Jane Anderson

Abbott Warned on Quality Issues

The Food and Drug Administration concluded that Abbott Diabetes Care Inc. exercised inadequate quality control in manufacturing its FreeStyle and FreeStyle Navigator blood glucose monitoring systems, in a July warning letter based on the findings of a month-long inspection at Abbott's Alameda, Calif., plant. Abbott also failed to have properly trained personnel overseeing FreeStyle device manufacturing, the agency said. The director of quality systems at the plant, for example, should have a bachelor of science or an equivalent degree, but the person in that post holds a business administration degree. Abbott recalled 5,449 of its FreeStyle Navigator units earlier this year after an investigation indicated that the device's plastic housing could crack, causing inaccurate readings. The company told the FDA that it was addressing the quality issues.

Judge Okays Zimulti Case Revival

A federal judge has granted permission for investors to refile a lawsuit against Sanofi-Aventis over the drug manufacturer's antiobesity drug rimonabant (Zimulti). Sanofi had sought FDA approval to market the drug in the United States but withdrew its application after an FDA advisory panel said that the drug's effects on weight loss could not overcome potential psychological side effects. The investors sued Sanofi in November 2007, saying the French manufacturer failed to disclose data on the medication's link to suicidal behavior, which led to a major loss in Sanofi stock value once the FDA panel made its decision. U.S. District Judge George Daniels dismissed the lawsuit in 2009, saying Sanofi had not acted recklessly, as the plaintiffs contended. But last month, the judge agreed to let the plaintiffs refile their complaint, saying in his ruling that the new complaint “adequately pleads violations of the federal securities laws.”

Generic Makers Claim Big Savings

Generic metabolism drugs accounted for 13% of a total $824 billion saved by use of all generic medications over brand name products in the past decade, according to a report from the Generic Pharmaceutical Association. Metabolism, cardiovascular, and central nervous system drugs accounted for nearly three-quarters of the total $139 billion saved by generics in 2009, the report said. The figures are growing each year as brand-name drugs lose patent protection and lower-cost generic alternatives hit the market, the report said. Two more diabetes medications will come off patent in the next 2 years: Takeda's Actos (pioglitazone) in 2011, and GlaxoSmithKline's Avandia (rosiglitazone) in 2012.

Preventive Training Supported

The Department of Health and Human Services has awarded 15 grants totaling $9 million to train 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support goes to accredited schools of public health and medicine and hospital-based residency programs, the agency said. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received $1 million.

State Backs Coordinated Care

Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency in its area. “Our current health care system rewards providers for seeing as many patients as possible. We're going to change that. Under this pilot project, we are moving to a system where health care providers will profit from spending time with their patients and keeping them healthy,” Gov. Lynch said in the statement.

J&J Discloses Physician Payments

Following in the footsteps of Pfizer, GlaxoSmithKline, and Medtronic, Johnson & Johnson is disclosing how much it pays physician speakers and consultants, at least for a number of its pharmaceutical subsidiaries. However, the data cover only J&J divisions that were subject to corporate integrity agreements with the federal government: PriCara, Ortho-McNeil Pharmaceutical, Ortho-McNeil Neurologics, Janssen, and McNeil Pediatrics. Payment disclosures are listed at those units' individual Web sites. Quarterly updates will give way to semiannual and then annual updates by 2012 for all the divisions. The company will start disclosing payments for medical devices and diagnostics by June 30, 2011, according to a spokesman for J&J.

Abbott Warned on Quality Issues

The Food and Drug Administration concluded that Abbott Diabetes Care Inc. exercised inadequate quality control in manufacturing its FreeStyle and FreeStyle Navigator blood glucose monitoring systems, in a July warning letter based on the findings of a month-long inspection at Abbott's Alameda, Calif., plant. Abbott also failed to have properly trained personnel overseeing FreeStyle device manufacturing, the agency said. The director of quality systems at the plant, for example, should have a bachelor of science or an equivalent degree, but the person in that post holds a business administration degree. Abbott recalled 5,449 of its FreeStyle Navigator units earlier this year after an investigation indicated that the device's plastic housing could crack, causing inaccurate readings. The company told the FDA that it was addressing the quality issues.

Judge Okays Zimulti Case Revival

A federal judge has granted permission for investors to refile a lawsuit against Sanofi-Aventis over the drug manufacturer's antiobesity drug rimonabant (Zimulti). Sanofi had sought FDA approval to market the drug in the United States but withdrew its application after an FDA advisory panel said that the drug's effects on weight loss could not overcome potential psychological side effects. The investors sued Sanofi in November 2007, saying the French manufacturer failed to disclose data on the medication's link to suicidal behavior, which led to a major loss in Sanofi stock value once the FDA panel made its decision. U.S. District Judge George Daniels dismissed the lawsuit in 2009, saying Sanofi had not acted recklessly, as the plaintiffs contended. But last month, the judge agreed to let the plaintiffs refile their complaint, saying in his ruling that the new complaint “adequately pleads violations of the federal securities laws.”

Generic Makers Claim Big Savings

Generic metabolism drugs accounted for 13% of a total $824 billion saved by use of all generic medications over brand name products in the past decade, according to a report from the Generic Pharmaceutical Association. Metabolism, cardiovascular, and central nervous system drugs accounted for nearly three-quarters of the total $139 billion saved by generics in 2009, the report said. The figures are growing each year as brand-name drugs lose patent protection and lower-cost generic alternatives hit the market, the report said. Two more diabetes medications will come off patent in the next 2 years: Takeda's Actos (pioglitazone) in 2011, and GlaxoSmithKline's Avandia (rosiglitazone) in 2012.

Preventive Training Supported

The Department of Health and Human Services has awarded 15 grants totaling $9 million to train 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support goes to accredited schools of public health and medicine and hospital-based residency programs, the agency said. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received $1 million.

State Backs Coordinated Care

Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency in its area. “Our current health care system rewards providers for seeing as many patients as possible. We're going to change that. Under this pilot project, we are moving to a system where health care providers will profit from spending time with their patients and keeping them healthy,” Gov. Lynch said in the statement.

J&J Discloses Physician Payments

Following in the footsteps of Pfizer, GlaxoSmithKline, and Medtronic, Johnson & Johnson is disclosing how much it pays physician speakers and consultants, at least for a number of its pharmaceutical subsidiaries. However, the data cover only J&J divisions that were subject to corporate integrity agreements with the federal government: PriCara, Ortho-McNeil Pharmaceutical, Ortho-McNeil Neurologics, Janssen, and McNeil Pediatrics. Payment disclosures are listed at those units' individual Web sites. Quarterly updates will give way to semiannual and then annual updates by 2012 for all the divisions. The company will start disclosing payments for medical devices and diagnostics by June 30, 2011, according to a spokesman for J&J.

Abbott Warned on Quality Issues

The Food and Drug Administration concluded that Abbott Diabetes Care Inc. exercised inadequate quality control in manufacturing its FreeStyle and FreeStyle Navigator blood glucose monitoring systems, in a July warning letter based on the findings of a month-long inspection at Abbott's Alameda, Calif., plant. Abbott also failed to have properly trained personnel overseeing FreeStyle device manufacturing, the agency said. The director of quality systems at the plant, for example, should have a bachelor of science or an equivalent degree, but the person in that post holds a business administration degree. Abbott recalled 5,449 of its FreeStyle Navigator units earlier this year after an investigation indicated that the device's plastic housing could crack, causing inaccurate readings. The company told the FDA that it was addressing the quality issues.

Judge Okays Zimulti Case Revival

A federal judge has granted permission for investors to refile a lawsuit against Sanofi-Aventis over the drug manufacturer's antiobesity drug rimonabant (Zimulti). Sanofi had sought FDA approval to market the drug in the United States but withdrew its application after an FDA advisory panel said that the drug's effects on weight loss could not overcome potential psychological side effects. The investors sued Sanofi in November 2007, saying the French manufacturer failed to disclose data on the medication's link to suicidal behavior, which led to a major loss in Sanofi stock value once the FDA panel made its decision. U.S. District Judge George Daniels dismissed the lawsuit in 2009, saying Sanofi had not acted recklessly, as the plaintiffs contended. But last month, the judge agreed to let the plaintiffs refile their complaint, saying in his ruling that the new complaint “adequately pleads violations of the federal securities laws.”

Generic Makers Claim Big Savings

Generic metabolism drugs accounted for 13% of a total $824 billion saved by use of all generic medications over brand name products in the past decade, according to a report from the Generic Pharmaceutical Association. Metabolism, cardiovascular, and central nervous system drugs accounted for nearly three-quarters of the total $139 billion saved by generics in 2009, the report said. The figures are growing each year as brand-name drugs lose patent protection and lower-cost generic alternatives hit the market, the report said. Two more diabetes medications will come off patent in the next 2 years: Takeda's Actos (pioglitazone) in 2011, and GlaxoSmithKline's Avandia (rosiglitazone) in 2012.

Preventive Training Supported

The Department of Health and Human Services has awarded 15 grants totaling $9 million to train 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support goes to accredited schools of public health and medicine and hospital-based residency programs, the agency said. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received $1 million.

State Backs Coordinated Care

Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency in its area. “Our current health care system rewards providers for seeing as many patients as possible. We're going to change that. Under this pilot project, we are moving to a system where health care providers will profit from spending time with their patients and keeping them healthy,” Gov. Lynch said in the statement.

J&J Discloses Physician Payments

Following in the footsteps of Pfizer, GlaxoSmithKline, and Medtronic, Johnson & Johnson is disclosing how much it pays physician speakers and consultants, at least for a number of its pharmaceutical subsidiaries. However, the data cover only J&J divisions that were subject to corporate integrity agreements with the federal government: PriCara, Ortho-McNeil Pharmaceutical, Ortho-McNeil Neurologics, Janssen, and McNeil Pediatrics. Payment disclosures are listed at those units' individual Web sites. Quarterly updates will give way to semiannual and then annual updates by 2012 for all the divisions. The company will start disclosing payments for medical devices and diagnostics by June 30, 2011, according to a spokesman for J&J.

Kids Insured, but More Are Poor

U.S. children were more likely than ever to have health insurance in 2008, but the proportion living in poverty and in households that couldn't always supply food rose that year, according to a federal report on child well-being. Issued by the Federal Interagency Forum on Child and Family Statistics, the annual report found that 19% of all children lived in poverty, and 22% lived in households that were “food insecure” at times during 2008, which marked the start of the recent severe recession. However, 90% had health insurance coverage at some point during 2008, an increase over 89% in 2007. In addition, teen births declined: In 2008, 21.7 per 1,000 teens ages 15 to 17 gave birth, compared with 22.2 per 1,000 in 2007. The report also noted that more teens completed high school and entered college, while fewer children had untreated dental caries or were exposed to secondhand smoke.

Child TV Viewing Is Still High

A survey of Oregon mothers found that nearly 20% of 2-year-old children watched television or videos 2 hours or more each day, the Centers for Disease Control and Prevention reported. In addition, more than 18% of 2-year-old children had a TV in their bedrooms, and more than one-third of those children clocked more than 2 hours' daily viewing time. Mothers who were not Hispanic or black and mothers who had taken fewer than four outings with the child during the preceding week were more likely to have 2-year-olds who watched that much TV. The American Academy of Pediatrics recommends that children watch no more than 1-2 hours of “quality programming” each day and that parents not place televisions in children's bedrooms.

Court Dismisses Thimerosal Case

The U.S. District Court for the District of Columbia has dismissed a case brought by the Coalition for Mercury-Free Drugs over the mercury-based preservative thimerosal because the coalition lacked standing to sue. The Silver Spring, Md.–based group had filed suit against the Department of Health and Human Services and the Food and Drug Administration seeking to have thimerosal banned from all pharmaceutical products, including vaccines, unless the manufacturers could prove it was safe. However, Judge Reggie B. Walton said that the coalition's leaders failed to prove that thimerosol's continued presence in some vaccines and other products causes actual harm to them, physicians, or patients. Judge Walton noted that although the U.S. Public Health Service has made thimerosal-free vaccines a goal, the FDA has found the preservative to be safe as currently used.

