey of physicians who are involved in direct patient care in the United States. “Larger practices appear to be gaining critical mass in adopting IT for patient care, but the smallest practices, which account for more than half of all practicing physicians, appear to be at risk of being left behind,” Joy M. Grossman, senior health researcher at HSC, said in a statement. The report is available online at

www.hschange.org/CONTENT/891

Omnicare Settles Drug Overcharges

Covington, Ky.-based Omnicare, which provides pharmacy services to nursing homes, has agreed to pay the federal government and 43 states $49.5 million to settle claims that the company overcharged Medicaid. The suit was filed by two whistle-blowers, who alleged that from 2000 to 2005, Omnicare was switching patients from cheaper to more costly versions of three drugs—ranitidine, fluoxetine, and buspirone—to inflate profits. In most cases, the company was substituting capsules for tablets or vice versa. Physicians either weren't aware of the switches or were falsely told that the substitution would cost less. The settlement was filed in U.S. District Court for the Northern District of Illinois in Chicago; Omnicare admitted no wrongdoing.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met in early November at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what is known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, said Ms. Mello. Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said that patients should not be required to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Only 15% of errors are competency-related, so solutions should focus on systems design, said Dr. O'Leary.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides—the top category—and surgical misadventures, the No. 2 category, said Dr. O'Leary. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

So far, 2,835 of the 6,000 physicians covered by the COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a consultant to the company. Physicians have had at least 3,200 discussions with patients, which closed the case in 2,000 instances, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, said Mr. Dikeou. Of 116 cases that went to court, 54 cases were closed without payment and without attorney involvement. Six cases were closed with payment, 40 are still open, and 16 have gone to trial.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met in early November at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what is known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, said Ms. Mello. Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said that patients should not be required to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Only 15% of errors are competency-related, so solutions should focus on systems design, said Dr. O'Leary.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides—the top category—and surgical misadventures, the No. 2 category, said Dr. O'Leary. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

So far, 2,835 of the 6,000 physicians covered by the COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a consultant to the company. Physicians have had at least 3,200 discussions with patients, which closed the case in 2,000 instances, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, said Mr. Dikeou. Of 116 cases that went to court, 54 cases were closed without payment and without attorney involvement. Six cases were closed with payment, 40 are still open, and 16 have gone to trial.

WASHINGTON — The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in the U.S. Congress and generated interest among state legislatures. But it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met in early November at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what is known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation, but decrease the size of awards, said Ms. Mello. Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that rewards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said that patients should not be required to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Only 15% of errors are competency-related, so solutions should focus on systems design, said Dr. O'Leary.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events—maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides—the top category—and surgical misadventures, the No. 2 category, said Dr. O'Leary. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

So far, 2,835 of the 6,000 physicians covered by the COPIC Insurance Co., a malpractice insurer, have participated in a program implementing the law, said George Dikeou, a consultant to the company. Physicians have had at least 3,200 discussions with patients, which closed the case in 2,000 instances, he said.

The insurer is authorized to pay up to $30,000 per case; the average payout over 711 cases has been about $5,300, said Mr. Dikeou. Of 116 cases that went to court, 54 cases were closed without payment and without attorney involvement. Six cases were closed with payment, 40 are still open, and 16 have gone to trial.

Hospitals will get an average 3% increase in pay for outpatient services under a final rule issued by the Centers for Medicare and Medicaid Services in early November.

But CMS also will cut reimbursement for implantation of some devices—mostly neurologic stimulation systems—under the Hospital Outpatient Prospective Payment System rule for 2007.

Not much has changed since the agency first proposed the rule in August, so there are few surprises.

With the 3% increase, Medicare will pay at least $32 billion to hospitals for outpatient procedures in 2007.

CMS has expressed concern that outpatient costs are rising precipitously—an estimated 12% in 2005 and 9% in 2007—mostly because of growth in volume and intensity of services. The increase in costs affects not only Medicare's overall budget but also seniors' pocketbooks due to the 25% copayments for outpatient services, according to the agency.

However, the agency only decreased payments in a few areas, for instance, cutting reimbursement by 3%–9% in 2007 for implantation of some neurologic devices. The agency said it will reduce payments for implantation of a neurostimulator—used to treat Parkinson's disease and essential tremor—by 7%, to $11,500 for 2007. CMS is reducing coverage of implantation of the leads and electrodes attached to the device by 9%, from $14,900 to $13,500.

