Mary Ellen Schneider

Monitoring the CAP Program

Members of Congress recently voted to keep an eye on how Medicare's Competitive Acquisition Program (CAP) is running. As part of the year-end omnibus tax and health care bill (H.R. 6111), Congress established a postpayment review process for CAP, a program under which physicians are paid for administering certain Part B drugs and biologics but do not take on the financial risk of purchasing the drugs. For 2007, only one vendor, BioScrip, has been chosen by the Centers for Medicare and Medicaid Services to participate in CAP. The review program mandated by Congress will be aimed at ensuring that when Medicare pays for a drug or biologic, it has actually been administered to the beneficiary.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be commissioner of the Food and Drug Administration, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the final 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 voted against invoking cloture and against confirmation. Sen. Grassley has been one of Dr. von Eschenbach's most vocal critics. Sen. Grassley, as chairman of the Finance Committee, and his staff have been investigating what they call an inappropriate approval of the antibiotic Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, the senator accused Dr. von Eschenbach of hiding documents and intimidating FDA employees who dissented. With the Democrats' taking control of Congress, Sen. Grassley will lose his Finance Committee chairmanship. But he warned his colleagues across the aisle 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,” Sen. Grassley said.

Arthritis Researcher Honored

The Arthritis Foundation has awarded the 2006 Lee C. Howley Sr. Prize for Research in Arthritis to Dr. Gary Firestein of the University of California, San Diego. The award recognizes researchers whose work over the past 5 years represents a significant advance in understanding, treating, and preventing arthritis and other rheumatic diseases. Dr. Firestein, chief of rheumatology, allergy, and immunology at UCSD, is currently studying how the central nervous system affects immune responses and joint inflammation. That work is being funded by the Arthritis Foundation.

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 for the beneficiaries the program is designed to serve,” Commonwealth Fund President Karen Davis said in a statement.

NIH Reform Act

Congress reauthorized the National Institutes of Health at the end of last year, calling for the creation of a new agency-wide electronic reporting system to track all NIH research activities. The reauthorizing legislation, the National Institutes of Health Act of 2006 (H.R. 6164), was expected to be signed by President Bush at press time. It also limits the overall size of the agency to the current 27 institutes and centers and creates a process for reevaluating the structure of NIH at least once every 7 years. These changes will help to increase transparency and strategic planning at the agency, Rep. Joe Barton (R-Texas), outgoing chair of the House Committee on Energy and Commerce, said in a statement. “The legislation preserves the core authorities of NIH, while adding new tools to maximize NIH's effectiveness,” Dr. Elias A. Zerhouni, NIH director, said in a statement. “Congress has taken an important step towards modernizing the operation of NIH, in conformance with a new era of science.”

Monitoring the CAP Program

Members of Congress recently voted to keep an eye on how Medicare's Competitive Acquisition Program (CAP) is running. As part of the year-end omnibus tax and health care bill (H.R. 6111), Congress established a postpayment review process for CAP, a program under which physicians are paid for administering certain Part B drugs and biologics but do not take on the financial risk of purchasing the drugs. For 2007, only one vendor, BioScrip, has been chosen by the Centers for Medicare and Medicaid Services to participate in CAP. The review program mandated by Congress will be aimed at ensuring that when Medicare pays for a drug or biologic, it has actually been administered to the beneficiary.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be commissioner of the Food and Drug Administration, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the final 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 voted against invoking cloture and against confirmation. Sen. Grassley has been one of Dr. von Eschenbach's most vocal critics. Sen. Grassley, as chairman of the Finance Committee, and his staff have been investigating what they call an inappropriate approval of the antibiotic Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, the senator accused Dr. von Eschenbach of hiding documents and intimidating FDA employees who dissented. With the Democrats' taking control of Congress, Sen. Grassley will lose his Finance Committee chairmanship. But he warned his colleagues across the aisle 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,” Sen. Grassley said.

Arthritis Researcher Honored

The Arthritis Foundation has awarded the 2006 Lee C. Howley Sr. Prize for Research in Arthritis to Dr. Gary Firestein of the University of California, San Diego. The award recognizes researchers whose work over the past 5 years represents a significant advance in understanding, treating, and preventing arthritis and other rheumatic diseases. Dr. Firestein, chief of rheumatology, allergy, and immunology at UCSD, is currently studying how the central nervous system affects immune responses and joint inflammation. That work is being funded by the Arthritis Foundation.

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 for the beneficiaries the program is designed to serve,” Commonwealth Fund President Karen Davis said in a statement.

NIH Reform Act

Congress reauthorized the National Institutes of Health at the end of last year, calling for the creation of a new agency-wide electronic reporting system to track all NIH research activities. The reauthorizing legislation, the National Institutes of Health Act of 2006 (H.R. 6164), was expected to be signed by President Bush at press time. It also limits the overall size of the agency to the current 27 institutes and centers and creates a process for reevaluating the structure of NIH at least once every 7 years. These changes will help to increase transparency and strategic planning at the agency, Rep. Joe Barton (R-Texas), outgoing chair of the House Committee on Energy and Commerce, said in a statement. “The legislation preserves the core authorities of NIH, while adding new tools to maximize NIH's effectiveness,” Dr. Elias A. Zerhouni, NIH director, said in a statement. “Congress has taken an important step towards modernizing the operation of NIH, in conformance with a new era of science.”

Monitoring the CAP Program

Members of Congress recently voted to keep an eye on how Medicare's Competitive Acquisition Program (CAP) is running. As part of the year-end omnibus tax and health care bill (H.R. 6111), Congress established a postpayment review process for CAP, a program under which physicians are paid for administering certain Part B drugs and biologics but do not take on the financial risk of purchasing the drugs. For 2007, only one vendor, BioScrip, has been chosen by the Centers for Medicare and Medicaid Services to participate in CAP. The review program mandated by Congress will be aimed at ensuring that when Medicare pays for a drug or biologic, it has actually been administered to the beneficiary.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be commissioner of the Food and Drug Administration, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the final 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 voted against invoking cloture and against confirmation. Sen. Grassley has been one of Dr. von Eschenbach's most vocal critics. Sen. Grassley, as chairman of the Finance Committee, and his staff have been investigating what they call an inappropriate approval of the antibiotic Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, the senator accused Dr. von Eschenbach of hiding documents and intimidating FDA employees who dissented. With the Democrats' taking control of Congress, Sen. Grassley will lose his Finance Committee chairmanship. But he warned his colleagues across the aisle 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,” Sen. Grassley said.

Arthritis Researcher Honored

The Arthritis Foundation has awarded the 2006 Lee C. Howley Sr. Prize for Research in Arthritis to Dr. Gary Firestein of the University of California, San Diego. The award recognizes researchers whose work over the past 5 years represents a significant advance in understanding, treating, and preventing arthritis and other rheumatic diseases. Dr. Firestein, chief of rheumatology, allergy, and immunology at UCSD, is currently studying how the central nervous system affects immune responses and joint inflammation. That work is being funded by the Arthritis Foundation.

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 for the beneficiaries the program is designed to serve,” Commonwealth Fund President Karen Davis said in a statement.

NIH Reform Act

Congress reauthorized the National Institutes of Health at the end of last year, calling for the creation of a new agency-wide electronic reporting system to track all NIH research activities. The reauthorizing legislation, the National Institutes of Health Act of 2006 (H.R. 6164), was expected to be signed by President Bush at press time. It also limits the overall size of the agency to the current 27 institutes and centers and creates a process for reevaluating the structure of NIH at least once every 7 years. These changes will help to increase transparency and strategic planning at the agency, Rep. Joe Barton (R-Texas), outgoing chair of the House Committee on Energy and Commerce, said in a statement. “The legislation preserves the core authorities of NIH, while adding new tools to maximize NIH's effectiveness,” Dr. Elias A. Zerhouni, NIH director, said in a statement. “Congress has taken an important step towards modernizing the operation of NIH, in conformance with a new era of science.”

Underage Drinking Legislation

Congress has passed legislation aimed at curbing teen drinking and better coordinating the efforts of federal agencies in this area. The legislation, the Sober Truth on Preventing (STOP) Underage Drinking Act (H.R. 864), was expected to be signed by the president at press time. The bill authorizes grants to prevent binge drinking by college students and calls for research on the scope of underage drinking. The legislation has support from both the medical community and the alcohol industry. The National Beer Wholesalers Association said the bill provides federal, state, and local governments with the tools they need to help prevent underage drinking. And the American Medical Association praised Congress for passing the first national underage drinking prevention legislation. “Alcohol is the No. 1 drug of choice for young people, and the age of initiation keeps getting younger. Alcohol causes memory and learning impairment, possibly irreversible in the adolescent brain,” Dr. Ronald M. Davis, AMA president-elect, said in a statement.

CMS Adds RVUs for Four Codes

In November, the Centers for Medicare and Medicaid Services added relative value units (RVUs) to four CPT codes, ending months of negotiations between pediatricians and the agency. The American Academy of Pediatrics and the AMA had recommended that RVUs be included for the following codes: 92551 for hearing screening, 99173 for vision screening, 99339 for care plan oversight of 15–29 minutes/month, and 99340 for care plan oversight of 30 or more minutes/month. AAP first met with CMS in May; when the proposed physician fee schedule was issued in September, the four codes were not included. After discussions, the codes were included in the final fee schedule. “Although most pediatricians are not paid by Medicare, 75% of private payers use Medicare rates to set their physician payments,” said Dr. Jay Berkelhamer, AAP President, in a statement. The AAP urges pediatricians to make sure that the new codes are recognized by private payers.

Congress Tackles Prematurity

Members of Congress gave their stamp of approval to legislation aimed at expanding research into prematurity at the end of its last session. The Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Act (S. 707) would establish a grant program to educate health professionals and the public about the signs of preterm labor. The grants would also provide support for parents caring for a premature baby in a neonatal intensive care unit. The legislation, which at press time was expected to be signed by President Bush, also calls for expanded research at the Centers for Disease Control and Prevention and studies focused on the relationship between prematurity and birth defects and developmental disabilities. The bill was praised by the March of Dimes. “In one of its most important provisions, the bill authorizes a Surgeon General's conference at which scientific and clinical experts from the public and private sectors will sit down together to formulate a national action agenda designed to speed development of prevention strategies for preterm labor and delivery,” Jennifer L. Howse, Ph.D., president of the March of Dimes, said in a statement.

Expanding Autism Research

President Bush recently signed legislation that authorizes a major expansion of autism research, education, and early detection efforts. The Combating Autism Act of 2006 (S. 843) calls for spending nearly $1 billion on activities and research related to autism spectrum disorders over the next 5 years. The new law also calls for research that would aid in developing and validating screening tools for autism spectrum disorders. “As the prevalence of autism grows, the odds are that every American will know a family who will directly benefit from the programs and research made possible by this legislation,” Jon Shestack, cofounder of Cure Autism Now, said in a statement.

Solitary Substance Abuse

Eighth-graders who used alcohol, cigarettes, and marijuana while alone were more likely to have health problems later in life, compared with adolescents who were social users only, according to a study from researchers at the Rand Corporation. Solitary drinkers were also less likely to graduate from college, more likely to engage in predatory violence, and more likely to have a history of drug and alcohol problems by age 23 than were social drinkers. The researchers recruited more than 6,500 seventh-grade students in California and Oregon and assessed their substance use and other social factors through age 23. “While substance use is a problem in itself, these findings suggest that risk among solitary users is especially high,” Joan Tucker, a Rand psychologist and lead author of the study, said in a statement. “Solitary use is a warning sign that youth will be less productive and have more problems as young adults—more problems, even, than others who also used substances during childhood.” The researchers advised that asking adolescent patients whether they engage in substance abuse when alone is an easy way to target substance abuse prevention efforts at those with the highest risk. The study was published in the December issue of Psychology of Addictive Behaviors.