Teens See More Food Ads

Exposure to television ads for sweet food and beverages, especially sugar-sweetened drinks, fell at least 20% for all children and adolescents between 2003 and 2007, but exposure to TV fast food ads increased, according to a study by researchers at the University of Illinois, Chicago. Young children saw nearly 5% more fast food ads, children ages 6 to 11 saw 12% more, and teens saw 20% more, the researchers reported in the online Archives of Pediatrics & Adolescent Medicine. Daily exposure to all food ads fell among children ages 2 to 11 but rose by nearly 4% among teens. Black children saw more food ads per day than white children, especially the ads for fast foods.

FDA: Intuniv Promotion Misleading

Promotional materials for the attention-deficit/hyperactivity disorder drug Intuniv (guanfacine) are misleading because they imply that the drug can correct “individual behavior problems” that “the whole family can see,” the FDA said. In a letter, the agency ordered the manufacturer, Shire Development Inc., to stop using those claims in parent guides and in-office brochures and displays. The materials mentioned temper outbursts, arguments with adults, deliberate annoyance of others, and irritability, the FDA said. However, the agency told Shire, “these behavioral problems are not symptoms specific to ADHD, and we are not aware of substantial evidence or substantial clinical experience demonstrating an effect of Intuniv on these behavioral problems.”

Parents Want Genetic Tests

Most parents are interested in having their children checked for disease risks using at-home genetic testing kits, according to a survey from C.S. Mott Children's Hospital in the University of Michigan Health System in Ann Arbor. The poll found that 53% of parents were either “very” or “somewhat” interested in testing their children. Almost that entire group said the testing might give them the chance to prevent diseases and could help them recognize children's health problems early. Two-thirds of those who said they wouldn't be interested in testing their children cited the possibility of discrimination against children who showed genetic risk of disease, and 87% of this group said testing would make them worry too much about their children's future.

Kids Insured, but More Are Poor

U.S. children were more likely than ever to have health insurance in 2008, but the proportion living in poverty and in households that couldn't always supply food rose that year, according to a federal report on child well-being. Issued by the Federal Interagency Forum on Child and Family Statistics, the annual report found that 19% of all children lived in poverty, and 22% lived in households that were “food insecure” at times during 2008, which marked the start of the recent severe recession. However, 90% had health insurance coverage at some point during 2008, an increase over 89% in 2007. In addition, teen births declined: In 2008, 21.7 per 1,000 teens ages 15 to 17 gave birth, compared with 22.2 per 1,000 in 2007. The report also noted that more teens completed high school and entered college, while fewer children had untreated dental caries or were exposed to secondhand smoke.

Child TV Viewing Is Still High

A survey of Oregon mothers found that nearly 20% of 2-year-old children watched television or videos 2 hours or more each day, the Centers for Disease Control and Prevention reported. In addition, more than 18% of 2-year-old children had a TV in their bedrooms, and more than one-third of those children clocked more than 2 hours' daily viewing time. Mothers who were not Hispanic or black and mothers who had taken fewer than four outings with the child during the preceding week were more likely to have 2-year-olds who watched that much TV. The American Academy of Pediatrics recommends that children watch no more than 1-2 hours of “quality programming” each day and that parents not place televisions in children's bedrooms.

Court Dismisses Thimerosal Case

The U.S. District Court for the District of Columbia has dismissed a case brought by the Coalition for Mercury-Free Drugs over the mercury-based preservative thimerosal because the coalition lacked standing to sue. The Silver Spring, Md.–based group had filed suit against the Department of Health and Human Services and the Food and Drug Administration seeking to have thimerosal banned from all pharmaceutical products, including vaccines, unless the manufacturers could prove it was safe. However, Judge Reggie B. Walton said that the coalition's leaders failed to prove that thimerosol's continued presence in some vaccines and other products causes actual harm to them, physicians, or patients. Judge Walton noted that although the U.S. Public Health Service has made thimerosal-free vaccines a goal, the FDA has found the preservative to be safe as currently used.

Teens See More Food Ads

Exposure to television ads for sweet food and beverages, especially sugar-sweetened drinks, fell at least 20% for all children and adolescents between 2003 and 2007, but exposure to TV fast food ads increased, according to a study by researchers at the University of Illinois, Chicago. Young children saw nearly 5% more fast food ads, children ages 6 to 11 saw 12% more, and teens saw 20% more, the researchers reported in the online Archives of Pediatrics & Adolescent Medicine. Daily exposure to all food ads fell among children ages 2 to 11 but rose by nearly 4% among teens. Black children saw more food ads per day than white children, especially the ads for fast foods.

FDA: Intuniv Promotion Misleading

Promotional materials for the attention-deficit/hyperactivity disorder drug Intuniv (guanfacine) are misleading because they imply that the drug can correct “individual behavior problems” that “the whole family can see,” the FDA said. In a letter, the agency ordered the manufacturer, Shire Development Inc., to stop using those claims in parent guides and in-office brochures and displays. The materials mentioned temper outbursts, arguments with adults, deliberate annoyance of others, and irritability, the FDA said. However, the agency told Shire, “these behavioral problems are not symptoms specific to ADHD, and we are not aware of substantial evidence or substantial clinical experience demonstrating an effect of Intuniv on these behavioral problems.”

Parents Want Genetic Tests

Most parents are interested in having their children checked for disease risks using at-home genetic testing kits, according to a survey from C.S. Mott Children's Hospital in the University of Michigan Health System in Ann Arbor. The poll found that 53% of parents were either “very” or “somewhat” interested in testing their children. Almost that entire group said the testing might give them the chance to prevent diseases and could help them recognize children's health problems early. Two-thirds of those who said they wouldn't be interested in testing their children cited the possibility of discrimination against children who showed genetic risk of disease, and 87% of this group said testing would make them worry too much about their children's future.

Kids Insured, but More Are Poor

U.S. children were more likely than ever to have health insurance in 2008, but the proportion living in poverty and in households that couldn't always supply food rose that year, according to a federal report on child well-being. Issued by the Federal Interagency Forum on Child and Family Statistics, the annual report found that 19% of all children lived in poverty, and 22% lived in households that were “food insecure” at times during 2008, which marked the start of the recent severe recession. However, 90% had health insurance coverage at some point during 2008, an increase over 89% in 2007. In addition, teen births declined: In 2008, 21.7 per 1,000 teens ages 15 to 17 gave birth, compared with 22.2 per 1,000 in 2007. The report also noted that more teens completed high school and entered college, while fewer children had untreated dental caries or were exposed to secondhand smoke.

Child TV Viewing Is Still High

A survey of Oregon mothers found that nearly 20% of 2-year-old children watched television or videos 2 hours or more each day, the Centers for Disease Control and Prevention reported. In addition, more than 18% of 2-year-old children had a TV in their bedrooms, and more than one-third of those children clocked more than 2 hours' daily viewing time. Mothers who were not Hispanic or black and mothers who had taken fewer than four outings with the child during the preceding week were more likely to have 2-year-olds who watched that much TV. The American Academy of Pediatrics recommends that children watch no more than 1-2 hours of “quality programming” each day and that parents not place televisions in children's bedrooms.

Court Dismisses Thimerosal Case

The U.S. District Court for the District of Columbia has dismissed a case brought by the Coalition for Mercury-Free Drugs over the mercury-based preservative thimerosal because the coalition lacked standing to sue. The Silver Spring, Md.–based group had filed suit against the Department of Health and Human Services and the Food and Drug Administration seeking to have thimerosal banned from all pharmaceutical products, including vaccines, unless the manufacturers could prove it was safe. However, Judge Reggie B. Walton said that the coalition's leaders failed to prove that thimerosol's continued presence in some vaccines and other products causes actual harm to them, physicians, or patients. Judge Walton noted that although the U.S. Public Health Service has made thimerosal-free vaccines a goal, the FDA has found the preservative to be safe as currently used.

Teens See More Food Ads

Exposure to television ads for sweet food and beverages, especially sugar-sweetened drinks, fell at least 20% for all children and adolescents between 2003 and 2007, but exposure to TV fast food ads increased, according to a study by researchers at the University of Illinois, Chicago. Young children saw nearly 5% more fast food ads, children ages 6 to 11 saw 12% more, and teens saw 20% more, the researchers reported in the online Archives of Pediatrics & Adolescent Medicine. Daily exposure to all food ads fell among children ages 2 to 11 but rose by nearly 4% among teens. Black children saw more food ads per day than white children, especially the ads for fast foods.

FDA: Intuniv Promotion Misleading

Promotional materials for the attention-deficit/hyperactivity disorder drug Intuniv (guanfacine) are misleading because they imply that the drug can correct “individual behavior problems” that “the whole family can see,” the FDA said. In a letter, the agency ordered the manufacturer, Shire Development Inc., to stop using those claims in parent guides and in-office brochures and displays. The materials mentioned temper outbursts, arguments with adults, deliberate annoyance of others, and irritability, the FDA said. However, the agency told Shire, “these behavioral problems are not symptoms specific to ADHD, and we are not aware of substantial evidence or substantial clinical experience demonstrating an effect of Intuniv on these behavioral problems.”

Parents Want Genetic Tests

Most parents are interested in having their children checked for disease risks using at-home genetic testing kits, according to a survey from C.S. Mott Children's Hospital in the University of Michigan Health System in Ann Arbor. The poll found that 53% of parents were either “very” or “somewhat” interested in testing their children. Almost that entire group said the testing might give them the chance to prevent diseases and could help them recognize children's health problems early. Two-thirds of those who said they wouldn't be interested in testing their children cited the possibility of discrimination against children who showed genetic risk of disease, and 87% of this group said testing would make them worry too much about their children's future.

Preventive Training Supported

The Department of Health and Human Services has awarded 15 grants totaling $9 million to train about 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support goes to accredited schools of public health and medicine and hospital-based residency programs, the agency said. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received about $1 million, DHHS said.

State Backs Coordinated Care

Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency. The current “system rewards providers for seeing as many patients as possible. We're going to change that. Under this pilot project, we are moving to a system where health care providers will profit from spending time with their patients and keeping them healthy,” Gov. Lynch said in the statement.

Generics Saved Nearly $1 Trillion

Use of generic drugs saved the U.S. health care system more than $824 billion in 2000–2009, according to a report commissioned by the Generic Pharmaceutical Association and conducted by research firm IMS Health. Cardiovascular drugs, nervous system drugs, and metabolism drugs accounted for three-quarters of the savings, according to the report. In 2009, generics saved $139.6 billion, an increase of 15% over 2008, and those savings are expected to accelerate as 6 of the 10 current largest-selling brand-name drugs will lose patent protection by 2014, the report said. In that groups are the cholesterol drug Lipitor (atorvastatin), the blood clot preventer Plavix (clopidogrel), and the asthma medication Singulair (montelukast).

Whites Least Hospitalized for HBP

Blacks were hospitalized for hypertension nearly five times as often as whites in 2006, and Hispanics were as likely as whites to be admitted for the condition, according to the Agency for Health Care Research and Quality. Whites had 33 admissions per 100,000 people each year, whereas the figure for blacks was 161 admissions and for Hispanics, 61 admissions. More than 250,000 people each year are hospitalized for hypertension with complications, the agency found. The poorest Americans were 2.5 times as likely to be admitted for hypertension as were the wealthiest.

Agencies Post Disability Guidance

The Departments of Justice and Health and Human Services have jointly issued new technical guidance for health providers to encourage care of people with mobility disabilities. “Access to Medical Care for Persons with Mobility Disabilities” details how the Americans with Disabilities Act (ADA) and other government rules on disabled access apply to providers. The 19-page document includes an overview of general ADA requirements, frequently asked questions, and illustrated examples of accessible facilities, exam rooms, and equipment. Providers can download the booklet at

www.ada.gov/medcare_ta.htm

FDA: Intuniv Promotion Misleading

Promotional materials for the attention-deficit hyperactivity disorder drug Intuniv (guanfacine) misleadingly imply that the drug can correct “individual behavior problems” that “the whole family can see,” the FDA said in a letter ordering the manufacturer, Shire Development, to stop using those claims in parent guides and in-office brochures and displays. The materials mentioned temper outbursts, arguments with adults, deliberate annoyance of others, and irritability, the FDA said in its letter. However, the agency told Shire, “these behavioral problems are not symptoms specific to ADHD, and we are not aware of substantial evidence or substantial clinical experience demonstrating an effect of Intuniv on these behavioral problems.”