Implantable cardiology devices such as pacemakers and implantable cardioverter defibrillators also are slated for increases. However, Medicare will no longer cover the cost of a device that is replaced under warranty or as part of a recall, said the agency. In the past, Medicare has paid for the procedure and the device, even though the hospital usually receives it free of charge. Beginning Jan. 1, the hospital can only charge less than $1.01 for those devices. The minimal charge will ensure that the claim is accepted and will also help CMS identify and track recalls, according to CMS.

In a statement, device industry group AdvaMed mostly supported the new rule, but continued to object to the agency using 2-year-old claims data as a basis for the new payment rates. Some procedures will be getting a fairly big boost, including implantation of drug infusion reservoirs (60% increase), drug infusion devices (16% increase), and pain management catheters (11% increase).

CMS said it is changing how it pays for care in part-time emergency departments. In an effort to track the relative costs of services provided in this type of facility as opposed to a full-fledged ED, CMS created five new HCPCS codes. Medicare will pay for five levels of service in the ED and in clinics and two levels of critical care—one with trauma, one without. The agency said it was backing off for the time being on creating 12 new HCPCS codes for clinics, full-fledged EDs, and critical care.

Finally, hospitals will not have to begin reporting on outpatient quality in 2007. CMS lifted that requirement, which was proposed in the initial rule and would have required reporting on certain measures to receive the increase in overall payments. Instead, the agency has postponed that requirement until 2009. In the meantime, CMS will develop outpatient-specific quality measures.

The American Hospital Association “is pleased that CMS will develop quality measures specifically for the outpatient setting and has correctly given hospitals ample time to implement a reporting system for hospital outpatient services,” AHA Executive Vice President Rick Pollack said in a statement.

As part of the final rule on outpatient pay, hospitals will be required to submit more inpatient quality data. To get the full inpatient pay increase in 2008, hospitals will have to report on measures endorsed by the National Quality Forum, and also measure patient satisfaction using the Hospital Consumer Assessment of Healthcare Providers and Systems.

Hospitals will get an average 3% increase in pay for outpatient services under a final rule issued by the Centers for Medicare and Medicaid Services in early November.

But CMS also will cut reimbursement for implantation of some devices—mostly neurologic stimulation systems—under the Hospital Outpatient Prospective Payment System rule for 2007.

Not much has changed since the agency first proposed the rule in August, so there are few surprises.

With the 3% increase, Medicare will pay at least $32 billion to hospitals for outpatient procedures in 2007.

CMS has expressed concern that outpatient costs are rising precipitously—an estimated 12% in 2005 and 9% in 2007—mostly because of growth in volume and intensity of services. The increase in costs affects not only Medicare's overall budget but also seniors' pocketbooks due to the 25% copayments for outpatient services, according to the agency.

However, the agency only decreased payments in a few areas, for instance, cutting reimbursement by 3%–9% in 2007 for implantation of some neurologic devices. The agency said it will reduce payments for implantation of a neurostimulator—used to treat Parkinson's disease and essential tremor—by 7%, to $11,500 for 2007. CMS is reducing coverage of implantation of the leads and electrodes attached to the device by 9%, from $14,900 to $13,500.

Implantable cardiology devices such as pacemakers and implantable cardioverter defibrillators also are slated for increases. However, Medicare will no longer cover the cost of a device that is replaced under warranty or as part of a recall, said the agency. In the past, Medicare has paid for the procedure and the device, even though the hospital usually receives it free of charge. Beginning Jan. 1, the hospital can only charge less than $1.01 for those devices. The minimal charge will ensure that the claim is accepted and will also help CMS identify and track recalls, according to CMS.

In a statement, device industry group AdvaMed mostly supported the new rule, but continued to object to the agency using 2-year-old claims data as a basis for the new payment rates. Some procedures will be getting a fairly big boost, including implantation of drug infusion reservoirs (60% increase), drug infusion devices (16% increase), and pain management catheters (11% increase).

CMS said it is changing how it pays for care in part-time emergency departments. In an effort to track the relative costs of services provided in this type of facility as opposed to a full-fledged ED, CMS created five new HCPCS codes. Medicare will pay for five levels of service in the ED and in clinics and two levels of critical care—one with trauma, one without. The agency said it was backing off for the time being on creating 12 new HCPCS codes for clinics, full-fledged EDs, and critical care.

Finally, hospitals will not have to begin reporting on outpatient quality in 2007. CMS lifted that requirement, which was proposed in the initial rule and would have required reporting on certain measures to receive the increase in overall payments. Instead, the agency has postponed that requirement until 2009. In the meantime, CMS will develop outpatient-specific quality measures.

The American Hospital Association “is pleased that CMS will develop quality measures specifically for the outpatient setting and has correctly given hospitals ample time to implement a reporting system for hospital outpatient services,” AHA Executive Vice President Rick Pollack said in a statement.