Alternatives to Mental Institutions

Medicaid officials recently awarded $218 million in grants over 5 years to aid states in developing alternatives to institutionalization for children with mental illness. Ten states—Alaska, Florida, Georgia, Indiana, Kansas, Maryland, Mississippi, Montana, South Carolina, and Virginia—are receiving funding to begin demonstration projects. Some of the programs include 24-hour support and crisis intervention for children living in the community, training for families, and after-school programs. “We believe these grants will result in a more caring, compassionate approach to meeting the needs of these children,” Leslie Norwalk, acting CMS administrator, said in a statement. “Integrating them back into their homes and communities gives them the best opportunity to lead successful, productive lives as adults.”

Underage Drinking Legislation

Congress has passed legislation aimed at curbing teen drinking and better coordinating the efforts of federal agencies in this area. The legislation, the Sober Truth on Preventing (STOP) Underage Drinking Act (H.R. 864), was expected to be signed by the president at press time. The bill authorizes grants to prevent binge drinking by college students and calls for research on the scope of underage drinking. The legislation has support from both the medical community and the alcohol industry. The National Beer Wholesalers Association said the bill provides federal, state, and local governments with the tools they need to help prevent underage drinking. And the American Medical Association praised Congress for passing the first national underage drinking prevention legislation. “Alcohol is the No. 1 drug of choice for young people, and the age of initiation keeps getting younger. Alcohol causes memory and learning impairment, possibly irreversible in the adolescent brain,” Dr. Ronald M. Davis, AMA president-elect, said in a statement.

CMS Adds RVUs for Four Codes

In November, the Centers for Medicare and Medicaid Services added relative value units (RVUs) to four CPT codes, ending months of negotiations between pediatricians and the agency. The American Academy of Pediatrics and the AMA had recommended that RVUs be included for the following codes: 92551 for hearing screening, 99173 for vision screening, 99339 for care plan oversight of 15–29 minutes/month, and 99340 for care plan oversight of 30 or more minutes/month. AAP first met with CMS in May; when the proposed physician fee schedule was issued in September, the four codes were not included. After discussions, the codes were included in the final fee schedule. “Although most pediatricians are not paid by Medicare, 75% of private payers use Medicare rates to set their physician payments,” said Dr. Jay Berkelhamer, AAP President, in a statement. The AAP urges pediatricians to make sure that the new codes are recognized by private payers.

Congress Tackles Prematurity

Members of Congress gave their stamp of approval to legislation aimed at expanding research into prematurity at the end of its last session. The Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Act (S. 707) would establish a grant program to educate health professionals and the public about the signs of preterm labor. The grants would also provide support for parents caring for a premature baby in a neonatal intensive care unit. The legislation, which at press time was expected to be signed by President Bush, also calls for expanded research at the Centers for Disease Control and Prevention and studies focused on the relationship between prematurity and birth defects and developmental disabilities. The bill was praised by the March of Dimes. “In one of its most important provisions, the bill authorizes a Surgeon General's conference at which scientific and clinical experts from the public and private sectors will sit down together to formulate a national action agenda designed to speed development of prevention strategies for preterm labor and delivery,” Jennifer L. Howse, Ph.D., president of the March of Dimes, said in a statement.

Expanding Autism Research

President Bush recently signed legislation that authorizes a major expansion of autism research, education, and early detection efforts. The Combating Autism Act of 2006 (S. 843) calls for spending nearly $1 billion on activities and research related to autism spectrum disorders over the next 5 years. The new law also calls for research that would aid in developing and validating screening tools for autism spectrum disorders. “As the prevalence of autism grows, the odds are that every American will know a family who will directly benefit from the programs and research made possible by this legislation,” Jon Shestack, cofounder of Cure Autism Now, said in a statement.

Solitary Substance Abuse

Eighth-graders who used alcohol, cigarettes, and marijuana while alone were more likely to have health problems later in life, compared with adolescents who were social users only, according to a study from researchers at the Rand Corporation. Solitary drinkers were also less likely to graduate from college, more likely to engage in predatory violence, and more likely to have a history of drug and alcohol problems by age 23 than were social drinkers. The researchers recruited more than 6,500 seventh-grade students in California and Oregon and assessed their substance use and other social factors through age 23. “While substance use is a problem in itself, these findings suggest that risk among solitary users is especially high,” Joan Tucker, a Rand psychologist and lead author of the study, said in a statement. “Solitary use is a warning sign that youth will be less productive and have more problems as young adults—more problems, even, than others who also used substances during childhood.” The researchers advised that asking adolescent patients whether they engage in substance abuse when alone is an easy way to target substance abuse prevention efforts at those with the highest risk. The study was published in the December issue of Psychology of Addictive Behaviors.

Alternatives to Mental Institutions

Medicaid officials recently awarded $218 million in grants over 5 years to aid states in developing alternatives to institutionalization for children with mental illness. Ten states—Alaska, Florida, Georgia, Indiana, Kansas, Maryland, Mississippi, Montana, South Carolina, and Virginia—are receiving funding to begin demonstration projects. Some of the programs include 24-hour support and crisis intervention for children living in the community, training for families, and after-school programs. “We believe these grants will result in a more caring, compassionate approach to meeting the needs of these children,” Leslie Norwalk, acting CMS administrator, said in a statement. “Integrating them back into their homes and communities gives them the best opportunity to lead successful, productive lives as adults.”

Underage Drinking Legislation

Congress has passed legislation aimed at curbing teen drinking and better coordinating the efforts of federal agencies in this area. The legislation, the Sober Truth on Preventing (STOP) Underage Drinking Act (H.R. 864), was expected to be signed by the president at press time. The bill authorizes grants to prevent binge drinking by college students and calls for research on the scope of underage drinking. The legislation has support from both the medical community and the alcohol industry. The National Beer Wholesalers Association said the bill provides federal, state, and local governments with the tools they need to help prevent underage drinking. And the American Medical Association praised Congress for passing the first national underage drinking prevention legislation. “Alcohol is the No. 1 drug of choice for young people, and the age of initiation keeps getting younger. Alcohol causes memory and learning impairment, possibly irreversible in the adolescent brain,” Dr. Ronald M. Davis, AMA president-elect, said in a statement.

CMS Adds RVUs for Four Codes

In November, the Centers for Medicare and Medicaid Services added relative value units (RVUs) to four CPT codes, ending months of negotiations between pediatricians and the agency. The American Academy of Pediatrics and the AMA had recommended that RVUs be included for the following codes: 92551 for hearing screening, 99173 for vision screening, 99339 for care plan oversight of 15–29 minutes/month, and 99340 for care plan oversight of 30 or more minutes/month. AAP first met with CMS in May; when the proposed physician fee schedule was issued in September, the four codes were not included. After discussions, the codes were included in the final fee schedule. “Although most pediatricians are not paid by Medicare, 75% of private payers use Medicare rates to set their physician payments,” said Dr. Jay Berkelhamer, AAP President, in a statement. The AAP urges pediatricians to make sure that the new codes are recognized by private payers.

Congress Tackles Prematurity

Members of Congress gave their stamp of approval to legislation aimed at expanding research into prematurity at the end of its last session. The Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Act (S. 707) would establish a grant program to educate health professionals and the public about the signs of preterm labor. The grants would also provide support for parents caring for a premature baby in a neonatal intensive care unit. The legislation, which at press time was expected to be signed by President Bush, also calls for expanded research at the Centers for Disease Control and Prevention and studies focused on the relationship between prematurity and birth defects and developmental disabilities. The bill was praised by the March of Dimes. “In one of its most important provisions, the bill authorizes a Surgeon General's conference at which scientific and clinical experts from the public and private sectors will sit down together to formulate a national action agenda designed to speed development of prevention strategies for preterm labor and delivery,” Jennifer L. Howse, Ph.D., president of the March of Dimes, said in a statement.

Expanding Autism Research

President Bush recently signed legislation that authorizes a major expansion of autism research, education, and early detection efforts. The Combating Autism Act of 2006 (S. 843) calls for spending nearly $1 billion on activities and research related to autism spectrum disorders over the next 5 years. The new law also calls for research that would aid in developing and validating screening tools for autism spectrum disorders. “As the prevalence of autism grows, the odds are that every American will know a family who will directly benefit from the programs and research made possible by this legislation,” Jon Shestack, cofounder of Cure Autism Now, said in a statement.

Solitary Substance Abuse

Eighth-graders who used alcohol, cigarettes, and marijuana while alone were more likely to have health problems later in life, compared with adolescents who were social users only, according to a study from researchers at the Rand Corporation. Solitary drinkers were also less likely to graduate from college, more likely to engage in predatory violence, and more likely to have a history of drug and alcohol problems by age 23 than were social drinkers. The researchers recruited more than 6,500 seventh-grade students in California and Oregon and assessed their substance use and other social factors through age 23. “While substance use is a problem in itself, these findings suggest that risk among solitary users is especially high,” Joan Tucker, a Rand psychologist and lead author of the study, said in a statement. “Solitary use is a warning sign that youth will be less productive and have more problems as young adults—more problems, even, than others who also used substances during childhood.” The researchers advised that asking adolescent patients whether they engage in substance abuse when alone is an easy way to target substance abuse prevention efforts at those with the highest risk. The study was published in the December issue of Psychology of Addictive Behaviors.

Alternatives to Mental Institutions

Medicaid officials recently awarded $218 million in grants over 5 years to aid states in developing alternatives to institutionalization for children with mental illness. Ten states—Alaska, Florida, Georgia, Indiana, Kansas, Maryland, Mississippi, Montana, South Carolina, and Virginia—are receiving funding to begin demonstration projects. Some of the programs include 24-hour support and crisis intervention for children living in the community, training for families, and after-school programs. “We believe these grants will result in a more caring, compassionate approach to meeting the needs of these children,” Leslie Norwalk, acting CMS administrator, said in a statement. “Integrating them back into their homes and communities gives them the best opportunity to lead successful, productive lives as adults.”

NEW YORK — Consistent, detailed record keeping and patient communication are key to avoiding legal complications and navigating HIPAA requirements, Dr. Noah Scheinfeld said at meeting on medical and surgical dermatology sponsored by Mount Sinai School of Medicine.

One area where record keeping is especially important is clinical photographs of patients. If you're going to take patient photographs, retain them as part of the patient's medical record because patient images are considered medical records and as such are legal evidence. In the event of a lawsuit, if the photos that were taken are not available, the court assumes that the missing records are in the plaintiff's favor, said Dr. Scheinfeld, Columbia University, New York, who also holds a law degree.

With the advent of digital photography, it's easy to take multiple images of the same area. Physicians do not need to save 10 images of the same thing, he said, but at least 1 of each should be retained with the rest of the patient's records.

Under federal law, records must be kept for 5 years, but individual states may have more rigorous standards. For example, New York requires that medical records be kept for 7 years, he said.

But one area that physicians can worry a little less about is enforcement under HIPAA, Dr. Scheinfeld said. While there have been more than 20,000 complaints since HIPAA privacy provisions went into effect in 2003, there has not been much in the way of enforcement.

“Lots of complaints; very little action,” he said.

Only a few hundred HIPAA violations have been referred for criminal action and so far only three cases have resulted in criminal charges. In 2004, a Seattle man who worked at an area cancer center was sentenced to 16 months in jail for using a cancer patient's personal information to obtain credit cards. In 2006, a Texas woman who worked in a physician's office was convicted of selling the medical records of an FBI agent. Most recently, the U.S. Attorney for the Southern District of Florida brought criminal charges against a woman who worked as the front desk office coordinator for a Florida clinic for allegedly selling patient information.

In general, it is important to notify patients of their privacy rights and the use of their personal health information, adopt and implement privacy procedures, and train employees in those procedures. Physicians also need to designate an individual to be responsible for ensuring that the office privacy procedures are followed. Patient records must be secured so that individually identified health information is not accessible to those who do not need it for treatment or payment reasons.

NEW YORK — Consistent, detailed record keeping and patient communication are key to avoiding legal complications and navigating HIPAA requirements, Dr. Noah Scheinfeld said at meeting on medical and surgical dermatology sponsored by Mount Sinai School of Medicine.