Parents Want Genetic Tests

Most parents are interested in having their children checked for disease risks using at-home genetic testing kits, according to a survey from C.S. Mott Children's Hospital in the University of Michigan Health System in Ann Arbor. The poll found 53% of parents either “very” or “somewhat” interested. Almost that entire group said the testing might give them the chance to prevent diseases and could help them recognize children's health problems early. Two-thirds of those who said they wouldn't be interested in testing their children cited the possibility of discrimination against children who showed genetic risk of disease.

Preventive Training Supported

The Department of Health and Human Services has awarded 15 grants totaling $9 million to train about 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support goes to accredited schools of public health and medicine and hospital-based residency programs, the agency said. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received about $1 million, DHHS said.

State Backs Coordinated Care

Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency. The current “system rewards providers for seeing as many patients as possible. We're going to change that. Under this pilot project, we are moving to a system where health care providers will profit from spending time with their patients and keeping them healthy,” Gov. Lynch said in the statement.

Generics Saved Nearly $1 Trillion

Use of generic drugs saved the U.S. health care system more than $824 billion in 2000–2009, according to a report commissioned by the Generic Pharmaceutical Association and conducted by research firm IMS Health. Cardiovascular drugs, nervous system drugs, and metabolism drugs accounted for three-quarters of the savings, according to the report. In 2009, generics saved $139.6 billion, an increase of 15% over 2008, and those savings are expected to accelerate as 6 of the 10 current largest-selling brand-name drugs will lose patent protection by 2014, the report said. In that groups are the cholesterol drug Lipitor (atorvastatin), the blood clot preventer Plavix (clopidogrel), and the asthma medication Singulair (montelukast).

Whites Least Hospitalized for HBP

Blacks were hospitalized for hypertension nearly five times as often as whites in 2006, and Hispanics were as likely as whites to be admitted for the condition, according to the Agency for Health Care Research and Quality. Whites had 33 admissions per 100,000 people each year, whereas the figure for blacks was 161 admissions and for Hispanics, 61 admissions. More than 250,000 people each year are hospitalized for hypertension with complications, the agency found. The poorest Americans were 2.5 times as likely to be admitted for hypertension as were the wealthiest.

Agencies Post Disability Guidance

The Departments of Justice and Health and Human Services have jointly issued new technical guidance for health providers to encourage care of people with mobility disabilities. “Access to Medical Care for Persons with Mobility Disabilities” details how the Americans with Disabilities Act (ADA) and other government rules on disabled access apply to providers. The 19-page document includes an overview of general ADA requirements, frequently asked questions, and illustrated examples of accessible facilities, exam rooms, and equipment. Providers can download the booklet at

www.ada.gov/medcare_ta.htm

FDA: Intuniv Promotion Misleading

Promotional materials for the attention-deficit hyperactivity disorder drug Intuniv (guanfacine) misleadingly imply that the drug can correct “individual behavior problems” that “the whole family can see,” the FDA said in a letter ordering the manufacturer, Shire Development, to stop using those claims in parent guides and in-office brochures and displays. The materials mentioned temper outbursts, arguments with adults, deliberate annoyance of others, and irritability, the FDA said in its letter. However, the agency told Shire, “these behavioral problems are not symptoms specific to ADHD, and we are not aware of substantial evidence or substantial clinical experience demonstrating an effect of Intuniv on these behavioral problems.”

Parents Want Genetic Tests

Most parents are interested in having their children checked for disease risks using at-home genetic testing kits, according to a survey from C.S. Mott Children's Hospital in the University of Michigan Health System in Ann Arbor. The poll found 53% of parents either “very” or “somewhat” interested. Almost that entire group said the testing might give them the chance to prevent diseases and could help them recognize children's health problems early. Two-thirds of those who said they wouldn't be interested in testing their children cited the possibility of discrimination against children who showed genetic risk of disease.

Preventive Training Supported

The Department of Health and Human Services has awarded 15 grants totaling $9 million to train about 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support goes to accredited schools of public health and medicine and hospital-based residency programs, the agency said. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received about $1 million, DHHS said.

State Backs Coordinated Care

Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency. The current “system rewards providers for seeing as many patients as possible. We're going to change that. Under this pilot project, we are moving to a system where health care providers will profit from spending time with their patients and keeping them healthy,” Gov. Lynch said in the statement.

Generics Saved Nearly $1 Trillion

Use of generic drugs saved the U.S. health care system more than $824 billion in 2000–2009, according to a report commissioned by the Generic Pharmaceutical Association and conducted by research firm IMS Health. Cardiovascular drugs, nervous system drugs, and metabolism drugs accounted for three-quarters of the savings, according to the report. In 2009, generics saved $139.6 billion, an increase of 15% over 2008, and those savings are expected to accelerate as 6 of the 10 current largest-selling brand-name drugs will lose patent protection by 2014, the report said. In that groups are the cholesterol drug Lipitor (atorvastatin), the blood clot preventer Plavix (clopidogrel), and the asthma medication Singulair (montelukast).

Whites Least Hospitalized for HBP

Blacks were hospitalized for hypertension nearly five times as often as whites in 2006, and Hispanics were as likely as whites to be admitted for the condition, according to the Agency for Health Care Research and Quality. Whites had 33 admissions per 100,000 people each year, whereas the figure for blacks was 161 admissions and for Hispanics, 61 admissions. More than 250,000 people each year are hospitalized for hypertension with complications, the agency found. The poorest Americans were 2.5 times as likely to be admitted for hypertension as were the wealthiest.

Agencies Post Disability Guidance

The Departments of Justice and Health and Human Services have jointly issued new technical guidance for health providers to encourage care of people with mobility disabilities. “Access to Medical Care for Persons with Mobility Disabilities” details how the Americans with Disabilities Act (ADA) and other government rules on disabled access apply to providers. The 19-page document includes an overview of general ADA requirements, frequently asked questions, and illustrated examples of accessible facilities, exam rooms, and equipment. Providers can download the booklet at

www.ada.gov/medcare_ta.htm

FDA: Intuniv Promotion Misleading

Promotional materials for the attention-deficit hyperactivity disorder drug Intuniv (guanfacine) misleadingly imply that the drug can correct “individual behavior problems” that “the whole family can see,” the FDA said in a letter ordering the manufacturer, Shire Development, to stop using those claims in parent guides and in-office brochures and displays. The materials mentioned temper outbursts, arguments with adults, deliberate annoyance of others, and irritability, the FDA said in its letter. However, the agency told Shire, “these behavioral problems are not symptoms specific to ADHD, and we are not aware of substantial evidence or substantial clinical experience demonstrating an effect of Intuniv on these behavioral problems.”

Parents Want Genetic Tests

Most parents are interested in having their children checked for disease risks using at-home genetic testing kits, according to a survey from C.S. Mott Children's Hospital in the University of Michigan Health System in Ann Arbor. The poll found 53% of parents either “very” or “somewhat” interested. Almost that entire group said the testing might give them the chance to prevent diseases and could help them recognize children's health problems early. Two-thirds of those who said they wouldn't be interested in testing their children cited the possibility of discrimination against children who showed genetic risk of disease.

Preventive Training Supported

The Department of Health and Human Services has awarded 15 grants totaling $9 million to train about 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support will go to accredited schools of public health and medicine and hospital-based residency programs, according to the agency. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received about $1 million, DHHS said.

State Backs Coordinated Care

Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency in its area. The program “will move New Hampshire away from the fee-for-service model,” according to a statement from the governor's office. “Our current health care system rewards providers for seeing as many patients as possible. We're going to change that,” Gov. Lynch said in the statement.

Generics Saved Nearly $1 Trillion

Use of generic drugs saved the U.S. health care system more than $824 billion in 2000-2009, according to a report commissioned by the Generic Pharmaceutical Association and conducted by research firm IMS Health. Cardiovascular drugs, nervous system drugs, and metabolism drugs accounted for three-quarters of the savings, according to the report. In 2009, generics saved $139.6 billion, an increase of 15% over 2008, and those savings are expected to accelerate as 6 of the 10 current largest-selling brand-name drugs will lose patent protection by 2014, the report said.

Whites Least Hospitalized for HBP

Blacks were hospitalized for hypertension nearly five times as often as whites in 2006, and Hispanics were as likely as whites to be admitted for the condition, according to the Agency for Health Care Research and Quality. Whites had 33 admissions per 100,000 people each year, whereas the figure for blacks was 161 admissions and for Hispanics, 61 admissions. More than 250,000 people each year are hospitalized for hypertension with complications, the agency found. The poorest Americans were 2.5 times as likely to be admitted for hypertension as were the wealthiest: 83 vs. 32 admissions per 100,000.

Agencies Post Disability Guidance

The Departments of Justice and Health and Human Services have jointly issued new technical guidance for health providers to encourage care of people with mobility disabilities. “Access to Medical Care for Persons with Mobility Disabilities” details how the Americans with Disabilities Act (ADA) and other government rules on disabled access apply to providers. The 19-page document includes an overview of general ADA requirements, frequently asked questions, and illustrated examples of accessible facilities, exam rooms, and medical equipment. Providers can download a copy of the booklet at

www.ada.gov/medcare_ta.htm

Call for U.S. Tobacco Strategy

The American College of Physicians has called for a new comprehensive federal strategy to control tobacco use, as opposed to what it called the “piecemeal actions” taken by states. “While tobacco use has decreased drastically over the last few decades, we still have a long way to go,” ACP President J. Fred Ralston Jr. said in a statement. The policy monograph “Tobacco Control and Prevention” says that in addition to more action against tobacco by the Food and Drug Administration, all states should establish and adequately fund efforts to prevent tobacco use among young people and provide information about tobacco dangers. All public and private insurers should provide tobacco-cessation and -treatment benefits to qualifying individuals, and physicians should help their patients quit, the ACP said.

ABIM Announces New Leadership

The American Board of Internal Medicine (ABIM) has new leadership: Dr. David Reuben, a professor at the University of California, Los Angeles, and chief of the division of geriatrics, will take over as chair, the ABIM said. Meanwhile, Dr. Catherine Lucey, director of residency training and vice dean for education at Ohio State University in Columbus was chosen as chair-elect. Dr. Talmadge King, the chair of the department of medicine at the University of California, San Francisco, will serve as secretary-treasurer of the board.

Preventive Training Supported

The Department of Health and Human Services has awarded 15 grants totaling $9 million to train about 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support will go to accredited schools of public health and medicine and hospital-based residency programs, according to the agency. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received about $1 million, DHHS said.

State Backs Coordinated Care

Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency in its area. The program “will move New Hampshire away from the fee-for-service model,” according to a statement from the governor's office. “Our current health care system rewards providers for seeing as many patients as possible. We're going to change that,” Gov. Lynch said in the statement.

Generics Saved Nearly $1 Trillion

Use of generic drugs saved the U.S. health care system more than $824 billion in 2000-2009, according to a report commissioned by the Generic Pharmaceutical Association and conducted by research firm IMS Health. Cardiovascular drugs, nervous system drugs, and metabolism drugs accounted for three-quarters of the savings, according to the report. In 2009, generics saved $139.6 billion, an increase of 15% over 2008, and those savings are expected to accelerate as 6 of the 10 current largest-selling brand-name drugs will lose patent protection by 2014, the report said.

Whites Least Hospitalized for HBP

Blacks were hospitalized for hypertension nearly five times as often as whites in 2006, and Hispanics were as likely as whites to be admitted for the condition, according to the Agency for Health Care Research and Quality. Whites had 33 admissions per 100,000 people each year, whereas the figure for blacks was 161 admissions and for Hispanics, 61 admissions. More than 250,000 people each year are hospitalized for hypertension with complications, the agency found. The poorest Americans were 2.5 times as likely to be admitted for hypertension as were the wealthiest: 83 vs. 32 admissions per 100,000.