As part of the final rule on outpatient pay, hospitals will be required to submit more inpatient quality data. To get the full inpatient pay increase in 2008, hospitals will have to report on measures endorsed by the National Quality Forum, and also measure patient satisfaction using the Hospital Consumer Assessment of Healthcare Providers and Systems.

Hospitals will get an average 3% increase in pay for outpatient services under a final rule issued by the Centers for Medicare and Medicaid Services in early November.

But CMS also will cut reimbursement for implantation of some devices—mostly neurologic stimulation systems—under the Hospital Outpatient Prospective Payment System rule for 2007.

Not much has changed since the agency first proposed the rule in August, so there are few surprises.

With the 3% increase, Medicare will pay at least $32 billion to hospitals for outpatient procedures in 2007.

CMS has expressed concern that outpatient costs are rising precipitously—an estimated 12% in 2005 and 9% in 2007—mostly because of growth in volume and intensity of services. The increase in costs affects not only Medicare's overall budget but also seniors' pocketbooks due to the 25% copayments for outpatient services, according to the agency.

However, the agency only decreased payments in a few areas, for instance, cutting reimbursement by 3%–9% in 2007 for implantation of some neurologic devices. The agency said it will reduce payments for implantation of a neurostimulator—used to treat Parkinson's disease and essential tremor—by 7%, to $11,500 for 2007. CMS is reducing coverage of implantation of the leads and electrodes attached to the device by 9%, from $14,900 to $13,500.

Implantable cardiology devices such as pacemakers and implantable cardioverter defibrillators also are slated for increases. However, Medicare will no longer cover the cost of a device that is replaced under warranty or as part of a recall, said the agency. In the past, Medicare has paid for the procedure and the device, even though the hospital usually receives it free of charge. Beginning Jan. 1, the hospital can only charge less than $1.01 for those devices. The minimal charge will ensure that the claim is accepted and will also help CMS identify and track recalls, according to CMS.

In a statement, device industry group AdvaMed mostly supported the new rule, but continued to object to the agency using 2-year-old claims data as a basis for the new payment rates. Some procedures will be getting a fairly big boost, including implantation of drug infusion reservoirs (60% increase), drug infusion devices (16% increase), and pain management catheters (11% increase).

CMS said it is changing how it pays for care in part-time emergency departments. In an effort to track the relative costs of services provided in this type of facility as opposed to a full-fledged ED, CMS created five new HCPCS codes. Medicare will pay for five levels of service in the ED and in clinics and two levels of critical care—one with trauma, one without. The agency said it was backing off for the time being on creating 12 new HCPCS codes for clinics, full-fledged EDs, and critical care.

Finally, hospitals will not have to begin reporting on outpatient quality in 2007. CMS lifted that requirement, which was proposed in the initial rule and would have required reporting on certain measures to receive the increase in overall payments. Instead, the agency has postponed that requirement until 2009. In the meantime, CMS will develop outpatient-specific quality measures.

The American Hospital Association “is pleased that CMS will develop quality measures specifically for the outpatient setting and has correctly given hospitals ample time to implement a reporting system for hospital outpatient services,” AHA Executive Vice President Rick Pollack said in a statement.

As part of the final rule on outpatient pay, hospitals will be required to submit more inpatient quality data. To get the full inpatient pay increase in 2008, hospitals will have to report on measures endorsed by the National Quality Forum, and also measure patient satisfaction using the Hospital Consumer Assessment of Healthcare Providers and Systems.

Guidant Must Disclose Prices

The device maker Guidant, a division of Boston Scientific, must publicly release documents that may reveal prices of its products and pricing strategies, a district court judge has ruled. The documents were sealed as part of a May settlement between Guidant and Aspen Health Care Metrics. Guidant had sued Aspen for publishing its pacemaker prices. After the settlement, the advocacy group Public Citizen filed a motion to unseal the documents. In late October, Judge Donovan Frank of the U.S. District Court for the District of Minnesota ruled that most of those documents should be unsealed because they are important to the public interest. However, he agreed to leave some documents secret. Public Citizen said it will pursue opening of those records, also. Documents made public so far are available at

www.citizen.org/litigation/forms/cases/CaseDetails.cfm?cID=234

Backing for Device Identifiers

The American College of Cardiology and the device industry trade group AdvaMed have both indicated to the Food and Drug Administration that they conditionally support the concept of assigning unique identifier codes to medical devices. In August, the agency said it was seeking comments on whether such identifiers—envisioned to be similar to bar codes on drugs—were a good idea, and the best way to go about developing them. The FDA has not yet proposed a rule requiring identifiers. In its letter to the FDA, the ACC said identifiers could improve patient safety. Unique codes will vastly improve the ACC's National Cardiovascular Data Registry's ability to track adverse events, said the group. AdvaMed said that unique identifiers could be useful, but that manufacturers should not be required to use them as there are no data showing they will reduce errors or improve tracking. The group said it may be neither “economically practical nor technologically feasible” to put an identifier on all unpackaged devices because they come in many different sizes, shapes and materials.