One area where record keeping is especially important is clinical photographs of patients. If you're going to take patient photographs, retain them as part of the patient's medical record because patient images are considered medical records and as such are legal evidence. In the event of a lawsuit, if the photos that were taken are not available, the court assumes that the missing records are in the plaintiff's favor, said Dr. Scheinfeld, Columbia University, New York, who also holds a law degree.

With the advent of digital photography, it's easy to take multiple images of the same area. Physicians do not need to save 10 images of the same thing, he said, but at least 1 of each should be retained with the rest of the patient's records.

Under federal law, records must be kept for 5 years, but individual states may have more rigorous standards. For example, New York requires that medical records be kept for 7 years, he said.

But one area that physicians can worry a little less about is enforcement under HIPAA, Dr. Scheinfeld said. While there have been more than 20,000 complaints since HIPAA privacy provisions went into effect in 2003, there has not been much in the way of enforcement.

“Lots of complaints; very little action,” he said.

Only a few hundred HIPAA violations have been referred for criminal action and so far only three cases have resulted in criminal charges. In 2004, a Seattle man who worked at an area cancer center was sentenced to 16 months in jail for using a cancer patient's personal information to obtain credit cards. In 2006, a Texas woman who worked in a physician's office was convicted of selling the medical records of an FBI agent. Most recently, the U.S. Attorney for the Southern District of Florida brought criminal charges against a woman who worked as the front desk office coordinator for a Florida clinic for allegedly selling patient information.

In general, it is important to notify patients of their privacy rights and the use of their personal health information, adopt and implement privacy procedures, and train employees in those procedures. Physicians also need to designate an individual to be responsible for ensuring that the office privacy procedures are followed. Patient records must be secured so that individually identified health information is not accessible to those who do not need it for treatment or payment reasons.

NEW YORK — Consistent, detailed record keeping and patient communication are key to avoiding legal complications and navigating HIPAA requirements, Dr. Noah Scheinfeld said at meeting on medical and surgical dermatology sponsored by Mount Sinai School of Medicine.

One area where record keeping is especially important is clinical photographs of patients. If you're going to take patient photographs, retain them as part of the patient's medical record because patient images are considered medical records and as such are legal evidence. In the event of a lawsuit, if the photos that were taken are not available, the court assumes that the missing records are in the plaintiff's favor, said Dr. Scheinfeld, Columbia University, New York, who also holds a law degree.

With the advent of digital photography, it's easy to take multiple images of the same area. Physicians do not need to save 10 images of the same thing, he said, but at least 1 of each should be retained with the rest of the patient's records.

Under federal law, records must be kept for 5 years, but individual states may have more rigorous standards. For example, New York requires that medical records be kept for 7 years, he said.

But one area that physicians can worry a little less about is enforcement under HIPAA, Dr. Scheinfeld said. While there have been more than 20,000 complaints since HIPAA privacy provisions went into effect in 2003, there has not been much in the way of enforcement.

“Lots of complaints; very little action,” he said.

Only a few hundred HIPAA violations have been referred for criminal action and so far only three cases have resulted in criminal charges. In 2004, a Seattle man who worked at an area cancer center was sentenced to 16 months in jail for using a cancer patient's personal information to obtain credit cards. In 2006, a Texas woman who worked in a physician's office was convicted of selling the medical records of an FBI agent. Most recently, the U.S. Attorney for the Southern District of Florida brought criminal charges against a woman who worked as the front desk office coordinator for a Florida clinic for allegedly selling patient information.

In general, it is important to notify patients of their privacy rights and the use of their personal health information, adopt and implement privacy procedures, and train employees in those procedures. Physicians also need to designate an individual to be responsible for ensuring that the office privacy procedures are followed. Patient records must be secured so that individually identified health information is not accessible to those who do not need it for treatment or payment reasons.

Public NPI Directory Possible

The Centers for Medicare and Medicaid Services is strongly 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 endorsed the idea of publishing a directory in August. 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

Better Quality at Integrated Groups?

University of Pittsburgh researchers say patients receiving care at integrated medical groups may be getting better-quality care, according to a study in the Dec. 5 issue of Annals of Internal Medicine. Dr. Ateev Mehrotra and colleagues analyzed data from 119 California physician groups that contracted with PacifiCare from 1999 to 2000. The authors found that patients in integrated medical groups were more likely than were those in independent practice associations to receive four of the six clinical quality measures—mammography, Pap smear screening, chlamydia screening, eye exams for diabetes patients, controller medications for asthma patients, and β-blockers for heart attack patients. Integrated medical groups were more likely to report using electronic medical records and quality improvement strategies, but that did not fully explain the difference, the authors said. The study was limited in that it only captured a fraction of potential quality measures and relied on self-reports, they said. In an editorial in the same issue, Dr. Lawrence P. Casalino of the University of Chicago said the results were not likely to be generalizable and should be interpreted with caution because they were based on only 19 large groups and six quality measures.

Consumer-Directed Plans Dictated

Many individuals enrolled in consumer-directed health plans may not have much of a choice in the matter, according to a report from the Center for Studying Health System Change. The report, based on survey responses from employers, found that about 39% of the 2.7 million American workers enrolled in employer-sponsored consumer-directed health plans had no other health plan choice in 2006. When employees had a choice of plans, they were more likely to choose a PPO or an HMO. Of the 8.9 million employees who had a choice of at least one other type of health plan, about 19% of employees chose consumer-directed health plans, compared with 55% of employees who chose PPO plans when given a choice. “Despite the buzz, consumer-directed health plans have barely gained a toehold among Americans with employer-sponsored insurance,” Jon Gabel, vice president of the Center for Studying Health System Change, said in a statement. The study was funded by the Robert Wood Johnson Foundation and is based on a 2006 random survey of more than 2,000 private and nonfederal employers with three or more workers. The survey's response rate was 48%.

Medicare Advantage Costs More

If the incoming Democrat-majority 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 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 for the beneficiaries the program is designed to serve,” Commonwealth Fund President Karen Davis said in a statement.

ALS Linked to Military Service

There is “limited and suggestive evidence” of a link between military service and the later development of amyotrophic lateral sclerosis (ALS), according to a report from the Institute of Medicine. A panel of experts convened by IOM reviewed the literature and identified one high-quality study that showed an association between military service and the development of ALS. Three other studies supported this link but had limitations. Another study did not show an association. The IOM committee recommended that the Department of Veterans Affairs, which sponsored the study, conduct additional research into the risk factors for ALS related to military service.

Public NPI Directory Possible

The Centers for Medicare and Medicaid Services is strongly 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 endorsed the idea of publishing a directory in August. 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

Better Quality at Integrated Groups?

University of Pittsburgh researchers say patients receiving care at integrated medical groups may be getting better-quality care, according to a study in the Dec. 5 issue of Annals of Internal Medicine. Dr. Ateev Mehrotra and colleagues analyzed data from 119 California physician groups that contracted with PacifiCare from 1999 to 2000. The authors found that patients in integrated medical groups were more likely than were those in independent practice associations to receive four of the six clinical quality measures—mammography, Pap smear screening, chlamydia screening, eye exams for diabetes patients, controller medications for asthma patients, and β-blockers for heart attack patients. Integrated medical groups were more likely to report using electronic medical records and quality improvement strategies, but that did not fully explain the difference, the authors said. The study was limited in that it only captured a fraction of potential quality measures and relied on self-reports, they said. In an editorial in the same issue, Dr. Lawrence P. Casalino of the University of Chicago said the results were not likely to be generalizable and should be interpreted with caution because they were based on only 19 large groups and six quality measures.

Consumer-Directed Plans Dictated

Many individuals enrolled in consumer-directed health plans may not have much of a choice in the matter, according to a report from the Center for Studying Health System Change. The report, based on survey responses from employers, found that about 39% of the 2.7 million American workers enrolled in employer-sponsored consumer-directed health plans had no other health plan choice in 2006. When employees had a choice of plans, they were more likely to choose a PPO or an HMO. Of the 8.9 million employees who had a choice of at least one other type of health plan, about 19% of employees chose consumer-directed health plans, compared with 55% of employees who chose PPO plans when given a choice. “Despite the buzz, consumer-directed health plans have barely gained a toehold among Americans with employer-sponsored insurance,” Jon Gabel, vice president of the Center for Studying Health System Change, said in a statement. The study was funded by the Robert Wood Johnson Foundation and is based on a 2006 random survey of more than 2,000 private and nonfederal employers with three or more workers. The survey's response rate was 48%.

Medicare Advantage Costs More

If the incoming Democrat-majority 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 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 for the beneficiaries the program is designed to serve,” Commonwealth Fund President Karen Davis said in a statement.

ALS Linked to Military Service

There is “limited and suggestive evidence” of a link between military service and the later development of amyotrophic lateral sclerosis (ALS), according to a report from the Institute of Medicine. A panel of experts convened by IOM reviewed the literature and identified one high-quality study that showed an association between military service and the development of ALS. Three other studies supported this link but had limitations. Another study did not show an association. The IOM committee recommended that the Department of Veterans Affairs, which sponsored the study, conduct additional research into the risk factors for ALS related to military service.

Public NPI Directory Possible

The Centers for Medicare and Medicaid Services is strongly 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 endorsed the idea of publishing a directory in August. 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

Better Quality at Integrated Groups?

University of Pittsburgh researchers say patients receiving care at integrated medical groups may be getting better-quality care, according to a study in the Dec. 5 issue of Annals of Internal Medicine. Dr. Ateev Mehrotra and colleagues analyzed data from 119 California physician groups that contracted with PacifiCare from 1999 to 2000. The authors found that patients in integrated medical groups were more likely than were those in independent practice associations to receive four of the six clinical quality measures—mammography, Pap smear screening, chlamydia screening, eye exams for diabetes patients, controller medications for asthma patients, and β-blockers for heart attack patients. Integrated medical groups were more likely to report using electronic medical records and quality improvement strategies, but that did not fully explain the difference, the authors said. The study was limited in that it only captured a fraction of potential quality measures and relied on self-reports, they said. In an editorial in the same issue, Dr. Lawrence P. Casalino of the University of Chicago said the results were not likely to be generalizable and should be interpreted with caution because they were based on only 19 large groups and six quality measures.

Consumer-Directed Plans Dictated

Many individuals enrolled in consumer-directed health plans may not have much of a choice in the matter, according to a report from the Center for Studying Health System Change. The report, based on survey responses from employers, found that about 39% of the 2.7 million American workers enrolled in employer-sponsored consumer-directed health plans had no other health plan choice in 2006. When employees had a choice of plans, they were more likely to choose a PPO or an HMO. Of the 8.9 million employees who had a choice of at least one other type of health plan, about 19% of employees chose consumer-directed health plans, compared with 55% of employees who chose PPO plans when given a choice. “Despite the buzz, consumer-directed health plans have barely gained a toehold among Americans with employer-sponsored insurance,” Jon Gabel, vice president of the Center for Studying Health System Change, said in a statement. The study was funded by the Robert Wood Johnson Foundation and is based on a 2006 random survey of more than 2,000 private and nonfederal employers with three or more workers. The survey's response rate was 48%.

Medicare Advantage Costs More

If the incoming Democrat-majority 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 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 for the beneficiaries the program is designed to serve,” Commonwealth Fund President Karen Davis said in a statement.

ALS Linked to Military Service

There is “limited and suggestive evidence” of a link between military service and the later development of amyotrophic lateral sclerosis (ALS), according to a report from the Institute of Medicine. A panel of experts convened by IOM reviewed the literature and identified one high-quality study that showed an association between military service and the development of ALS. Three other studies supported this link but had limitations. Another study did not show an association. The IOM committee recommended that the Department of Veterans Affairs, which sponsored the study, conduct additional research into the risk factors for ALS related to military service.

The field of palliative care took a major step forward last year, when members of the American Board of Medical Specialties voted to approve hospice and palliative medicine as a recognized subspecialty.

The application to recognize the subspecialty had broad support and was cosponsored by 10 medical specialty boards.