Agencies Post Disability Guidance

The Departments of Justice and Health and Human Services have jointly issued new technical guidance for health providers to encourage care of people with mobility disabilities. “Access to Medical Care for Persons with Mobility Disabilities” details how the Americans with Disabilities Act (ADA) and other government rules on disabled access apply to providers. The 19-page document includes an overview of general ADA requirements, frequently asked questions, and illustrated examples of accessible facilities, exam rooms, and medical equipment. Providers can download a copy of the booklet at

www.ada.gov/medcare_ta.htm

Call for U.S. Tobacco Strategy

The American College of Physicians has called for a new comprehensive federal strategy to control tobacco use, as opposed to what it called the “piecemeal actions” taken by states. “While tobacco use has decreased drastically over the last few decades, we still have a long way to go,” ACP President J. Fred Ralston Jr. said in a statement. The policy monograph “Tobacco Control and Prevention” says that in addition to more action against tobacco by the Food and Drug Administration, all states should establish and adequately fund efforts to prevent tobacco use among young people and provide information about tobacco dangers. All public and private insurers should provide tobacco-cessation and -treatment benefits to qualifying individuals, and physicians should help their patients quit, the ACP said.

ABIM Announces New Leadership

The American Board of Internal Medicine (ABIM) has new leadership: Dr. David Reuben, a professor at the University of California, Los Angeles, and chief of the division of geriatrics, will take over as chair, the ABIM said. Meanwhile, Dr. Catherine Lucey, director of residency training and vice dean for education at Ohio State University in Columbus was chosen as chair-elect. Dr. Talmadge King, the chair of the department of medicine at the University of California, San Francisco, will serve as secretary-treasurer of the board.

Preventive Training Supported

The Department of Health and Human Services has awarded 15 grants totaling $9 million to train about 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support will go to accredited schools of public health and medicine and hospital-based residency programs, according to the agency. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received about $1 million, DHHS said.

State Backs Coordinated Care

Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency in its area. The program “will move New Hampshire away from the fee-for-service model,” according to a statement from the governor's office. “Our current health care system rewards providers for seeing as many patients as possible. We're going to change that,” Gov. Lynch said in the statement.

Generics Saved Nearly $1 Trillion

Use of generic drugs saved the U.S. health care system more than $824 billion in 2000-2009, according to a report commissioned by the Generic Pharmaceutical Association and conducted by research firm IMS Health. Cardiovascular drugs, nervous system drugs, and metabolism drugs accounted for three-quarters of the savings, according to the report. In 2009, generics saved $139.6 billion, an increase of 15% over 2008, and those savings are expected to accelerate as 6 of the 10 current largest-selling brand-name drugs will lose patent protection by 2014, the report said.

Whites Least Hospitalized for HBP

Blacks were hospitalized for hypertension nearly five times as often as whites in 2006, and Hispanics were as likely as whites to be admitted for the condition, according to the Agency for Health Care Research and Quality. Whites had 33 admissions per 100,000 people each year, whereas the figure for blacks was 161 admissions and for Hispanics, 61 admissions. More than 250,000 people each year are hospitalized for hypertension with complications, the agency found. The poorest Americans were 2.5 times as likely to be admitted for hypertension as were the wealthiest: 83 vs. 32 admissions per 100,000.

Agencies Post Disability Guidance

The Departments of Justice and Health and Human Services have jointly issued new technical guidance for health providers to encourage care of people with mobility disabilities. “Access to Medical Care for Persons with Mobility Disabilities” details how the Americans with Disabilities Act (ADA) and other government rules on disabled access apply to providers. The 19-page document includes an overview of general ADA requirements, frequently asked questions, and illustrated examples of accessible facilities, exam rooms, and medical equipment. Providers can download a copy of the booklet at

www.ada.gov/medcare_ta.htm

Call for U.S. Tobacco Strategy

The American College of Physicians has called for a new comprehensive federal strategy to control tobacco use, as opposed to what it called the “piecemeal actions” taken by states. “While tobacco use has decreased drastically over the last few decades, we still have a long way to go,” ACP President J. Fred Ralston Jr. said in a statement. The policy monograph “Tobacco Control and Prevention” says that in addition to more action against tobacco by the Food and Drug Administration, all states should establish and adequately fund efforts to prevent tobacco use among young people and provide information about tobacco dangers. All public and private insurers should provide tobacco-cessation and -treatment benefits to qualifying individuals, and physicians should help their patients quit, the ACP said.

ABIM Announces New Leadership

The American Board of Internal Medicine (ABIM) has new leadership: Dr. David Reuben, a professor at the University of California, Los Angeles, and chief of the division of geriatrics, will take over as chair, the ABIM said. Meanwhile, Dr. Catherine Lucey, director of residency training and vice dean for education at Ohio State University in Columbus was chosen as chair-elect. Dr. Talmadge King, the chair of the department of medicine at the University of California, San Francisco, will serve as secretary-treasurer of the board.

Medicare will now cover the use of facial fillers for those beneficiaries whose facial lipoatrophy resulted from treatment for HIV infection and has contributed significantly to their depression, the Centers for Medicare and Medicaid Services announced.

The decision, which applies only to fillers that are specifically approved for use in facial lipoatrophy, became effective immediately, according to the agency's national coverage determination memo.

Facial lipoatrophy, is a side effect of highly active antiretroviral therapy (HAART).

It involves the localized loss of fat from the face and the thinning of overlying skin, which causes an excessively thin and hollow appearance in the patient's cheeks.

As the condition progresses, the underlying facial muscles may appear more prominent, which makes the patient appear ill or prematurely aged.

Fat that is lost from the face may then redistribute to other parts of the body, such as the abdomen, neck, and breasts.

“Patients have reported feeling stigmatized by these changes, particularly if their HIV status has not been disclosed previously,” and they may believe that their relationships with others are adversely affected,” the decision said.

About 13%-38% of HAART-treated patients suffer from facial lipoatrophy, which leads some of them to discontinue their medications, according to the decision.

Two fillers—Radiesse (calcium hydroxylapatite) and Sculptra (poly-L-lactic acid)—are approved by the Food and Drug Administration to correct facial fat loss in people with HIV.

According to the CMS decision, the agency will cover the costs of the procedure only in patients whose gaunt appearance “is a significant contributor to their depression.”

Studies have shown that the use of facial fillers can improve patients' self-image and relieve their symptoms of depression.

This improvement may lead to better compliance with their antiretroviral treatment, CMS said in its decision.

Although HIV is rare in the Medicare population that is older than age 65, some HIV-infected individuals who are younger than 65 years may qualify for Medicare, based on their disability.

Implants or injectable soft-tissue materials—such as bovine or human collagen, silicone, or autologous fat—also have been used to treat HIV-related facial lipoatrophy, according to CMS.

However, the agency did not address those substances in its decision.

Medicare will now cover the use of facial fillers for those beneficiaries whose facial lipoatrophy resulted from treatment for HIV infection and has contributed significantly to their depression, the Centers for Medicare and Medicaid Services announced.

The decision, which applies only to fillers that are specifically approved for use in facial lipoatrophy, became effective immediately, according to the agency's national coverage determination memo.

Facial lipoatrophy, is a side effect of highly active antiretroviral therapy (HAART).

It involves the localized loss of fat from the face and the thinning of overlying skin, which causes an excessively thin and hollow appearance in the patient's cheeks.

As the condition progresses, the underlying facial muscles may appear more prominent, which makes the patient appear ill or prematurely aged.

Fat that is lost from the face may then redistribute to other parts of the body, such as the abdomen, neck, and breasts.

“Patients have reported feeling stigmatized by these changes, particularly if their HIV status has not been disclosed previously,” and they may believe that their relationships with others are adversely affected,” the decision said.

About 13%-38% of HAART-treated patients suffer from facial lipoatrophy, which leads some of them to discontinue their medications, according to the decision.

Two fillers—Radiesse (calcium hydroxylapatite) and Sculptra (poly-L-lactic acid)—are approved by the Food and Drug Administration to correct facial fat loss in people with HIV.

According to the CMS decision, the agency will cover the costs of the procedure only in patients whose gaunt appearance “is a significant contributor to their depression.”

Studies have shown that the use of facial fillers can improve patients' self-image and relieve their symptoms of depression.

This improvement may lead to better compliance with their antiretroviral treatment, CMS said in its decision.

Although HIV is rare in the Medicare population that is older than age 65, some HIV-infected individuals who are younger than 65 years may qualify for Medicare, based on their disability.

Implants or injectable soft-tissue materials—such as bovine or human collagen, silicone, or autologous fat—also have been used to treat HIV-related facial lipoatrophy, according to CMS.

However, the agency did not address those substances in its decision.

Medicare will now cover the use of facial fillers for those beneficiaries whose facial lipoatrophy resulted from treatment for HIV infection and has contributed significantly to their depression, the Centers for Medicare and Medicaid Services announced.

The decision, which applies only to fillers that are specifically approved for use in facial lipoatrophy, became effective immediately, according to the agency's national coverage determination memo.

Facial lipoatrophy, is a side effect of highly active antiretroviral therapy (HAART).

It involves the localized loss of fat from the face and the thinning of overlying skin, which causes an excessively thin and hollow appearance in the patient's cheeks.

As the condition progresses, the underlying facial muscles may appear more prominent, which makes the patient appear ill or prematurely aged.

Fat that is lost from the face may then redistribute to other parts of the body, such as the abdomen, neck, and breasts.

“Patients have reported feeling stigmatized by these changes, particularly if their HIV status has not been disclosed previously,” and they may believe that their relationships with others are adversely affected,” the decision said.

About 13%-38% of HAART-treated patients suffer from facial lipoatrophy, which leads some of them to discontinue their medications, according to the decision.

Two fillers—Radiesse (calcium hydroxylapatite) and Sculptra (poly-L-lactic acid)—are approved by the Food and Drug Administration to correct facial fat loss in people with HIV.

According to the CMS decision, the agency will cover the costs of the procedure only in patients whose gaunt appearance “is a significant contributor to their depression.”

Studies have shown that the use of facial fillers can improve patients' self-image and relieve their symptoms of depression.

This improvement may lead to better compliance with their antiretroviral treatment, CMS said in its decision.

Although HIV is rare in the Medicare population that is older than age 65, some HIV-infected individuals who are younger than 65 years may qualify for Medicare, based on their disability.

Implants or injectable soft-tissue materials—such as bovine or human collagen, silicone, or autologous fat—also have been used to treat HIV-related facial lipoatrophy, according to CMS.

However, the agency did not address those substances in its decision.

Bill Addresses Gestational Diabetes

Two House lawmakers have introduced a bill that would foster prevention activities and research on gestational diabetes. The legislation, backed by Reps. Eliot Engel (D-N.Y.) and Michael Burgess (R-Tex.), who is an obstetrician, would create a Centers for Disease Control and Prevention research advisory committee and provide funding for community-based education and prevention. The bill also would improve state and federal collection of data on gestational diabetes cases in an effort to develop better prevention methods. Gestational diabetes occurs in 2%-5% of pregnant women, according to federal government statistics. “This bill will improve detection and lead to more effective preventive measures that will reduce clinical costs for the patients as well as the states,” said Rep. Burgess.

Some Clinics Skip Screening

Local public health departments that lack the resources to hire health educators are less likely to conduct diabetes screening or obesity prevention programs, indicating that residents in poor areas lack access to those services, a study shows. However, local health departments in areas with high diabetes prevalence are more likely to offer diabetes screening, the study revealed. Health departments that conducted chronic disease surveillance also offered diabetes screening more frequently, according to the report by researchers at the CDC. Published in the American Journal of Public Health, the study showed that about half of public health clinics offer diabetes screening, half offer obesity prevention, and one-third offer both.

Drug Suspected in 1,354 Deaths

Type 2 diabetes drug rosiglitazone (Avandia) accounted for 1,354 patient deaths in 2009, more than any other prescription drug, according to a report from the Institute for Safe Medication Practices. However, the institute blamed publicity about the drug's cardiovascular safety risks in part for the large number of fatalities reported to the FDA. “The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company,” the report said. The institute excluded reports it knew were associated with legal claims but said it couldn't rule out the bad publicity as the reason for increased reporting of cardiovascular events and deaths associated with rosiglitazone in 2009.

FDA to Share Drug-Risk Findings

The Food and Drug Administration said it will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population, including previously unidentified risks and known adverse events that occur more frequently than expected.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, which could previously be covered only under Medicaid waivers. Connecticut said it initially will cover childless adults who make up to 56% of the federal poverty level, or $6,650 per year, estimated to be about 45,000 extra people. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early.