Power Mobility Device Coverage

Medicare officials recently announced changes to the fee schedule for new power mobility devices in an effort to improve the accuracy of the prices. The “refinements” will increase the fees paid for complex rehabilitation power wheelchairs used by the severely disabled. The changes will also result in increases to the fees for standard geriatric mobility power wheelchairs. The price increases are intended to reflect the greater durability and performance of these chairs compared with others, according to officials from the Centers for Medicare and Medicaid Services. The refinements are based on updated and validated information related to manufacturer applications and test results. The fee schedule was originally released in October. Additional information on the code refinements is available online at

https://www.cms.hhs.gov/DMEPOSFeeSched/01a_Power_Mobility_Devices.asp

Health IT Gaps

The adoption gap in health information technology continues to widen, with physicians in smaller practices being left behind, according to a report from the Center for Studying Health System Change (HSC). Between 2000–2001 and 2004–2005, physicians in all types of practices increased their use of health IT for accessing patient notes, generating preventive care reminders, exchanging clinical data, obtaining treatment guidelines, and writing prescriptions. However, practices with two or fewer physicians increased their use of health IT for writing prescriptions by 5%, compared with 28% among practices with more than 50 physicians. The gaps are likely due to the greater financial resources of larger practices along with more administrative resources and economies of scale. Large practices may also have an advantage in health IT adoption because of more active physician leaders who are promoting IT and quality improvement, according to the report. The data in the report are from the HSC Community Tracking Study Physician survey, a nationally representative telephone survey of physicians involved in direct patient care in the United States. “Larger practices appear to be gaining critical mass in adopting IT for patient care, but the smallest practices, which account for more than half of all practicing physicians, appear to be at risk of being left behind,” Joy M. Grossman, a coauthor of the report and a senior health researcher at HSC, said in a statement. The report is available online at

www.hschange.org/CONTENT/891

Guidant Must Disclose Prices

The device maker Guidant, a division of Boston Scientific, must publicly release documents that may reveal prices of its products and pricing strategies, a district court judge has ruled. The documents were sealed as part of a May settlement between Guidant and Aspen Health Care Metrics. Guidant had sued Aspen for publishing its pacemaker prices. After the settlement, the advocacy group Public Citizen filed a motion to unseal the documents. In late October, Judge Donovan Frank of the U.S. District Court for the District of Minnesota ruled that most of those documents should be unsealed because they are important to the public interest. However, he agreed to leave some documents secret. Public Citizen said it will pursue opening of those records, also. Documents made public so far are available at

www.citizen.org/litigation/forms/cases/CaseDetails.cfm?cID=234

Backing for Device Identifiers

The American College of Cardiology and the device industry trade group AdvaMed have both indicated to the Food and Drug Administration that they conditionally support the concept of assigning unique identifier codes to medical devices. In August, the agency said it was seeking comments on whether such identifiers—envisioned to be similar to bar codes on drugs—were a good idea, and the best way to go about developing them. The FDA has not yet proposed a rule requiring identifiers. In its letter to the FDA, the ACC said identifiers could improve patient safety. Unique codes will vastly improve the ACC's National Cardiovascular Data Registry's ability to track adverse events, said the group. AdvaMed said that unique identifiers could be useful, but that manufacturers should not be required to use them as there are no data showing they will reduce errors or improve tracking. The group said it may be neither “economically practical nor technologically feasible” to put an identifier on all unpackaged devices because they come in many different sizes, shapes and materials.