As a result, physicians in several specialties–including psychiatry, neurology, internal medicine, family medicine, pediatrics, surgery, emergency medicine, and obstetrics and gynecology–will be able to seek the certification.

The first certification examination is expected to be administered in 2008, according to Dr. F. Daniel Duffy, senior adviser to the president of the American Board of Internal Medicine.

“It's going to be a real boost to patient care,” Dr. Duffy said.

The milestone is just the latest in a series of developments in the size and status of the field of palliative care. Between 2000 and 2004, the number of hospital-owned palliative care programs in the United States increased by nearly 75%, jumping from 632 in 2000 to 1,102 in 2004.

As of 2004, 63% of large hospitals–those with at least 200 general adult beds–reported that they had some type of palliative care program in operation, according to the Center to Advance Palliative Care.

Last summer, palliative medicine received a nod from the Accreditation Council for Graduate Medical Education (ACGME) when the organization voted to approve an accreditation process for hospice and palliative medicine fellowship training programs.

ACGME is expected to begin accepting applications this summer.

“We're well beyond the tipping point,” said Dr. Diane Meier, director of the Center to Advance Palliative Care and director of the Hertzberg Palliative Care Institute at Mount Sinai School of Medicine in New York.

At Dr. Meier's institution, palliative care has become so well accepted that asking for a palliative care consult is as routine as calling for an infectious disease consult.

Physicians no longer see it as a personal failure in their treatment of the patient to get assistance from palliative care, she said.

Now the focus has shifted from selling the concept of palliative medicine to ensuring that programs across the country have consistently high standards, Dr. Meier said.

Work is already underway in this area. The National Consensus Project for Quality Palliative Care, which is sponsored by three national palliative medicine organizations, has released quality guidelines.

These guidelines include having interdisciplinary teams, making grief and bereavement services available to patients and families, and providing evidence-based pain and symptom relief, among others.

The standards are a guidepost but will be challenging for smaller programs, Dr. Meier said, and should be filtered by the size of the facility, the staff available, and the needs of the institution.

The National Quality Forum approved its own framework for palliative and hospice care in 2006. “That's real legitimacy,” Dr. Meier said.

In an effort to ensure that new programs have high-quality processes in place, the Center to Advance Palliative Care launched the Palliative Care Leadership Centers–six centers of excellence in palliative care across the country charged with the taks of training teams of health care providers.

The program includes intensive, 2-day training sessions in which teams are sent to one of the six centers and leaders at the centers act as mentors for a year after training.

The cost of the program is about $1,750 for a four-person team.

When the site visits started in 2004, Dr. Meier and others at the Center to Advance Palliative Care estimated that about 30% of the teams trained would successfully establish a program, she said. But she said the percentage has been closer to 70% to date.

However, the process of establishing such programs is not a speedy one, and it sometimes takes more than a year for teams to get their programs up and running, she said.

The Mount Carmel Health System in Columbus, Ohio, is one of the six leadership centers. The program was launched in 1997 in an effort to treat patients with serious, advanced diseases who were not candidates for hospice care, said Mary Ann Gill, who serves as executive director of palliative care services at Mount Carmel.

The program at Mount Carmel, which includes a palliative care consult team and three dedicated palliative care units across three hospitals, is popular with teams working to start programs in community hospitals.

During the training, members of a palliative care team are encouraged to get to know one another better and begin drafting a work plan to take back to their institution.

The training focuses on the clinical aspects of the program, as well as on financial management and how to sustain the program, Ms. Gill said.

Much of the interest in palliative medicine has been from physicians at midcareer, but there is increasing interest among young physicians and residents, said Dr. Philip H. Santa-Emma, medical director for the palliative care service at Mount Carmel.

“I've seen a huge increase in the number of residents coming through,” Dr. Santa-Emma said.

But the training of new physicians in palliative care also represents one of the next big challenges in the field, Dr. Meier said.

Currently, a cap exists on the number of residency positions that are funded by Medicare. And that limit makes it difficult for a new subspecialty to gain a foothold, she said.

Palliative care fellowships are currently funded by philanthropy.

As the field continues to move forward, there also needs to be continual education of the health care team about when to get palliative care involved, Dr. Santa-Emma said.

This is a message that has to get out to all members of the health care team, not just physicians, he said.

And members of the palliative care team need to figure out better ways to integrate their care into the intensive care unit and the emergency department, he said.

The field of palliative care took a major step forward last year, when members of the American Board of Medical Specialties voted to approve hospice and palliative medicine as a recognized subspecialty.

The application to recognize the subspecialty had broad support and was cosponsored by 10 medical specialty boards.

As a result, physicians in several specialties–including psychiatry, neurology, internal medicine, family medicine, pediatrics, surgery, emergency medicine, and obstetrics and gynecology–will be able to seek the certification.

The first certification examination is expected to be administered in 2008, according to Dr. F. Daniel Duffy, senior adviser to the president of the American Board of Internal Medicine.

“It's going to be a real boost to patient care,” Dr. Duffy said.

The milestone is just the latest in a series of developments in the size and status of the field of palliative care. Between 2000 and 2004, the number of hospital-owned palliative care programs in the United States increased by nearly 75%, jumping from 632 in 2000 to 1,102 in 2004.

As of 2004, 63% of large hospitals–those with at least 200 general adult beds–reported that they had some type of palliative care program in operation, according to the Center to Advance Palliative Care.

Last summer, palliative medicine received a nod from the Accreditation Council for Graduate Medical Education (ACGME) when the organization voted to approve an accreditation process for hospice and palliative medicine fellowship training programs.

ACGME is expected to begin accepting applications this summer.

“We're well beyond the tipping point,” said Dr. Diane Meier, director of the Center to Advance Palliative Care and director of the Hertzberg Palliative Care Institute at Mount Sinai School of Medicine in New York.

At Dr. Meier's institution, palliative care has become so well accepted that asking for a palliative care consult is as routine as calling for an infectious disease consult.

Physicians no longer see it as a personal failure in their treatment of the patient to get assistance from palliative care, she said.

Now the focus has shifted from selling the concept of palliative medicine to ensuring that programs across the country have consistently high standards, Dr. Meier said.

Work is already underway in this area. The National Consensus Project for Quality Palliative Care, which is sponsored by three national palliative medicine organizations, has released quality guidelines.

These guidelines include having interdisciplinary teams, making grief and bereavement services available to patients and families, and providing evidence-based pain and symptom relief, among others.

The standards are a guidepost but will be challenging for smaller programs, Dr. Meier said, and should be filtered by the size of the facility, the staff available, and the needs of the institution.

The National Quality Forum approved its own framework for palliative and hospice care in 2006. “That's real legitimacy,” Dr. Meier said.

In an effort to ensure that new programs have high-quality processes in place, the Center to Advance Palliative Care launched the Palliative Care Leadership Centers–six centers of excellence in palliative care across the country charged with the taks of training teams of health care providers.

The program includes intensive, 2-day training sessions in which teams are sent to one of the six centers and leaders at the centers act as mentors for a year after training.

The cost of the program is about $1,750 for a four-person team.

When the site visits started in 2004, Dr. Meier and others at the Center to Advance Palliative Care estimated that about 30% of the teams trained would successfully establish a program, she said. But she said the percentage has been closer to 70% to date.

However, the process of establishing such programs is not a speedy one, and it sometimes takes more than a year for teams to get their programs up and running, she said.

The Mount Carmel Health System in Columbus, Ohio, is one of the six leadership centers. The program was launched in 1997 in an effort to treat patients with serious, advanced diseases who were not candidates for hospice care, said Mary Ann Gill, who serves as executive director of palliative care services at Mount Carmel.

The program at Mount Carmel, which includes a palliative care consult team and three dedicated palliative care units across three hospitals, is popular with teams working to start programs in community hospitals.

During the training, members of a palliative care team are encouraged to get to know one another better and begin drafting a work plan to take back to their institution.

The training focuses on the clinical aspects of the program, as well as on financial management and how to sustain the program, Ms. Gill said.

Much of the interest in palliative medicine has been from physicians at midcareer, but there is increasing interest among young physicians and residents, said Dr. Philip H. Santa-Emma, medical director for the palliative care service at Mount Carmel.

“I've seen a huge increase in the number of residents coming through,” Dr. Santa-Emma said.

But the training of new physicians in palliative care also represents one of the next big challenges in the field, Dr. Meier said.

Currently, a cap exists on the number of residency positions that are funded by Medicare. And that limit makes it difficult for a new subspecialty to gain a foothold, she said.

Palliative care fellowships are currently funded by philanthropy.

As the field continues to move forward, there also needs to be continual education of the health care team about when to get palliative care involved, Dr. Santa-Emma said.

This is a message that has to get out to all members of the health care team, not just physicians, he said.

And members of the palliative care team need to figure out better ways to integrate their care into the intensive care unit and the emergency department, he said.

The field of palliative care took a major step forward last year, when members of the American Board of Medical Specialties voted to approve hospice and palliative medicine as a recognized subspecialty.

The application to recognize the subspecialty had broad support and was cosponsored by 10 medical specialty boards.

As a result, physicians in several specialties–including psychiatry, neurology, internal medicine, family medicine, pediatrics, surgery, emergency medicine, and obstetrics and gynecology–will be able to seek the certification.

The first certification examination is expected to be administered in 2008, according to Dr. F. Daniel Duffy, senior adviser to the president of the American Board of Internal Medicine.

“It's going to be a real boost to patient care,” Dr. Duffy said.

The milestone is just the latest in a series of developments in the size and status of the field of palliative care. Between 2000 and 2004, the number of hospital-owned palliative care programs in the United States increased by nearly 75%, jumping from 632 in 2000 to 1,102 in 2004.

As of 2004, 63% of large hospitals–those with at least 200 general adult beds–reported that they had some type of palliative care program in operation, according to the Center to Advance Palliative Care.

Last summer, palliative medicine received a nod from the Accreditation Council for Graduate Medical Education (ACGME) when the organization voted to approve an accreditation process for hospice and palliative medicine fellowship training programs.

ACGME is expected to begin accepting applications this summer.

“We're well beyond the tipping point,” said Dr. Diane Meier, director of the Center to Advance Palliative Care and director of the Hertzberg Palliative Care Institute at Mount Sinai School of Medicine in New York.

At Dr. Meier's institution, palliative care has become so well accepted that asking for a palliative care consult is as routine as calling for an infectious disease consult.

Physicians no longer see it as a personal failure in their treatment of the patient to get assistance from palliative care, she said.

Now the focus has shifted from selling the concept of palliative medicine to ensuring that programs across the country have consistently high standards, Dr. Meier said.

Work is already underway in this area. The National Consensus Project for Quality Palliative Care, which is sponsored by three national palliative medicine organizations, has released quality guidelines.

These guidelines include having interdisciplinary teams, making grief and bereavement services available to patients and families, and providing evidence-based pain and symptom relief, among others.

The standards are a guidepost but will be challenging for smaller programs, Dr. Meier said, and should be filtered by the size of the facility, the staff available, and the needs of the institution.

The National Quality Forum approved its own framework for palliative and hospice care in 2006. “That's real legitimacy,” Dr. Meier said.

In an effort to ensure that new programs have high-quality processes in place, the Center to Advance Palliative Care launched the Palliative Care Leadership Centers–six centers of excellence in palliative care across the country charged with the taks of training teams of health care providers.

The program includes intensive, 2-day training sessions in which teams are sent to one of the six centers and leaders at the centers act as mentors for a year after training.

The cost of the program is about $1,750 for a four-person team.

When the site visits started in 2004, Dr. Meier and others at the Center to Advance Palliative Care estimated that about 30% of the teams trained would successfully establish a program, she said. But she said the percentage has been closer to 70% to date.

However, the process of establishing such programs is not a speedy one, and it sometimes takes more than a year for teams to get their programs up and running, she said.

The Mount Carmel Health System in Columbus, Ohio, is one of the six leadership centers. The program was launched in 1997 in an effort to treat patients with serious, advanced diseases who were not candidates for hospice care, said Mary Ann Gill, who serves as executive director of palliative care services at Mount Carmel.