Men Less Likely to Get Care

Men are much less likely than women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as those with private insurance to make a routine care appointment, the agency said.

Bill Addresses Gestational Diabetes

Two House lawmakers have introduced a bill that would foster prevention activities and research on gestational diabetes. The legislation, backed by Reps. Eliot Engel (D-N.Y.) and Michael Burgess (R-Tex.), who is an obstetrician, would create a Centers for Disease Control and Prevention research advisory committee and provide funding for community-based education and prevention. The bill also would improve state and federal collection of data on gestational diabetes cases in an effort to develop better prevention methods. Gestational diabetes occurs in 2%-5% of pregnant women, according to federal government statistics. “This bill will improve detection and lead to more effective preventive measures that will reduce clinical costs for the patients as well as the states,” said Rep. Burgess.

Some Clinics Skip Screening

Local public health departments that lack the resources to hire health educators are less likely to conduct diabetes screening or obesity prevention programs, indicating that residents in poor areas lack access to those services, a study shows. However, local health departments in areas with high diabetes prevalence are more likely to offer diabetes screening, the study revealed. Health departments that conducted chronic disease surveillance also offered diabetes screening more frequently, according to the report by researchers at the CDC. Published in the American Journal of Public Health, the study showed that about half of public health clinics offer diabetes screening, half offer obesity prevention, and one-third offer both.

Drug Suspected in 1,354 Deaths

Type 2 diabetes drug rosiglitazone (Avandia) accounted for 1,354 patient deaths in 2009, more than any other prescription drug, according to a report from the Institute for Safe Medication Practices. However, the institute blamed publicity about the drug's cardiovascular safety risks in part for the large number of fatalities reported to the FDA. “The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company,” the report said. The institute excluded reports it knew were associated with legal claims but said it couldn't rule out the bad publicity as the reason for increased reporting of cardiovascular events and deaths associated with rosiglitazone in 2009.

FDA to Share Drug-Risk Findings

The Food and Drug Administration said it will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population, including previously unidentified risks and known adverse events that occur more frequently than expected.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, which could previously be covered only under Medicaid waivers. Connecticut said it initially will cover childless adults who make up to 56% of the federal poverty level, or $6,650 per year, estimated to be about 45,000 extra people. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early.

Men Less Likely to Get Care

Men are much less likely than women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as those with private insurance to make a routine care appointment, the agency said.

Bill Addresses Gestational Diabetes

Two House lawmakers have introduced a bill that would foster prevention activities and research on gestational diabetes. The legislation, backed by Reps. Eliot Engel (D-N.Y.) and Michael Burgess (R-Tex.), who is an obstetrician, would create a Centers for Disease Control and Prevention research advisory committee and provide funding for community-based education and prevention. The bill also would improve state and federal collection of data on gestational diabetes cases in an effort to develop better prevention methods. Gestational diabetes occurs in 2%-5% of pregnant women, according to federal government statistics. “This bill will improve detection and lead to more effective preventive measures that will reduce clinical costs for the patients as well as the states,” said Rep. Burgess.

Some Clinics Skip Screening

Local public health departments that lack the resources to hire health educators are less likely to conduct diabetes screening or obesity prevention programs, indicating that residents in poor areas lack access to those services, a study shows. However, local health departments in areas with high diabetes prevalence are more likely to offer diabetes screening, the study revealed. Health departments that conducted chronic disease surveillance also offered diabetes screening more frequently, according to the report by researchers at the CDC. Published in the American Journal of Public Health, the study showed that about half of public health clinics offer diabetes screening, half offer obesity prevention, and one-third offer both.

Drug Suspected in 1,354 Deaths

Type 2 diabetes drug rosiglitazone (Avandia) accounted for 1,354 patient deaths in 2009, more than any other prescription drug, according to a report from the Institute for Safe Medication Practices. However, the institute blamed publicity about the drug's cardiovascular safety risks in part for the large number of fatalities reported to the FDA. “The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company,” the report said. The institute excluded reports it knew were associated with legal claims but said it couldn't rule out the bad publicity as the reason for increased reporting of cardiovascular events and deaths associated with rosiglitazone in 2009.

FDA to Share Drug-Risk Findings

The Food and Drug Administration said it will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population, including previously unidentified risks and known adverse events that occur more frequently than expected.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, which could previously be covered only under Medicaid waivers. Connecticut said it initially will cover childless adults who make up to 56% of the federal poverty level, or $6,650 per year, estimated to be about 45,000 extra people. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early.

Men Less Likely to Get Care

Men are much less likely than women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as those with private insurance to make a routine care appointment, the agency said.

Kellogg Drops Health Claim

For the second time in a year, Kellogg Company has agreed to drop a questionable health claim from one of its cereals. In an expanded settlement with the Federal Trade Commission, Kellogg agreed to stop using statements on Rice Krispies that the product “now helps support your child's immunity” and “has been improved to include antioxidants and nutrients that your family needs to help them stay healthy.” In the original settlement last year, the company stopped claiming that Frosted Mini-Wheats cereal was “clinically shown to improve kids' attentiveness by nearly 20%” and agreed it would refrain from cognitive health claims about its breakfast or snack products. The expanded settlement now prohibits Kellogg from making claims about any health benefit of any food unless those claims are backed by scientific evidence.

FDA Issues Final Tobacco Rule

The Food and Drug Administration has implemented its new rule designed to significantly curb children's use of cigarettes and smokeless tobacco products by making those products less accessible and attractive. The new rule prohibits cigarette sales to minors and ends sales from self-service machines and displays. It also prohibits tobacco–brand name sponsorship of athletic, musical, social, or cultural events and of teams. The rule bans tobacco-logo items such as hats and t-shirts and the reward of gifts or other items given in exchange for buying tobacco products. It requires that audio ads for cigarettes and smokeless tobacco use only words with no music or sound effects. The FDA said it is working with manufacturers and retailers to make sure they understand the new requirements, but it also reminded them that retailers who don't comply with the new rules may be subject to enforcement action.

School Food Bill Introduced

School lunch programs would receive 6 cents more per lunch served—the first real increase in reimbursement in 30 years—under legislation introduced by key House lawmakers to improve child nutrition (H.R. 5504). The bill, sponsored by Rep. George Miller (D-Calif.), chairman of the House Education and Labor Committee, also would increase the number of children eligible for free meals, increase funding for nutrition education in schools, and work to incorporate local produce into school lunches. The bill would extend Department of Agriculture nutrition requirements to foods sold in vending machines and a-la-carte items—not just meals—in schools. It also would require schools to sell only low-fat milk in their lunch lines. The legislation, which would cost $8 billion over 10 years, includes proposals from First Lady Michelle Obama's initiative against childhood obesity. A similar bill is pending in the Senate.

Childhood Obesity Toolkit Out

Blue Cross Blue Shield of North Carolina and the Blue Cross and Blue Shield Association are rolling out a physician toolkit designed to combat childhood obesity and diabetes. Initially developed by the North Carolina Blues organization in conjunction with the American Diabetes Association and the American Academy of Pediatrics, the toolkit will be made available to pediatricians nationwide. It includes tip sheets, wall posters, physician reference materials, tracking sheets, and brochures with educational information. It comes in both English and Spanish. The educational materials encourage children to eat fruits and vegetables, limit their screen time, skip sweetened drinks, and exercise.

State to Cover Autism Treatment

Wisconsin's Medicaid program said it will pay for families' use of Rethink Autism, a Web-based program with a comprehensive evidence-based curriculum. The program provides parents with more than 1,200 video-based teaching steps, parent training modules, an assessment tool, and features for tracking a child's progress. The curriculum spans the entire autism spectrum and covers a broad range of skills, including academic, language, social, motor, daily living, and behavior management. The company behind Rethink Autism said in a statement that its program will be important for families that are no longer receiving intensive autism interventions, those waiting for intensive in-home autism treatment services, and those looking to complement their existing treatment plan.

FDA to Review Dental Amalgam

The FDA said it will hold an advisory panel meeting in December to review issues related to possible risk from dental amalgam for pregnant women, fetuses, and young children. Dental amalgam is a mixture of metals, including liquid mercury and a powdered amalgam alloy composed primarily of silver, tin, and copper. The FDA last year designated special controls for dental amalgam and dental mercury. Since then, scientific and advocacy groups have raised questions about the FDA's analysis of the risks posed by mercury and dental amalgam, the cumulative biological effect of mercury, the exposure of pediatric populations to mercury vapor, and the adequacy of the clinical studies on dental amalgam.

Kellogg Drops Health Claim

For the second time in a year, Kellogg Company has agreed to drop a questionable health claim from one of its cereals. In an expanded settlement with the Federal Trade Commission, Kellogg agreed to stop using statements on Rice Krispies that the product “now helps support your child's immunity” and “has been improved to include antioxidants and nutrients that your family needs to help them stay healthy.” In the original settlement last year, the company stopped claiming that Frosted Mini-Wheats cereal was “clinically shown to improve kids' attentiveness by nearly 20%” and agreed it would refrain from cognitive health claims about its breakfast or snack products. The expanded settlement now prohibits Kellogg from making claims about any health benefit of any food unless those claims are backed by scientific evidence.

FDA Issues Final Tobacco Rule

The Food and Drug Administration has implemented its new rule designed to significantly curb children's use of cigarettes and smokeless tobacco products by making those products less accessible and attractive. The new rule prohibits cigarette sales to minors and ends sales from self-service machines and displays. It also prohibits tobacco–brand name sponsorship of athletic, musical, social, or cultural events and of teams. The rule bans tobacco-logo items such as hats and t-shirts and the reward of gifts or other items given in exchange for buying tobacco products. It requires that audio ads for cigarettes and smokeless tobacco use only words with no music or sound effects. The FDA said it is working with manufacturers and retailers to make sure they understand the new requirements, but it also reminded them that retailers who don't comply with the new rules may be subject to enforcement action.

School Food Bill Introduced

School lunch programs would receive 6 cents more per lunch served—the first real increase in reimbursement in 30 years—under legislation introduced by key House lawmakers to improve child nutrition (H.R. 5504). The bill, sponsored by Rep. George Miller (D-Calif.), chairman of the House Education and Labor Committee, also would increase the number of children eligible for free meals, increase funding for nutrition education in schools, and work to incorporate local produce into school lunches. The bill would extend Department of Agriculture nutrition requirements to foods sold in vending machines and a-la-carte items—not just meals—in schools. It also would require schools to sell only low-fat milk in their lunch lines. The legislation, which would cost $8 billion over 10 years, includes proposals from First Lady Michelle Obama's initiative against childhood obesity. A similar bill is pending in the Senate.

Childhood Obesity Toolkit Out

Blue Cross Blue Shield of North Carolina and the Blue Cross and Blue Shield Association are rolling out a physician toolkit designed to combat childhood obesity and diabetes. Initially developed by the North Carolina Blues organization in conjunction with the American Diabetes Association and the American Academy of Pediatrics, the toolkit will be made available to pediatricians nationwide. It includes tip sheets, wall posters, physician reference materials, tracking sheets, and brochures with educational information. It comes in both English and Spanish. The educational materials encourage children to eat fruits and vegetables, limit their screen time, skip sweetened drinks, and exercise.

State to Cover Autism Treatment

Wisconsin's Medicaid program said it will pay for families' use of Rethink Autism, a Web-based program with a comprehensive evidence-based curriculum. The program provides parents with more than 1,200 video-based teaching steps, parent training modules, an assessment tool, and features for tracking a child's progress. The curriculum spans the entire autism spectrum and covers a broad range of skills, including academic, language, social, motor, daily living, and behavior management. The company behind Rethink Autism said in a statement that its program will be important for families that are no longer receiving intensive autism interventions, those waiting for intensive in-home autism treatment services, and those looking to complement their existing treatment plan.