Power Mobility Device Coverage

Medicare officials recently announced changes to the fee schedule for new power mobility devices in an effort to improve the accuracy of the prices. The “refinements” will increase the fees paid for complex rehabilitation power wheelchairs used by the severely disabled. The changes will also result in increases to the fees for standard geriatric mobility power wheelchairs. The price increases are intended to reflect the greater durability and performance of these chairs compared with others, according to officials from the Centers for Medicare and Medicaid Services. The refinements are based on updated and validated information related to manufacturer applications and test results. The fee schedule was originally released in October. Additional information on the code refinements is available online at

https://www.cms.hhs.gov/DMEPOSFeeSched/01a_Power_Mobility_Devices.asp

Health IT Gaps

The adoption gap in health information technology continues to widen, with physicians in smaller practices being left behind, according to a report from the Center for Studying Health System Change (HSC). Between 2000–2001 and 2004–2005, physicians in all types of practices increased their use of health IT for accessing patient notes, generating preventive care reminders, exchanging clinical data, obtaining treatment guidelines, and writing prescriptions. However, practices with two or fewer physicians increased their use of health IT for writing prescriptions by 5%, compared with 28% among practices with more than 50 physicians. The gaps are likely due to the greater financial resources of larger practices along with more administrative resources and economies of scale. Large practices may also have an advantage in health IT adoption because of more active physician leaders who are promoting IT and quality improvement, according to the report. The data in the report are from the HSC Community Tracking Study Physician survey, a nationally representative telephone survey of physicians involved in direct patient care in the United States. “Larger practices appear to be gaining critical mass in adopting IT for patient care, but the smallest practices, which account for more than half of all practicing physicians, appear to be at risk of being left behind,” Joy M. Grossman, a coauthor of the report and a senior health researcher at HSC, said in a statement. The report is available online at

www.hschange.org/CONTENT/891

Guidant Must Disclose Prices

The device maker Guidant, a division of Boston Scientific, must publicly release documents that may reveal prices of its products and pricing strategies, a district court judge has ruled. The documents were sealed as part of a May settlement between Guidant and Aspen Health Care Metrics. Guidant had sued Aspen for publishing its pacemaker prices. After the settlement, the advocacy group Public Citizen filed a motion to unseal the documents. In late October, Judge Donovan Frank of the U.S. District Court for the District of Minnesota ruled that most of those documents should be unsealed because they are important to the public interest. However, he agreed to leave some documents secret. Public Citizen said it will pursue opening of those records, also. Documents made public so far are available at

www.citizen.org/litigation/forms/cases/CaseDetails.cfm?cID=234

Backing for Device Identifiers

The American College of Cardiology and the device industry trade group AdvaMed have both indicated to the Food and Drug Administration that they conditionally support the concept of assigning unique identifier codes to medical devices. In August, the agency said it was seeking comments on whether such identifiers—envisioned to be similar to bar codes on drugs—were a good idea, and the best way to go about developing them. The FDA has not yet proposed a rule requiring identifiers. In its letter to the FDA, the ACC said identifiers could improve patient safety. Unique codes will vastly improve the ACC's National Cardiovascular Data Registry's ability to track adverse events, said the group. AdvaMed said that unique identifiers could be useful, but that manufacturers should not be required to use them as there are no data showing they will reduce errors or improve tracking. The group said it may be neither “economically practical nor technologically feasible” to put an identifier on all unpackaged devices because they come in many different sizes, shapes and materials.

Power Mobility Device Coverage

Medicare officials recently announced changes to the fee schedule for new power mobility devices in an effort to improve the accuracy of the prices. The “refinements” will increase the fees paid for complex rehabilitation power wheelchairs used by the severely disabled. The changes will also result in increases to the fees for standard geriatric mobility power wheelchairs. The price increases are intended to reflect the greater durability and performance of these chairs compared with others, according to officials from the Centers for Medicare and Medicaid Services. The refinements are based on updated and validated information related to manufacturer applications and test results. The fee schedule was originally released in October. Additional information on the code refinements is available online at

https://www.cms.hhs.gov/DMEPOSFeeSched/01a_Power_Mobility_Devices.asp

Health IT Gaps

The adoption gap in health information technology continues to widen, with physicians in smaller practices being left behind, according to a report from the Center for Studying Health System Change (HSC). Between 2000–2001 and 2004–2005, physicians in all types of practices increased their use of health IT for accessing patient notes, generating preventive care reminders, exchanging clinical data, obtaining treatment guidelines, and writing prescriptions. However, practices with two or fewer physicians increased their use of health IT for writing prescriptions by 5%, compared with 28% among practices with more than 50 physicians. The gaps are likely due to the greater financial resources of larger practices along with more administrative resources and economies of scale. Large practices may also have an advantage in health IT adoption because of more active physician leaders who are promoting IT and quality improvement, according to the report. The data in the report are from the HSC Community Tracking Study Physician survey, a nationally representative telephone survey of physicians involved in direct patient care in the United States. “Larger practices appear to be gaining critical mass in adopting IT for patient care, but the smallest practices, which account for more than half of all practicing physicians, appear to be at risk of being left behind,” Joy M. Grossman, a coauthor of the report and a senior health researcher at HSC, said in a statement. The report is available online at

www.hschange.org/CONTENT/891