The program at Mount Carmel, which includes a palliative care consult team and three dedicated palliative care units across three hospitals, is popular with teams working to start programs in community hospitals.

During the training, members of a palliative care team are encouraged to get to know one another better and begin drafting a work plan to take back to their institution.

The training focuses on the clinical aspects of the program, as well as on financial management and how to sustain the program, Ms. Gill said.

Much of the interest in palliative medicine has been from physicians at midcareer, but there is increasing interest among young physicians and residents, said Dr. Philip H. Santa-Emma, medical director for the palliative care service at Mount Carmel.

“I've seen a huge increase in the number of residents coming through,” Dr. Santa-Emma said.

But the training of new physicians in palliative care also represents one of the next big challenges in the field, Dr. Meier said.

Currently, a cap exists on the number of residency positions that are funded by Medicare. And that limit makes it difficult for a new subspecialty to gain a foothold, she said.

Palliative care fellowships are currently funded by philanthropy.

As the field continues to move forward, there also needs to be continual education of the health care team about when to get palliative care involved, Dr. Santa-Emma said.

This is a message that has to get out to all members of the health care team, not just physicians, he said.

And members of the palliative care team need to figure out better ways to integrate their care into the intensive care unit and the emergency department, he said.

VA Underspent on Mental Health

Officials at the Department of Veterans Affairs failed to spend all of the funds planned for expanding mental health services to veterans in 2005 and 2006, according to a report from the Government Accountability Office. In the report, GAO officials call on VA leadership to improve how it tracks resources for the agency's mental health strategic plan initiatives. The report, which was requested by Democrats on the House Veterans Affairs Committee, found that VA failed to spend $12 million of $100 million planned for expanding mental health services in fiscal year 2005 and failed to spend approximately $42 million out of $200 million in planned funding in fiscal year 2006. The GAO report also found that the agency's tracking of funds for the plan was “inadequate.” While VA officials did not comment on the findings, the report's conclusions have drawn criticism on Capitol Hill. “This report reinforces the need for the VA to present a real plan for how they intend to care for the thousands of new veterans returning home with mental health needs,” Sen. Patty Murray (D-Wash.) said in a statement. “The VA plan must address the need to increase spending to meet demand, the need to fully disperse current funding, and the need to ensure that mental health funding is being spent on mental health initiatives.”

Underage Drinking Legislation

Congress has passed legislation aimed at curbing teen drinking and better coordinating the efforts of federal agencies in this area. The legislation, the Sober Truth on Preventing (STOP) Underage Drinking Act (H.R. 864), was expected to be signed by the President at press time. The bill authorizes grants to prevent binge drinking by college students and calls for research on the scope of underage drinking. The legislation enjoys support from both the medical community and the alcohol industry. The National Beer Wholesalers Association said the bill provides federal, state, and local governments with the tools they need to help prevent underage drinking. And the American Medical Association praised Congress for passing the first national underage drinking prevention legislation. “Alcohol is the number one drug of choice for young people, and the age of initiation keeps getting younger. Alcohol causes memory and learning impairment, possibly irreversible in the adolescent brain,” AMA president-elect Dr. Ronald M. Davis said in a statement.

Support for the Drug Czar

Members of Congress signaled their support for the White House Office of National Drug Policy by voting to authorize the office for another 5 years. The legislation, H.R. 6344, also reauthorizes the National Youth Anti-Drug Media Campaign and authorizes increased funding for a program to coordinate federal, state, and local efforts to reduce drug trafficking and production. Having a national “drug czar” at the cabinet level is essential to coordinate federal drug policy, said Sen. Joseph R. Biden, Jr. (D-Del.). “Today, we must continue to make drug policy a priority,” he said in a statement. “This legislation retains as its central goal that every administration and every president be held accountable when it comes to drug policy.”

Mental Health Research Grants

A mental health research funding organization awarded a total of $19 million to support studies on the causes, treatment, and prevention of severe mental illnesses in 2006. NARSAD: The Mental Health Research Association awarded grants to 273 scientists from around the world last year. The various research projects include studies to identify the genes associated with schizophrenia, bipolar disorder, anxiety, attention-deficit hyperactivity disorder, autism, and depression; to explore the role of stress in the development of mental illnesses; and to examine the effects of antidepressant use during pregnancy. The organization, which is supported by donor funds, has distributed more than $199 million in grants since 1987. “This group of scientists will extend the research potential for mental health,” Constance E. Lieber, president of NARSAD, said in a statement. “Their work will continue to accelerate progress in the study of all areas of psychiatric disorders.”

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be commissioner of the Food and Drug Administration, 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 voted against invoking cloture and against confirmation. Sen. Grassley 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. With Democrats' taking control of Congress, Sen. Grassley will lose his Finance Committee chairmanship. But he warned his colleagues across the aisle 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.

VA Underspent on Mental Health

Officials at the Department of Veterans Affairs failed to spend all of the funds planned for expanding mental health services to veterans in 2005 and 2006, according to a report from the Government Accountability Office. In the report, GAO officials call on VA leadership to improve how it tracks resources for the agency's mental health strategic plan initiatives. The report, which was requested by Democrats on the House Veterans Affairs Committee, found that VA failed to spend $12 million of $100 million planned for expanding mental health services in fiscal year 2005 and failed to spend approximately $42 million out of $200 million in planned funding in fiscal year 2006. The GAO report also found that the agency's tracking of funds for the plan was “inadequate.” While VA officials did not comment on the findings, the report's conclusions have drawn criticism on Capitol Hill. “This report reinforces the need for the VA to present a real plan for how they intend to care for the thousands of new veterans returning home with mental health needs,” Sen. Patty Murray (D-Wash.) said in a statement. “The VA plan must address the need to increase spending to meet demand, the need to fully disperse current funding, and the need to ensure that mental health funding is being spent on mental health initiatives.”

Underage Drinking Legislation

Congress has passed legislation aimed at curbing teen drinking and better coordinating the efforts of federal agencies in this area. The legislation, the Sober Truth on Preventing (STOP) Underage Drinking Act (H.R. 864), was expected to be signed by the President at press time. The bill authorizes grants to prevent binge drinking by college students and calls for research on the scope of underage drinking. The legislation enjoys support from both the medical community and the alcohol industry. The National Beer Wholesalers Association said the bill provides federal, state, and local governments with the tools they need to help prevent underage drinking. And the American Medical Association praised Congress for passing the first national underage drinking prevention legislation. “Alcohol is the number one drug of choice for young people, and the age of initiation keeps getting younger. Alcohol causes memory and learning impairment, possibly irreversible in the adolescent brain,” AMA president-elect Dr. Ronald M. Davis said in a statement.

Support for the Drug Czar

Members of Congress signaled their support for the White House Office of National Drug Policy by voting to authorize the office for another 5 years. The legislation, H.R. 6344, also reauthorizes the National Youth Anti-Drug Media Campaign and authorizes increased funding for a program to coordinate federal, state, and local efforts to reduce drug trafficking and production. Having a national “drug czar” at the cabinet level is essential to coordinate federal drug policy, said Sen. Joseph R. Biden, Jr. (D-Del.). “Today, we must continue to make drug policy a priority,” he said in a statement. “This legislation retains as its central goal that every administration and every president be held accountable when it comes to drug policy.”

Mental Health Research Grants

A mental health research funding organization awarded a total of $19 million to support studies on the causes, treatment, and prevention of severe mental illnesses in 2006. NARSAD: The Mental Health Research Association awarded grants to 273 scientists from around the world last year. The various research projects include studies to identify the genes associated with schizophrenia, bipolar disorder, anxiety, attention-deficit hyperactivity disorder, autism, and depression; to explore the role of stress in the development of mental illnesses; and to examine the effects of antidepressant use during pregnancy. The organization, which is supported by donor funds, has distributed more than $199 million in grants since 1987. “This group of scientists will extend the research potential for mental health,” Constance E. Lieber, president of NARSAD, said in a statement. “Their work will continue to accelerate progress in the study of all areas of psychiatric disorders.”

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be commissioner of the Food and Drug Administration, 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 voted against invoking cloture and against confirmation. Sen. Grassley 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. With Democrats' taking control of Congress, Sen. Grassley will lose his Finance Committee chairmanship. But he warned his colleagues across the aisle 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.

VA Underspent on Mental Health

Officials at the Department of Veterans Affairs failed to spend all of the funds planned for expanding mental health services to veterans in 2005 and 2006, according to a report from the Government Accountability Office. In the report, GAO officials call on VA leadership to improve how it tracks resources for the agency's mental health strategic plan initiatives. The report, which was requested by Democrats on the House Veterans Affairs Committee, found that VA failed to spend $12 million of $100 million planned for expanding mental health services in fiscal year 2005 and failed to spend approximately $42 million out of $200 million in planned funding in fiscal year 2006. The GAO report also found that the agency's tracking of funds for the plan was “inadequate.” While VA officials did not comment on the findings, the report's conclusions have drawn criticism on Capitol Hill. “This report reinforces the need for the VA to present a real plan for how they intend to care for the thousands of new veterans returning home with mental health needs,” Sen. Patty Murray (D-Wash.) said in a statement. “The VA plan must address the need to increase spending to meet demand, the need to fully disperse current funding, and the need to ensure that mental health funding is being spent on mental health initiatives.”

Underage Drinking Legislation

Congress has passed legislation aimed at curbing teen drinking and better coordinating the efforts of federal agencies in this area. The legislation, the Sober Truth on Preventing (STOP) Underage Drinking Act (H.R. 864), was expected to be signed by the President at press time. The bill authorizes grants to prevent binge drinking by college students and calls for research on the scope of underage drinking. The legislation enjoys support from both the medical community and the alcohol industry. The National Beer Wholesalers Association said the bill provides federal, state, and local governments with the tools they need to help prevent underage drinking. And the American Medical Association praised Congress for passing the first national underage drinking prevention legislation. “Alcohol is the number one drug of choice for young people, and the age of initiation keeps getting younger. Alcohol causes memory and learning impairment, possibly irreversible in the adolescent brain,” AMA president-elect Dr. Ronald M. Davis said in a statement.

Support for the Drug Czar

Members of Congress signaled their support for the White House Office of National Drug Policy by voting to authorize the office for another 5 years. The legislation, H.R. 6344, also reauthorizes the National Youth Anti-Drug Media Campaign and authorizes increased funding for a program to coordinate federal, state, and local efforts to reduce drug trafficking and production. Having a national “drug czar” at the cabinet level is essential to coordinate federal drug policy, said Sen. Joseph R. Biden, Jr. (D-Del.). “Today, we must continue to make drug policy a priority,” he said in a statement. “This legislation retains as its central goal that every administration and every president be held accountable when it comes to drug policy.”

Mental Health Research Grants

A mental health research funding organization awarded a total of $19 million to support studies on the causes, treatment, and prevention of severe mental illnesses in 2006. NARSAD: The Mental Health Research Association awarded grants to 273 scientists from around the world last year. The various research projects include studies to identify the genes associated with schizophrenia, bipolar disorder, anxiety, attention-deficit hyperactivity disorder, autism, and depression; to explore the role of stress in the development of mental illnesses; and to examine the effects of antidepressant use during pregnancy. The organization, which is supported by donor funds, has distributed more than $199 million in grants since 1987. “This group of scientists will extend the research potential for mental health,” Constance E. Lieber, president of NARSAD, said in a statement. “Their work will continue to accelerate progress in the study of all areas of psychiatric disorders.”

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be commissioner of the Food and Drug Administration, 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 voted against invoking cloture and against confirmation. Sen. Grassley 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. With Democrats' taking control of Congress, Sen. Grassley will lose his Finance Committee chairmanship. But he warned his colleagues across the aisle 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.

Physicians who report quality data to Medicare will receive bonus payments of 1.5% starting in July, under a provision of the omnibus legislation passed at the end of the 109th Congress.

Under the provision, bonus payments would be linked to participation in the Physician Voluntary Reporting Program administered by the Centers for Medicare and Medicaid Services. The program, which allows physicians to submit quality data to CMS and receive feedback on their performance, was launched in 2006.