FDA to Review Dental Amalgam

The FDA said it will hold an advisory panel meeting in December to review issues related to possible risk from dental amalgam for pregnant women, fetuses, and young children. Dental amalgam is a mixture of metals, including liquid mercury and a powdered amalgam alloy composed primarily of silver, tin, and copper. The FDA last year designated special controls for dental amalgam and dental mercury. Since then, scientific and advocacy groups have raised questions about the FDA's analysis of the risks posed by mercury and dental amalgam, the cumulative biological effect of mercury, the exposure of pediatric populations to mercury vapor, and the adequacy of the clinical studies on dental amalgam.

Kellogg Drops Health Claim

For the second time in a year, Kellogg Company has agreed to drop a questionable health claim from one of its cereals. In an expanded settlement with the Federal Trade Commission, Kellogg agreed to stop using statements on Rice Krispies that the product “now helps support your child's immunity” and “has been improved to include antioxidants and nutrients that your family needs to help them stay healthy.” In the original settlement last year, the company stopped claiming that Frosted Mini-Wheats cereal was “clinically shown to improve kids' attentiveness by nearly 20%” and agreed it would refrain from cognitive health claims about its breakfast or snack products. The expanded settlement now prohibits Kellogg from making claims about any health benefit of any food unless those claims are backed by scientific evidence.

FDA Issues Final Tobacco Rule

The Food and Drug Administration has implemented its new rule designed to significantly curb children's use of cigarettes and smokeless tobacco products by making those products less accessible and attractive. The new rule prohibits cigarette sales to minors and ends sales from self-service machines and displays. It also prohibits tobacco–brand name sponsorship of athletic, musical, social, or cultural events and of teams. The rule bans tobacco-logo items such as hats and t-shirts and the reward of gifts or other items given in exchange for buying tobacco products. It requires that audio ads for cigarettes and smokeless tobacco use only words with no music or sound effects. The FDA said it is working with manufacturers and retailers to make sure they understand the new requirements, but it also reminded them that retailers who don't comply with the new rules may be subject to enforcement action.

School Food Bill Introduced

School lunch programs would receive 6 cents more per lunch served—the first real increase in reimbursement in 30 years—under legislation introduced by key House lawmakers to improve child nutrition (H.R. 5504). The bill, sponsored by Rep. George Miller (D-Calif.), chairman of the House Education and Labor Committee, also would increase the number of children eligible for free meals, increase funding for nutrition education in schools, and work to incorporate local produce into school lunches. The bill would extend Department of Agriculture nutrition requirements to foods sold in vending machines and a-la-carte items—not just meals—in schools. It also would require schools to sell only low-fat milk in their lunch lines. The legislation, which would cost $8 billion over 10 years, includes proposals from First Lady Michelle Obama's initiative against childhood obesity. A similar bill is pending in the Senate.

Childhood Obesity Toolkit Out

Blue Cross Blue Shield of North Carolina and the Blue Cross and Blue Shield Association are rolling out a physician toolkit designed to combat childhood obesity and diabetes. Initially developed by the North Carolina Blues organization in conjunction with the American Diabetes Association and the American Academy of Pediatrics, the toolkit will be made available to pediatricians nationwide. It includes tip sheets, wall posters, physician reference materials, tracking sheets, and brochures with educational information. It comes in both English and Spanish. The educational materials encourage children to eat fruits and vegetables, limit their screen time, skip sweetened drinks, and exercise.

State to Cover Autism Treatment

Wisconsin's Medicaid program said it will pay for families' use of Rethink Autism, a Web-based program with a comprehensive evidence-based curriculum. The program provides parents with more than 1,200 video-based teaching steps, parent training modules, an assessment tool, and features for tracking a child's progress. The curriculum spans the entire autism spectrum and covers a broad range of skills, including academic, language, social, motor, daily living, and behavior management. The company behind Rethink Autism said in a statement that its program will be important for families that are no longer receiving intensive autism interventions, those waiting for intensive in-home autism treatment services, and those looking to complement their existing treatment plan.

FDA to Review Dental Amalgam

The FDA said it will hold an advisory panel meeting in December to review issues related to possible risk from dental amalgam for pregnant women, fetuses, and young children. Dental amalgam is a mixture of metals, including liquid mercury and a powdered amalgam alloy composed primarily of silver, tin, and copper. The FDA last year designated special controls for dental amalgam and dental mercury. Since then, scientific and advocacy groups have raised questions about the FDA's analysis of the risks posed by mercury and dental amalgam, the cumulative biological effect of mercury, the exposure of pediatric populations to mercury vapor, and the adequacy of the clinical studies on dental amalgam.

Reminders Boost Screenings

Automated telephone reminders can increase colon cancer screening rates by 30%, according to a study from the Kaiser Permanente Center for Health Research. The study looked at nearly 6,000 patients who were overdue for screening. Half the patients received up to three reminder calls stressing the importance of screening. The phone calls also offered patients an in-home kit to detect blood in the stool. Within 6 months, more than 22% of people who received calls ordered and completed a stool card test, compared with only 16% of those who didn't receive the phone calls but may have been reminded of testing during a physician visit. Kaiser said it now uses the automated phone calls to remind all members who are overdue for colon cancer screening.

FDA to Share Drug-Risk Findings

The Food and Drug Administration said it will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population, including previously unidentified risks and known adverse events that occur more frequently than expected. The initial reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, and depression, the agency said.

Immunization Programs Rewarded

The American Academy of Family Physicians has recognized 10 family medicine residency programs that have developed and implemented creative ways to increase immunization rates in their communities. The AAFP chose residencies that achieved high immunization rates within a year, that overcame barriers to improve immunization rates within a year, and that implemented new systems to increase immunization rates among medically underserved children. The 2010 AAFP Foundation Pfizer Immunization Awards provide grants and scholarships for residents to attend the AAFP's national conference for medical students and residents.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, who could previously be covered only under Medicaid waivers. Connecticut said it initially will cover an estimated 45,000 childless adults who make up to 56% of the federal poverty level, or $6,650 per year. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early. The law will provide federal funding for Medicaid for people earning up to 133% of the federal poverty level, or $14,400 for an individual.

U.S. Invests in Primary Care

The Department of Health and Human Services said it will invest $250 million to increase the number of primary care health providers and strengthen the primary care workforce. The investment, which Congress approved as part of health care reform legislation, will provide $168 million to train more than 500 new primary care physicians by 2015. In addition, $32 million will go toward training 600 physician assistants, $30 million will help nursing students attend school full-time, $15 million will support 10 nurse-managed health clinics, and $5 million will go to states for strategies that expand their primary care workforces by up to 25% over the next decade.

First-Year Compensation Up

Guaranteed first-year compensation for primary care physicians hired by group practices has increased by more than 17% since 2006 while shrinking about 2% for specialists, according to the Medical Group Management Association. Primary care physicians reported a median first-year guaranteed compensation of $160,000 in 2009, while specialists reported $230,000. At multispecialty practices, pay for first-year primary care physicians increased about 14% since 2006, the MGMA said. Hospital-owned practices offered more in guaranteed first-year compensation in 2009 to both primary care and specialty care physicians, which could be driving more physicians to such practices, the MGMA said. Nearly two-thirds of established physicians and about half of new physicians accepted offers from hospital-owned practices in 2009.

Men Less Likely to Get Care

Men are much less likely than are women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as those with private insurance to make a routine care appointment, the agency said. About three-quarters of respondents who said they were in excellent health reported making an appointment for routine medical care, compared with only half of those who said their health was fair or poor.

Feds Issue Patient's Bill of Rights

Obama administration has spelled out details of new insurance protections in a set of regulations it's calling the Patient's Bill of Rights. The interim final rules implement elements of the Affordable Care Act, such as banning pre-existing condition exclusions for children under age 19, banning the practice of insurance rescissions, eliminating lifetime limits on coverage, and restricting annual dollar limits on insurance coverage. The regulations also address patients' right to seeing an ob.gyn. without a referral, and bar insurers from charging higher cost sharing for out of network emergency services. The provisions will apply to most health plans for plan years beginning on or after Sept. 23, 2010, according to the White House. The regulations were issued by the Departments of Health and Human Services; Labor; and Treasury in June.

Reminders Boost Screenings

Automated telephone reminders can increase colon cancer screening rates by 30%, according to a study from the Kaiser Permanente Center for Health Research. The study looked at nearly 6,000 patients who were overdue for screening. Half the patients received up to three reminder calls stressing the importance of screening. The phone calls also offered patients an in-home kit to detect blood in the stool. Within 6 months, more than 22% of people who received calls ordered and completed a stool card test, compared with only 16% of those who didn't receive the phone calls but may have been reminded of testing during a physician visit. Kaiser said it now uses the automated phone calls to remind all members who are overdue for colon cancer screening.

FDA to Share Drug-Risk Findings

The Food and Drug Administration said it will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population, including previously unidentified risks and known adverse events that occur more frequently than expected. The initial reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, and depression, the agency said.

Immunization Programs Rewarded

The American Academy of Family Physicians has recognized 10 family medicine residency programs that have developed and implemented creative ways to increase immunization rates in their communities. The AAFP chose residencies that achieved high immunization rates within a year, that overcame barriers to improve immunization rates within a year, and that implemented new systems to increase immunization rates among medically underserved children. The 2010 AAFP Foundation Pfizer Immunization Awards provide grants and scholarships for residents to attend the AAFP's national conference for medical students and residents.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, who could previously be covered only under Medicaid waivers. Connecticut said it initially will cover an estimated 45,000 childless adults who make up to 56% of the federal poverty level, or $6,650 per year. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early. The law will provide federal funding for Medicaid for people earning up to 133% of the federal poverty level, or $14,400 for an individual.

U.S. Invests in Primary Care

The Department of Health and Human Services said it will invest $250 million to increase the number of primary care health providers and strengthen the primary care workforce. The investment, which Congress approved as part of health care reform legislation, will provide $168 million to train more than 500 new primary care physicians by 2015. In addition, $32 million will go toward training 600 physician assistants, $30 million will help nursing students attend school full-time, $15 million will support 10 nurse-managed health clinics, and $5 million will go to states for strategies that expand their primary care workforces by up to 25% over the next decade.

First-Year Compensation Up

Guaranteed first-year compensation for primary care physicians hired by group practices has increased by more than 17% since 2006 while shrinking about 2% for specialists, according to the Medical Group Management Association. Primary care physicians reported a median first-year guaranteed compensation of $160,000 in 2009, while specialists reported $230,000. At multispecialty practices, pay for first-year primary care physicians increased about 14% since 2006, the MGMA said. Hospital-owned practices offered more in guaranteed first-year compensation in 2009 to both primary care and specialty care physicians, which could be driving more physicians to such practices, the MGMA said. Nearly two-thirds of established physicians and about half of new physicians accepted offers from hospital-owned practices in 2009.

Men Less Likely to Get Care

Men are much less likely than are women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as those with private insurance to make a routine care appointment, the agency said. About three-quarters of respondents who said they were in excellent health reported making an appointment for routine medical care, compared with only half of those who said their health was fair or poor.

Feds Issue Patient's Bill of Rights

Obama administration has spelled out details of new insurance protections in a set of regulations it's calling the Patient's Bill of Rights. The interim final rules implement elements of the Affordable Care Act, such as banning pre-existing condition exclusions for children under age 19, banning the practice of insurance rescissions, eliminating lifetime limits on coverage, and restricting annual dollar limits on insurance coverage. The regulations also address patients' right to seeing an ob.gyn. without a referral, and bar insurers from charging higher cost sharing for out of network emergency services. The provisions will apply to most health plans for plan years beginning on or after Sept. 23, 2010, according to the White House. The regulations were issued by the Departments of Health and Human Services; Labor; and Treasury in June.

Reminders Boost Screenings

Automated telephone reminders can increase colon cancer screening rates by 30%, according to a study from the Kaiser Permanente Center for Health Research. The study looked at nearly 6,000 patients who were overdue for screening. Half the patients received up to three reminder calls stressing the importance of screening. The phone calls also offered patients an in-home kit to detect blood in the stool. Within 6 months, more than 22% of people who received calls ordered and completed a stool card test, compared with only 16% of those who didn't receive the phone calls but may have been reminded of testing during a physician visit. Kaiser said it now uses the automated phone calls to remind all members who are overdue for colon cancer screening.

FDA to Share Drug-Risk Findings

The Food and Drug Administration said it will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population, including previously unidentified risks and known adverse events that occur more frequently than expected. The initial reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, and depression, the agency said.