In 2007, CMS officials have expanded the number of quality measures included in the program from 16 to 45. CMS also released an additional set of 21 measures that it plans to introduce later in the year. Bonus payments will apply to services delivered from July 1 through Dec. 31, 2007. Under the legislation, CMS must post any changes to the quality measures by no later than April 1.

More details on the program will be forthcoming from CMS, hopefully in January, according to a CMS spokesperson. For now, Congress has set up some parameters for reporting to the voluntary program. For example, if there are three or fewer measures that are applicable to a physician's practice, participating physicians must report on each relevant quality measure. If four or more quality measures are applicable, participating physicians must report on at least three measures.

CMS is required to publish a set of proposed quality measures for 2008 no later than Aug. 15 with a final set of measures to be published by Nov. 15. Congress also has instructed the secretary of Health and Human Services to address a mechanism for physicians to submit data through a medical registry system, such as the Society of Thoracic Surgeons National Database, in 2008.

Officials at the American Medical Association plan to work with CMS on the implementation of the quality reporting program. The AMA noted that it will work to ensure that the quality measures developed by its Physician Consortium for Performance Improvement continue to be the foundation of Medicare's reporting program.

“We will work closely with the incoming Congress to address concerns with the current reporting framework,” said Dr. Cecil Wilson, AMA board chair, in a statement.

Officials at the American College of Physicians voiced concerns about the program.

Dr. Michael S. Barr, vice president of practice, advocacy, and improvement at the ACP, said that not all of the 45 measure being rolled out in January have been endorsed by either the National Quality Forum or the AQA alliance, originally known as the Ambulatory Care Quality Alliance. Although some measures are going through the process, they could still be rejected.

“We're concerned about going too fast,” he said.

ACP officials also would like to hear more from CMS about the results of the first year of the program, including blinded quality data. “We would love to see information from CMS about what happened in 2006,” he said.

For more information about the program, visit www.cms.hhs.gov/PVRP

Physicians who report quality data to Medicare will receive bonus payments of 1.5% starting in July, under a provision of the omnibus legislation passed at the end of the 109th Congress.

Under the provision, bonus payments would be linked to participation in the Physician Voluntary Reporting Program administered by the Centers for Medicare and Medicaid Services. The program, which allows physicians to submit quality data to CMS and receive feedback on their performance, was launched in 2006.

In 2007, CMS officials have expanded the number of quality measures included in the program from 16 to 45. CMS also released an additional set of 21 measures that it plans to introduce later in the year. Bonus payments will apply to services delivered from July 1 through Dec. 31, 2007. Under the legislation, CMS must post any changes to the quality measures by no later than April 1.

More details on the program will be forthcoming from CMS, hopefully in January, according to a CMS spokesperson. For now, Congress has set up some parameters for reporting to the voluntary program. For example, if there are three or fewer measures that are applicable to a physician's practice, participating physicians must report on each relevant quality measure. If four or more quality measures are applicable, participating physicians must report on at least three measures.

CMS is required to publish a set of proposed quality measures for 2008 no later than Aug. 15 with a final set of measures to be published by Nov. 15. Congress also has instructed the secretary of Health and Human Services to address a mechanism for physicians to submit data through a medical registry system, such as the Society of Thoracic Surgeons National Database, in 2008.

Officials at the American Medical Association plan to work with CMS on the implementation of the quality reporting program. The AMA noted that it will work to ensure that the quality measures developed by its Physician Consortium for Performance Improvement continue to be the foundation of Medicare's reporting program.

“We will work closely with the incoming Congress to address concerns with the current reporting framework,” said Dr. Cecil Wilson, AMA board chair, in a statement.

Officials at the American College of Physicians voiced concerns about the program.

Dr. Michael S. Barr, vice president of practice, advocacy, and improvement at the ACP, said that not all of the 45 measure being rolled out in January have been endorsed by either the National Quality Forum or the AQA alliance, originally known as the Ambulatory Care Quality Alliance. Although some measures are going through the process, they could still be rejected.

“We're concerned about going too fast,” he said.

ACP officials also would like to hear more from CMS about the results of the first year of the program, including blinded quality data. “We would love to see information from CMS about what happened in 2006,” he said.

For more information about the program, visit www.cms.hhs.gov/PVRP

Physicians who report quality data to Medicare will receive bonus payments of 1.5% starting in July, under a provision of the omnibus legislation passed at the end of the 109th Congress.

Under the provision, bonus payments would be linked to participation in the Physician Voluntary Reporting Program administered by the Centers for Medicare and Medicaid Services. The program, which allows physicians to submit quality data to CMS and receive feedback on their performance, was launched in 2006.

In 2007, CMS officials have expanded the number of quality measures included in the program from 16 to 45. CMS also released an additional set of 21 measures that it plans to introduce later in the year. Bonus payments will apply to services delivered from July 1 through Dec. 31, 2007. Under the legislation, CMS must post any changes to the quality measures by no later than April 1.

More details on the program will be forthcoming from CMS, hopefully in January, according to a CMS spokesperson. For now, Congress has set up some parameters for reporting to the voluntary program. For example, if there are three or fewer measures that are applicable to a physician's practice, participating physicians must report on each relevant quality measure. If four or more quality measures are applicable, participating physicians must report on at least three measures.

CMS is required to publish a set of proposed quality measures for 2008 no later than Aug. 15 with a final set of measures to be published by Nov. 15. Congress also has instructed the secretary of Health and Human Services to address a mechanism for physicians to submit data through a medical registry system, such as the Society of Thoracic Surgeons National Database, in 2008.

Officials at the American Medical Association plan to work with CMS on the implementation of the quality reporting program. The AMA noted that it will work to ensure that the quality measures developed by its Physician Consortium for Performance Improvement continue to be the foundation of Medicare's reporting program.

“We will work closely with the incoming Congress to address concerns with the current reporting framework,” said Dr. Cecil Wilson, AMA board chair, in a statement.

Officials at the American College of Physicians voiced concerns about the program.

Dr. Michael S. Barr, vice president of practice, advocacy, and improvement at the ACP, said that not all of the 45 measure being rolled out in January have been endorsed by either the National Quality Forum or the AQA alliance, originally known as the Ambulatory Care Quality Alliance. Although some measures are going through the process, they could still be rejected.

“We're concerned about going too fast,” he said.

ACP officials also would like to hear more from CMS about the results of the first year of the program, including blinded quality data. “We would love to see information from CMS about what happened in 2006,” he said.

For more information about the program, visit www.cms.hhs.gov/PVRP

Public NPI Directory Possible

The Centers for Medicare and Medicaid Services is strongly 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. But the law did not allow publication of a directory of NPI providers. Physicians have said that such a directory helps facilitate referrals. Medicare's Practicing Physicians Advisory Council endorsed the idea of publishing a directory in August. 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

WSJ.com/Harris

Medicare Advantage Costs More

If the incoming Democrat-majority Congress is looking for funding to expand the Medicare drug benefit, Medicare Advantage may be a ripe target, according to an analysis by researchers at the Commonwealth Fund. They 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 for the beneficiaries the program is designed to serve,” Commonwealth Fund President Karen Davis said in a statement.

Consumer-Directed Plans Dictated

Many individuals enrolled in consumer-directed health plans may not have much of a choice in the matter, according to a report from the Center for Studying Health System Change. The report, based on survey responses from employers, found that about 39% of the 2.7 million American workers enrolled in employer-sponsored consumer-directed health plans had no other health plan choice in 2006. When employees had a choice of plans, they were more likely to choose a PPO or an HMO. Of the 8.9 million employees who had a choice of at least one other type of health plan, about 19% of employees chose consumer-directed health plans, compared with 55% of employees who chose PPO plans when given a choice. “Despite the buzz, consumer-directed health plans have barely gained a toehold among Americans with employer-sponsored insurance,” Jon Gabel, vice president of the Center for Studying Health System Change, said in a statement. The study was funded by the Robert Wood Johnson Foundation and is based on a 2006 random survey of more than 2,000 private and nonfederal employers with three or more workers. The survey's response rate was 48%.

ALS Linked to Military Service

There is “limited and suggestive evidence” of a link between military service and the later development of amyotrophic lateral sclerosis (ALS), according to a report from the Institute of Medicine. A panel of experts convened by IOM reviewed the literature and identified one high-quality study that showed an association between military service and the development of ALS. Three other studies supported this link but had limitations. Another study did not show an association. The IOM committee recommended that the Department of Veterans Affairs, which sponsored the study, conduct additional research into the risk factors for ALS related to military service.

Better Quality at Integrated Groups?

University of Pittsburgh researchers say patients receiving care at integrated medical groups may get better-quality care, according to a study in the Dec. 5 issue of Annals of Internal Medicine. Dr. Ateev Mehrotra and colleagues analyzed data from 119 California physician groups that contracted with PacifiCare from 1999 to 2000. Patients in integrated medical groups were more likely than were those in independent practice associations to receive four of the six clinical quality measures—mammography, Pap smear screening, chlamydia screening, eye exams for diabetes patients, controller medications for asthma patients, and β-blockers for heart attack patients. Integrated medical groups were more likely to report using electronic medical records and quality improvement strategies, but that did not fully explain the difference, the authors said. The study was limited in that it only captured a fraction of potential quality measures and relied on self-reports, they said. In an editorial, Dr. Lawrence P. Casalino of the University of Chicago said the results were not likely to be generalizable and should be interpreted with caution since they were based on only 19 large groups and six quality measures.

Public NPI Directory Possible

The Centers for Medicare and Medicaid Services is strongly 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. But the law did not allow publication of a directory of NPI providers. Physicians have said that such a directory helps facilitate referrals. Medicare's Practicing Physicians Advisory Council endorsed the idea of publishing a directory in August. 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

WSJ.com/Harris

Medicare Advantage Costs More

If the incoming Democrat-majority Congress is looking for funding to expand the Medicare drug benefit, Medicare Advantage may be a ripe target, according to an analysis by researchers at the Commonwealth Fund. They 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 for the beneficiaries the program is designed to serve,” Commonwealth Fund President Karen Davis said in a statement.

Consumer-Directed Plans Dictated

Many individuals enrolled in consumer-directed health plans may not have much of a choice in the matter, according to a report from the Center for Studying Health System Change. The report, based on survey responses from employers, found that about 39% of the 2.7 million American workers enrolled in employer-sponsored consumer-directed health plans had no other health plan choice in 2006. When employees had a choice of plans, they were more likely to choose a PPO or an HMO. Of the 8.9 million employees who had a choice of at least one other type of health plan, about 19% of employees chose consumer-directed health plans, compared with 55% of employees who chose PPO plans when given a choice. “Despite the buzz, consumer-directed health plans have barely gained a toehold among Americans with employer-sponsored insurance,” Jon Gabel, vice president of the Center for Studying Health System Change, said in a statement. The study was funded by the Robert Wood Johnson Foundation and is based on a 2006 random survey of more than 2,000 private and nonfederal employers with three or more workers. The survey's response rate was 48%.

ALS Linked to Military Service

There is “limited and suggestive evidence” of a link between military service and the later development of amyotrophic lateral sclerosis (ALS), according to a report from the Institute of Medicine. A panel of experts convened by IOM reviewed the literature and identified one high-quality study that showed an association between military service and the development of ALS. Three other studies supported this link but had limitations. Another study did not show an association. The IOM committee recommended that the Department of Veterans Affairs, which sponsored the study, conduct additional research into the risk factors for ALS related to military service.

Better Quality at Integrated Groups?