Immunization Programs Rewarded

The American Academy of Family Physicians has recognized 10 family medicine residency programs that have developed and implemented creative ways to increase immunization rates in their communities. The AAFP chose residencies that achieved high immunization rates within a year, that overcame barriers to improve immunization rates within a year, and that implemented new systems to increase immunization rates among medically underserved children. The 2010 AAFP Foundation Pfizer Immunization Awards provide grants and scholarships for residents to attend the AAFP's national conference for medical students and residents.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, who could previously be covered only under Medicaid waivers. Connecticut said it initially will cover an estimated 45,000 childless adults who make up to 56% of the federal poverty level, or $6,650 per year. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early. The law will provide federal funding for Medicaid for people earning up to 133% of the federal poverty level, or $14,400 for an individual.

U.S. Invests in Primary Care

The Department of Health and Human Services said it will invest $250 million to increase the number of primary care health providers and strengthen the primary care workforce. The investment, which Congress approved as part of health care reform legislation, will provide $168 million to train more than 500 new primary care physicians by 2015. In addition, $32 million will go toward training 600 physician assistants, $30 million will help nursing students attend school full-time, $15 million will support 10 nurse-managed health clinics, and $5 million will go to states for strategies that expand their primary care workforces by up to 25% over the next decade.

First-Year Compensation Up

Guaranteed first-year compensation for primary care physicians hired by group practices has increased by more than 17% since 2006 while shrinking about 2% for specialists, according to the Medical Group Management Association. Primary care physicians reported a median first-year guaranteed compensation of $160,000 in 2009, while specialists reported $230,000. At multispecialty practices, pay for first-year primary care physicians increased about 14% since 2006, the MGMA said. Hospital-owned practices offered more in guaranteed first-year compensation in 2009 to both primary care and specialty care physicians, which could be driving more physicians to such practices, the MGMA said. Nearly two-thirds of established physicians and about half of new physicians accepted offers from hospital-owned practices in 2009.

Men Less Likely to Get Care

Men are much less likely than are women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as those with private insurance to make a routine care appointment, the agency said. About three-quarters of respondents who said they were in excellent health reported making an appointment for routine medical care, compared with only half of those who said their health was fair or poor.

Feds Issue Patient's Bill of Rights

Obama administration has spelled out details of new insurance protections in a set of regulations it's calling the Patient's Bill of Rights. The interim final rules implement elements of the Affordable Care Act, such as banning pre-existing condition exclusions for children under age 19, banning the practice of insurance rescissions, eliminating lifetime limits on coverage, and restricting annual dollar limits on insurance coverage. The regulations also address patients' right to seeing an ob.gyn. without a referral, and bar insurers from charging higher cost sharing for out of network emergency services. The provisions will apply to most health plans for plan years beginning on or after Sept. 23, 2010, according to the White House. The regulations were issued by the Departments of Health and Human Services; Labor; and Treasury in June.

Heart failure patients discharged from hospitals with high levels of early postdischarge follow-up are less likely to be readmitted to the hospital within 30 days, according to a large study.

However, most heart failure patients do not visit a physician within 7 days of discharge.

The study, which looked at hospital-level rates of early outpatient follow-up after discharge, included data on more than 30,000 heart failure patients from 225 hospitals. It found that the median rate of follow-up within 7 days of discharge was 38% (JAMA 2010;303:1716-22).

“For patients with heart failure, the transition from inpatient to outpatient care can be an especially vulnerable period because of the age of the patients, complex medical regimens, the large number of comorbid conditions, and the multiple clinicians who may be involved,” wrote Dr. Adrian F. Hernandez of Duke University, Durham, N.C., and his coauthors. “Our findings highlight a need for improvement and greater uniformity in coordination of care from inpatient to outpatient settings.”

Overall, about 21% of heart failure patients were readmitted to the hospital within 30 days of discharge. Patients in hospitals with higher rates of early follow-up had a lower risk of readmission, the study found.

After adjustment for case mix, admission laboratory results, provision of discharge instructions, and length of stay, the risk-adjusted hazard of 30-day readmission was 15% lower in the hospitals with higher rates of early follow-up, the study found. Whereas 20% of patients whose initial hospital stay took place in a hospital with the highest rates of early follow-up were readmitted, 23% of patients in the hospitals with the lowest follow-up rates were readmitted, a significant difference.

Still, the authors only found differences in rehospitalization rates in the hospitals that ranked in the lowest quartile of posthospitalization follow-up; rates at the other 75% of hospitals were similar.

The researchers did find some racial differences: The proportion of black patients was “markedly higher” among hospitals with the lowest rates of early follow-up. They also found that patients discharged from hospitals with the highest rates of early follow-up by a cardiologist had lower risk of 30-day mortality, which they noted is consistent with other studies of cardiology care for heart failure.

Most follow-up during the transitional period, especially the first week, is handled by general internists, the study authors found. More than two-thirds of patients hospitalized for heart failure are evaluated by a cardiologist during their inpatient stays, but fewer than 10% see a cardiologist within 7 days of hospital discharge.

However, neither early follow-up with a cardiologist nor continuity of care from the same physician seen during the hospitalization was a significant predictor of 30-day readmission, they wrote.

Documentation of discharge instructions, which many physicians presume helps to ensure early follow-up and better outcomes, also was not associated with lower readmission rates. “This finding raises the possibility that discharge instructions are becoming rote processes that do not adequately address elements of care that ensure a safe transition,” the authors wrote.

The study provides evidence in support of guidelines recommending the use of postdischarge systems of care, the authors said. “Achieving early follow-up may be difficult for some physician practices, but models of care that include nurse practitioners or physician assistants under physician supervision may result in increased access to and timeliness of care.”

In addition, they said, early follow-up is a potential quality measure that could be used as part of heart failure performance measure sets.

Disclosures: The study was supported by grants from the American Heart Association, GlaxoSmithKline, Medtronic, and the Agency for Healthcare Research and Quality. The study authors reported a variety of financial support, grants, consulting arrangements, and honoraria from drug manufacturers, other health care companies, and nonprofit organizations.

Heart failure patients discharged from hospitals with high levels of early postdischarge follow-up are less likely to be readmitted to the hospital within 30 days, according to a large study.

However, most heart failure patients do not visit a physician within 7 days of discharge.

The study, which looked at hospital-level rates of early outpatient follow-up after discharge, included data on more than 30,000 heart failure patients from 225 hospitals. It found that the median rate of follow-up within 7 days of discharge was 38% (JAMA 2010;303:1716-22).

“For patients with heart failure, the transition from inpatient to outpatient care can be an especially vulnerable period because of the age of the patients, complex medical regimens, the large number of comorbid conditions, and the multiple clinicians who may be involved,” wrote Dr. Adrian F. Hernandez of Duke University, Durham, N.C., and his coauthors. “Our findings highlight a need for improvement and greater uniformity in coordination of care from inpatient to outpatient settings.”

Overall, about 21% of heart failure patients were readmitted to the hospital within 30 days of discharge. Patients in hospitals with higher rates of early follow-up had a lower risk of readmission, the study found.

After adjustment for case mix, admission laboratory results, provision of discharge instructions, and length of stay, the risk-adjusted hazard of 30-day readmission was 15% lower in the hospitals with higher rates of early follow-up, the study found. Whereas 20% of patients whose initial hospital stay took place in a hospital with the highest rates of early follow-up were readmitted, 23% of patients in the hospitals with the lowest follow-up rates were readmitted, a significant difference.

Still, the authors only found differences in rehospitalization rates in the hospitals that ranked in the lowest quartile of posthospitalization follow-up; rates at the other 75% of hospitals were similar.

The researchers did find some racial differences: The proportion of black patients was “markedly higher” among hospitals with the lowest rates of early follow-up. They also found that patients discharged from hospitals with the highest rates of early follow-up by a cardiologist had lower risk of 30-day mortality, which they noted is consistent with other studies of cardiology care for heart failure.

Most follow-up during the transitional period, especially the first week, is handled by general internists, the study authors found. More than two-thirds of patients hospitalized for heart failure are evaluated by a cardiologist during their inpatient stays, but fewer than 10% see a cardiologist within 7 days of hospital discharge.

However, neither early follow-up with a cardiologist nor continuity of care from the same physician seen during the hospitalization was a significant predictor of 30-day readmission, they wrote.

Documentation of discharge instructions, which many physicians presume helps to ensure early follow-up and better outcomes, also was not associated with lower readmission rates. “This finding raises the possibility that discharge instructions are becoming rote processes that do not adequately address elements of care that ensure a safe transition,” the authors wrote.

The study provides evidence in support of guidelines recommending the use of postdischarge systems of care, the authors said. “Achieving early follow-up may be difficult for some physician practices, but models of care that include nurse practitioners or physician assistants under physician supervision may result in increased access to and timeliness of care.”

In addition, they said, early follow-up is a potential quality measure that could be used as part of heart failure performance measure sets.

Disclosures: The study was supported by grants from the American Heart Association, GlaxoSmithKline, Medtronic, and the Agency for Healthcare Research and Quality. The study authors reported a variety of financial support, grants, consulting arrangements, and honoraria from drug manufacturers, other health care companies, and nonprofit organizations.

Heart failure patients discharged from hospitals with high levels of early postdischarge follow-up are less likely to be readmitted to the hospital within 30 days, according to a large study.

However, most heart failure patients do not visit a physician within 7 days of discharge.

The study, which looked at hospital-level rates of early outpatient follow-up after discharge, included data on more than 30,000 heart failure patients from 225 hospitals. It found that the median rate of follow-up within 7 days of discharge was 38% (JAMA 2010;303:1716-22).

“For patients with heart failure, the transition from inpatient to outpatient care can be an especially vulnerable period because of the age of the patients, complex medical regimens, the large number of comorbid conditions, and the multiple clinicians who may be involved,” wrote Dr. Adrian F. Hernandez of Duke University, Durham, N.C., and his coauthors. “Our findings highlight a need for improvement and greater uniformity in coordination of care from inpatient to outpatient settings.”

Overall, about 21% of heart failure patients were readmitted to the hospital within 30 days of discharge. Patients in hospitals with higher rates of early follow-up had a lower risk of readmission, the study found.

After adjustment for case mix, admission laboratory results, provision of discharge instructions, and length of stay, the risk-adjusted hazard of 30-day readmission was 15% lower in the hospitals with higher rates of early follow-up, the study found. Whereas 20% of patients whose initial hospital stay took place in a hospital with the highest rates of early follow-up were readmitted, 23% of patients in the hospitals with the lowest follow-up rates were readmitted, a significant difference.

Still, the authors only found differences in rehospitalization rates in the hospitals that ranked in the lowest quartile of posthospitalization follow-up; rates at the other 75% of hospitals were similar.

The researchers did find some racial differences: The proportion of black patients was “markedly higher” among hospitals with the lowest rates of early follow-up. They also found that patients discharged from hospitals with the highest rates of early follow-up by a cardiologist had lower risk of 30-day mortality, which they noted is consistent with other studies of cardiology care for heart failure.

Most follow-up during the transitional period, especially the first week, is handled by general internists, the study authors found. More than two-thirds of patients hospitalized for heart failure are evaluated by a cardiologist during their inpatient stays, but fewer than 10% see a cardiologist within 7 days of hospital discharge.

However, neither early follow-up with a cardiologist nor continuity of care from the same physician seen during the hospitalization was a significant predictor of 30-day readmission, they wrote.

Documentation of discharge instructions, which many physicians presume helps to ensure early follow-up and better outcomes, also was not associated with lower readmission rates. “This finding raises the possibility that discharge instructions are becoming rote processes that do not adequately address elements of care that ensure a safe transition,” the authors wrote.

The study provides evidence in support of guidelines recommending the use of postdischarge systems of care, the authors said. “Achieving early follow-up may be difficult for some physician practices, but models of care that include nurse practitioners or physician assistants under physician supervision may result in increased access to and timeliness of care.”

In addition, they said, early follow-up is a potential quality measure that could be used as part of heart failure performance measure sets.