University of Pittsburgh researchers say patients receiving care at integrated medical groups may get better-quality care, according to a study in the Dec. 5 issue of Annals of Internal Medicine. Dr. Ateev Mehrotra and colleagues analyzed data from 119 California physician groups that contracted with PacifiCare from 1999 to 2000. Patients in integrated medical groups were more likely than were those in independent practice associations to receive four of the six clinical quality measures—mammography, Pap smear screening, chlamydia screening, eye exams for diabetes patients, controller medications for asthma patients, and β-blockers for heart attack patients. Integrated medical groups were more likely to report using electronic medical records and quality improvement strategies, but that did not fully explain the difference, the authors said. The study was limited in that it only captured a fraction of potential quality measures and relied on self-reports, they said. In an editorial, Dr. Lawrence P. Casalino of the University of Chicago said the results were not likely to be generalizable and should be interpreted with caution since they were based on only 19 large groups and six quality measures.

Public NPI Directory Possible

The Centers for Medicare and Medicaid Services is strongly 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. But the law did not allow publication of a directory of NPI providers. Physicians have said that such a directory helps facilitate referrals. Medicare's Practicing Physicians Advisory Council endorsed the idea of publishing a directory in August. 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

WSJ.com/Harris

Medicare Advantage Costs More

If the incoming Democrat-majority Congress is looking for funding to expand the Medicare drug benefit, Medicare Advantage may be a ripe target, according to an analysis by researchers at the Commonwealth Fund. They 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 for the beneficiaries the program is designed to serve,” Commonwealth Fund President Karen Davis said in a statement.

Consumer-Directed Plans Dictated

Many individuals enrolled in consumer-directed health plans may not have much of a choice in the matter, according to a report from the Center for Studying Health System Change. The report, based on survey responses from employers, found that about 39% of the 2.7 million American workers enrolled in employer-sponsored consumer-directed health plans had no other health plan choice in 2006. When employees had a choice of plans, they were more likely to choose a PPO or an HMO. Of the 8.9 million employees who had a choice of at least one other type of health plan, about 19% of employees chose consumer-directed health plans, compared with 55% of employees who chose PPO plans when given a choice. “Despite the buzz, consumer-directed health plans have barely gained a toehold among Americans with employer-sponsored insurance,” Jon Gabel, vice president of the Center for Studying Health System Change, said in a statement. The study was funded by the Robert Wood Johnson Foundation and is based on a 2006 random survey of more than 2,000 private and nonfederal employers with three or more workers. The survey's response rate was 48%.

ALS Linked to Military Service

There is “limited and suggestive evidence” of a link between military service and the later development of amyotrophic lateral sclerosis (ALS), according to a report from the Institute of Medicine. A panel of experts convened by IOM reviewed the literature and identified one high-quality study that showed an association between military service and the development of ALS. Three other studies supported this link but had limitations. Another study did not show an association. The IOM committee recommended that the Department of Veterans Affairs, which sponsored the study, conduct additional research into the risk factors for ALS related to military service.

Better Quality at Integrated Groups?

University of Pittsburgh researchers say patients receiving care at integrated medical groups may get better-quality care, according to a study in the Dec. 5 issue of Annals of Internal Medicine. Dr. Ateev Mehrotra and colleagues analyzed data from 119 California physician groups that contracted with PacifiCare from 1999 to 2000. Patients in integrated medical groups were more likely than were those in independent practice associations to receive four of the six clinical quality measures—mammography, Pap smear screening, chlamydia screening, eye exams for diabetes patients, controller medications for asthma patients, and β-blockers for heart attack patients. Integrated medical groups were more likely to report using electronic medical records and quality improvement strategies, but that did not fully explain the difference, the authors said. The study was limited in that it only captured a fraction of potential quality measures and relied on self-reports, they said. In an editorial, Dr. Lawrence P. Casalino of the University of Chicago said the results were not likely to be generalizable and should be interpreted with caution since they were based on only 19 large groups and six quality measures.

BOSTON — Any proposals to reform the Food and Drug Administration should meet the test that the changes would have prevented the arthritis drug Vioxx from getting to the market, Dr. David J. Graham said at the annual meeting of the American Public Health Association.

Dr. Graham, an FDA scientist who testified before Congress in 2004 about the unwillingness of FDA officials to recognize safety problems with Vioxx (rofecoxib), was among a panel of experts who called for changes at the FDA and reforms in the way that pharmaceutical companies design clinical trials.

The criticism comes on the heels of a report from the Institute of Medicine that recommends significant reforms at the FDA, including the establishment of performance goals for safety.

The FDA has been "captured" by the industry and has taken on the value system of the pharmaceutical companies, said Dr. Graham, of the FDA Office of Surveillance and Epidemiology, who was speaking as an individual and not on behalf of the agency.

FDA officials now see their jobs as getting drugs on the market as fast as possible, Dr. Graham said. "We have at FDA a lack of checks and balances."

FDA leadership was quick to rebut those charges. The vast majority of physicians, scientists, and staff members at the FDA reject the concept that the agency is beholden to the drug industry, Dr. Steven Galson, director of the Center for Drug Evaluation and Research (CDER), said in an interview.

In light of calls for reform, FDA officials have already taken a series of steps over the last 2 years to try to improve the processes within the agency, Dr. Galson said. For example, the agency has created a new drug safety oversight board that includes individuals from the FDA and other government agencies to provide advice on drug safety issues, and it has increased the number of staff working in the postmarketing safety area. FDA officials have also redesigned the drug label so that physicians can quickly see the key information they need to make prescribing decisions. And the agency has a long to-do list of reforms aimed at promoting early detection of safety problems and improving communication with physicians and patients.

But the biggest advances in drug safety are more likely to come from basic science advances, he said. These advances, which the FDA is trying to foster through its Critical Path Initiative, will help scientists better predict which drugs in development will run into safety problems later. "The best way to improve drug safety is by improving the science of drug development," Dr. Galson said.

But the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson, a clinical instructor in the department of ambulatory care and prevention at Harvard Medical School, Boston. The current system—in which physicians voluntarily report drug-related adverse events—does not work, because it's passive, he said. The FDA could instead be doing epidemiologic studies to monitor side effects in the entire population taking a drug.

Panelists also took aim at how the pharmaceutical industry designs clinical trials. Drug trials are conducted primarily to maximize return on investment to shareholders by emphasizing benefits of the drug and minimizing risks, Dr. Abramson said.

Drug companies used to simply provide financial support for studies, but they now also design the study and keep the research, said panelist Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a senior lecturer on social medicine at Harvard.

One possible way to limit the influence of pharmaceutical companies in study design would be to create an arm of the National Institutes of Health that would oversee the design of trials, Dr. Angell said, adding that such a body could be wholly or partially funded by industry. Registration of clinical trials at their inception should be a requirement to enroll human subjects, she said.

The panel also criticized the FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require a new drug to be better than existing medications on the market. This leads to approval of drugs with limited benefits and unknown risks, Dr. Angell said.

She cited Vioxx as an example of a drug that should never have been approved because it had only marginal benefits over existing drugs to treat the same condition. In Dr. Angell's opinion, any FDA reform should require that approval of a new drug be based on comparison with existing medications to treat the same condition. Such a change would force drug companies to spend more time on innovative drugs and less time developing "me too" products, she said.

In an interview, CDER's Dr. Galson agreed that more innovation needs to come from pharmaceutical companies, and said that Congress must be careful to ensure that any additional regulatory authority doesn't hamper innovation.

Members of Congress also will have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The PDUFA law, originally passed by Congress in 1992, set up a system in which the pharmaceutical industry pays user fees to the FDA in exchange for the agency's agreeing to meet certain deadlines in the review of drug applications.

BOSTON — Any proposals to reform the Food and Drug Administration should meet the test that the changes would have prevented the arthritis drug Vioxx from getting to the market, Dr. David J. Graham said at the annual meeting of the American Public Health Association.

Dr. Graham, an FDA scientist who testified before Congress in 2004 about the unwillingness of FDA officials to recognize safety problems with Vioxx (rofecoxib), was among a panel of experts who called for changes at the FDA and reforms in the way that pharmaceutical companies design clinical trials.

The criticism comes on the heels of a report from the Institute of Medicine that recommends significant reforms at the FDA, including the establishment of performance goals for safety.

The FDA has been "captured" by the industry and has taken on the value system of the pharmaceutical companies, said Dr. Graham, of the FDA Office of Surveillance and Epidemiology, who was speaking as an individual and not on behalf of the agency.

FDA officials now see their jobs as getting drugs on the market as fast as possible, Dr. Graham said. "We have at FDA a lack of checks and balances."

FDA leadership was quick to rebut those charges. The vast majority of physicians, scientists, and staff members at the FDA reject the concept that the agency is beholden to the drug industry, Dr. Steven Galson, director of the Center for Drug Evaluation and Research (CDER), said in an interview.

In light of calls for reform, FDA officials have already taken a series of steps over the last 2 years to try to improve the processes within the agency, Dr. Galson said. For example, the agency has created a new drug safety oversight board that includes individuals from the FDA and other government agencies to provide advice on drug safety issues, and it has increased the number of staff working in the postmarketing safety area. FDA officials have also redesigned the drug label so that physicians can quickly see the key information they need to make prescribing decisions. And the agency has a long to-do list of reforms aimed at promoting early detection of safety problems and improving communication with physicians and patients.

But the biggest advances in drug safety are more likely to come from basic science advances, he said. These advances, which the FDA is trying to foster through its Critical Path Initiative, will help scientists better predict which drugs in development will run into safety problems later. "The best way to improve drug safety is by improving the science of drug development," Dr. Galson said.

But the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson, a clinical instructor in the department of ambulatory care and prevention at Harvard Medical School, Boston. The current system—in which physicians voluntarily report drug-related adverse events—does not work, because it's passive, he said. The FDA could instead be doing epidemiologic studies to monitor side effects in the entire population taking a drug.

Panelists also took aim at how the pharmaceutical industry designs clinical trials. Drug trials are conducted primarily to maximize return on investment to shareholders by emphasizing benefits of the drug and minimizing risks, Dr. Abramson said.

Drug companies used to simply provide financial support for studies, but they now also design the study and keep the research, said panelist Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a senior lecturer on social medicine at Harvard.

One possible way to limit the influence of pharmaceutical companies in study design would be to create an arm of the National Institutes of Health that would oversee the design of trials, Dr. Angell said, adding that such a body could be wholly or partially funded by industry. Registration of clinical trials at their inception should be a requirement to enroll human subjects, she said.

The panel also criticized the FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require a new drug to be better than existing medications on the market. This leads to approval of drugs with limited benefits and unknown risks, Dr. Angell said.

She cited Vioxx as an example of a drug that should never have been approved because it had only marginal benefits over existing drugs to treat the same condition. In Dr. Angell's opinion, any FDA reform should require that approval of a new drug be based on comparison with existing medications to treat the same condition. Such a change would force drug companies to spend more time on innovative drugs and less time developing "me too" products, she said.

In an interview, CDER's Dr. Galson agreed that more innovation needs to come from pharmaceutical companies, and said that Congress must be careful to ensure that any additional regulatory authority doesn't hamper innovation.

Members of Congress also will have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The PDUFA law, originally passed by Congress in 1992, set up a system in which the pharmaceutical industry pays user fees to the FDA in exchange for the agency's agreeing to meet certain deadlines in the review of drug applications.

BOSTON — Any proposals to reform the Food and Drug Administration should meet the test that the changes would have prevented the arthritis drug Vioxx from getting to the market, Dr. David J. Graham said at the annual meeting of the American Public Health Association.

Dr. Graham, an FDA scientist who testified before Congress in 2004 about the unwillingness of FDA officials to recognize safety problems with Vioxx (rofecoxib), was among a panel of experts who called for changes at the FDA and reforms in the way that pharmaceutical companies design clinical trials.

The criticism comes on the heels of a report from the Institute of Medicine that recommends significant reforms at the FDA, including the establishment of performance goals for safety.

The FDA has been "captured" by the industry and has taken on the value system of the pharmaceutical companies, said Dr. Graham, of the FDA Office of Surveillance and Epidemiology, who was speaking as an individual and not on behalf of the agency.

FDA officials now see their jobs as getting drugs on the market as fast as possible, Dr. Graham said. "We have at FDA a lack of checks and balances."