Disclosures: The study was supported by grants from the American Heart Association, GlaxoSmithKline, Medtronic, and the Agency for Healthcare Research and Quality. The study authors reported a variety of financial support, grants, consulting arrangements, and honoraria from drug manufacturers, other health care companies, and nonprofit organizations.

Patients who received two out of six infection prevention measures recommended by the Surgical Care Improvement Project had a lower risk of postoperative infection, compared with patients who hadn't received at least two of the measures, according to a large retrospective study.

However, adherence on individual SCIP measures did not significantly lower the probability of postoperative infection, the study found. Currently, those individual measures are the only ones reported publicly by the Centers for Medicare and Medicaid Services (CMS).

“Based on our findings, the individual item performance rates reported publicly do not fulfill their stated purpose of pointing consumers toward high-quality hospitals,” the authors wrote. “However, when taken in aggregate, improved performance on our global all-or-none composite measure is associated with improved outcomes at the discharge level. Therefore, while the individual items may not imply quality differences, the overall ability to demonstrate adherence to multiple SCIP processes of care may.”

The study, led by a research team from Case Western Reserve University, Cleveland, used data on 405,720 discharges from 398 hospitals in which SCIP performance was recorded (JAMA 2010;303:2479-85).

The researchers analyzed individual SCIP postoperative infection prevention measures. They also combined these six measures into two global measures of discharge-level adherence.

In the first global measure, patients needed to receive prophylactic antibiotics within 1 hour prior to surgical incision (2 hours if they received vancomycin). They also needed to have their prophylactic antibiotics discontinued within 24 hours after surgery (48 hours for cardiac surgery).

In the second measure, the researchers recorded whether patients had received any two of the six measures recommended by SCIP to reduce infection.

Demonstrated adherence to SCIP on the first, “all-or-none” composite measure decreased the likelihood of developing a postoperative infection from 11.5 infections per 1,000 discharges to 5.3 infections per 1,000 discharges, which was not statistically significant.

The second measure—receipt of two of six SCIP-recommended infection prevention procedures—did show a statistically significant association: Risk of postoperative infection fell from 14.2 to 6.8 postoperative infections per 1,000.

The CMS uses SCIP results as a component of its Medicare value-based purchasing initiatives, which are intended to improve quality of care through incentive-based reimbursement, and also publishes individual SCIP measures to help patients select surgical “centers of excellence.”

“This publicized use implies that reported adherence on these measures is directly related to improved outcomes. Our findings are unable to support this assertion,” the study's authors concluded.

Disclosures: No financial disclosures were reported. The study was supported by grants from the Agency for Healthcare Research and Quality and the National Cancer Institute.

My Take

Narrow Measures Are Not Effective

The Surgical Care Improvement Project (SCIP) was established in 2006 with the goal of reducing surgical complications by 25% in 2010. Of the nine performance measures, six are related to surgical site infection prevention. Efforts to reduce surgical site infection are important because this complication results in significant morbidity and additional resource use.

The SCIP measures were added to the Hospital Compare Web site to help patients determine where to receive surgical care. The underlying assumption was that higher performance on these measures equals better surgical outcomes. Furthermore, the Centers for Medicare and Medicaid Services has proposed use of the SCIP measures for value-based purchasing and payment to hospitals.

The report by Stulberg et al. is the largest study to date that fails to demonstrate an association between adherence to SCIP measures and the occurrence of postoperative infections.

Ideal surgical quality-improvement efforts would measure whether the right patient receives the right operation at the right time and whether the operation is effective. This is more challenging to measure given the complex nature of the health care system, including barriers to access, financial incentives, and the uniqueness of the therapeutic intent of individual surgical procedures.

Current mandated surgical quality–improvement processes such as SCIP focus on incremental and narrow process measures that are purported to measure the overall quality of an episode of surgical care. Despite enormous resources committed to these measures and marked improvement in adherence, the evidence to date suggests that SCIP has not improved surgical outcomes. Future quality improvement endeavors should have linkage between discrete performance and outcome measures so the effectiveness of combined efforts can be unequivocally measured and clearly evaluated.

MARY T. HAWN, M.D., is from the Center for Surgical and Medical Acute Care Research and Transitions at the Veterans Affairs Medical Center in Birmingham, and the department of surgery, University of Alabama at Birmingham. Her comments were made in a published editorial accompanying the study (JAMA 2010;303:2527-8).

Patients who received two out of six infection prevention measures recommended by the Surgical Care Improvement Project had a lower risk of postoperative infection, compared with patients who hadn't received at least two of the measures, according to a large retrospective study.

However, adherence on individual SCIP measures did not significantly lower the probability of postoperative infection, the study found. Currently, those individual measures are the only ones reported publicly by the Centers for Medicare and Medicaid Services (CMS).

“Based on our findings, the individual item performance rates reported publicly do not fulfill their stated purpose of pointing consumers toward high-quality hospitals,” the authors wrote. “However, when taken in aggregate, improved performance on our global all-or-none composite measure is associated with improved outcomes at the discharge level. Therefore, while the individual items may not imply quality differences, the overall ability to demonstrate adherence to multiple SCIP processes of care may.”

The study, led by a research team from Case Western Reserve University, Cleveland, used data on 405,720 discharges from 398 hospitals in which SCIP performance was recorded (JAMA 2010;303:2479-85).

The researchers analyzed individual SCIP postoperative infection prevention measures. They also combined these six measures into two global measures of discharge-level adherence.

In the first global measure, patients needed to receive prophylactic antibiotics within 1 hour prior to surgical incision (2 hours if they received vancomycin). They also needed to have their prophylactic antibiotics discontinued within 24 hours after surgery (48 hours for cardiac surgery).

In the second measure, the researchers recorded whether patients had received any two of the six measures recommended by SCIP to reduce infection.

Demonstrated adherence to SCIP on the first, “all-or-none” composite measure decreased the likelihood of developing a postoperative infection from 11.5 infections per 1,000 discharges to 5.3 infections per 1,000 discharges, which was not statistically significant.

The second measure—receipt of two of six SCIP-recommended infection prevention procedures—did show a statistically significant association: Risk of postoperative infection fell from 14.2 to 6.8 postoperative infections per 1,000.

The CMS uses SCIP results as a component of its Medicare value-based purchasing initiatives, which are intended to improve quality of care through incentive-based reimbursement, and also publishes individual SCIP measures to help patients select surgical “centers of excellence.”

“This publicized use implies that reported adherence on these measures is directly related to improved outcomes. Our findings are unable to support this assertion,” the study's authors concluded.

Disclosures: No financial disclosures were reported. The study was supported by grants from the Agency for Healthcare Research and Quality and the National Cancer Institute.

My Take

Narrow Measures Are Not Effective

The Surgical Care Improvement Project (SCIP) was established in 2006 with the goal of reducing surgical complications by 25% in 2010. Of the nine performance measures, six are related to surgical site infection prevention. Efforts to reduce surgical site infection are important because this complication results in significant morbidity and additional resource use.

The SCIP measures were added to the Hospital Compare Web site to help patients determine where to receive surgical care. The underlying assumption was that higher performance on these measures equals better surgical outcomes. Furthermore, the Centers for Medicare and Medicaid Services has proposed use of the SCIP measures for value-based purchasing and payment to hospitals.

The report by Stulberg et al. is the largest study to date that fails to demonstrate an association between adherence to SCIP measures and the occurrence of postoperative infections.

Ideal surgical quality-improvement efforts would measure whether the right patient receives the right operation at the right time and whether the operation is effective. This is more challenging to measure given the complex nature of the health care system, including barriers to access, financial incentives, and the uniqueness of the therapeutic intent of individual surgical procedures.

Current mandated surgical quality–improvement processes such as SCIP focus on incremental and narrow process measures that are purported to measure the overall quality of an episode of surgical care. Despite enormous resources committed to these measures and marked improvement in adherence, the evidence to date suggests that SCIP has not improved surgical outcomes. Future quality improvement endeavors should have linkage between discrete performance and outcome measures so the effectiveness of combined efforts can be unequivocally measured and clearly evaluated.

MARY T. HAWN, M.D., is from the Center for Surgical and Medical Acute Care Research and Transitions at the Veterans Affairs Medical Center in Birmingham, and the department of surgery, University of Alabama at Birmingham. Her comments were made in a published editorial accompanying the study (JAMA 2010;303:2527-8).

Patients who received two out of six infection prevention measures recommended by the Surgical Care Improvement Project had a lower risk of postoperative infection, compared with patients who hadn't received at least two of the measures, according to a large retrospective study.

However, adherence on individual SCIP measures did not significantly lower the probability of postoperative infection, the study found. Currently, those individual measures are the only ones reported publicly by the Centers for Medicare and Medicaid Services (CMS).

“Based on our findings, the individual item performance rates reported publicly do not fulfill their stated purpose of pointing consumers toward high-quality hospitals,” the authors wrote. “However, when taken in aggregate, improved performance on our global all-or-none composite measure is associated with improved outcomes at the discharge level. Therefore, while the individual items may not imply quality differences, the overall ability to demonstrate adherence to multiple SCIP processes of care may.”

The study, led by a research team from Case Western Reserve University, Cleveland, used data on 405,720 discharges from 398 hospitals in which SCIP performance was recorded (JAMA 2010;303:2479-85).

The researchers analyzed individual SCIP postoperative infection prevention measures. They also combined these six measures into two global measures of discharge-level adherence.

In the first global measure, patients needed to receive prophylactic antibiotics within 1 hour prior to surgical incision (2 hours if they received vancomycin). They also needed to have their prophylactic antibiotics discontinued within 24 hours after surgery (48 hours for cardiac surgery).

In the second measure, the researchers recorded whether patients had received any two of the six measures recommended by SCIP to reduce infection.

Demonstrated adherence to SCIP on the first, “all-or-none” composite measure decreased the likelihood of developing a postoperative infection from 11.5 infections per 1,000 discharges to 5.3 infections per 1,000 discharges, which was not statistically significant.

The second measure—receipt of two of six SCIP-recommended infection prevention procedures—did show a statistically significant association: Risk of postoperative infection fell from 14.2 to 6.8 postoperative infections per 1,000.

The CMS uses SCIP results as a component of its Medicare value-based purchasing initiatives, which are intended to improve quality of care through incentive-based reimbursement, and also publishes individual SCIP measures to help patients select surgical “centers of excellence.”

“This publicized use implies that reported adherence on these measures is directly related to improved outcomes. Our findings are unable to support this assertion,” the study's authors concluded.

Disclosures: No financial disclosures were reported. The study was supported by grants from the Agency for Healthcare Research and Quality and the National Cancer Institute.

My Take

Narrow Measures Are Not Effective

The Surgical Care Improvement Project (SCIP) was established in 2006 with the goal of reducing surgical complications by 25% in 2010. Of the nine performance measures, six are related to surgical site infection prevention. Efforts to reduce surgical site infection are important because this complication results in significant morbidity and additional resource use.

The SCIP measures were added to the Hospital Compare Web site to help patients determine where to receive surgical care. The underlying assumption was that higher performance on these measures equals better surgical outcomes. Furthermore, the Centers for Medicare and Medicaid Services has proposed use of the SCIP measures for value-based purchasing and payment to hospitals.

The report by Stulberg et al. is the largest study to date that fails to demonstrate an association between adherence to SCIP measures and the occurrence of postoperative infections.

Ideal surgical quality-improvement efforts would measure whether the right patient receives the right operation at the right time and whether the operation is effective. This is more challenging to measure given the complex nature of the health care system, including barriers to access, financial incentives, and the uniqueness of the therapeutic intent of individual surgical procedures.

Current mandated surgical quality–improvement processes such as SCIP focus on incremental and narrow process measures that are purported to measure the overall quality of an episode of surgical care. Despite enormous resources committed to these measures and marked improvement in adherence, the evidence to date suggests that SCIP has not improved surgical outcomes. Future quality improvement endeavors should have linkage between discrete performance and outcome measures so the effectiveness of combined efforts can be unequivocally measured and clearly evaluated.

MARY T. HAWN, M.D., is from the Center for Surgical and Medical Acute Care Research and Transitions at the Veterans Affairs Medical Center in Birmingham, and the department of surgery, University of Alabama at Birmingham. Her comments were made in a published editorial accompanying the study (JAMA 2010;303:2527-8).