FDA leadership was quick to rebut those charges. The vast majority of physicians, scientists, and staff members at the FDA reject the concept that the agency is beholden to the drug industry, Dr. Steven Galson, director of the Center for Drug Evaluation and Research (CDER), said in an interview.

In light of calls for reform, FDA officials have already taken a series of steps over the last 2 years to try to improve the processes within the agency, Dr. Galson said. For example, the agency has created a new drug safety oversight board that includes individuals from the FDA and other government agencies to provide advice on drug safety issues, and it has increased the number of staff working in the postmarketing safety area. FDA officials have also redesigned the drug label so that physicians can quickly see the key information they need to make prescribing decisions. And the agency has a long to-do list of reforms aimed at promoting early detection of safety problems and improving communication with physicians and patients.

But the biggest advances in drug safety are more likely to come from basic science advances, he said. These advances, which the FDA is trying to foster through its Critical Path Initiative, will help scientists better predict which drugs in development will run into safety problems later. "The best way to improve drug safety is by improving the science of drug development," Dr. Galson said.

But the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson, a clinical instructor in the department of ambulatory care and prevention at Harvard Medical School, Boston. The current system—in which physicians voluntarily report drug-related adverse events—does not work, because it's passive, he said. The FDA could instead be doing epidemiologic studies to monitor side effects in the entire population taking a drug.

Panelists also took aim at how the pharmaceutical industry designs clinical trials. Drug trials are conducted primarily to maximize return on investment to shareholders by emphasizing benefits of the drug and minimizing risks, Dr. Abramson said.

Drug companies used to simply provide financial support for studies, but they now also design the study and keep the research, said panelist Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a senior lecturer on social medicine at Harvard.

One possible way to limit the influence of pharmaceutical companies in study design would be to create an arm of the National Institutes of Health that would oversee the design of trials, Dr. Angell said, adding that such a body could be wholly or partially funded by industry. Registration of clinical trials at their inception should be a requirement to enroll human subjects, she said.

The panel also criticized the FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require a new drug to be better than existing medications on the market. This leads to approval of drugs with limited benefits and unknown risks, Dr. Angell said.

She cited Vioxx as an example of a drug that should never have been approved because it had only marginal benefits over existing drugs to treat the same condition. In Dr. Angell's opinion, any FDA reform should require that approval of a new drug be based on comparison with existing medications to treat the same condition. Such a change would force drug companies to spend more time on innovative drugs and less time developing "me too" products, she said.

In an interview, CDER's Dr. Galson agreed that more innovation needs to come from pharmaceutical companies, and said that Congress must be careful to ensure that any additional regulatory authority doesn't hamper innovation.

Members of Congress also will have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The PDUFA law, originally passed by Congress in 1992, set up a system in which the pharmaceutical industry pays user fees to the FDA in exchange for the agency's agreeing to meet certain deadlines in the review of drug applications.

Von Eschenbach Confirmed

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 Finance Committee chairman, 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.

Liability Issues Have Impact

Many obstetricians report making changes to their practices out of fear of being sued for malpractice, according to a survey conducted by the American College of Obstetricians and Gynecologists. About 37% of ACOG members surveyed said they had increased the number of cesarean deliveries they perform, while 33% reported decreasing the number of high-risk obstetrics patients that they care for and no longer offering vaginal birth after cesarean. More than 8% of respondents said they had stopped practicing obstetrics because of the risk of liability claims and more than 7% reported that they stopped doing so because of the lack of affordable or available liability insurance. “Medical lawsuit abuse continues to wreak havoc on physicians across America, and today fewer and fewer ob.gyns. are available to provide prenatal and delivery care, routine gynecological care or major gynecologic surgery,” Dr. Douglas W. Laube, ACOG president, said in a statement. The survey covers January 2003 through December 2005. ACOG commissions a survey on medical liability experience every 2–4 years. The most recent survey included members for all 50 states, the District of Columbia, and Puerto Rico and had a 37% response rate.

Abortion Refusal Clause Upheld

Abortion opponents scored a victory last month when a federal appeals court upheld a statute that prohibits federal, state, and local governments that receive federal funds from discriminating against providers and insurers that refuse to provide abortion services. The provision, known as the Weldon Amendment, was enacted in December 2004. The law was challenged in court by the National Family Planning and Reproductive Health Association shortly after its passage and the provision was upheld by a federal district court last year. A federal appeals court rejected the National Family Planning and Reproductive Health Association's appeal on the grounds the group lacked standing and that no actual injury had occurred.

Hormone-Compound Regs Urged

The Food and Drug Administration should conduct surveys of the purity and dosage accuracy of bioidentical hormone compounds, according to a new policy adopted by the American Medical Association at its interim meeting last month. These compounds are often used by women in place of Food and Drug Administration-approved hormone preparations for replacement therapy, according to the AMA. The new policy also calls for mandatory reporting by drug manufacturers, including compounding pharmacies, of adverse events from bioidentical hormone usage. The FDA also should require standard patient information on packaging of compounded bioidentical hormone products, according to the policy. The AMA also noted that the term “bioidentical” should not be used unless the compound has been approved by the FDA. “There is no scientific basis for claims that compounded hormone therapies have a different risk-benefit ratio than FDA-approved hormone replacement therapies,” Dr. Ardis Hoven, an AMA board member, said in a statement.

Plan B Court Battles Continue

Despite the FDA's recent approval of over-the-counter sales of Plan B emergency contraception for women aged 18 years and older, the Center for Reproductive Rights is continuing its court battle over the product. In the latest chapter in this continuing legal saga, a U.S. magistrate ruled that the Center for Reproductive Rights can subpoena White House documents as part of its lawsuit. The group is suing the FDA for failing to make Plan B available over the counter for women of all ages. The group filed the lawsuit in 2001 and has already deposed some current and former top FDA officials. As a result of this latest ruling, the group plans to subpoena communications between the Domestic Policy Office of the White House and select employees of the FDA that occurred between April 2003 and September 2006 that relate to Plan B.

Von Eschenbach Confirmed

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 Finance Committee chairman, 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.

Liability Issues Have Impact

Many obstetricians report making changes to their practices out of fear of being sued for malpractice, according to a survey conducted by the American College of Obstetricians and Gynecologists. About 37% of ACOG members surveyed said they had increased the number of cesarean deliveries they perform, while 33% reported decreasing the number of high-risk obstetrics patients that they care for and no longer offering vaginal birth after cesarean. More than 8% of respondents said they had stopped practicing obstetrics because of the risk of liability claims and more than 7% reported that they stopped doing so because of the lack of affordable or available liability insurance. “Medical lawsuit abuse continues to wreak havoc on physicians across America, and today fewer and fewer ob.gyns. are available to provide prenatal and delivery care, routine gynecological care or major gynecologic surgery,” Dr. Douglas W. Laube, ACOG president, said in a statement. The survey covers January 2003 through December 2005. ACOG commissions a survey on medical liability experience every 2–4 years. The most recent survey included members for all 50 states, the District of Columbia, and Puerto Rico and had a 37% response rate.

Abortion Refusal Clause Upheld

Abortion opponents scored a victory last month when a federal appeals court upheld a statute that prohibits federal, state, and local governments that receive federal funds from discriminating against providers and insurers that refuse to provide abortion services. The provision, known as the Weldon Amendment, was enacted in December 2004. The law was challenged in court by the National Family Planning and Reproductive Health Association shortly after its passage and the provision was upheld by a federal district court last year. A federal appeals court rejected the National Family Planning and Reproductive Health Association's appeal on the grounds the group lacked standing and that no actual injury had occurred.

Hormone-Compound Regs Urged

The Food and Drug Administration should conduct surveys of the purity and dosage accuracy of bioidentical hormone compounds, according to a new policy adopted by the American Medical Association at its interim meeting last month. These compounds are often used by women in place of Food and Drug Administration-approved hormone preparations for replacement therapy, according to the AMA. The new policy also calls for mandatory reporting by drug manufacturers, including compounding pharmacies, of adverse events from bioidentical hormone usage. The FDA also should require standard patient information on packaging of compounded bioidentical hormone products, according to the policy. The AMA also noted that the term “bioidentical” should not be used unless the compound has been approved by the FDA. “There is no scientific basis for claims that compounded hormone therapies have a different risk-benefit ratio than FDA-approved hormone replacement therapies,” Dr. Ardis Hoven, an AMA board member, said in a statement.

Plan B Court Battles Continue

Despite the FDA's recent approval of over-the-counter sales of Plan B emergency contraception for women aged 18 years and older, the Center for Reproductive Rights is continuing its court battle over the product. In the latest chapter in this continuing legal saga, a U.S. magistrate ruled that the Center for Reproductive Rights can subpoena White House documents as part of its lawsuit. The group is suing the FDA for failing to make Plan B available over the counter for women of all ages. The group filed the lawsuit in 2001 and has already deposed some current and former top FDA officials. As a result of this latest ruling, the group plans to subpoena communications between the Domestic Policy Office of the White House and select employees of the FDA that occurred between April 2003 and September 2006 that relate to Plan B.

Von Eschenbach Confirmed

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 Finance Committee chairman, 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.

Liability Issues Have Impact

Many obstetricians report making changes to their practices out of fear of being sued for malpractice, according to a survey conducted by the American College of Obstetricians and Gynecologists. About 37% of ACOG members surveyed said they had increased the number of cesarean deliveries they perform, while 33% reported decreasing the number of high-risk obstetrics patients that they care for and no longer offering vaginal birth after cesarean. More than 8% of respondents said they had stopped practicing obstetrics because of the risk of liability claims and more than 7% reported that they stopped doing so because of the lack of affordable or available liability insurance. “Medical lawsuit abuse continues to wreak havoc on physicians across America, and today fewer and fewer ob.gyns. are available to provide prenatal and delivery care, routine gynecological care or major gynecologic surgery,” Dr. Douglas W. Laube, ACOG president, said in a statement. The survey covers January 2003 through December 2005. ACOG commissions a survey on medical liability experience every 2–4 years. The most recent survey included members for all 50 states, the District of Columbia, and Puerto Rico and had a 37% response rate.

Abortion Refusal Clause Upheld

Abortion opponents scored a victory last month when a federal appeals court upheld a statute that prohibits federal, state, and local governments that receive federal funds from discriminating against providers and insurers that refuse to provide abortion services. The provision, known as the Weldon Amendment, was enacted in December 2004. The law was challenged in court by the National Family Planning and Reproductive Health Association shortly after its passage and the provision was upheld by a federal district court last year. A federal appeals court rejected the National Family Planning and Reproductive Health Association's appeal on the grounds the group lacked standing and that no actual injury had occurred.

Hormone-Compound Regs Urged

The Food and Drug Administration should conduct surveys of the purity and dosage accuracy of bioidentical hormone compounds, according to a new policy adopted by the American Medical Association at its interim meeting last month. These compounds are often used by women in place of Food and Drug Administration-approved hormone preparations for replacement therapy, according to the AMA. The new policy also calls for mandatory reporting by drug manufacturers, including compounding pharmacies, of adverse events from bioidentical hormone usage. The FDA also should require standard patient information on packaging of compounded bioidentical hormone products, according to the policy. The AMA also noted that the term “bioidentical” should not be used unless the compound has been approved by the FDA. “There is no scientific basis for claims that compounded hormone therapies have a different risk-benefit ratio than FDA-approved hormone replacement therapies,” Dr. Ardis Hoven, an AMA board member, said in a statement.

Plan B Court Battles Continue

Despite the FDA's recent approval of over-the-counter sales of Plan B emergency contraception for women aged 18 years and older, the Center for Reproductive Rights is continuing its court battle over the product. In the latest chapter in this continuing legal saga, a U.S. magistrate ruled that the Center for Reproductive Rights can subpoena White House documents as part of its lawsuit. The group is suing the FDA for failing to make Plan B available over the counter for women of all ages. The group filed the lawsuit in 2001 and has already deposed some current and former top FDA officials. As a result of this latest ruling, the group plans to subpoena communications between the Domestic Policy Office of the White House and select employees of the FDA that occurred between April 2003 and September 2006 that relate to Plan B.